FDA Wrapping Up Sunscreen Label Changes
Among the Label Changes: SPF
Claims
of More Than 50+ Won't Be Allowed
By Salynn Boyles
WebMD Health News
Reviewed by Louise Chang, MD
May 21, 2009 -- After years of delay, the FDA is poised to finalize
long-awaited sunscreen label changes designed to give consumers a better idea of
the sun protection they're getting.
For the first time, sunscreen manufacturers will be required to provide
information on the amount of ultraviolet A (UVA)
screening provided by their products. UVA rays do not cause sunburns, but they
do contribute to skin cancer and sun-related skin aging.
The new regulation will also prohibit manufacturers from
claiming sun protection factors (SPF
) of more than 50+, so those very high SPF sunscreens
that now line drugstore and grocery-store shelves may go away.
In an interview with WebMD, Rita Chappelle of the FDA confirmed that the
agency hopes to finalize the label rules before the end of the year and that SPF
claims will be capped at 50+.
But sunscreen companies will have a year to 18 months after the new rules are
enacted to make the label changes or provide scientific evidence justifying a
higher SPF rating.
Chappelle also confirmed that the terms "sunblock," "waterproof," "sweat-proof," and
"all-day protection" will no longer be allowed on sunscreen
labels under the new regulations.
"No product can completely block out the rays from the sun and no product is
completely waterproof," Chappelle says. "And labels will have to advise
consumers to limit their time in the sun, wear protective clothing, and reapply
sunscreen at a minimum of every two hours, especially after swimming or
perspiring."
Label Changes a Decade in the Making
It has been a decade since the FDA first proposed a standardized UVA rating
system, but there was widespread disagreement about how to best evaluate the
level of UVA protection that sunscreens provide.
"It took some time for the science to catch up," Chappelle says.
Under the new regulations, sunscreens will be subjected to lab and human skin
tests using a standardized sun simulator.
Almost two years ago, the FDA unveiled a proposed four-star rating system,
with one star representing low UVA protection and four stars representing the
highest UVA protection available in an over-the-counter product.
The stars would appear near the SPF rating on sunscreen labels.
Chappelle would not say if the proposed star system will be adopted in the
finalized plan.
She says the agency received more than 3,000 comments about the proposed
label changes and an "unprecedented" amount of scientific data from companies
challenging those changes.
"Typically when we put out a proposed rule we get five or 10 submissions of
scientific data," she says. "We received over 100 on this and they all had to be
analyzed."
Sunscreen Companies Respond
Representatives of sunscreen manufacturers Neutrogena, Banana Boat, Hawaiian
Tropic, and Coppertone all told WebMD they will comply with the FDA label
changes.
But they also left the door open for challenging the SPF 50+ cap.
"The FDA has asked for data supporting high SPF products," Coppertone
spokeswoman Jennifer Samolewicz notes in a written statement. "Many
manufacturers, including Coppertone, have submitted new data for review and are
awaiting the FDA's response."
A spokeswoman for Energizer Personal Care, which makes Banana Boat and
Hawaiian Tropic sunscreens, tells WebMD that the company will assess its options
after seeing the final FDA label requirements.
Farah Ahmed, who is general council for the cosmetics industry group Personal
Care Products Council, tells WebMD that although the group doesn't object to
capping SPF levels at 50+, it strongly disagrees with a proposal to prohibit
sunscreens from claiming that they protect against skin cancer and premature
skin aging.
"We are not saying that sunscreens alone prevent skin cancer and wrinkles,"
she says. "What we are saying is that when used as an overall sun-safe regimen,
sunscreens reduce the risk of certain types of skin cancer and photo damage."
Sonya Lunder, who is a senior analyst for the environmental advocacy
organization Environmental Working Group, says the FDA rule changes are long
overdue and urgently needed.
"It's kind of a Wild West environment out there now," she
tells WebMD "Companies can make all kinds of claims, and they are making them.
Claims like ‘all-day protection' and ‘complete-protection' are proof that
manufacturers are not following the (now voluntary) FDA guidelines."
SOURCES:
Rita Chappelle, spokeswoman, FDA.
Farah Ahmed, general council, Personal Care Products Council.
Sonya Lunder, senior analyst, Environmental Working Group.
Jennifer Samolewicz, manager, global communications services, Schering-Plough.
Ariel Kern, spokeswoman, Energizer Personal Care.
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