335 U.S. 345 (1948)

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SEVENTH CIRCUIT.

[346] Arthur D. Herrick argued the cause and filed a brief for petitioner.

Solicitor General Perlman argued the cause for the United States. With him on the brief were Philip Elman, William W. Goodrich and Bernard D. Levinson.

Opinion of the Court by MR. JUSTICE DOUGLAS, announced by MR. JUSTICE REED.

This case and United States v. Urbuteit, post, p. 355, decided this day, are here on certiorari to resolve a conflict among the circuits in the construction of the Federal Food, Drug, and Cosmetic Act of June 25, 1938. 52 Stat. 1040, 21 U.S.C. § 301 et seq.

Kordel was charged by informations containing twenty counts of introducing or delivering for introduction into interstate commerce misbranded drugs. He was tried without a jury, found guilty, and fined two hundred dollars on each count. 66 F. Supp. 538. This judgment was affirmed on appeal. 164 F.2d 913.

Kordel writes and lectures on health foods from information derived from studies in public and private libraries. Since 1941 he has been marketing his own health food products, which appear to be compounds of various vitamins, minerals and herbs. The alleged misbranding consists of statements in circulars or pamphlets distributed to consumers by the vendors of the products, relating to their efficacy. The petitioner supplies these pamphlets as well as the products to the vendors. Some of the literature was displayed in stores in which the petitioner's products were on sale. Some of it was given [347] away with the sale of products; some sold independently of the drugs; and some mailed to customers by the vendors.

It is undisputed that petitioner shipped or caused to be shipped in interstate commerce both the drugs and the literature. Seven of the counts charged that the drugs and literature were shipped in the same cartons. The literature involved in the other counts was shipped separately from the drugs and at different times — both before and after the shipments of the drugs with which they were associated. The question whether the separate shipment of the literature saved the drugs from being misbranded within the meaning of the Act presents the main issue in the case.

Section 301 (a) of the Act prohibits the introduction into interstate commerce of any drug that is adulterated or misbranded.^[1] It is misbranded according to § 502 (a) if its "labeling is false or misleading in any particular" and unless the labeling bears "adequate directions for use." § 502 (f). The term labeling is defined in § 201 (m) to [348] mean "all labels^[2] and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." Section 303 makes the violation of any of the provisions of § 301 a crime.^[3]

In this case the drugs and the literature had a common origin and a common destination. The literature was used in the sale of the drugs. It explained their uses. Nowhere else was the purchaser advised how to use them. It constituted an essential supplement to the label attached to the package. Thus the products and the literature were interdependent, as the Court of Appeals observed.

It would take an extremely narrow reading of the Act to hold that these drugs were not misbranded. A criminal [349] law is not to be read expansively to include what is not plainly embraced within the language of the statute (United States v. Resnick, 299 U.S. 207; Kraus & Bros. v. United States, 327 U.S. 614, 621-622), since the purpose fairly to apprise men of the boundaries of the prohibited action would then be defeated. United States v. Sullivan, 332 U.S. 689, 693; Winters v. New York, 333 U.S. 507. But there is no canon against using common sense in reading a criminal law, so that strained and technical constructions do not defeat its purpose by creating exceptions from or loopholes in it. See Roschen v. Ward, 279 U.S. 337, 339.

It would, indeed, create an obviously wide loophole to hold that these drugs would be misbranded if the literature had been shipped in the same container but not misbranded if the literature left in the next or in the preceding mail. The high purpose of the Act to protect consumers who under present conditions are largely unable to protect themselves in this field^[4] would then be easily defeated. The administrative agency charged with its enforcement^[5] has not given the Act any such restricted construction.^[6] The textual structure of the Act is not agreeable to it. Accordingly, we conclude that the phrase "accompanying such article" is not restricted to labels that are on or in the article or package that is transported.

The first clause of § 201 (m) — all labels "upon any article or any of its containers or wrappers" — clearly [350] embraces advertising or descriptive matter that goes with the package in which the articles are transported. The second clause — "accompanying such article" — has no specific reference to packages, containers or their contents as did a predecessor statute. See Seven Cases v. United States, 239 U.S. 510, 513, 515. It plainly includes what is contained within the package whether or not it is "upon" the article or its wrapper or container. But the second clause does not say "accompanying such article in the package or container," and we see no reason for reading the additional words into the text.

One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant. The analogy to the present case is obvious. We need not labor the point.

The false and misleading literature in the present case was designed for use in the distribution and sale of the drug, and it was so used. The fact that it went in a different mail was wholly irrelevant whether we judge the transaction by purpose or result. And to say that the prior or subsequent shipment of the literature disproves that it "is" misbranded when introduced into commerce within the meaning of § 301 (a), is to overlook the integrated nature of the transactions established in this case.

Moreover, the fact that some of the booklets carried a selling price is immaterial on the facts shown here. As stated by the Court of Appeals, the booklets and drugs were nonetheless interdependent; they were parts of an integrated distribution program. The Act cannot be circumvented by the easy device of a "sale" of the advertising matter where the advertising performs the function of labeling.

[351] Petitioner points out that in the evolution of the Act the ban on false advertising was eliminated, the control over it being transferred to the Federal Trade Commission. 52 Stat. 114, 15 U.S.C. § 55 (a). We have searched the legislative history in vain, however, to find any indication that Congress had the purpose to eliminate from the Act advertising which performs the function of labeling. Every labeling is in a sense an advertisement. The advertising which we have here performs the same function as it would if it were on the article or on the containers or wrappers. As we have said, physical attachment or contiguity is unnecessary under § 201 (m) (2).

There is a suggestion that the offense in this case falls under § 301 (k) of the Act which includes misbranding of a drug while it is held for sale after shipment in interstate commerce.^[7] Since the informations contain no such charge, it is therefore claimed that the judgment must be reversed. We do not agree. Section 301 (k) has a broad sweep, not restricted to those who introduce or deliver for introduction drugs in interstate commerce.^[8] See United States v. Sullivan, supra. Nor is it confined to adulteration or misbranding as is § 301 (a). Id. It is, however, restricted to cases where the article is held for sale after shipment in interstate commerce; and, unlike § 301 (a), it does not reach situations where the manufacturer sells directly to the consumer. Cf. United States v. Urbuteit, supra. Hence we conclude that we do not disturb the statutory scheme when we refuse to take from § 301 (a) what is fairly included in it in order to leave [352] the matter wholly to the service of § 301 (k). The reach of § 301 (a) is in this respect longer. Such a transfer to § 301 (k) would create a new hiatus in the Act and thus disturb the pattern which we discern in it.

We have considered the other objections tendered by petitioner and find them without merit.

Affirmed.

MR. JUSTICE BLACK, with whom MR. JUSTICE FRANK-FURTER, MR. JUSTICE MURPHY and MR. JUSTICE JACKSON concur, dissenting.

I agree with the Court's interpretation of § 502 (a) and § 201 (m) of the Federal Food, Drug, and Cosmetic Act. These sections considered together provide a definition for the "misbranding" of drugs. I agree that a drug is misbranded within the meaning of the statute if false and misleading written, printed, or graphic matter is either placed upon the drug, its container or wrappers, or used in the sale of the drug as a supplement to the package label to advise consumers how to use the drug. I agree that false labels may, within the meaning of the statute, "accompany," that is go along with, a drug on its interstate journey even though not in the same carton, on the same train, in the same mail, or delivered for shipment the same day. But these agreements do not settle all the problems in this case.

The Federal Food, Drug, and Cosmetic Act does not purport to make all misbranding of drugs within the foregoing definition a federal offense. Congressional power to pass the Act is based upon the commerce clause. Consequently misbranding is only an offense if the misbranded drugs bear the statutorily defined relationships to interstate commerce. For illustration, if a person misbranded a drug which had not been and was not thereafter introduced into interstate commerce, there would be no [353] violation of the federal Act, whatever violation there might be of state law.

As we pointed out in United States v. Sullivan, 332 U.S. 689, the Federal Food, Drug, and Cosmetic Act creates several offenses each of which separately depends upon the relationship the misbranded drug then bears to interstate commerce. Section 301 (a) forbids the "introduction or delivery for introduction into interstate commerce" of misbranded drugs; § 301 (b) forbids misbranding while the drugs are "in interstate commerce"; § 301 (c) prohibits the "receipt" of such drugs in interstate commerce; and § 301 (k) forbids misbranding while drugs are "held for sale after shipment in interstate commerce."

The twenty counts of the information upon which this petitioner's conviction rests, charge that he had introduced drugs into interstate commerce, and that "when" he so introduced the drugs, they were "misbranded . . . in that . . . statements appearing in . . . bulletins and booklets accompanying" the drugs "were false and misleading." (Emphasis supplied.) The undisputed evidence as to thirteen of these counts showed that when the drugs were "introduced" into interstate commerce for shipment, they were not within any fair meaning of the word "accompanied" by the printed matter relied on as "labeling." The evidence under one count was that the drugs were shipped July 10, 1942, while the booklets said to be "labels" were sent a year and a half later, January 18, 1944. Thus, each of these counts charged a violation of the separate and distinct offense of introducing misbranded drugs into interstate commerce, prohibited by § 301 (a). The evidence proves the offense, if any, of violation of § 301 (k), which prohibits the misbranding of drugs while held for sale after an interstate shipment.

[354] The Court's interpretation of § 301 (a) seems to me to create a new offense to make it a crime to introduce drugs into interstate commerce if they should subsequently be misbranded, even so long as eighteen months later while held for sale. This judicial action is justified in part on the ground that the offense Congress created in § 301 (k) for holding misbranded drugs for sale after interstate shipment might not reach all situations covered by the congressionally created offense defined by § 301 (a). If as the Court believes, Congress in § 301 (k) has limited the situations for which it will direct punishment for holding misbranded articles for sale, I cannot agree that we should rewrite § 301 (a) so as to broaden its coverage. If Congress left a hiatus, Congress should fill it if it so desires. While I do not doubt the wisdom of separating these offenses as Congress has here done, we must remember that there are dangers in splitting up one and the same transaction into many offenses. See Blockburger v. United States, 284 U.S. 299, 304-305.

These are serious offenses. While petitioner was fined only $200 on each count, or a total of $4,000, the maximum allowable punishment was $1,000 per count and imprisonment for one year, or for three years under other circumstances. § 303 (a). The approach of Congress in this field of penal regulation has been cautious. The language used by Congress in the present law in defining new offenses has been marked by precision. I think we should exercise a similar caution before reading into the "introduction into interstate commerce" offense, conduct which patently fits into the "held for sale" offense.

I would reverse the judgment here insofar as it rests on the thirteen counts in which the Government charged offenses under § 301 (a) and failed to prove them.

[1] Section 301 in relevant part reads as follows:

"The following acts and the causing thereof are hereby prohibited:

"(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

"(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

"(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

.....

"(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale after shipment in interstate commerce and results in such article being misbranded."

[2] The term label is defined as "a display of written, printed, or graphic matter upon the immediate container of any article." § 201 (k).

[3] "SEC. 303. (a) Any person who violates any of the provisions of section 301 shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine; but if the violation is committed after a conviction of such person under this section has become final such person shall be subject to imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine.

"(b) Notwithstanding the provisions of subsection (a) of this section, in case of a violation of any of the provisions of section 301, with intent to defraud or mislead, the penalty shall be imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine."

The informations, in charging violations of § 301 (a), did not allege that the acts committed were done "with intent to defraud." Hence the maximum penalty was imprisonment for not more than a year, or a fine of not more than $1,000, or both. Prosecution by information was therefore authorized by the statute (see Duke v. United States, 301 U.S. 492) and by Rule 7 (a) of the Federal Rules of Criminal Procedure.

[4] See United States v. Dotterweich, 320 U.S. 277, 280; United States v. Sullivan, supra, p. 696.

[5] See § 701 and § 201 (c); 1940 Reorg. Plan No. IV, § 12, 54 Stat. 231, 5 U.S.C. § 133 (u).

[6] The Federal Security Agency by regulation (21 C.F.R. Cum. Supp. § 2.2) has ruled:

"Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce."

[7] See note 1, supra.

[8] The purpose of § 301 (k) was described in H.R. Rep. No. 2139, 75th Cong., 3d Sess. 3 (1938), as follows:

"In order to extend the protection of consumers contemplated by the law to the full extent constitutionally possible, paragraph (k) has been inserted prohibiting the changing of labels so as to misbrand articles held for sale after interstate shipment."

221 U.S. 488 (1911)

ERROR TO THE DISTRICT COURT OF THE UNITED STATES FOR THE WESTERN DISTRICT OF MISSOURI.

[489] The Solicitor General, with whom Mr. Assistant Attorney General Denison, Mr. George P. McCabe and Mr. Loring C. Christie, Special Assistants to the Attorney General, were on the brief, for the United States.

Mr. James H. Harkless, with whom Mr. Charles S. Crysler and Mr. Clifford Histed were on the brief, for defendant in error.

[495] MR. JUSTICE HOLMES delivered the opinion of the court.

This is an indictment for delivering for shipment from Missouri to Washington, D.C., packages and bottles of medicine bearing labels that stated or implied that the contents were effective in curing cancer, the defendant well knowing that such representations were false. On motion of the defendant the District Judge quashed the indictment (177 Fed. Rep. 313), and the United States brought this writ of error under the Act of March 2, 1907, c. 2564, 34 Stat. 1246.

The question is whether the articles were misbranded within the meaning of § 2 of the Food and Drugs Act of June 30, 1906, c. 3915, 34 Stat. 768, making the delivery of misbranded drugs for shipment to any other State or Territory or the District of Columbia a punishable offense. By § 6 the term drug includes any substance or mixture intended to be used for the cure, mitigation or prevention of disease. By § 8, c. 3915, 34 Stat., p. 770, the [496] term misbranded "shall apply to all drugs, or articles of food, .. . the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced. . . . An article shall also be deemed to be misbranded: In case of drugs: First. If it be an imitation of or offered for sale under the name of another article. Second. [In case of a substitution of contents,] or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein."

