Warning Letters Cite Cosmetics as Adulterated Due to Violative Use of 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. 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