Fd&c Red No. 4--delisted

FD&C Red No. 4, also known as Amaranth or CI Food Red 9, is a synthetic azo dye (CAS Number: 4548-53-2) that was historically used as a food coloring agent. The designation "FD&C" refers to colorants approved by the FDA for use in foods, drugs, and cosmetics. FD&C Red No. 4 produced a bright red to crimson color and was utilized primarily in food and beverage applications before its delisting.

Prior to its delisting, FD&C Red No. 4 was used to color a variety of food products, including beverages, candies, baked goods, and other processed foods where red coloration was desired. The dye was also used in some cosmetic and pharmaceutical applications. However, since its removal from the FDA's approved list in 1976, it has not been permitted for use in food products in the United States.

The delisting of FD&C Red No. 4 was driven by toxicological research conducted during the 1970s. Studies raised concerns about the safety profile of the additive, particularly regarding its potential carcinogenic effects in animal models. The FDA reviewed available scientific evidence and determined that the data did not support continued approval for food use.

While the FDA database shows zero recorded adverse events and zero recalls associated with FD&C Red No. 4, this reflects the fact that the additive has been removed from the food supply in the United States for nearly 50 years. Historical safety concerns, rather than documented consumer harm reports, were the basis for its delisting. The European Union similarly restricted or prohibited the use of this colorant in food products based on safety evaluations.

FD&C Red No. 4 was officially delisted by the FDA in 1976 and is no longer permitted as a food additive in the United States. This delisting means that manufacturers cannot legally add this dye to food products intended for U.S. consumers. The additive remains prohibited under current FDA regulations for food use.

In other countries, the regulatory status varies. The European Food Safety Authority (EFSA) has also restricted or prohibited the use of this colorant in food. Some countries may permit its use in limited applications, but it is not widely accepted internationally as a food additive.

Manufacturers seeking to achieve red coloration in foods must now use other approved colorants, such as FD&C Red No. 40 (Allura Red AC), which underwent more extensive safety testing and is currently approved for food use in the United States and many other countries.

The scientific basis for FD&C Red No. 4's delisting came from toxicological studies conducted in the early-to-mid 1970s. Research suggested potential concerns related to carcinogenicity and other health effects based on animal studies. The FDA evaluated this evidence using the standards of food safety assessment available at that time and made the decision to remove the additive from the approved list.

While specific peer-reviewed studies from this period are the foundation of the delisting decision, the regulatory determination reflected the precautionary approach taken by the FDA when safety questions emerged. The delisting of FD&C Red No. 4 marked a shift in how the agency evaluated synthetic food colorants, leading to more stringent testing requirements for similar additives.

Historically, FD&C Red No. 4 represents an example of how regulatory agencies can and do remove food additives from the market when safety concerns are identified, even in the absence of widespread consumer complaints or documented harm in the general population.