The Food and Drug Administration (FDA) has the responsibility of regulating all color additives used in the processing of food in the United States. The FDA is in charge of certifying all man-made food colorings, with both the manufacturer and the FDA testing each batch of man-made dye. The FDA notes that this process is intended to “assure the safety, quality, consistency, and strength of the color additive prior to its use in foods.” Color additives that come from natural sources or those that are man-made counterparts of naturally derived coloring agents do not need certification by the FDA prior to use. However, food manufacturers vigorously test all food additives for safety prior to use.
Safety of color additives
All food manufacturers must petition the FDA for approval. Frequently documented studies are required of long-term, large-dose use in animals. Sometimes, the FDA also requires submission of studies showing use of the additives in humans. The FDA must determine “reasonable certainty” (although never guaranteed) of harmlessness from consumption of the food additive at amounts an individual is likely to consume. The FDA then decides the:
- Types of foods that can include the coloring
- Maximum amount for a food
- How to list the color additive on the food label
Any color additive used in meat or poultry also must receive approval from the US Dept of Agriculture (USDA).
The FDA has an Adverse Reactions Monitoring System (ARMS), which monitors and investigates any complaints by individuals or physicians related or possibly related to color additives. The computerized database helps officials decide when an adverse reaction is capable of having hazardous effects on the American population.
Colorings in medication
Three separate categories of certifiable man-made colorings exist:
- Food, Drug, and Cosmetic (FD&C)—with applications in foods, drugs, or cosmetics
- Drug and Cosmetic (D&C)—with applications in drugs and cosmetics
- External Drug and Cosmetic (External D&C)—with applications in externally applied drugs (eg, ointments) and externally applied cosmetics
The ingredient list must list all color additives used in a product by its usual name.
FD&C Yellow No.5 causes hives in less than 1 in 10,000 people. No proof exists to confirm allegations that the coloring causes asthma attacks in people. The FDA has proposed rescinding the use of FD&C Red No.3, because of studies showing associated thyroid tumors in rats.
Hyperactivity and learning disabilities
The FDA states that well-controlled studies have proven no correlation between food coloring and hyperactivity or learning disabilities. However, on June 3, 2008, the Center for Science in the Public Interest called for the FDA to ban all artificial coloring in foods in the United States, based on the claim that the coloring leads to attention deficit hyperactivity disorder. Many parents now remove artificially colored food from their children’s diet and report positive results. In Britain, the government is so concerned about the potential link that Britain has switched to natural colorings in many food items. These food items still are artificially colored in the United States.
References and recommended readings
International Food Information Council Foundation, US Food and Drug Administration. Food ingredients and colors. Available at: http://www.ific.org/publications/brochures/upload/foodingredientsandcolorsbroch.pdf. Accessed November 8, 2008.
Paddock C. Ban food dyes says U.S. watchdog. Available at: http://www.medicalnewstoday.com/articles/109838.php. Accessed November 8, 2008.
US Food and Drug Administration. Food color facts. Available at: http://vm.cfsan.fda.gov/~lrd/colorfac.html. Accessed November 8, 2008.
Review Date 12/08