While there are numerous pathways for companies to bring substances intended for use in or in contact with human food to market, a recent directive from the U.S. Department of Health and Human Services (HHS) to the U.S. Food and Drug Administration (FDA) to begin rulemaking could result in changes to the generally recognized as safe (GRAS) pathway that will impact the food and beverage industry. Beyond FDA, we’ve also seen state action aimed at reforming the GRAS pathway. 

Use of the GRAS Pathway

While FDA premarket review and approval is required for food additives, substances that are GRAS for the intended use are explicitly excluded from these requirements. 

 Under the Federal Food, Drug, and Cosmetic Act, the definition of “food additive” excludes any substance that is generally recognized “among experts qualified by scientific training and experience to evaluate its safety” to be safe under the conditions of its use. Demonstrating that a substance is GRAS for the intended use requires “common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the conditions of its intended use.” 

For substances that were not used in food before Jan. 1, 1958, this knowledge must be based on “scientific procedures” and “require[s] the same quantity and quality of scientific evidence as is required to obtain approval of a food additive.” 

While FDA has historically “strongly encouraged” using the voluntary GRAS notification program, companies are permitted to reach their own position that a substance is GRAS for the intended use without premarket consultation or review by FDA, known as a self-affirmed GRAS position. The same quantity and quality of scientific evidence is required to support a GRAS determination, regardless of whether a notification is submitted to FDA. 

In 2021, a federal court in New York upheld use of the GRAS pathway by the food and beverage industry, including FDA’s authority to permit industry to rely on self-affirmed GRAS positions, noting that FDA retained the power to take enforcement action if it disagreed with a GRAS determination. 

Risks and Benefits for Industry 

A company is ultimately legally responsible for ensuring that its food and beverage products do not raise a health or safety concern, no matter what was relied upon to establish a suitable FDA regulatory status for the products’ ingredients and packaging materials. 

Reliance on a self-affirmed GRAS position allows for the immediate use of a new ingredient or component of packaging material upon concluding that it is GRAS for the intended use, while use of the GRAS notification program requires waiting until FDA acknowledges the notification via a “no questions” letter (though it is also possible that FDA could conclude that the notice does not provide a sufficient basis for a GRAS conclusion or cease evaluating the GRAS notice at the notifier’s request). 

While FDA is required by law to respond to submitted GRAS notifications within 180 days, it can extend that statutory deadline by 90 days if needed. In practice, it can take much longer to receive a response from FDA, resulting in delays in bringing new ingredients and packaging materials to market. 

Proposed Changes

We have already seen FDA become more active in reconsidering the safety of approved food additives. FDA has also proposed new approaches for its post-market assessment of substances present in human food and published a discussion paper outlining its proposed approach for identifying and targeting substances that are currently in the food supply for post-market review. 

States have taken similar actions. Most recently, West Virginia passed new legislation that will ban the use of certified color additives and two preservatives in food and beverage products beginning Jan. 1, 2028, adding to the myriad existing and proposed state-specific restrictions on food additives. 

Self-affirmed GRAS determinations made by industry, which have been permitted since 1997, are also now being called into question at federal and state levels, even without any type of health or safety concern associated with the intended use of the substances that are designated as GRAS. 

Federal: The Secretary of HHS, Robert F. Kennedy Jr., has called for heightened government oversight of ingredients used in food as part of the “Make America Healthy Again” agenda. This includes reconsideration of FDA’s food additive standards, including rulemaking to eliminate industry’s ability to rely on a self-affirmed GRAS position for substances used in or in contact with food and beverage products.  

On March 10, 2025, HHS issued a notice indicating that FDA was directed “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.” The aim is to “require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.” Legislation is another option being explored to eliminate the self-affirmed GRAS pathway. 

State: There are also proposed changes at the state level that would require industry to share information used to support GRAS determinations for substances used in or in contact with food and beverage products. For example, the Food Safety and Chemical Disclosure Act was proposed in New York that would require a report containing specified information about “any new use of any GRAS substance” to be submitted to the commissioner of the New York State Department of Agriculture and Markets (and included in a state database). Among other items, that report would have to include details about “certain characteristics of the data and information being used as the basis for the manufacturer’s conclusion that the substance is GRAS.” 

Recommendations for Industry

Proposed changes to the GRAS pathway could significantly impact the way new substances intended for use in or in contact with human food are brought to market. To prepare for federal or state actions that could affect the use of the GRAS pathway, the food and beverage industry should consider taking these actions:

• Identify a point person at your company to evaluate all ingredients and packaging materials used for your food and beverage products. Special attention is required for substances that are used in or in contact with food and beverage products already on the market based on a self-affirmed GRAS position. 
• Consider the potential need to reformulate or repackage new and existing food and beverage products in response to state and federal requirements.
• Start thinking ahead about new ingredients and packaging materials for food and beverage products in your portfolio, as changes to FDA’s food additive standards and GRAS pathway could result in delays in your ability to bring new products to market.
• Continue to track developments in the administration’s “Make America Healthy Again” agenda and state-specific developments related to food additives and substances that are designed as GRAS for the intended use, including notices of proposed rulemaking and opportunities for input from industry.