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FDA’s Proposed GRAS Rule: What Food Manufacturers Should Know

Articles
September 3, 2026

by Katie Harshman and Laura Short

The FDA recently proposed changes to the Generally Recognized as Safe (GRAS) framework that would make certain notifications mandatory. The proposal is not final, and nothing changes for manufacturers today.

From TriVista’s view, no immediate action is required, but manufacturers should be aware of the proposal. If finalized, we expect it to mean additional work for suppliers bringing new ingredients to market and greater manufacturer diligence around the ingredients they source and how they are used.

What is GRAS?

GRAS stands for “Generally Recognized as Safe.” In practical terms, it refers to substances whose safety for a particular food use is generally recognized by qualified experts based on scientific evidence, or substances used in food before 1958 based on experience from common use in food.

Examples of longstanding GRAS substances include flavorings such as salt and other spices, preservatives such as citric acid and lactic acid, emulsifiers such as lecithin, antioxidants such as vitamin E, and stabilizers such as guar gum.

Currently, if an ingredient meets the legal requirements to be considered GRAS for it’s intended use, it does not have to go through FDA’s food additive approval process.

Today, FDA notification is voluntary. A company can independently conclude that an ingredient is GRAS for its intended use without first notifying FDA, or it can voluntarily submit a GRAS notice to FDA for review.  Importantly, a GRAS conclusion applies to its specific conditions of use, including amount and product type.

What are the Proposed Changes?

In March 2025, the U.S. Department of Health and Human Services asked FDA to explore changes to the current GRAS framework.

On August 10, 2026, the FDA proposed a rule that would make GRAS notifications mandatory. Under the proposal, companies relying on a GRAS conclusion would be required to notify the FDA and provide scientific information supporting that conclusion.

The goal is to give the FDA greater visibility into substances entering the food supply through the GRAS pathway. It would also put greater emphasis on the scientific evidence and documentation supporting a company’s GRAS conclusion.

For manufacturers, that documentation piece is important. It may no longer be enough to simply know that a supplier considers an ingredient GRAS; manufacturers may need greater visibility into the basis supporting that conclusion.

The Key Point: Nothing has changed yet, and the rule is still only a proposal. The current voluntary notification framework remains in place, and the FDA is accepting comments through December 9, 2026.

Source: FDA proposed rule and comment information

What Could This Mean for Food Manufacturers?

If the rule moves forward, the practical question for manufacturers will be: How well do you understand the GRAS basis for the ingredients you buy?

  • Has your supplier submitted a GRAS notice to FDA?
  • If not, how did the supplier reach its GRAS conclusion?
  • What scientific evidence and documentation support that conclusion?
  • Does the GRAS conclusion cover how you use the ingredient, including the amount used and the type of product?

Manufacturers do not necessarily need answers to every one of these questions today. But if the proposal advances, companies with well-documented ingredient and supplier approval processes will likely be better positioned to respond.

What Should Manufacturers Do Now?

The FDA proposed a change to the GRAS framework worth watching, but the new requirements are not yet final and could change during the rulemaking process.

For most manufacturers, this is a monitor-and-prepare issue, not an immediate compliance concern. The proposed rule does not currently require manufacturers to change their products or processes immediately.

Companies that want to prepare can use their normal supplier and ingredient review processes to better understand which ingredients rely on GRAS conclusions, whether those conclusions were submitted to FDA, what supporting documentation is available, and if the GRAS conclusions fit their use of the substance

There is no need to overhaul supplier approval programs today, but knowing where potential gaps exist could make it easier to respond if FDA ultimately finalizes the requirements.

Need Help Navigating Evolving Food Safety Requirements?

TriVista helps food and beverage companies assess regulatory compliance, supplier quality, and operational readiness. We can help identify gaps in ingredient documentation, supplier oversight, and review processes, then prioritize practical next steps as requirements evolve.

Learn more about TriVista’s Food & Beverage consulting services.