The FDA is responsible for regulating all color additives used in foods, drugs, cosmetics (except for coal- tar hair dyes), and certain medical devices to ensure that they meet the FDA’s safety standard and are accurately labeled. A color additive is any dye, pigment, or other substance which when added or applied to a food, drug, cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color.
Color additives serve a useful purpose in many products, making them attractive, appealing, appetizing, and informative. Added color can serve as a kind of code that allows us to identify products on sight, like candy flavors, medicine dosages, and left or right contact lenses. One of the FDA’s roles is to assure that color additives are safely and appropriately used.
"Color" includes white, black, and gray. A substance capable of imparting color is a color additive unless the substance is used in a product solely for a purpose other than coloring and the substance is clearly unimportant to the marketability of the product. In addition, a chemical that reacts with another substance and causes formation of a color may be a color additive. For example, dihydroxyacetone (DHA), which is authorized for use as a color additive in certain cosmetics including sunless “tanning” products, when applied to the skin, reacts with the protein of the skin to impart color. Even though DHA is colorless, it acts as a color additive when used for this purpose and is regulated as a color additive.
Color additives are classified as straight colors, lakes, and mixtures:
- Straight colors are color additives that have not been mixed or chemically reacted with any other substance (for example, FD&C Blue No. 1 or Blue 1).
- Lakes are formed by chemically reacting straight colors with precipitants and substrata (for example, Blue 1 Lake). Lakes for food use must be made from certified batches of straight colors. (One exception to the certification requirement is carmine, which is a lake made from cochineal extract.) Lakes for food use also must be made with aluminum cation and aluminum hydroxide.
- Mixtures are color additives formed by mixing one color additive with one or more other color additives or non-colored diluents (substances used to dilute something), without a chemical reaction (for example, food inks used to mark confectionery).
The FDA’s Safety Review of Color Additives
Under the Federal Food, Drug, and Cosmetic Act, all color additives and new uses for listed color additives must be approved by the FDA before they may be used in foods, drugs, cosmetics, or certain medical devices, or on the human body. There is no "generally recognized as safe" (GRAS) provision within the statutory definition of a color additive. A listing of all approved color additives is available in the FDA’s Regulatory Status of Color Additives inventory. More information about our regulatory approach to color additives is available on Understanding How the FDA Regulates Color Additives.
Certain color additives, known as certified colors, which are generally synthetic dyes and pigments, are required to undergo batch certification before they may be used in products. In this process, the FDA chemically analyzes a representative sample of each batch of the color additive to ensure the batch meets the required identity and specifications.
The FDA continually monitors reports of problems that may be related to color additives and takes action when necessary. The FDA can issue a warning letter to the manufacturer, detain products before they are shipped to stores, issue import alerts, or even seize products that are found to be unsafe or to contain color additives that are misused, not authorized, or not properly identified as ingredients. The FDA may also revoke or amend its regulations of current authorized uses as needed.
The FDA has reviewed and continues to examine the effects of color additives on children’s behavior. The totality of scientific evidence shows that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them. In 2011, the FDA convened its Food Advisory Committee (FAC) to consider whether available relevant data demonstrate a link between children’s consumption of certified color additives in foods and adverse effects on their behavior. The FAC concluded that a link between children’s consumption of certified color additives causing behavioral effects had not been established. Further neurobehavioral research is needed to explain potential pathways underlying these sensitivities. In 2019, the FDA presented new information to its Science Board including the FDA’s published comprehensive dietary exposure assessment for all seven FD&C color additives approved for use in foods and an updated scientific literature review. The FDA will continue to assess the emerging science and ensure the safety of approved color additives. Parents who wish to limit the amount of color additives in their children’s diet may check the food ingredient list on labels. Parents may also discuss any concerns with their family physician.
The FDA Monitors Reports or Problems Related to Color Additives
If you think that you experienced an adverse reaction to a food, including a color additive, you can report the reaction to the FDA. To report a problem to the FDA:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
If you are a member of the food industry who needs to submit a Reportable Food Registry report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals, please visit the Reportable Food Registry page.
For More Information:
- Understanding How the FDA Regulates Color Additives
- Color Additives in Foods
- Inventory of Color Additives
- Questions and Answers on Color Additives
- Consumer Update: How Safe are Color Additives
- Color Additives and Cosmetics Fact Sheet
- Color Additives Permitted Use in Cosmetics
- Summary of Color Additives for Use in the U.S. in Foods, Drugs, Cosmetics, and Medical Devices