"FDA-approved" is not why most of what's in your pantry is legal to sell. For decades, a company has been able to decide, on its own, that a new ingredient is safe — and never tell the FDA at all. On August 11, 2026, the FDA proposed changing that.
The proposal, published in the Federal Register as "Substances Generally Recognized as Safe" (91 FR 51834), would convert the agency's current GRAS notification program from voluntary to mandatory. Companies would have to file a GRAS notice with the FDA before introducing a substance into commerce — not just for ingredients added directly to food, but for indirect substances too, including ones that migrate from food packaging. The rule also proposes a limited transition option for substances already on the market, letting them come into the new system without restarting from zero. Public comments are open through December 9, 2026.
The rule text is careful about what it is and isn't. As of this writing, it's a proposal, not law. And even if finalized as written, it would not turn GRAS into a premarket approval process the way a formal food additive petition is. The proposal's own preamble notes that under the current voluntary program, "there is no requirement that a notifier must wait to receive a response from FDA regarding their GRAS conclusion before introducing the substance into interstate commerce" — and nothing in the new proposal appears to change that. In plain terms: mandatory notification means FDA has to be told before a substance is sold. It does not mean FDA has to say yes first. The rule's own preamble names its trigger directly — a March 10, 2025 directive from HHS Secretary Robert F. Kennedy Jr. instructing FDA to explore closing "the pathway for firms to introduce purported GRAS uses of substances into the market without notifying FDA of the basis for their GRAS conclusions," framed as part of the administration's transparency push on what goes into the food supply.
To see why that distinction matters, it helps to know how GRAS got here. The category itself is old: the 1958 Food Additives Amendment exempted substances "generally recognized as safe" by qualified experts from the formal premarket review required of new food additives, and by the end of that year FDA had already published its first GRAS list. For decades after that, a company seeking official recognition filed a formal GRAS affirmation petition — a process so slow that by the 1990s petitions were taking years to resolve. In 1997, FDA proposed a faster alternative: a notification procedure, where a company tells the agency about its GRAS conclusion and FDA responds with a letter rather than a rulemaking. That system was finalized in 2016, effective October 17 of that year, and it is still the one in place today, codified in part at 21 CFR 170.205.
Here is the detail that surprises most people: notifying FDA under that 2016 system was, and still is, optional. A company can conclude on its own — using outside experts, not government reviewers — that an ingredient meets the GRAS standard, sell it, and never file anything with FDA at all. Advocacy groups have challenged that arrangement in court; in 2021, a federal district court in Center for Food Safety v. Becerra rejected a lawsuit arguing the self-affirmation framework was unlawful, leaving the voluntary system intact. It stayed that way until HHS Secretary Robert F. Kennedy Jr., in a March 10, 2025 directive, told FDA to explore rulemaking that would close what his office called a "loophole" allowing ingredients "with unknown safety data" onto the market without the agency ever hearing about them. The August 2026 proposal is the result.
Where this lands the U.S. next to other regulators is instructive. The EU has never had an equivalent to self-affirmed GRAS. Under Regulation (EC) No 1333/2008, a food additive cannot go on the EU market at all until the European Food Safety Authority has run a safety evaluation and the additive has been added to the EU's own positive list — a premarket gate that applies to every additive, with no self-determined path around it. Even if the FDA's proposed rule is finalized as written, the U.S. system would still work differently: companies would have to tell FDA what they've concluded, but FDA approving that conclusion before market entry is not what mandatory notification means. Notification is visibility. It is not the same thing as premarket authorization, and the proposal doesn't claim to be.
None of this shows up anywhere on a label today, and the proposed rule wouldn't change that by itself. A U.S. ingredient list has no way of telling you whether the substance in it went through FDA's formal food additive petition process, through a voluntary GRAS notice FDA reviewed and didn't object to, or through a self-determination that no one outside the manufacturer ever looked at. All three routes can produce the same line of text on a package. If the mandatory-notification rule is finalized, the practical change for a shopper would be indirect: more of what's on shelves would eventually have a GRAS notice on file with FDA, searchable in the agency's own GRAS notice inventory — but "on file" still would not mean "reviewed and approved" the way a new drug is.
That gap between what a label implies and what actually happened in Washington is exactly the kind of thing PurityIQ exists to close. The app puts the public regulatory record in front of you at the shelf — whether an ingredient has an FDA GRAS notice on file, what kind of review (if any) that represents, and how that compares with how the same substance is treated elsewhere — cited to the primary source, with no score and no verdict attached. You see the record. You decide.
Sources
FDA, "Substances Generally Recognized as Safe," proposed rule, 91 Fed. Reg. 51834 (Aug. 11, 2026) — https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe
FDA, "How U.S. FDA's GRAS Notification Program Works" — https://www.fda.gov/food/generally-recognized-safe-gras/how-us-fdas-gras-notification-program-works
FDA, "FDA's Approach to the GRAS Provision: A History of Processes" — https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes
FDA, GRAS notification final rule, 81 Fed. Reg. 54960 (Aug. 17, 2016) — https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19164.pdf
HHS, "Revising GRAS Pathway" press release (Mar. 10, 2025) — https://www.hhs.gov/press-room/revising-gras-pathway.html
Center for Food Safety v. Becerra, 565 F. Supp. 3d 519 (S.D.N.Y. 2021)
European Food Safety Authority, "Food additive application procedure" (Regulation (EC) No 1333/2008) — https://www.efsa.europa.eu/en/applications/food-additive