Warning Letters Cite Cosmetics as Adulterated Due to Violative Use of the Color Additive Canthaxanthin

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it is illegal to market an adulterated cosmetic in interstate commerce (FD&C Act, section 301(a). Under the law, one of the ways a cosmetic can become adulterated is if it contains a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act (FD&C Act, sec. 601(e)).

FDA issued warning letters to the following firms, citing cosmetic products as adulterated due to the violative use of a color additive. In these cases, products containing canthaxanthin were marketed for use in coloring the skin to simulate a tan, which is not a permitted use for this color additive.

• USA Chemicals, Inc. (also available in PDF) March 1, 2005
• RPM Total Vitality June 29, 2004
• World Class Nutrition June 29, 2004
• Affordable Supplements June 28, 2004
• SmartBodyz Nutrition June 28, 2004
• Wow.Muscle.com, c/o Prime Nutrition June 28, 2004
• Higher Power, Inc. June 25, 2004
• American Sports Nutrition June 24, 2004

For related information, see Tanning Pills and Color Additives.