Composition

Because of the way federal law defines adulteration, an initial question in determining whether a food is adulterated is whether it contains a substance that is either added to the food or inherent in the food. A substance is a material that comprises a food product. Consider FDCA section 402(a)(1), 21 U.S.C. § 342(a)(1). If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health. That is, merely because a food contains a poisonous or deleterious substance, it is not necessarily adulterated. If the substance naturally inheres in the food, then it is only adulterated if it satisfies the “ordinarily injurious to health” standard. If the substance is “added” then the food is adulterated it satisfies the “may render injurious” standard which establishes adulteration by proof of the possibility of harm. These differences are more than merely semantic. The may-render-injurious standard takes into account especially vulnerable groups like children, the elderly, or those allergic. The ordinarily-injurious-to-health standard does not, focusing instead on the effect of the substance on the food-consuming public in general.