What is FD&C Red No. 2?
FD&C Red No. 2, also known as amaranth, was a synthetic azo dye derived from coal tar. It was one of the original FDA-approved color additives when the Color Additives Amendment was enacted in 1960. The additive had the CAS number 915-67-3 and was classified as a synthetic organic dye used primarily for cosmetic coloring purposes in foods.
Common Uses
Before its delisting, FD&C Red No. 2 was widely used as a red colorant in various food products, including candies, baked goods, beverages, and processed foods. It was valued by manufacturers for its bright red color and stability in food applications. The dye was also used in cosmetics and pharmaceuticals. At its peak usage in the 1970s, it was one of the most commonly used food colorants in the United States.
Safety Assessment
While the FDA's adverse event database shows zero reported adverse events specifically linked to FD&C Red No. 2, the additive was delisted due to concerns about potential health risks identified through laboratory and animal studies. Research during the 1970s raised questions about carcinogenic potential, though human epidemiological data remained limited. The decision to delist the additive reflected regulatory caution in response to animal toxicology findings rather than documented human harm.
No FDA recalls are associated with this additive, and the regulatory action was precautionary rather than responsive to consumer injury reports. However, the accumulation of laboratory evidence was considered sufficient by FDA scientists to warrant removal from the approved list.
Regulatory Status
FD&C Red No. 2 was delisted by the FDA in February 1976, following reviews of scientific literature that raised safety concerns. This action made it illegal to use the additive in food, cosmetics, and pharmaceuticals sold in the United States. The delisting was part of broader scrutiny of synthetic food colorants during this period.
Other countries handled this additive differently. The European Union and some other nations continued to permit its use under the designation E123 (amaranth) for certain applications, indicating different regulatory risk assessments across jurisdictions. However, it has subsequently been delisted or restricted in many countries.
Today, manufacturers use alternative red colorants such as FD&C Red No. 40 (allura red) and natural alternatives like carmine and lycopene instead.
Key Studies
The scientific reviews that led to the delisting primarily focused on animal toxicology studies, though specific published literature on FD&C Red No. 2 from this era is less frequently cited in modern databases. The FDA's decision reflected the regulatory environment of the 1970s, when synthetic dyes faced increased scrutiny following the Delaney Clause, which prohibited food additives shown to cause cancer in any animal species at any dose.
The delisting of FD&C Red No. 2 represented a significant moment in food safety regulation, establishing precedent for removing previously approved additives based on emerging scientific evidence. It influenced subsequent regulatory approaches to synthetic colorants and contributed to the trend toward preference for natural colorants in food manufacturing.
