Study: Hun­dreds of di­etary sup­ple­ments tainted with un­ap­proved drugs

The Washington Post - - POLITICS & THE NATION - BY LENNY BERN­STEIN leonard.bern­stein@wash­post.com

Re­searchers found un­ap­proved and some­times dan­ger­ous drugs in 746 di­etary sup­ple­ments, al­most all of them mar­keted for sex­ual en­hance­ment, weight loss or mus­cle growth, a new anal­y­sis pub­lished Fri­day shows.

The re­view of a Food and Drug Ad­min­is­tra­tion data­base of con­tam­i­nated sup­ple­ments for the years 2007 to 2016 most com­monly turned up silde­nafil — sold as Vi­a­gra — and other erec­tile dys­func­tion drugs in sex en­hance­ment prod­ucts; sibu­tramine and the lax­a­tive phe­nolph­thalein, both banned by the FDA, in weight-loss sup­ple­ments; and steroids or their ana­logues in mus­cle-build­ing prod­ucts.

About 80 per­cent of the sup­ple­ments were con­tam­i­nated by one phar­ma­ceu­ti­cal that should not have been in the prod­uct. Twenty per­cent con­tained at least two such drugs, and two of the sup­ple­ments con­tained six un­ap­proved drugs. De­spite these con­tam­i­nants, fewer than half the prod­ucts were re­called.

The pres­ence of un­known drugs in sup­ple­ments “poses a se­ri­ous pub­lic health risk,” the re­searchers wrote. More than 50 per­cent of the U.S. pop­u­la­tion con­sumes di­etary sup­ple­ments, and many con­sumers mis­tak­enly believe the prod­ucts are care­fully reg­u­lated and ac­cu­rately la­beled.

Con­tro­versy over adul­ter­ated sup­ple­ments stretches back decades. Un­der a 1994 law, the Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act, the prod­ucts are reg­u­lated as food and there­fore not sub­ject to pre­mar­ket safety and ef­fec­tive­ness test­ing im­posed on phar­ma­ceu­ti­cals. The $35 bil­lion sup­ple­ment mar­ket in­cludes mul­ti­vi­ta­mins, min­er­als, botan­i­cals and other prod­ucts.

The new pa­per, writ­ten by a team from the Cal­i­for­nia De­part­ment of Pub­lic Health, was pub­lished on­line Fri­day in JAMA Net­work Open.

In an in­ter­view, Daniel Fabri­cant, pres­i­dent of the Nat­u­ral Prod­ucts As­so­ci­a­tion, a sup­ple­ment in­dus­try trade group, said it is un­fair to con­sider sex en­hance­ment, weight-loss and mus­cle build­ing prod­ucts in the same cat­e­gory as tra­di­tional di­etary sup­ple­ments such as vi­ta­mins. He said these are fringe prod­ucts, of­ten made by fly-by-night man­u­fac­tur­ers and sold on the In­ter­net or in con­ve­nience stores.

“We’re com­pletely on the FDA’s side here,” said Fabri­cant, who worked at the fed­eral agency reg­u­lat­ing sup­ple­ments ear­lier this decade. “This is some­one spik­ing the prod­uct. They’re say­ing it’s a sup­ple­ment. It’s not a sup­ple­ment in any way, shape or form.”

Fabri­cant said his or­ga­ni­za­tion sup­ports the FDA us­ing its author­ity to bring mis­de­meanor charges against com­pa­nies that adul­ter­ate sup­ple­ments with drugs.

But Pi­eter Co­hen, who wrote an ed­i­to­rial that ac­com­pa­nied the new study, said many tainted sup­ple­ments come from well­known man­u­fac­tur­ers based in the United States. He cited a 2014 study that he and oth­ers con­ducted that found 20 of 27 sup­ple­ments were still adul­ter­ated with drugs and avail­able for pur­chase be­tween eight and 52 months af­ter they were re­called by the FDA.

In his ed­i­to­rial, Co­hen, who con­ducts re­search into the safety of di­etary sup­ple­ments at Har­vard Med­i­cal School, called on the FDA to be more ag­gres­sive and urged an over­haul of the 1994 law. He sug­gested that com­pa­nies be re­quired to reg­is­ter the prod­ucts with the FDA be­fore sale.

In a state­ment, an FDA spokesman said the agen­cy­was an­a­lyz­ing the find­ings.

“The FDA is com­mit­ted to do­ing ev­ery­thing within its re­sources and author­i­ties to iden­tify and re­move un­safe prod­ucts from the mar­ket” and “to help en­sure that prod­ucts mar­keted as di­etary sup­ple­ments are safe, well-man­u­fac­tured, and ac­cu­rately la­beled.”

The spokesman, Jeremy Kahn, said that when the FDA takes ac­tion against one dis­trib­u­tor oth­ers may still mar­ket the prod­uct, and that sup­ple­ments are some­times re­la­beled to evade de­tec­tion.

The new anal­y­sis of the FDA’s Tainted Prod­ucts Mar­keted as Di­etary Sup­ple­ments data­base con­tained alarm­ing find­ings. The pre­scrip­tion an­tide­pres­sant flu­ox­e­tine, or Prozac, was found in about 5 per­cent of the weight-loss prod­ucts. Sibu­tramine, widely found in the weight-loss prod­ucts, can sub­stan­tially in­crease blood pres­sure and pulse rate. The FDA with­drew it from the mar­ket in 2010 be­cause of its po­ten­tial to cause strokes.

The ac­tive in­gre­di­ents in Vi­a­gra, Cialis and Le­vi­tra — widely found in the sex en­hance­ment sup­ple­ments — can in­ter­act with ni­trates found in medicine pre­scribed for di­a­betes, high blood pres­sure and high choles­terol and can dan­ger­ously lower blood pres­sure, the re­searchers said.

Men pre­cluded from tak­ing erec­tile dys­func­tion drugs may turn to these sup­ple­ments, not re­al­iz­ing that they are get­ting the very same phar­ma­ceu­ti­cals, they said.

Oth­ers may choose them be­cause they are less ex­pen­sive or be­cause they are read­ily avail­able at gas sta­tions and con­ve­nience stores, Co­hen said.

“As the di­etary sup­ple­ment in­dus­try con­tin­ues to grow in the United States, it is es­sen­tial to fur­ther address this sig­nif­i­cant pub­lic health is­sue,” the re­searchers wrote.

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