Secretary of Health and Human Services Robert F. Kennedy Jr. has directed the acting FDA commissioner 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.

HHS said in its March 10 announcement that the move would “enhance the 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,” Kennedy said in the announcement. “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.”  

For the dietary supplement industry, the GRAS pathway has been a detour around the New Dietary Ingredient Notification (NDIN) process. After two attempts at draft guidance on NDINs, in 2011 and 2016, FDA began issuing final guidance documents in 2024, but substantive guidance has stalled.

Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.

Currently, the FDA encourages manufacturers to submit GRAS notices through the agency’s GRAS Notification Program, but industry can self-affirm that the use of a substance is GRAS without notifying the FDA.

According to the 2016 final rule, FDA states: “Although we have premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without our premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS).”

The FDA has completed and published more than 1,000 GRAS notices and evaluates an average of 75 notices per year. The agency 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 Acting FDA Commissioner Sara Brenner, MD, MPH. “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 said it is committed to working 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.”

Industry on Notice

Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA), said if the GRAS affirmation process were eliminated, then many old dietary ingredients (ODI) may be subject to NDI notification rules; food additives/food chemicals would also be subject to pre-market approval or re-assessment.

“In both cases this would require resources FDA currently lacks,” he noted. “That said, I understand and agree with the Secretary’s desire to create a more transparent process for all of us to better understand the safety of our food and all the ingredients that go into them.”

Israelsen added that the current list of ODIs is “in urgent need of revision,” and additional data is needed to confirm the status of many dietary ingredients. “The need for an ODI 2.0 is now more relevant and urgent than ever. We need to do our part to support the goal of affirming the safety of food and dietary ingredients.”

UNPA is working on developing a new list of ODIs “using AI and multiple channels of traditional food and medicine contacts to develop the next generation of understanding of how dietary ingredients, particularly botanicals, have been in safe and common use in the U.S. for many, many years,” Israelsen said.

Andrea Wong, senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN), said that eliminating the self-GRAS process would stifle innovation.

“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.”

Israelsen said industry should heed the message from HHS and the MAHA movement about affirming safety of food ingredients. “We hear and understand both the Secretary and the MAHA public to assure that the foods and their ingredients are safe. This will require government and industry investment, and urge that both make the commitment to assess the safety of food ingredients in the interest of public confidence.”