Hun­dreds of di­etary prod­ucts tainted

Study dis­cov­ers il­licit in­gre­di­ents in sup­ple­ments

San Francisco Chronicle Late Edition - - FRONT PAGE - By Erin All­day

Nearly 800 di­etary sup­ple­ments sold in the United States were found to be con­tam­i­nated with un­ap­proved in­gre­di­ents — in some cases, drugs that have been banned by the Food and Drug Ad­min­is­tra­tion — in an in­dus­try anal­y­sis by Cal­i­for­nia pub­lic health sci­en­tists.

Most of the tainted sup­ple­ments were mar­keted for sex­ual en­hance­ment, mus­cle build­ing or weight loss, and the in­gre­di­ents found in them were of­ten phar­ma­ceu­ti­cal drugs — such as steroids or the ac­tive in­gre­di­ent in Vi­a­gra — that con­sumers nor­mally need a pre­scrip­tion to take.

The tainted prod­ucts were listed in a pub­lic data­base main­tained by the Food and Drug Ad­min­is­tra­tion, but in most cases the agency is­sued no other pub­lic no­tice and only rarely were the man­u­fac­tur­ers or dis­trib­u­tors sub­jected to warn­ing let­ters or other penal­ties. The FDA is­sued re­calls on less than half of the sup­ple­ments that were found to be con­tam­i­nated.

The study, pub­lished on­line Fri­day, is one of the largest and most com­pre­hen­sive of an in­dus­try whose prod­ucts have long been known to some­times con­tain in­gre­di­ents that put the pub­lic at risk. The find­ings are likely just “the tip of the ice­berg,” said Dr. John Swartzberg, direc­tor of the UC Berke­ley Well­ness Let­ter who has stud­ied the sup­ple­ment in­dus­try, but was not part of the new re­search.

“You’ve got an FDA that’s un­der­funded and not given the ad­e­quate re­sources to look at these prod­ucts,” Swartzberg said. “What we’ve cre­ated is an in­dus­try that many have de­scribed as the Wild West, with very poor con­trols.”

FDA of­fi­cials said in a state­ment Fri­day that they were aware of the study and were re­view­ing the find­ings. But of­fi­cials noted that there are mul­ti­ple bar­ri­ers to reg­u­lat­ing the in­dus­try, in­clud­ing man­u­fac­tur­ers and dis­trib­u­tors that ac­tively try to evade en­force­ment.

Once a sup­ple­ment is found to con­tain an un­ap­proved sub­stance, the FDA fo­cuses on in­form­ing the pub­lic about po­ten­tial health risks and re­mov­ing the prod­uct from the mar­ket “as soon as pos­si­ble,” ac­cord­ing to the state­ment.

More than half of Amer­i­cans take sup­ple­ments, which in­clude ev­ery­thing from vi­ta­mins and min­er­als like iron, to herbal or other so-called nat­u­ral reme­dies. Sup­ple­ments are reg­u­lated as a food, not as a drug, which means the FDA has no author­ity to test the ef­fi­cacy or safety of the prod­ucts be­fore they’re sold to con­sumers.

The risk to peo­ple who use sup­ple­ments isn’t en­tirely clear. Man­u­fac­tur­ers are sup­posed to re­port any com­pli­ca­tions — in­clud­ing side ef­fects re­sult­ing in hos­pi­tal­iza­tion or death — caused by their prod­ucts, but it’s un­likely that ev­ery ad­verse event is recorded. One study es­ti­mated that sup­ple­ments cause as many as 23,000 emer­gency room vis­its a year.

Daniel Fabri­cant, pres­i­dent of the in­dus­try group Nat­u­ral Prod­ucts As­so­ci­a­tion, said the large ma­jor­ity of prod­ucts found to be con­tam­i­nated in the new anal­y­sis are not rep­re­sen­ta­tive of the sup­ple­ment mar­ket. And he sup­ports the FDA tak­ing ag­gres­sive ac­tions against pro­duc­ers of drug­tainted prod­ucts: “The FDA has the ax. They should swing it,” he said.

“These (pro­duc­ers) are not peo­ple who are part of the rep­utable (sup­ple­ment) in­dus­try,” Fabri­cant said. “These come from dark cor­ners of the in­ter­net. They’re not what you get at your health food store.”

