Unregulated supplements are a tragedy in waiting

The latest supplement toxic alert thankfully involves only two young soldiers who died suddenly, both reported to have the unregulated amphetamine-like dimethylamylamine, DMAA, aka “Jack3d” and “OxyelitePro,” as the suspected death-dealing toxicant.

Who knows how many other unexplained deaths and near-deaths can be attributed to the vast experiment foisted upon an unwary American populace by such drugs — I mean, “supplements”?

Thanks to 1994′s Hatch Act, the Dietary Supplement Health and Education Act (DSHEA), pushed through Congress and released upon a then-unprotesting public by Utah’s Sen. Orrin Hatch (R-UT), substances which may be benign, toxic, and everything in between, as long as they are sold as “dietary nutritional supplements,” get a virtual free pass.

The supplement manufacturer can make “structure-function” claims, such as “supports sexual health,” but not health claims. Such assertions must clarify that the substance is not FDA approved “to diagnose, treat, cure or prevent any disease.”

Part of the law mandates that ingredients brought to market after 1994, so-called “novel” ingredients — and only those — be shown to have passed safety tests.

Older ingredients got “grandfathered” in without the need to be proven either safe or effective.

How is that working out? There have been approximately 51,000 new ingredients brought to market since DSHEA passed, of which about 0.3% — that’s not a misprint, 170 out of 51,000 — have documented safety tests.

Who cares? “Why worry?,” perhaps under the delusion that some substance termed “natural” must be safe, seems to be the governing mantra of the American consumer on this subject, since about 100 million of us spend, at last tally, over $28 billion per year on these products — vitamins, minerals, potions, herbals, biologicals, who-knows-what.

If a shopper has a question about the efficacy or danger of a supplement, they may simply ask the health-food store employee.

Obviously, trusting a sales clerk to be expert is pure foolishness.

We Americans, so concerned about minute amounts of this or that chemical in our food and water, and ready to challenge our board-certified internist on treatment decisions, gobble down supplements with alarming obliviousness to their potential dangers and denial of the overwhelming absence of evidence of benefit.

A “Perspective” article in a recent New England Journal of Medicine by Dr. Pieter Cohen called for a tightening — no, not even that, merely actually enforcing the law as written — by having the FDA demand that, instead of pleading with, the supplement manufacturers supply the agency with at least the legal minimum of data on their products’ safety.

Some have responded with protests over “Big Government” intervention.

One of these days some supplement, contaminated or virginal, will kill a bunch of naive customers, and cries will ring out over their lax regulation.

Responsible public health authorities should effect long overdue legal and regulatory control over this millions-strong, uncontrolled experiment before such a tragedy forces their hands.

George Lundberg is a MedPage Today Editor-at-Large and former editor of the Journal of the American Medical Association. Gilbert Ross is the Executive Director and Medical Director of the American Council on Science and Health.

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  • http://www.facebook.com/youDunno D’Anne Graham

    Please tell me y’all have never heard of Tambocor, because if you have and you still wrote this, then you are a couple of hypocritical a***oles–and there far too many of those in medicine.

  • http://www.facebook.com/JEHealthCareSolutions Andy Edley

    Who is going to regulate it?  The FDA which lets the big drug companies put out drugs with very little or even faked results.  When the FDA is no longer run by the big drug companies and is a true natural protection agency then I say find.  Until then we as consumers we have no one looking out for us.  I feel before anything is put on the market it should have several trails all done by independent groups that get no money from the company that is making the drug or supplement.  Doctors need to accept the fact that natural products that have been used for years and years deserve to be looked at in a un-basis way and not just dismissed because they are not made by some big Drug company.  Right now We as health consumers don’t have anyone we can trust.

    • Anonymous

       I think someone has been watching to many Kevin Trudeau infomercials.  Just because a product has been used for years and is “natural” does not mean it is safe and effective.  Oh, I know the Big Drug Companies are only in it for the money, they don’t care who they kill or injure.   But, the health food supplement makers are philanthropic, and are only in business to help people.

  • http://twitter.com/livewellthy Stewart Segal

    I have written multiple articles regarding this subject and am glad to see Dr Lundberg speak out about the unknown risks of taking supplements.  Labeling a pill as “natural” is just wrong!  Supplements are manufactured and are, in fact, taken on medicine by those who fall prey to the manufacturer’s marketing department.

