U.S. Government Proposes Four-Star Safety Sunscreen Ratings

WASHINGTON, DC, August 23, 2007 (ENS) - The U.S. Food and Drug Administration today proposed a new four-star rating system for over-the-counter sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

The proposed regulations would for the first time put a permanent safety standard in place for UVA protection.

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 over-the-counter sunscreen product

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

"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 von Eschenbach, MD, 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."

When finalized, the proposed regulation would amend the existing over-the-counter sunscreen rule published in 1999 that established regulations related to UVB light and mandated that such sunscreen products be labeled with a SPF.

The Environmental Working Group, EWG, a nonprofit advocacy group based in Washington, says the Food and Drug Administration first announced its intention to implement safety standards for sunscreens 28 years ago, but to date, none have been finalized.

"The proposed sunscreen safety regulations by FDA are a positive step forward, but we¹ve been here before and seen FDA cave in to industry objections," said Jane Houlihan, EWG vice president for research.

"FDA first pledged to implement federal safety sunscreen regulations over 28 years ago and to date nothing has been finalized," Houlihan said. "We hope this time FDA moves much faster so the public can have confidence in the claims that they see on sunscreen product labels."

Earlier this summer the Environmental Working Group launched the first online database consumers can use to see which sunscreens provide the best combination of safety and effectiveness. There are currently close to 800 name brand suncreens in the database.  

Houlihan says the database was created largely because of the lack of any comprehensive federal safety standards.

Sunlight is composed of the visible light that we can see, and ultraviolet, UV, 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 FDA regulation sets standards for formulating, testing and labeling sunscreens.

The four-star 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 would 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, MD, 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."

FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically at the Federal eRulemaking Portal: www.regulations.gov or at the FDA website: www.fda.gov/dockets/ecomments  

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