FDA Regulations

GRAS [Generally Recognized As Safe]

There are currently no federal regulations for mandatory labeling of GM food or drink products in the United States. The FDA believes GM products to be GRAS. If there has been so much controversy and debate over this often ambiguous term, why does the FDA believe them to be safe and free of harm to the public?

In 1999, FDA meetings took place regarding the concern and labeling of food products created by biotechnology. Approximately 50,000 written public comments were published about the safety and labeling of GM foods. Within these comments, there was a general agreement that the labeling of these foods would be useful to consumers. Fifteen years later, despite the public comments and concerns, there is still no FDA law or regulation regarding the labeling of these biotechnological organisms.

After reviewing these comments, as well as the 1992 policy which stated these products are generally recognized as safe, the FDA came to the conclusion that:

“these comments did not provide data or other information regarding consequences to consumers from eating the foods” (Levy & Derby). Although the comments expressed health and environmental concerns of the long-term consequences of bioengineered foods, “they did not contend that any of the engineered foods already on the market had adverse health effects…FDA is therefore reaffirming its decision to not require special labeling of all bioengineered food” (Levy & Derby).

The new policy states: “FDA has no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new technologies present any different or greater safety concern than foods developed by traditional plant breeding” (Levy & Derby).



Levy, A.S and Derby, B.M. “Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance.” FDA. Washington, DC. 2000. http://www.fda.gov