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FDA Finally Writes New Sunscreen Labeling Rules

Aug 15, 2007 | Parker Waichman LLP, LLP

The Food & Drug Administration (FDA) has finally proposed new labeling requirements for sunscreen that are meant to give consumers a better idea of exactly how much protection such products provide.   The FDA action comes after years of complaints by consumer groups that sunscreen labels often promised more sun protection than the product really provided.  Because of such empty promises, millions of sunscreen users were exposed to an increased risk of skin cancer.

The FDA proposed the new rules Thursday.   It is hoped that the new information will eventually lead to lower rates of skin cancer.   More than 1 million Americans are diagnosed with skin cancer every year.  While most skin cancers can be treated effectively, a form of the disease called melanoma is more aggressive and can lead to death.  The sun’s rays produce two types of ultraviolet radiation – UVA rays, which cause sun tans, and UVB rays, which are responsible for sun burns.  Currently the Sun Protection Factor (SPF) listed on sunscreen labels only measures protection against UVB rays.

For years, it was thought that UVB rays were responsible for most skin cancers, but research has proven that  UVA rays penetrated deeper into the skin, and caused premature aging and even cancer.  The new system will rate sunscreens on how well they protect against both UVB and UVA rays.  Sunscreens will be assigned between one and four stars to indicate how well they protect against the UVA rays, with four stars offering the highest levels of protection. Once implemented, the new FDA rules will require sunscreen manufacturers to test their products twice for UVA protection – once in the lab and once on human volunteers.

The new FDA rules would also make changes to the SPF ratings used to measure UVB protection.  Only those sunscreens providing an SPF of 50 would be given an FDA stamp of approval.    And the FDA is also requesting warnings on sunscreens that say exposure to the sun increases the risk of skin cancer.  The warning will say that no sunscreen can guarantee complete protection from the sun’s rays, and that consumers should avoid the midday sun regardless of the amount of protection offered by a sunscreen.

The FDA had first promised to propose new sunscreen labeling laws 28 years ago, but the agency kept delaying its proposal.  Congress had ordered the agency to finish its proposal by May 2006, but the FDA missed the deadline.  Members of congress then mounted a letter-writing campaign in order to pressure the FDA to issue new rules.  In 2006, a class action lawsuit was filed against five of the leading U.S. makers of sunscreen lotions and sprays alleging that the products were deceptively promoted as offering protection from the sun’s harmful rays


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