FDA tar­gets prod­ucts false­ly claim­ing to treat Alzheimer’s dis­ease

De­vel­op­ing treat­ments for Alzheimer’s dis­ease has been no­to­ri­ous­ly dif­fi­cult, and now the FDA is crack­ing down on com­pa­nies fraud­u­lent­ly claim­ing that their di­etary sup­ple­ments can help treat, pre­vent or even cure the dis­ease.

The FDA on Mon­day re­leased 12 warn­ing let­ters and five ad­vi­so­ry let­ters to for­eign and do­mes­tic com­pa­nies that are il­le­gal­ly sell­ing more than 58 un­ap­proved new drugs and/or mis­brand­ed drugs that claim to pre­vent, treat or cure Alzheimer’s dis­ease and a num­ber of oth­er se­ri­ous dis­eases and health con­di­tions.

“To­day’s ac­tions are part of the FDA’s larg­er ef­fort to ad­dress the boom­ing growth of the di­etary sup­ple­ment in­dus­try through the im­ple­men­ta­tion of mod­ern reg­u­la­to­ry ini­tia­tives that will en­able the agency to pre­serve the bal­anced vi­sion of the Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act (DSHEA), en­act­ed by Con­gress 25 years ago,” FDA Com­mis­sion­er Scott Got­tlieb said.

In­creased Reg­u­la­tion

Got­tlieb al­so out­lined sev­er­al ways in which the FDA is look­ing to move its reg­u­la­tion of di­etary sup­ple­ments for­ward, par­tic­u­lar­ly as in the 25 years since Con­gress passed the Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act (DSHEA), the law that en­abled the FDA’s au­thor­i­ty to reg­u­late di­etary sup­ple­ments, the di­etary sup­ple­ment mar­ket has grown sig­nif­i­cant­ly.

“What was once a $4 bil­lion in­dus­try com­prised of about 4,000 unique prod­ucts, is now an in­dus­try worth more than $40 bil­lion, with more than 50,000 – and pos­si­bly as many as 80,000 or even more,” Got­tlieb said.

As far as up­com­ing changes, the FDA is ex­plor­ing new ways to com­mu­ni­cate more quick­ly when con­cerns arise that an in­gre­di­ent is un­law­ful and po­ten­tial­ly dan­ger­ous and should not be mar­ket­ed in di­etary sup­ple­ments. He al­so not­ed how the FDA is push­ing to­ward the sub­mis­sion of new di­etary in­gre­di­ent (NDI) no­ti­fi­ca­tions so the FDA could eval­u­ate the safe­ty of a new in­gre­di­ent be­fore it be­comes avail­able.

“We’re con­tin­u­ing to de­vel­op guid­ance for prepar­ing NDI no­ti­fi­ca­tions to en­sure FDA can thor­ough­ly re­view the safe­ty of these in­gre­di­ents. In con­junc­tion with this ef­fort, we’re plan­ning to up­date our com­pli­ance pol­i­cy re­gard­ing NDIs,” he said.

The agency is al­so plan­ning a pub­lic meet­ing this spring on the top­ic of re­spon­si­ble in­no­va­tion in the di­etary sup­ple­ment in­dus­try, open­ing the pos­si­bil­i­ty for a broad­er con­ver­sa­tion on whether cer­tain changes to the DSHEA might be help­ful.

For ex­am­ple, some stake­hold­ers have sug­gest­ed that the statute should be amend­ed to es­tab­lish av­enues for di­etary sup­ple­ment ex­clu­siv­i­ty and add a prod­uct list­ing re­quire­ment. A manda­to­ry list­ing re­quire­ment could al­so pro­vide sig­nif­i­cant ben­e­fits by im­prov­ing trans­paren­cy in the mar­ket­place and pro­mot­ing risk-based reg­u­la­tion, Got­tlieb said.

The Coun­cil for Re­spon­si­ble Nu­tri­tion, a trade as­so­ci­a­tion for the di­etary sup­ple­ment and func­tion­al food in­dus­try, ap­plaud­ed the moves by Got­tlieb and the FDA, and called on Con­gres­sion­al ap­pro­pri­a­tors to al­lo­cate to the FDA the fund­ing re­quired to ad­e­quate­ly po­lice sup­ple­ments and fol­low through on en­force­ment.

First pub­lished here and syn­di­cat­ed in part­ner­ship with RAPS. 

Im­age: Scott Got­tlieb. AP IM­AGES


Zachary Brennan

managing editor, RAPS

John Hood [file photo]

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