On January 15, 2025, the Food and Drug Administration (FDA) announced that they are banning the use of FD&C Red No. 3 in food and ingested drugs. FD&C Red No. 3, also known as erythrosine, is a petroleum-based dye that gives products a bright cherry red color. This dye is often found in candy, frosting, and baked goods such as cakes, cookies, or frozen desserts.
The History
The decision to ban FD&C Red No. 3 comes as a response to the 2022 color additive petition in which the Delaney Cause was sited. The Delaney Clause was added into the Color Additives Amendment to the FD&C Act in 1960. This clause prohibited the FDA from authorizing any food additive or color that has been found to cause cancer in humans or animals.
Although the FDA banned the use of this dye in cosmetics and topical drugs in 1990, they did not ban its use in food at the time. Concerns with FD&C Red No. 3 first arose in the 1980’s following scientific studies. These studies, conducted on male rats, revealed a link between this dye and thyroid cancer. However, there is currently no link to cancer in humans. Additionally, the US is not the only country to have banned this dye. The EU, Australia, and New Zealand have banned the use of FD&C Red No. 3 in all foods except maraschino cherries.
Furthermore, as manufacturers adjust to this new requirement, natural dyes such as beet extract are potential options to replace FD&C Red No. 3. In addition, institutions such The Ohio State University College of Food, Agricultural, and Environmental Sciences (CFAES) are developing natural replacements derived from anthocyanins that can be used in place of petroleum-based dyes. Anthocyanins are plant-based pigments and anthocyanin-rich foods have been linked to possible health benefits.
Next Steps
Manufactures have until January 15, 2027, or January 18, 2028, to remove FD&C Red No. 3 from their products. However, consumers may still see this dye listed as an ingredient after these dates. This would occur if the product was manufactured prior to the effective date. If you’d like to stay up to date with the latest industry news, make sure to subscribe to receive our Industry Updates emails! Safe Food Alliance here to help you with your food safety needs from our full-service lab to our training and consulting services. See how we can help you today!
