M-Drol & H-Drol Manufacturer Busted
Sitesh Bansi Patel originally of Irvine, California, man was found guilty following a 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.
A federal jury sitting in the United States District Court for the Western District of Virginia in Abingdon found Sitesh Bansi Patel, 33, of Irvine, California guilty of one count of conspiracy to defraud the FDA, one count of conspiracy to commit mail fraud and three counts of mail fraud.
Patel originally was faced with up to 85 years in prison, a fine of up to $1.25 million and the potential forfeiture of assets acquired through criminal behavior.
However, Sitesh Bansi Patel, 33, was later sentenced 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.
In a separate hearing, a co-conspirator in the matter, Guillermo “Willy” Ramos, 41, of Oceanside, California, was sentenced to two years’ probation for his role in the conspiracy. Steven Donald Wood, 38, of Danville, Virginia, was previously sentenced to probation for a term of one year and ordered to forfeit $1.5 million, which was paid prior to Wood pleading guilty. Wood was also ordered to pay a $10,000 fine.
According to evidence presented during last week’s trial, Patel was the vice president of SK Labs, a California-based supplement manufacturer. Patel has a Pharm.D degree. In 2008 and 2009, Patel used SK Labs to produce H-Drol and M-Drol for Steve Wood’s company Competitive Edge Labs.
The products labeled M-Drol and H-Drol contained prohormones. 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 Steve Wood, who was a significant customer of SK Labs, to meet Willy Ramos, of Oceanside, California, via email so that Ramos could begin producing H-Drol and M-Drol for Steve Wood. Patel received, at his home, the first shipments of the raw powders, labels, and payment from Wood.
On more than one occasion, Patel transported those items to a shopping mall parking lot where he delivered them to Ramos. Ramos encapsulated, bottled, and labeled the H-Drol and M-Drol on several occasions. Patel arranged for the first shipment of finished product to be sent to Wood in the Danville, Virginia, area. Patel was paid by Ramos and Wood for his role.
Wood testified he sent Patel $8,000 to $10,000 in cash on at least two occasions. The cash was sent in supplement bottles. Ramos testified that he paid Patel $7,500 in cash. Ramos quit producing the products when Steve Wood was arrested on September 14, 2011, in the Danville, Virginia, area.
Wood obtained his raw powder 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 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.