The U.S. Food and Drug Administration is writing tough new rules that would require health warnings on certain tanning oils and would "strongly discourage" sunscreens for babies, alterations that would vastly change the tanning industry.
The rules also would ban as unnecessary sun blocks with sun protection factors, or SPFs, over 30, said William E. Gilbertson, director of the FDA's over-the-counter drug division, in a telephone interview.
The FDA's action comes as Americans are stocking up on tanning oils and sunscreens for the Fourth of July holiday, a time when sales soar. Industry officials said that the FDA's rules could ultimately slow sales, especially of products for children.
Gilbertson said that although the industry "gives consumers a useful product," some sunscreen claims "have gone too far over the edge." He cited a tanning oil with "SPF 0" on the label. "That's useless," said Gilbertson. "That's like using water."
The agency's proposal focuses on protection from the sun's cancer-causing rays. Evidence has mounted over the last decade that sunburns can lead to skin cancer; experts estimate that 600,000 Americans will contract skin cancer this year.
This spring, the U.S. Environmental Protection Agency reinforced the need for sun protection with a study that linked rapid deterioration of the ozone layer to an increase in annual skin cancer deaths. The atmosphere's ozone layer filters out dangerous ultra violet rays.
Gilbertson said that the FDA wants products that offer no protection from the sun to carry warning labels about the health risk.
The agency also wants to ban -- or at least discourage -- baby sun blocks because it fears such products encourage parents to put children in the sun, exposing them to a potential health risk. "Our feeling is that young children should not be in the sun," he
The agency also wants to crack down on too much protection. Currently there is no limit on SPF ratings, and some products boast protection levels over 45. Most experts say no one needs that much protection; many dermatologists recommended an SPF of 15.
Representatives for several of the nation's largest sun care companies, including Schering-Plough, Chesebrough-Pond and Estee Lauder, said that they could not comment on the FDA's proposal without studying it.