Supplement Manufacturer Pleads Guilty To Selling Product Containing Unapproved Drug
SAN JOSE, Calif. – Myogenix Corp. (Myogenix), a corporation registered in California, 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 Melinda Haag announced. The guilty plea was entered on behalf of the corporate defendant by Mark Newman, the director of operations for Myogenix, before U.S. District Judge D. Lowell Jensen.
In pleading guilty, Myogenix admitted that, beginning in approximately September of 2007 and continuing through July of 2009, Myogenix knowingly caused to be manufactured and distributed in interstate commerce, the purported dietary supplement, “Spawn,” which contained a drug that was not approved by the Food and Drug Administration (FDA). Spawn’s main active ingredient was the synthetic steroid Estradienedione/Estra/Tren, also known by the chemical name, 4,9(10)-estradiene-3, 17-dione, Myogenix knowingly labeled Spawn in a manner that was intended to deceive consumers and the FDA, in that it was labeled as a dietary supplement, when in fact Spawn was a synthetic steroid. Spawn was actually a drug not approved by the FDA.
Myogenix 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. Myogenix was sentenced to a fine of $50,000, and a criminal forfeiture of $100,000, which the defendant paid immediately.
The plea agreements require that Myogenix, and any other continuing entities involved in the manufacture and distribution of dietary and nutritional supplements operated or controlled by Myogenix or its principals, 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 agreements also require that Myogenix and any other continuing entities operated or controlled by Myogenix or its principals 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 the FDA that are authorized by statute or regulations.
Matt Parrella and Jeff Nedrow are the Assistant U.S. Attorneys who prosecuted the case with the assistance of Elise Etter. The prosecution is the result of an investigation by the Food and Drug Administration, Office of Criminal Investigations.