The white paper was developed in response to a March 10 directive from Robert F. Kennedy Jr., Secretary of the Department of Health and Human Services, for the Food and Drug Administration (FDA) to explore the elimination of the self-affirmed GRAS pathway for ingredients.
“We support Secretary Kennedy’s intention to remove the most toxic substances from our food supply,” said 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.”
GRAS: With or without notification
Generally Recognized as Safe (GRAS), established by the Food Additive Amendment of 1958, is a determination that a substance added intentionally to food is deemed to be safe under its intended conditions of use. It is a notification process and not an approval process.
Under the statute, there are two options available to companies: One is to submit their safety data to the FDA. If the agency does not object to the determination, it will issue a letter of no objection, colloquially referred to as a “Good Day Letter”. Notifications to FDA are publicly available via the FDA’s GRAS inventory.
The other option is to convene an independent panel of experts and have them assess the safety data. This is what is known as self-affirmed GRAS. A company is not required to notify FDA of its self-affirmed status, and there is no public database or listing of self-affirmed ingredients.
Secretary Kennedy discussed the GRAS pathways during his confirmation hearings and recently directed FDA to take steps to explore potential rulemaking to revise its Substances GRAS Final Rule and related guidance 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 U.S. food supply without notification to the FDA or the public,” Secretary Kennedy said in a press release.
“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.”
ANH proposal for an alternative
The ANH white paper advocates for an alternative to the total elimination of the self-affirmed GRAS pathway.
“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 stated.
ANH’s white paper has reportedly been endorsed by a range of groups, including the the Global Wellness Forum, the Organic Consumers Association, and the National Foundation for Integrative Medicine.
The Council for Responsible Nutrition welcomed the white paper, telling NutraIngredients: “The ANH white paper raises a number of persuasive objections to the proposal to completely eliminate the self-GRAS pathway, ones that CRN’s own members have also raised and that would cripple innovation.
“The ANH paper likewise offers some thought-provoking solutions that would address legitimate concerns about the current self-GRAS process that introduces opportunities for potential conflicts of interest, bias, lack of transparency and insufficient scientific rigor.
“We look forward to sharing these recommendations with CRN’s member Task Force on self-GRAS and evaluating their benefits and feasibility. Ultimately, we share the same goals as ANH to enhance transparency, strengthen oversight, ensure rigor and prioritize public health without stifling responsible innovation or inadvertently harming public health by preventing safe products from reaching the consumer.”
“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,” said Robert Verkerk, Ph.D., ANH’s executive and scientific director and white paper co-author. In Europe, only about 400 ingredients are currently permitted as food additives.
Key points
The white paper proposes several key reforms:
1. Targeted Approach to Unsafe Ingredients: Prioritize the removal of specific unsafe ingredients, such as potassium bromate, propylparaben, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium benzoate and brominated vegetable oil (BVO).
2. Public Transparency Register: Create a comprehensive online database of all GRAS determinations to complement the FDA’s recently announced Chemical Contaminants Transparency Tool.
3. Tiered Risk/Benefit Assessment: Implement a four-tier system that calibrates evidence requirements based on an ingredient’s history of use and safety profile. “Substances with at least 30 years of safe use would face minimal requirements, while those with evidence of potential toxicity would require more robust safety data,” ANH stated.
4. “Safe Harbor” for Time-Tested Ingredients: Create a pathway for ingredients with a documented history of safe use for over 60 years, predating the 1958 Food Additive Amendment.
5. Appropriate Warning Requirements: When specific populations may be vulnerable to otherwise safe ingredients, warnings rather than outright bans should be required. The FDA would recognize such warnings as creating a presumption of safety for the ingredient.
NPA: ‘An important part of the discussion’
Commenting on the ANH proposal, Dr. Daniel Fabricant, president and CEO of the Natural Products Association, said: “I think the overarching principle about the precautionary principle not being the driver behind any new or overhauled GRAS system is an important part of the discussion.
“Speaking independent of the white paper, the conversation on GRAS really needs to be focused on what specific and real problems are looking at being addressed, not just hypotheticals and concerns, which many are trying to get their foot in the door and emotionally charge those discussions. With very rare exception, emotion makes for bad policy.”
