Scroll down for FDA Proposal and links.
The proposal 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.
Consumers have 90 days in which to comment on the new proposed standards.
Manufacturers will be given 12 months to comply to the new standards once they come into force, so consumers should not expect to see the new labeling before then.
Besides this, the term "sun protection factor" will have to be replaced by the term "sunburn protection factor." in order to avoid the misconception of a user of being absolutely invincible against the sun and the ensuing false sense of security.
A dermatologist who specializes in skin cancer who practises St Petersburg in Florida, Dr James Spencer, told the New York Times the new standards are good news for consumers:
"Now when you go to the drugstore and buy sunscreen, you will finally know what you are getting."
Dr Perry Robins, President of the Skin Cancer Foundation (sponsored among others by the cosmetics industry) also welcomed the news, saying that over 90 per cent of skin cancers are caused by sun exposure and:
"We now know that UVA plays a very direct role in skin cancer comparable to that of UVB. Therefore, introducing a UVA test method will enable consumers to know how well the product protects against UVA rays as well as UVB rays."
Skin cancer is cancer that forms in the tissues of the skin. There are mainly two types, both of which usually result from exposure to sunlight. One type of cancer is when the cells that form pigment become cancerous, this is called melanoma. The other type of skin cancer develops in cells that do not form pigment and there are two types of these cells: basal (small and round cells in the base of the outer layer of skin) and squamous (flat cells on the surface of the skin).
Skin cancer is the most common form of cancer in the United States. More than 1 million new cases are diagnosed every year.
FDA Release.
FDA Proposes New Rule for Sunscreen Products Highlights Include New UVA Rating System, Sun Warning Information
The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.
"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 (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 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 (one star) 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."
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. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:
Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments
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