An agency that claimed it lacked the authority to impose GRAS notifications changes its mind: that is the heart of the ongoing FDA GRAS overhaul, analysed by Todd Harrison, partner and co-chair of the FDA group at law firm Venable LLP, in the NutraCast podcast of 14 August 2026.
The mechanism is simple to state, heavy to apply. Today, a manufacturer can self-declare an ingredient “Generally Recognized As Safe” without informing the FDA. The proposal would make that notification mandatory. Harrison sums up the flaw: “The law says you must notify if you are a food additive, unless you are GRAS. It does not say: unless you are GRAS and you file a notification.”
For ingredient suppliers and functional beverage brands, this FDA GRAS overhaul moves the boundary between what reaches the market freely and what passes under the agency’s prior control. The stake is not theoretical: it directly affects launch timelines and legal exposure on the US market.
What is GRAS status, and why is its regime changing?
GRAS status stems from the Federal Food, Drug and Cosmetic Act. An ingredient “generally recognized as safe” escapes the heavy approval procedure for food additives. Recognition rests on an expert consensus, not on a systematic green light from the agency.
For years, notification to the FDA has been voluntary. A company can conclude on its own that an ingredient is GRAS — the practice known as “self-affirmed GRAS” — and market it without filing a dossier. The proposal turns that option into an obligation.
Harrison points to the reversal: the FDA had previously stated it did not have the authority to impose these notifications. Moving to mandatory requires, in his view, “a more solid justification” for the change of position. It is precisely this deficit of grounding that makes the FDA GRAS overhaul open to challenge.
Why the FDA GRAS overhaul risks stumbling in court
Harrison is blunt: “I think they are going to struggle in court.” His reasoning rests on a shift in American administrative law.
In 2024, the Supreme Court’s Loper Bright ruling ended “Chevron deference”. In plain terms: judges are no longer bound to defer to an agency’s interpretation of an ambiguous text. They determine the best reading of the law themselves.
Consequence for the agency: if the text of the FD&C Act does not explicitly impose notification — and Harrison asserts it does not — a court can rule against the FDA without granting it the benefit of the doubt. The FDA GRAS overhaul thus arrives at the worst moment for an expansive reading of the agency’s powers.
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Contested legal basis: the FD&C Act does not require notification for a GRAS ingredient.
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Unjustified reversal: the FDA had admitted it lacked the authority to impose it.
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Loper Bright context (2024): end of deference to agencies, reinforced judicial review.
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No clear remedy: what happens if the FDA contests a determination after notification?
The procedural void that worries companies most
The most operational point is not the challenge itself, but the aftermath. What happens when the FDA disagrees with a company’s GRAS determination after receiving the notification?
Harrison stresses that the proposal offers neither a clear remedy nor a final agency decision. A company could find itself exposed to commercial consequences — clients withdrawing, distributors hesitating — without any formal FDA action being engaged. Disagreement alone is enough to cast doubt on an ingredient.
Another blind spot: resources. Harrison doubts the FDA can process the potential volume of ingredients and botanical extracts concerned. His counter-proposal: a database requiring companies to declare the ingredients present in the food supply, allowing the agency to focus its means on genuine safety signals.
The triage to run before betting on the US market
Harrison warns: if the proposal withstands judicial review, it could “very well end the functional beverage space”. For an ingredient supplier, the FDA GRAS overhaul imposes a concrete arbitration, even before any entry into force.
Three workstreams to open now:
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Map your “self-affirmed” ingredients: which rest on an internal determination never notified to the FDA? Those are the most exposed.
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Solidify the safety dossier: under reinforced judicial review, a documented and recent expert consensus is worth more than an old declaration.
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Anticipate the commercial risk, not only the regulatory risk: an unresolved disagreement with the FDA can scare your CPG clients before any sanction.
In other words, uncertainty is already a cost — on product roadmaps and supply negotiations towards the United States.
What the FDA GRAS overhaul redistributes for the ingredients sector
The functional food and beverage market has multiplied the presence of dietary ingredients in mass-market products. It is precisely this segment that Harrison identifies as the most vulnerable to a mandatory notification regime.
The business reading holds in one tension: the FDA GRAS overhaul aims at more transparency on safety, but its poorly calibrated execution could freeze ingredient innovation on the world’s largest market. A mandatory dossier, with no remedy and no final decision, turns every launch into a legal bet.
| Aspect | Current regime | FDA proposal |
|---|---|---|
| GRAS notification | Voluntary | Mandatory |
| Self-determination | Allowed (self-affirmed) | Under increased control |
| Remedy in case of disagreement | Not specified | Still not clarified |
| Legal solidity | Long established | Weakened by Loper Bright (2024) |
Nothing is settled. The proposal must still survive court review, and Harrison bets it will meet “major hurdles” there. But for a regulatory or R&D lead, waiting for the verdict means flying blind. The question is no longer whether the FDA GRAS overhaul will succeed as drafted, but which ingredients in your portfolio would stand if it did.
References
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NutraIngredients-USA. (2026). NutraIngredients-USA Podcast. iHeart.
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NutraIngredients-USA. (2026). NutraIngredients-USA Podcast. Spotify.
FAQ
What does the FDA GRAS overhaul concretely change for an ingredient supplier?
It would turn the GRAS notification, currently voluntary, into an obligation. According to Todd Harrison (Venable LLP), any ingredient self-declared “self-affirmed” without a dossier filed with the FDA would become the most exposed, with a direct impact on US launch timelines.
Why does the proposal risk being struck down in court?
Harrison believes the Federal Food, Drug and Cosmetic Act does not explicitly require notification for a GRAS ingredient. Since the Supreme Court’s Loper Bright ruling in 2024, which removed Chevron deference, judges decide a text’s interpretation themselves without deferring to the agency.
What happens if the FDA contests a GRAS determination after notification?
The proposal provides neither a clear remedy nor a final agency decision, according to Harrison. A company could suffer commercial consequences (distrust from distributors and clients) even without formal FDA action.
Which segment is most threatened by this reform?
The functional food and beverage market, where dietary ingredients are multiplying in mass-market products. Harrison warns that the reform, if it survives judicial review, could “end the functional beverage space”.
What alternative does Harrison propose to mandatory notification?
He suggests a database requiring companies to declare the ingredients present in the food supply. This would let the FDA focus its limited resources on genuine safety signals rather than processing every notification.
Should companies wait for the court decision before acting?
No. Uncertainty is already an operational cost. Mapping self-affirmed ingredients, strengthening recent safety dossiers and anticipating commercial risk are workstreams to open from 2026, regardless of the judicial outcome.