GRAS at a Crossroads: Inside MAHA’s Reform Agenda 

In a previous post, we explored several proposed federal bills aimed at reshaping food safety regulations—two of which take direct aim at the GRAS (Generally Recognized as Safe) process. At the heart of the debate is the controversial self-affirmed pathway, which allows companies to introduce new ingredients without formal FDA review. With growing scrutiny from lawmakers and public health advocates, this once-standard route may be on the verge of a major overhaul.

In the sections below, we break down what GRAS really means, why the self-affirmed process has sparked concern, and how the proposed legislation could redefine the future of ingredient approval in the U.S. food system.

What is GRAS?

Taken straight form the US FDA website, "GRAS" is an acronym for the phrase Generally Recognized as Safe.¹ Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

The Current GRAS Process

There are two avenues for gaining GRAS approval:

A) Voluntary Notification

B) Self-Determination

Currently, the concerns being raised, and addressed in the proposed bills, surround the self-determination process. Below, each process is outlined with a table comparing certain aspects.

Option A: Voluntary Notification

1. A company develops or selects a food additive
2. It hires a panel of scientists or toxicologists to review the safety data
3. If the panel agrees it's safe, the company submits a "GRAS Notice" to the FDA
4. FDA reviews the submission and says one of the following:
   1. "No questions"
   2. "We disagree"
   3. "Insufficient data"

Option B: Self-GRAS Determination

1. A company decides an ingredient is safe and never notifies the FDA and it enters the food supply chain
2. In almost all cases, the company will hire a scientist to review the safety data

Comparing Self-Affirmed vs. FDA-Notified GRAS

Concerns with Self-Affirmed GRAS

The concerns with the GRAS process lie with the self-affirmed avenue. It's not to say that all companies abuse the self-affirmed pathway, but some companies are accused of using biased safety reviews to get new ingredients to market. The objection raised by lawmakers is that, in many cases, companies use experts that are paid for by the company and give them clearance for ingredients by only looking at the positives and ignoring the safety concerns. It's not to say that if they followed the voluntary notification process that they wouldn't get approved, but it certainly raises concerns for lawmakers and opens the door for abuse. The aim of lawmakers is to end the self-affirmed pathway, and all future ingredients would follow a mandatory notification process through the FDA.

Proposed Legislation

Two bills have been proposed at the federal level that are focused on revamping the GRAS process. While the bills are very similar in nature, the more recent bill (Ensuring Safe and Toxic-Free Foods Act of 2025 introduced by Senator Markey) takes a much bolder approach to reforming the GRAS process. Both bills would end the future self-affirmed pathway, but the Markey bill calls for total overhaul of the GRAS process including reassessing prior self-affirmed ingredients with stricter safety definitions.

Next Chapter 

Both federal bills currently under consideration, along with the latest MAHA report, call for a critical reassessment of the GRAS (Generally Recognized as Safe) process—specifically targeting the elimination of the self-affirmed approval pathway. This mechanism, which allows companies to independently determine the safety of ingredients without FDA review, has come under increasing scrutiny from public health advocates, consumer groups, and policymakers. While there’s no guarantee that either bill will pass, the mounting public pressure suggests that the self-affirmed process is on the brink of a significant overhaul—or perhaps complete elimination.

For companies operating in the food and supplement space, this signals a clear shift in regulatory expectations. To avoid future disruptions, including potential product removals or compliance setbacks, it would be prudent to begin adopting the voluntary notification process now. This more transparent approach not only aligns with emerging policy trends but also demonstrates a proactive commitment to safety and accountability—qualities that resonate with regulators, retailers, and consumers alike.

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Additional Resources 

MAHA & The Food Industry: A New Era of Reform and Responsibility

The MAHA Effect—Even Before Release, Lawmakers Are Acting

References 

1. https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras#:~:text=%22GRAS%22%20is%20an%20acronym%20for,phrase%20Generally%20Recognized%20As%20Safe.
2. Is the FDA Ending Self-Affirmed GRAS? What You Need to Know

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