Sun exposure warnings sought for sunscreens FDA asks products to have statements


WASHINGTON -- The Food and Drug Administration is proposing that all sunscreens and tanning products be required to carry warnings about the dangers of sun exposure and that cosmetic products that only promote tanning -- but do not screen against the harmful rays of the sun -- display a warning that they do not protect against sunburn.

"There is overwhelming evidence that overexposure to radiation from the sun is a health hazard," FDA Commissioner David A. Kessler said in a statement. "Consumers should not have to guess how much protection, if any, they'll get from sunscreen and tanning products on the market."

The proposal would require all products to carry statements about the sun's potential harm and their ability to protect users.

One statement that the FDA proposes to require on sunscreen products reads:

"Sun Alert: The sun causes skin damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer and other harmful effects due to the sun."

Sunscreens and tanning products -- a $650 million-a-year market -- have been growing in use in recent years as health-conscious Americans have become increasingly aware of the risks of sun exposure. These dangers include premature aging of the skin and skin cancer.

Skin cancer, in which ultraviolet radiation from the sun is considered a major contributing factor, is the most common form of cancer.

There are more than 700,000 cases annually of highly curable basal cell or squamous cell skin cancers and about 32,000 cases of melanoma, a potentially fatal type of skin cancer, according to the American Cancer Society. An estimated 9,100 people will die of skin cancer this year.

"Since the late 1970s, considerable advances have been made in understanding the effects of sun radiation on the body, while the number of visits to doctors' offices for skin cancer has increased more than 50 percent," Mr. Kessler said.

The proposals, which will be subject to a six-month period of public comment, likely would not become effective for about 18 months, the FDA said.

Officials at the Cosmetic, Toiletry and Fragrance Association, the industry group that represents most manufacturers of the products, refused to comment.

But the changes were applauded by the American Cancer Society as a valuable way to increase consumer awareness of skin cancer.

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