FDA Denies Request for Public Hearing on Repeal of Authorizations for FD&C Red No. 3
by Hutchinsons Law | Aug 5, 2026 | Law |
- Today FDA rejected an objection and request for a public hearing on the Agency’s final order to repeal the color additive regulations for FD&C Red No. 3 when used in food (21 CFR 74.303) and in ingested drugs (21 CFR 74.1303). The objection and request was submitted on behalf of Micro-Tracers, a company that uses tracers containing Red 3 in medicated feeds to verify the presence and uniform mixing of components of the feed.
- We have previously blogged on FDA’s revocation of the color additive listings for Red 3. The revocation was based on studies showing that high doses of Red 3 can cause cancer in rats through a mechanism of action not applicable to humans. Thus, although FDA did not find a safety issue with the authorized uses of Red 3, it revoked the authorizations as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.
- The objection and hearing request raised objections to: (1) the scientific basis for the revocation of the Red 3 authorizations, (2) FDA’s failure to consider the specific use in tracers, and (3) FDA’s failure to exempt the intended use in tracers from the revocation or permit the intended use through the establishment of a safe tolerance.
- FDA rejected each of these arguments. With respect to Objection 2, FDA stated that the revocation of the Red 3 listings was a legal decision and was not based on the safety of a specific intended use. The Agency also rejected the argument that the intended use in tracers was not subject to the Delaney clause because it was neither a color additive nor a food additive. FDA stated that Red 3 was added “for purposes of imparting color during a quality assurance testing phase,” and was therefore a color additive. Furthermore, even if not a color additive, it was a food additive because it was intentionally added.
- The filing of the objection had operated as an automatic stay of FDA’s repeal of the color additive authorizations. FDA’s denial of the objection ended the stay and confirms the effective dates for the repeal of the authorizations for Red 3; January 15, 2027, for use in food and January 18, 2028, for use in ingested drugs.
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