Health Care

Your Sunscreen Is Really Out of Date. Here’s What Congress Is Doing About It.

A House committee advanced a bill Tuesday to streamline FDA approval of new sunscreen ingredients.

SYDNEY, AUSTRALIA - JANUARY 08: Beach-goers apply sunscreen to each other at Bondi Beach on January 8, 2013 in Sydney, Australia. Temperatures are expected to reach as high as 43 degrees around Sydney today. (Photo by Marianna Massey/Getty Images)
National Journal
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Sophie Novack
July 15, 2014, 9:15 a.m.

The U.S. may fi­nally catch up to oth­er coun­tries in sun­screen tech­no­logy.

The in­gredi­ents that make their sun­screen su­per­i­or have been await­ing ap­prov­al — or any sort of de­cision — from the Food and Drug Ad­min­is­tra­tion for at least 12 years, with the last over-the-counter sun­screen in­gredi­ent ap­proved by the agency in the 1990s. There are cur­rently eight such in­gredi­ents stuck in the sys­tem.

Mean­while, these tech­no­lo­gies have been avail­able in Europe, Asia, and Cent­ral and South Amer­ica, some­times for more than 15 years. As a res­ult of the back­log, Amer­ic­an con­sumers have been un­able to buy the sun­screens that provide the most ef­fect­ive pro­tec­tions against harm­ful rays.

But the 12-year back­log may soon come to an end. The House En­ergy and Com­merce’s Health Sub­com­mit­tee ad­vanced le­gis­la­tion Tues­day to ex­ped­ite the FDA’s ap­prov­al pro­cess for sun­screen in­gredi­ents. The Sun­screen In­nov­a­tion Act passed by a voice vote Tues­day, bring­ing the le­gis­la­tion one step closer to pas­sage.

Sup­port­ers of the bill ex­pect it to pass the House be­fore Au­gust re­cess, and to be taken up by the Sen­ate in the near fu­ture.

The le­gis­la­tion aims to im­prove on the fed­er­al gov­ern­ment’s latest at­tempt to make it­self more nimble in keep­ing up with sun­block tech­no­logy — a 2002 pro­ced­ur­al change from the FDA that the agency hoped would speed up its ap­prov­al pro­cess.

But without a single in­gredi­ent be­ing ap­proved since then, ad­voc­ates say it’s time to try again.

At stake is more than sun­burns: Skin can­cer is the most com­mon form of can­cer in the United States. More than 2 mil­lion cases are dia­gnosed each year, many of which could be pre­ven­ted by pro­tect­ing the skin from sun ex­pos­ure, ac­cord­ing to the Amer­ic­an Can­cer So­ci­ety.

Un­der cur­rent law, if an in­gredi­ent is on the mar­ket in an­oth­er coun­try for five years, it may go through a pro­cess to be de­term­ined eli­gible by the FDA. An ad­vis­ory com­mit­tee of ex­perts then weighs in on the safety and ef­fect­ive­ness of the product, and the agency makes the fi­nal de­term­in­a­tion as to wheth­er it is ap­proved.

The Sun­screen In­nov­a­tion Act would in­sti­tute a timeline for re­view, and would no longer re­quire the FDA to is­sue a reg­u­la­tion every time it wants to ap­prove an in­gredi­ent. The bill re­quires fi­nal de­cisions on pending ap­plic­a­tions with­in one year, and de­cisions on new ap­plic­a­tions with­in one and a half.

An FDA spokes­man has said the agency has “pri­or­it­ized re­view­ing the safety and ef­fect­ive­ness of ad­di­tion­al sun­screen in­gredi­ents as quickly as pos­sible giv­en the agency’s re­sources.”

The bi­par­tis­an le­gis­la­tion was in­tro­duced by Reps. Ed Whit­field, R-Ky., and John Din­gell, D-Mich., in the House and Sens. Johnny Isak­son, R-Ga., and Jack Reed, D-R.I., in the Sen­ate.

“This [le­gis­la­tion] will al­low Amer­ic­ans ac­cess to the best products on the mar­ket and also spur in­nov­a­tion in an area of sig­ni­fic­ant pub­lic health im­port­ance,” said Whit­field. “With skin can­cer be­ing by far the most com­mon form of this ter­rible dis­ease, it’s im­port­ant that con­sumers have ac­cess to the latest break­throughs in sun­screen tech­no­logy.”


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