The pa­per iden­ti­fied 776 sup­ple­ments listed in the FDA data­base of con­tam­i­nated prod­ucts from 2007 through 2016. The data­base is not a com­plete list of all adul­ter­ated prod­ucts that may be on the mar­ket — it in­cludes only sup­ple­ments that were tested by the FDA. Nearly 75 per­cent of the sup­ple­ments were sold on­line or through in­ter­na­tional mail or­ders.

Among the in­gre­di­ents found in con­tam­i­nated prod­ucts were ephedrine, a stim­u­lant once pop­u­lar for weight loss that was banned by the FDA in 2004 af­ter thou­sands of ad­verse events were re­ported, mostly re­lated to heart prob­lems. Sev­eral other in­gre­di­ents found in weight-loss sup­ple­ments had been de­nied FDA ap­proval over safety con­cerns.

The most com­mon un­ap­proved sub­stance was silde­nafil, the ac­tive in­gre­di­ent in Vi­a­gra, which is used to treat erec­tile dys­func­tion. More than 80 per­cent of the 353 con­tam­i­nated sex­ual en­hance­ment sup­ple­ments the study looked at in­cluded silde­nafil.

Nearly 90 per­cent of the tainted sup­ple­ments for body build­ing con­tained steroids or steroid-like in­gre­di­ents.

When the phar­ma­ceu­ti­cal drugs used in these prod­ucts are prop­erly pre­scribed, they come with la­bels to warn con­sumers about pos­si­ble side ef­fects or drug in­ter­ac­tions. Silde­nafil, for ex­am­ple, can in­ter­fere with drugs to treat di­a­betes, high blood pres­sure or high choles­terol. But if con­sumers don’t know the drug is in a sup­ple­ment that they think is safe, they won’t know to take proper pre­cau­tions.

In gen­eral, con­sumers should be wary of us­ing prod­ucts in the three main cat­e­gories cited by the study — sex­ual en­hance­ment, mus­cle build­ing and weight loss — but prob­lems in man­u­fac­tur­ing can oc­cur across the in­dus­try, said Cathi Den­nehy, a health sci­ences clin­i­cal pro­fes­sor at the UCSF School of Phar­macy who has stud­ied sup­ple­ments for two decades.

She be­lieves some sup­ple­ments can be health­ful. “I worry about throw­ing the baby out with the bath­wa­ter” and dis­miss­ing all sup­ple­ments based on an anal­y­sis of those con­tain­ing un­ap­proved in­gre­di­ents, she said. But it’s of­ten up to con­sumers to de­ter­mine whether some­thing is safe — or at least likely so.

They can start by look­ing at the FDA data­base, though that can be dif­fi­cult to sort through. The web­site Con­ tests and rec­om­mends sup­ple­ments and other prod­ucts. Sup­ple­ments with the NSF — for Na­tional San­i­ta­tion Foun­da­tion — stamp on their la­bel are prob­a­bly safe bets, said Ray­mond Palko, a reg­is­tered di­eti­tian with Stan­ford Health Care.

“This study shouldn’t make ev­ery­body empty out ev­ery sup­ple­ment they have in their cab­i­net and never step foot in the sup­ple­ment aisle of the again,” Palko said. “But it should make them have a mo­ment of re­flec­tion about what they get out of their sup­ple­ment and where they get it.”

Fabri­cant had one other tip for con­sumers: “Does it sound too good to be true? It prob­a­bly is.”

“If the com­pany is say­ing it works like Vi­a­gra or you’re go­ing to gain mus­cle like you’re on steroids — that’s not a sup­ple­ment. That’s a drug,” Fabri­cant said. “Di­etary sup­ple­ments are meant to main­tain health, not to take 30 min­utes be­fore sex.”

“This study ... should make them have a mo­ment of re­flec­tion about what they get out of their sup­ple­ment and where they get it.” Ray­mond Palko, reg­is­tered di­eti­tian, Stan­ford Health Care

Nina Der­mawan / Mo­ment Ed­i­to­rial / Getty Im­ages

Nearly 800 di­etary sup­ple­ments sold in the U.S. were found to be con­tam­i­nated with un­ap­proved in­gre­di­ents, in­clud­ing banned drugs, in a study by Cal­i­for­nia pub­lic health sci­en­tists.


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