Making Decisions about the Risks of Chemicals in Foods with Limited Scientific Information

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U.S. Legal Framework

An extensive legal framework involving key federal statutes, such as the Federal Food, Drug and Cosmetic (FD&C) Act, provides a strong foundation for U.S. food safety policy and decision making that incorporates precaution and science-based risk analyses (FDA-USDA 2000). This report focuses on food safety decision-making relating to chemical substances; thus, the legal framework presented herein excludes aspects of the regulatory authority for meat and poultry by the U.S. Dept. of Agriculture (USDA). This report also does not address the legal framework for rDNA biotechnology-derived foods (see the IFT Expert Report "Biotechnology and Food" for information on biotechnology).

The safety of food products other than meat, poultry, and certain egg products is regulated in the United States by the FD&C Act, as interpreted and applied by the FDA and, on occasion, federal courts. The FD&C Act prohibits introducing any food that is adulterated into interstate commerce and the adulteration of any food already in interstate commerce. An adulterated food is subject to a civil seizure action in a U.S. district court, and corporations or individuals responsible for introducing adulterated food into interstate commerce food are subject to an injunction proceeding and/or to criminal prosecution in the U.S. district courts. A food may be deemed adulterated for a number of different reasons, the following of which are relevant to this report:

  • the presence of any poisonous or deleterious substance that may render a food injurious to health unless the substance is not an added substance and present in an amount that does not ordinarily render it injurious to health;
  • the presence of any unavoidable added poisonous or deleterious substance, other than a pesticide residue, a food additive, a color additive, or a new animal drug unless the quantity of such substance does not exceed an applicable FDA-designated tolerance level;
  • the presence of a pesticide chemical residue at levels that exceed an applicable tolerance level or that is not subject to an exemption;
  • the presence of an unapproved food additive or unapproved color additive;
  • the presence of a new animal drug (or conversion product thereof) unless the drug residue falls within an applicable tolerance for such drug;
  • the dietary supplement or a dietary ingredient therein that presents a significant or unreasonable risk of illness or injury under recommended or labeled conditions of use, or if no such recommendations or labeling, under normal conditions of use; or
  • failure to submit to FDA a new dietary ingredient premarket notification at least 75 days prior to marketing a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered (21 USC §§ 331–333, 342, 350b).

The intended use of an item determines its regulatory status under the FD&C Act, and its regulatory status dictates the standard that is to be applied in evaluating its safety. Whether an article is regulated as a food or falls within a different regulatory classification depends on its intended use, rather than its source, biochemical composition, or ingestive status. Items classified as food are presumed safe, and the FDA bears the burden of establishing by a preponderance of the evidence that a particular food is injurious to health. However, this presumption of safety does not extend to most food components, the vast majority of which fall into specific regulatory classifications with attendant safety standards that must be met by manufacturers. Such food components include food additives, color additives, processing aids, substances that migrate into food from processing equipment or packaging materials, dietary ingredients in dietary supplements, pesticide residues, and animal drug residues. Circumstances requiring expert decision-making with respect to the safety of a food or food component range from the introduction of a new food ingredient or a new food use to the presence of an unapproved food additive or color additive and the intentional or unintentional addition of a contaminant. (See 21 USC § 321 (f); Nutrilab Inc. v. Schweiker, 713 F.2d 335, 337–8 (7th Cir. 1983); Jones v. Rath Packing Co. 430 US 519 (1997); U.S. v. O.F. Bayer & Co., 188 F.2d 555 (2nd Cir. 1951).)

Introduction of new substance, new use

The Food Additives Amendment of 1958 added food additive provisions to the 1958 FD&C Act. The amendment established a broad definition for food additives and required FDA premarket approval of such substances. Exempted from food additive status were substances used in accordance with a sanction or approval granted by either the FDA or the USDA prior to the enactment (known as prior-sanctioned substances), generally recognized as safe substances (commonly referred to as GRAS substances), color additives, pesticide chemical residues, pesticide chemicals, and new animal drugs. The Dietary Supplement Health and Education Act (DSHEA) of 1994 later exempted certain dietary supplement ingredients from the food additive definition. Of the substances exempted from regulation as food additives, only prior-sanctioned substances, GRAS substances, and certain dietary supplement ingredients do not require FDA approval or notification prior to use. However, exemption from food additive status does not exempt a substance from other provisions of the FD&C Act relating to safety. If the FDA were to conclude that a substance, which was prior-sanctioned or believed to be GRAS at a time when certain risks were not perceived, subsequently became known to be dangerous for use, the agency could object to use of the substance as an added poisonous or deleterious substance.

Food additives. The FD&C Act defines a food additive as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food … , if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used … prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use" (21 USC § 321(s)).

A substance that may become a component of food, either directly or indirectly, is regulated as a food additive unless the substance is considered a GRAS substance or falls within a category of substances exempt from regulation as food additives. Use of a food additive is prohibited unless FDA first approves the substance and publishes a regulation prescribing the conditions under which the additive may be safely used in foods (21 USC §§ 331, 342, 348).

The practical effect of classifying a product as a food additive rather than a food is twofold: (1) FDA premarket approval is required, and (2) the burden shifts to the manufacturer to demonstrate safety. Predictably, disputes have arisen as to whether a particular product constitutes a food or a food additive. The courts have held that whether a substance is a food additive is not dependent on quantity. Substances present in both large and small quantities can be food additives, and a substance may be both a food and a food additive regardless of whether the substance ordinarily would be considered a food.

However, not every component of food is a food additive. In the court case U.S. v. Two Plastic Drums … Vipointe Ltd, black currant oil was encased in a capsule made from gelatin and glycerin to facilitate swallowing. Seeking to condemn the component, the FDA claimed that the black currant oil was a food additive because the combination of black currant oil, glycerin, and gelatin created a food and merely being a component of food rendered the black currant oil a food additive. The 7th Circuit U.S. Court of Appeals disagreed with the FDA's broad interpretation of the food additive definition, subsequently concluding that "to be a food additive, a substance must not only be added to food, but it must also have the purpose or effect of altering a food's characteristic" (Vipointe at 818). Shortly thereafter, the first Circuit U.S. Court of Appeals confronted the issue again in the court case U.S. v. 29 Cartons … an Article of Food (Oakmont Investments), which also involved capsules of black current oil, finding that the gelatin capsule itself was not a food additive within the meaning of the FD&C Act. The court wrote, "The proposition that placing a single-ingredient food product into an inert capsule … converts that food into a food additive perverts the statutory text, undermines legislative intent, and defenestrates common sense." (See U.S. v. Two Plastic Drums … Vipointe Ltd, 984 F.2d 814 (7th Cir. 1993); U.S. v. 29 Cartons … an Article of Food (Oakmont Investments), 987 F.2d 33, 35 (first Cir. 1993).)

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