Is this the start of RFK, Jr., making good on his promise to transform the food industry?
Newly appointed Secretary of Health and Human Services (HHS), Robert F. Kennedy, Jr., directed the U.S. Food and Drug Administration (FDA) to “take steps 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 [1],” on March 10, 2025.
The stated rationale for directing FDA to explore the potential elimination of self-GRAS determinations is to “bring transparency to American consumers” about what ingredients are in the nation’s food supply and to close 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,” according to Secretary Kennedy.
Authorization clearing the use of GRAS substances in food stems from the 1958 Food Additive Amendments, which amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to require premarket clearance by FDA for “food additives.” In defining the term “food additive,” Congress specifically excluded from that definition substances that are “generally recognized as safe.” By so doing, Congress exempted GRAS substances from the Food and Drug Administration’s premarket review authority over food additives. (GRAS substances are defined under Section 201(s) in the Act as substances that are “generally recognized, among experts qualified by scientific training and experience to evaluate [their] safety . . . under the conditions of [their] intended use [2].”)
The GRAS Final Rule that the Secretary directed FDA to revise was published in August 2016 and has been effective since October of that year [3]. The rule formally established a voluntary notification process that allowed FDA to consider and comment on, as needed, the GRAS determinations made by industry. In practice, though, FDA began accepting these GRAS notifications in 1997. The GRAS submissions with accompanying data are linked to an FDA Inventory, along with comments made by the Agency on the submissions. Currently, there are 1219 GRAS submissions listed on the Inventory. FDA evaluates an estimated 75 a year. (Prior to 1997, companies were free to petition FDA to affirm by regulation a determination that a substance was GRAS for its intended use. See 21 C.F.R. Part 184.)
Given the personnel cuts and budget shortages being faced by FDA, it remains to be seen whether FDA will have the resources to effectively undertake the regulatory review in any timely way.
There is also a significant question as to what, if any, authority FDA has “to eliminate the self-affirmed GRAS pathway” as described in the press release, without amendment of the Food, Drug, and Cosmetic Act. Right now, the law provides FDA with jurisdiction to authorize only food additives, as defined in the Act, to be used in food. Since the definition of food additive excludes, among other things, GRAS substances, FDA does not have much room, if any, to regulate these substances beyond the way they already have.
Until the day that FDA completes its task of exploring regulatory pathways to end self-GRAS determinations, or Congress intervenes in the meantime to act on the matter, the Secretary’s announcement has no legal effect on the status of ingredients currently marketed.
[1] HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe | HHS.gov
[2] See the Food Additives Amendment Act of 1958, signed into law on September 6, 1958, and amending the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 301 et seq.
[3] Federal Register :: Substances Generally Recognized as Safe