This electronic document was downloaded from the GPO web site, December 1999, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

[Code of Federal Regulations]
[Title 21, Volume 7, Parts 600 to 799]
[Revised as of April 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR740]
 
[Page 145-147]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 740--COSMETIC PRODUCT WARNING STATEMENTS--Table of Contents
 
                           Subpart A--General
 
Sec. 740.1  Establishment of warning statements.
 
 
    (a) The label of a cosmetic product shall bear a warning statement
whenever necessary or appropriate to prevent a health hazard that may be
associated with the product.
    (b) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
publish a proposal to establish or amend, under subpart B of this part,
a regulation prescribing a warning for a cosmetic. Any such petition
shall include an adequate factual basis to support the petition, shall
be in the form set forth in part 10 of this chapter, and will be
published for comment if it contains reasonable grounds for the proposed
regulation.
 
[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 15676, Mar. 22, 1977]
 
 
Sec. 740.2  Conspicuousness of warning statements.
 
    (a) A warning statement shall appear on the label prominently and
conspicuously as compared to other words, statements, designs, or
devices and in bold type on contrasting background to render it likely
to be read and understood by the ordinary individual under customary
conditions of purchase and use, but in no case may the letters and/or
numbers be less than \1/16\ inch in height, unless an exemption pursuant
to paragraph (b) of this section is established.
    (b) If the label of any cosmetic package is too small to accommodate
the information as required by this section, the Commissioner may
establish by regulation an acceptable alternative method, e.g., type
size smaller than \1/16\ inch in height. A petition requesting such a
regulation, as an amendment to this section, shall be submitted to the
Dockets Management Branch in the form established in part 10 of this
chapter.
 
[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 15676, Mar. 22, 1977]
 
 
                      Subpart B--Warning Statements
 
Sec. 740.10  Labeling of cosmetic products for which adequate substantiation
of safety has not been obtained.
 
    (a) Each ingredient used in a cosmetic product and each finished
cosmetic product shall be adequately substantiated for safety prior to
marketing. Any such ingredient or product whose safety is not adequately
substantiated prior to marketing is misbranded unless it contains the
following conspicuous statement on the principal display panel:
 
    Warning--The safety of this product has not been determined.
 
    (b) An ingredient or product having a history of use in or as a
cosmetic may at any time have its safety brought into question by new
information that in itself is not conclusive. The warning required by
paragraph (a) of this section is not required for such an ingredient or
product if:
    (1) The safety of the ingredient or product had been adequately
substantiated prior to development of the new information;
    (2) The new information does not demonstrate a hazard to human
health; and
    (3) Adequate studies are being conducted to determine expeditiously
the safety of the ingredient or product.
    (c) Paragraph (b) of this section does not constitute an exemption
to the adulteration provisions of the Act or to
 
[[Page 146]]
 
any other requirement in the Act or this chapter.
 
[40 FR 8917, Mar. 3, 1975]
 
 
Sec. 740.11  Cosmetics in self-pressurized containers.
 
    (a)(1) The label of a cosmetic packaged in a self-pressurized
container and intended to be expelled from the package under pressure
shall bear the following warning:
 
    Warning--Avoid spraying in eyes. Contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120 deg. F.
Keep out of reach of children.
 
    (2) In the case of products intended for use by children, the phrase
``except under adult supervision'' may be added at the end of the last
sentence in the warning required by paragraph (a)(1) of this section.
    (3) In the case of products packaged in glass containers, the word
``break'' may be substituted for the word ``puncture'' in the warning
required by paragraph (a)(1) of this section.
    (4) The words ``Avoid spraying in eyes'' may be deleted from the
warning required by paragraph (a)(1) of this section in the case of a
product not expelled as a spray.
    (b)(1) In addition to the warning required by paragraph (a)(1) of
this section, the label of a cosmetic packaged in a self-pressurized
container in which the propellant consists in whole or in part of a
halocarbon or a hydrocarbon shall bear the following warning:
 
