A little-known regulatory pathway lets food companies add thousands of ingredients to your food without any FDA safety review. Here is how GRAS works, why it matters, and what is changing.
When you scan an ingredient list and see something unfamiliar, you might assume the FDA reviewed it before it landed in your food. For thousands of additives, that assumption is wrong.
The United States allows approximately 10,000 substances in the food supply. The European Union allows around 2,000. That gap is not explained by science. It is explained by a regulatory pathway called GRAS, and it has become one of the most significant consumer safety debates in food policy.
The GRAS designation comes from the Food Additives Amendment of 1958, which Congress passed to require FDA safety reviews before new substances could be added to food. The law carved out an exception for substances with a well-established safety track record, those that were "generally recognized as safe" by qualified experts based on published scientific evidence.
The original intent was narrow. Salt, vinegar, flour, baking soda. Ingredients with centuries of safe consumption history. No one thought it made sense to run years of animal trials on table salt.
That intention made sense in 1958. What happened over the following decades did not.
The law requires that a substance be "generally recognized" as safe, meaning there must be broad scientific consensus, based on publicly available evidence, that the ingredient is not harmful at the levels it is used.
What the law does not require is that any government body verify that conclusion.
Since 1997, the FDA has run a voluntary GRAS notification program. Companies that want to introduce a new ingredient can submit a dossier for FDA review and receive a "no questions" letter confirming their determination. Over 1,200 notifications have been filed this way.
The voluntary pathway is not the problem. The problem is the alternative.
Companies may also simply decide, on their own, that an ingredient qualifies as GRAS. This is called self-affirmation. They hire their own panel of experts, review the safety data themselves, and reach their own conclusion. They are not required to inform the FDA. They are not required to submit to any public review. No database of self-affirmed GRAS ingredients exists.
How many ingredients have entered the food supply this way? No one knows precisely, because the pathway is secret by design.
A March 2026 investigation by the Environmental Working Group identified at least 111 food chemicals that companies had self-affirmed as GRAS without notifying the FDA. Of those, 49 were found in thousands of products listed in the USDA's Branded Foods Database, a public database of commercial food products and their ingredients. None of the 111 chemicals had gone through any form of public government safety review before entering the food supply.
The broader estimate is starker. The Natural Resources Defense Council has reported that more than 1,000 additives in the US food supply have never received a formal FDA review of any kind. They entered the food supply through self-affirmation and stayed.
The GRAS pathway's critics point to several cases where self-affirmation produced outcomes that later required regulatory correction.
Partially hydrogenated oils. Trans fats were considered GRAS for decades. Companies self-affirmed their use in margarines, crackers, baked goods, and fried foods. Research connecting trans fats to cardiovascular disease accumulated slowly, and the FDA did not revoke GRAS status for partially hydrogenated oils until 2018, well after their health risks were well established. The delay cost years of public health exposure to a known harm.
BHA (butylated hydroxyanisole). This preservative appears in cereals, cured meats, snack foods, and baked goods under GRAS status. The National Toxicology Program classified it as a probable human carcinogen decades ago. The European Union restricts it in foods. The FDA ordered a new safety reassessment in February 2026, decades after independent researchers flagged concerns.
Four Loko and caffeinated alcohol. Caffeine is a legitimate GRAS substance for use in colas and certain beverages. In the mid-2000s, alcoholic beverage brands self-affirmed that caffeine was also GRAS for use in highly alcoholic energy drinks. The FDA eventually determined these self-affirmations were illegal, citing evidence of serious injury and death linked to the combination. But by then, the products had been on the market for years.
Tara flour. In 2022, the FDA challenged a self-affirmed GRAS determination for tara flour, a legume-based ingredient that had entered the food supply without agency review. The FDA concluded the ingredient had not been adequately studied for safety.
Each of these cases followed the same pattern: a company or industry made a private safety determination, the ingredient entered the market, problems emerged later, and a correction took years.
Critics of self-affirmation focus not just on the secrecy but on the structural conflict of interest embedded in the process.
Companies determine their own safety conclusions. They hire their own expert panels. They commission their own studies. The financial incentive to reach an affirmative GRAS determination is obvious.
