While the FRESH Act promises GRAS reform, a closer look reveals a shift toward burdensome FDA gatekeeping that could restrict access to safe, natural ingredients. Action Alert!
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THE TOPLINE
- The bill eliminates the long-standing “self-GRAS” pathway, effectively transforming GRAS into a pre-market approval system rather than a flexible safety standard.
- It introduces a two-tier review process that still expands federal control, including FDA-influenced third-party panels and increased reporting requirements.
- It imposes significant administrative burdens without adopting a risk-based approach, potentially stifling innovation and limiting access to low-risk, natural ingredients.
We’re inching closer to policies that will restrict access to natural ingredients you rely on.
At first glance, the FRESH Act looks like a measured attempt to modernize the “Generally Recognized as Safe” (GRAS) pathway. It is less disastrous than some of the other proposals we’ve seen introduced in Congress. Yet a closer look shows that this bill, too, fundamentally reshapes GRAS into something much closer to a pre-market approval regime that will negatively impact our access to safe, natural ingredients.
The Elimination of “Self-GRAS”
The most consequential change in the FRESH Act is that, moving forward, a substance can no longer be considered GRAS unless the FDA has been notified.
In other words, the longstanding “self-GRAS” pathway—where qualified experts can determine an ingredient is safe without mandatory FDA submission—is effectively eliminated.
Proponents argue that self-GRAS is a loophole that allows unsafe substances into the food supply. But that characterization doesn’t hold up under scrutiny. As we’ve documented before, many of the ingredients frequently cited in media reports as problematic were actually reviewed by the FDA—not slipped through via self-GRAS.
The real issue with self-GRAS isn’t that companies can reach GRAS conclusions independently. It’s that these determinations are generally not transparent.
Transparency, Not Pre-Market Gatekeeping
ANH-USA has consistently argued that GRAS reform should focus on transparency—not expanding FDA gatekeeping authority.
Our proposed solution, as documented in our April 2025 white paper, is straightforward: a comprehensive, publicly accessible transparency register of all GRAS determinations. This would allow independent scientists, researchers, and watchdogs to evaluate the evidence behind safety conclusions.
Increasing the FDA’s pre-market authority over food ingredients risks replacing one perceived problem with a far more restrictive system that slows innovation without meaningfully improving safety.
A Two-Tier System—With Strings Attached
The FRESH Act outlines two pathways for new GRAS ingredients:
- Full Notification: Companies must submit detailed information, including identity, manufacturing process, specifications, and a scientific rationale. The FDA has 90 days to review and can request more data or reject the submission.
- Third-Party Review Pathway: Ingredients reviewed by an “established scientific panel” can bypass full notification—but only if the panel is accredited by the Secretary and submits basic information to the FDA.
On paper, this second pathway appears to preserve some flexibility. In reality, it adds a new layer of federal control: scientific panels must be formally accredited, and their conclusions still have to be reported to the FDA. When the agency is effectively shaping who gets to serve on these panels, it’s reasonable to expect a narrow range of viewpoints—ones that tend to lean towards ever more EU-style, precautionary approaches. The result risks becoming more “government science” that is inherently skeptical of natural products, especially those that could compete with drug-based interventions.
Existing Ingredients: Not a Tsunami—But Still a Tidal Wave
To its credit, the FRESH Act does not require all existing GRAS ingredients to undergo full FDA review. Instead, companies must meet one of two conditions:
- Submit a basic notification (identity and intended use), or
- Ensure the substance is already listed in the FDA’s Substances Added to Foods database.
Basic notifications are automatically accepted and take effect after 30 days unless the FDA intervenes.
This avoids the worst-case scenario—a regulatory “tsunami” overwhelming both industry and the agency. But it still represents a massive administrative burden: a tidal wave of filings that smaller companies may struggle to manage.
The Missing Piece: Risk-Based Reform
One of the biggest shortcomings of the FRESH Act is its one-size-fits-all approach.
Not all ingredients pose the same level of risk. A synthetic chemical with no history of human consumption should not be treated the same as a vitamin co-factor, botanical ingredient or mushroom used safely for generations.
At ANH-USA, we are advocating for a tiered, risk-based system, where:
- Low-risk, natural ingredients with a long history of safe use face minimal regulatory burden
- Higher-risk, novel, or synthetic substances receive more rigorous evaluation
This approach protects public health and preserves access to beneficial products. The FRESH Act, by contrast, casts too wide a net.
Reform Without Overreach
There are problems with the current GRAS system. Bad actors can exploit gaps, and greater accountability is needed.
But eliminating self-GRAS and replacing it with a quasi pre-market approval system is not the answer.
GRAS has long served as an essential pathway for thousands of safe, health-promoting ingredients to reach consumers. Weakening that pathway risks reducing access, stifling innovation, and consolidating control over the food supply.
We should not throw the baby out with the bathwater.
A Better Path Forward
If lawmakers are serious about improving GRAS, they should focus on:
- Full transparency: A universal registry of all GRAS determinations
- Risk-based oversight: Tailored requirements based on an ingredient’s safety profile
- Preserving flexibility: Maintaining pathways for safe, natural ingredients to enter the market efficiently
The FRESH Act takes a step toward reform—but in doing so, it risks creating a system that is more restrictive, more bureaucratic, and ultimately less effective.
We can do better.
Action Alert!
