Food Safety & Regulatory: The Future of GRAS Self-Determinations
Serious consideration must be given by FDA as to whether the agency has the authority to dispatch the self-affirmed Generally Recognized As Safe pathway without amending the Food, Drug, and Cosmetic Act.
In an unexpected move, Robert F. Kennedy Jr., Dept. of Health & Human Services (HHS) secretary, directed the FDA “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.”
The announcement, which was issued on March 10, also indicated that HHS was “committed to working with Congress to explore ways legislation can completely close the GRAS loophole.” FDA may encounter a myriad of difficulties trying to carry out this task by way of the rulemaking process considering current statutory provisions and a host of other practical considerations.
The concept of GRAS substances stems from the 1958 Food Additive Amendments, which revised the Federal Food, Drug, and Cosmetic Act (FDCA) to require premarket authorization by FDA for food additives. In defining the term “food additive,” Congress specifically excluded any substance that is “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures ... or experience based on common use in food to be safe under the conditions of its intended use.”
In other words, Congress concluded that if scientific experts could readily agree that a substance is safe, there was no need for FDA to approve it as safe as well. Thus, this provision of the law recognizes that since GRAS substances are, by definition, not food additives, FDA cannot require such substances to be subject to agency authorization by way of a notice or a petition prior to marketing these substances.
Nonetheless, FDA did institute an affirmation process, whereby a company taking a GRAS position could submit a petition requesting FDA to affirm its conclusion of GRAS.
However, in 1997, FDA proposed a rule to replace the GRAS affirmation process with a notification system. This rule established a notification procedure where FDA can consider and comment on (though not endorse) the GRAS determinations made by industry. Importantly, under the GRAS notification process, a party is permitted, but is not required, to notify the agency of its GRAS determinations.
Several practical and legal questions arise as to how FDA can carry out Secretary Kennedy’s missive. First, Secretary Kennedy in March slashed some 10,000 jobs at HHS, which included 3,500 at FDA. Given these deep personnel cuts, one must ask whether the agency will have sufficient human resources to undertake this regulatory review in a timely way.
Second, and perhaps more significantly, serious consideration must be given by FDA as to whether the agency has the authority to dispatch the self-affirmed GRAS pathway without amending the FDCA – a point which, notably, FDA had previously conceded and a point on which FDA prevailed in a case a few short years ago. Amending the FDCA would require an act of Congress.
As to the HHS commitment to work “with Congress to explore ways legislation can completely close the GRAS loophole,” several legislative attempts on the federal and state levels have been made in the last few years to modify the GRAS program at FDA. While none of these efforts had gained much traction previously, attention by a cabinet secretary of a Republican administration combined with support of consumer food safety advocacy groups could muster bipartisan support for the effort. However, whether such legislation could be successful without some level of consensus among FDA, the food industry, and consumer advocacy groups remains to be seen.
Practically speaking, were FDA to be granted authority to require premarket notification of GRAS determinations, how the program would operate in practice would need to be determined. For example, would businesses that rely on GRAS status for specified ingredients or components be required retroactively to seek FDA review, and would FDA be willing to extend enforcement discretion while that process is being undertaken?
Additionally, would the FDA review period for reviewing GRAS determinations be time-limited or could the process take years to complete, as is the case now with Food Additive Petitions? Further, what liability could extend to a downstream user who is unaware that its product contains a self-GRAS substance?
The most important takeaway for now is that Secretary Kennedy’s announcement has no legal effect on the status of ingredients currently marketed as GRAS and will not until FDA completes its task of exploring regulatory pathways to end self-GRAS determinations or Congress intervenes through legislation. In the meantime, industry stakeholders should closely monitor legislative and regulatory developments, as potential changes could reshape the future of food safety compliance in the U.S.
*This article is reprinted with the permission of Food Processing Magazine. It first appeared in the May 2025 issue.