FDA proposes new rule for sunscreen products

Sunscreen manufacturers may have to start making new labels for all those creams and sprays following a U.S. Food and Drug Administration proposal requiring a new rating system for protection against ultraviolet type-A rays. The proposed rule also sets additional standards for formulating and testing products.

The FDA announced in August that it would require manufacturers to use a four-star rating system to help consumers determine the level of UVA protection offered by a sunscreen. One star would represent the lowest UVA protection in an over-the-counter sunscreen. A sunscreen that does not provide at least a low level of protection would have to bear a no UVA protection marking on the front label near the SPF value.

The regulation would amend the existing OTC sunscreen rule published in 1999 that mandated UVB sunscreen products be labeled with an SPF number. "We were concerned [in 1999] about UVA rays, but unfortunately, the science had not caught up with our concerns and we didn't have a methodology by which to accurately assess the impacts of UVA rays and the protection that any product could actually provide," said Rita Chappelle, a spokeswoman for the FDA.

Of the two types of UV light, UVA is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer. Ratings would be derived from two tests. One would measure a product's ability to reduce the amount of UVA radiation that passes through it. The second would measure a product's ability to prevent tanning, in a process nearly identical to the existing SPF test used to determine the effectiveness of UVB sunscreen products.

"We're also requiring certain language no longer be allowed, like 'sunblock.' No product can block out all of the sun's rays. It can screen," Chappelle explained. Another term that will be banned: waterproof. There's no such thing, she said, adding that products may only say they are water resistant.

In addition, manufacturers will be required to put a warning statement in the Drug Facts box. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen."

More than 1 million new cases of skin cancer will be diagnosed in the United States this year and 108,230 of those will be new cases of melanoma, the deadliest form of skin cancer, according to the American Academy of Dermatology Association, which lauded the FDA proposal.

"The proposed one-to-four-star rating of a sunscreen's UVA protective effect … will allow consumers to more easily understand the degree of protection afforded by a particular product against the long-wave rays of the sun," said Dr. Diane Baker, president of the academy, in a statement.?

A consumer watchdog organization, Environmental Working Group, also welcomed the proposal, though a spokeswoman for EWG expressed concern about FDA's political will to see the process through.

"FDA's way behind Europe in terms of approving new active ingredients in sunscreens," said Sonya Lunder, an EWG senior analyst.

EWG conducted its own scientific review of more than 800 sunscreens, and it found that 84 percent of them offer inadequate protection from the sun or contain ingredients with significant safety concerns, according to its Web site (www.cosmeticsdatabase.com). The assessment is based on a review of nearly 400 scientific studies, industry models of sunscreen efficacy, and toxicity and regulatory information from about 60 government, academic and industry databases.

"It's a computer-based analysis, where we look at the data that's been provided about laboratory effectiveness," Lunder explained. "So we looked at each active ingredient and the concentration it is in the sunscreen from what's listed on the label. And then we looked at interaction between those ingredients [and inactive ingredients]." It took about a year for EWG to assemble the sunscreen database, which provides a hazard score for each product.

"We took sunscreens as a special case because we know that there are immediate harms of intensive sun exposure—skin cancer, skin damage, immune suppression," Lunder said.

The FDA also is upping the recognized SPF values from SPF30+ to SPF50+. SPF is a rough measurement of how long a person wearing sunscreen can be exposed to sunlight before getting sunburned, compared with the amount of time he or she can be exposed without sunscreen. For example, SPF30 would offer 300 minutes of protection if a person would normally burn after 10 minutes in the sun.

The FDA is accepting comments on the new rule until Nov. 26. Comments must be identified with Docket No. 1978N-0038 and can be submitted by mail or at www.regulations.gov or www.fda.gov/dockets/ecomments.

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