It is a postulate, as the case comes before us, that in a certain sense the statement on the label was false, or, at least, misleading. What we have to decide is whether such misleading statements are aimed at and hit by the words of the act. It seems to us that the words used convey to an ear trained to the usages of English speech a different aim; and although the meaning of a sentence is to be felt rather than to be proved, generally and here the impresson may be strengthened by argument, as we shall try to show.

We lay on one side as quite unfounded the argument that the words `statement which shall be misleading in any particular' as used in the statute do not apply to drugs at all — that the statements referred to are those `regarding such article,' and that `article' means article of food, mentioned by the side of drugs at the beginning of the section. It is enough to say that the beginning of the sentence makes such a reading impossible, and that article expressly includes drugs a few lines further on in what we have quoted, not to speak of the reason of the [497] thing. But we are of opinion that the phrase is aimed not at all possible false statements, but only at such as determine the identity of the article, possibly including its strength, quality and purity, dealt with in § 7. In support of our interpretation the first thing to be noticed is the second branch of the sentence: `Or the ingredients or substances contained therein.' One may say with some confidence that in idiomatic English this half, at least, is confined to identity, and means a false statement as to what the ingredients are. Logically it might mean more, but idiomatically it does not. But if the false statement referred to is a misstatement of identity as applied to a part of its objects, idiom and logic unite in giving it the same limit when applied to the other branch, the article, whether simple or one that the ingredients compose. Again, it is to be noticed that the cases of misbranding, specifically mentioned and following the general words that we have construed, are all cases analogous to the statement of identity and not at all to inflated or false commendation of wares. The first is a false statement as to the country where the article is manufactured or produced; a matter quite unnecessary to specify if the preceding words had a universal scope, yet added as not being within them. The next case is that of imitation and taking the name of another article, of which the same may be said, and so of the next, a substitution of contents. The last is breach of an affirmative requirement to disclose the proportion of alcohol and certain other noxious ingredients in the package — again a matter of plain past history concerning the nature and amount of the poisons employed, not an estimate or prophecy concerning their effect. In further confirmation, it should be noticed that although the indictment alleges a wilful fraud, the shipment is punished by the statute if the article is misbranded, and that the article may be misbranded without any conscious fraud at all. It was natural enough to throw this risk on [498] shippers with regard to the identity of their wares, but a very different and unlikely step to make them answerable for mistaken praise. It should be noticed still further that by § 4 the determination whether an article is misbranded is left to the Bureau of Chemistry of the Department of Agriculture, which is most natural if the question concerns ingredients and kind, but hardly so as to medical effects.

To avoid misunderstanding we should add that, for the purposes of this case, at least, we assume that a label might be of such a nature as to import a statement concerning identity, within the statute, although in form only a commendation of the supposed drug. It may be that a label in such form would exclude certain substances so plainly to all common understanding as to amount to an implied statement of what the contents of the package were not; and it may be that such a negation might fall within the prohibitions of the act. It may be, we express no opinion upon that matter, that if the present indictment had alleged that the contents of the bottles were water, the label so distinctly implied that they were other than water, as to be a false statement of fact concerning their nature and kind. But such a statement as to contents, undescribed and unknown, is shown to be false only in its commendatory and prophetic aspect, and as such is not within the act.

In view of what we have said by way of simple interpretation we think it unnecessary to go into considerations of wider scope. We shall say nothing as to the limits of constitutional power, and but a word as to what Congress was likely to attempt. It was much more likely to regulate commerce in food and drugs with reference to plain matter of fact, so that food and drugs should be what they professed to be, when the kind was stated, than to distort the uses of its constitutional power to establishing criteria in regions where opinions are far apart. See School of [499] Magnetic Healing v. McAnnulty, 187 U.S. 94. As we have said above, the reference of the question of misbranding to the Bureau of Chemistry for determination confirms what would have been our expectation and what is our understanding of the words immediately in point.

Judgment affirmed.

MR. JUSTICE HUGHES, with whom MR. JUSTICE HARLAN and MR. JUSTICE DAY concurred, dissenting:

I am unable to concur in the judgment in this case, for the following reasons:

The defendant was charged with delivering for shipment in interstate commerce certain packages and bottles of drugs alleged to have been misbranded in violation of the Food and Drugs Act of June 30, 1906, chapter 3915, 34 Stat. 768.

The articles were labeled respectively "Cancerine tablets," "Antiseptic tablets," "Blood purifier," "Special No. 4," "Cancerine No. 17," and "Cancerine No. 1," — the whole constituting what was termed in substance "Dr. Johnson's Mild Combination Treatment for Cancer." There were several counts in the indictment with respect to the different articles. The labels contained the words "Guaranteed under the Pure Food and Drugs Act, June 30, 1906;" and some of the further statements were as follows:

"Blood Purifier. This is an effective tonic and alterative. It enters the circulation at once, utterly destroying and removing impurities from the blood and entire system. Acts on the bowels, kidneys, and skin, eliminating poisons from the system, and when taken in connection with the Mild Combination Treatment gives splendid results in the treatment of cancer and other malignant diseases. I always advise that the Blood Purifier be continued some little time after the cancer has been killed and removed and the sore healed.

[500] "Special No. 4. . . . It has a strong stimulative and absorptive power; will remove swelling, arrest development, restore circulation, and remove pain. Is indicated in all cases of malignancy where there is a tendency of the disease to spread, and where there is considerable hardness surrounding the sore. Applied thoroughly to a lump or to an enlarged gland will cause it to soften, become smaller, and be absorbed.

"Cancerine No. 1. . . . Tendency is to convert the sore from an unhealthy to a healthy condition and promote healing. Also that it destroys and removes dead and unhealthy tissue."

In each case the indictment alleged that the article was "wholly worthless," as the defendant well knew.

In quashing the indictment the District Court construed the statute. The substance of the decision is found in the following words of the opinion: "Having regard to the intendment of the whole act, which is to protect the public health against adulterated, poisonous, and deleterious food, drugs, etc., the labeling or branding of the bottle or container, as to the quantity or composition of `the ingredients or substances contained therein which shall be false or misleading,' by no possible construction can be extended to an inquiry as to whether or not the prescription be efficacious or worthless to effect the remedy claimed for it." And the question on this writ of error is whether or not this construction is correct. United States v. Keitel, 211 U.S. 370.

What then is the true meaning of the statute?

Section 8 provides:

"SEC. 8. That the term `misbranded,' as used herein, shall apply to all drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any [501] particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced."

The words "such article" in this section, as is shown by the immediate context, refer to "drugs" as well as to "food."

"Drugs" are thus defined in § 6:

"SEC. 6. That the term `drug,' as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals."

Articles, then, intended to be used for curative purposes, such as those described in the indictment, are within the statute, though they are not recognized in the United States Pharmacopoeia or the National Formulary. And the offense of misbranding is committed if the package or label of such an article bears any statement regarding it "which shall be false or misleading in any particular."

But it is said that these words refer only to false statements which fix the identity of the article. According to the construction placed upon the statute by the court below in quashing the indictment, if one puts upon the market, in interstate commerce, tablets of inert matter or a liquid wholly worthless for any curative purpose as he well knows, with the label "Cancer Cure" or "Remedy for Epilepsy," he is not guilty of an offense, for in the sense attributed by that construction to the words of the statute he has not made a statement regarding the article which is false or misleading in any particular.

I fail to find a sufficient warrant for this limitation, and on the contrary, it seems to me to be opposed to the intent of Congress and to deprive the act of a very salutary effect.

[502] It is strongly stated that the clause in § 8, — "or the ingredients or substances contained therein," — has reference to identity and that this controls the interpretation of the entire provision. This, in my judgment, is to ascribe an altogether undue weight to the wording of the clause and to overlook the context. The clause, it will be observed, is disjunctive. If Congress had intended to restrict the offense to misstatements as to identity, it could easily have said so. But it did not say so. To a draftsman with such a purpose the language used would not naturally occur. Indeed, as will presently be shown, Congress refused, with the question up, so to limit the statute.

Let us look at the context. In the very next sentence, the section provides (referring to drugs) that an article shall "also" be deemed to be misbranded if it be "an imitation of or offered for sale under the name of another article," or in case of substitution of contents or of failure to disclose the quantity or proportion of certain specified ingredients, if present, such as alcohol, morphine, opium, cocaine, etc.

It is a matter of common knowledge that the "substances" or "mixtures of substances" which are embraced in the act, although not recognized by the United States Pharmacopoeia or National Formulary, are sold under trade names without any disclosure of constituents, save to the extent necessary to meet the specific requirements of the statute. Are the provisions of the section to which we have referred, introduced by the word "also," and the one relating to the place of manufacture, the only provisions as to descriptive statements which are intended to apply to these medicinal preparations? Was it supposed that with respect to this large class of compositions, nothing being said as to ingredients except as specifically required, there could be, within the meaning of the act, no false or misleading statement in [503] any particular? If false and misleading statements regarding such articles were put upon their labels, was it not the intent of Congress to reach them? And was it not for this very purpose that the general language of § 8 was used?

The legislative history of the section would seem to negative the contention that Congress intended to limit the provision to statements as to identity. The provision in question as to misbranding, as it stood in the original bill in the Senate (then § 9) was as follows:

"If the package containing it, or its label, shall bear any statement regarding the ingredients or the substances contained therein, which statement shall be false or misleading in any particular."

The question arose upon this language whether or not it should be taken as limited strictly to statements with respect to identity. It was insisted that the words had a broader range and the effort was made to procure an amendment which should be so specific as to afford no basis for the conclusion that any thing but false statements as to identity or constituents was intended. An amendment was then adopted in the Senate making the provision read:

"any statement as to the constituent ingredients, or the substances contained therein, which statement shall be false or misleading in any particular."

With this amendment the bill was passed by the Senate and went to the House. There the provision was changed by striking out the word "constituent" and inserting the word "regarding," so that it should read:

"any statement regarding the ingredients or substances contained in such article, which statement shall be false or misleading in any particular."

Finally, it appears, that in conference the bill was amended by inserting the words "design, or device," and also the words "such article, or;" and thus the section became [504] a part of the law in its present form — containing the words:

"any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular."

It is difficult to suppose that, with the question distinctly raised, Congress would have rejected the provision of the Senate bill and broadened the language in the manner stated if it had been intended to confine the prohibition to false statements as to identity. Reading the act with the sole purpose of giving effect to the intent of Congress, I cannot escape the conclusion that it was designed to cover false and misleading statements of fact on the packages or labels of articles intended for curative purposes, although the statements relate to curative properties.

It is, of course, true, that when Congress used the words "false or misleading statement" it referred to a well defined category in the law and must be taken to have intended statements of fact and not mere expressions of opinion.

The argument is that the curative properties of articles purveyed as medicinal preparations are matters of opinion, and the contrariety of views among medical practitioners, and the conflict between the schools of medicine, are impressively described. But, granting the wide domain of opinion, and allowing the broadest range to the conflict of medical views, there still remains a field in which statements as to curative properties are downright falsehoods and in no sense expressions of judgment. This field I believe this statute covers.

The construction which the District Court has placed upon this statute is that it cannot be extended to any case where the substance labeled as a cure, with a description of curative properties, is "wholly worthless" and is known by the defendant to be such. That is the charge of the indictment.

[505] The question then is whether, if an article is shipped in interstate commerce, bearing on its label a representation that it is a cure for a given disease, when on a showing of the facts there would be a unanimous agreement that it was absolutely worthless and an out and out cheat, the act of Congress can be said to apply to it. To my mind the answer appears clear. One or two hypothetical illustrations have been given above. Others may readily be suggested. The records of actual prosecutions, to which I am about to refer, shows the operation the statute has had and I know of no reason why this should be denied to it in the future.

Our attention has been called to the construction which was immediately placed upon the enactment by the officers charged with its enforcement in the Department of Justice and the Department of Agriculture. It is true that the statute is a recent one, and, of course, the question is one for judicial decision. But it is not amiss to note that the natural meaning of the words used in the statute, reflected in the refusal of Congress to adopt a narrower provision, was the meaning promptly attributed to it in the proceedings that were taken to enforce the law. And this appears to have been acquiesced in by the defendants in many prosecutions in which the defendants pleaded guilty. We have been referred to the records of the Department of Agriculture showing nearly thirty cases in which either goods had been seized and no defense made, or pleas of guilty had been entered. Among these are found such cases as the following:

"No. 29. Hancock's Liquid Sulphur, falsely represented, among other things, to be `Nature's Greatest Germicide. . . . The Great Cure for . . . Diptheria.' Investigation begun November 22, 1907. Plea of guilty."

"No. 180. Gowan's Pneumonia Cure, falsely represented, among other things, that it `Supplies an easily [506] absorbed food for the lungs that quickly effects a permanent cure.' Investigation begun November 22, 1907. Criminal information. Plea of guilty."

"No. 181. `Eyelin,' falsely represented, among other things, that it `Repairs and Rejuvenates the Eye and Sight.' Investigation begun February 13, 1908. Plea of guilty."

"No. 261. `Sure Thing Tonic,' falsely represented, among other things, to be `Sure Thing Tonic. . . . Restores Nerve Energy. Renews Vital Force.' Investigation begun June 3, 1909. Pleaded guilty."

"No. 424. `Tuckahoe Lithia Water,' falsely represented, among other things, to be `a sure solvent for calculi, either of the kidneys or liver, especially indicated in all diseases due to uric diathesis, such as gout, rheumatism, gravel stone, incipient diabetes, Bright's Disease, inflamed bladder, eczema, stomach, nervous, and malarial disorders.' Investigation begun July 9, 1908. Plea of guilty."

"No. 427. `Cancerine,' falsely represented, among other things, to be `A remarkably curative extract which if faithfully adhered to will entirely eradicate cancerous poison from the system. . . . A specific cure for cancer in all its forms.' Investigation begun about April 12, 1909. Criminal information. Plea of guilty."

I find nothing in the language of the statute which requires the conclusion that these persons who have confessed their guilt in making false and misleading statements on their labels should be privileged to conduct their interstate traffic in their so-called medicines, admittedly worthless, because Congress did not intend to reach them.

