On January 15, 2025, the FDA revoked authorization for FD&C Red No. 3 (erythrosine) for use in foods, including dietary supplements, and in ingested drugs. The agency followed a petition process and concluded the animal data met the statutory test requiring delisting.
FDA also set compliance dates so industry can reformulate:
The delisting means demand for Red 3 in food and ingestible drug uses will fall to zero by the compliance dates, creating immediate commercial and supply-chain implications for suppliers and customers.
Ingredient companies should:
The FDA’s action was driven by animal carcinogenicity evidence and the operation of a statutory legal trigger known as the Delaney Clause. Studies in laboratory animals, notably in long-term rat feeding studies, showed an increased incidence of thyroid tumors in male rats exposed to Red 3 at high doses.
Under the Delaney Clause, an additive that induces cancer in animals or humans for a listed use is treated as unsafe and must be removed. This legal standard does not require a quantified estimate of human risk at typical exposure levels — the presence of carcinogenicity in animal studies is enough to compel delisting.
Industry stakeholders have offered alternative interpretations of the animal findings and pointed to study limitations, but FDA concluded the statutory criterion was met. Importantly, cosmetic (topical) uses are not covered by this delisting.
A color additive petition is the formal submission to FDA asking the agency to allow a specific color additive for certain uses or to change an existing regulation. The petition must provide a complete technical package including:
The petition also supports the rulemaking steps FDA must complete before granting authorization. If a colorant is already listed for the intended use and you comply with the specifications, a petition is not required.
You generally need a petition when you want to market a color additive that is not already permitted for a specific use (food, drug, cosmetic, or medical device), add or change a listed use, or alter permitted levels or conditions.
For ingestible products, the bar is higher. FDA expects robust technical and safety data. If the replacement colorant is already permitted, you can proceed under that existing regulation as long as your material meets specifications.
A well-prepared petition should include:
Exposure calculations should use realistic consumption assumptions. Because FDA may request additional studies or clarifications, it is wise to anticipate follow-up needs and consider seeking pre-submission advice from the agency.
If your ingredient is supplied to drug manufacturers, replacing a color in an approved drug can trigger regulatory filings by the drug sponsor. Depending on the nature of the change, this may include:
Coordinate early with drug customers to determine who will handle filings and to align timing so product approvals and manufacturing changes do not disrupt supply.
Start by mapping your inventory and customers to find every product that currently uses Red 3. For each potential replacement, confirm whether it is already listed for the intended use. If not, plan for the data and timeline needed to support a color additive petition.
Begin assembling the technical package now:
Communicate early with downstream customers — food, beverage, and drug manufacturers — to coordinate reformulation plans and regulatory responsibilities. Consider asking FDA for pre-filing feedback to reduce the chance of data gaps.
The Red 3 delisting is a regulatory reminder that animal carcinogenicity findings can trigger definitive legal outcomes that force market change. Ingredient companies should act promptly:
Taking these steps now will help meet compliance timelines with minimal disruption.