Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Color Additives

Color Additives

                        FD&C Red No. 3


                        Color Additive Inventories
          Color Additive Laws, Regulations, and Guidance
          Color Additive Petitions
          Color Additive Science and Research
          Color Additives in Specific Products
          Color Certification
          Compliance & Enforcement of Color Additives
          Color Additives History Home
          For Industry
          Color Additives
          FD&C Red No. 3Color Additives FD&C Red No. 3
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThe 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 1958, 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

How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety
	How Safe are Color Additives?
	Color Additives in Foods
	Color Additives Information for Consumers
	Inventory of Color Additives
	Color Additives History
	Understanding How the FDA Regulates Color Additives
	Lists of Select Chemicals in the Food Supply Under FDA Review
	FDA Works to Enhance the Assessment of Ingredients in Foods and Food Contact Substances on the Market

                                                                                  Content current as of:
      12/14/2023
              
              
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  IngredientsColor Additives

          
                        FD&C Red No. 3


                        Color Additive Inventories
          Color Additive Laws, Regulations, and Guidance
          Color Additive Petitions
          Color Additive Science and Research
          Color Additives in Specific Products
          Color Certification
          Compliance & Enforcement of Color Additives
          Color Additives History
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop