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theless serve to provide the FDA's interpretation of the Laws and applicable Regulations (see Figure 1).

Federal regulations of cosmetics involves oversight of print, radio, television, and multimedia advertising as well as of product package labeling. The jurisdiction of the FTC to regulate the advertising of cosmetic and ''Over-the-Counter'' (OTC) Cosmetic-Drug products overlaps that of the FDA, and is largely based upon the portion of Section 5 of the 1914 Federal Trade Commission Act (FTCA) and subsequent amendments and legislation to the FTCA that prohibits ''unfair'' and ''deceptive'' acts or practices (2). the FDA and FTC have established a memorandum of understanding (MOU) to clarify the parameters and boundaries of this relationship (3).

FDA also shares its regulatory responsibilities for the regulation of cosmetics and topical personal care products with other Federal agencies. The U.S. Consumer Product Safety Commission (CPSC) exercises regulatory authority over ''soap'' products not making cosmetic or drug performance claims under the 1960 Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA) (4e-g); more about the regulation of soap will be discussed later in this chapter. The CPSC also is delegated the authority under the 1970 Poison Prevention Packaging Act (PPPA) for promulgating ''child-resistant'' packaging (CR Packaging) regulations for cosmetic products and soap products (4a); these regulations are codified at 16 CFR 1700. In recent years, final rules have been promulgated, requiring CR packaging for nail care products (for example, primers) containing >5% methacrylic acid (4b), household (artificial nail) glue removers containing acetonitrile (4d), and home cold wave permanent neutralizers containing sodium bromate or potassium bromate (4d). A proposed rule has also been published in the Federal Register, which would require CR packaging for fluid cosmetic products (among other categories of household substances) formulated with >10% of low viscosity hydrocarbons (<100 SUS @ 100 deg. F) (4c). Finally, the Environmental Protection Agency (EPA) has regulatory authority over some multi-functional personal care products, such as cosmetic liquids, lotions, or sprays that are also insect repellants. EPA's authority to

Figure 1 Basic U.S. legal and regulatory structure for cosmetics.

regulate such products is derived from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (5).

Table 1 summarizes the federal agency interrelationships involved in the regulation of cosmetics in the United States.

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