Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
September 8, 2011
United States Attorney
District of New Colorado
John F. Walsh
DENVER - Axis Labs, LLC, a company based in Centennial, Colorado, has been charged by Information with one count of mail fraud in connection to 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. An attorney and a representative of Axis Labs appeared in U.S. District Court in Denver yesterday to be advised of the charges pending against the company.
According to the Information, 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 United States Code. Moreover, they were also new drugs and lacked the approved New Drug Application also required by United States Code.
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.
"It is critically important that consumers know the contents of what they are consuming," said U.S. Attorney John Walsh. "In this case, the product contained synthetic anabolic steroids, and because of its potential for harm, it was a prescription drug that could only be dispensed pursuant to a valid prescription. Thus, the defendant's distribution of this product put consumers' health at risk."
"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."
Axis Labs, LLC faces a fine of up to $500,000.
This case was investigated by Food and Drug Administration – Office of Criminal Investigations.
This case is being prosecuted by Assistant U.S. Attorneys Jaime Pena and Tonya Andrews.
The charges contained in the Information are allegations, and the defendant is presumed innocent unless and until found guilty.