  • Rick Howell

    Taken in the recommended doses these supplements can be considered safe.  The doses consumed in the unfortunate deaths of the soldiers where reportedly “extremely high”.  Any supplement can really be considered dangerous when taken at “extremely high” doses.  Should we also regulate coffee consumption?

  • Anonymous

    Let’s see, it was about 90 days ago that 30+ people died
    from eating contaminated cantaloupe. People who take a “supplement”
    because it promises “jacked up” performance also think that Red Bull
    is to let you take in more alcohol before passing out, and  that Ecstasy
    is just a “recreational” drug. Maybe they should take a drug which is
    “proven safe and effective” like children’s acetaminophen, which according to
    the CDC kills 35o-400 children a year, causes 700+ liver transplants, and over
    2,000 hospitalizations when taken as directed.  The biggest dangers of supplements are those
    which contain hidden drugs, which makes them an unapproved drug, not a
    supplement. Supplements are attacked because people try to peddle dangerous
    drugs and quasi-legal combinations off as supplements, but they are counterfeit
    supplements. By every measure including death, drugs and foods are more
    dangerous than supplements. Save your outrage for the stupidity of people who
    think that “Jack3d” performance is benign.

    • Anonymous

      Unfortunately young people can buy this crap and it puts them at risk.

  • Anonymous

    I’m waiting for some pre-teens to overdose on these
    super caffeinated drinks. This is a disaster waiting to happen.

  • Anonymous

    You know, I wouldn’t think it would be good for KevinMD to allow postings like this bilge, without disclosing the fact that the so-called American Council on Science & Health” is an outfit that will slay your adversary with authoritative sounding words, as long as you come up with enough cash.

    Some of the ACSH’s “donors”
    ALCOA FoundationAllied Signals Foundation, Inc.American Cyanamid CompanyAmerican Meat InstituteAmoco Foundation, Inc.Anheuser-Busch FoundationArcher Daniels Midland CompanyAshland Oil FoundationBoise Cascade CorporationBristol-Myers Fund, Inc.Burger King CorporationCampbell Soup CompanyCarnation CompanyChevron Environmental Health CenterCiba-Geigy CorporationCoca-Cola CompanyConsolidated EdisonCooper Industries FoundationAdolph Coors FoundationCrystal TrustShelby Cullum Davis FoundationDow Chemical Canada, Inc.Dow Corning CorporationE.I. Du Pont de Nemours & CompanyEthyl CorporationExxon CorporationFMC FoundationFord Motor Company FundFrito-LayGeneral Electric FoundationGeneral Mills, Inc.General Motors FoundationGerber Products CompanyRollin M. Gerstacker FoundationHershey Foods Corporation FundHeublein, Inc.ICI Americas Inc.Johnson & JohnsonJohnson’s Wax Fund, Inc.Kellogg CompanyEster A. and Joseph Klingenstein Fund, Inc.David H. Koch Charitable FoundationKraft FoundationKraft General Foods (now part of Altria Group)Licensed Beverage Information CouncilThomas J. Lipton Foundation, Inc.M&M MarsMerck Company FoundationMobil Foundation, Inc.Monsanto FundNational Agricultural Chemicals AssociationNational Dairy CouncilNational Soft Drink AssociationNational Starch and Chemical FoundationNestléSamuel Roberts Nobel Foundation, Inc.Northwood InstituteNutraSweet CompanyJohn M. Olin Foundation Inc.Oscar Mayer FoodsPepsico Foundation Inc. (Pepsi-Cola)Pfizer Inc.Pillsbury CompanyPPG Industries FoundationProcter & Gamble FundRalston PurinaRohm & Haas CompanySalt InstituteSarah Scaife Foundation, Inc.Schultz FoundationG.D. Searle Charitable TrustJoseph E. Seagrams & Sons, Inc.Shell Oil Company FoundationStare FundStarr FoundationSterling Drug, Inc.Stouffer CompanyStroh Brewery CompanySugar Association, Inc.Sun Company, Inc.Syntex CorporationUnion Carbide CorporationUniroyal Chemical Co.USX Corp.Warner-Lambert FoundationWine Growers of California

  • Anonymous

    A friend of mine took a supplement that contained peanuts. They nearly died (others have).

    This hazardous legume (which contaminates so many products) should either be outlawed immediately or all peanut butter companies should be forced to submit safety data on what would happen if your diet was to consist solely of peanuts.