Sitesh Bansi Patel Was Previously Tried and Convicted in Federal Court
Abingdon, VIRGINIA - A California man, who was previously found guilty following a five-day jury trial on conspiracy and mail fraud charges in relation to his role in a conspiracy to defraud the United States Food and Drug Administration by misbranding synthetic steroids was sentenced today in federal court, Acting United States Attorney Rick A. Mountcastle announced.
Sitesh Bansi Patel, 33, of Irvine, Calif., was sentenced today to imprisonment for a term of eight months, ordered to forfeit $77,000, and fined $50,000. He was convicted following a five-day jury trial of one count of conspiracy to defraud the FDA, one count of conspiracy to commit mail fraud and three counts of mail fraud.
Patel, who holds a Pharm.D degree and is a licensed pharmacist, is the vice president of SK Labs, a California-based supplement manufacturer. In 2008 and 2009, Patel used SK Labs to produce H-Drol and M-Drol. The products labeled M-Drol and H-Drol contained prohormones, a/k/a synthetic steroids. The products were misbranded because the labels identified them as “dietary supplements" when, in fact, they were drugs. The active ingredients in H-Drol and M-Drol are now classified by the DEA as anabolic steroids. In 2009, when it became widely known in the supplement industry that these types of products were being actively investigated by the FDA, SK Labs quit producing H-Drol and M-Drol. However, beginning in December 2010, Patel arranged for the manufacture of H-Drol and M-Drol by others at another facility in California. Patel, working as go-between, received, at his home, shipments of raw powder, labels, and money. Patel transported those items to a shopping mall parking lot. Patel then arranged for the finished product to be shipped to Virginia.
The raw powder used to manufacture these products was imported from Xinli “Eric" Li, a Chinese national, who pleaded guilty in federal court in Abingdon on December 4, 2015. Li forfeited $1.6 million and served five months in prison prior to being deported to China.
M-Drol listed its single active ingredient as 2a, 17a di methyl etiocholan 3-one, 17b-ol, a chemical nomenclature for methasterone, also known as “Superdrol." The FDA has identified methasterone as a “designer steroid" or “designer drug", a structural or functional analog of a controlled substance designed to mimic the pharmacological effects of the original drug. H-Drol listed its single active ingredient as 4-chloro-17a-methyl-androst-1,4-diene-3-17b-diol, the nomenclature for a designer drug identified as halovar, a clone of halodrol. Both products were deemed to be misbranded drugs because the label was false, that is, the product was labeled as a “dietary supplement" but contained a “steroid" or drug. Therefore, neither product met the definition of a dietary supplement. Both products were popular among those seeking an increase in muscle mass and loss of body fat and were distributed widely in the U.S. and overseas, both at retail stores and via the internet. The use of anabolic steroids or dietary supplements that contain anabolic steroids or designer steroids may trigger numerous adverse health effects in the human body.
The investigation, known as Operation Grasshopper, has resulted in the forfeiture of over $3.5 million and felony convictions for seven different individuals from Virginia, California, Florida, New York and China.
The investigation was conducted by the United States Food and Drug Administration - Office of Criminal Investigations. The Pittsylvania County Sheriff’s Office provided valuable assistance in the case. Assistant United States Attorney Randy Ramseyer prosecuted the case for the United States.
Source: U.S. Department of Justice, Office of the United States Attorneys
