The U.S. Food and Drug Administration proposed a new set of standards
for sunscreens that sets standards for formulating, testing and labeling
over-the-counter sunscreen drug products with ultraviolet A (UVA) and
ultraviolet B (UVB) protection.
UVB radiation is the cause for “sun-burn”. UVA radiation
causes premature skin ageing, interferences with the human immune system, and
is an important contributor to the skin-cancer risk. However, the so-called
‘sun protection factor (SPF)’ only protects against sunburn (UVB radiation).
Under the new FDA’s proposal 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.
"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."
The rating system will be based on stars. For example, a
sunscreen rated with one star will provide the lowest UVA protection, while four
stars would represent the highest UVA protection available.
The FDA also proposed the introduction of a
"Warnings" statement in the "Drug Facts" box 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 FDA’s proposal is supported also by the The American
Academy of Dermatology Association.
"The Academy strongly supports the FDA's ongoing
efforts to provide current and useful information to help the public make
knowledgeable decisions about protecting themselves from the dangers of the
sun." stated practicing dermatologist Diane R. Baker, MD, FAAD, president
of the Academy.
"The proposed one to four star rating of a sunscreen's
UVA protective effect (corresponding to low, medium, high or very high
protection) will allow consumers to more easily understand the degree of
protection afforded by a particular product against the long wave (UVA) rays of
the sun," added Dr. Baker.
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+.
FDA is accepting comments on the new rule for 90 days until
November 26, 2007.
