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Dietary Supplement Companies Guilty in Marketing Unapproved Drugs

Two supplement manufacturers registered in California and Nevada have pled guilty to introducing unapproved drugs.

Two supplement manufacturing corporations registered in California and Nevada have pled guilty in federal court to introducing into commerce unapproved drugs with the intent to mislead and defraud the public. The guilty pleas were entered on behalf of Kevin Smith, the president of Anabolic Resources, before U.S. District Judge D. Lowell Jensen. The prosecution in this landmark case was the result of an exhaustive inquiry led by the FDA’s Office of Criminal Investigations.

Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the dietary supplement and we can help.

What’s the problem?

November 9, 2011 – In pleading guilty to the charges, Anabolic Resources admitted that, beginning in 2005, the company knowingly manufactured and marketed the so-called dietary supplement Anabolic Resources Superdrol, which contained an ingredient that was not approved by the FDA.

Specifically, Anabolic Resources Superdrol was found to contain a purported dietary supplement whose main active ingredient was the synthetic steroid methasteron (chemical name 17 β-Hydroxy-2α, 17α-dimethyl-5α-androstane-3-one). The manufacturer knowingly labeled the drug as a dietary supplement with the intention to deceive consumers and the authorities, when in fact the active ingredient was an anabolic steroid that had not been approved by the FDA.

The other company involved, Nutrition Distribution, admitted that it knowingly manufactured and marketed two purported dietary supplements known as Anabolic Xtreme Hyperdrol and Anabolic Xtreme Slim Xtreme. Both of these products were found to contain active ingredients that have not been approved by the FDA.

According to court records, the company knowingly manufactured and marketed Anabolic Extreme Hyperdrol as a dietary supplement, when in fact the main active ingredient was a synthetic drug known as 6-Bromodione. Additionally, multiple lots of the drug contained the scheduled anabolic steroid androstenedione. FDA regulations state that Anabolic Xtreme Hyperdrol could not legally be defined as a dietary supplement because its active ingredient was a synthetic drug, and in certain lots contained a scheduled anabolic steroid.

Furthermore, Nutrition Distribution knowingly manufactured and marketed Anabolic Xtreme Slim Xtreme as a dietary supplement, when in actuality its main active ingredient was a synthetic designer stimulant known as 2-diphenylmethyl pyrrolidine. This drug could not be classified as a dietary supplement since its main ingredient was an unapproved drug.

Although Anabolic Resources and Nutrition Distribution were separate entities, they were run by the same principals and each used the dba Anabolic Xtreme in its own capacity.

The plea agreements include:

  • Anabolic Resources pleaded guilty to violating 21 U.S.C. §§ 331(d) and 333(a)(2), a felony, and was ordered to pay a fine of $500,000 (the maximum fine allowed by law).
  • Nutrition Distribution pleaded guilty to violating 21 U.S.C. §§ 331(d) and 333(a)(2), a felony, and was sentenced to a forfeiture of $100,000.
  • Anabolic Resources and Nutrition Distribution must monitor and test, at its own expense, all products distributed by the companies for the next five years. The testing must be conducted by an independent organization agreed upon by the parties.
  • Anabolic Resources and Nutrition Distribution may not manufacture or market any products until the monitoring and testing results have been received by the FDA.
  • Anabolic Resources and Nutrition Distribution must destroy all remaining Superdrol, Hyperdrol, and Slim Xtreme products still in existence. The destruction of these products must be certified, and the certificate must be received by the government within one month of said action.

Do You Have a Dietary Supplement Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dietary supplement lawsuits. We are handling individual litigation nationwide and currently accepting new dietary supplement injury cases in all 50 states.

Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a dietary supplement suit and we can help.

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