FDA Proposes New Rule for Sunscreen Products

[Neon Beach]

FOR IMMEDIATE RELEASE

August 23, 2007

Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



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

Written submissions can be submitted by fax or mail:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax: 301-827-6870

For more information:
FDA Web site for Sunscreen Proposed Rule

Consumer Article: FDA Aims to Upgrade Sunscreen Labeling

Source

[clubby]

allows new combinations of active ingredients; and
asks for comments on the issue of nanoparticles.

What's a "nanoparticale"?

[Neon Beach]

[Donsense]

The "key" statement in the FDA press release pertains to the real reason that UVA filters have been added to sunscreens.

The sentence "The second test measures a product's ability to prevent tanning." says it all, i.e., that use of a sunscreen with a UVA filter prevents the development of facultative pigmentation (a.k.a., a "tan") and, therefore, makes the user totally dependant upon using a sunscreen.

When a sunscreen containing only a UVB filter is used the individual can develop a tan, i.e., take advantage of Mother Nature's "normal and natural" means of protecting us against UVR. Thus, UVA filters should be banned.

In addition, the UVA filter prevents the longer wavelengths (i.e., UVA1) that stimulate our immune defense system from being absorbed and this another reason why UVA filters should be banned.

The large pharmaceutical companies marketing sunscreens have a lot of power at FDA and so this "scam" will be approved to the detriment of the American public.

FYI, "nanoparticles" are nanometer size (i.e., 1/millionth of an inch) solid particles that absorb UVR on the surface of the skin. Since they are so small, there is (valid) concern that they can be absorbed by the body.

More information about the reasons that UVA filters should be banned can be found in an article in the September, 2007 issue of Looking Fit. In the October (trade show) issue, we show how facultative pigmentation (i.e., a tan) significantly increases our tolerance to UVR (TUVR).

[Neon Beach]

Thanks Don.

[tanthis]

I heard this in my sleep on Cnn this morning. Dr.gupta was trying to explain it. I couldn't help but think geeze the FDA is in the pockets of derms. and doctors. It just doesn't matter, slap a bandaid on it and it's true as long as it comes from a doctor.

[Sunsally]

Originally Posted by Neon Beach

Thanks Don.

Not only "Thanks", but WELCOME, WELCOME, WELCOME!!

Sure hope to hear from you more on threads to come!!

[mr belvedere]

That's crazy!

[Marca]

Yay:

welcome Don!!!

~love the name donsense!~

[Apples]

good posts neon and DOn