After more than 30 years, FDA has yet to issue final regulations for sunscreens

By Lyndsey Layton
Washington Post Staff Writer
Friday, June 18, 2010; A26

The Bee Gees were topping the charts with "Saturday Night Fever," the first test-tube baby had just been born and gas cost 63 cents a gallon when the Food and Drug Administration began writing regulations for sunscreens.

Thirty-two years later, the agency has yet to issue its final regulations.

That means sunscreen manufacturers are not legally required to prove that their products meet advertising claims such as "waterproof," "broad-based" or "lasts all day," or that they offer a specific sun-protection factor, or SPF.

In fact, several public health and consumer groups have taken issue with the SPF claims made by some sunscreen manufacturers, saying that the products offer less protection than advertised. At least nine class-action lawsuits have been filed against sunscreen makers, alleging false advertising.

Since the agency began working on the regulations in 1978, the FDA has received two requests from seven U.S. senators, a petition from one state attorney general and a congressional mandate to finish the job.

"It's truly irresponsible," said Jane Houlihan, senior vice president for research at the Environmental Working Group, a nonprofit environmental advocacy group that has repeatedly asked the FDA to complete the sunscreen regulations. "They are decades late in getting this done."

The FDA did issue final rules for sunscreens in 1999, but they never took effect. The agency stayed the rules after the Cosmetic, Toiletry and Fragrance Association objected to certain aspects and agency officials decided that the rules were not comprehensive enough, because they dealt only with sunscreens that offered protection from UVB radiation and not UVA radiation.

UVB rays are the primary cause of sunburn, while UVA rays lead to premature aging of the skin. Both types of ultraviolet radiation can lead to skin cancer. Manufacturers can voluntarily follow the testing and labeling standards of the 1999 rule but are not required to do so, and the FDA has no power to enforce them.

The FDA again published proposed rules in 2007, this time governing sunscreens that protect against both UVA and UVB radiation. The draft regulations would prohibit companies from labeling sunscreens with an SPF greater than "50+," because the FDA said the higher values are 'inherently misleading" and there is "no assurance that the specific values themselves are in fact truthful."

While the agency continues to work on the rules, more sunscreens are being promoted as having SPF values greater than 50. The Environmental Working Group said about one in six sunscreens lists SPF values greater than 50, compared with one in eight last year. Of 500 sunscreens analyzed by the environmental group in its recent sunscreen guide, the group recommends 39.

Some dermatologists and scientists worry that products carrying high-SPF labels encourage people to increase their exposure to the sun, escalating the risk for skin damage and cancer.

"It gives a false sense of security," said Margaret Parsons, a dermatologist in Sacramento who serves on the board of the American Academy of Dermatology. "They see that higher number and think they can just put it on in the morning and stay out all day."

The FDA "is taking forever" to issue regulations, Parsons said. "I appreciate the effort to do it correctly and scientifically, but it's created all this confusion at the consumer level."

Shelly Burgess, an FDA spokeswoman, said the 2007 proposed rule got delayed because the agency received 3,000 public comments, as opposed to 100 submissions it typically gets for a proposed regulation.

Burgess said in an e-mail, "Some of these submissions included new data which require scientific evaluation. Therefore, developing the sunscreen final rule has required more FDA resources than . . . anticipated."

The FDA intends to publish the final rules -- for real -- in October.

Under most circumstances, it would take effect a year after being published.

But manufacturers are already asking the FDA for more time, saying it will take more than a year to meet requirements.

The FDA has not decided whether it will sanction yet another delay, Burgess said.

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