As a former senior policy advisor at the U.S. Food and Drug Administration (FDA or Agency), I am proud to say that America has one of the safest food supplies in the world. And that’s, in large part, because of the stringent regulations set forth by the FDA and the unwavering commitment and adherence by food and beverage companies to meet rigorous science-based standards.

Recently, there’s been a lot of media coverage about America’s food supply and the ingredients used in the food and beverage staples Americans rely on every day. Consumers are asking more questions—not just about what’s in their food, but how ingredient safety decisions are made. That’s a good thing. Transparency helps build trust. What is not helpful, however, is sensationalism that misstates how the regulations function to obscure scientific evidence and create unnecessary confusion.

So, I want to provide some clarity about food substances Generally Recognized as Safe (GRAS) and address some common myths.

Myth: GRAS Isn’t Clearly Defined

FACT: GRAS substances are defined in the Federal Food Drugs and Cosmetic Act under section 201(s) as, “Generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.

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Section 201(s) in the Federal Food, Drug, and Cosmetic Act describes a GRAS substance as one that is:

Generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.

Thus, here are two different bases for establishing a substance is GRAS for its intended use in food. A GRAS determination may be based on either (a) recognition by qualified experts of safety based on common use in food before 1958 or (b) recognition by qualified experts as safe based on scientific procedures.

Common use in food is defined by regulation as “a substantial history of consumption for food use by a significant number of consumers.” Common use in food determinations must be based solely on food use of the substance prior to 1958 and ordinarily be based on generally available data and information. Examples include salt, pepper, vinegar and baking powder.

If the substance did not have a common history of use prior to 1958, then the use of the substance can be considered GRAS if vetted through scientific procedures. A GRAS determination based on scientific procedures requires an assessment of published scientific data. The regulations require the same quantity and quality of data needed to obtain approval of a food additive. The safety standard that must be met is a “reasonable certainty of no harm.” In addition, the key data or information must be in the public domain.

Myth: GRAS Ingredients Aren’t Properly Evaluated for Safety

FACT: GRAS status requires safety evidence that is publicly available and widely accepted by qualified experts, with key data published (typically in peer-reviewed journals) and a consensus that the substance is safe for its intended use.

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GRAS status for a particular use of a substance must be based on evidence of safety and a basis to conclude that this evidence of safety is common knowledge. Common knowledge is defined by two things. First, the data and information relied on to establish safety must be generally available. Second, there must be a consensus among qualified experts, with experience evaluating the safety of substances directly or indirectly added to food, about the safety of the substance for its intended use. The key data must be published, with unpublished data only used for corroboration. Publication in a peer-reviewed scientific journal is the common mechanism to establish that scientific information is generally available.

Myth: GRAS Is Just a Loophole

FACT: GRAS is not a loophole; it’s a science-based regulatory pathway established by Congress and overseen by the FDA. GRAS ingredients don’t require FDA pre-market review, but they must still meet the same “reasonable certainty of no harm” standard, supported by robust, publicly available scientific evidence on their use and safety. substances remain subject to FDA oversight and post-market enforcement.

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GRAS ingredients do not require pre-market review by FDA (enter the incorrect but often used claim that GRAS is a “loophole” to “sneak in” ingredients). However, the lack of a requirement for FDA to perform a pre-market review does not mean that substantiation of GRAS status to confirm safety is a light matter. On the contrary, the same safety standard applies to both GRAS substances and approved food additives – “reasonable certainty of no harm.”

The GRAS regulatory scheme permits companies to make their own determination of GRAS status and in doing so must develop and maintain information regarding the basis of their conclusion including the method of manufacture, dietary exposure from conditions of its intended use, self-limiting levels, history of use, a scientific narrative providing the basis of the safety finding, and a list of publicly available data that supports the finding.[1] A company may voluntarily notify FDA of its determination that a particular use of a substance is GRAS, which provides additional transparency to the Agency and the public, or it may self-determine the GRAS status of a substance without notifying the Agency. But in all cases, the safety standard—and general recognition of that safety by qualified experts —must be met. Furthermore, FDA may perform a post-market review of a self-affirmed GRAS determination with the authority to act against substances that it believes are not GRAS. For example, FDA can alert consumers and companies through warning letters and public alerts, if it believes an ingredient is not GRAS. If the situation is not corrected, FDA can take further action. FDA has a list of post-market determinations that a substance is not GRAS.

Myth: Nothing Happens if New Safety Concerns Emerge

FACT: GRAS safety determinations are made case-by-case using current scientific knowledge, must be conducted by qualified experts, and can change over time as new evidence emerges. Companies reevaluate their GRAS determinations as new safety data or concerns emerge. FDA is able to act if a substance is no longer considered safe.

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The evaluation of whether a use of a substance in food is safe and whether safety is generally recognized, is a case-by-case evaluation. All GRAS conclusions must be considered in context based on the knowledge and information available at a point in time, because scientific knowledge and information about a particular substance can evolve and sometimes change over time. Companies reevaluate their safety determinations as new information becomes available. FDA has taken action when it has concluded that a substance used in food before 1958 is not GRAS under its intended conditions of use, as it did regarding the use of caffeine in alcoholic beverages and the use of partially hydrogenated oils in human food.

Myth: The Food Industry Opposes GRAS Reform

FACT: The CPG industry supports greater transparency and welcomes GRAS reform—including possible new FDA rules, legislation and mandatory notification—while maintaining a science-based, nationally uniform approach to ingredient safety.

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The consumer packaged goods (CPG) industry understands that consumers want more information about what is in their foods and that consumers are asking for more transparency into the GRAS process and new and existing GRAS ingredients. Amending the current Federal process could result from FDA regulatory changes, or by Congress amending the FD&C Act to expand the authority of the Agency to require more information from food manufacturers prior to bringing ingredients to the marketplace. Further, the industry has developed SmartLabel, an easily accessible application to provide consumers with more information about ingredients than fits on the product label.

Under the Trump Administration, Secretary Kennedy has been very vocal about changing the GRAS regulatory process. FDA is in the process of amending the current GRAS rule, and we anticipate a proposed regulation sometime in mid-2026.

Consumer Brands is part of a coalition, Americans for Ingredient Transparency, that is advocating for federal legislation establishing national uniformity for ingredient safety and disclosure and we support GRAS reform being a part of that bill, including establishing a mandatory notification process for all new substances seeking GRAS status from FDA.

With science, transparency and a nationally uniform regulatory approach for new ingredients, the CPG industry can continue providing consumers with a variety of safe food and beverage options that match their specific needs.

[1] The full list of information companies must develop and maintain for GRAS substances can be found in in FDA Regulations – eCFR :: 21 CFR Part 170 Subpart E — Generally Recognized as Safe (GRAS) Notice