Nor does it seem to me that any serious question arises in this case as to the power of Congress. I take it to be conceded that misbranding may cover statements as to strength, quality and purity. But so long as the statement is not as to matter of opinion, but consists of a false [507] representation of fact — in labeling the article as a cure when it is nothing of the sort from any point of view, but wholly worthless — there would appear to be no basis for a constitutional distinction. It is none the less descriptive — and falsely descriptive — of the article. Why should not worthless stuff, purveyed under false labels as cures, be made contraband of interstate commerce, — as well as lottery tickets? Champion v. Ames, 188 U.S. 331.

I entirely agree that in any case brought under the act for misbranding, — by a false or misleading statement as to curative properties of an article, — it would be the duty of the court to direct an acquittal when it appeared that the statement concerned a matter of opinion. Conviction would stand only where it had been shown that, apart from any question of opinion, the so-called remedy was absolutely worthless and hence the label demonstrably false; but in such case it seems to me to be fully authorized by the statute.

Accordingly, I reach the conclusion that the court below erred in the construction that it gave the statute, and hence in quashing the indictment, and that the judgment should be reversed.

I am authorized to say that MR. JUSTICE HARLAN and MR. JUSTICE DAY concur in this dissent.

In Error to the District Court of the United States for the Western District of Missouri.

The Hall-Baker Grain Company was convicted of misbranding a car load of mixed wheat and of adulterating it by mixing with inferior wheat, and brings error. Reversed and remanded for new trial.

[614] Syllabus by the Court

The purpose of the Pure Food Act of June 30, 1906, c. 3915, 34 Stat. 768 (U.S. comp. St. Supp. 1909, p. 1187), was (1) to protect purchasers from injurious deceits by the sale of inferior for superior articles, and (2) to protect the health of the people from the sale of normally wholesome articles to which have been added substances poisonous or detrimental to health.

The H. Company, at Kansas City, Mo., on April 3, 1909, contracted to sell to the W. Company at Ft. Worth, Tex., 5,000 bushels of No. 2 red wheat, according to the Missouri official state grades. On April 29, 1909, the H. Company ordered the operator of a public elevator where it stored its grain to ship to the W. Company in fulfillment of this contract No. 2 red wheat. The operator loaded and sent to the W. Company a car of wheat. After this wheat was loaded, the official inspector of the state of Missouri at Kansas City inspected, adjudged, and certified this wheat to be No. 2 red wheat. An invoice of it was forwarded to the W. Company dated May 3, 1909, showing that it was shipped under the contract of April 3, 1909, and subject to Kansas City weights and grades. The wheat arrived in Texas without change. The Texas inspector, the federal inspector, and other witnesses there found it to be, and it was, wheat of another and less valuable grade. None of the officers or employes of the H. Company had any knowledge of this fact, or anything to do with the grading or shipping, except to order the operator of the public elevator to ship No. 2 red wheat.

Held, the H. Company was not guilty of misbranding or of adulterating within the meaning of sections 7 and 8 of the Pure Food Act (Act June 30, 1906, c. 3915, 34 Stat. 768, 769 (U.S. Comp. St. Supp. 1909, pp. 1190, 1191)).

Edwin C. Meservey, Frank Hagerman, and Henry A. Bundschu, (Haff, Meservey, German & Michaels, of counsel), for plaintiff in error.

Leslie J. Lyons, U.S. Atty. (Thad. B. Landon, Asst. U.S. Atty., on the brief), for the United States.

Before SANBORN and HOOK, Circuit Judges.

[615] SANBORN, Circuit Judge.

The defendant below, the Hall-Baker Grain Company, a corporation, engaged in the purchase and sale of grain at Kansas City, Mo., was convicted of misbranding a car load of mixed wheat, No. 2 red wheat, and of adulterating the same by mixing other inferior wheat with it, in violation of the Pure Food Act of June 30, 1906, 34 Stat. 768, sections 7 and 8, U.S. Comp. Stat. Supp. 1909, pp. 1191, 1192. It attacks the judgment against it on many grounds, one of which is that there was no substantial evidence of the charges against it and the court below refused to instruct the jury, as it requested, to return a verdict in its favor.

The defendant was found guilty of misbranding under the second, and adulteration under the fourth, count of the indictment. The second count was based on these provisions of section 8 of the act:

'That for the purposes of this act an article shall also be deemed to be misbranded, * * * in the case of foods, first, if it be an imitation of, or offered for sale under, a distinctive name of another article; second, if it be labeled or branded so as to deceive or mislead the purchaser.'

And the second count charged that the mixed wheat was offered for sale by the defendant as No. 2 red wheat, and that it was labeled No. 2 red wheat, when it was in fact mixed wheat, so as to deceive and mislead the purchasers thereof.

The fourth count was founded on this declaration of section 7 of the act:

'That for the purposes of this act an article shall be deemed to be adulterated in the case of food, first, if any substance has been mixed and packed with it so as to reduce, or lower, or injuriously affect its quality or strength; second, if any substance has been substituted in whole or in part for the article; third, if any valuable constituent of the article has been wholly or in part abstracted; fourth, if it be mixed, colored, powdered, coated or stained in a manner whereby damage or inferiority is concealed.'

And the fourth count charged that each of these things had been done to the car load of wheat. There was evidence tending to establish these facts: Kansas City, Mo., was a grain market. There was a public elevator capable of containing 1,000,000 bushels of wheat, operated by a corporation which had no interest in this transaction, which classified wheat purchased by the defendant and other dealers according to its quality and grade as it came to it and was inspected by the official Missouri inspectors and stored it in its various bins, so that wheat of the same grades or qualities went into the same bins and those of different grades and qualities into different bins. On receipt of orders from the owners of this wheat to ship out wheat of any grade, the elevator company loaded it out of the bin containing that grade of wheat into a car, that car load of wheat was then inspected by an official inspector of the state of Missouri and certified to be of the grade and character which he found and adjudged it to be. There were rules for this inspection that had been established pursuant to laws of the state of Missouri and the inspection was made by officers of the state. One of these rules was that No. 2 red wheat was 'to be sound, well cleaned, dry, red winter wheat, weighing not less than 59 pounds to the measured bushel.'

[616] On April 3, 1909, the defendant agreed to sell 5,000 bushels of No. 2 red wheat according to Missouri state inspection and Kansas City weights to the Walker Grain Company at Ft. Worth, Tex. On April 29, 1909, the elevator company, pursuant to an order from the defendant, loaded into a car 45,000 pounds of wheat which an official inspector of the state of Missouri inspected, adjudged and certified to be No. 2 red wheat, and caused this car load of wheat to be forwarded to the Walker Grain Company in Texas. No officer or employe of the defendant ever saw this load of wheat, or had anything to do with its shipment, except to order the elevator company to ship a car load of No. 2 red wheat. There was an invoice of this wheat dated May 3, 1909, which stated that the Walker Grain Company bought of the defendant on April 3, 1909, this and another car load of '2 red wheat. * * * K. C. Wts. and Grades.' No. 2 red wheat is a soft wheat, containing not over 5 per cent. of hard wheat, and soft wheat which contains from 20 per cent. to 45 per cent. of hard wheat is No. 2 or No. 3 mixed wheat, or some other grade of wheat, and the mixture of such a percentage of hard wheat with No. 2 red wheat depreciates its value in the Southwestern markets. This wheat was delivered to the consignee in Texas in the same condition that it was when inspected in Kansas City. When this load of wheat arrived in Texas, it was inspected by a Texas inspector, a federal inspector and others, who found it to contain from 20 per cent. to 45 per cent. of hard wheat. They differed in their estimates of the percentage of hard wheat in it and in the grade of mixed wheat to which it belonged, but agreed that it was not No. 2 red wheat. It is impracticable to keep the crops of wheat of different farms separate in the transportation of and traffic in this article from the purchaser to the consumer, and it is generally bought and sold by official or established grades, according to the inspection of specified officers or persons. Such officers or persons sometimes differ in their judgments of the grades to which specific lots belong. Wheat generally contains some hard wheat and some soft wheat. Some wheat is very hard and some very soft. There are many degrees of hardness and of softness of wheat which pass imperceptibly into each other, and there is no fixed and clear line of demarcation whereby all wheat may be indubitably separated into hard wheat and soft wheat. No other facts were disclosed at the trial which are material to the question before us.

The act for the violation of which the defendant was convicted is entitled 'An act for preventing the manufacture, sale or transportation of adulterated, or misbranded, or poisonous, or deleterious foods, drugs, medicine and liquors.' This title and the act itself, when carefully read and considered, demonstrate the fact that the sole purpose of its enactment was (1) to protect purchasers from injurious deceits by the sale of inferior for superior articles; and (2) to protect the health of the people by preventing the sale of normally wholesome articles to which have been added substances poisonous or detrimental to health. The clauses of the act [617] under which the defendant was convicted were evidently enacted to prevent the injurious deceit of purchasers. But where in the facts that were proved and that have been recited is there any evidence of any intent to accomplish deceit, or of any violation of the provisions of this law?

The first charge was that the car load of wheat was offered for sale under a distinctive name of another article of food, to wit, No. 2 red wheat, when it was in fact mixed wheat. The proof was that the defendant offered to sell and sold 5,000 bushels, not of No. 2 red wheat, but of such wheat as under the laws of Missouri the official inspector of that state at Kansas City should decide and certify to be No. 2 red wheat, that it delivered the load of wheat in question pursuant to that contract and that this load of wheat was such wheat as under the laws of Missouri the official inspector of that state at Kansas City did adjudge and certify to be No. 2 red wheat. Concede that the inspector was mistaken, and that the wheat was in fact mixed wheat. Nevertheless it was the wheat which the Missouri inspector adjudged and certified to be No. 2 red wheat, and the wheat that he should so adjudge and certify and no other, whatever its actual grade, was the article the defendant offered to sell and sold. It was the undoubted right of the parties to this sale to make the Missouri official inspector the arbiter between them of the character and grade of the wheat in which they dealt, and to make his decision and inspection an ineradicable term of its description. That they did, when they agreed that the wheat sold should be No. 2 red wheat according to the Missouri inspection, and, as the defendant offered and sold no other, there was no evidence in this case that he offered one article under the distinctive name of another.

The second charge was that the wheat was labeled and marked No. 2 red wheat when it was in fact mixed wheat, so as to deceive and mislead the purchasers thereof. But there was no evidence that it was ever labeled or marked at all. The government offered the invoice of the wheat in evidence, over the objection of the defendant, to prove a label, but this invoice contained a provision similar to that in the contract of sale to the effect that the wheat was to be governed by the Missouri grades, and the wheat had been already inspected and graded No. 2 red wheat by the official inspector several days before the invoice was issued. There was no evidence of any false labeling to deceive purchasers here.

The fourth count of the indictment charged (a) that other grades of wheat had been mixed with the wheat shipped so as to injuriously affect it; (b) that other grades of wheat had been substituted in part for the No. 2 red wheat pretended to be sold; (c) that a part of the No. 2 red wheat had been abstracted and a like quantity of of wheat of inferior grade substituted; and (d) that the wheat was mixed and packed with other grades of wheat whereby damage and inferiority was concealed. But, as has already appeared, the proof was conclusive that the wheat sold and delivered was the identical article offered for sale, to wit, that wheat which under the laws of Missouri the official inspector of that state should and did adjudge [618] and certify to be No. 2 red wheat. There was no evidence that any other grade of wheat was ever mixed with that wheat or substituted in part for it, or mixed or packed with it, or that any part of it had been abstracted. The proof was that on the order of the defendant the operator of the public elevator loaded it into the car, the official inspector tested it, adjudged and certified it to be No. 2 red wheat, it was hauled without mixing, abstraction, or substitution, to the consignee in Texas, where other inspectors found it to be mixed wheat, and there the evidence on this subject ceases. There was no evidence to sustain the conviction of this defendant on either count of this indictment.

The act of Congress was not enacted to catch and punish merchants who are conducting their business by customary and approved methods with no intent to deceive purchasers, or to injure the public health, for the mistakes of third persons over whom they have no control, nor for trivial errors of their own, which at first blush may seem to bring their action within the inhibition of the law, but by which in reality they violate neither its letter nor its spirit. Many other questions of law arose at the trial, and were discussed by counsel at the bar. But the conclusion which has been reached renders it unnecessary to consider them, and because there was no evidence to sustain any of the charges in this indictment the judgment below must be reversed and the case must be remanded to the court below for a new trial; and it is so ordered.

244 F.2d 34 (1957)

[35] [36] Milton A. Bass, New York City, and Vincent A. Kleinfeld, Washington, D. C., on the brief, for appellants.

George H. Lewald, Asst. U. S. Atty., Boston, Mass., with whom Anthony Julian, U. S. Atty., Boston, Mass., Joseph L. Maguire, Sp. Asst. U. S. Atty., and William W. Goodrich, Asst. Gen. Counsel, Department of Health, Education, and Welfare, Washington, D. C., were on the brief, for appellee.

Before MAGRUDER, Chief Judge, and WOODBURY and HARTIGAN, Circuit Judges.

Writ of Certiorari Denied June 17, 1957. See 77 S.Ct. 1383.

MAGRUDER, Chief Judge.

V. E. Irons, Inc., and V. Earl Irons in his individual capacity stand convicted, after a three-weeks trial, on a six-count information for causing the introduction into interstate commerce of misbranded food and drugs in violation of the Federal Food, Drug, and Cosmetic Act,^[1] 52 Stat. 1040, as amended, 21 U.S.C.A. § 301 et seq.

Count I of the information charged that the defendants (appellants herein) caused to be introduced into interstate commerce articles of food, known as Vit-Ra-Tox 21A (raw veal bone, defatted wheat germ, and the concentrate of juices of young, green cereal shoots) and Vit-Ra-Tox 21B (garlic derivative, wheat germ, and lecithin as emulsifiers), which were misbranded under 21 U.S.C.A. § 343(j)^[2] in that they "purported to be and [were] represented as a food for special dietary uses by man by reason of [their] vitamin and mineral content and [37] [their] label[s] failed to bear such information concerning [their] vitamin and mineral properties as had been determined to be and by regulations^[3] prescribed as necessary in order fully to inform purchasers as to [their] value for such uses".

