Eliminating the self-affirmed GRAS process might sound like a win for food safety—but without smart reform, we’re convinced it would do more harm than good. Action Alert!
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THE TOPLINE
- While the self-affirmed GRAS (Generally Recognized as Safe) pathway allows companies to introduce food ingredients without notifying the FDA, many of the most harmful additives were approved through official FDA channels, exposing a deeper issue of outdated safety standards, lax oversight and probable conflicts of interest.
- Proposals to abolish the self-affirmed GRAS process would overwhelm the FDA and destabilize the food and supplement industries. A more productive solution is to reform the system by making self-GRAS determinations transparent and subject to public scrutiny.
Earlier this year, FDA Commissioner Marty Makary touted “GRAS reform” among his first 100 day accomplishments, saying the agency is “exploring rulemaking” to “stop industry’s long-standing practice of introducing ingredients into the food supply without FDA knowledge or oversight.” The practice Commissioner Makary is referring to is known as self-affirmed GRAS (Generally Recognized as Safe) or self-GRAS.
We were surprised to see this touted among the Commissioner’s accomplishments in his first 100 days. That’s because no formal policy has yet been announced!
What Dr. Makary and Bobby Kennedy have both expressed is a view contained in the HHS press release of March 10: and that’s the proposal to abolish self-GRAS through rulemaking. This remains the sole document on the “Keeping Food Ingredients Safe” the HHS’s Radical Transparency portal.
It’s true that the GRAS system is deeply flawed. It’s also true that many, if not all, of the problematic ingredients in the food supply that are often cited by critics as evidence of the need for GRAS reform were explicitly approved by the FDA—not snuck in by industry under self-GRAS.
The solution isn’t to eliminate the self-affirmed GRAS pathway. It’s to bring it into the light, as we argued in our white paper released in April of this year that outlined a rational approach to reforming GRAS without erecting unnecessary regulatory hurdles for ingredients that have a well-established safety record.
A System Built on Loopholes and Silence
Since 1997, the FDA has allowed companies to voluntarily notify the agency when they determine a substance is GRAS—essentially safe for its intended use in food. This shift was prompted by resource constraints at the FDA and a mounting backlog of GRAS petitions. This created a system where transparency is optional, not required.
Today, an estimated 10,000 ingredients are on the market through self-affirmed GRAS determinations—many of which have never been reviewed by the FDA, disclosed to the public, or independently evaluated. This includes not just food additives but also botanicals, micronutrients, and other novel compounds.
Over 80% of companies who do voluntarily notify the FDA receive “no questions” letters, which often rubber-stamp the company’s own safety data.
There’s a common misconception that the self-affirmed GRAS pathway is the main culprit behind the flood of harmful ingredients in our food supply. But many of the additives most often cited by critics—Red 40, Yellow 5, titanium dioxide, potassium bromate, aspartame, sodium nitrite, and BHA—have actually been reviewed and approved by the FDA, either as food or color additives or through the GRAS process itself. These substances were greenlit despite substantial evidence of health risks. The real issue, then, is that most harmful additives were approved through official FDA channels—not industry exploitation of loopholes.
Simply put: closing the self-GRAS pathway won’t solve the problem of dangerous ingredients lurking in our food.
Misguided Calls to Abolish Self-GRAS
In fact, abolishing the self-GRAS pathway altogether would wreak havoc on the food and dietary supplement industries and create an enormous workload for the FDA, which the agency would likely be unable to manage. Creating another de facto pre-approval system undermines the original purpose of the GRAS pathway: to streamline the introduction of safe ingredients, including many natural ingredients, into food.
Instead, ANH-USA has offered a smarter solution—one that preserves the practical benefits of self-GRAS while fixing its fatal flaw: lack of transparency.
What Real Reform Looks Like
In our recent white paper, Reforming GRAS: Food Safety Without Sacrifice, we outline a clear path forward:
- Prioritize the removal of truly harmful ingredients from the market.
- Preserve access to safe, health-promoting ingredients used in supplements, functional foods, and natural products.
- Create a GRAS Transparency Register, making all GRAS determinations public for review by independent experts, consumer groups, and researchers.
- Introduce a tiered, proportionate risk assessment model rooted in the Paracelsian, rather than the precautionary, principle—i.e., “the dose makes the poison”—so that low-risk ingredients aren’t treated the same as high-risk ones.
- Avoid importing overly precautionary European-style policies that unnecessarily limit consumer access to beneficial nutrients and foods.
This approach empowers both the FDA and the public to make more informed decisions.
The FDA Must Do Better
If the FDA is serious about protecting public health, it must address the systemic failures that allow harmful chemicals to enter and remain in our food supply. That starts with reforming—not abolishing—the self-affirmed GRAS pathway.
Help us restore integrity to the entire system that governs what we eat.
Action Alert!
