The first food standards to be issued under the 1938 act were for canned tomato products; by the 1960s about half of the food supply was subject to a standard. As food technology changed and the number of possible ingredients–including fortifying nutrients–grew, the agency developed recipe standards for foods, lists of ingredients that could lawfully be included in a product. A food that varied from the recipe would have to be labeled as imitation.
As with the 1938 act, a therapeutic disaster compelled passage of the new law; in this case the disaster was narrowly averted. Thalidomide, a sedative that was never approved in this country, produced thousands of grossly deformed newborns outside of the United States. The new law mandated efficacy as well as safety before a drug could be marketed, required FDA to assess the efficacy of all drugs introduced since 1938, instituted stricter agency control over drug trials (including a requirement that patients involved must give their informed consent), transferred from the Federal Trade Commission to the FDA.
January 15, 2025 – The USFDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The FDA is making changes to color additives regulations to NO LONGER allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition from advocates who argue that the additive is associated with cancer and behavioral issues in children. FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. It has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.
Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products. Other countries still currently allow for certain uses of FD&C Red No. 3. However, foods imported to the U.S. must comply with U.S. requirements.
