In 1990, a significant decision was made by the FDA as they banned Red No. 3, also known as erythrosine, from cosmetics and topical drugs under the Delaney Clause. This move sparked a series of events and petitions that have had a lasting impact on the food and drug industries. The FDA is currently engaged in a thorough review of a petition filed for FD&C Red No. 3, which is authorized for use in food and ingested drugs. The petition emphasizes that the Delaney Clause obligates the FDA to repeal the color additive regulations allowing its use in foods and ingested drugs.Consumer Reports' Call for Action
Another petition initiated by Consumer Reports has been making waves. It demands that the FDA act promptly to prohibit the use of Red Dye No. 3 in food, medicine, and supplements. This dye, which is known to be a carcinogen, has already been banned in food in the European Union and California starting in 2027. Despite this, the FDA has failed to fulfill its promise of a national ban on this dye in our food products, especially those marketed to children like candy and junk food. It is high time that we remove this unnecessary and dangerous additive from our food.Understanding the Delaney Clause
Enacted in 1960, the Delaney Clause prevents the FDA from finding a color additive safe if it has been shown to cause cancer in humans or animals at any dose. Color additives, such as Red No. 3, are commonly used in foods in very small amounts and must obtain FDA approval. Red No. 3 is a color additive derived from petroleum that gives foods and drinks a vivid cherry-red color. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), color additives, including FD&C Red No. 3, are subject to FDA approval before they can be used in food, drugs, or cosmetics, or in medical devices in contact with the bodies of people or animals for a significant period.The FDA has evaluated the safety of FD&C Red No. 3 on multiple occasions since its approval in 1969. Currently, there are two authorizing color additive regulations for FD&C Red No. 3 - one for food (CFR – Code of Federal Regulations Title 21 (fda.gov)) and one for ingested drugs (CFR – Code of Federal Regulations Title 21 (fda.gov)). The agency is dedicated to continuously evaluating all relevant scientific information and data when considering whether changes to the food supply are warranted.Regulatory Approach and Certification
Most color additives, including FD&C Red No. 3, require pre-market review and approval by the FDA. The law demands evidence that a color additive is safe under its intended conditions of use before it can be added to foods. FD&C Red No. 3 is only permitted from batches that the FDA has certified. This means that FDA chemists analyze a sample from the batch and ensure it meets the requirements for composition and purity stated in the regulation for that color additive.When evaluating the safety of a new color additive or a new use for a listed color additive, the FDA considers various factors such as likely consumption amount, intended use, the manufacturing process, and its physical and chemical properties. When the FDA approves the use of a color additive, the regulations specify the products in which it can be used, any maximum amounts allowed, and how it should be declared on the label. In the US, FD&C Red No. 3 must be declared in the ingredient list on food labels by its specific name, such as “FD&C Red No. 3” or without the “FD&C” prefix or the term “No.” - for example, “FD&C Red 3” or “Red 3”. It's interesting to note that in other countries like Canada and Europe, Red No. 3 may be found under a different name, such as erythrosine.Monitoring and Post-Market Review
The food industry has the responsibility to ensure the safety of the food it markets and meets all FDA requirements. FDA scientists continuously review publicly available information about the safety and toxicology of color additives to determine if their use remains safe under the Federal Food, Drug, and Cosmetic Act. This ongoing monitoring is crucial in safeguarding public health.In conclusion, the FDA's stance on Red No. 3 and its associated regulations have significant implications for the food and drug industries. The agency's commitment to evaluating scientific information and data ensures that consumers are protected from potentially harmful substances. By understanding these processes and regulations, we can make more informed decisions about the food we consume and the drugs we take.