Americans Can’t Buy the Top-Notch Sunscreen That Europeans Have Been Using for Years

The best sunburn protections are blocked by a federal backlog, but Congress is pushing legislation it says will clear the way.

National Journal
Sophie Novack
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Sophie Novack
April 7, 2014, 10:04 a.m.

Sun­screens that have been avail­able in Europe and oth­er for­eign mar­kets for years re­main banned from U.S. stores be­cause of a back­log in the fed­er­al bur­eau­cracy.

The in­gredi­ents that make the sun­screen su­per­i­or have been await­ing ap­prov­al — or any sort of de­cision — from the Food and Drug Ad­min­is­tra­tion for at least 12 years. There are cur­rently eight such in­gredi­ents stuck in the sys­tem.

Without ac­cess to the in­gredi­ents, con­sumers may be blocked from buy­ing the sun­screens that provide the most ef­fect­ive pro­tec­tions against harm­ful rays.

Con­gress has a plan to break the 12-year back­log: The House En­ergy and Com­merce Com­mit­tee on Monday is look­ing at le­gis­la­tion that would ex­ped­ite the FDA’s ap­prov­al pro­cess for sun­screen in­gredi­ents. Should the pan­el ap­prov­al the meas­ure, it would put the bill one step closer to pas­sage.

A com­pan­ion ver­sion of the House bill is pending with the Sen­ate’s Health Com­mit­tee.

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 for an­oth­er try.

“FDA’s goal was to cre­ate a more stream­lined pro­cess; it just didn’t work out that way,” says a staff mem­ber of the Pub­lic Ac­cess to Sun­Screens Co­ali­tion. “Every­one — melan­oma re­search­ers, the com­munity, man­u­fac­tur­ers, pa­tients, even the FDA — every­one agrees the cur­rent situ­ation is not work­ing. When you com­bine that with the in­creas­ing rates of skin can­cer, it’s a ser­i­ous pub­lic-health con­cern.”

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.

Con­gres­sion­al ad­voc­ates hope they can im­prove the FDA’s ex­ist­ing pro­ced­ure without upend­ing the en­tire sys­tem.

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 makes two primary changes to this pro­cess. First, it would in­sti­tute an eight-month dead­line for the FDA to make a de­cision, re­pla­cing a cur­rent re­view pro­cess that lacks a man­dat­ory end date. Second, the bill would no longer re­quire the FDA to is­sue a reg­u­la­tion every time it wants to ap­prove an in­gredi­ent.

The FDA de­clined to com­ment on the bill, but a spokes­per­son said the agency has “pri­or­it­ized re­view­ing the safety and ef­fect­ive­ness of ad­di­tion­al sun­screen in­gredi­ents as quickly as pos­sible giv­en the agency’s re­sources.”

This frus­tra­tion has boiled over to Cap­it­ol Hill, with match­ing House and Sen­ate bills to ad­dress the prob­lem. The House ver­sion be­ing con­sidered Monday was in­tro­duced by Re­pub­lic­an Ed Whit­field and Demo­crat John Din­gell. The Sen­ate ver­sion came from Demo­crat Jack Reed and Re­pub­lic­an Johnny Isak­son.

With back­ing from both parties, ad­voc­ates are cau­tiously op­tim­ist­ic about the bills be­com­ing law, but they re­cog­nize that bi­par­tis­an sup­port is no guar­an­tee of pas­sage — par­tic­u­larly in the cur­rent grid­locked en­vir­on­ment.

“Try­ing to pre­dict what Con­gress is go­ing to do is kind of like hav­ing a per­fect March Mad­ness brack­et,” the sun­screens co­ali­tion staff mem­ber said. “But I will say there has been tre­mend­ous bi­par­tis­an, bicam­er­al sup­port.”

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