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FDA Sunscreen Rules Could be Ready by Year's End

May 22, 2009 | Parker Waichman Alonso LLP

After spending years  promising to do so, federal regulators are said to be near releasing new guidelines for sunscreens. According to WebMD, the new sunscreen labeling rules should be finalized by the end of the year.

More than 1 million Americans are diagnosed with skin cancer every year, all the result of damage caused by the sun's rays. While most skin cancers can be treated effectively, a form of the disease called melanoma is more aggressive and can lead to death.   

For best protection, sunscreen should be applied generously, about 20-30 minutes before going outside.  It should also be reapplied every 2 hours.  Unfortunately, because of confusing - and some say misleading - sunscreen labels,  many consumers don't know they should be applying that much, that often.

The Food & Drug  Administration (FDA) had first promised to propose new sunscreen labeling regulations more than a decade 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 .

According to WebMD, the new rules would for the first time require sunscreen labels to provide information on how well they protect users from ultraviolet A (UVA)  rays.  These rays don't cause sunburn, but they do contribute to skin cancers and skin aging, the report said.  

Makers of sunscreen will also no longer be able to use certain claims  on labels, WebMD said.  For example, claims  of SPFs higher than 50 will be barred unless they can be backed up by scientific evidence.  Also terms like “sunblock,” "waterproof,” “sweat-proof,” and “all-day protection” will not be allowed.

Labels will also have to advise consumers to limit their time in the sun, wear protective clothing, and reapply sunscreen at a minimum of every two hours, especially after swimming or perspiring, WebMD said.  Sunscreens will also be subjected to lab and human skin tests using a standardized sun simulator.

Once the new regulations are announced by the FDA, sunscreen makers will have 18 months to change their labels.  The major manufacturers told WebMD that they planned to comply, although some said they may challenge the 50+ SPF cap.