[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR740.10]

[Page 151]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 740--COSMETIC PRODUCT WARNING STATEMENTS--Table of Contents
 
                      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 any other requirement in 
the Act or this chapter.

[40 FR 8917, Mar. 3, 1975]