Guilty Plea a Case for Certification

Last month, VMG Global, Inc. ( dba American Cellular), manufacturer of Tren Xtreme and Mass Xtreme, pleaded guilty to selling steroids masquerading as supplements. The Plea Agreement makes for some interesting reading.
To start with,

  1. the defendant agreed to plead guilty of the introduction and delivery for introduction of unapproved new drugs with intent to defraud and mislead. (maximum fine $500,000, maximum supervised release term 3 years)
  2. the defendant agreed that it is guilty of having caused to be manufactured and distributed two purported dietary supplements both of which contained anabolic steroids.

The plea then went on to reaffirm that the product did not meet the definition of a supplement. With the two products in question, the company received approximately $5.6 million in revenue over some 4 and a half years.

In addition to waiving venue and rights to trial and appeal the defendant, “VMG Global, including American Cellular Laboratories and any other continuing entities involved in the manufacture and distribution of dietary and nutritional supplements operated or controlled by Andreas Sommer, agrees to monitor and test all products distributed by those companies for a period of five years.”

The document continues to describe that monitoring and testing should include sampling and analysis, at defendant’s expense, of each and every lot by NSF International (or another independent testing organization agreed upon by the parties) involved in the testing and certification of food, water, dietary supplements, and other consumer goods.

In closing this particular section of the document, the defendant is asked to instruct the lab to submit test results to the FDA office, waiting for results before entering into commerce.

I’m more than a little intrigued by the inclusion of third party testing and certification in this agreement. I’m even more interested in the direct mention of NSF International, although the agreement does allow for other ‘equivalent’ testing. For the court to recognize the benefit of appropriate third party certification and its application to this type of problem I think is noteworthy. This type of court-ordered action should heighten the profile of the certifiers, reinforce the credibility of the programs with the vocal elite sports community as represented by USADA and others, and provide appropriate assurance that those charged in this type of case have future control placed on their operations.
We’ll see whether this is a bell-weather for future court decisions. Stay tuned.

Ironically, the website has a special section denoting military discounts

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