• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

November 9, 2011: Supplement Manufacturers Plead Guilty to Selling Products Containing Unapproved Drugs

 

OCI Small Clear Seal 

 


 

 

 

Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release

 

 

For Immediate Release
November 9, 2011

United States Attorney

Northern District of California

Contact: Jack Gillund

(415) 436-6599

Jack.Gillund@usdoj.gov

 

Anabolic Resources, Inc. Admits Selling Supplements Containing Methasteron (Superdrol)

 

Nutrition Distribution, Inc. Admits Selling Supplements Containing 6-Bromodione (Hyperdrol) and 2-diphenylmethyl pyrrolidine (Slim Xtreme) 2

 

            SAN JOSE - Anabolic Resources, Inc., doing business as Anabolic Xtreme (hereafter “Anabolic Resources”), 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 MELINDA HAAG announced.  The guilty plea was entered on behalf of the corporate defendant by Kevin Smith, the president of Anabolic Resources, before US District Judge D. Lowell Jensen.

 

            At the same court appearance, Nutrition Distribution, Inc., which also did business as Anabolic Xtreme (hereafter “Nutrition Distribution”), pleaded guilty before US District Judge D. Lowell Jensen 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.  That guilty plea was also entered on behalf of the corporate defendant by Kevin Smith, who is also the president of Nutrition Distribution.

 

            Although Anabolic Resources and Nutrition Distribution were separate corporations, they were owned and operated by the same principals and each used the dba “Anabolic Xtreme” at different times.

 

Anabolic Resources: 

 

            In pleading guilty, Anabolic resources admitted that, beginning in approximately April of 2005 and continuing through January of 2006, Anabolic Resources knowingly caused to be manufactured and distributed in interstate commerce, the purported dietary supplement, “Anabolic Resources Superdrol,” which contained a drug that was not approved by the Food and Drug Administration.

 

            Specifically, Anabolic Resources knowingly caused to be manufactured and distributed in interstate commerce “Anabolic Resources Superdrol,” a purported dietary supplement whose main active ingredient was the synthetic steroid “methasteron,” also known by the chemical name “17 β-Hydroxy-2α, 17α-dimethyl-5α-androstane-3-one.” Anabolic Resources knowingly labeled “Anabolic Resources Superdrol” 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 “Anabolic Resources Superdrol” could not be defined as a dietary supplement because the active ingredient in the product was a synthetic steroid. Superdrol was actually a drug not approved by the Food and Drug Administration.

 

Nutrition Distribution:

 

            In pleading guilty, Nutrition Distribution admitted that, beginning in approximately February of 2007, and continuing through August of 2009, Nutrition Distribution knowingly caused two purported dietary supplements to be manufactured and distributed in interstate commerce: “Anabolic Xtreme Hyperdrol,” and “Anabolic Xtreme Slim Xtreme,” both of which contained drugs that were not approved by the Food and Drug Administration.

 

            Specifically, Nutrition Distribution knowingly caused “Anabolic Xtreme Hyperdrol,” a purported dietary supplement whose main active ingredient was the synthetic drug, “6-Bromodione” to be manufactured and distributed in interstate commerce.  Furthermore, multiple lots of “Anabolic Xtreme Hyperdrol” contained the scheduled anabolic steroid androstenedione. Nutrition Distribution knowingly labeled “Anabolic Xtreme Hyperdrol” 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 “Anabolic Xtreme Hyperdrol” could not be defined as a dietary supplement, as the active ingredient in the product was a synthetic drug, and in some lots, contained a scheduled anabolic steroid.

 

            In addition, Nutrition Distribution knowingly caused “Anabolic Xtreme Slim Xtreme,” a purported dietary supplement whose main ingredient was the synthetic designer stimulant, 2-diphenylmethyl pyrrolidine, to be manufactured and distributed in interstate commerce. “Anabolic Xtreme Slim Xtreme” also could not be defined as a dietary supplement, as the active ingredient in the product was a drug.

 

The Plea Agreements:

 

            Anabolic Resources 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.  Anabolic Resources was sentenced to a fine of $500,000, the maximum fine allowable under the statute.

 

            Nutrition Distribution 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.  Nutrition Distribution was sentenced to a forfeiture of $100,000, which the defendant paid immediately.

 

            The plea agreements require that Anabolic Resources, Nutrition Distribution, and any other continuing entities involved in the manufacture and distribution of dietary and nutritional supplements operated or controlled by Anabolic Resources or Nutrition Distribution, 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 Anabolic Resources, Nutrition Distribution and any other continuing entities operated or controlled by Anabolic Resources or Nutrition Distribution 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 Anabolic Resources and Nutrition Distribution destroy, at its own expense, any remaining “Superdrol,” “Hyperdrol,” and “Slim 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.

 

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

 

 

Further Information:

 

            Case #: CR-11-00790-DLJ (Nutrition Distribution)

                         CR-11-00791-DLJ (Anabolic Resources)

                                               

            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.