RFK Jr. Takes Aim at GRAS Self-Affirmation Process

Read the press release here.

Under the Federal Food, Drug, and Cosmetic Act, ingredients or other substances that are to be added to food must first be approved by the FDA as food additives. However, such substances do not have to go through this food additive approval process if they can be shown to be GRAS, based either on scientific procedures or on their common use in food prior to 1958. To demonstrate GRAS status through scientific procedures, a manufacturer or sponsor should follow the criteria set forth in 21 CFR part 170 subpart E, which may include convening a panel of experts to review the data and concur with a GRAS conclusion for the substance in question. At that point, the supporting information and conclusions may be submitted to the FDA in the form of a GRAS notification or simply kept on file by the manufacturer or sponsor in the form of a “self-affirmation” or what was once known as a “self-determination.” In the case of a GRAS notification, the FDA will review it and respond to the notifier by letter, stating either that it has “no further questions” or that the information submitted is insufficient for a GRAS determination.

In the preamble to the August 16, 2016, GRAS final rule, the FDA clearly allows for both the formal notification to the FDA of a GRAS finding, or simply a “self-affirmation” of such a finding without its submission to the agency. In particular, the FDA states:

We are making these conforming changes to clarify that there would be no distinction between a conclusion of GRAS status submitted to us as a GRAS notice and a conclusion of GRAS status that remains with its proponent as an independent conclusion (formerly referred to as a ‘‘self-determination’’) of GRAS status. (P. 54984.)

Therefore, we recommend that any person who intends to use a substance in food based on a conclusion of GRAS status, but does not intend to submit a GRAS notice to us, use the provisions of [21 CFR] part 170, subpart E as guidance. We also recommend that such persons organize the data and information that support an independent conclusion of GRAS status according to the organization presented by Parts 1 through 7 of a GRAS notice. Doing so would facilitate our evaluation of that independent conclusion of GRAS status if circumstances warrant, e.g., if we have cause to question the independent conclusion of GRAS status. (P. 55027.)

In 2021, the Federal Court for the Southern District of New York subsequently upheld the validity of the self-affirmation process following a challenge from the Center for Food Safety. Although the FDA reserves the right to evaluate and question the self-affirmed GRAS status of a substance after the fact, that appears to have been a rare occurrence. In the HHS announcement, Secretary Kennedy states that he considers the self-affirmation process to be “a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public… Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.” The announcement goes on to state that HHS “is committed to working with Congress to explore ways legislation can close the GRAS loophole” and thereby force companies to adhere to the process of submitting formal GRAS notifications to the FDA for prior review and acceptance.

There currently is no indication of an attempt to revisit existing GRAS self-affirmations, although this and related issues will need to be followed closely given the large number of self-affirmed GRAS ingredients in the US food supply.

The Food, Drug, Medical Device & Cosmetics group at ArentFox Schiff is ready to respond to any questions you might have about the GRAS process and Administration efforts to change it. Please feel free to reach out to any members of the team.