More health prob­lems re­ported from cos­metic prod­ucts

Tehran Times - - HEALTH - By Vic­to­ria Knight

Com­plaints of ad­verse health events re­lated to cos­metic and per­sonal care prod­ucts more than dou­bled from 2015 to 2016, ac­cord­ing to a study pub­lished Mon­day in the jour­nal JAMA In­ter­nal Medicine.

The ma­jor­ity of those com­plaints stemmed from hair care prod­ucts.

North­west­ern Univer­sity re­searchers looked at com­plaints col­lected by the Food and Drug Ad­min­is­tra­tion from 2004 to 2016. The in­for­ma­tion came from the FDA’s Cen­ter for Food Safety and Ap­plied Nu­tri­tion’s Ad­verse Event Re­port­ing Sys­tem, which al­lows con­sumers or health care pro­fes­sion­als to sub­mit com­plaints about harm caused by us­ing cos­metic prod­ucts.

The study found that there were 706 re­lated ad­verse events re­ported in 2015 and 1,591 in 2016. Com­pared with the aver­age num­ber of re­ports across the 12-year study pe­riod, that’s a 78% in­crease in 2015 and a 300% in­crease in 2016.

How­ever, the lead study au­thor, Dr. Steve Xu, be­lieves the num­ber of ad­verse health events is prob­a­bly much higher and more data are needed.

“Th­ese num­bers are likely un­der­re­ported. We need bet­ter re­port­ing, from both con­sumers and clin­i­cians,” Xu said. “Broadly, the hope of our paper was to con­tinue this dis­cus­sion to mod­ern­ize and ex­pand the col­lec­tion of data about per­sonal care prod­ucts. If you can’t mea­sure it, you can’t man­age it, was our key point.”

The study au­thors largely at­tribute in­creases in re­ported ad­verse health events to WEN by Chaz Dean hair care prod­ucts. In 2014, the FDA an­nounced that it was in­ves­ti­gat­ing WEN by Chaz Dean Cleans­ing Con­di­tioner prod­ucts be­cause it had re­ceived com­plaints of hair loss, hair break­age, bald­ing, itch­ing and rash. As of Novem­ber, the FDA had re­ceived 1,386 com­plaints of ad­verse health events from th­ese prod­ucts.

In the course of the in­ves­ti­ga­tion, the FDA dis­cov­ered that Chaz Dean Inc. and par­ent com­pany Guthy Renker LLC had re­ceived more than 21,000 com­plaints. How­ever, un­der cur­rent reg­u­la­tions, the com­pa­nies are not re­quired to re­port th­ese com­plaints to the FDA.

Al­though the FDA in­ves­ti­ga­tion is on­go­ing, the WEN con­di­tion­ing prod­ucts have not been pulled from the mar­ket. The FDA has no au­thor­ity to re­call cos­met­ics prod­ucts, al­though it can rec­om­mend re­calls.

Man­u­fac­tur­ers also do not have to re­ceive ap­proval from the FDA be­fore cos­met­ics go on sale.

In an email, the FDA said that “The law does not re­quire cos­metic com­pa­nies to share their safety in­for­ma­tion, in­clud­ing con­sumer com­plaints, with the FDA. FDA’s data on cos­metic ad­verse events are lim­ited be­cause re­port­ing is vol­un­tary. The FDA may take reg­u­la­tory ac­tion against cos­met­ics on the mar­ket that do not com­ply with the laws we en­force, if we have re­li­able in­for­ma­tion in­di­cat­ing that a cos­metic is adul­ter­ated or mis­branded.”

Xu said he still thinks most cos­met­ics are OK to use. “When it comes to cos­met­ics on the shelves that are dan­ger­ous, it’s very hard to prove,” Xu said. “In gen­eral, cos­met­ics are a very safe prod­uct class.”

The Per­sonal Care Prod­ucts Coun­cil said in a state­ment that it “be­lieves that manda­tory ad­verse event re­port­ing is crit­i­cally im­por­tant, which is why we have long ad­vo­cated for it on Capi­tol Hill.” The coun­cil is a na­tional trade as­so­ci­a­tion rep­re­sent­ing the cos­metic and per­sonal care prod­ucts in­dus­try.

“Nev­er­the­less, de­spite the re­cent in­crease in re­port­ing, the fact re­mains that only a very small per­cent­age of cos­met­ics prod­ucts on the mar­ket are as­so­ci­ated with ad­verse events. And of those, a frac­tion are listed as ‘se­ri­ous,’” the coun­cil said. “In other words, even with the in­crease, ad­verse re­ac­tions as­so­ci­ated with cos­met­ics and per­sonal care prod­ucts are extremely rare.”

Dr. Robert Califf, for­mer head of the FDA, said the root of th­ese com­plaints lies in the FDA’s lim­ited abil­ity to reg­u­late cos­met­ics.

“For cos­met­ics -- and for di­etary supplements -- the FDA’s over­sight au­thor­ity re­mains stuck at the lev­els es­tab­lished in 1938, nearly 80 years ago,” Califf said in an edi­to­rial ac­com­pa­ny­ing the study in JAMA In­ter­nal Medicine.

Sens. Diane Fe­in­stein, D-Cal­i­for­nia, and Su­san Collins, R-Maine, in­tro­duced a bill in May that would re­quire fur­ther reg­u­la­tion of per­sonal care prod­ucts. If passed, the bill will re­quire the FDA to test cer­tain in­gre­di­ents. It would also give the agency au­thor­ity to is­sue re­calls and re­quire more com­plete prod­uct la­bels and warn­ings from man­u­fac­tur­ers.

Kim Har­ley, associate di­rec­tor at the Univer­sity of Cal­i­for­nia, Berke­ley’s Cen­ter for En­vi­ron­men­tal Re­search and Chil­dren’s Health, said this kind of reg­u­la­tion, if en­forced, could help the FDA learn more about the long-term health ef­fects of cos­met­ics, which still re­main largely un­known.

“When you think about harm­ful chem­i­cals, you can think of two lev­els,” Har­ley said. “You can think of acute harm and chronic ex­po­sure. Acute would be ‘I use a cos­metic prod­uct, and I get this rash that’s al­most im­me­di­ate, or hair loss, or some­thing like that.’ It’s an ex­treme re­ac­tion that’s hap­pen­ing so close in time to when you use the prod­uct, it seems it’s linked to the use of this prod­uct.”

Har­ley, who em­pha­sized that most cos­met­ics are not harm­ful, says acute events are most likely the kind re­ported in the North­west­ern study.

“On the other hand, there are chem­i­cals that might, if we use them ev­ery day over a long pe­riod of time, have small, long-term im­pacts on our health,” said Har­ley, who con­ducts re­search on the ef­fects of chem­i­cal hor­mone dis­rup­tors in cos­met­ics but was not af­fil­i­ated with the new study.

“Th­ese ef­fects may not be ob­vi­ous on a day-to-day ba­sis, but you know if you’ve been us­ing this prod­uct for 20 years of your life, maybe it would have some sort of health im­pact over the long-term. And this is why we need more re­search. With th­ese long-term health im­pacts, there’s so much we don’t know.”

In the mean­time, the FDA en­cour­ages con­sumers and pro­fes­sion­als to re­port any ad­verse events.

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