FDA Revokes Authorization for the Use of FD&C Red No. 3, Cites Studies Showing Cancer Risk in Rats
January 16, 2025
DOCUMENTS
- Federal Register
WASHINGTON, D.C. –– The U.S. Food and Drugs Administration has revoked the authorization for the use of FD&C Red No. 3 under the Delaney Clause, citing two studies showing cancer in laboratory male rats who were exposed to high levels of the food additive.
In a Jan. 15 press release, the federal agency noted that the way that Red No. 3 was shown to cause cancer in male rates “does not occur in humans.”
“Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” the FDA …
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