Sunscreens today carry an SPF (sun protection factor) rating indicating how well they protect against UVB rays, which cause sunburn. But many dermatologists consider protection against UVA rays, which penetrate deeper into the skin and do longer-lasting damage by destroying collagen and other proteins, equally or more important.
The FDA last year approved U.S. sales of products with L'Oreal's UVA-protecting ingredient Mexoryl, which long had been smuggled into the U.S. from Europe and Canada by U.S. fans of the product. L'Oreal since has marketed products in its Anthelios SX line -- and more recently its mass-market L'Oreal moisturizer brand -- with Mexoryl.
But while L'Oreal has made comparative claims about its sunscreen's effectiveness in advertising and sales efforts directed at doctors, the FDA had no standard in place for consumers to compare the effectiveness of products in protecting against UVA rays.
Johnson & Johnson, which markets Neutrogena and Aveeno products with its Helioplex UVA-protecting ingredient, last year sued L'Oreal, saying it falsely claimed its products protect better against UVA rays than J&J's. The sides have since exchanged counterclaims seeking to poke holes in the testing behind one another's claims. A trial in the case is set to begin next month.
The FDA, meanwhile, also disclosed that it's considering applications by two other undisclosed marketers for new compounds to protect against UVA rays.
Prevent more disputes
If ultimately approved, the FDA's new standards could provide a method of refereeing or preventing disputes between sunscreen marketers over protection, as well as providing some objective guidance for consumers.
In a conference call, Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said there are at least 10 tests used internationally to measure UVA protection and no generally accepted standard. The FDA is proposing using two of those tests as a base for its new four-star ratings. Sunscreens would get the number of stars warranted by the lower of the two test results, and the UVA ratings would appear alongside UVB ratings with equal prominence on labels.
Nearly the entire sunscreen industry has been the target of class-action consumer litigation in California over sunscreen protection claims. The suits charge that by failing to disclose how well -- or poorly -- sunscreens protect against UVA rays, advertisers are engaging in false advertising.
Interested parties have 90 days to review and comment on the proposed labeling rules, but FDA officials declined to estimate when they might take effect.