The
U.S. Food and Drug Administration (FDA) has proposed a new rule for sunscreen
products, including a new UVA rating system and sun warning information.
The
FDA 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.
The
FDA reports that because consumers have been able to identify the level of UVB
protection for more than 30 years, the new rule is designed to also alert them
to the level of UVA protection.
According
to the FDA, sunlight is composed of the visible light that humans can see, and
ultraviolet (UV) light is composed of the light that humans cannot see. There
are two types of UV light – UVA and UVB. UVA light is responsible for tanning,
and UVB is responsible for sunburn. Both can damage the skin and increase the
risk of skin cancer.
Skin
cancer is the abnormal growth of skin cells. It most often develops on skin
exposed to the sun, but it can also occur on areas that are not ordinarily
exposed to sunlight. Skin cancer is generally divided into two stages, local
(where the cancer affects only the skin) and metastatic (where cancer has
spread beyond the skin).
Researchers
estimate that more than one million new cases of skin cancer will be diagnosed
in the United States this year. One out of five Americans will develop some
form of skin cancer during their lifetime.
The
FDA reports that 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. Additionally, 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, the FDA is proposing that such products be required to 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.
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. The FDA is also
amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+.
Previously, the FDA had recognized SPF values up to 30+. Under the proposed
amendment, the range would be SPF2 to SPF50+. Products that are SPF50 provide
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.
The
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.
For
more information about integrative therapies that may help block ultraviolet
rays, please visit Natural Standard’s Foods, Herbs & Supplements database. For
more information about skin cancer, please visit Natural Standard’s Medical Conditions database.