FDA Directed to Explore Elimination of Food Additive "Loophole"
Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA.
On March 10, 2025, U.S. Department of Health and Human Services ("HHS") Secretary Robert F. Kennedy Jr. announced that he directed the U.S. Food and Drug Administration ("FDA") to explore potential rulemaking to revise its oversight of food ingredients that are "generally recognized as safe" ("GRAS"). Specifically, Kennedy directed FDA to take steps to revise its GRAS Final Rule and related guidance to eliminate the "self-affirmed GRAS pathway."
Under current law, food ingredients and additives are generally subject to premarket review and approval by FDA, unless an exception applies. One such exception is for GRAS substances. A GRAS substance is one that is generally recognized among qualified experts as shown to be safe under the conditions of its intended use. For these substances, FDA encourages—but does not require—manufacturers to submit a notification to the Agency with evidence of the substance's safety before marketing a food containing the substance. Manufacturers may instead independently conclude, or "self-affirm," that the substance is GRAS and market foods containing it without any notification to or approval by FDA. The GRAS standard is identical regardless of whether a company notifies FDA or self-affirms.
Kennedy seeks to eliminate the GRAS self-affirmation option through his directive, which would require formal notice-and-comment rulemaking. If implemented, companies seeking to introduce new ingredients in foods will be required to publicly notify FDA of the intended use of such ingredients before introducing them into the food supply. And because imported and domestically produced foods must meet the same legal requirements in the United States, manufacturers of imported foods would also no longer be able to utilize GRAS self-affirmations. However, because the GRAS exception to premarket approval is written into the applicable statute, FDA cannot wholly eliminate the exception without Congressional action. Kennedy's announcement notes that HHS is "committed to working with Congress to explore ways legislation can completely close the GRAS loophole."
We will continue to monitor proposed changes to the regulation of food additives and the GRAS pathway, including both through FDA rulemaking and Congressional action.
