Alliance for Natural Health defends self-GRAS in FDA reform debate

The Alliance for Natural Health (AHN) is urging relevant FDA and Health and Human Services members, including Secretary Robert F. Kennedy, Jr., to reconsider the full elimination of self-affirmed generally recognized as safe (GRAS).

In a newly published white paper, the nonprofit echoes worries that the GRAS system creates loopholes for unsafe ingredients to enter the market and lacks FDA oversight. However, instead of eliminating it completely, the authors call for a balanced approach to ensure continued consumer access to healthy ingredients and supplements.

“We support Secretary Kennedy’s intention to remove the most toxic substances from our food supply,” says Jonathan Emord, J.D., ANH general counsel and co-author of the white paper. 

“However, the government should avoid complete elimination of self-GRAS, which would create a massive regulatory bottleneck, potentially removing thousands of safe ingredients from the market along with those that are unsafe.”

As the FDA is undergoing reform and funding cuts, AHN urges the agency to focus on promoting transparency, strengthening oversight, and prioritizing public health to restore confidence in the US food regulatory system. 

GRAS in favor of supplements

The paper proposes a targeted approach to removing unsafe ingredients, a public transparency register, a four-tier risk/benefit assessment, a “safe harbor” for time-tested ingredients over 60 years old, and appropriate warning requirements for vulnerable populations, enhancing accountability and consumer information.

“Reforms to the GRAS system will have significant consequences for the dietary supplement industry and consumer access to an array of healthy products because ingredients determined to be GRAS, as well as those regarded as old dietary ingredients, i.e., supplements sold before October 15, 1994, may be used as ingredients in dietary supplements without notification to the FDA,” warns the paper. 

“For dietary supplement companies, the GRAS system is often a more attractive option for introducing new products that contain new ingredients that would otherwise be prohibited as new dietary ingredients under the Dietary Supplement Health & Education Act of 1994.”

This is because those wanting to sell a new supplement with a new dietary ingredient have to notify the FDA and show its safety. However, companies can overcome this step if an ingredient is affirmed as GRAS by the FDA and used in food products. If there are no chemical alterations to the ingredient, companies can include it in dietary supplements without notifying it as a new dietary ingredient. 

ANH says the FDA has a more favorable view of GRAS than the new dietary ingredient notification due to its greater familiarity with GRAS procedures and standards.The paper claims that the FDA has a more favorable view of GRAS than the new dietary ingredient notification due to more familiarity with GRAS procedures and standards. “One analysis found the FDA deemed approximately 30% of new dietary ingredient notification submissions as favorable, whereas the agency viewed 75% of GRAS notifications as favorable.”

Balancing safety and freedom 

The paper, endorsed by the Global Wellness Forum and the Organic Consumers Association, argues that self-GRAS enables important and healthy ingredients to reach markets faster. 

The ANH notes that self-GRAS was established in 1998 to prevent unnecessary regulatory burdens on ingredients with a well-established safety record. It believes there is reason to believe most self-GRAS ingredients are known to be safe, and if fully regulated, they would clog FDA notification channels. 

Eventually, it may take years or decades to determine which ones meet new approval standards, the nonprofit flags. The FDA has received and filed more than 1,200 GRAS notices through the official notification process and over 10,000 ingredients are self-GRAS since the program began in 1998.

“By focusing regulatory scrutiny on the small subset of ingredients with demonstrated safety concerns rather than attempting to review all 10,000+ self-affirmed ingredients, this strategy allows the FDA to efficiently protect public health even with limited staff and resources,” the white paper suggests.

However, the paper takes a contrasting stance against EU regulations, which it sees as overly cautious. The region permits only around 400 substances — mostly vitamins and minerals — under harmonized EU-wide rules, which ANH argues may deprive consumers of access to beneficial options. While individual member states may allow additional ingredients, these are not approved across the EU as a whole.

“Our white paper defines a strategy for balanced GRAS reform while avoiding the EU model of extensive regulatory overreach in favor of freedom of choice,” adds Robert Verkerk, Ph.D., ANH’s executive & scientific director and white paper co-author.

Last month, Kennedy directed the FDA to explore how to eliminate self-affirmed GRAS. “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 US food supply without notification to the FDA or the public,” he said.

Meanwhile, a legal analysis urged Congress to authorize user fees for food companies to boost FDA funding and close safety loopholes. The Center for Science in the Public Interest warned that underfunding and restructuring threaten FDA oversight, while major food and health groups urged Congress to allocate US$30 million for chemical safety reviews.