On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS self-affirmation “loophole” for additives in food products.
In the statement issued by HSS, Secretary Kennedy claimed that “[i]ngredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals—often with unknown safety data—to be introduced into the US food supply without notification to the FDA or the public.”
What Is This “Loophole”?
Under the Federal Food, Drug, and Cosmetic Act (FDCA), new substances added to food must be approved by the FDA before the additives may be used in a food product. The FDCA defines “food additives” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” However, substances found to be generally recognized as safe (GRAS) are not considered food additives under the FDCA and may be used in food without FDA pre-market approval.
Traditional GRAS Process
FDA regulations set certain criteria for classifying a food substance as GRAS. To classify a substance as GRAS, there must be “common knowledge” throughout the scientific community that there is a reasonable certainty that the substance is not harmful under conditions of intended use. “Common knowledge” can be established through either known scientific procedures or, for food substances used prior to 1958, based on common use in food.
In 2016, the FDA published a final rule which established a voluntary pathway under which “any person” can determine that a food substance is GRAS under conditions of its intended use and inform FDA of its determination by filing a GRAS notice. A GRAS notice must include certain information to support its determination, including scientific evidence that demonstrates the safety of the substance, and such evidence must be generally known and accepted among qualified experts. Additionally, the notice should include information about the identity and properties of the substance and a discussion of the notifier’s reasons for concluding that the substance is GRAS for its intended use.
The cost of submitting a GRAS notice to the FDA can vary significantly, but it typically involves substantial costs for conducting safety studies and preparing the necessary documentation, potentially ranging from tens of thousands to hundreds of thousands of dollars. The most significant expense is the cost of conducting the necessary safety studies and toxicological testing to demonstrate that the substance is safe under the intended conditions of use. Such studies often take years to design and conduct before compiling the GRAS notification.
Following review of the GRAS notice, FDA will respond to the notifier in a letter stating either that FDA does not question the GRAS determination (via a publicly available “no questions” letter), or that the GRAS notice does not provide a sufficient basis for a GRAS determination.
Self-Affirmed GRAS Process
The “voluntary” pathway operates as the name suggests—voluntarily. Companies may, but are not required, to notify FDA that a substance is GRAS for its intended use. In the GRAS final rule preamble, FDA recognizes that companies may also self-affirm the GRAS status of an ingredient for a particular intended use without notifying FDA. Companies must still maintain the relevant information to support such determination, including proper scientific evidence that demonstrates the safety of the substance. There is no public database identifying self-affirmed GRAS ingredients.
For functional food companies, self-affirmation means faster market entry. Although the FDA reserves the right to evaluate and question a product’s self-affirmation GRAS status, such questions are rare given the agency’s limited resources. As such, functional food companies reap the benefits from the ability to rely on their own safety data.
If the self-affirmation process were removed, functional food companies would be required to follow the traditional GRAS process and inform the FDA whenever they intend to use a novel ingredient that is not a “food additive” or already “generally recognized as safe,” a rigorous and cost-intensive process.
Removing the GRAS “Loophole”
In order to eliminate the GRAS self-affirmation process under Secretary Kennedy’s directive, the FDA would be required to undergo formal notice-and-comment rulemaking to amend FDA regulations. Additionally, because the GRAS exception to premarket approval is written into the FDCA, the FDA cannot eliminate the exception without Congressional approval. Both of these processes would likely take several years to implement and could ultimately result in litigation to challenge the implementation of the change.
If the GRAS self-affirmation process were removed from FDA regulations, functional food companies seeking to introduce new or novel ingredients in foods would be required to notify the FDA of the intended use of such ingredients before introducing them into the food supply.
The FDA currently aims to respond to a GRAS notice within 180 days of filing. However, this timeline is usually extended, and it can often take a year or longer to receive a final response from FDA.
By removing the self-affirming GRAS process, GRAS notice reviews would likely be subject to even longer timelines for review. At a time when the FDA has been subject to large scale layoffs, it is unclear how the FDA would be able to prioritize the review of GRAS notices without significant staffing and resources changes.
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