Opinion: SPF debate: FDA revamps sunscreen safety labeling

Jun 01, 2008, 4:00am

The Food and Drug Administration has been revamping sunscreen safety labeling since the implementation of the final monograph was delayed in 2002. Last August, the FDA issued proposed guidelines for the product labels, with a comment period open until November, 2007. The deadline for comment was extended until late December, and as of May first no new guidelines had been announced.

Key Points

The Food and Drug Administration (FDA) has been revamping sunscreen safety labeling since the implementation of the final monograph was delayed in 2002.

Last August, the FDA issued proposed guidelines for the product labels, with a comment period open until November 2007. The deadline for comment was extended until late December, and as of May 1, no new guidelines had been announced.

A major change in labeling would specify how much UVA protection sunscreens provide. Another proposal would prohibit companies from making specific claims about the efficacy of sunscreens with an SPF greater than 50.

Just a few years ago, the standard advice from dermatologists was that patients wear sunscreens with an SPF 15. On Call wondered what dermatologists are telling their patients now about these new, high-strength sunscreens touting SPFs five times the old standard.

On Call also asked several dermatologists around the country whether they were waiting for the new FDA guidelines to be implemented.

Doctors' response

Most of the doctors simply laughed when hearing about the SPFs ranging up to 80, although the general consensus is that an SPF 15 isn't high enough.

Jill O. Moore, M.D., is part of group practice in Boone, N.C.

"I tell my patients that an SPF 30 is adequate, but the most important thing is to remember to reapply it every hour-and-a-half to two hours. I try not to recommend specific brands, with the exception of a very few, just to keep it simple.

"I also tell them SPF 30 is fine, as long as it blocks both UVA and UVB rays - but the most important thing is to reapply," Dr. Moore tells Dermatology Times.

Do her patients comply with the directive to reapply regularly?

"Well ... Do you? Do I do that all the time?" she laughs.

In Buffalo, N.Y., Craig C. Miller, M.D., has no time for the soaring SPF ratings.

"SPF 80 has no meaning. I tell my patients that anything over SPF 30, I don't care. Plus, it's only UVB that the SPF measures.

"There's no quantifiable measure for UVA protection - that's what the FDA is working on.

"SPF 80 is just a marketing gimmick. I explain that SPF 80 is not a simple linear-scale increase. Going from an SPF 15 to an SPF 30 doesn't double their sun protection, and this is more of a logarithmic equation. There is such a small gain for increases in SPF above 30, it really doesn't matter."

A practitioner for 23 years, Jerry M. McCormack, M.D., in Brooklyn Center, Minn., says his practice isn't really affected by changes in sunscreen marketing.

"I have a list of sunscreens that I recommend. I just tell patients the FDA is in the process of reviewing the numbering system we currently have, but until something changes, this is what I recommend."

Dr. Miller, assistant professor at the University at Buffalo and director of the residency program at the University of Rochester, Rochester, N.Y., laughs.

"I'm a VA (Veterans Administration) dermatologist, and we get one sunscreen from the government. That's all. SPF 30. That's what we give our patients."