United States v. New England Grocers Supply Co.

1. Search, Seizure, and Warrants. It is blackletter law that a warrant is required for a search to be considered reasonable under the Fourth Amendment, whether the search is of a home or a business. See See v. City of Seattle, 387 U.S. 541, 545 (1967). For businesses, however, the Court has also relaxed the requirement because there is said to be a lesser expectation of privacy. New York v. Burger, 482 U.S. 691, 699 (1987). Moreover, the warrant requirement has been further relaxed to account for administrative inspections “designed to enforce regulatory statutes.” Id. at 700. 2. Pervasively Regulated Industries. As the Supreme Court said in United States v. Biswell, 406 U.S. 311 (1972), “When a dealer chooses to engage in a pervasively regulated business and to accept a federal license, he does so with the knowledge that his business records, . . . will be subject to effective inspection.” Biswell at 406 U.S. at 316. Biswell was a case involving warrantless inspection in the gun industry, but many circuits including the Eight, Ninth, and Sixth, have subsequently held the same is true for FDCA inspections. See United States v. Jamieson–McKames Pharmaceuticals, Inc., 651 F.2d 532 (8th Cir.1981) (holding drug manufacturing industry; United States v. Argent Chemical Laboratories, Inc., 93 F.3d 572 (9th Cir.1996) (finding pharmaceutical industry “closely regulated”); United States v. Acklen, 690 F.2d 70, 75 (6th Cir.1982) (same). 3. What is Reasonable? In what is known as the Colonnade-Biswell doctrine, the Supreme Court has articulated three criteria to determine what constitutes a reasonable warrantless government inspection: This warrantless inspection, however, even in the context of a pervasively regulated business, will be deemed to be reasonable only so long as three criteria are met. First, there must be a “substantial” government interest that informs the regulatory scheme pursuant to which the inspection is made. See Donovan v. Dewey, 452 U.S., at 602, 101 S.Ct., at 2540 (“substantial federal interest in improving the health and safety conditions in the Nation's underground and surface mines”); United States v. Biswell, 406 U.S., at 315, 92 S.Ct., at 1596 (regulation of firearms is “of central importance to federal efforts to prevent violent crime and to assist the States in regulating the firearms traffic within their borders”); Colonnade Corp. v. United States,397 U.S., at 75, 90 S.Ct., at 776 (federal interest “in protecting the revenue against various types of fraud”). Second, the warrantless inspections must be “necessary to further [the] regulatory scheme.” Donovan v. Dewey, 452 U.S., at 600, 101 S.Ct., at 2539. For example, in Dewey we recognized that forcing mine inspectors to obtain a warrant before every inspection *703 might alert mine owners or operators to the impending inspection, thereby frustrating the purposes of the Mine Safety and Health Act-to detect and thus to deter safety and health violations. Id., at 603, 101 S.Ct., at 2540. Finally, “the statute's inspection program, in terms of the certainty and regularity of its application, [must] provid[e] a constitutionally adequate substitute for a warrant.” Ibid. In other words, the regulatory statute must perform the two basic functions of a warrant: it must advise the owner of the commercial premises that the search is being made pursuant to the law and has a properly defined scope, and it must limit the discretion of the inspecting officers. See Marshall v. Barlow's, Inc., 436 U.S., at 323, 98 S.Ct., at 1826; see also id., at 332, 98 S.Ct., at 1830 (STEVENS, J., dissenting). To perform this first function, the statute must be “sufficiently comprehensive and defined that the owner of commercial property cannot help but be aware that his property will be subject to periodic inspections undertaken for specific purposes.” Donovan v. Dewey,452 U.S., at 600, 101 S.Ct., at 2539. In addition, in defining how a statute limits the discretion of the inspectors, we have observed that it must be “carefully limited in time, place, and scope.” United States v. Biswell, 406 U.S., at 315, 92 S.Ct., at 1596. New York v. Burger, 482 U.S. 691, 702-03 (1987). 4. From routine administrative inspection to criminal investigation. The defendants in new England Grocers Supply argued that even if no warrant was required, the inspections became unreasonable once the FDA agents had probable cause to suspect violations of the Act. As the court held, however, so long as the inspection is otherwise valid, there is no legal requirement to suspend the inspection and obtain a warrant once there is reason to believe violations have occurred.