Count II charged that the appellants caused to be introduced into interstate commerce articles or drug known as Vit-Ra-Tox 21A and Vit-Ra-Tox 21B (the same products referred to in Count I) which were (a) misbranded under 21 U.S.C.A. § 352(a)^[4] in that their accompanying labeling — consisting of certain leaflets and various issues of a newsletter — falsely represented "when viewed in [their] entirety as well as through specific claims * * * that nearly everyone in this country is suffering [38] from malnutrition or in danger of such suffering because of demineralization and depletion of soils and the refining and processing of foods, that particularly all illnesses and diseases of mankind are due to improper nutrition, that said article[s] possessed nutritive properties superior to any other vitamin and mineral supplement, that said article[s] would be effective in the cure, treatment, and prevention of the ills and diseases of mankind," including certain specific diseases; and which were (b) misbranded under 21 U.S.C.A. § 352(f) (1)^[5] in that their labeling failed to bear adequate directions for the use for which they were intended, namely, for treatment of the specific diseases which appellants represented that the drugs could cure or prevent.

Counts III and V named two products similar to the vitamin and mineral products specified in Counts I and II, and alleged that the said articles (being also articles of "drug" within the meaning of the statutory definition) were introduced into interstate commerce on or about July 28, 1953, and July 14, 1953, respectively, consigned to the Delvita Company, Wilmington, Delaware, and to one Joseph T. Stoeckl, of Buffalo, New York, respectively, and were (a) misbranded under 21 U.S.C.A. § 352(a) in that their labeling, when viewed in its entirety, falsely represented and suggested that "nearly everyone in this country is suffering from malnutrition or is in danger of such suffering because of the demineralization and depletion of soils and the refining and processing of foods, that practically all human ailments and diseases are traceable to improper nutrition, that the best way to treat, cure, and prevent all the diseases of mankind would be by using said article[s] of drug, that said article[s] [possess] nutritive properties superior to any other vitamin or mineral supplement, that said article[s] constituted an adequate and effective cure, preventive and treatment" for various specific diseases; and were (b) misbranded under 21 U.S.C.A. § 352(f) (1) in that their labeling failed to bear adequate directions for use.

Counts IV and VI involved a different product, known as Vit-Ra-Tox "16", whose label described it as "An Adsorbent Aid in Systematic Detoxification and An Intestinal Purificant", and alleged that said article of drug was introduced into interstate commerce on or about July 28, 1953, and December 3, 1952, respectively, and consigned to the Delvita Company, Wilmington, Delaware, and to one Joseph T. Stoeckl, of Buffalo, New York, respectively, and was (a) misbranded under 21 U.S.C.A. § 352(a) in that its labeling falsely represented that the article was an adequate and effective treatment for certain specific disorders and disturbances; and was (b) misbranded under 21 U.S.C.A. § 352(f) (1) in that its labeling failed to bear adequate directions for use.

At the trial it was shown that appellants were engaged in the manufacture and distribution of certain "natural" vitamin products (distinguished from synthetic vitamins in that they are produced from natural food sources), and that sales of the products were made to consumers by distributors who received from appellants both the product to be sold and supporting literature. The evidence indicated that appellants recruited salespeople from among their customers and acquaintances, as well as through advertisements in newspapers. Selling techniques were explained to these people at meetings and by printed material comprising the sales kit, which contained certain leaflets in addition to supplemental newsletters written at frequent intervals by appellants and sent to such distributors. The printed promotional material was shown to be an integral part of the selling process, and constitutes the major source of the government's proof of the charges contained in the information.

[39] The written, printed, and graphic material used was all identified and introduced into evidence by a food and drug inspector of the Department of Health, Education, and Welfare, who had posed as a salesman in order to obtain the material from appellants. The inspector made application and became an accepted distributor; he obtained a complete sales kit, purchased products, attended a lecture by Irons, and received a series of newsletters.

At the conclusion of the trial the jury returned a verdict of guilty against both defendants on all six counts. The court sentenced V. Earl Irons to one year of imprisonment on each of the six counts, the sentences to run concurrently; and imposed upon the defendant corporation a fine of $1,000 on each count. Appeals were duly taken by both defendants.

The brief for appellants lists twelve major points as grounds for reversal, as well as a large number of subpoints. But after a complete reading of the voluminous record, we are satisfied that no error was committed by the district court.

Since appellants make no serious argument with respect to Count I, it may be dealt with summarily. The label on the carton introduced into evidence by the government states that Vit-Ra-Tox No. 21A retains "Nature's vitamins, living enzymes, synergists, and activating materials (except Vitamin D); a rich natural source of Carotene (pro-vitamin A) and the complete natural complexes of Vitamins B, C, E, F, and K with the P fractions of the C complex and the Wulzen factor of the F complex, plus the living enzymes, synergists and mineral activators. It contains organic iron, calcium, phosphorus, iodine and a host of other minerals in trace amounts * * *." The label thus represents that the product has special dietary uses for man, by reason of its vitamin and mineral properties, within the scope of the Administrator's regulations contained in note 3, supra; and because there is no claim that the label satisfied the requirements of the regulations, it is quite clear that there was a violation of the Act, so far as Count I is concerned.

Before proceeding further, it is to be noted that the Act makes a distinction between the terms "label" and "labeling". Under 21 U.S.C.A. § 321(k), "label" is defined to mean "a display of written, printed, or graphic matter upon the immediate container of any article * * *." But by 21 U.S.C.A. § 321(m), "labeling" means "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." It is clear that the term "labeling" must be given a broad meaning to include all literature used in the sale of food and drugs, whether or not it is shipped into interstate commerce along with the article. "One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant." Kordel v. United States, 1948, 335 U.S. 345, 350, 69 S.Ct. 106, 109, 93 L.Ed. 52. There is no doubt that the printed circulars, pamphlets, brochures and newsletters distributed by appellants in the present case constituted "labeling" within the statutory definition, and thus may properly be received in evidence as proof of false or misleading statements.

In determining whether such labeling contained "false or misleading" statements, we must be careful not to read the literature with the eyes either of experts in nutrition or of overly skeptical buyers. What is pertinent is the effect the claims would have on those to whom they are addressed, namely, prospective purchasers and actual customers of appellants, who cannot be presumed to have special expertness or to be unduly cautious, but who are more likely than not to be persons who are pathetically eager to find some simple cure-all for the diseases with which they are afflicted or who are susceptible to luridly painted scare literature as to the prospect of [40] being disease-ridden unless they consistently partake of the vaunted drug product. This approach has been authoritatively approved. In Federal Trade Commission v. Standard Education Society, 1937, 302 U.S. 112, 116, 58 S.Ct. 113, 115, 82 L.Ed. 141, it is stated: "The fact that a false statement may be obviously false to those who are trained and experienced does not change its character, nor take away its power to deceive others less experienced. There is no duty resting upon a citizen to suspect the honesty of those with whom he transacts business. Laws are made to protect the trusting as well as the suspicious. The best element of business has long since decided that honesty should govern competitive enterprises, and that the rule of caveat emptor should not be relied upon to reward fraud and deception." See also Donaldson v. Read Magazine, Inc., 1948, 333 U.S. 178, 188, 68 S.Ct. 591, 92 L.Ed. 628.

When appellants' labeling is examined in this light and in its entirety, it readily appears that the government introduced at least sufficient evidence to warrant submission to the jury of the issues whether appellants made the representations charged against them, and whether these representations were false or misleading.

The literature contains considerable material that is either obviously harmless or irrelevant to this case, such as lists of food with their vitamin content, instructions to salesmen, and shipping details for the various products. But, beyond that, many representations are made that, fairly interpreted, provide adequate support for the government's charges. There are, first of all, numerous assertions that "all human ailments" can be traced to nutritive deficiencies and that various specific ills are caused thereby. For example, there is the statement:

"The evidence is overwhelming! That we Are what we Eat. That practically All Human ailments are traceable to our food. From the time we are conceived until we reach 150 lbs;

"It's the Material Out of Which we are built that determines the structure. If that material is faultty the structure Breaks Down. If it is Not faulty, it does Not Break Down * * * It's our Food, that makes us sick or well."

Similarly, in one of appellants' pamphlets it is stated: "We believe that practically all the ailments that beset our civilized world are caused by deficient foods which can lower one's resistance."

With respect to specific diseases, the literature quotes from the writings of one Dr. Sutherland^[6] that:

"At the present time many conditions are considered as essentially deficiency diseases and are associated in one's thought with the classical Beri-Beri, Pellagra, Rickets and Scurvy. Such conditions are Infantile Scorbutus, Marasmus, Dentition Difficulties and Imperfect Teeth in Children and Adults, Dyspepsias, Indigestions, Diarrhoeas and Constipation, Obesity, Inability to Nurse Children, Diabetes, Neuroses, Infantile Paralysis, Certain Myalgias or `Rheumatism,' Dementia Praecox, and even Tuberculosis and Cancer. The list can be extended but it is already a formidable one."

Furthermore, there are numerous examples in the record of statements attributing extraordinary powers to appellants' products:

"Our customers are indeed fortunate that Vit-Ra-Tox was chosen by Green Life Products Co. of Kansas City, as the First and Only organization of its Kind to offer to the public Green Life, the richest, most potent and easily assimilated Natural Food, known to man.

[41] "We believe that Green Life, because of its high concentration of Nature's unknown mysteries, is at present the only hope for overcoming the deficiencies of civilized, processed foods. Green Life alone should be able to help lessen current deficiencies in an average reasonable daily diet if the right amount for each individual can be determined through experience."

At another point appellants modestly state in an unqualified way that "It [Vit-Ra-Tox No. 21] is the One Hope for suffering humanity." And again, that "`This Product' alone of all products now on the market has all the vitamins, minerals, enzymes, co-enzymes, mineral activators and synergists (co-workers or helpers) needed by the human body (except Vitamin D)."

Apart from these general representations about the value of their product, the record discloses that appellants claimed the power to cure or ameliorate specific diseases. These claims are to be found both with respect to the products which were the subject of Counts II, III and V, and also with respect to those which were the subject of Counts IV and VI. Regarding the products mentioned in Counts II, III and V, it is said: "Hence Dr. Lee believes that arthritis cannot possibly reside permanently in a body which has a sufficient daily intake of this product." And, again quoting Dr. Lee,^[7] "No one could continue to have arthritis and use this product daily."

With respect to Vit-Ra-Tox 16 (the Bentonite product) referred to in Counts IV and VI, a book of appellants' which was provided to all distributors quoted, somewhat out of context, from U. S. Government Bureau of Mines Booklet No. 609: "Moistened with water or glycerin, it ["Alkali Bentonites"] also has been used, apparently with some success, for rheumatic and pulmonary affections, disorders of the scrofulous and eczeatous type, abscesses, and the cleansing of sores and wounds."

Laying aside these specific claims, it is true that most of the representations in the literature relating to diseases are more indirect; virtues of appellants' products are juxtaposed with descriptions of the symptoms or cures for various diseases, although no statement is made overtly correlating the products with the diseases. For example, the first few pages of one of the pamphlets are devoted to very general statements about nutritive deficiencies in the United States; it then goes on to say:

"No one can listen to the radio or television day after day without being reminded of the enormity of this health problem. Constantly we hear appeals for donations to the Heart Fund on the grounds that over 50% of all the deaths in 1951 were due to Heart trouble of some kind. Yet in 1890 only 5% of the deaths were from Heart Disease. This indicates a 1,000% increase in 60 years. Can anyone doubt that this is a major problem?

"In their recent plea, the Cancer Fund announced that one-fifth of those now living will die of Cancer (1/5th of 150,000,000 is 30,000,000). Since 1890 the percent of Deaths from Cancer has increased 650%. In the drive for a better understanding of Diabetes is was broadcast and advertised that 1,000,000 people in the country have Diabetes that don't know they have it. Dr. [42] Joslin, the greatest living authority on Diabetes states that at the rate we are going, almost every one in America will have Diabetes within 50 years."

Later on in the same pamphlet appellants proceed to discuss the virtues of their products: "To the best of our knowledge there is absolutely nothing on the market today with which Vit-Ra-Tox No. 16 can be compared. It seems to have the faculty of assisting the body in removing toxins and poisons." Another example of the juxtaposition of a discussion of appellants' products with a discussion of specific diseases is contained in one of the newsletters in which, under the heading "The Garlic Cure for Tuberculosis", there is a long exposition of certain alleged cures of tuberculosis by garlic and garlic products. The latter part of the newsletter contains information for salesmen as to how to speed up their orders for the Vit-Ra-Tox products which contain a garlic derivative. The record discloses many other illustrations of references to specific diseases cleverly coupled with boosts for or information concerning Vit-Ra-Tox. On the basis of this record it is not at all surprising that a lay jury reading the literature came to the conclusion that special curative or at least preventive powers for the diseases mentioned were claimed by appellants for their Vit-Ra-Tox line.^[8] And if such was the impression made upon the jury, it seems more than likely that a prospective purchaser, hoping finally to obtain relief from a long-endured disease, would not read appellants' literature with any skeptical literalness. Bearing in mind the broadly remedial purposes of the Act in preventing deception, the Congress must be taken to have meant to strike not only at palpably false claims but also at clever indirection and ambiguity in the creation of misleading impressions. See United States v. One Device, Intended for Use as a Colonic Irrigator, 10 Cir., 1947, 160 F.2d 194, 200.

In order to show that many of the representations contained in the literature, or labeling, were "false or misleading", the government put on the stand five expert medical witnesses, authorities in the field of nutrition or internal medicine.

