Di­etary sup­ple­ments tar­geted

The FDA, wor­ried about the risks to con­sumers, plans to strengthen over­sight.

Los Angeles Times - - THE NATION - By Lau­rie McGin­ley McGin­ley re­ports for the Wash­ing­ton Post.

The Food and Drug Ad­min­is­tra­tion said Mon­day it planned to beef up over­sight of the sprawl­ing, $50 bil­liona-year di­etary sup­ple­ments in­dus­try, warn­ing that the sec­tor’s ex­plo­sive growth had re­sulted in risks to con­sumers — such as an in­crease in sup­ple­ments “spiked” with un­listed drug in­gre­di­ents and false and mis­lead­ing claims about health ben­e­fits.

The agency un­der­scored the need for greater over­sight by an­nounc­ing it had sent 12 warn­ing let­ters and five ad­vi­sory let­ters this month to com­pa­nies the FDA said are sell­ing dozens of prod­ucts that con­tain un­ap­proved drugs or use il­le­gal claims for treat­ing Alzheimer’s and other dis­eases.

FDA Com­mis­sioner Scott Got­tlieb said the agency was plan­ning pol­icy changes that could lead to the most im­por­tant reg­u­la­tory mod­ern­iza­tion since en­act­ment of the 1994 Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act, which con­sid­ers sup­ple­ments safe un­til proved oth­er­wise.

Got­tlieb said in an in­ter­view that al­though most sup­ple­ment mak­ers were re­spon­si­ble, the huge growth in the in­dus­try had al­lowed “bad ac­tors” to sell dan­ger­ous prod­ucts or ones that carry un­proven claims. “I’m con­cerned that changes in the sup­ple­ment mar­ket may have out­paced the evo­lu­tion of our own poli­cies and our ca­pac­ity to man­age emerg­ing risks,” he said.

Un­der the 1994 law, di­etary sup­ple­ments are reg­u­lated as food and, there­fore, are not sub­ject to pre-mar­ket ap­proval or the kind of safety and ef­fec­tive­ness test­ing re­quired for drugs. Since the law was en­acted, the in­dus­try has grown from 4,000 prod­ucts and $4 bil­lion a year in sales to as many as 80,000 prod­ucts and $50 bil­lion in sales, the FDA said.

While the FDA doesn’t clear the prod­ucts ahead of time, it is charged with re­mov­ing un­safe sup­ple­ments from the mar­ket.

Three out of four Amer­i­cans take a di­etary sup­ple­ment on a reg­u­lar ba­sis, and for older Amer­i­cans the pro­por­tion is four out of five, the agency said. One in three chil­dren also take sup­ple­ments.

Got­tlieb said he planned a “bal­anced ap­proach” to im­prove safety, re­duce in­ac­cu­rate claims and en­cour­age in­dus­try in­no­va­tion. For ex­am­ple, the agency plans to cre­ate a rapid-re­sponse tool to quickly alert the pub­lic if a sup­ple­ment con­tains an il­le­gal and po­ten­tially dan­ger­ous in­gre­di­ent. It in­tends to stream­line the han­dling of sup­ple­ments con­tain­ing pre­scrip­tion drugs, such as the generic ver­sion of Vi­a­gra, and to in­crease en­force­ment ac­tions.

In a nod to the in­dus­try, he said the agency would re­view its reg­u­la­tions on new di­etary in­gre­di­ents to make sure they are f lex­i­ble enough to en­sure prod­uct im­prove­ments. He promised to call a pub­lic meet­ing to dis­cuss that and other top­ics.

Got­tlieb also waded into an in­tense de­bate over whether there should be a manda­tory FDA registry where sup­ple­ment mak­ers would be re­quired to list their prod­ucts and in­gre­di­ents. He said manda­tory list­ing “could pro­vide sig­nif­i­cant ben­e­fits by im­prov­ing trans­parency in the mar­ket­place” and al­low­ing the FDA to fo­cus its en­force­ment ef­forts. But he ac­knowl­edged that such a change prob­a­bly would re­quire leg­is­la­tion.

Man­u­fac­tur­ers are sup­posed to reg­is­ter their fa­cil­i­ties with the FDA — but are not re­quired to list their prod­ucts or in­gre­di­ents. It’s not clear how many are com­ply­ing with the min­i­mal re­quire­ment.

San­dra Eskin, who di­rects the food safety project at the Pew Trusts, wel­comed Got­tlieb’s com­ments and em­pha­sized the need for manda­tory list­ing.

The “FDA needs to know what sup­ple­ment prod­ucts each com­pany makes, as well as the in­gre­di­ents and copies of the prod­uct la­bels,” she said. “This in­for­ma­tion is the cor­ner­stone of an ef­fec­tive over­sight and en­force­ment sys­tem, and Con­gress should re­quire that sup­ple­ment com­pa­nies pro­vide it to the agency.”

Steve Mis­ter, pres­i­dent and chief ex­ec­u­tive of the Coun­cil for Re­spon­si­ble Nu­tri­tion, which rep­re­sents sup­ple­ment mak­ers, said in a state­ment that the FDA “shares our vi­sion to fur­ther de­velop the thriv­ing, in­no­va­tive and safe mar­ket­place for di­etary sup­ple­ments.”

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