FDA to toughen sup­ple­ment rules

Agency say $50 bil­lion in­dus­try’s growth has added risks

Arkansas Democrat-Gazette - - BUSINESS & FARM - LAU­RIE McGIN­LEY

Food and Drug Ad­min­is­tra­tion said Mon­day that it plans to beef up over­sight of the sprawl­ing, $50 bil­lion-a-year di­etary sup­ple­ments in­dus­try, warn­ing that the sec­tor’s ex­plo­sive growth has 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 ear­lier 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 se­ri­ous dis­eases.

FDA Com­mis­sioner Scott Got­tlieb said the agency is 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 while most sup­ple­ment mak­ers are re­spon­si­ble, the huge growth in the in­dus­try has 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, ac­cord­ing to the FDA.

While the FDA doesn’t clear the prod­ucts ahead of time, it is in charge of removing un­safe ones 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 plans 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 flex­i­ble enough to en­sure prod­uct im­prove­ments. And

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 ma­jor change likely 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. The re­sult is that the agency doesn’t have a clear idea of who is mak­ing what.

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

In­creas­ingly, of­fi­cials and pub­lic health ex­perts have be­come con­cerned about un­safe in­gre­di­ents — such as the ac­tive in­gre­di­ents in drugs, of­ten from over­seas — show­ing up in sup­ple­ments. An anal­y­sis pub­lished in October, writ­ten by a team from the Cal­i­for­nia Depart­ment of Pub­lic Health, found un­ap­proved and some­times dan­ger­ous drugs in 746 di­etary sup­ple­ments, al­most all of them mar­keted for sex­ual en­hance­ment, weight loss or mus­cle growth. The drugs in­cluded silde­nafil — the ac­tive in­gre­di­ent in Vi­a­gra — and steroids in mus­cle-build­ing prod­ucts.

In the fall, the FDA warned con­sumers to avoid Rhino male en­hance­ment prod­ucts that con­tained silde­nafil. It said it had re­ceived re­ports of peo­ple ex­pe­ri­enc­ing chest pain, se­vere headaches and pro­longed erec­tions af­ter tak­ing a Rhino prod­uct. The agency also warned com­pa­nies mar­ket­ing sup­ple­ments for opi­oid ad­dic­tion that con­tained an un­ap­proved an­tide­pres­sant called tianep­tine.

Di­etary sup­ple­ment mak­ers are al­lowed to make what are called “struc­ture/func­tion claims” on how a nu­tri­ent or di­etary in­gre­di­ent af­fects the body — for ex­am­ple, “cal­cium builds strong bones.” But they aren’t per­mit­ted to say their prod­ucts treat or cure spe­cific dis­eases such as os­teo­poro­sis. Such claims would mean the prod­uct would be reg­u­lated as a drug and sub­ject to pre­mar­ket ap­proval re­quire­ments.

Bloomberg

An em­ployee or­ga­nizes bot­tles of fish oil sup­ple­ments at a GNC store in New York. The Food and Drug Ad­min­is­tra­tion an­nounced plans Mon­day to step up polic­ing of di­etary sup­ple­ments, a $50 bil­lion in­dus­try.

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