[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR700.16]

[Page 128]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 700--GENERAL--Table of Contents
 
         Subpart B--Requirements for Specific Cosmetic Products
 
Sec. 700.16  Use of aerosol cosmetic products containing zirconium.

    (a) Zirconium-containing complexes have been used as an ingredient 
in cosmetics and/or cosmetics that are also drugs, as, for example, 
aerosol antiperspirants. Evidence indicates that certain zirconium 
compounds have caused human skin granulomas and toxic effects in the 
lungs and other organs of experimental animals. When used in aerosol 
form, some zirconium will reach the deep portions of the lungs of users. 
The lung is an organ, like skin, subject to the development of 
granulomas. Unlike the skin, the lung will not reveal the presence of 
granulomatous changes until they have become advanced and, in some 
cases, permanent. It is the view of the Commissioner that zirconium is a 
deleterious substance that may render any cosmetic aerosol product that 
contains it injurious to users.
    (b) Any aerosol cosmetic product containing zirconium is deemed to 
be adulterated under section 601(a) of the Federal Food, Drug, and 
Cosmetic Act.
    (c) Any such cosmetic product introduced in interstate commerce 
after September 15, 1977 is subject to regulatory action.

[42 FR 41376, Aug. 16, 1977]