    Warning--Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
 
    (2) The warning required by paragraph (b)(1) of this section is not
required for the following products:
    (i) Products expelled in the form of a foam or cream, which contain
less than 10 percent propellant in the container.
    (ii) Products in a container with a physical barrier that prevents
escape of the propellant at the time of use.
    (iii) Products of a net quantity of contents of less than 2 ozs.
that are designed to release a measured amount of product with each
valve actuation.
    (iv) Products of a net quantity of contents of less than \1/2\ oz.
    (c) Labeling requirements for cosmetics packaged in a self-
pressurized container containing or manufactured with a
chlorofluorocarbon propellant or other ozone-depleting substance
designated by the Environmental Protection Agency (EPA) are set forth in
40 CFR part 82.
 
[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 22033, Apr. 29, 1977; 54
FR 39640, Sept. 27, 1989; 61 FR 20101, May 3, 1996]
 
 
Sec. 740.12  Feminine deodorant sprays.
 
    (a) For the purpose of this section, the term ``feminine deodorant
spray'' means any spray deodorant product whose labeling represents or
suggests that the product is for use in the female genital area or for
use all over the body.
    (b) The label of a feminine deodorant spray shall bear the following
statement:
 
    Caution--For external use only. Spray at least 8 inches from skin.
Do not apply to broken, irritated, or itching skin. Persistent, unusual
odor or discharge may indicate conditions for which a physician should
be consulted. Discontinue use immediately if rash, irritation, or
discomfort develops.
 
 
The sentence ``Spray at least 8 inches from skin'' need not be included
in the cautionary statement for products whose expelled contents do not
contain a liquified gas propellant such as a halocarbon or hydrocarbon
propellant.
    (c) Use of the word ``hygiene'' or ``hygienic'' or a similar word or
words renders any such product misbranded under section 602(a) of the
Federal Food, Drug, and Cosmetic Act. The use of any word or words which
represent or suggest that such products have a medical usefulness
renders such products misbranded under section 502(a) of the Act and
illegal new drugs marketed in violation of section 505 of the Act.
 
[40 FR 8929, Mar. 3, 1975]
 
 
Sec. 740.17  Foaming detergent bath products.
 
    (a) For the purpose of this section, a foaming detergent bath
product is any product intended to be added to a bath for the purpose of
producing foam that contains a surface-active agent serving as a
detergent or foaming ingredient.
    (b) The label of foaming detergent bath products within the meaning
of paragraph (a) of this section, except for
 
[[Page 147]]
 
those products that are labeled as intended for use exclusively by
adults, shall bear adequate directions for safe use and the following
caution:
 
    Caution--Use only as directed. Excessive use or prolonged exposure
may cause irritation to skin and urinary tract. Discontinue use if rash,
redness, or itching occurs. Consult your physician if irritation
persists. Keep out of reach of children.
 
    (c) In the case of products intended for use by children, the phrase
``except under adult supervision'' may be added at the end of the last
sentence in the caution required by paragraph (b) of this section.
 
[51 FR 20475, June 5, 1986]
 
 
Sec. 740.18  Coal tar hair dyes posing a risk of cancer.
 
    (a) The principal display panel of the label and any labeling
accompanying a coal tar hair dye containing any ingredient listed in
paragraph (b) of this section shall bear, in accordance with the
requirements of Sec. 740.2, the following:
 
    Warning--Contains an ingredient that can penetrate your skin and has
been determined to cause cancer in laboratory animals.
 
    (b) Hair dyes containing any of the following ingredients shall
comply with the requirements of this section: (1) 4-methoxy-m-
phenylenediamine (2,4-diaminoanisole) and (2) 4-methoxy-m-
phenylenediamine sulfate (2,4-diaminoanisole sulfate).
 
[44 FR 59522, Oct. 16, 1979]
 
    Effective Date Note:  At 47 FR 7829, Feb. 23, 1982, the
effectiveness of Sec. 740.18 was stayed until further notice. The stay
was effective Sept. 18, 1980.


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