Inspections, Compliance, Enforcement, and Criminal Investigations
February 2, 2011: Three Indicted for Selling Mislabeled Steroids
Little Rock - Christopher R. Thyer, United States Attorney for the Eastern District of Arkansas; and Patrick J. Holland, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, Kansas City Field Office (FDA-OCI) announced that David Paglianite, age 39, of Conway, Arkansas, dba See More Results; Mathew Christman, age 21, of Little Rock; and Thomas J. Jucha, age 23, of Little Rock were charged in a federal indictment handed down today with fraud related to the misbranding and dispensing of steroids without a valid prescription under the names of “MASS XTREME” and “TREN XTREME”.
“The United States Attorney’s Office and the FDA are committed to protecting the health and welfare of the American people from the effects of illicit steroid use. Steroid traffickers market their product with promises of enhanced performance and appearance, with no mention of, or regard for, the devastating toll that unprescribed steroid use can have on the human body. The illegal use of anabolic steroids can be a dangerous practice, especially for young people and athletes, both of which groups often constitute the target market,” stated Thyer. Thyer added, “These particular steroids, MASS XTREME and TREN XTREME, were prominently mentioned in a July 2009 FDA Public Health Advisory. The full text of that Advisory can be read at www.fda.gov/drugs/drugsafety.”
“Today’s announcement demonstrates the continued commitment of FDA's Office of Criminal Investigations to aggressively pursue those who offer and sell unapproved and misbranded drugs,” said Special Agent in Charge Patrick J. Holland of FDA’s Office of Criminal Investigations. “We will remain vigilant in our efforts to protect consumers from these products.”
In July, 2009, the Federal Food and Drug Administration sent a warning letter to the manufacturer and certain distributors advising that “MASS XTREME” and “TREN XTREME” and other products violated various provisions of federal law and that they contained synthetic steroids. The letter advised that anabolic steroids may cause serious long-term health consequences including liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
After the letter was sent, “MASS XTREME” and “TREN XTREME” were stocked and sold in See More Results, a store owned and operated by Paglianite in west Little Rock. Two undercover buys were made in the store by a narcotics detective from the Little Rock Police Department in late October and mid-November, 2009 of “MASS XTREME” and “TREN XTREME” respectively. A federal search warrant was obtained and executed on November 24, 2009 at See More Results, at which time agents located several bottle of “MASS XTREME” and “TREN XTREME” for sale in the store.
“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.
The case is the result of a joint investigation conducted by agents with the Food and Drug Administration-Office of Criminal Investigations and the Little Rock Police Department. The case is being prosecuted by Assistant United States Attorney Angela Jegley.
An indictment contains only allegations. The defendants are presumed innocent unless and until proven guilty.