These experts testified, first of all, that not all human illnesses are traceable to nutritive deficiencies, as appellants claimed, pointing out that some diseases are caused by congenital defects, others by specific viruses, or bacteria, and that numerous degenerative diseases of old age have nothing to do with nutrition. Moreover, they stated that, after experiments with appellants' products, these were found to lack the powers attributed to them, either as general aids to health or in connection with the specific diseases mentioned in the literature. One doctor said: "In the directions recommended, it would have absolutely no effect in any of the ten leading causes of death in the United States, or in any other way you would like to take it." [43] There is no need to recite the evidence in detail, for the record is replete with medical testimony contradicting the various claims; and there is no doubt that the jury was provided with a sufficient foundation for its findings.

Appellants introduced their own expert witnesses at the trial, but it does not take one well versed in the field of nutrition to appreciate why the jury might have accorded their testimony diminished weight. One of them was a soils expert who was not shown to be qualified to discuss human nutrition or the claim that soil deficiency resulted either in national malnutrition or in diseases of man. Several practising physicians also testified, but none seemed to possess extensive qualifications in nutrition. One of these, who had not practised medicine for over thirty years, testified to laboratory tests he made for high blood pressure using garlic on cats and on humans, but he admitted on cross-examination that, to supply a daily dose comparable to the dose of garlic administered in his tests, he would have to give a patient 855 tablets of Vit-Ra-Tox 21B per day. Appellants also presented two dentists, neither of whom disclosed any additional training to equip him as an expert in nutrition, and one of whose writings — those of Dr. Lee — had been employed as part of appellants' sales literature. See note 7, supra. Incidentally, this is the Dr. Lee whom one of the government's experts caustically referred to as "known as one of the biggest charlatans in the food quackery business." The jury, after hearing these expert witnesses for both sides, was in a position to compare their respective qualifications, and we are not prepared to set aside its determination as to where the truth lay.

Concerning the accuracy of therapeutic claims, it was held in an earlier mail fraud case that fraud could not be found to exist so long as bona fide differences of medical opinion existed. American School of Magnetic Healing v. McAnnulty, 1902, 187 U.S. 94, 23 S.Ct. 33, 47 L.Ed. 90. But the terms of the Federal Food, Drug, and Cosmetic Act of 1938, outlawing "false or misleading" labeling, and the regulations issued under the Act, proceed upon a different basis. One may be guilty of the misdemeanor described in 21 U.S. C.A. § 333(a) without having any intent to defraud or mislead. In contrast with this is the provision of § 333(b), which imposes more severe penalties in case of a violation of any of the provisions of § 331, "with intent to defraud or mislead". In the applicable regulations it is provided: "The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation." 21 C.F.R. § 1.3. The cases decided under the Act indicate that the jury will be allowed to determine the truth of a therapeutic claim as it would that of any other fact. United States v. Kaadt, 7 Cir., 1949, 171 F.2d 600, 603. The danger has been pointed out, in 67 Harv. L.Rev. 632 at 654, "that juries, if always allowed to determine the validity of a claim after hearing contradictory medical testimony, will brand false new, temporarily unpopular, but possibly correct scientific theories." On the other hand, the potentiality of harm to gullible consumers, from acceptance of false or misleading representations, may be just as real even though the maker of the representations has a bona fide belief in their truth. Which of these more or less competing considerations is to be accorded priority is of course a matter of policy for the Congress to decide. See United States v. Dotterweich, 1943, 320 U.S. 277, 284, 285, 64 S.Ct. 134, 88 L.Ed. 48.

It must be remembered that a representation may be "misleading" from the very fact of overemphasis and exaggeration, even though the product in question may be helpful, and in some circumstances useful, though not really indispensable to good health. This is no doubt what one of the government's expert [44] witnesses had in mind when he testified:

"Well, obviously food is important, and we have to develop our bodies from building materials and blocks we get from food; but in order to utilize our food properly we have to have a liver that is functioning, and a pancreas that is functioning, and various other of our body organs, in order to utilize food properly. So we may very well get the best of food, and yet if we have faulty processes of digestion, or liver functioning, which is mentioned specifically, we can't get the most out of our food. On the other hand, if we have a good liver and a good pancreas and a good insides, you might say, working properly and we get poor food, we aren't going to do a good job either, so the answer to the last part is Yes or No, food is important but other things are also important."

The same expert testified subsequently, on cross-examination:

"If anybody eats nothing but sugar, that is, this white sugar you mentioned, nothing but white bread, you would need some type of vitamin and mineral supplement. If you put in a little milk, if you put in a little meat, if you put in a little egg, vegetable, fruits, you don't need Mr. Irons or anybody else, if you are in good health."

Turning now to the second charge contained in each of Counts II-VI of the information, that is, that the articles of drug were misbranded in that their labeling failed to bear "adequate directions for use" for the various diseases and conditions for which they were intended, it may be pointed out that we are free to look to all relevant sources in order to ascertain what is the "intended use" of a drug, and are not merely confined to the labels on the drug or the "labeling". The legislative history of the 1938 Act makes this clear. See Dunn, Federal Food, Drug, and Cosmetic Act 111-12, 240 (1938). Such also has been the undeviating opinion of the courts which have had occasion to deal with the issue. For example, in a recent decision the Third Circuit said:

"The intended uses of the products in the present issue as in Kordel [Kordel v. United States, supra, 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52] were to cure, ameliorate or prevent diseases. The evidence to prove their uses included both graphic materials distributed and testimony of oral representations to users and prospective users. The latter are no less relevant on the question than the former. Both show that the products shipped were to be used as drugs." United States v. El Rancho Adolphus Products, 3 Cir., 243 F. 2d 367. See also United States v. 3 Cartons, More or Less, "No. 26 Formula GM etc.," D.C.S.D.Cal.1952, 132 F.Supp. 569, 574.

In the present case, therefore, we are entitled to utilize all of appellants' literature as well as the oral representations made by V. Earl Irons at his lectures or by authorized sales distributors.^[9]

[45] As a matter of fact, appellants introduced no label which provided adequate directions if the use of the products is to be taken to effect the cure or prevention of the various diseases mentioned in the literature. Indeed, appellants do not maintain that they ever issued any such label, but content themselves in saying that the government's case must fall because there was no showing that the voluminous literature admitted in evidence constituted all of the labeling of the products; in other words, it is argued that other items of labeling which might exist might have contained adequate directions for use. But once the government has introduced into evidence a substantial number of documents constituting "labeling" of the various drug products, none of which provided "adequate directions for use", it seems perfectly reasonable to require that the defendants have the burden of going forward with the production of other labeling which does satisfy the demands of the statute. It would be quite unthinkable to impose upon the government the further necessity of proving that there are no other, secreted, labelings in existence, especially since all such literature used by appellants can be assumed to be in their possession. Therefore we find no error in the conclusion that the labeling of appellants' products did not provide adequate directions for use.

Appellants present a variety of other defenses, some of which are clearly untenable. For example, it is a bit late in the day to sustain the assertion that the Federal Food, Drug, and Cosmetic Act is unconstitutionally vague. Nor, after a review of the entire record, are we able to agree that the court below committed prejudicial procedural errors in its conduct of the trial.

However, the propriety of the sentences imposed merits a brief comment. It is argued that Counts I and II of the information and Counts III and IV each charged but a single offense and therefore that it was an error to sentence appellants separately on each of these four counts. (The individual defendant is hardly in a position to raise this point, since the sentences imposed upon him were to run concurrently. However, separate fines were imposed upon the corporate defendant as to each count.) The rule is now well settled that a conviction with sentence upon one indictment or information does not bar conviction with sentence upon another "if the evidence required to support the one would not have been sufficient to warrant the conviction upon the other without proof of an additional fact * * *." Ebeling v. Morgan, 1915, 237 U.S. 625, 631, 35 S.Ct. 710, 712, 59 L.Ed. 1151; Ekberg v. United States, 1 Cir., 1948, 167 F.2d 380, 384. In the present case this test is satisfactorily met. The violation in Count I is based upon the charge that the article was represented as a food for special dietary uses by reason of its vitamin and mineral content, and that the label did not bear certain information required under the authorized regulations issued by the Secretary of Health, Education, and Welfare. In contrast, Count II alleges the same product to be a misbranded drug on the basis of false and misleading statements which appear on the "labeling" literature disseminated by appellants; and to obtain a conviction under this count the government had to prove the additional fact that the statements contained in such literature were false or misleading.

[46] The arguments based on Counts III and IV are even more flimsy, for these counts involve entirely different drugs. The drug named in Count III is a tablet known as Vit-Ra-Tox No. 21, which is said on its label to contain "a mixture of dried extracted juices of cereal grasses, green life, plus bone meal, brewer's yeast, fish liver oils, alfalfa, kelp (or dulse)." The drug which is the subject of Count IV is a liquid known as Vit-Ra-Tox No. 16, described in the label thus: "Colloidal Bentonite (U. S. P. Grade). Distilled water as vehicle with certified flavor and color." Obviously they are different drugs. As the statute forbids the introduction into interstate commerce of any drug that is adulterated or misbranded, 21 U.S.C.A. § 331(a), Counts III and IV do not charge the commission of a single offense but rather two separate and distinct offenses, and the sentence imposed upon the corporate defendant by the trial court was therefore entirely proper.

A judgment will be entered affirming the judgments of the District Court.

[1] Evidence introduced at the trial seems conclusively to establish that the defendants did introduce their products into interstate commerce. No issue as to this has been seriously pressed on appeal.

[2] "§ 343. Misbranded food

"A food shall be deemed to be misbranded — * * *

"(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Administrator determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses."

[3] The pertinent regulations are as follows:

"§ 125.2 General label statements. (a) If a food (including food to which any one or more of §§ 125.3 to 125.8, inclusive, is applicable) purports to be or is represented for any special dietary use by man, its label shall bear a statement of the dietary properties upon which such use is based in whole or in part. Such statement shall show the presence or absence of any substance, any alteration of the quantity or character of any constituent, and any other dietary property of such food upon which such use is so based.

"(b) If a food (including food to which any one or more of §§ 125.3 to 125.8, inclusive, is applicable) purports to be or is represented for special dietary use by reason of its use for treating any disease resulting from a dietary deficiency in man, its label shall bear, in addition to the information required under paragraph (a) of this section, adequate directions for such use.

"§ 125.3 Label statements relating to vitamins. (a) (1) If a food purports to be or is represented for special dietary use by man by reason of its vitamin property in respect of:

Vitamin A or its precursors, Vitamin B1 (thiamine), Vitamin C (ascorbic acid), Vitamin D, or Riboflavin (vitamin B2, vitamin G).

the label * * * shall bear a statement of the proportion of the minimum daily requirement for such vitamin supplied by such food when consumed in a specified quantity during a period of one day. * * *

"(2) If a food purports to be or is represented for special dietary use by man by reason of its vitamin property in respect of any vitamin not listed in subparagraph (1) of this paragraph, the label shall bear a statement of the quantity of such vitamin in a specified quantity of such food. The quantity of food specified as required by this section, shall be the quantity customarily or usually consumed during a period of one day, or a quantity reasonably suitable for and practicable of consumption within such period. If the need in human nutrition for such vitamin has not been established, the label shall also bear the statement `The need for .......... in human nutrition has not been established,' the blank to be filled in with the name of such vitamin. * * *

"§ 125.4 Label statements relating to minerals. (a) (1) If a food purports to be or is represented for special dietary use by man by reason of its mineral property in respect of:

Calcium, Phosphorus, Iron, or Iodine,

the label * * * shall bear a statement of the proportion of the minimum daily requirement for such element supplied by such food when consumed in a specific quantity during a period of one day. * * *

"(2) If a food purports to be or is represented for special dietary use by man by reason of its mineral property in respect of any element not listed in subparagraph (1) of this paragraph, the label shall bear a statement of the quantity of such element in a specified quantity of such food. Except in the case of foods subject to § 125.9, the quantity of food specified as required in this section shall be the quantity customarily or usually consumed during a period of one day, or a quantity reasonably suitable for and practicable of consumption within such period. If the need in human nutrition for such element has not been established, the label shall also bear the statement `The need for . . . in human nutrition has not been established,' the blank to be filled in with the name of such element. * * *" (21 C.F.R. 247-249 (1955).

[4] "§ 352. Misbranded drugs and devices

"A drug or device shall be deemed to be misbranded —

"(a) If its labeling is false or misleading in any particular."

[5] "§ 352. Misbranded drugs and devices

"A drug or device shall be deemed to be misbranded — * * *

"(f) Unless its labeling bears (1) adequate directions for use * * *."

[6] The literature employs quotations from the writings of others. It is obvious that so long as these writings are quoted with approval, they become the representations of appellants and can be used by the government to sustain its charges.

[7] The newsletter containing the second statement attributed to Dr. Lee said: "The above is what Dr. Lee thinks of the base of our new product and we consider him tops, the best authority on vitamins and minerals in the country today." Dr. Lee testified at the trial. It appeared that he was a licensed dentist (1924) not presently practising dentistry but whose "principal business" was the Lee Engineering Company which manufactured custom-made electrical equipment.

There was evidence that these representations were effective to induce purchases of "Green Life". One witness testified that he was told, when handed the literature, that the product would cure arthritis and that he bought it for that purpose.

[8] On its cartons and in one or two of appellants' newsletters or pamphlets, one may find disclaimers such as the following:

"Important — We do not diagnose or prescribe

"Neither we nor our Vit-Ra-Tox Distributors are doctors. We do not attempt to diagnose or prescribe. We do not approach our customer's health problem from the standpoint of specific ailments. We are however, interested in teaching them how, to the extent possible through nutritional influences, we can help them. * * *

"Our sales talk and theory of body building through nutritional elements are not to be interpreted as entering the field of medicine or as violating a doctor's prerogative. Since, therefore, we try only to improve the nutritional vitality of our customers, if any dangerous acute conditions exist, or are suspected, a physician should be consulted."

Such disclaimers occur only rarely. And even when they appear in conjunction with some of the literature found to be false or misleading, they should not be regarded as conferring any immunity on appellants, so long as the literature in its entirety is reasonably understood by readers to make the curative claims alleged by the government.

[9] The following testimony of the food and drug inspector about a speech made by appellant V. Earl Irons was thus admissible in order to show the intended use of the products.

