Terra Sigillata

It seems that bodybuilding supplement makers are challenging erectile dysfunction supplement makers to see who can recall the greatest number of products adulterated with undeclared, unapproved drugs.

In this case, an internet retailer of the following supplements has issued a voluntary recall of the following supplements sold between June 1, 2009 and November 17, 2009. The recall follows an FDA warning letter on detection of undeclared, synthetic anabolic steroids in these products:

  • Advanced Muscle Science Dienedrone, 60 caps
  • Advanced Muscle Science Liquidrone, 60 ml
  • Anabolic Formulation M1, 4AD, 60 caps
  • Anabolic Formulations 1, 4 AD, 60 caps
  • Anabolic Xtreme Hyperdrol X2
  • Anabolic Xtreme 3-AD, 90 caps
  • BCS Labs Testra-Flex, 90 caps
  • Competitive Edge Labs M-Drol, 90 Caps
  • Competitive Edge Labs P-Plex, 90 caps
  • Competitive Edge Labs X-Tren, 90 caps
  • 4Ever Fit D-Drol, 60 caps
  • Gaspari Novedex XT 60 Caps
  • Gaspari Halodrol Liquigels, 60 gels
  • iForce 1,4 AD BOLD 200, 60 Caps
  • iForce MethaDROL, 90 caps
  • iForce Dymethazine, 60 caps
  • Monster Caps, 60 caps


According to the FDA:

Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using one or more of the products.

Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-800-240-4767) or e-mail (returns@musclemaster.com) the Company.

Any adverse events that may be related to the use of the Recalled Products should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA- 0178].

Why should consumers be concerned?:

FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” While MuscleMaster.com cannot independently confirm the FDA’s concerns, that any one or more of the Recalled Products in fact contain these ingredients, MuscleMaster.com is undertaking this voluntary recall out of an abundance of caution and in deference to FDA’s stated concerns.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

As of this morning, the MuscleMaster.com website was no longer live.

As mentioned earlier, MuscleMaster supplements have not been linked to acute cases of adverse reactions, so the recall is voluntary under theoretical considerations. This was not the case for previous recalls of American Cellular Labs products (pulmonary embolism reports), Teston-6 (aggressive prostate cancer).

We’ve previously spoken more broadly on this issue of unapproved drug adulteration of dietary supplements. Adulteration with pharmacologically active substances may be responsible for anecdotal reports that supplements exhibit quantifiable physiological effects. In fact, my November post on Stiff Nights erectile dysfunction supplement, known to contain Viagra-like phosphodiesterase-5 (PDE5) inhibitors, continues to rank among our most-read posts and garners testimonials galore – five in the past month alone.

Contrary to my earlier criticism of the DHSEA legislation that I thought allowed these cases to happen, I’ve since become more aware that DSHEA did nothing permissive for these cases. Following a great on-blog discussion with some legal and regulatory experts, we’ve learned that FDA has already had the authority to step in on these cases long before the 1994 passage of DSHEA.

Commenters have disagreed as to whether FDA is being aggressive enough in nailing these companies with more severe actions than simple warning letters. Given the steady stream of these warnings and “voluntary” recalls, it seems that the current level of FDA action is not perceived by companies as a sufficient deterrent.

Comments

  1. #1 Marc Ullman
    January 19, 2010

    One significant difference between the current musclemaster.com recall and the earlier bodybuildong.com recall is that the products recalled by musclemaster include items from at least one large “sports supplement” manufacturer (as opposed to the fly by nights usually associated with this problem).

    The question that needs to be asked now is whether FDA is at this manufacturer’s facility and where is the recall from this manufacturer to its other suppliers? If no such recall is forthcoming, there’d better be a good explanation (like the recalled products were counterfeit).

  2. #2 Jeff
    January 19, 2010

    Given the steady stream of these warnings and “voluntary” recalls, it seems that the current level of FDA action is not perceived by companies as a sufficient deterrent.

    I agree. Under 1994′s DSHEA this kind of adulteration is a criminal offence – the FDA could take much stronger action. The continued lax enforcement by the FDA will probably result in more editorials calling for amending or repealing DSHEA. Many think this is exactly the response some FDA bureaucrats hope for. DSHEA was landmark legislation; I hate to see it sabotaged by weak enforcement, perhaps deliberately, by those in the FDA who have never believed in this law.

  3. #3 Jeff
    January 19, 2010

    On a more positive note the American Association of Poison Control Centers has just released their annual report for 2008. Legal dietary supplements continue to demonstrate how safe they are, especially when compared to pharmaceuticals:

    No Deaths from Vitamins, Minerals, Amino Acids or Herbs: Poison Control Statistics Prove Supplements’ Safety

  4. #4 Jeff
    January 24, 2010

    At least in one adulteration case the FDA followed through with a successful felony prosecution:

    Guilty Plea in Sale of Products With Steroids

    Here’s an article about lax FDA enforcement with comments by Marc Ullman:

    FDA fails to deter H1N1 fraud, claims New York legal expert

  5. #5 Katharine
    January 25, 2010

    “bodybuildong.com”

    An apt description of what these men are trying to compensate for.