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On March 10, 2025, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. instructed the Food and Drug Administration (“FDA” or “the Agency”) to evaluate the food industry’s continued use of the Generally Recognized As Safe (GRAS) self-affirmation process (or “self-affirming”) to substantiate the safety of new ingredients. FDA proposes rulemaking to prevent industry from continuing to self-affirm that new ingredients are GRAS viewing the practice as a loophole in some cases that has allowed new ingredients to be used in foods without sufficient safety data and a known safety profile.

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If implemented, such a change would significantly impact both the food and feed industries marking a dramatic shift in how new ingredients are evaluated. Not only would the Agency now require companies to notify it and potentially pursue FDA premarket approval, eliminating the self-affirming option would most definitely increase the total amount of safety data required to show GRAS while also increasing the cost of going to market. The proposed reversal would prevent industry from continuing to make its own independent assessments of GRAS and instead put the decision in the hands of the Agency.

GRAS self-affirmation allows manufacturers to introduce new food additives to the market without FDA notice or premarket review and approval by simply self-affirming that a new substance is safe for its intended use. In practice the process involves the creation and maintaining of an internal safety file that traditionally includes safety studies, published literature and expert panel reports. Discretion is afforded to industry to determine what constitutes sufficient safety data to support a new ingredient’s safety. Such files need not be submitted to FDA for premarket approval although FDA encourages industry to notify it of all such ingredient self-affirmations. The FDA keeps track of these notices on a <a href="https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices">public inventory</a><u>,</u> which allows industry to track new substances and relevant safety data.

In addition to reducing regulatory oversight, GRAS self-affirmation provides efficiency and certainty in marketing new products. Industry rather than FDA controls a new ingredient’s fate.

FDA is now reconsidering this much relied upon option. If the GRAS self-affirmation option is revoked, industry will presumably be required to notify FDA of new ingredients and accompanying safety data; provide notification and most likely undergo premarket review <em>prior </em>to introduction into the market. While this would provide enhanced transparency in food products generally, eliminating the GRAS self-affirmation process will increase the burden on industry to establish safety and also substantially delay the introduction of new ingredients into the market by several years.

Michael Best has a team of experienced food and feed lawyers and lobbyists that are ready to answer your questions about the proposed change and assist you in being involved in the rulemaking process.

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The GRAS is Not Always Greener: FDA to Reconsider the Food Industry’s Continued Use of GRAS Self-Affirmation

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