Basic Us Regulatory Structure For Cosmetics Definitions Cosmetics Soaps and Drugs

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The statutory definition of ''cosmetic'' is given at Section 201 (i) of the FD&C Act as:

(1) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles, except that such term shall not include soap.

For reasons discussed earlier in this book (see Chap. 2), the use of the term ''cosmetics'' refers not only to finished cosmetic products marketed to consumers, but also to constituent ingredients and other components of such finished products (for example, packaging). Under current legal standards, topical products functioning as cosmetics may cleanse, beautify, promote attractiveness, or alter appearance of the human body. The FDA Voluntary Cosmetic Registration Program (VCRP) currently lists 13 subdivided cosmetic product categories, which appear in the codified regulations at 21 CFR 720.4 (see Chap. 2, Table 1).

Table 1 U.S. Federal Statutes for Personal Care Products

Cosmetics and OTC drug-cosmetics

Products, ingredients, packaging, and labeling (FDA, CPSC, BATFa, EPAb) Federal Food, Drug, and Cosmetic Act (FD&C Act), 1938 Color Additive Amendments to the FD&C Act, 1960 Federal Fair Packaging and Labeling Act (FPLA), 1966 Federal Hazardous Substances Act (FHSA), 1960 Federal Poisoning Prevention Packaging Act (PPPA), 1970 Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA)b, 1947 Print and media advertising (FTC)

Federal Trade Commission Act (FTCA), 1914 Wheeler-Lea Act, 1938

Magnuson-Moss Warranty-Federal Trade Commission Improvement Act, 1975 Soap Products

Soap (saponification), FHSA, CPSA Soap (detergent, "syndet"'), FD&C Act Soap (combination saponification + "syndet"), FD&C Act Soap (with active drug ingredient), FD&C Act

Soap (saponification or "syndet" making cosmetic claims), FD&C Act, FPLA

a BATF = Bureau of Alcohol, Tobacco, and Firearms (U.S. Dept. of the Treasury), for Specially

Denatured Alcohol formulations (see 27 CFR 21). b Containing pesticide or claiming insect-repellant efficacy. c "Syndet" = synthetic detergent.

''Soap'' products are generally exempt from the cosmetic provisions of the FD&C Act, and, indeed, from the definition of ''cosmetic'' given in the statute. The FDA interprets the term ''soap'' at 21 CFR 701.20 to apply to products

Intended for cleansing the human body

Labeled, sold, and represented solely as soap

Consisting primarily of alkali metal salts of free fatty acids (i.e., the bulk of its nonvolatile matter that serves as the detergent)

Detergent properties of which articles are due to the alkali metal salts of free fatty acids

Liquid and solid product formulations consisting of synthetic detergents (''syndets''), combinations of soap and synthetic detergents (''combo'' bars) intended not only for cleansing but also claiming other cosmetic product performance attributes (e.g., ''beauty bars'' or ''body bars'' claiming to beautify, moisturize, soften, or smooth the skin) must comply with the regulatory requirements applicable to cosmetics (e.g., bear ingredient declarations required at 21 CFR 701.3). Indeed, even if such detergent or combination soap-detergent products are intended solely for cleansing of the human body, possess the characteristics consumers generally ascribe to ''soap,'' and are identified in labeling as ''soap'' or some fanciful adaptation of this descriptor (e.g., ''sope,'' ''jabon,'' ''liquid soap,'' etc.), these products are still regulated as cosmetics.

The statutory definition of the term ''drug'' is given at Section 201 (g)(1) of the FD&C Act, in pertinent part, as:

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention in man .. . and (C) articles (other than food) intended to affect the structure or any function of the body of man . . . and (D) articles intended for use as a component of any [such] articles.

Regardless of their respective legal standings as ''cosmetics'' regulated under the FD&C Act or ''soaps'' regulated under the CPSA/FHSA, personal-care products that are also intended to treat or prevent disease or otherwise affect the structure or functions of the human body are considered ''drugs'' and must comply with these provisions of the law as well as any other provisions as cosmetics or soaps, respectively. Most currently marketed cosmetics that are also drugs are OTC drugs (e.g., 'fluoride' anticaries toothpastes, antiperspirant deodorants, antidandruff shampoos, and sunscreen lotions). However, several drug-cosmetics are ''new drugs'' [6], for which safety and effectiveness had to be proven to the agency before they could be marketed. Analogously, soap products formulated to contain ''active ingredients,'' if intended to cure, treat, or prevent disease, or if intended to affect the structure or any function of the human body, may also be regulated as drugs. This would include, for example ''medicated'' anti-acne soaps, the ''antibacterial'' bar and liquid soaps first introduced into the market in the late 1980s [7], and the alcohol-based liquid ''hand sanitizers'' of the late 1990s [8].

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