For decades, “GRAS” — Generally Recognized as Safe — has functioned as a quiet cornerstone of food formulation. If an ingredient was GRAS, it was widely assumed to be acceptable for use without much additional scrutiny. For many brands, that assumption became operational shorthand: GRAS meant green light.
That era is shifting.
With the emergence of the MAHA (Make America Healthy Again) movement and increased federal and state scrutiny, ingredients long considered safe are being reevaluated. In some cases, they are being restricted, reformulated, or removed entirely from acceptable use in certain applications. The implication is clear: GRAS is no longer a static designation — it’s a moving target.
What GRAS actually means (and what it doesn’t)
Under the U.S. Food and Drug Administration framework, an ingredient is considered GRAS if qualified experts deem it safe under the conditions of its intended use, based on scientific evidence or a long history of common use in food.
Importantly:
- GRAS does not mean universally safe under all conditions
- GRAS does not require formal FDA approval
- GRAS determinations can be self-affirmed by companies
That last point has drawn increasing attention. Regulators and advocacy groups have questioned whether self-affirmed GRAS creates gaps in transparency and oversight — and whether some ingredients have remained in the food supply longer than they should.
Why GRAS is under pressure now
Several forces are converging:
- Federal review: The FDA has named specific substances — including BHA, BHT, propylparaben, and petroleum-based synthetic dyes — for active post-market safety reassessment. More significantly, FDA is expected to publish a proposed rule requiring mandatory submission of GRAS notices for all self-affirmed substances, a dramatic shift from the current voluntary system that has allowed companies to introduce ingredients without FDA review or public disclosure.
- State-level action: States like California, New York, West Virginia, Texas, and Louisiana continue to push ahead with their own ingredient restrictions and mandatory warning label requirements, often moving faster than federal timelines. During the 2025 legislative session alone, more than 100 bills across 17 states were introduced related to food ingredients.
- Retailer standards: Major retailers — including Whole Foods, Target, and Trader Joe’s — maintain publicly available restricted ingredient lists that go well beyond federal regulatory requirements. For many brands, failing a retailer’s ingredient standards is a faster and more immediate barrier than a regulatory action.
- Consumer pressure: Clean-label expectations are now the baseline, not premium.
MAHA has accelerated this momentum by explicitly targeting ingredients once considered acceptable. This creates a regulatory gray zone in which something may still be technically GRAS — but commercially or regionally nonviable.
Perhaps most surprising: scrutiny now extends to foundational processing ingredients that brands have long taken for granted. In 2025, former FDA Commissioner David Kessler filed a formal citizen petition calling for the revocation of GRAS status for refined carbohydrates used in industrial food processing — including corn syrups, maltodextrin, and extrusion-modified flours. HHS Secretary Kennedy has publicly stated the administration intends to act on that petition. If pursued, the implications for formulation across the packaged-food industry would be far-reaching.
What this means for your formulation strategy
Food and beverage companies can no longer treat GRAS status as a one-time checkbox. Instead, it must be actively managed as part of a broader compliance and risk strategy.
Key actions to consider:
- Build ingredient transparency from the ground up
Know not just your ingredients, but your sub-ingredients, carriers, and processing aids. Many compliance risks are hiding one layer down. - Invest in formulation intelligence tools
Platforms like ESHA Genesis R&D allow teams to track ingredient composition, flag regulatory concerns, and model reformulations quickly. This is becoming less of a “nice to have” and more of an operational necessity. - Pressure-test your portfolio
Identify which products rely on ingredients that are under scrutiny. Prioritize reformulation pathways before mandates force rapid change. - Monitor state-by-state divergence
A product compliant at the federal level may not be viable in California or other leading states. Market access planning must now include regulatory mapping. - Document your GRAS rationale
Whether self-affirmed or supplier-supported, maintain clear documentation of safety determinations. Expect increased demand for substantiation.
The bottom line
GRAS still matters — but it no longer guarantees stability.
The opportunity right now is to get ahead of the curve: treat GRAS as a dynamic input rather than a fixed conclusion. Companies that invest now in visibility, systems, and reformulation readiness will be far better positioned as regulatory definitions continue to evolve. (Read our next blog: “GRAS is Changing: What Your Company Needs to Do Next“)
