The GRAS list is a collection of food substances that the U.S. Food and Drug Administration considers “Generally Recognized as Safe” for their intended use in food. Rather than going through the FDA’s formal approval process for food additives, these substances get an exemption because qualified scientific experts already agree they’re safe. Common examples include vinegar, baking soda, black pepper, vegetable oils, and mustard. The list has grown to include more than 1,000 substances, and understanding how it works reveals both a practical regulatory shortcut and a system with real gaps.
How GRAS Differs From FDA Approval
Under federal law, any substance intentionally added to food is technically a food additive and needs premarket review and approval by the FDA. The GRAS designation is the major exception to that rule. If a substance is generally recognized by qualified experts as safe for its intended use, it skips the formal approval process entirely.
The key distinction comes down to who reviews the safety data. For a regular food additive, the FDA itself evaluates the science and grants approval. For a GRAS substance, experts outside the government can make that safety determination. The scientific data supporting safety must be widely available and publicly known, and there must be consensus among qualified experts that the substance is safe at the levels and in the ways it’s being used.
Two Paths to GRAS Status
A substance can earn GRAS status through one of two routes. The first is scientific procedures: published studies, toxicology data, and expert review that together establish safety. This is the path for newer ingredients. The second route is available only to substances used in food before January 1, 1958, and it relies on experience based on common use. If people have been eating something safely for decades or centuries (think salt, pepper, or sugar), that long track record can serve as the safety evidence.
This two-track system was created by the 1958 Food Additives Amendment to federal law. Congress recognized that requiring formal premarket review of every substance already in widespread use would be impractical. Ingredients with a long, safe history in the food supply didn’t need the same scrutiny as a brand-new chemical preservative. The GRAS exemption was the solution.
Self-Affirmed GRAS: The Voluntary System
Here’s where the system gets controversial. Companies can determine on their own that a substance is GRAS without ever telling the FDA. This is called a “self-affirmed” GRAS determination. A company assembles a panel of qualified experts, presents the safety data, and if the panel agrees the substance is safe, the company can start using it in food products.
There is a voluntary notification program where companies can inform the FDA about their GRAS determinations. The FDA has received about 1,290 of these voluntary notices since the program began in 1998. After reviewing a notice, the FDA responds with one of three types of letters. The most favorable states that the agency “does not question” the basis for the company’s GRAS conclusion. But that’s not the same as approval. The FDA is simply saying it has no objections based on what was submitted.
The critical word here is “voluntary.” Companies are not required to notify the FDA, and the agency generally has no information about GRAS determinations that companies choose not to submit. No one knows exactly how many self-affirmed GRAS substances are in the food supply without FDA awareness.
Who Decides What Counts as Safe
The expert panels that evaluate GRAS substances carry significant weight. The FDA’s guidance specifies that panel members must have scientific training and experience directly relevant to the safety questions at hand. A panel of experts in one field wouldn’t be credible evaluating a substance that raises concerns in a completely different area of science. The panel is supposed to function as a representative sample of the broader scientific community knowledgeable about food safety.
In practice, the company seeking the GRAS determination selects and often pays the panel members. Critics argue this creates a conflict of interest, since the experts are being hired by the very company that wants a favorable outcome. Defenders of the system point out that the experts’ professional reputations are on the line and that the scientific data must be publicly available for scrutiny.
Gaps in Oversight
A Government Accountability Office investigation found significant weaknesses in how the FDA oversees GRAS substances. The report concluded that the FDA’s process “does not help ensure the safety of all new GRAS determinations” because the agency only reviews what companies voluntarily submit. The GAO also found that the FDA had not issued guidance to companies on how to document their GRAS determinations, and had not monitored whether companies were conducting those determinations appropriately.
Ongoing safety is another concern. FDA regulations technically require that a substance’s GRAS status be reconsidered when new scientific evidence emerges. But the agency has not systematically reconsidered GRAS substances since the 1980s. The GAO found that between 2004 and 2008, individuals and consumer groups filed 11 citizen petitions raising safety concerns about GRAS substances, including salt and the trans fats in partially hydrogenated vegetable oils. The FDA made a decision on the validity of those concerns in only one of the 11 cases.
The FDA has also never finalized the rule that governs its voluntary notification program. The framework has existed as a proposed rule since 1997, which the GAO noted could detract from the program’s credibility.
What This Means for Your Food
If you’re reading ingredient labels and wondering whether the additives in your food have been vetted, the answer is: it depends. Some GRAS substances, like common spices and basic cooking ingredients, have centuries of safe use behind them. Others, particularly newer food ingredients, may have been reviewed only by a company-hired expert panel that the FDA never saw.
The GRAS system isn’t a single list you can look up in one place, though the FDA does maintain a searchable inventory of the voluntary GRAS notices it has received. The original GRAS list from the 1960s and 1970s covered several hundred substances and was reviewed by panels of scientists convened by the FDA. Since then, the landscape has expanded through company-driven self-determinations that may or may not appear in any public database.
The practical takeaway is that “Generally Recognized as Safe” is a legal status, not a guarantee of exhaustive government review. For many everyday ingredients, the designation is well-supported. For others, the safety conclusion rests on a system where the company making the product is also the one deciding whether its ingredients are safe enough to skip formal oversight.