[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: 21CFR700.11]

[Page 136]
 
                        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. 700.11  Cosmetics containing bithionol.


    (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.