21 CFR 700.11 - Cosmetics Containing Bithionol

Overview:

21 CFR 700.11 addresses the use of bithionol in cosmetics. The FDA has determined that bithionol can cause photosensitivity and may lead to cross-sensitization with other chemicals, making it harmful to users. 

As a result, any cosmetic containing bithionol is considered adulterated and subject to regulatory action if shipped after March 15, 1968.

(a) 

Bithionol has been used to some extent as an antibacterial agent in cosmetic preparations such as detergent bars, shampoos, creams, lotions, and bases used to hide blemishes. New evidence of clinical experience and photopatch tests indicate that bithionol is capable of causing photosensitivity in man when used topically and that in some instances the photosensitization may persist for prolonged periods as severe reactions without further contact with sensitizing articles. Also, there is evidence to indicate that bithionol may produce cross-sensitization with other commonly used chemicals such as certain halogenated salicylanilides and hexachlorophene. It is, therefore, the view of the Food and Drug Administration that bithionol is a deleterious substance which may render any cosmetic product that contains it injurious to users. Accordingly, any cosmetic containing bithionol is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.

(b) 

Regulatory proceedings may be initiated with respect to any cosmetic preparation containing bithionol shipped within the jurisdiction of the act after March 15, 1968.