FDA proposes new sunscreen labeling

MIAMI – The Food and Drug Administration on Thursday proposed new labels for sunscreens that would eliminate misleading claims such as “sunblock” and “waterproof” and create a new system for rating products’ effectiveness against damaging ultraviolet rays.

The new rules, which must go through a 90-day public comment period, are meant to get sunscreen makers to replace what the FDA has called “unsupported, absolute” claims with less definitive language such as “water resistant” or “very water resistant.”

Labels on many sunscreens proclaim they’re waterproof or sweatproof, but the small type on the back often says, “Rinse with water to remove.” The FDA tried in 1999 to stop manufacturers from using such absolute terms, but the rules never went into effect.

This time around, experts say the rules have a better chance of being adopted because of greater agreement between the government and the industry. Even then, manufacturers would have two years to comply.

The new rules would change how the sun protection factor (SPF) rating is expressed. Currently, SPF is expressed by numbers from 2 to 70. The new system would create categories – “low,” “medium,” “high” and “highest” – to represent number ranges. This would more clearly state a sunscreen’s protection against UVB rays, which cause sunburn and skin cancer.

The rules also would create a four-star system of rating a sunscreen’s protection against UVA rays, which scientists have come to believe cause wrinkling, leathering and deadly forms of skin cancer. Recent studies have shown that UVA rays can also damage the immune system, possibly causing melanomas even on areas not exposed to the sun.

The new rules would urge users not to count on sunscreen alone for protection, but to shorten stays in the sun and wear protective hats and clothing.

Dermatologists praised the new rules.

“We want the public to know what they’re getting,” said Dr. Robert Kirsner, vice chairman of the department of dermatology at the University of Miami School of Medicine. “If you’re using sunscreen, you want it to protect you from burning and skin damage and skin cancer. These rules are good in that respect.”

Manufacturers declined to offer detailed comment on the proposed rules, which comprise 236 pages.

“We’re excited that it’s out. We look forward to reviewing it and commenting,” said Jennifer Samolewicz, of Schering-Plough, which makes Coppertone sun products.

More than 1 million skin cancers are diagnosed annually in the United States, including 59,940 melanomas, the most deadly form. About 8,000 Americans die from melanoma each year, according to the Skin Cancer Foundation.

Racial minorities are more likely to get sunburns than nonminorities, a June study by the U.S. Centers for Disease Control and Prevention said.

The study reported 35.6 percent of non-Hispanic whites had at least one sunburn in the previous year, compared with 45.6 percent for Hispanics and 50.4 percent for non-Hispanic blacks.

The reasoning: People with darker skin were less likely to believe they could burn.

One area where the FDA and manufacturers are coming closer together is the high end of the SPF ratings. The FDA in 1999 tried to get manufacturers to limit the claims to SPF 30, expressing anything stronger as “30+.” The FDA’s new proposals call for a limit of SPF 50, with anything stronger called “50+.”

Some doctors say they fear ultra-high SPF ratings will make suntanners think it’s safe to stay in the sun for much longer periods of time. Manufacturers argue that it’s important to tell people like construction workers or yard workers, who spend long hours in the sun, that a stronger product is available.

It’s unclear whether manufacturers will fight to keep terms like “waterproof” and “sweatproof.”

Neither John Bailey, executive vice president for science for the Cosmetics, Toiletry and Fragrances Association, nor Farah Ahmed, its assistant general counsel, would comment on that issue.

Ahmed pointed out that the 1999 FDA proposal was never finalized.

Added Bailey: “When it’s a regulation, everyone will follow it to the letter.”

The new labels would warn users to apply and reapply sunscreen liberally.

“We want people to know how to use it right, to reapply it every two hours and to apply enough,” said Matthew Holman, the FDA’s Interdisciplinary Scientist Team Leader on the study.