"Q. In what way? What did he say about conditions? A. Well, he mentioned there are four different types of cancer, he mentioned female troubles, and he also mentioned sexual impotence, sexual perversion. With regard to female troubles, he said, he mentioned a case of a woman who had not menstruated for a long time and after starting on Vit-Ra-Tox had no more trouble in that regard.

"Mr. Foley: If your Honor please, I just want to make sure I have a running objection to all of this.

"The Court: Oh, yes, yes. Perfectly admissible.

"Q. Will you go on mentioning the others?

"The Court: Go ahead. A. Certainly.

"Q. Give to the best of your memory the substance of this lecture given by Mr. Irons. A. When he began to talk about cancer, he made the statement: `Ladies and gentlemen, I would rather have cancer than a bad case of asthma because cancer can be cured in three to ten weeks.'"

One consumer testified without objection that he had bought some Vit-Ra-Tox No 21 upon an oral representation by the salesman that it would cure arthritis (see note 7, supra). The court charged the jury, in terms that were not objected to at the conclusion of the charge (see Rule 30, F.R.Cr.P., 18 U.S.C.A.), that they might consider oral statements of Irons or a distributor of the corporation in determining whether the product was offered for treatment of specific diseases.

999 F.2d 692 (1993)

[693] Julia P. Heit, New York City, for defendants-appellants.

Emily Berger, Asst. U.S. Atty., New York City (Mary Jo White, U.S. Atty., Susan [694] Corkery, Asst. U.S. Atty., E.D.N.Y., of counsel) for appellee.

Before MINER, McLAUGHLIN and FRIEDMAN,^[1] Circuit Judges.

MINER, Circuit Judge:

Defendants-appellants Jerome Strauss ("Jerome") and Adam Strauss ("Adam") appeal from judgments of conviction entered on December 14, 1992 in the United States District Court for the Eastern District of New York (Mishler, J.). The Strausses were convicted, following a jury trial, on one count of conspiring to hold for sale misbranded and adulterated dog food, in violation of 21 U.S.C. §§ 343(a)(1) and 342(a)(1) and 18 U.S.C. § 371 and on twelve counts of causing false labels to be affixed to dog food with the intent to defraud and mislead, in violation of 21 U.S.C. §§ 331(k), 333(a)(2) and 343(a)(1). Jerome was sentenced to a term of imprisonment of twenty-seven months to be followed by three years of supervised release. Adam was sentenced to a one-year term of probation, four months of which were to be served under house arrest. On appeal, the Strausses principally contend that there was insufficient evidence to prove that they mislabeled or adulterated the dog food, and that, as applied to them, 21 U.S.C. § 343(a)(1) is unconstitutionally vague. For the reasons that follow, the judgments of conviction are affirmed.

BACKGROUND

Bow Wow Meow Pet Food Stores ("BWM") was a chain of eleven pet food and pet accessory stores located throughout Nassau County, New York. Jerome was BWM's owner and president, and his son Adam became vice-president in 1991 after graduating from college. BWM sold a variety of nationally advertised baked kibble (crushed or broken up dry dog food), as well as its own brand of kibble called "Professional Choice," which it purchased from Triumph Pet Industries, Inc. ("Triumph"), a leading producer of kibble located in Hillburn, New York.

Jerome began purchasing kibble from Triumph around 1980. The kibble was packaged at Triumph's plant in bags designed by Jerome. Triumph manufactured twelve kinds of kibble. Eight kinds of kibble were formulated for particular ages, sizes or activity levels of dogs and included: (1) "Standard"; (2) "Lite & Lean"; (3) "Natural"; (4) "High Protein"; (5) "Original"; (6) "Special Puppy Blend"; (7) "Special Adult Blend"; and (8) "Special Senior Blend." Four kinds of kibble were artificially flavored and colored varieties of the Standard kibble and included: (9) "Milk-Beef-Liver"; (10) "Chicken-Beef-Cheese"; (11) "Egg-Beef-Cheese"; and (12) "Supreme Stew." Over the years, Jerome purchased Standard kibble (both flavored and unflavored), containing twenty-three percent protein; Lite & Lean kibble, containing twenty percent protein; Natural kibble, containing twenty-five percent protein; and High Protein kibble, containing thirty percent protein. Lite & Lean kibble was less expensive than Standard kibble because it contained less protein and was made from broken biscuits rejected by another customer of Triumph. High Protein kibble was the most expensive due to the additional protein.

All the kibble manufactured by Triumph contained the amount of fat and protein required by the Food and Drug Administration ("FDA") for a balanced and nutritional dog food. Pursuant to FDA requirements, the bags' labels listed the ingredients (e.g., wheat flour, meat and bone meal, poultry by-product and animal fat). See 21 C.F.R. § 501.4 (1992). The labels also included a chart comparing the FDA-recommended minimum requirements of protein, fat, vitamins, minerals and other nutrients with the average level of those nutrients contained in the packaged kibble. Also listed was the recommended serving size according to the weight of the dog to be fed.

Until 1985, Jerome bought only Standard kibble (including all of the artificially flavored and colored varieties). From 1985 to 1988, in addition to the Standard kibbles, he purchased [695] High Protein kibble, Natural kibble and Lite & Lean kibble. In 1989 and 1990, Jerome bought only three varieties of kibble: unflavored Standard kibble; the Chicken-Beef-Cheese variation of Standard kibble; and Lite & Lean kibble. By 1991, he was purchasing only the unflavored Standard kibble and the Lite & Lean kibble. At no time did Jerome purchase any Special Puppy Blend, Special Adult Blend or Special Senior Blend kibble. Triumph's president, Isadore Gittelman, testified that he was not aware of significant nutritional differences among the various types of kibble sold to BWM and that the kibble was nutritionally adequate for all kinds of dogs.

All Professional Choice kibble was packaged in bags of the same design. A label was affixed to each bag indicating the age, size or activity level of the dog for which that particular kibble was manufactured. Until 1988 or 1989, Triumph would attach the labels prior to shipping the bags to BWM. To reduce its expenses, Triumph advised the Strausses that it would discontinue this practice. Thereafter, Triumph shipped unlabeled bags on pallets that identified the type of kibble (e.g., Standard or Lite & Lean) on each pallet. Labels would be affixed to the bags once they arrived at BWM's warehouse.

Gary Evers, a BWM store manager, testified that, under Jerome's supervision, he instructed BWM's warehousemen on the procedure for labeling the bags. Triumph delivered to BWM each month approximately 1000 pounds of kibble packaged in twenty-and forty-pound bags. As directed by Jerome, the warehousemen generally disregarded the type of kibble actually in the bags and affixed labels according to the weekly requests received from BWM stores for particular varieties of Professional Choice. Kibble that was identified by Triumph as "Original" would be labeled "Original," "High Protein," "Jumbo" and "All Natural." The kibble Triumph identified as "Chicken-Beef-Cheese" would be labeled "Chicken-Beef-Cheese," "Egg-Beef-Cheese" or "Milk-Beef-Liver." Finally, the kibble designated by Triumph as "Lite & Lean" was labeled "Lite & Lean," "Supreme Stew," "Special Puppy Blend," "Special Adult Blend" or "Special Senior Blend."

Several former employees of BWM testified at trial that Jerome instructed them to ascertain the type, age and activity level of a customer's dog and then to recommend the Professional Choice kibble appropriate for that particular canine. The government introduced testimony that, on at least one occasion, when an employee could not fill a customer's request, the store supervisor simply removed the label from a Professional Choice bag in stock and relabeled the bag as the variety requested by the customer. Indeed, when questioned by an employee regarding this practice, Adam allegedly responded that "it was just a marketing technique and basically people didn't know the difference." Moreover, in perhaps the first covert operation involving the purchase of dog food by the Federal Bureau of Investigation, special agents posed as customers at eight BWM stores. In each case, after discerning the size, age or activity level of the dog allegedly owned by the undercover agent, the BWM employee would recommend Professional Choice as the food best suited for that canine. The agent, relying on this representation, would purchase the kibble, even though it was not in fact specifically manufactured for the particular type of dog he described.

Finally, when the kibble became bug infested, store managers were instructed to return the bags to the BWM warehouse. There, the Strausses would remove the kibble, spray the food with Zema Home and Kennel Spray, let it dry, rebag the food and then return it to stock. Testimony by former employees of BWM revealed that hundreds of twenty- and forty-pound bags of kibble were treated in this manner. Marcia Van Gemert, Chief of Toxicology in the Health Effects Division of the Environmental Protection Agency, an expert on the effects of pesticides on animals, testified that the active ingredient in Zema is chlorpyrifos, a "very, very toxic chemical" in the chemical family of organophosphates. She further explained that organophosphates are chemicals that were first developed by the Nazis during World War II as nerve gas agents. Over the years, they have been developed and "chemically [696] changed so they have different properties" and are now a common ingredient in pesticides.

On appeal, the Strausses claim that the evidence was insufficient to show that they misbranded or adulterated the dog food and that, as applied to them, 21 U.S.C. § 343(a)(1) is unconstitutionally vague. They also contend that Van Gemert's reference to the Nazis' development of organophosphates was so inflammatory that it constituted plain error and requires reversal of their convictions.

DISCUSSION

A. Sufficiency of the Evidence

The Strausses were convicted of knowingly and wilfully conspiring (1) "to cause false labels to be affixed to Professional's [sic] Choice dog food while the food was held for sale after shipment in interstate commerce, causing the food to be misbranded in violation of [21 U.S.C. §] 343(a)(1)"; and (2) "to cause insecticide to be sprayed on Professional's [sic] Choice dog food while the food was held for sale after shipment in interstate commerce, causing the food to be adulterated in violation of [21 U.S.C. §] 342(a)(1)." The Strausses contend that there was insufficient evidence to convict them of the conspiracy or of the substantive violations.

To set aside a jury verdict on the ground that there was insufficient evidence to establish the elements of a criminal offense, a defendant must demonstrate that there was no evidence from which a reasonable mind "`might fairly conclude guilt beyond a reasonable doubt.'" United States v. Mariani, 725 F.2d 862, 865 (2d Cir.1984) (quoting United States v. Taylor, 464 F.2d 240, 243 (2d Cir.1972)). The burden placed on a defendant to meet this criteria is "very heavy." United States v. Chang An-Lo, 851 F.2d 547, 553 (2d Cir.), cert. denied, 488 U.S. 966, 109 S.Ct. 493, 102 L.Ed.2d 530 (1988). "`[W]e must credit every inference that could have been drawn in the government's favor.'" United States v. Benitez, 920 F.2d 1080, 1088-89 (2d Cir.1990) (quoting United States v. Villegas, 899 F.2d 1324, 1339 (2d Cir.), cert. denied, 498 U.S. 991, 111 S.Ct. 535, 112 L.Ed.2d 545 (1990)), and the government need not have "preclude[d] every reasonable hypothesis ... consistent with innocence." Chang An-Lo, 851 F.2d at 554. Finally, a conviction may be based upon circumstantial evidence and inferences based upon the evidence, Mariani, 725 F.2d at 865-66, and the jury is exclusively responsible for determining a witness' credibility, United States v. Roman, 870 F.2d 65, 71 (2d Cir.), cert. denied, 490 U.S. 1109, 109 S.Ct. 3164, 104 L.Ed.2d 1026 (1989). The evidence here meets these standards of sufficiency.

1. Mislabeling the Dog Food

Section 343(a)(1) provides that food is misbranded if "its labeling [is] false or misleading in any particular." See United States v. Hoxsey Cancer Clinic, 198 F.2d 273, 281 (5th Cir.1952) (government not required to prove that each and every representation was false or misleading), cert. denied, 344 U.S. 928, 73 S.Ct. 496, 97 L.Ed. 714 (1953). Relying on Gittelman's testimony that Professional Choice was nutritionally adequate for all dogs, the Strausses contend that, because Professional Choice was in fact a single, all-purpose dog food, the application of labels indicating various kinds and flavors of kibble was not a false or deceptive practice. They argue that this practice was a marketing technique typically employed by other manufacturers and retailers of dog food.

Even if Professional Choice were nutritionally proper for all dogs, "the appropriate inquiry is whether the ultimate purchaser will be misled." Libby, McNeill & Libby v. United States, 148 F.2d 71, 74 (2d Cir.1945). It also is irrelevant that a reasonable consumer reading the labels would realize that all Professional Choice varieties, and indeed all other dog foods, contain roughly the same ingredients and that the artificial flavoring adds no nutritional value to the dog food. We have construed section 343 broadly, since the test is not the effect of the label on a reasonable consumer, but upon "`the ignorant, the unthinking and the credulous'" consumer. United States v. An Article ... Sudden Change, 409 F.2d 734, 740 (2d Cir.1969) (quoting Florence Mfg. Co. v. J.C. Dowd & Co., 178 F. 73, 75 (2d Cir.1910)). Here, an [697] ignorant, unthinking and credulous consumer would be misled into believing that he or she was purchasing a product designed especially for a dog of a particular age, size or activity level due to the Strausses' misbranding of the Professional Choice bags.

Finally, the "Guaranteed Analysis" (accurately listing the percentages of protein, fat, fiber and moisture content of the kibble) found on the Professional Choice bags does not detract from the deception caused by the Strausses' misbranding. Despite the fact that one part of the label was accurate, the other part was not, and the label as a whole falsely represented that the kibble was manufactured specifically for a particular type of canine. In United States v. An Article of Food ... "Manischewitz ... Diet Thins", 377 F.Supp. 746 (E.D.N.Y.1974), the defendant marketed matzoh crackers with a label bearing the name "Diet-Thins." In fact, the crackers in these boxes were no different from the defendant's "regular crackers." The defendant argued that it had not mislabeled its product because any customer who read the ingredients would see that the crackers were the same and because both kinds of crackers were appropriate for someone on a diet. The district court rejected these arguments, finding that "[i]t [was] not necessary to show that anyone was actually misled or deceived" and that "a technically accurate description of a food or drug's content may violate" the statute "if the description is misleading in other respects." Id. at 749. Similarly, although the "Guaranteed Analysis" portion of the labels technically may have been accurate, the labels were misleading and deceptive because they identified the kibble as being specifically manufactured for a dog of a certain age, size or activity level.

