[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: 21CFR700.13]

[Page 136-137]
 
                        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. 700.13  Use of mercury compounds in cosmetics including use as 

skinbleaching agents in cosmetic preparations also regarded as drugs.

    (a) Mercury-containing cosmetic preparations have been represented 
for many years as skin-bleaching agents or as preparations to remove or 
prevent freckles and/or brown spots (so-called age spots). Preparations 
intended for such use are regarded as drugs as well as cosmetics. In 
addition to such use as skin-bleaching agents, mercury compounds have 
also been widely used as preservatives in cosmetics such as

[[Page 137]]

hand and body creams and lotions; hair shampoos, hair sets and rinses, 
hair straighteners, hair coloring, and other preparations; bath oils, 
bubble bath, and other bath preparations; makeup; antiperspirants and 
deodorants; and eye-area cosmetics.
    (b) The toxicity of mercury compounds is extensively documented in 
scientific literature. It is well known that mercury compounds are 
readily absorbed through the unbroken skin as well as through the lungs 
by inhalation and by intestinal absorption after ingestion. Mercury is 
absorbed from topical application and is accumulated in the body, giving 
rise to numerous adverse effects. Mercury is a potent allergen and 
sensitizer, and skin irritation is common after topical application. 
Cosmetic preparations containing mercury compounds are often applied 
with regularity and frequency for prolonged periods. Such chronic use of 
mercury-containing skin-bleaching preparations has resulted in the 
accumulation of mercury in the body and the occurrence of severe 
reactions. Recently it has also been determined that microorganisms in 
the environment can convert various forms of mercury into highly toxic 
methyl mercury which has been found in the food supply and is now 
considered to be a serious environmental problem.
    (c) The effectiveness of mercury-containing preparations as skin-
bleaching agents is questionable. The Food and Drug Administration has 
not been provided with well controlled studies to document the 
effectiveness of these preparations. Although mercurial preservatives 
are recognized as highly effective, less toxic and satisfactory 
substitutes are available except in the case of certain eye-area 
cosmetics.
    (d) Because of the known hazards of mercury, its questionable 
efficacy as a skin-bleaching agent, and the availability of effective 
and less toxic nonmercurial preservatives, there is no justification for 
the use of mercury in skin-bleaching preparations or its use as a 
preservative in cosmetics, with the exception of eye-area cosmetics for 
which no other effective and safe nonmercurial preservative is 
available. The continued use of mercurial preservatives in such eye-area 
cosmetics is warranted because mercury compounds are exceptionally 
effective in preventing Pseudomonas contamination of cosmetics and 
Pseudomonas infection of the eye can cause serious injury, including 
blindness. Therefore:
    (1) The Food and Drug Administration withdraws the opinion expressed 
in trade correspondence TC-9 (issued May 13, 1939) and concludes that 
any product containing mercury as a skin-bleaching agent and offered for 
sale as skin-bleaching, beauty, or facial preparation is misbranded 
within the meaning of sections 502(a), 502(f)(1) and (2), and 502(j), 
and may be a new drug without approval in violation of section 505 of 
the Federal Food, Drug, and Cosmetic Act. Any such preparation shipped 
within the jurisdiction of the Act after January 5, 1973 will be the 
subject of regulatory action.
    (2) The Food and Drug Administration withdraws the opinion expressed 
in trade correspondence TC-412 (issued Feb. 11, 1944) and will regard as 
adulterated within the meaning of section 601(a) of the Act any cosmetic 
containing mercury unless the cosmetic meets the conditions of paragraph 
(d)(2) (i) or (ii) of this section.
    (i) It is a cosmetic containing no more than a trace amount of 
mercury and such trace amount is unavoidable under conditions of good 
manufacturing practice and is less than 1 part per million (0.0001 
percent), calculated as the metal; or
    (ii) It is a cosmetic intended for use only in the area of the eye, 
it contains no more than 65 parts per million (0.0065 percent) of 
mercury, calculated as the metal, as a preservative, and there is no 
effective and safe nonmercurial substitute preservative available for 
use in such cosmetic.