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By Jack Persico, Editor-in-Chief
This month's cover story on the many unresolved issues in sunscreen
relabeling brings to light the frustration that many dermatologists
are feeling fight now. After announcing in May 1999 that it would publish
a new monograph on the testing, labeling, and marketing of sunscreens,
the FDA has yet to meet its own two-year deadline for completion, and
has extended it to December 2002.
What this means for dermatologists and sunscreen manufacturers is
another 18 months of debate and discussion about the ability of sunscreens
to block LTVA, whether or not there should be a cap on SPF values at
30, and several other pressing topics. Once the final monograph is released,
manufacturers will most likely have a year to phase-in whatever new
regulations will be imposed, further delaying any substantive changes
in sunscreen regulations. This delay is unfortunate but necessary. The
FDA's intervention comes at a crucial time, since newer sunscreen products
increasingly make claims of "broadspectrum" protection against
both UVA and UVB radiation. Claiming that a product blocks LJVB and
thereby extends the amount of time one can safely spend outdoors is
one thing; it is a far more serious to imply that a product mitigates
photoaging and carcinogenesis by blocking UVA.
Given that manufacturers have raised the stakes by adding UVA claims
to sunscreens, the FDA deserves more support and less flak from dermatologists
about delaying its publication of a final monograph intended to cover,
in one fell swoop, the labeling of literally hundreds of products in
the sunscreen category. Yes, the delay is frustrating, but the FDA is
right to step in and reassure the public that UVA claims are justified...
and that's not a decision to be made quickly.
Similarly, the debate about SPF values needs to continue. In a recent
study conducted by Darrell Rigel, MD a product's SPF value didn't matter
as much as frequency of reapplication of the product in determining
sunburn rates. That's the sort of finding that needs further scrutiny,
since it runs counter to the conventional wisdom about higher SPF values
offering longer sun-exposure times.
What should dermatologists do in the meantime? For one thing, provide
feedback to both the FDA and sunscreen manufacturers. Let both groups
know what your patients have reported to you about their motivations
for and against using sunscreens. And don't be afraid to take the agency
to task for proposing regulations that you consider ineffective.
As one dermatologist, Bernard Raskin, MD, pointed out in a letter
to the FDA, "all sunscreens labeled moderate (from I I to 29) will
basically be an 11, since no sunscreen company is going to pay the extra
money to manufacture an SPF 29 when it is going to be lumped with the
SPF 11s." That sort of candor is what the FDA needs if it is to
publish a monograph that accurately reflects the way these products
are manufacturered, marketed, and used.
Skin & Aging, June 15, 2001
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