In short — The FDA wants to make GRAS notifications, which are currently voluntary, mandatory. According to Todd Harrison (Venable LLP), the FDA’s GRAS overhaul rests on a fragile legal basis, which is open to challenge following the 2024 Loper Bright ruling. For any ingredient supplier targeting the US, the uncertainty is already operational.
An agency that claimed not to have the authority to mandate GRAS notifications has changed its mind: this is the heart of the GRAS FDA redesign ongoing, analysed by Todd Harrison, partner and co-chair of the FDA group at the law firm Venable LLP, on the NutraCast podcast of 14 August 2026.
The mechanism is simple to state, heavy with consequences to apply. Today, a manufacturer can self-certify an ingredient as «Generally Recognized As Safe» without informing the FDA. The proposal would make this notification mandatory. Harrison summarises the flaw: «The law says you must notify if you are a food additive, unless you are GRAS. It doesn't say: unless you are GRAS and that you file a notification.»
For ingredient suppliers and functional beverage brands, this GRAS FDA redesign shifts the boundary between what can be placed on the market freely and what is subject to prior agency control. The issue is not a theoretical one: it directly affects launch timelines and legal exposure on the US market.
What is the GRAS status, and why is its regime changing?
The GRAS status stems from the Federal Food, Drug and Cosmetic Act. A «generally recognised as safe» ingredient avoids the cumbersome food additive approval process. Recognition is based on expert consensus, not a systematic green light from the agency.
For years, notification to the FDA has been voluntary. A company may itself conclude that an ingredient is GRAS — a practice known as «self-affirmed GRAS» — and market it without submitting a dossier. The proposal turns this option into an obligation.
Harrison highlights the U-turn: the FDA had previously stated that it did not have the authority to impose these notifications. In his view, making them mandatory requires «a more robust justification» for the change in position. It is precisely this lack of a sound basis that makes the GRAS FDA redesign open to criticism.
Why the FDA's GRAS overhaul risks stumbling in court
Harrison is blunt: «I think they're going to struggle in court.» His reasoning is based on a shift in American administrative law.
In 2024, the Supreme Court, in the Loper Bright judgement, put an end to «Chevron deference». Put simply: judges are no longer required to defer to an agency’s interpretation of an ambiguous text. They determine for themselves the best interpretation of the law.
Implication for the agency: if the text of the FD&C Act does not explicitly require notification — and Harrison argues that it does not — a court may rule against the FDA without granting it deference. The GRAS FDA redesign It therefore comes at the worst possible time for a broad interpretation of the agency’s powers.
- Contested legal basis : The FD&C Act does not require notification for a GRAS ingredient.
- Unjustified reversal : the FDA had admitted that it did not have the authority to impose it.
- Background: Loper Bright (2024) end of deference to agencies, enhanced judicial review.
- Lack of a clear remedy : What happens if the FDA challenges a determination following notification?
The procedural loophole that causes businesses the greatest concern
The most practical aspect is not the challenge itself, but what happens afterwards. What happens when the FDA disagrees with a company’s GRAS determination? after receipt of the notification?
Harrison points out that the proposal offers neither a clear avenue of appeal nor a final decision from the agency. A company could find itself exposed to commercial implications — customers pulling out, retailers showing hesitation — without the FDA even having taken any formal action. The disagreement alone is enough to cast doubt on an ingredient.
Another blind spot: resources. Harrison doubts that the FDA will be able to cope with the potential volume of botanical ingredients and extracts involved. His counter-proposal: a database requiring companies to declare the ingredients present in food products, which would enable the agency to focus its resources on genuine safety concerns.
The due diligence required before investing in the US market
Harrison warns that if the proposal withstands judicial scrutiny, it could «very well spell the end of the functional drinks sector». For an ingredients supplier, the GRAS FDA redesign requires a practical compromise, even before it comes into force.
Three key areas to be opened up right away:
- Mapping your «self-affirmed» ingredients» : which are based on an internal determination never notified to the FDA? These are the most exposed.
- Strengthen the safety case under enhanced judicial supervision, a documented and recent expert consensus is worth more than an old statement.
- Anticipating commercial risk, not just regulatory risk: an unresolved disagreement with the FDA can scare off your CPG customers before any sanction.
In other words, uncertainty is already a cost — in terms of product roadmaps and supply negotiations with the United States.
What the FDA’s GRAS revision means for the ingredients sector
The functional foods and drinks market has led to a proliferation of dietary ingredients in mass-market products. It is precisely this segment that Harrison identifies as being most vulnerable to a mandatory notification scheme.
Business reading comes down to one tension: the GRAS FDA redesign aims for greater transparency on safety, but its poorly calibrated execution could freeze ingredient innovation in the world's leading market. A mandatory dossier, with no remedy or final decision, turns every launch into a legal gamble.
| Aspect | Current regime | FDA proposal |
|---|---|---|
| GRAS notification | Volunteer | Mandatory |
| Self-determination | Self-certified | Under increased control |
| Recourse in the event of a disagreement | Not specified | Still not clarified |
| Legal robustness | Long-established | Weakened by Loper Bright (2024) |
Nothing is set in stone. The proposal still has to survive court scrutiny, and Harrison is betting it will encounter «major obstacles» there. But for a regulatory or R&D manager, waiting for the verdict is like navigating blind. The question is no longer whether the GRAS FDA redesign will happen as it is, but which ingredients in your portfolio would hold up if it did.
References
- NutraIngredients-USA. (2026). NutraCast: FDA’s GRAS shake-up likely to face ‘major’ legal hurdles. Apple Podcasts.
- NutraIngredients-USA. (2026). NutraIngredients-USA Podcast. iHeart.
- NutraIngredients-USA. (2026). NutraIngredients-USA Podcast. Spotify.
FAQ
What does the FDA GRAS overhaul actually change for an ingredient supplier?
It would turn the GRAS notification, which is currently voluntary, into a mandatory requirement. According to Todd Harrison (Venable LLP), any self-affirmed ingredient without a dossier filed with the FDA would become the most vulnerable, directly impacting time-to-market in the United States.
Why is the proposal likely to be invalidated in court?
Harrison considers that 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 eliminated Chevron deference, judges now decide the interpretation of a text themselves without deferring to the agency.
What happens if the FDA challenges a GRAS determination after notification?
According to Harrison, the proposal provides neither a clear recourse nor a final agency decision. A company could suffer commercial consequences (distrust from distributors and customers) even without formal FDA action.
Which segment is most threatened by this reform?
The functional food and beverage market, where dietary ingredients are proliferating in mass-market consumer goods. Harrison warns that the reform, if it survives judicial review, could «put an end to 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 allow the FDA to focus its limited resources on genuine safety signals rather than processing every notification.
Should we wait for the court decision before taking action?
No. Uncertainty is already an operational cost. Mapping its self-affirmed ingredients, strengthening recent safety dossiers and anticipating commercial risk are projects to be launched as early as 2026, regardless of the legal outcome.