January 19, 2012
DENVER – Axis Labs, LLC, a company based in Centennial, Colorado, was sentenced yesterday by Chief U.S. District Court Judge Wiley Y. Daniel to serve one year probation and pay $107,000 to the U.S. Asset Forfeiture Fund as well as pay a fine of $50,000 in connection with the illegal distribution of product containing synthetic anabolic steroids.
On September 7, 2011 Axis Labs was charged by Information with mail fraud. On October 13, 2011 the company pled guilty to mail fraud. They were sentenced yesterday, January 18, 2012.
According to court documents, Axis Labs was involved in the illegal distribution of a product called “Monster Caps” which contained synthetic anabolic steroids, United States Attorney John Walsh and FDA Office of Criminal Investigations Special Agent in Charge Patrick Holland announced.
Axis Labs engaged in the business of manufacturing, labeling, shipping and selling certain food products. The business was active in and responsible for the distribution and marketing of a product called “Monster Caps.” The intended use of the product was to enable weight loss and the production of muscle mass. The product falsely purported pursuant to its label to be a “dietary supplement” and therefore could be distributed and dispensed without prior approval from the FDA and without a prescription from a duly authorized physician.
“Monster Caps” contained anabolic steroids, or similar synthetic compounds. Because Axis Labs intended these products to affect the structure and function of the human body, they were actually drugs regulated by law. Moreover, they were also new drugs and lacked the approved New Drug Application as required by law.
Between June 2008 and May 2009, Axis Labs sold “Monster Caps” on the internet, to customers throughout the United States without the required FDA approval for a new drug and without requiring a prescription. The company distributed the product by delivering it, or causing it to be delivered to customers via the United States Mail, or UPS.
“Consumers need to have confidence that products claiming to be ‘dietary supplements’ are not, in fact, unapproved new drugs,” said Patrick J. Holland, Special Agent in Charge of the FDA Office of Criminal Investigations. “We will aggressively investigate those who place profits over public health by marketing purported dietary supplements that contain drug substances such as synthetic anabolic steroids.”
This case was investigated by Food and Drug Administration – Office of Criminal Investigations.
This case was prosecuted by Assistant U.S. Attorneys Jaime Pena and Tonya Andrews.