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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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November 15, 2012: Supplement Manufacturer Pleads Guilty to Selling Product Containing Unapproved Drug

 

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Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release

 

 

For Immediate Release
November 15, 2012

www.usdoj.gov/usao/can

 

 

United States Attorney

Northern District of California

Contact: Jack Gillund

(415) 436-6599

Jack.Gillund@usdoj.gov

 

Myogenix Corp. Admits Selling “Spawn” Knowing it Contained the Synthetic Steroid Estradienedione

 

            SAN JOSE - 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 US 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.

 

            Specifically, Myogenix knowingly caused to be manufactured and distributed in interstate commerce “Spawn,” a purported dietary supplement whose 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 Food and Drug Administration, 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 Food and Drug Administration.

 

            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 FDA which are authorized by statute or regulations.

 

            Matt Parrella and Jeff Nedrow are the Assistant U.S. Attorneys who are prosecuting 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.

 

Further Information:

            Case #: CR-12-00758 DLJ

                                               

            A copy of this press release may be found on the U.S. Attorney's Office's Web site at www.usdoj.gov/usao/can. 

 

            Electronic court filings and further procedural and docket information are available at https://ecf.cand.uscourts.gov/cgi-bin/login.pl.

 

            Judges' calendars with schedules for upcoming court hearings can be viewed on the court's Web site at www.cand.uscourts.gov. 

 

            All press inquiries to the U.S. Attorney's Office should be directed to Jack Gillund at (415) 436-6599 or by email at Jack.Gillund@usdoj.gov.