Eliminating GRAS Self-Affirmed Route Will Change Direction of U.S. Food Industry

SINCE GRAS (Generally Regarded as Safe) was established in 1958, its implementation has had a significant impact on the US food supply.

With pressure mounting on food substances, and with the Department of Health & Human Services (HHS) having ordered the Food and Drug Administratioin (FDA) to find a route to eliminate the self-affirmed GRAS pathway for food and beverage ingredients, we are on the precipice of a new direction that is likely to result in increased oversight and slower FDA responses.

Any substance that becomes a component or otherwise impacts the characteristics of food (that is, used in processing, storing, transporting) is considered a food additive and requires pre-market approval unless it can be established as GRAS. A substance used in the specified conditions can be recognized generally recognized as safe (GRAS) based on:

• History of use preceding 1958 (for example, sodium chloride/salt)
• Scientific procedures (for example, many sweeteners) based on generally available and generally accepted data.

Common examples of GRAS substances include salt, vinegar, baking powder, ascorbic acid and citric acid. If any food contains a substance that has not been pre-qualified as either an additive or GRAS, the food is considered adulterated, which is a criminal offense.

Both food additives and GRAS substances are held to the same safety standard of reasonable certainty of no harm. In the current process, food additives result in legal rules from the FDA, whereas GRAS status is not certified by the FDA.

GRAS has evolved over three distinct waves. In the first wave, the GRAS List was established with substances in the food supply pre-1958.  For a new substance, manufacturers requested FDA opinion letters for an informal opinion on its GRAS status based on either history of use or scientific procedures.

The second wave commenced when the FDA removed cyclamate salts from the GRAS list in 1969, given its linkage to tumors in rats. This drove the Nixon Administration to direct the FDA to reexamine the safety of GRAS substances, resulting in tightened oversight and rule making. Contractors formed a Select Committee of GRAS Substances to complete independent evaluations of GRAS substances with the FDA then reviewing the results to decide on whether to issue a final rule. In later years, industry would submit GRAS petitions directly to the FDA.

By 1990, virtually all GRAS affirmation petitions took more than 72 months to complete, slowing innovation and product development and driving the need for a more efficient process. This brought about a third wave in 1997 with the GRAS notification and self-affirmation process, which is what we have today.

The GRAS notification process starts with manufacturers submitting notices to the FDA, which issues a response letter (not a certification or approval). A self-affirmation route was also established that doesn’t require any involvement of the FDA, but requires companies follow the same process and gather the same level of data and expert consensus as the notification route. This self-affirmation process is now what is being called into question and is driving a fourth wave of change for GRAS.

What’s driving this new wave is that an estimated 1,000+ substances have entered the food supply without FDA’s knowledge through the self-affirmed route and, in select cases, food products have been adulterated without food additive approvals or GRAS status.

Moving from GRAS petitions to notices and self-affirmation has significantly sped up the GRAS process. The challenge is that the FDA isn’t aware of the GRAS status of all substances from the self-affirmed route. While GRAS theoretically provides equal safety standards to the food additive route, it relies on independent food value chain compliance, rather than oversight. Case studies indicate that it sometimes fails in the real world.

Challenges around GRAS are nothing new. Efficient routes to GRAS status have brought improved speed-to-market and innovation, but have increased adulteration risk. Intensive rule-making processes have ensured the substances in the food supply meet the reasonable certainty of no harm, but have stalled innovation.

Eliminating self-affirmed GRAS will require more FDA oversight on food substances. This is challenged by the February 2025 FDA employment cuts. These cuts included members of the Human Foods Program, including toxicologists and microbiologists, who worked on food additive approvals, GRAS notification responses and food substance post-market reviews.

A change to the GRAS pathway will result in industry players needing to prepare notification to the FDA on every GRAS substance. This means companies will have to review their entire portfolio for GRAS substances that were established through the self-affirmed route over the last 25 years and prepare notifications for each.

As GRAS is revised, the Administration needs to determine how to ensure proper yet expedient review of substances so that the pace of product development is not stifled.  Whatever final decision is made, it will most certainly lead to a new wave of direction for the U.S. food industry.  
Michelle Briffett is Principal, Roland Berger. For more information, please visit www.rolandberger.com.