2. Adulteration of the Kibble

The Strausses also argue that there was insufficient evidence to show that they violated 21 U.S.C. §§ 331(k) and 342(a)(1). Section 331(k) provides, in relevant part, that adulterated food may not be "held for sale." Section 342(a)(1) provides, in relevant part, that "[a] food shall be deemed to be adulterated ... [i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health." The Strausses admit that they adulterated the dog food, but they argue that the government failed to introduce direct evidence showing that they held any adulterated kibble for sale. They support this argument by asserting that the government provided no evidence that any adulterated kibble was ever sold to any customer of BWM. Proof of resale was not necessary, and we find that there was sufficient evidence for the jury to infer that the kibble was, in fact, held for sale. See Mariani, 725 F.2d at 865-66.

B. Void for Vagueness

The substantive counts of the indictment charged that the Strausses,

with the intent to defraud and mislead, unlawfully caused false labels to be affixed to Professional's [sic] Choice dog food while the food was held for sale after shipment in interstate commerce, causing the food to be misbranded in violation of [21 U.S.C. §] 343(a)(1), in that the labeling of the foods represented and suggested that the foods were different in nutritional value or flavor, whereas in truth and fact, the said foods were the same in both nutritional value and flavor.

The Strausses contend that section 343(a)(1) "is impermissibly vague as applied to [them]" because no guidelines or regulations govern dog food labeling and, accordingly, "they could not reasonably anticipate that marketing an all purpose dog food that meets the needs of dogs at all stages of life" would subject them to criminal liability. This argument has no merit.

To determine whether a statute is unconstitutionally vague as applied, a two-part test is used: a court must "first determine whether the statute `give[s] the person of ordinary intelligence a reasonable opportunity to know what is prohibited' and then consider whether the law `provide[s] explicit standards for those who apply [it].'" United States v. Schneiderman, 968 F.2d 1564, 1568 (2d Cir.1992) (quoting Grayned v. City of Rockford, 408 U.S. 104, 108, 92 S.Ct. 2294, 2298-99, 33 L.Ed.2d 222 (1972) (footnote omitted)), cert. denied, ___ U.S. ___, 113 [698] S.Ct. 1283, 122 L.Ed.2d 676 (1993). Because "the statute is judged on an as-applied basis," Maynard v. Cartwright, 486 U.S. 356, 361, 108 S.Ct. 1853, 1858, 100 L.Ed.2d 372 (1988), one whose conduct is clearly proscribed by a statute may not successfully challenge it for vagueness. See Village of Hoffman Estates v. The Flipside, Hoffman Estates, Inc., 455 U.S. 489, 495 n. 7, 102 S.Ct. 1186, 1191 n. 7, 71 L.Ed.2d 362 (1982). "Objections to vagueness ... rest on the lack of notice, and hence may be overcome in any specific case where reasonable persons would know that their conduct is at risk." Maynard, 486 U.S. at 361, 108 S.Ct. at 1857.

Section 343 is a substantive offense under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394 (the "FFDCA"). The Strausses' acts of affixing false labels to the Professional Choice bags violated both section 343(a)(1) and section 331, which lists the acts prohibited under the FFDCA. Included among these acts is the

alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food ... if such act is done while such article is held for sale ... after shipment in interstate commerce and results in such article being adulterated or misbranded.

21 U.S.C. § 331(k) (1988). A violation of section 331 committed "with the intent to defraud or mislead" is a felony. See 21 U.S.C. § 333(a)(2).

The Strausses argue that the scienter requirement of section 333 does not save section 343(a)(1) from a vagueness challenge because the definition of "mislabel" is too broad. However, a "`scienter requirement may mitigate a law's vagueness, especially with respect to the adequacy of notice ... that [the] conduct is proscribed.'" Schneiderman, 968 F.2d at 1568 (quoting Hoffman Estates, 455 U.S. at 499, 102 S.Ct. at 1193-94). In Schneiderman, we inferred a scienter requirement from the statutory provision limiting the definition of drug paraphernalia to those items "primarily intended or designed for use" with illegal drugs. See id. at 1566. Here, the scienter requirement need not even be inferred; it is plain from 21 U.S.C. § 333 that to be a felony, the misbranding must occur "with the intent to defraud or mislead."

The Strausses, relying on Schneiderman, also argue that because there are no regulatory standards or existing objective criteria in the dog food industry that focus on the labeling of dog food products "against which to measure possible violations of the law," see id. at 1568, section 343(a)(1) is unconstitutionally vague as applied, and the district court circumvented this issue by holding that the scienter requirement of section 333(a)(2) relieved them of meeting such a burden. In Schneiderman, we held that the Mail Order Drug Paraphernalia Control Act, 21 U.S.C. § 857, was not unconstitutionally vague as applied to the facts of that case because the statute included a scienter element and there were sufficient "guidelines ... to minimize the likelihood of arbitrary enforcement by providing objective criteria against which to measure possible violations of the law." Id. at 1568. These guidelines: (1) included fifteen examples of targeted paraphernalia; (2) listed eight factors to be considered, which logically were relevant to a determination of whether the defendant had the requisite scienter; and (3) included specific exemptions, which restricted the range of the statute and helped safeguard against discriminatory enforcement. See id. at 1569. Because seemingly innocuous items may be illegal in connection with the use of drugs, the list of targeted items "provid[es] objective criteria against which to measure possible violations" and the exemptions "help safeguard legitimate users of legal products." Id. at 1568. Here, legitimate sellers of dog food will find protection in the provisions in 21 U.S.C. §§ 333(a)(2) and 343(a)(1), even in the absence of guidelines or regulations, because the terms "intent to defraud and mislead" and "false and misleading" are commonly used words with definite meanings. Moreover, the FTC has promulgated regulations expressly forbidding the misrepresentation of a dog food's suitability for a particular purpose. See 16 C.F.R. § 241.4.

C. Testimony of the Government Witness

Finally, the Strausses argue that Van Gemert's reference to the Nazis' development [699] of organophosphates was so inherently prejudicial and inflammatory that no jury objectively could determine their guilt. Van Gemert testified that:

[Organophosphates] ... were first developed during the second World War as nerve gas agents. The Nazis first started using them. And they were the ones who actually developed them. They are very, very powerful chemicals. They kill anything they come in contact with and that's why they were used very effective [sic].

Because they failed to object to this testimony, we can only reverse if the district court committed plain error. See Fed.R.Evid. 103(d).

The Strausses claim that the impact of Van Gemert's testimony was to portray them to the jury in the same light as the "hated Nazis" and that no valid reason existed to justify Van Gemert's statement. Thus, they argue that the plain error was "both obvious and substantial" and that comparing the Strausses' reputed acts with those of the Nazis was an error of "such horrendous proportions" that it would constitute a gross miscarriage of justice to turn a blind eye to its impact.

However, the comment was far more innocuous than claimed. Van Gemert did not "compare the Strausses' reputed acts with those of the Nazis," but rather recited the origins of a chemical component of the pesticide used by the Strausses. Given the context in which this statement was made and the evidence used to convict them, the Strausses have failed to show that this statement seriously affected the fairness, integrity or public reputation of the judicial proceedings or produced an unduly harsh result. See United States v. Hutcher, 622 F.2d 1083, 1087-88 (2d Cir.), cert. denied, 449 U.S. 875, 101 S.Ct. 218, 66 L.Ed.2d 96 (1980). Accordingly, this claim also is without merit.

CONCLUSION

For the foregoing reasons, the judgments of the district court are hereby affirmed.

[1] The Honorable Daniel M. Friedman of the United States Court of Appeals for the Federal Circuit, sitting by designation.

999 F.2d 692 (1993)

[693] Julia P. Heit, New York City, for defendants-appellants.

Emily Berger, Asst. U.S. Atty., New York City (Mary Jo White, U.S. Atty., Susan [694] Corkery, Asst. U.S. Atty., E.D.N.Y., of counsel) for appellee.

Before MINER, McLAUGHLIN and FRIEDMAN,^[1] Circuit Judges.

MINER, Circuit Judge:

Defendants-appellants Jerome Strauss ("Jerome") and Adam Strauss ("Adam") appeal from judgments of conviction entered on December 14, 1992 in the United States District Court for the Eastern District of New York (Mishler, J.). The Strausses were convicted, following a jury trial, on one count of conspiring to hold for sale misbranded and adulterated dog food, in violation of 21 U.S.C. §§ 343(a)(1) and 342(a)(1) and 18 U.S.C. § 371 and on twelve counts of causing false labels to be affixed to dog food with the intent to defraud and mislead, in violation of 21 U.S.C. §§ 331(k), 333(a)(2) and 343(a)(1). Jerome was sentenced to a term of imprisonment of twenty-seven months to be followed by three years of supervised release. Adam was sentenced to a one-year term of probation, four months of which were to be served under house arrest. On appeal, the Strausses principally contend that there was insufficient evidence to prove that they mislabeled or adulterated the dog food, and that, as applied to them, 21 U.S.C. § 343(a)(1) is unconstitutionally vague. For the reasons that follow, the judgments of conviction are affirmed.

BACKGROUND

Bow Wow Meow Pet Food Stores ("BWM") was a chain of eleven pet food and pet accessory stores located throughout Nassau County, New York. Jerome was BWM's owner and president, and his son Adam became vice-president in 1991 after graduating from college. BWM sold a variety of nationally advertised baked kibble (crushed or broken up dry dog food), as well as its own brand of kibble called "Professional Choice," which it purchased from Triumph Pet Industries, Inc. ("Triumph"), a leading producer of kibble located in Hillburn, New York.

Jerome began purchasing kibble from Triumph around 1980. The kibble was packaged at Triumph's plant in bags designed by Jerome. Triumph manufactured twelve kinds of kibble. Eight kinds of kibble were formulated for particular ages, sizes or activity levels of dogs and included: (1) "Standard"; (2) "Lite & Lean"; (3) "Natural"; (4) "High Protein"; (5) "Original"; (6) "Special Puppy Blend"; (7) "Special Adult Blend"; and (8) "Special Senior Blend." Four kinds of kibble were artificially flavored and colored varieties of the Standard kibble and included: (9) "Milk-Beef-Liver"; (10) "Chicken-Beef-Cheese"; (11) "Egg-Beef-Cheese"; and (12) "Supreme Stew." Over the years, Jerome purchased Standard kibble (both flavored and unflavored), containing twenty-three percent protein; Lite & Lean kibble, containing twenty percent protein; Natural kibble, containing twenty-five percent protein; and High Protein kibble, containing thirty percent protein. Lite & Lean kibble was less expensive than Standard kibble because it contained less protein and was made from broken biscuits rejected by another customer of Triumph. High Protein kibble was the most expensive due to the additional protein.

All the kibble manufactured by Triumph contained the amount of fat and protein required by the Food and Drug Administration ("FDA") for a balanced and nutritional dog food. Pursuant to FDA requirements, the bags' labels listed the ingredients (e.g., wheat flour, meat and bone meal, poultry by-product and animal fat). See 21 C.F.R. § 501.4 (1992). The labels also included a chart comparing the FDA-recommended minimum requirements of protein, fat, vitamins, minerals and other nutrients with the average level of those nutrients contained in the packaged kibble. Also listed was the recommended serving size according to the weight of the dog to be fed.

Until 1985, Jerome bought only Standard kibble (including all of the artificially flavored and colored varieties). From 1985 to 1988, in addition to the Standard kibbles, he purchased [695] High Protein kibble, Natural kibble and Lite & Lean kibble. In 1989 and 1990, Jerome bought only three varieties of kibble: unflavored Standard kibble; the Chicken-Beef-Cheese variation of Standard kibble; and Lite & Lean kibble. By 1991, he was purchasing only the unflavored Standard kibble and the Lite & Lean kibble. At no time did Jerome purchase any Special Puppy Blend, Special Adult Blend or Special Senior Blend kibble. Triumph's president, Isadore Gittelman, testified that he was not aware of significant nutritional differences among the various types of kibble sold to BWM and that the kibble was nutritionally adequate for all kinds of dogs.

All Professional Choice kibble was packaged in bags of the same design. A label was affixed to each bag indicating the age, size or activity level of the dog for which that particular kibble was manufactured. Until 1988 or 1989, Triumph would attach the labels prior to shipping the bags to BWM. To reduce its expenses, Triumph advised the Strausses that it would discontinue this practice. Thereafter, Triumph shipped unlabeled bags on pallets that identified the type of kibble (e.g., Standard or Lite & Lean) on each pallet. Labels would be affixed to the bags once they arrived at BWM's warehouse.

Gary Evers, a BWM store manager, testified that, under Jerome's supervision, he instructed BWM's warehousemen on the procedure for labeling the bags. Triumph delivered to BWM each month approximately 1000 pounds of kibble packaged in twenty-and forty-pound bags. As directed by Jerome, the warehousemen generally disregarded the type of kibble actually in the bags and affixed labels according to the weekly requests received from BWM stores for particular varieties of Professional Choice. Kibble that was identified by Triumph as "Original" would be labeled "Original," "High Protein," "Jumbo" and "All Natural." The kibble Triumph identified as "Chicken-Beef-Cheese" would be labeled "Chicken-Beef-Cheese," "Egg-Beef-Cheese" or "Milk-Beef-Liver." Finally, the kibble designated by Triumph as "Lite & Lean" was labeled "Lite & Lean," "Supreme Stew," "Special Puppy Blend," "Special Adult Blend" or "Special Senior Blend."

Several former employees of BWM testified at trial that Jerome instructed them to ascertain the type, age and activity level of a customer's dog and then to recommend the Professional Choice kibble appropriate for that particular canine. The government introduced testimony that, on at least one occasion, when an employee could not fill a customer's request, the store supervisor simply removed the label from a Professional Choice bag in stock and relabeled the bag as the variety requested by the customer. Indeed, when questioned by an employee regarding this practice, Adam allegedly responded that "it was just a marketing technique and basically people didn't know the difference." Moreover, in perhaps the first covert operation involving the purchase of dog food by the Federal Bureau of Investigation, special agents posed as customers at eight BWM stores. In each case, after discerning the size, age or activity level of the dog allegedly owned by the undercover agent, the BWM employee would recommend Professional Choice as the food best suited for that canine. The agent, relying on this representation, would purchase the kibble, even though it was not in fact specifically manufactured for the particular type of dog he described.

