January 21, 2010

SUPPLEMENT MANUFACTURER PLEADS GUILTY TO SELLING PRODUCTS CONTAINING ANABOLIC STEROIDS

VMG Global, Inc. Admits Selling Spiked Supplements Containing “Tren,”or "4-estra," and "Madol," or "DMT."

SAN JOSE - VMG Global, Inc., doing business as American Cellular Labs (hereafter “VMG Global”), a corporation registered in California and Nevada, pleaded guilty today in federal court in San Jose to the introduction and delivery for introduction of unapproved new drugs into interstate commerce with intent to defraud and mislead, United States Attorney JOSEPH P. RUSSONIELLO announced. The guilty plea was entered on behalf of the corporate defendant by Andreas Sommer, the President and CEO of VMG Global after the charging documents were unsealed by US District Judge Jeremy Fogel.

VMG Global pleaded guilty pursuant to a plea agreement with the government to violating 21 U.S.C. §§ 331(d) and 333(a)(2), a felony, and was sentenced immediately after the entry of the guilty plea. VMG Global was sentenced to a fine of $500,000, the maximum fine allowable under the statute.

The plea agreement also requires that 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, monitor and test, at its own expense, all products distributed by those companies for a period of five years. The testing must be done by an independent testing organization agreed upon by the parties.

The plea agreement also requires that VMG Global, American Cellular Laboratories and any other continuing entities operated or controlled by Andreas Sommer not introduce into interstate commerce any products unless and until the monitoring and testing results of that specific lot of product has been received by the FDA from the independent third party testing organization. This monitoring and testing is also separate from, and in addition to, any inspections, sampling, testing or other regulatory actions by FDA which are authorized by statute or regulations.

The plea agreement further requires that VMG Global destroy, at its own expense, any remaining “Tren Xtreme,” and “Mass Xtreme” product that was not seized by the government previously. The defendant further agreed to provide certification of such destruction to the government within 30 days of said action.

In pleading guilty, VMG Global admitted that, beginning in approximately January of 2005, and continuing through July of 2009, VMG Global, and its related corporation, American Cellular Labs, knowingly caused to be manufactured and distributed in interstate commerce two purported dietary supplements, identified respectively as, "Tren Xtreme," and "Mass Xtreme," each of which contained new synthetic compounds presently classified as anabolic steroids pursuant to the final rule contained in 21 CFR Part 1300. These products were actually drugs that were not approved by the Food and Drug Administration.

Specifically, VMG Global knowingly caused to be manufactured and distributed in interstate commerce the American Cellular Labs product, "Tren Xtreme," a purported dietary supplement whose main active ingredient is the anabolic steroid "Tren," or "4-estra," which is also known by the chemical names: 19-Nor-4,9(10)-androstadienedion; 4,9(10)-estradiene-3,17-dione; 19-Norandrosta 4,9(10)-diene-3,17-dione; 19-Norandrosta 4,9-diene-3,17-dione; and Estra-4,9(10)-diene-3,17-dione. The American Cellular Labs product, "Tren Xtreme," was knowingly and intentionally labeled in a manner that was meant to deceive consumers and the Food and Drug Administration, in that it was labeled as a dietary supplement, when in fact the active ingredient in the product was a synthetic anabolic steroid, and thus did not meet the legal definition of a dietary supplement. Since the product was also marketed for increasing muscle mass (among other things), and did not qualify as a dietary supplement, it was actually a drug.

Additionally, VMG Global knowingly caused to be manufactured and distributed in interstate commerce the American Cellular Labs product, "Mass Xtreme," a purported dietary supplement whose main active ingredient is the anabolic steroid "Madol" or "DMT," which is also known by the chemical names: desoxymethyltestosterone; 17a-methyl-5a-androst-2-en-17b-ol; and 17a-methyl-etioallocholan-2-ene-17b-ol. The American Cellular Labs product, "Mass Xtreme," was knowingly and intentionally labeled in a manner that was meant to deceive consumers and the Food and Drug Administration, in that it was labeled as a dietary supplement, when in fact the active ingredient in the product was a synthetic anabolic steroid, and thus did not meet the legal definition of a dietary supplement. Since the product was also marketed for increasing muscle mass (among other things), and did not qualify as a dietary supplement, it was actually a drug.

“Products such as Tren Xtreme and Mass Xtreme which are spiked with dangerous and illegal anabolic steroids are a threat to the public and provide an avenue for the distribution of illegal performance-enhancing drugs,” said United States Attorney JOSEPH P. RUSSONIELLO. “Companies and individuals that continue to engage in such unlawful conduct are on notice that when we discover such activity criminal investigations and prosecutions will be vigorously pursued.”

Matt Parrella and Jeff Nedrow are the Assistant U.S. Attorneys who are prosecuting the case with the assistance of Lauri Gomez. The prosecution is the result of an investigation by the Food and Drug Administration, Office of Criminal Investigations.

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