Introduction To The Regulation of Genetically Modified Foods by the FDA

Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration (“FDA” or “Agency”) is the lead regulatory agency of food articles. It is in charge of ensuring the safety and effectiveness of food (other than meat), food additives, medical devices, drugs, veterinary drugs, cosmetics[i] and genetically engineered food.[ii] The FDA is also the agency with safety and labeling authority for most whole foods, food additives, and dietary supplements (similar authorities apply to animal feeds).[iii] Indeed, the FDA’s authority to regulate genetically modified foods is broader than that of the Environmental Protection Agency and that of the United States Department of Agriculture.

The FDA derives its authority mainly from two federal statutes: The Federal Food, Drug, and Cosmetic Act (“FFDCA”)[iv] and the Public Health Service Act (“PHSA”).[v]

FDA Regulation of Foods

Under FFDCA, whole foods are generally recognized as safe (“GRAS”), while novel food additives require a safety review of all ingredients that have not been granted the GRAS status.[vi] A manufacturer may place a food product on the market without FDA premarket approval because whole foods are GRAS.[vii] Under the FFDCA, the manufacturer bears responsibility for ensuring that a product is not adulterated or misbranded.[viii] However, if it is shown that the food is adulterated,[ix] the FDA is authorized to seek sanctions through seizure, injunction, or criminal prosecution.[x]

As far as novel food additives are concerned, FFDCA does not require FDA to make a premarketing determination that a potential food additive is GRAS; that determination is made by the food manufacturer without FDA review. The FDA does, however, have a voluntary “affirmation” process under which a manufacturer may ask for pre-market guidance on whether a substance is GRAS.[xi]

In a proposed rule, however, that the FDA published in 1997, FDA explained why the agency could no longer devote resources to the voluntary GRAS affirmation petition process and proposed to replace it with a notification procedure. The agency has not yet issued a final rule however, and the petition procedure remains in the agency’s regulations. According to the FDA, however, the agency is not committing resources to the review of GRAS affirmation petitions.

Under the proposed voluntary notification program, a person or entity may inform FDA of a determination that the use of a substance is GRAS, rather than petition FDA to affirm that the use of a substance is GRAS. The submitted notice includes a “GRAS exemption claim” that includes a succinct description of the substance, the applicable conditions of use, and the statutory basis for the GRAS determination (i.e., through scientific procedures or through experience based on common use in food). A GRAS notice also includes information about the identity and properties of the notified substance and a discussion of the notifier’s reasons for concluding that the substance is GRAS for its intended use.

Despite biotechnology ushering in an era of novel methods of food production, the regulatory framework for genetically modified remains the same as for non-genetically modified foods.[xii] The next articles will examine this framework in greater detail.

Sheldon Krimsky and Nora K. Murphy, Epidemiology and Science: Biotechnology at the Dinner Table: FDA’s Oversight of Transgenic Food, 584 Annals 80, 82 (2002).

See John Charles Kunich, Mother Frankenstein, Doctor Nature, and the Environmental Law of Genetic Engineering, 74 S. Cal. L. Rev. 807, 843 (2001).

Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products (2001), available at (last visited on August 18, 2009).

21 U.S.C. § 301 et seq.

42 U.S.C. § 201 et seq. In general, the PHSA authorizes the FDA to “make and enforce such regulations as … are necessary to prevent the introduction, transmission, or spread of communicable diseases… from one state … into any other state.” To enforce such regulations, the statute authorizes the FDA to “provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, or other measures.” See 42 U.S.C. §264(a).

Sophia Kolehmainen, Precaution Before Profits: An Overview of Issues on Genetically Engineered Food and Crops, 20 Va. Envtl. L.J. 267, 289 (2001); see also Judson O. Berkey, The Regulation of Genetically Modified Foods (1999), American Society of International Law, available at (last visited on August 18, 2009).

See Emily Marden, Risk and Regulation: U.S. Regulatory Policy On Genetically Modified Food and Agriculture, 44 B.C.L.R., 733, 745 (2003); see also Pew Initiative, supra note iii at 21 (citing 21 U.S.C. § 342(a)(1)).

See Marden, supra note vii, at 745; see also Pew Initiative, supra note iii at 21.

Under the FFDCA, food is deemed adulterated if it, among other things, “bears or contains any poisonous or deleterious substance which may render it injurious to health … or if it bears or contains any food additive that is unsafe … or a new animal drug (or conversion product thereof) that is unsafe.” See 21 U.S.C. § 342.

21 U.S.C. §§ 331(b), 332, 333, 334.

21 U.S.C. §§ 331(b), 332, 333, 334; Pew Initiative, supra note iii at 20, citing 21 CFR 170.35(c)(4) and (c)(5).

See generally, Pew Initiative, supra note iii; see also Berkey, supra note vi.