FDA News

Leading U.S. Physician Criticizes Delaying FDA Sunscreen Labeling Decision For Another Month

(Nov 29, 2007)-- The U.S. Food and Drug Administration on Tuesday delayed its decision on adopting a new rule and rating system for over-the-counter sunscreen products, further delaying better sun protection for consumers everywhere, according to Dr. Karl Gruber, a surgical pathologist and expert in sun protection.

The new rule and rating system would require sunscreen manufacturers to provide more detailed information about their products' level of protection against damaging ultraviolet A (UVA) rays because the link between UVA exposure, melanoma and solar aging is compelling. The FDA has been wrestling with the UVA rule and rating issue and the need to update sunscreen regulations since 1999. On Tuesday, the agency extended its comment period on the proposed regulations to December 26, 2007.

"It is difficult to see how extending the comment period by a month for an issue that has been debated for eight years is going to make any difference -- except to deny consumers the information they need to make the best decisions about their own health," says Dr. Gruber, a physician who has studied carefully and fully endorses the FDA's proposed regulations.

Since 1978, over-the-counter sunscreen protection has been rated solely by SPF values, which only provides information on a product's level of protection from the sun's ultraviolet B (UVB) radiation that causes sunburn.

The American Academy of Dermatologists now recommends that consumers use a broad-spectrum sunscreen that blocks exposure to both UVA and UVB to help prevent skin cancer, the most prevalent of all types of cancers. More than 1 million new cases of skin cancer will be diagnosed in the U.S. this year alone, and more than 80 percent of these new cases could be prevented by protection from the sun's rays.

Dr. Gruber regularly sees new cases of skin cancer in his Charleston, S.C. practice and subsequently created LUCA(TM) Sunscreen, which provides the maximum level of protection against both UVA and UVB rays. It is the only sun protection product in the U.S. to print on the bottle its critical wavelength value, the highest in the country and the most effective way to rate UVA protection.

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