Investigation Identifies More than 100 GRAS Ingredients Used in Foods Without FDA Notification
Although controversial, GRAS determinations do require specific data demonstrating a substance's safety.
The Environmental Working Group (EWG) has published a list of 111 food additives that have been introduced to the food supply without a formal safety review by the U.S. Food and Drug Administration (FDA) through the “Generally Recognized as Safe” (GRAS) process.
Of these GRAS ingredients, 49 are used in thousands of food products, per EWG.
EWG compiled its list based on corporate press releases announcing self-affirmed GRAS status, trade publication announcements, and publicly available GRAS substance databases.
How GRAS Self-Determinations Work
Established in 1958 through an amendment to the Federal Food, Drug, and Cosmetic Act, the GRAS process enables food substances to be used without premarket approval by FDA as long as scientific experts determine the substance to be “safe” under the conditions of its intended use. GRAS determinations effectively exempt a food substance from being subjected to the premarket safety review process required for food additives by FDA.
GRAS determinations do require specific data providing evidence of a substance's safety, but these determinations can be made by experts outside of the government, using literature compiled by food companies. It is important to note, however, that the extent of data and evidence required for self-affirmed GRAS determinations is the same as what is required for FDA food additive petitions, which are reviewed directly by FDA. Additionally, the data used to support GRAS determinations must be publicly available.
At the same time, food companies can choose to voluntarily notify FDA when they have made a GRAS determination about a new substance—or they can begin using the intended ingredient without notifying FDA once they have compiled the scientific evidence required to make their determination.
The GRAS process was originally intended to allow widely used food ingredients, commonly understood to be safe for consumption (e.g., salt, yeast), to remain on the market without extensive review.
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GRAS Could Allow Potentially Unsafe Ingredients to Enter Food Supply
In recent years, GRAS has increasingly come under public scrutiny for the introduction of new ingredients, which have not been proven to be safe, to the food supply.
For example, in 2022, consumers experienced liver injury due to the consumption of tara flour, a self-affirmed GRAS ingredient, which was used as an ingredient in a ground beef substitute. In 2024, FDA conducted an independent evaluation of the ingredient and concluded that tara flour is not “generally recognized as safe,” and is therefore unapproved as a food additive.
Forthcoming FDA Rule Will Tighten GRAS Oversight
Following orders from U.S. Health Secretary Robert F. Kennedy Jr., a proposed FDA rule to tighten GRAS oversight is currently pending White House review.
This proposed rule would amend the Code of Federal Regulations to enforce stricter GRAS oversight in several ways:
- Making FDA notification of GRAS submissions mandatory for most substances, with exemptions allowed only for substances already listed by FDA, substances that have a “no questions letter,” or substances covered by a regulation
- Require FDA to maintain and update a public-facing GRAS notice inventory for all GRAS substance notifications and their conditions of intended use
- Clarify the process under which FDA would determine that a substance is not GRAS.
In a February CBS News 60 Minutes interview, Secretary Kennedy asserted that, because of GRAS, the U.S. Government “does not know how many ingredients there are in American food,” and cited estimates between 4,000 and 10,000.
