Bloomberg, Justin Blum
Published August 22, 2007
Aug. 23 (Bloomberg) -- Sun lotions should be required to carry new ratings letting consumers compare for the first time how well the products guard against a form of skin-damaging ultraviolet rays, U.S. regulators said.
Labels for sunscreens would display as many as four stars to indicate their effectiveness against the sun's UVA rays, the Food and Drug Administration said in a rule proposed today. The products also would include a new warning saying ultraviolet rays from the sun increase skin cancer risks.
Consumer groups have called for the FDA to require that sunscreens specify how well they shield against UVA radiation because many now make imprecise claims such as ``Extra UVA protection.'' The new ratings would appear along with the SPF, or sun protection factor, numbers already used on lotions to measure how effectively they fend off sunburn caused by another type of ultraviolet ray.
``It provides some consistency and reliability to the claims that are being made,'' said Richard Wiles, executive director of the Environmental Working Group, an advocacy organization that has studied sunscreens, in an interview. ``Manufacturers make claims about UVA, but you have no idea what it really means.''
U.S. sales of sunscreens were $650 million last year, according to Kline & Co., a Little Falls, New Jersey, market research firm. The proposed rules would affect products sold without a prescription, such as Coppertone, made by Schering- Plough Corp. of Kenilworth, New Jersey, and Hawaiian Tropic, from Playtex Products Inc. of Westport, Connecticut.
SPF Ratings
The SPF ratings already required on labels gauge a product's ability to protect against the sun's UVB rays.
While UVB radiation can cause sunburn, UVA can penetrate the skin and damage tissue at deeper levels, according to the FDA's Web site. Damage caused by UVA rays may lead to skin cancer and premature aging, according to the National Cancer Institute, a government agency.
``FDA considers both UVB and UVA radiation protection equally important at this time because scientific data demonstrates that both have harmful effects on the skin,'' the agency said in its proposal today.
The FDA sought public comment before adopting the rules. To give manufacturers time to test products and craft new labels, the regulations would go in effect about two years after adoption of the regulations.
One to Four Stars
The new system would use one to four stars to rate effectiveness against UVA rays, along with corresponding descriptions ranging from ``low'' to ``highest.'' That information would appear on packages in the same type size as the SPF rating.
Products that don't provide the minimum UVA protection described in the FDA's guidelines would display no stars and say ``no UVA protection'' as prominently as the SPF value. Companies that don't test their products for UVA protection would have to add the same wording.
The new ratings would help consumers ``make informed decisions about protecting themselves and their children against the harmful effects of the sun,'' said Andrew von Eschenbach, the FDA commissioner, in a statement.
`Long Overdue'
The FDA's proposal is ``long overdue,'' said Senator John Kerry, a Democrat from Massachusetts, in an e-mail statement. ``I urge the FDA to finalize this rule quickly and provide consumers with the confidence that these products do what they claim.''
The proposal describes specific guidelines for testing in people and in the laboratory that manufacturers need to complete to support effectiveness claims. The rules also would allow some new ingredients to be added to the products.
Companies could list a maximum SPF rating of ``50+'' unless they provide data to the FDA justifying a higher number. Some products now contain higher SPF numbers.
The meaning of SPF also would change from ``sun protection factor'' to ``sunburn protection factor'' to avoid giving consumers ``the impression of solar invincibility and a false sense of security,'' according to the FDA proposal.
Under the proposal, sunscreens would carry a warning saying: ``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.''
Directions on sunscreens also would tell consumers to reapply ``at least every 2 hours.''
The Environmental Working Group, based in Washington, issued a report in June criticizing the FDA, saying the government missed a deadline imposed by Congress to set sunscreen safety standards by last year.
The organization found that 13 percent of 386 sunscreens with SPF ratings greater than 30 don't contain ingredients known to protect from UVA radiation.
Schering-Plough was reviewing the FDA's proposal and didn't have an immediate comment, company spokeswoman Mary-Frances Faraji said. Playtex hadn't studied the proposal, said Paul Yestrumskas, the general counsel.
