Code of Federal Regulations

  Title 21, Volume 7, Parts 600 to 799

  Revised as of April 1, 1996

 From the U.S. Government Printing Office via GPO Access

  CITE: 21CFR740

 

  Page 200-202

 

         TITLE 21--FOOD AND DRUGS

 

 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

 

 PART 740--COSMETIC PRODUCT WARNING STATEMENTS

 

            Subpart A--General

 

 Sec.

 740.1  Establishment of warning statements.

 740.2  Conspicuousness of warning statements.

 

       Subpart B--Warning Statements

 

 740.10  Labeling of cosmetic products for which adequate substantiation

           of safety has not been obtained.

 740.11  Cosmetics in self-pressurized containers.

 740.12  Feminine deodorant sprays.

 740.17  Foaming detergent bath products.

 740.18  Coal tar hair dyes posing a risk of cancer.

 

     Authority: Secs. 201, 301, 502, 505, 601, 602, 701, 704 of the

 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 352, 355, 361,

 362, 371, 374).

 

            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

 

   Page 201

 

 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 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)(1) In addition to the warnings required by paragraphs (a)(1) and

 (b)(1) of this section, the label on each package of a cosmetic in a

 self-pressurized container in which the propellant consists in whole or

 in part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon)

 shall bear the following warning:

 

     Warning--Contains a chlorofluorocarbon that may harm the public

 health and environment by reducing ozone in the upper atmosphere.

 

     (2) The warning required by paragraph (c)(1) of this section shall

 appear on an appropriate panel with such prominence and conspicuousness

 as to render it likely to be read and understood by ordinary individuals

 under normal conditions of purchase. The warning may appear on a firmly

 affixed tag, tape, card, or sticker or similar overlabeling attached to

 the package. The warning shall comply in all other respects with

 Sec. 740.2, e.g., type-size requirements.

     (3) The warning required by paragraph (c)(1) of this section is

 applicable only to self-pressurized containers that use a

 chlorofluorocarbon in whole or in part as a propellant to expel from the

 

   Page 202

 

 container liquid or solid material different from the propellant.

 

  40 FR 8917, Mar. 3, 1975, as amended at 42 FR 22033, Apr. 29, 1977; 54

 FR 39640, Sept. 27, 1989

 

 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 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.