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Regulatory authority of the FDA
Regulation of food additives
Food safety issues considered by the FDA
Labeling of genetically engineered foods

The US Food and Drug Administration (FDA), responsible for the safety of food and food additives, determined in 1986 that existing regulations were adequate to regulate new genetically engineered (GE) foods. Coincident with the development of the first GE food, the "Flavr Savr" tomato, the FDA published its official interpretation of these regulations in the 1992 "Statement of Policy: Foods Derived from New Plant Varieties." This policy report details the existing food safety regulations and outlines its procedure for the regulation of new GE foods, including several decision-making flowcharts to guide developers through the process. The discussion that follows is largely a summary of that document.

Strictly speaking, the food safety oversight of the FDA is largely post-market (that is, after the product is on grocery shelves). The FDA, under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDC, 1938), has the authority to regulate or remove foods from the market which are found to be "adulterated"-- that is, containing an added substance that may render the food harmful. The "adulteration" concept also applies to deliberate food additives (but see next section). Thus, the legal responsibility to ensure the safety of food products or additives falls entirely on the developer of the food. In practice, however, developers generally work closely with the FDA in the development of new foods, to determine whether the FDA would consider a new food adulterated or not.

With genetically engineered foods in particular, developers engage the FDA in an informal back-and-forth consultation process. The FDA suggests specific safety issues that should be examined by the developer and recommends testing protocols to be used. The developer supplies summaries of their results. The FDA suggests new tests, etc. Eventually, the developer submits a formal summary of its data to the FDA, and the FDA makes a final recommendation. So far, all genetically engineered foods on the market today have passed through the pre-market consultation process with the FDA, although consultation is voluntary. On May 3, 2000, however, the FDA announced that it would seek to make consultation mandatory.

An updated list of all GE plant varieties that have completed the FDA's pre-market consultation process are listed on the FDA website.
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Because of public concern for the safety of an increasing number of new food additives, in 1958 the Food Additive Amendment was appended to the FFDC Act, requiring pre-market approval of all food additives. Developers must demonstrate "reasonable certainty of no harm" of a new food additive-- if not, foods containing the additive may be considered adulterated under the original act. The amendment, however, contains an important exception: if an additive is "generally regarded as safe" (GRAS), then the additive is exempt from formal pre-market safety review. The intent of this exception was to prevent common food additives (like salt, pepper, spices, etc) from having to undergo unnecessary safety testing. The determination of GRAS status is not a formal process, and the developer may presume an additive to be GRAS, only to be contradicted later by the FDA.

In the case of GE foods, the FDA has consistently agreed with the developers of the new products that the DNA and proteins "added" to a conventional food by genetic engineering are GRAS. Arguing that DNA and comparable proteins are already widespread in the human diet and present in similar concentrations, the additions to GE foods are therefore not subject to formal pre-market safety review. The FDA maintains, however, that if new GE foods are developed for which GRAS status is unclear-- if, for example, the GE food contains a potential allergen or a novel sweetener-- formal safety reviews may be required.
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During the consultation process, the FDA advises the developer of a new GE food to consider several important food safety questions. Some of these topics address the question of adulteration (unintended heath consequences), while others may affect the GRAS status of GE "additives."

Safety of new substances: Does the protein product created by the engineered gene raise food safety issues? Are there any other new substances created in the GE food that may render the food harmful? Does the new GE plant contain substances that are not intended for widespread human consumption (in the case of a GE plant that makes pharmaceutical or industrial compounds)?

Nutritional value: Does the new GE food have altered nutritional value (decreased nutrients or increased anti-nutrients) or an increased levels of naturally occurring plant toxins?

Allergenicity: Does the introduced GE protein have an increased risk of causing allergic reactions in humans?

Antibiotic markers: Could the use of antibiotic resistance genes as "selection markers" affect human or animal health, by potentially increasing antibiotic resistance in bacteria?

Animal feed issues: Food safety issues might be different for animals than for humans, because animals are often fed diets with a high concentration of a single plant species (corn, for example) and consume plant parts not normally eaten by humans. Could animals be more sensitive to certain food safety risks than humans?

Although not officially stated in FDA guidelines, the FDA uses the idea of substantial equivalence when considering the safety and regulatory status of GE foods. If nutritional and toxin content of a new GE food falls within the range of concentrations normally observed in conventional varieties, and if there are no new health risks associated with the added genes & proteins, then the FDA does not regulate GE foods any differently than the conventional food (that is, GE corn equals corn).
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