SEP 04 (SAN JOSE, Calif.) –Aris Aristidis Vavasis pleaded guilty in federal court yesterday to Felony Distribution of Unapproved New Drugs and Felony Distribution of Misbranded Drugs, announced United States Attorney Melinda Haag, Drug Enforcement Administration Special Agent in Charge Jay Fitzpatrick, and U.S. Food and Drug Administration Office of Criminal Investigations Acting Director Philip J. Walsky, and Department of Justice Office of the Inspector General Special Agent in Charge Ronald G. Gardella, New York Field Office.
In pleading guilty, Vavasis admitted to being the owner of the internet supplement company Nutrition Dome, Inc., located at 4518 11th Avenue, 2nd level, Brooklyn, New York, 11219, and to using that company to knowingly distribute two purported dietary supplements, “Methastadrol,” and “Lipodrene,” both of which contained misbranded drugs, in interstate commerce, including to the Northern District of California. Methastadrol contained the Schedule III anabolic steroid Methasterone (also known by the chemical name 17α-methyldrostanolone) as an active ingredient.
Lipodrene contained the active ingredient ephedrine. On February 11, 2004, the FDA published in the Federal Register a final rule that established a regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use (69 FR 6787). The final rule became effective on April 12, 2004.
Vavasis admitted that during the time he was operating Nutrition Dome, Inc., he was employed as a Deputy United States Marshal in the Eastern District of New York. In addition to his home computer system, Vavasis utilized the computer system of the United States Marshals Service in the Eastern District of New York, without authorization, to operate Nutrition Dome, Inc. business, including but not limited to communicating with purchasers, fulfilling orders, and otherwise administering the business of Nutrition Dome, Inc. Vavasis retired from the United States Marshals Service after the execution of a federal search warrant at the location of Nutrition Dome in July, 2012.
“The distribution of anabolic steroids and misbranded drugs through internet supplement companies constitutes a serious danger to the health and safety of consumers,” said United States Attorney Melinda Haag. “The fact that this defendant abused his position as a Deputy United States Marshal and utilized the computer system of the United States Marshals Service in the Eastern District of New York to commit these crimes is especially disturbing.”
“Distribution of anabolic steroids and misbranded drugs is a danger to the community. DEA will continue to collaborate with our law enforcement partners to pursue those who violate public trust and put their health and safety at risk,” stated Drug Enforcement Administration, San Francisco Field Office Special Agent in Charge Jay Fitzpatrick.
“Dietary supplements and drugs each have very specific FDA requirements that manufacturers must meet in order to protect the public’s health,” said Philip J. Walsky, acting director, FDA’s Office of Criminal Investigation. “Our agents will continue to pursue and bring to justice those who would put consumers’ health at risk through false representations about the status and safety of the products they sell.”
New York Field Office Special Agent-in-Charge Ronald G. Gardella of the Department of Justice Office of the Inspector General thanked the Drug Enforcement Administration and Food and Drug Administration Office of Criminal Investigation agents who collaborated in the investigation, stating that “the public has every right to expect the highest integrity from those entrusted with authority and we are determined to hold accountable anyone who betrays that trust.”
Vavasis, 51, of Brooklyn, New York, was charged with the introduction and delivery for introduction of an unapproved new drug into interstate commerce, in violation of 21 U.S.C. § 331(d), and the introduction and delivery for introduction of a misbranded drug, in violation of 21 U.S.C. § 331(a). Under the plea agreement, Vavasis pleaded guilty to all counts.
Vavasis was released on a recognizance bond, and his sentencing hearing is scheduled for Dec. 22, 2014, before the Honorable Lucy H. Koh, United States District Court Judge, in San Jose. The maximum statutory penalty for each count in violation of 21 U.S.C. § 331(d) & 331(a) is three years custody, three years supervised release, and a fine of $10,000.00 plus restitution if appropriate. However, any sentence will be imposed by the court only after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.
Matt Parrella and Jeff Nedrow are the Assistant U.S. Attorneys who are prosecuting the case with the assistance of Elise Etter. The prosecution is the result of an investigation by the DEA, the FDA Office of Criminal Investigation, and the Department of Justice Office of the Inspector General.