FDA Tightening Curbs on Sun Care Products

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 complexion of 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 with The Times.

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 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 sun burns 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 ultraviolet rays.

Gilbertson said that the FDA wants products that offer no protection from the sun to carry warning labels about the health risk, although the wording has not been determined. The industry markets these products as “tanning oils” or “tanning magnifiers.”

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,” Gilbertson said.

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.

“The truth is, for any latitude in the United States, you don’t need anything more than a 15,” Gilbertson said. The agency’s proposal will allow bigger numbers, up to 30, he said, “for people in special situations. They spend a lot of time in the sun or in the tropics.”

Representatives for several of the nation’s largest sun care firms, including Schering-Plough, Chesebrough-Pond and Estee Lauder, said they could not comment on the FDA’s proposal without studying it.

An executive with Tanning Research Labs, the nation’s second-largest sun care company next to Schering, said the FDA’s proposals on baby blocks and tanning oils could discourage sunscreen use.

“I am not sure the consumer is hugely better off,” said Jack Surette, marketing vice president.

Surette disagreed with the FDA’s reasoning on baby blocks and expressed doubts that parents would allow their children to bake in the sun, even with a sunscreen. “I give the American public more credit than that,” he said.

Surette said he did not think warnings on tanning oils were appropriate. “It implies the consumer is worse off with an oil than with nothing at all.”

For the sunscreen companies, huge dollars are at stake. Kline & Co., a New Jersey research firm, said Americans will spend $400 million on sunscreens this year and millions more dollars on such extras as cocoa butter and sunburn salves.

Much of the industry’s growth comes from products with high sun protection factors and from specialty items, such as sun blocks for babies. Schering’s heavily promoted “Water Babies” is among the nation’s best-selling brands.

In their search for new markets, sunscreen makers have been taking the SPF numbers “higher and higher every year,” said Kline analyst Cornelia Stanek. Manufacturers also developed special products for lips, bald spots and noses to encourage consumers to buy more sunscreens and spend more money. Manufacturers also brought out “kid sprays” and “baby blocks,” also to boost sales. The result, says Stanek, “is a confused market.”

The FDA’s proposed rules are part of a massive overhaul of a draft sunscreen regulation that came out in 1978. The earlier draft was never formally adopted.

The centerpiece of the 1978 proposal was a system for measuring how well a sunscreen protected against the sun’s ultraviolet B rays--the rays linked to sunburn and skin cancer. The old proposal set up a rating system that went from a low of 2 to a high of 15. Since the proposal was never adopted, manufacturers have been free to take the numbers as high as technology allows.

Gilbertson said the FDA’s 550-page sunscreen proposal would not be completed until September. At that time, it would be open to industry comment. Gilbertson said the proposal could change before it is adopted, probably sometime next year.