FDA Revokes the Use of Red No. 3 (Erythrosine) in Food and Ingested Drugs
Keywords: FDA / Erythrosine / Regulatory Affairs / Formulation / Export
The FDA (Food and Drug Administration, United States) announced on January 15, 2025, that it will revoke authorization for the use of FD&C Red No. 3 in food and ingested drugs, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This decision responds to a 2022 petition citing studies in male rats that showed cancer development after exposure to high levels of the dye. In its statement, the FDA declared: “The way that FD&C Red No. 3 causes cancer in male rats 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.”
Additionally, human exposure levels are significantly lower, and studies in other species and humans have not demonstrated similar risks.
Key Dates
The Delaney Clause, in effect since 1960, prohibits the authorization of food additives or colorants shown to induce cancer in humans or animals. Red No. 3, primarily used in candies, cakes, cookies, ice cream, and certain medications, will be phased out gradually: food products must be reformulated by January 15, 2027, and medications by January 18, 2028.
The Delaney Clause, in effect since 1960, prohibits the authorization of food additives or colorants shown to induce cancer in humans or animals. Red No. 3, primarily used in candies, cakes, cookies, ice cream, and certain medications, will be phased out gradually: food products must be reformulated by January 15, 2027, and medications by January 18, 2028.
Although other countries permit its use under the name erythrosine, food imported into the U.S. must comply with this regulation.
For inquiries on how this alert may affect your products in Central America and the Dominican Republic, contact us at info@scheelconsulting.com.
Source: FDA Update
