Tracking Health and Wellness Applications of Brain Science

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

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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: