The Back Story
What triggered the study? "We did this analysis because the FDA has not set comprehensive safety standards for sunscreens," Houlihan says, "and we think people need to know about products on the market that are safe and effective."
The FDA has set guidelines for UVB protection in sunscreen but not for UVA protection. The FDA "is currently working on regulations for over-the-counter sunscreen drug products that would address, among other things, UVA testing and SPF labeling issues," according to a statement released by the FDA after the sunscreen report. In the U.S., sunscreen products are regulated by the FDA, either under the new drug approval process or over-the-counter drug review, with the majority regulated under the OTC review.
A Dermatologist's View
The new report got mixed reviews from Henry W. Lim, MD, the vice president of the American Academy of Dermatology and chairman of dermatology at Henry Ford Hospital in Detroit. One of his criticisms is that they did not test the sunscreens directly. Yet, he understands why they did not. "It's not practical for them to test these in the field," he says. "There are too many.
"I'm certain that some of the findings are accurate," he says. In particular, he says, some sunscreens indeed may contain ingredients that are not stable and do break down in sunlight, as the report shows. "But the way it came out, it seems to me it's a very negative report," Lim tells WebMD.
Not surprisingly, the sunscreen industry blasted the findings. "They have taken a number of studies and then, without going into the lab, are asserting that somehow these products don't provide the amount of protection they should," says John Bailey, executive vice president for science for the Cosmetic, Toiletry, and Fragrance Association, a Washington, D.C.-based industry group.
In particular, Bailey took issue with the finding that some of the products break down in sunlight. The products have to be made according to good manufacturing requirements for drugs, he says. "They have to be shown to be stable as part of that requirement."
A statement released by the organization says that "Consumers should have a high level of confidence that sunscreen products are safe and effective when used as directed."
"The report is encouraging people to be sure [the sunscreens] are 100% photo stable," says Julie Lux, spokeswoman for Schering-Plough Corp. in Kenilworth, N.J., which makes Coppertone sunscreens.
"Coppertone has reformulated," she adds. "If you get a Coppertone product all are photo stable."
Johnson & Johnson, which makes Neutrogena sunscreen products, some of which are on the avoid list, issued a statement saying, "All Neutrogena products undergo extensive testing to ensure safety and efficacy."