Diet, mus­cle and sex pills tainted, study shows

The pres­ence of un­known drugs poses se­ri­ous health risk, re­searchers say

Tulsa World - - Front Page - By Lenny Bern­stein

Re­searchers found un­ap­proved and some­times dan­ger­ous drugs in 746 di­etary sup­ple­ments, al­most all of them mar­keted for sex­ual en­hance­ment, weight loss or mus­cle growth, an 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 — the drug 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. One prod­uct con­tained a drug that raises blood pres­sure and an­other drug that low­ers it. 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.

The drugs found in the sup­ple­ments have “the po­ten­tial to cause se­ri­ous ad­verse health ef­fects ow­ing to ac­ci­den­tal mis­use, overuse or in­ter­ac­tion with other med­i­ca­tions, un­der­ly­ing health con­di­tions or other phar­ma­ceu­ti­cals,” the re­searchers wrote.

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 are 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 sex­ual 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 fully 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 ac­tu­ally come from well-known 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, an as­so­ci­ate pro­fes­sor at Har­vard Med­i­cal School who con­ducts re­search into the safety of di­etary sup­ple­ments, called on the FDA to more ag­gres­sively act against com­pa­nies that pro­duce adul­ter­ated sup­ple­ments and urged re­form of the 1994 law. He sug­gested that com­pa­nies be re­quired to reg­is­ter the prod­ucts with the FDA be­fore sale.

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