by Josh Long
September 16, 2025
A future GRAS rulemaking is making waves, and I’m not talking about marijuana.
A proposed rule from the U.S. Department of Health and Human Services (HHS) and FDA would require the mandatory submission of GRAS (generally recognized as safe) notices for the use of human and animal food substances that are purported to be GRAS.
The federal government is targeting October 2025 for the release of a notice of proposed rulemaking.
“FDA is also working to update regulations to reform the ‘generally recognized as safe’ (GRAS) designation to close the GRAS loophole by ending industry’s long-standing practice of introducing ingredients into the food supply without FDA knowledge or oversight,” HHS Secretary Robert F. Kennedy Jr. said in recent remarks on Capitol Hill. “This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers. HHS also is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.”
As Natural Products Association President and CEO Daniel Fabricant, Ph.D., told NutraIngredients-USA on Sept. 9, the proposal raises more questions than answers. It’s not clear — yet — how an amended GRAS rule would impact government oversight of novel dietary ingredients that are first introduced in conventional food and beverages, then later marketed in botanicals, vitamins and other supplements.
Will the GRAS proposal influence FDA’s premarket review of new dietary ingredient notifications, including the volume of submissions it receives annually from supplement companies?
FDA has said that its only statutory mechanism for reviewing the identity and safety of NDIs (before they are marketed in supplements) is through the NDI notification process — not GRAS review.
HHS’s proposal serves as a reminder that enforcement remains a key component to ensuring compliance with FDA’s dietary supplement rules.
Dr. Fabricant, who oversaw the FDA Division of Dietary Supplement Programs under the Obama administration, has urged FDA to rigorously enforce the premarket NDI notification requirement to ensure that NDIs (marketed in supplements) are reasonably expected to be safe.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) features an exception to the notification requirement for certain NDIs in the conventional food supply. Justifiably or not, critics have dubbed this exception “the GRAS loophole,” and argued that the exception has swallowed the rule.
Many responsible companies in the natural products industry have relied on the exception to the NDI notification requirement, are within their legal rights to do so, and have legitimately demonstrated the safety of their dietary ingredients through the self-affirmed GRAS pathway, which does not involve FDA review.
But if there is any doubt over whether an NDI is subject to a premarket notification to FDA — especially if evidence has been presented demonstrating the potential for consumer harm — FDA can and should regularly ask distributors and manufacturers for documentation regarding the legal status of their dietary ingredients, then follow up to ensure the agency isn’t being hoodwinked.
Perhaps, FDA is doing this already. If that’s the case, I wonder why only dozens — and not hundreds of NDI safety dossiers — are submitted annually to the agency in a $70 billion-and-growing industry.
NPA is grateful that FDA has been preparing additional guidance documents and educational materials on NDIs. These materials likely increase our members’ odds of making successful submissions to FDA and clarify the circumstances in which an NDI is subject to notification.
Here’s the rub, though. Without robust FDA enforcement and routine warning letters highlighting such actions, hundreds of pages of NDI guidance documents won’t significantly increase compliance.
Presumably, HHS’s GRAS proposal is focused on conventional food and beverages, but as the natural products industry is well aware, the consequences of a rulemaking are no less significant for supplement makers and distributors.
Any rational conversation around a GRAS rulemaking must not lose sight of FDA’s current authorities and obligations to enforce the NDI notification requirement in DSHEA.
Without vigorous enforcement today, and FDA announcements of its actions to compel compliance, the mainstream media and other critics will continue to disseminate the false narrative that our industry is a Wild West and that FDA lacks the tools to protect the public from harmful new products.
Responsible industry knows that FDA’s dietary supplement rules, including those applicable to NDIs, are effective — but only to the extent that the government exercises the will and devotes the resources to enforce them. A GRAS rulemaking won’t change that fact.
Josh Long is Vice President of Communications and Regulatory Affairs with the Natural Products Association in Washington, D.C. You can reach him at jlong@npanational.org.
