Washington, DC—The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration FDA) announced a commitment to "promoting radical transparency to make sure all Americans know what is in their food." As part of that focus, HHS Secretary Robert F. Kennedy Jr. has directed Acting FDA Commissioner Sara Brenner, M.D., M.P.H., to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. According to an HHS announcement, this will enhance FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.
“For far too long, ingredient manufacturers and sponsors have exploited 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,” said Secretary Kennedy. “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.”
As HHS explained in the announcement, industry can self-affirm that the use of a substance is GRAS without notifying the FDA. That said, FDA "strongly encourages manufacturers to submit GRAS notices through the agency’s GRAS Notification Program. If the self-affirmation process is eliminated, companies looking to introduce new ingredients in foods would be required to publicly notify FDA of the intended use of the ingredients, along with underlying safety data, before those ingredients are introduced in the food supply.
HHS reported that FDA has completed and published more than 1,000 GRAS notices, evaluates an average of 75 notices per year, and maintains a public inventory where all GRAS notices that have been filed by the agency—along with the supporting data and FDA’s final agency response letters—are available for review and download by the public.
“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food,” said Dr. Brenner. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”
HHS also intends to work with Congress to explore ways legislation can completely close the GRAS loophole. "Such legislation, in tandem with potential future rulemaking, are crucial steps necessary to Make America Healthy Again," HHS explained in its announcement.
The American Herbal Products Association (AHPA) noted that the HHS announcement was not accompanied by any specific timeframe for evaluation or specifics of how the elimination would occur, but updates will be shared as they become available.
Andrea Wong, SVP of Scientific and Regulatory Affairs at the Council for Responsible Nutrition (CRN), offered a suggestion for FDA as it explores options: "Rather than dismantling a system that allows scientifically reviewed ingredients to reach the market efficiently, FDA should focus on strengthening enforcement mechanisms to ensure the GRAS process is used responsibly. CRN shares the goal of increasing safety and transparency for consumers and stands ready to work with the FDA to achieve it. The solution is not to eliminate self-GRAS, which would stifle innovation, but to provide FDA with the resources and tools it needs to maintain an effective regulatory system that fosters both safety and progress."
Also responding to the announcement, Scott Faber, Senior Vice President for Government Affairs at the Environmental Working Group (EWG), said this announcement is "best seen as a 'plan to plan'" and "merely suggests that chemical companies must tell the FDA when the companies, not the FDA, have concluded the chemicals we eat are safe."
Faber wants to see real progress toward ensuring our food is safe, noting, "This announcement merely suggests that chemical companies must tell the FDA when the companies, not the FDA, have concluded the chemicals we eat are safe. This announcement will not in any way ensure that the food chemicals are reviewed by the FDA or that the chemicals we eat are actually safe. And it will not change the fact that 99 percent of food chemicals are reviewed for safety by the chemical companies, not the FDA. Congress intended that 99%, not 1%, of chemicals are reviewed for safety by the FDA, not the chemical companies. Sadly, the reverse is true. It remains to be seen whether the agency will restore the intent of Congress or will instead preserve a system that allows chemical companies to submit summaries of chemical industry science to the FDA for its ratification. The most significant danger facing consumers is not the new food chemicals that escape any meaningful FDA review; the most significant danger is that thousands of chemicals are already being used in our food without ever having been reviewed by the FDA, or without having been reviewed by the FDA for many decades."
