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The FDA is actively reviewing a petition filed for FD&C Red No. 3, which is authorized for use as a color additive in food and ingested drugs. The petition states that the Delaney Clause obligates the FDA to repeal the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The Delaney Clause, enacted in 1960, prevents FDA from finding a color additive to be safe if it has been found to induce cancer in humans or animals at any dose. Color additives are typically used in foods available in the U.S. marketplace in very small amounts and must be approved by the FDA. Red No. 3 is a color additive made from petroleum that gives foods and drinks a bright cherry-red color.

Regulation of FD&C Red No. 3 in Cosmetics vs. Food

In 1990, based on the Delaney Clause, FDA denied a petition to authorize use of Red No. 3 in cosmetics and topical drugs due to the existence of data demonstrating that it is associated with animal carcinogenicity. The use of Red No. 3 in foods and ingested drugs had already been authorized at that time. The way that Red No. 3 causes cancer in animals, specifically rats, does not occur in humans so these animal results have limited relevance to humans. Because these studies did not raise safety concerns, the FDA did not take action to revoke the authorization of Red No. 3 in food.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Chapter VII, section 721), color additives, including FD&C Red No. 3 are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time. The FDA has evaluated the safety of FD&C Red No. 3 multiple times since its approval in 1969. Currently, the FDA has 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 committed to continuing its evaluation of all relevant scientific information and data when considering if changes that could impact the food supply, are warranted.

Regulatory Approach  

Most color additives, including FD&C Red No. 3, require pre-market review and approval by the FDA. The law requires evidence that a color additive is safe under its intended conditions of use before it may be added to foods.  In addition, FD&C Red No. 3 is a color additive that is permitted only from batches that FDA has certified. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation for that color additive.

In the case of color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the intended use. The FDA evaluates the petition, and other existing data and information, and if the data available demonstrates that the substance is safe under the proposed conditions of use, the agency issues a regulation authorizing the use of the color additive. When evaluating the safety of a new color additive or a new use for a listed color additive, the FDA considers factors, including likely amount of consumption, intended use, the manufacturing process, and its physical and chemical properties, among others. 

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 to be used, and how the color additive is to be declared on the label. FDA requires FD&C Red No. 3 to be declared in the ingredient list on food labels by the name of the color additive listed by the applicable regulation, i.e., “FD&C Red No. 3” or without the “FD&C” prefix or the term “No.”– e.g., “FD&C Red 3” or “Red 3”.Red No. 3 may be found in food in other countries under a different name , such as in Canada and Europe under the name erythrosine. 

Monitoring Color Additives and Post Market Review

The food industry is responsible for ensuring the food it markets is safe and meets all applicable FDA requirements. FDA scientists continue to review publicly available information about the safety and toxicology of color additives to determine whether the use continues to be safe under the Federal Food, Drug, and Cosmetic Act. 

Additional Information

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