The owner and employees of a Little Rock sports supplement retailer are personally facing federal felony charges and imprisonment related to the sale of two popular products sold at hundreds of supplement stores around the country that were found to contain illegal steroids. What does this mean for other supplement retailers under investigation, such as Bodybuilding.com who have sold similar products?
The United States Attorney’s Office for the Eastern District of Arkansas and the Food and Drug Administration and Office of Criminal Investigations (FDA-OCI) have indicted David Paglianite, owner of See More Results in Little Rock, and two employees, Matthew Christman and Thomas Jucha, for selling American Cellular Labs’ “Tren Xtreme” and “Mass Xtreme“. The active ingredients in Tren Xtreme and Mass Xtreme are commonly referred to as “Tren” and “Madol”, respectively.
The FDA issued warning letters and public health advisories for the active ingredients in ACL’s “Tren Xtreme” and “Mass Xtreme” in late July 2009 in conjunction with the raid on American Cellular Labs. See More Results allegedly continued to sell “Tren Xtreme” and “Mass Xtreme” after these FDA notices were published. Tren and Madol were later purchased in two separate undercover purchases by narcotics detectives on October 28, 2009 and November 10, 2009. Federal agents finally raided the store on November 24, 2009.
The indictment against the owner and employees of a small supplement retailer is surprising when compared to the government treatment of the manufacturers. The manufacturer of American Cellular Labs “Tren Xtreme” and “Mass Xtreme“ negotiated a nice plea agreement where they were able to pay a fine while keeping the principals of the company from personally facing felony charges and imprisonment. The owner of IForce Nutrition, another manufactuer producing similar illegal products, also avoided personally facing steroid charges when his company agreed to pay a fine.
It is increasingly clear that supplement manufacturers AND supplement retailers are both at risk of prosecution. It seems unusual that manufacturers are penalized with fines while retailers may face jail. Supplement retailers have often assumed that the manufacturers of products they sold would be the only ones facing legal risks. In fact, retailers have often stocked up on remaining inventory of steroid-containing supplements that were to be pulled from the market. This is particularly ill-advised given the increased regulatory oversight by the FDA.
What does this mean for owners and employees of other supplement retailers that have been the subject of government criminal investigations, such as Bodybuilding.com?
Bodybuilding.com also sold similar products containing “tren” and “madol” to federal agents in an undercover purchase that took place after the July 23, 2009 FDA public advisory on “tren” and “madol”. Agents ordered the following products on August 6, 2009 which allegedly contained either “tren” andor “madol”: iForce Nutrition’s “17a PheraFLEX”, Nutra Coastal’s “D-Stianozol”, Nutra Coastal’s “MD1T”, Nutra Coastal’s “Trena”, APS’ “Ultra Ripped Stack”. In addition, at least 26 products allegedly containing “tren” and/or “madol” were found to be “in stock” during a “simulated purchased” conducted by federal investigators on September 21, 2009.
The multi-million dollar question is what action will be taken against Bodybuilding.com? The similarities to the See More Results case suggest the government has not ruled out indictment of the principals. However, See More Results is a small retailer owned by an individual who filed bankruptcy last year. Bodybuilding.com is an online supplement retailer valued in excess of $100 million whose controlling owner is the publicly-trade media conglomerate Liberty Media Corporation.
Bodybuilding.com will be able to afford a better defense than an individual in the midst of bankruptcy proceeding. The most likely scenario is that the government will seek substantial forfeiture of revenues given the finances of Bodybuilding.com. Any government action against Bodybuilding.com would have chilling effects on the sports nutrition industry.
In July 2009, MESO-Rx published several predictions and warnings to supplement companies in response to the FDA Tren/Madol public advisory letter:
1. FDA Special Agent Jeff Novitzky is fully aware of the existence of MANY similar products and clones produced by SEVERAL additional supplement companies. He has also been involved in other (apparently non-publicized) raids of supplement companies producing similar products.
2. Owners of supplement companies producing similar products are cooperating with Special Agent Jeff Novitzky in his steroid investigation targeting the supplement industry.
3. Jeff Novitzky asserts that “Tren” and “Madol” are legally classified as “anabolic steroids” under his interpretation of federal law.
4. The government may be likely to crack down harshly on supplement companies that ignored the DEA’s proposed rule regarding “Madol” and “Tren” over 15 months ago.
5. Jeff Novitzky’s assertion that “Madol” and “Tren” are legally classified as Schedule III Controlled Substances (anabolic steroids) is based upon (a) the testimony of FDA pharmacologist James Tolliver and (b) the April 28, 2009 DEA proposed rule published in the Federal Register.
The predictions for a government crackdown are being confirmed by recent government actions. Surprisingly, it seems that supplement RETAILERS are being targeted more aggressively than supplement MANUFACTURERS thus far.
The principals of supplement retailers who were attentive to government warnings may not face the same aggressive treatment as See More Results.
Read more about the criminal felony charges faced by the owner and employees of See More Results from the FDA Press Release:
“MASS XTREME” and “TREN XTREME” are not dietary supplements because they do not contain any dietary ingredients listed in applicable law and the only ingredient contained in the products is a synthetic steroid which is not a dietary ingredient. All of the claims made by the two products relate to their synthetic steroid content.
Paglianite, Christman and Jucha are all charged with one count of conspiracy to defraud and mislead, dispensing prescription drugs, “MASS XTREME” and “TREN XTREME,” without a valid prescription issued by a licensed practitioner. The maximum statutory penalty for conspiracy is not more than five (5) years imprisonment and/or a $250,000 fine with 3 years supervised release. Count Two charges Paglianite and Christman with aiding and abetting one another with the intent to defraud and mislead by dispensing the prescription drug mislabled as “MASS XTREME” without a valid prescription issued by a licensed practitioner. Count Three charges Paglianite with committing the same offense charged in Count Two with Jucha with regard to “TREN XTREME.” The maximum penalty for aiding and abetting is not more than three (3) years incarceration and/or $10,000 fine with one (1) year of supervised release.