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FDA Proposes New Sunscreen Rules

But critics say the new rules don't go far enough

August 23, 2007

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The U.S. Food and Drug Administration has proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter sunscreen drug products with ultraviolet A and ultraviolet B protection, but stops short of addressing some longstanding consumer complaints.

“For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs.

“Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun.”

Sunlight is composed of the visible light that we can see, and ultraviolet light that we can not. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars.

One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product.

If a sunscreen product does not provide at least a low level of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.

Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light.

The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a “Warnings” statement in the “Drug Facts” box will be required of all sunscreen product manufacturers. The warning will say: “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.” The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

“Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens,” said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. “The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen.”

"Snake oil"

The new rules follow a lengthy campaign by consumer advocates for more accurate labeling of sunscreen products. Last year major sunscreen makers were hit with a class action lawsuit by consumers who complained they were lied to.

“Sunscreen is the snake oil of the 21st Century and these companies that market it are Fortune 500 Snake Oil salesmen,” said Samuel Rudman, a New York attorney. “False claims such as 'sunblock' 'waterproof" and 'all-day protection' should be removed from these products immediately."

“Parents, especially, have been defrauded into believing the false labeling and advertising claims of these products. They have sent their children to play or swim in the sun, believing that slathering them with one of these products specifically marketed for children provides protection, when it does not,” said Mitchell Twersky, another New York attorney. “And the guys who are marketing these products know their claims are false,” he added.

The new FDA rules do not address the concerns highlighted in the suit.

When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Additionally, the proposed rule:

• revises the existing SPF (UVB) testing procedures;

• allows new combinations of active ingredients; and

• asks for comments on the issue of nanoparticles.

FDA is accepting comments on the new rule for 90 days until November 26, 2007.

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