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The FDA cracks down on dozens of supplements claiming to prevent or cure Alzheimer’s Disease


FDA takes action against 17 com­pa­nies for ille­gal­ly sell­ing prod­ucts claim­ing to treat Alzheimer’s dis­ease (US Food & Drug Admin­is­tra­tion):

The U.S. Food and Drug Admin­is­tra­tion today post­ed 12 warn­ing let­ters and 5 online advi­so­ry let­ters issued to for­eign and domes­tic com­pa­nies that are ille­gal­ly sell­ing more than 58 prod­ucts, many that are sold as dietary sup­ple­ments, which are 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. These prod­ucts, which are often sold on web­sites and social media plat­forms, have not been reviewed by the FDA and are not proven safe and effec­tive to treat the dis­eases and health con­di­tions they claim to treat. These prod­ucts may be inef­fec­tive, unsafe and could pre­vent a per­son from seek­ing an appro­pri­ate diag­no­sis and treat­ment…

In a state­ment issued today, FDA Com­mis­sion­er Got­tlieb also out­lined sev­er­al impor­tant new actions and pol­i­cy pri­or­i­ties the agency will take in the com­ing months to improve the safe­ty of dietary sup­ple­ments and pur­port­ed dietary sup­ple­ments, includ­ing efforts to more rapid­ly com­mu­ni­cate poten­tial safe­ty issues with dietary sup­ple­ment prod­ucts with the pub­lic, estab­lish­ing a flex­i­ble reg­u­la­to­ry frame­work that pro­motes inno­va­tion and upholds prod­uct safe­ty and oth­er, new steps the FDA could con­sid­er tak­ing to bet­ter ensure prod­uct safe­ty and integri­ty.”

The Statement:

State­ment from FDA Com­mis­sion­er Scott Got­tlieb, M.D., on the agency’s new efforts to strength­en reg­u­la­tion of dietary sup­ple­ments by mod­ern­iz­ing and reform­ing FDA’s over­sight (FDA):

The use of dietary sup­ple­ments, such as vit­a­mins, min­er­als or herbs, has become a rou­tine part of the Amer­i­can lifestyle. Three out of every four Amer­i­can con­sumers take a dietary sup­ple­ment on a reg­u­lar basis. For old­er Amer­i­cans, the rate ris­es to four in five. And one in three chil­dren take sup­ple­ments, either giv­en to them by their par­ents or, com­mon­ly in teens, tak­ing them on their own.

That’s why today we are announc­ing a new plan for pol­i­cy advance­ments with the goal of imple­ment­ing one of the most sig­nif­i­cant mod­ern­iza­tions of dietary sup­ple­ment reg­u­la­tion and over­sight in more than 25 years…In the com­ing months, we’ll be pro­vid­ing addi­tion­al details on the steps we are tak­ing to con­tin­ue mov­ing our dietary sup­ple­ment pro­gram for­ward to imple­ment these pri­or­i­ties. Our new approach ben­e­fits con­sumers by bal­anc­ing new poli­cies to pro­mote inno­va­tion and effi­cien­cy in the mar­ket­place for dietary sup­ple­ments with increased steps to pro­tect the pub­lic from poten­tial safe­ty issues.”

The Statement in Context:

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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