“This process has forced our hand on some valuable lessons that mark the new standards that Anabolic Xtreme believes and operates in, a set of standards that we hope will become commonplace throughout the nutritional supplement industry.”
Tempe, AZ (PRWEB) November 09, 2011
Today in Federal Court, Nutrition Distribution, doing business as Anabolic Xtreme, pleaded guilty to a number of charges related to the since discontinued products, Hyperdrol X2 and Slim Xtreme.
This plea agreement is the result of Anabolic Xtreme’s full cooperation with a FDA investigation into two former products that was initiated in August 2009. By entering into this plea agreement (United States District Court, Northern District of California, CR11-00790-DLJ) Anabolic Xtreme admits and accepts responsibility for the company’s actions. The process has also been a tremendous learning experience and will have a positive impact on the Anabolic Xtreme brand and products going forward.
In the plea agreement, Anabolic Xtreme admitted to knowingly distributing the ingredients, "6-Bromodione", and "2-diphenylmethyl pyrrolidine" (Phenyl-pyrrolidinyltoluene), which fail to meet the guidelines of a New Dietary Ingredient as outlined in the Dietary Supplement Health Education Act of 1994 (DSHEA). Any new ingredient that fails to meet the guidelines for DSHEA and without an approved NDI is categorized as an unapproved new drug.
At the time that Anabolic Xtreme included the ingredient, "6-Bromodione" in the product Hyperdrol X2, it was already being widely used as an ingredient in other supplement products marketed by a variety of supplement companies and was widely sold in vitamin stores across North America. The investigation into this ingredient and subsequent testing of the product, (United States District Court, Northern District of California, CR11-00790-DLJ) also uncovered trace amounts of a scheduled anabolic steroid (androsteinedione), which Anabolic Xtreme believes was introduced to the product by the degradation of "6-Bromodione" " as a likely result of sub-par manufacturing processes and was not detected by the company due to lack of extensive post-production testing.
Additionally, Anabolic Xtreme utilized the ingredient "2-diphenylmethyl pyrrolidine" and vaguely labeled this ingredient as a "Proline Analog." According to Anabolic Xtreme, this was in an attempt to protect what was believed to be a competitive advantage of a novel ingredient against other supplement companies, in an industry where it is difficult to protect one’s discoveries and work.
During the investigation process, Anabolic Xtreme was strongly advised by their legal counsel not to talk about the circumstances; an unfortunate result of this was that the company was then left open to public scrutiny and misleading speculation regarding the ingredient in question. This quickly led to unsubstantiated claims and rumors about the company’s products and left Anabolic Xtreme without the recourse to explain the factual circumstances. The company never knowingly put any controlled substances in any products.
The company states “This process has forced our hand on some valuable lessons that mark the new standards that we believe and operate in, a set of standards that we hope will become commonplace in the nutritional supplement industry.”
As a result of lessons learned through this situation, Anabolic Xtreme has instituted, and will continue to incorporate the following corrective actions in the future:
1: Anabolic Xtreme is fully committed to support DSHEA regulations and will subject every novel ingredient to the costly, yet important process, of verification with a reputable regulatory compliance team, even if that ingredient is being used by other supplement companies.
2: Anabolic Xtreme has been working with the Banned Substance Control Group (BSCG) for over two years. BSCG is commissioned to test every batch of every AX product for banned substances before it ships to retail locations.
3: Anabolic Xtreme is committed to complete labeling transparency for each and every product. The company believes that its future competitiveness will be achieved through a combination of introducing new safe, effective, and innovative products that adhere to a new set of principles that will instill trust in Anabolic Xtreme’s products and brand.
The company further states “We regret and accept full responsibility for our actions. The best lessons are sometimes the hardest, yet we are excited to move forward in the industry armed with realigned values and principles that we hope will instill trust in our customers and create leadership in the industry.
About Anabolic Xtreme:
Anabolic Xtreme, a leading sports supplement company based out of Tempe, Arizona, develops, manufactures, and distributes nutritional supplements in the United State and internationally.