FDA Announces New Rules About Sunscreen Labeling

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On June 14, 2011, the Food and Drug Administration (FDA) issued new rules regulating sunscreen labeling. The rules standardize the testing that manufacturers must conduct, provide guidelines for labeling in connection with which sunscreens provide protection against cancer and eliminate claims that any sunscreen is waterproof. Although the rules become effective next year (except for manufacturers with annual sales of less than $25,000, which have two years to comply), some of the language used by the FDA gives rise to a more immediate concern over potential false advertising and unfair competition litigation by plaintiffs' attorneys against companies that manufacture or market sunscreens. There has been litigation over sunscreen marketing claims.

Rulemaking History

The FDA has been evaluating sunscreen labeling for 33 years. It first issued proposed rules for over-the-counter (OTC) sunscreen products in 1993. Those rules addressed labeling and sun protection factor (SPF) testing to prevent sunburn, which is primarily caused by ultraviolet B (UVB) radiation. Before those rules became effective, Congress passed the Food and Drug Administration Modernization Act of 1997, which required regulations for OTC products for the prevention of sunburn. In 1999, new rules were proposed governing UVB labeling, but were stayed to add ultraviolet A (UVA) testing and labeling requirements. Both UVA and UVB radiation contribute to skin cancer. In 2007, revised proposed rules were issued, but never adopted.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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