Cosmetics
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Are All Personal Care Products Regulated as Cosmetics?
People often use the term "personal care products" to refer to a wide variety of items that we commonly find in the health and beauty departments of drug and department stores. The term "personal care product," however, is not defined by law. Under the law, some of the products commonly referred to as "personal care products" are cosmetics. These include, for example, skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants. Some, however, are regulated as drugs. Among these are skin protectants (such as lip balms and diaper ointments), mouthwashes marketed with therapeutic claims, antiperspirants, and treatments for dandruff or acne. Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Cosmetic p Read More... -
FDA Authority Over Cosmetics
What does the law say about cosmetic safety and labeling? The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act1 (FD&C Act) and the Fair Packaging and Labeling Act2 (FPLA). The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action. Under the FD&C Act, a cosmetic is adulterated if-- "it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" [with an exception made for hair dyes3]; "it consists in whole or in part of any filthy putrid, or deco Read More... -
What are the Differences between Cosmetics and Over-The-Counter Drugs?
The Food, Drug, and Cosmetic Act1 (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. Some products meet the Read More...
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