A 2010 report found that in voluntary GRAS notifications, the panels assessing ingredient safety were often composed of individuals with direct financial ties to the company seeking the GRAS determination. None of the self-affirmed cases that regulators later challenged were voluntarily withdrawn by the companies that approved them.
The EU operates on a fundamentally different principle. Under European food law, a new additive cannot enter the food supply without a pre-market authorization from the European Food Safety Authority. The burden of proof is on the manufacturer to demonstrate safety, not on regulators to prove harm after the fact. That process explains why the EU permits roughly 2,000 food additives compared to the US figure of 10,000.
Two significant legislative efforts are targeting the GRAS loophole, both at the state level.
California AB 2034, introduced in early 2026, would require food companies to submit notice to the California Department of Public Health before using any new food additive or dietary ingredient in products sold in the state. The California department would review the notice, publish it in a public database, and either issue or decline a license for the additive. Critically, the bill would prohibit any substance shown to cause cancer from receiving a GRAS designation in California, even if the FDA has approved it federally. It would also end the ability of companies to hide ingredients under vague terms like "natural flavors," "artificial flavors," "spices," and "artificial colors," requiring full ingredient disclosure. AB 2034 is currently in the legislative process, with requirements set to take effect July 1, 2027 if passed.
New York's Food Safety and Chemical Disclosure Act passed both the State Assembly and Senate as of April 2026 and was awaiting the governor's signature. It would require public disclosure of GRAS substances used in foods manufactured or sold in New York, creating the kind of transparency that federal law has never required.
At the federal level, HHS Secretary Robert F. Kennedy Jr. directed the FDA in early 2025 to explore rulemaking that would eliminate the self-affirmation pathway entirely. Doing so would require formal notice-and-comment rulemaking to change FDA regulations and, because the GRAS exception is embedded in the Federal Food, Drug, and Cosmetic Act itself, would ultimately require Congressional approval. Legal analysts consider a full elimination unlikely in the near term, but increased transparency requirements are seen as a realistic near-term outcome.
The GRAS system means that ingredient lists can include substances that have never been independently reviewed for safety. For context on how this plays out in practice, our guide to the FDA's "no artificial colors" labeling change in 2026 shows how regulatory decisions can create new consumer-facing ambiguity even when the stated intent is greater transparency. Understanding that reality changes how you might approach label reading.
Several specific steps are worth taking:
Look for "flavors" and "colors" disclaimers. Both terms can cover dozens of individual ingredients that manufacturers are not required to name. If a product lists "artificial flavors" or "natural flavors" as an ingredient, you cannot know from the label what chemicals are actually present.
Cross-reference against EU approval status. If an ingredient is permitted in the EU, it has passed a formal pre-market safety review. If it is prohibited or restricted in the EU but present in a US product, that gap in regulatory treatment is meaningful information.
Treat novel ingredients with appropriate skepticism. Ingredients that are new to the food supply, particularly functional ingredients, processing aids, and emulsifiers that did not exist in previous generations of food, are more likely to have entered via self-affirmation than older, well-studied additives.
Check the FDA's GRAS Notice Inventory. If a company did file a voluntary notification, it will appear in the FDA's public database. If an ingredient is not there, it may have been self-affirmed without any government review.
The GRAS loophole is not a secret within the food industry. It is a business tool. Companies use it to bring new ingredients to market faster and at lower cost than the formal food additive petition process, which typically takes years and several hundred thousand dollars.
The problem is not that GRAS ingredients are necessarily dangerous. Most of them are probably fine. The problem is that nobody can be certain, because the review that would establish that certainty never happened. Consumers eating these products are, in effect, participants in an uncontrolled safety trial.
The legislative activity of 2025 and 2026 suggests that tolerance for this arrangement is ending, at least at the state level. Whether federal reform follows will depend on political will that has historically been difficult to sustain against a well-resourced food industry.
IngrediCheck scans ingredient lists and cross-references substances against regulatory databases from the US, EU, and other jurisdictions, helping you see how each additive is treated in different regulatory environments. For GRAS ingredients with uncertain safety records, that comparison can surface information that product labels are not required to show you.
Source lists are maintained with our editorial policy.
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