~/blog/fda-rin-0910-ai91-unnamed-ingredient-rule
FDA has an agenda entry to un-exclude one unnamed ingredient, and July has passed
An entry in the current Unified Agenda would declare a specific ingredient not excluded from the dietary supplement definition. It never says which one, its target month was July, and nothing has published.
Almost every argument on this desk is about dose. This one sits below that, at eligibility: whether a substance may be a dietary ingredient at all, before anyone prints a milligram on a panel.
The entry is RIN 0910-AI91, listed by HHS and FDA as “Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition”. The abstract says that, if finalised, “products containing this ingredient could be lawfully marketed as dietary supplements”, provided they otherwise meet the definition.
It never says which ingredient.
The mechanism underneath
The listed authority is sections 201(ff)(3)(B), 301(ll)(2) and 701(a) of the FD&C Act. The first does the work: it keeps an article approved as a new drug, or authorised for investigation as one with substantial clinical investigations instituted and made public, outside the supplement definition — unless it was marketed as a supplement or a food first. The escape hatch is a regulation, after notice and comment, finding the article lawful; this entry reaches for it. The abstract adds a second effect: under the rule, adding the ingredient to a supplement would not be a prohibited act under section 301(ll).
Its CFR citation is 21 CFR 190.1, a section that does not currently exist. In Part 190, the dietary supplements part of the code, Subpart A is reserved and empty; the only live section is § 190.6, the 75-day new dietary ingredient notification.
The month that has gone
The agenda gives one timetable action, an NPRM dated 07/00/2026 — notation for July, no day fixed — with the FR Cite column empty. A Federal Register search for the RIN returns nothing, and none of the thirteen FDA proposed rules published since 15 June 2026 — the mandatory GRAS notice proposal among them — is this one. Legal deadline: “None”.
July is not the first month missed, either: the entry’s Spring 2025 edition set the NPRM at 01/00/2026, and January went the same way.
The HHS agenda notice of 14 August does not print it either: that paper issue carries only rulemakings likely to weigh on small entities, pointing to reginfo.gov for the rest. Priority is “Other Significant”; the executive order designation, “Deregulatory”.
What it means on a shelf
Nothing yet, and that is the honest answer. An agenda entry is not a rule: no comment period has opened, and it may never publish. It tells you only that the agency holds a deregulatory item for an ingredient it will not name, and that another self-set month has gone.
Two words worth keeping apart, since this rule pushes them together: eligible is not endorsed. Clearing the definition lets an ingredient into a category; it is not an FDA evaluation, and nothing that qualifies as a supplement is intended to diagnose, treat, cure or prevent disease. Whatever it turns out to be, ask a clinician who knows what else you take.