Code of Federal Regulations Title 21. Food and Drugs § 21.700.15 Use of certain halogenated salicylanilides as ingredients in cosmetic products

(a) Halogenated salicylanilides (tribromsalan (TBS,3,4’,5–tribromosalicylanilide), dibromsalan (DBS,4’5–dibromosalicylanilide), metabromsalan (MBS, 3,5 – dibromosalicylanilide) and 3,3’,4,5’– tetrachlorosalicylanilide (TCSA)) have been used as antimicrobial agents for a variety of purposes in cosmetic products. These halogenated salicylanilides are potent photosensitizers and cross-sensitizers and can cause disabling skin disorders. In some instances, the photosensitization may persist for prolonged periods as a severe reaction without further exposure to these chemicals. Safer alternative antimicrobial agents are available.

(b) These halogenated salicylanilides are deleterious substances which render any cosmetic that contains them injurious to users. Therefore, any cosmetic product that contains such a halogenated salicylanilide as an ingredient at any level for any purpose is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.

(c) Any cosmetic product containing these halogenated salicylanilides as an ingredient that is initially introduced into interstate commerce after December 1, 1975, that is not in compliance with this section is subject to regulatory action.