Finally, when the kibble became bug infested, store managers were instructed to return the bags to the BWM warehouse. There, the Strausses would remove the kibble, spray the food with Zema Home and Kennel Spray, let it dry, rebag the food and then return it to stock. Testimony by former employees of BWM revealed that hundreds of twenty- and forty-pound bags of kibble were treated in this manner. Marcia Van Gemert, Chief of Toxicology in the Health Effects Division of the Environmental Protection Agency, an expert on the effects of pesticides on animals, testified that the active ingredient in Zema is chlorpyrifos, a "very, very toxic chemical" in the chemical family of organophosphates. She further explained that organophosphates are chemicals that were first developed by the Nazis during World War II as nerve gas agents. Over the years, they have been developed and "chemically [696] changed so they have different properties" and are now a common ingredient in pesticides.

On appeal, the Strausses claim that the evidence was insufficient to show that they misbranded or adulterated the dog food and that, as applied to them, 21 U.S.C. § 343(a)(1) is unconstitutionally vague. They also contend that Van Gemert's reference to the Nazis' development of organophosphates was so inflammatory that it constituted plain error and requires reversal of their convictions.

DISCUSSION

A. Sufficiency of the Evidence

The Strausses were convicted of knowingly and wilfully conspiring (1) "to cause false labels to be affixed to Professional's [sic] Choice dog food while the food was held for sale after shipment in interstate commerce, causing the food to be misbranded in violation of [21 U.S.C. §] 343(a)(1)"; and (2) "to cause insecticide to be sprayed on Professional's [sic] Choice dog food while the food was held for sale after shipment in interstate commerce, causing the food to be adulterated in violation of [21 U.S.C. §] 342(a)(1)." The Strausses contend that there was insufficient evidence to convict them of the conspiracy or of the substantive violations.

To set aside a jury verdict on the ground that there was insufficient evidence to establish the elements of a criminal offense, a defendant must demonstrate that there was no evidence from which a reasonable mind "`might fairly conclude guilt beyond a reasonable doubt.'" United States v. Mariani, 725 F.2d 862, 865 (2d Cir.1984) (quoting United States v. Taylor, 464 F.2d 240, 243 (2d Cir.1972)). The burden placed on a defendant to meet this criteria is "very heavy." United States v. Chang An-Lo, 851 F.2d 547, 553 (2d Cir.), cert. denied, 488 U.S. 966, 109 S.Ct. 493, 102 L.Ed.2d 530 (1988). "`[W]e must credit every inference that could have been drawn in the government's favor.'" United States v. Benitez, 920 F.2d 1080, 1088-89 (2d Cir.1990) (quoting United States v. Villegas, 899 F.2d 1324, 1339 (2d Cir.), cert. denied, 498 U.S. 991, 111 S.Ct. 535, 112 L.Ed.2d 545 (1990)), and the government need not have "preclude[d] every reasonable hypothesis ... consistent with innocence." Chang An-Lo, 851 F.2d at 554. Finally, a conviction may be based upon circumstantial evidence and inferences based upon the evidence, Mariani, 725 F.2d at 865-66, and the jury is exclusively responsible for determining a witness' credibility, United States v. Roman, 870 F.2d 65, 71 (2d Cir.), cert. denied, 490 U.S. 1109, 109 S.Ct. 3164, 104 L.Ed.2d 1026 (1989). The evidence here meets these standards of sufficiency.

1. Mislabeling the Dog Food

Section 343(a)(1) provides that food is misbranded if "its labeling [is] false or misleading in any particular." See United States v. Hoxsey Cancer Clinic, 198 F.2d 273, 281 (5th Cir.1952) (government not required to prove that each and every representation was false or misleading), cert. denied, 344 U.S. 928, 73 S.Ct. 496, 97 L.Ed. 714 (1953). Relying on Gittelman's testimony that Professional Choice was nutritionally adequate for all dogs, the Strausses contend that, because Professional Choice was in fact a single, all-purpose dog food, the application of labels indicating various kinds and flavors of kibble was not a false or deceptive practice. They argue that this practice was a marketing technique typically employed by other manufacturers and retailers of dog food.

Even if Professional Choice were nutritionally proper for all dogs, "the appropriate inquiry is whether the ultimate purchaser will be misled." Libby, McNeill & Libby v. United States, 148 F.2d 71, 74 (2d Cir.1945). It also is irrelevant that a reasonable consumer reading the labels would realize that all Professional Choice varieties, and indeed all other dog foods, contain roughly the same ingredients and that the artificial flavoring adds no nutritional value to the dog food. We have construed section 343 broadly, since the test is not the effect of the label on a reasonable consumer, but upon "`the ignorant, the unthinking and the credulous'" consumer. United States v. An Article ... Sudden Change, 409 F.2d 734, 740 (2d Cir.1969) (quoting Florence Mfg. Co. v. J.C. Dowd & Co., 178 F. 73, 75 (2d Cir.1910)). Here, an [697] ignorant, unthinking and credulous consumer would be misled into believing that he or she was purchasing a product designed especially for a dog of a particular age, size or activity level due to the Strausses' misbranding of the Professional Choice bags.

Finally, the "Guaranteed Analysis" (accurately listing the percentages of protein, fat, fiber and moisture content of the kibble) found on the Professional Choice bags does not detract from the deception caused by the Strausses' misbranding. Despite the fact that one part of the label was accurate, the other part was not, and the label as a whole falsely represented that the kibble was manufactured specifically for a particular type of canine. In United States v. An Article of Food ... "Manischewitz ... Diet Thins", 377 F.Supp. 746 (E.D.N.Y.1974), the defendant marketed matzoh crackers with a label bearing the name "Diet-Thins." In fact, the crackers in these boxes were no different from the defendant's "regular crackers." The defendant argued that it had not mislabeled its product because any customer who read the ingredients would see that the crackers were the same and because both kinds of crackers were appropriate for someone on a diet. The district court rejected these arguments, finding that "[i]t [was] not necessary to show that anyone was actually misled or deceived" and that "a technically accurate description of a food or drug's content may violate" the statute "if the description is misleading in other respects." Id. at 749. Similarly, although the "Guaranteed Analysis" portion of the labels technically may have been accurate, the labels were misleading and deceptive because they identified the kibble as being specifically manufactured for a dog of a certain age, size or activity level.

2. Adulteration of the Kibble

The Strausses also argue that there was insufficient evidence to show that they violated 21 U.S.C. §§ 331(k) and 342(a)(1). Section 331(k) provides, in relevant part, that adulterated food may not be "held for sale." Section 342(a)(1) provides, in relevant part, that "[a] food shall be deemed to be adulterated ... [i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health." The Strausses admit that they adulterated the dog food, but they argue that the government failed to introduce direct evidence showing that they held any adulterated kibble for sale. They support this argument by asserting that the government provided no evidence that any adulterated kibble was ever sold to any customer of BWM. Proof of resale was not necessary, and we find that there was sufficient evidence for the jury to infer that the kibble was, in fact, held for sale. See Mariani, 725 F.2d at 865-66.

B. Void for Vagueness

The substantive counts of the indictment charged that the Strausses,

with the intent to defraud and mislead, unlawfully caused false labels to be affixed to Professional's [sic] Choice dog food while the food was held for sale after shipment in interstate commerce, causing the food to be misbranded in violation of [21 U.S.C. §] 343(a)(1), in that the labeling of the foods represented and suggested that the foods were different in nutritional value or flavor, whereas in truth and fact, the said foods were the same in both nutritional value and flavor.

The Strausses contend that section 343(a)(1) "is impermissibly vague as applied to [them]" because no guidelines or regulations govern dog food labeling and, accordingly, "they could not reasonably anticipate that marketing an all purpose dog food that meets the needs of dogs at all stages of life" would subject them to criminal liability. This argument has no merit.

To determine whether a statute is unconstitutionally vague as applied, a two-part test is used: a court must "first determine whether the statute `give[s] the person of ordinary intelligence a reasonable opportunity to know what is prohibited' and then consider whether the law `provide[s] explicit standards for those who apply [it].'" United States v. Schneiderman, 968 F.2d 1564, 1568 (2d Cir.1992) (quoting Grayned v. City of Rockford, 408 U.S. 104, 108, 92 S.Ct. 2294, 2298-99, 33 L.Ed.2d 222 (1972) (footnote omitted)), cert. denied, ___ U.S. ___, 113 [698] S.Ct. 1283, 122 L.Ed.2d 676 (1993). Because "the statute is judged on an as-applied basis," Maynard v. Cartwright, 486 U.S. 356, 361, 108 S.Ct. 1853, 1858, 100 L.Ed.2d 372 (1988), one whose conduct is clearly proscribed by a statute may not successfully challenge it for vagueness. See Village of Hoffman Estates v. The Flipside, Hoffman Estates, Inc., 455 U.S. 489, 495 n. 7, 102 S.Ct. 1186, 1191 n. 7, 71 L.Ed.2d 362 (1982). "Objections to vagueness ... rest on the lack of notice, and hence may be overcome in any specific case where reasonable persons would know that their conduct is at risk." Maynard, 486 U.S. at 361, 108 S.Ct. at 1857.

Section 343 is a substantive offense under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394 (the "FFDCA"). The Strausses' acts of affixing false labels to the Professional Choice bags violated both section 343(a)(1) and section 331, which lists the acts prohibited under the FFDCA. Included among these acts is the

alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food ... if such act is done while such article is held for sale ... after shipment in interstate commerce and results in such article being adulterated or misbranded.

21 U.S.C. § 331(k) (1988). A violation of section 331 committed "with the intent to defraud or mislead" is a felony. See 21 U.S.C. § 333(a)(2).

The Strausses argue that the scienter requirement of section 333 does not save section 343(a)(1) from a vagueness challenge because the definition of "mislabel" is too broad. However, a "`scienter requirement may mitigate a law's vagueness, especially with respect to the adequacy of notice ... that [the] conduct is proscribed.'" Schneiderman, 968 F.2d at 1568 (quoting Hoffman Estates, 455 U.S. at 499, 102 S.Ct. at 1193-94). In Schneiderman, we inferred a scienter requirement from the statutory provision limiting the definition of drug paraphernalia to those items "primarily intended or designed for use" with illegal drugs. See id. at 1566. Here, the scienter requirement need not even be inferred; it is plain from 21 U.S.C. § 333 that to be a felony, the misbranding must occur "with the intent to defraud or mislead."

The Strausses, relying on Schneiderman, also argue that because there are no regulatory standards or existing objective criteria in the dog food industry that focus on the labeling of dog food products "against which to measure possible violations of the law," see id. at 1568, section 343(a)(1) is unconstitutionally vague as applied, and the district court circumvented this issue by holding that the scienter requirement of section 333(a)(2) relieved them of meeting such a burden. In Schneiderman, we held that the Mail Order Drug Paraphernalia Control Act, 21 U.S.C. § 857, was not unconstitutionally vague as applied to the facts of that case because the statute included a scienter element and there were sufficient "guidelines ... to minimize the likelihood of arbitrary enforcement by providing objective criteria against which to measure possible violations of the law." Id. at 1568. These guidelines: (1) included fifteen examples of targeted paraphernalia; (2) listed eight factors to be considered, which logically were relevant to a determination of whether the defendant had the requisite scienter; and (3) included specific exemptions, which restricted the range of the statute and helped safeguard against discriminatory enforcement. See id. at 1569. Because seemingly innocuous items may be illegal in connection with the use of drugs, the list of targeted items "provid[es] objective criteria against which to measure possible violations" and the exemptions "help safeguard legitimate users of legal products." Id. at 1568. Here, legitimate sellers of dog food will find protection in the provisions in 21 U.S.C. §§ 333(a)(2) and 343(a)(1), even in the absence of guidelines or regulations, because the terms "intent to defraud and mislead" and "false and misleading" are commonly used words with definite meanings. Moreover, the FTC has promulgated regulations expressly forbidding the misrepresentation of a dog food's suitability for a particular purpose. See 16 C.F.R. § 241.4.

C. Testimony of the Government Witness

Finally, the Strausses argue that Van Gemert's reference to the Nazis' development [699] of organophosphates was so inherently prejudicial and inflammatory that no jury objectively could determine their guilt. Van Gemert testified that:

[Organophosphates] ... were first developed during the second World War as nerve gas agents. The Nazis first started using them. And they were the ones who actually developed them. They are very, very powerful chemicals. They kill anything they come in contact with and that's why they were used very effective [sic].

Because they failed to object to this testimony, we can only reverse if the district court committed plain error. See Fed.R.Evid. 103(d).

The Strausses claim that the impact of Van Gemert's testimony was to portray them to the jury in the same light as the "hated Nazis" and that no valid reason existed to justify Van Gemert's statement. Thus, they argue that the plain error was "both obvious and substantial" and that comparing the Strausses' reputed acts with those of the Nazis was an error of "such horrendous proportions" that it would constitute a gross miscarriage of justice to turn a blind eye to its impact.

However, the comment was far more innocuous than claimed. Van Gemert did not "compare the Strausses' reputed acts with those of the Nazis," but rather recited the origins of a chemical component of the pesticide used by the Strausses. Given the context in which this statement was made and the evidence used to convict them, the Strausses have failed to show that this statement seriously affected the fairness, integrity or public reputation of the judicial proceedings or produced an unduly harsh result. See United States v. Hutcher, 622 F.2d 1083, 1087-88 (2d Cir.), cert. denied, 449 U.S. 875, 101 S.Ct. 218, 66 L.Ed.2d 96 (1980). Accordingly, this claim also is without merit.

CONCLUSION

For the foregoing reasons, the judgments of the district court are hereby affirmed.

[1] The Honorable Daniel M. Friedman of the United States Court of Appeals for the Federal Circuit, sitting by designation.