Under the self-affirmed GRAS pathway, US food companies can add new additives to products without notifying the FDA. At least 111 ingredients entered the food supply this way, per an EWG analysis from March 2026. HHS directed the FDA in March 2025 to close this pathway. A proposed rule is expected in late spring or early summer 2026.
Walk into any grocery store, pick up a packaged product, and you will find a list of ingredients. Most people assume each ingredient on that list was evaluated by a government agency before reaching store shelves. For many ingredients, that assumption holds. For a meaningful number of them, it does not.
A regulatory category called self-affirmed GRAS is how companies can legally add ingredients to food without submitting any safety file to the FDA. At least 111 additives entered the US food supply this way. That number comes from a March 2026 Environmental Working Group analysis and represents documented, traceable cases.
That gap is now closing, slowly. This post explains how it works, what is changing, and what shoppers can do now.
What is self-affirmed GRAS, and how does it actually work?
GRAS stands for Generally Recognized As Safe. Under 21 CFR 170.30, it is a US food law category for ingredients with a long history of safe use that do not require formal pre-market FDA approval. Congress created this pathway to avoid burdening regulators with routine reviews of obviously safe ingredients like salt, vinegar, and vegetable oil.
Two paths lead to GRAS status:
The notification path: A company voluntarily submits its safety evidence to the FDA. The agency reviews the file and, if satisfied, issues a "no objection" letter. This step is voluntary, not mandatory. At least a federal scientist reviews the data.
The self-affirmation path: A company convenes its own panel of experts, reviews its own safety data, concludes the ingredient qualifies as GRAS, and adds it to food. No notification to the FDA is required. No government scientist ever sees the file. The ingredient can appear in products on store shelves from that point forward (21 CFR 170.30; Nutritional Outlook).
The second path is the one that attracted regulatory scrutiny. A company effectively acts as the judge of its own safety case. The FDA has no formal window into how many determinations have been made, which ingredients they cover, or what evidence was reviewed.
How many food additives have entered the US food supply through this pathway?
At least 111 food additives entered the US food supply through the self-affirmed GRAS pathway, according to the EWG March 2026 analysis. EWG drew from corporate press releases, trade publications, the AIBMR GRAS substance database covering 2001 to August 2025, the FDA voluntary submissions database, and the USDA Branded Foods Database. The 111 figure represents traceable, documented cases, not an estimate.
Each of those 111 additives is legal. Each can appear on an ingredient list today. Until recently, no rule required the companies that added them to notify the FDA they existed.
This is what a regulatory gap looks like: a class of ingredients that passed a safety review with no government body involved. These additives might be entirely benign. The point is that no independent party checked.
See our guide to common food additives for a broader breakdown of how US additive categories work.
What is the FDA actually proposing to change in 2026?
On March 10, 2025, HHS Secretary Kennedy directed the FDA to begin rulemaking to eliminate the self-affirmed GRAS pathway (Epstein Becker Green; American Bar Association). The stated rationale was closing the gap between what companies determine internally and what the public can verify.
By late 2025, the proposed rule was under review at the Office of Management and Budget. In March 2026, the FDA's food chemical safety chief confirmed a proposed rule was expected that spring or early summer (Chemical & Engineering News; Food Business News).
The current direction is to close the self-affirmed pathway for new additives. A final rule would require companies to submit safety evidence for government review before adding a new ingredient to food, rather than running the process internally (Venable LLP).
What about the 111 additives already in the supply? No clear answer yet. The treatment of ingredients that already entered the food supply through self-affirmation is not defined in the current proposal. No announcement of a retroactive review process has been made. Regulatory finalization for complex rules typically takes well over a year, often longer. Any change in status for existing ingredients is years away at best.
Which common ingredients on US shelves were approved this way?
The EWG March 2026 analysis names specific documented cases. Green tea extracts and alternative proteins from fermentation and fungi are among the ingredients that entered the food supply via self-affirmed GRAS determinations. You find them in functional beverages, plant-based protein products, and wellness supplements.
These examples matter because they show the self-GRAS pathway was not reserved for obscure industrial chemicals. Ingredients consumers associate with "natural" or "functional" categories used the same process as synthetic additives.
The labeling problem makes this harder to track. US food labels do not disclose which GRAS pathway an ingredient used (EWG). An ingredient reviewed by the FDA and one the company assessed internally look identical on the ingredient list. No asterisk, no notation.
The titanium dioxide piece on our blog shows a related pattern: the same ingredient can face a ban in one jurisdiction while remaining approved in another, depending on how regulators interpret the same safety file. The GRAS gap is one layer of this; regulatory divergence across borders is another.
What does this mean for clean-label shoppers right now?
In practical terms, not much changes at the grocery store today. Even if the proposed rule is finalized, the 111-plus additives already in the food supply are not subject to automatic re-review under the current proposal. Regulatory finalization takes well over a year after publication. A realistic effective date for a final rule would be late 2027 or beyond.
The practical move right now is knowing what is in the products you buy.
Ingredient lists are long and use technical names most people cannot parse on sight. Most shoppers cannot tell whether a specific compound went through formal FDA review or company self-review just by reading a label. A food transparency tool handles the decoding.
The NoJunk app shows the regulatory profile of each ingredient in the products you scan. It gives you the ingredient-level picture that label reading alone does not provide. You can also cross-reference specific additives using our food additives guide.
The regulatory shift is real. The timeline runs in years. Knowing what is in your food now is the step you can take today.
NoJunk reads any ingredient list with your phone camera and flags additives with weak regulatory oversight, controversial dyes, and ultra-processing markers. Download free on iOS.
Frequently Asked Questions
What does "GRAS" mean?
GRAS stands for Generally Recognized As Safe. It is a US food law category under 21 CFR 170.30 covering ingredients with a long history of safe use that do not need formal pre-market FDA approval. Congress designed it for obviously safe and widely used ingredients. The problem that led to the HHS March 2025 directive is that the same exemption was applied to novel ingredients for which "generally recognized" is a much harder standard to meet.
Can a company really decide that its own ingredient is safe?
Under the self-affirmed GRAS pathway, yes. A company can convene its own expert panel, review its own data, conclude the ingredient qualifies as GRAS, and begin adding it to food without ever notifying the FDA (21 CFR 170.30). The company retains the safety file, but that file is never submitted to or reviewed by any government body unless the FDA initiates an inquiry. The HHS March 2025 directive named this exact mechanism as the one to be eliminated.
When will the new FDA rule take effect?
The FDA is expected to publish a proposed rule in late spring or early summer 2026 (Chemical & Engineering News). A proposed rule is not a final rule. It goes through a public comment period, then agency review of comments, then a final rule. Regulatory finalization for complex rules typically takes well over a year. A realistic effective date, if the rule is finalized as proposed, would be late 2027 or later.
Will additives already in food have to be re-reviewed?
The current direction is to close the self-affirmed pathway for new additives going forward. The treatment of additives that already entered the food supply through self-affirmation is not yet defined in the proposal (Venable LLP). No retroactive review process has been announced. Existing self-GRAS additives may remain on the market under current status while any further regulatory process plays out.
How can a shopper tell whether a food contains a self-affirmed GRAS additive?
US labels do not distinguish self-affirmed GRAS from FDA-reviewed GRAS (EWG). The ingredient name looks the same either way. A food transparency tool is currently the most reliable way to flag ingredients with limited independent safety review. The NoJunk app shows the regulatory profile of each ingredient in the products you scan.
Last reviewed: May 17, 2026