[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR700.15]

[Page 138]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 700_GENERAL--Table of Contents
 
          Subpart B_Requirements for Specific Cosmetic Products
 
Sec. 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.

[40 FR 50531, Oct. 30, 1975]