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Cosmetics, Drugs and Labels

By: Rick Van Arnam, Esq.
Posted: January 10, 2008, from the January 2008 issue of GCI Magazine.

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This threshold determination is important if a company intends to market a cosmetic in a way that touts certain uses or benefits that could fall within the drug definition. Cosmetics are not subject to premarket approval by the FDA. Premarket approval is the process where the FDA requires scientific review to ensure the safety and effectiveness of products it oversees. Drugs, on the other hand, are subject to FDA approval, either through the premarket approval process or because the FDA currently recognizes certain drugs or drug ingredients as safe and effective and publishes this recognition in monographs. These monographs identify how certain nonprescription drugs can be used without further premarket approval and what ingredients may be used to make them.

For a company to allege that its cosmetic product provides a benefit or use that meets the definition of a drug, that company must have either done the necessary premarket review with the FDA, or the product or ingredient thereof must be covered by an existing FDA monograph and used in a pre-approved way. Absent that, any representations of a cosmetic product as having an intended use for preventing or treating a disease, or affecting the structure or function of the human body, would be considered an unapproved and misbranded drug.

Labels on Cosmetics and Cosmetic/Drug Combination Products
Not only must distributors of cosmetics be concerned with whether representations being made on their labeling implicates a drug use, but if in fact the product is a cosmetic/drug combination, then the representation on the actual label differs slightly from that for a pure cosmetic. Both pure cosmetics and cosmetic/drug combinations distributed in the U.S. must comply with the labeling requirements promulgated by the FDA, under the authority of the FD&C Act and the Fair Packaging and Labeling (FP&L) Act. These regulations require that key product information be conveyed to the consumer. The required information and placement thereof is dependent upon several factors, including whether the product is sold in retail packaging apart from the actual container holding the product and whether the product is a cosmetic/drug combination requiring the disclosure of additional information.

For both classes of products, the label on the outer packaging must convey much information. The name and street address (unless it is listed in the phone book) of the firm marketing the product must be stated on the information panel of the label. If the distributor is not the manufacturer or packer, then the label must state “Manufactured for” or “Distributed by.” The outermost label must contain directions for safe use and any warning statement necessary or appropriate to prevent a health hazard associated with the product.

The ingredient declaration is also found on this label. All cosmetics sold at retail for personal use must have an ingredient declaration. This list—which appears on the information panel of the package or on a firmly affixed tag, tape or card—must declare ingredients by the names established or adopted by regulation, in descending order of predominance. Color additives and ingredients that constitute 1% or less may be declared in any order. Ingredients exempted by the FDA from public disclosure may be stated as “and other ingredients.”