NEWARK, N.J. - The owner and president of a dietary supplement manufacturing company in Flanders, New Jersey, was sentenced today to 40 months in prison for directing the sale of diluted and adulterated dietary ingredients and supplements sold by his company, U.S. Attorney Paul J. Fishman announced.
Barry Steinlight, 70, of Hackettstown, New Jersey, previously pleaded guilty before U.S. District Judge Esther Salas to a one-count information charging him with conspiring to commit wire fraud. Judge Salas imposed the sentence today in Newark federal court.
“Consumers expect labels that accurately describe the products they ingest," U.S. Attorney Fishman said. “Steinlight deceived his customers as part of a four-year scheme in which he delivered bogus, mislabeled products. Today he was appropriately punished for his crime."
“The Justice Department has increased its attention on supplement sellers like Barry Steinlight who sell products that are not what they claim to be," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “We will investigate and prosecute companies and individuals that sell supplements that threaten the health of the American public and drain their bank accounts with misrepresented products."
“Today’s announcement demonstrates that those who sell adulterated dietary supplements and purposely subvert the regulatory functions of the FDA by providing false and misleading information will be held accountable for their actions," stated Jeffrey J. Ebersole, Acting Special Agent in Charge, FDA Office of Criminal Investigations’ New York Field Office. “We commend the efforts of the Department of Justice for vigorously pursuing the prosecution of this matter."
According to documents filed in this case and statements made in court:
Steinlight was the president and owner of Raw Deal Inc., a dietary supplement manufacturing facility. From at least 2009 through November 2013, Steinlight instructed Raw Deal employees to add “fillers," including maltodextrin, viobin cocoa replacer and rice flours to the dietary ingredients and supplements packaged for, and sold to, Raw Deal’s customers. These “fillers" were added without customer consent or knowledge. Steinlight also directed Raw Deal employees not to list the “fillers" as ingredients on the certificates of analysis (COAs) issued to its customers as proof of the identity of the ingredients contained in the products.
In addition to directing the dilution and adulteration of Raw Deal’s products, Steinlight also directed Raw Deal employees to create COAs that falsely certified that certain of Raw Deal’s products were kosher or organic. Also, during an FDA inspection of Raw Deal in February 2012, Steinlight instructed employees to alter a document before providing it to the FDA.
Raw Deal’s executive vice president, Catherine Palmer, 38, of Budd Lake, New Jersey, admitted that during the 2012 FDA inspection, she ordered a subordinate to falsify an ingredient list of a dietary supplement product before submitting it to the FDA. In addition, she admitted instructing a Raw Deal employee not to run blenders during the 2012 inspection so that the FDA would not see “fillers" being added to customer orders.
In addition to the prison term, Judge Salas sentenced Steinlight to one year of supervised release. During his plea hearing, Steinlight admitted that Raw Deal’s gross profits during the scheme were between $7 million and $20 million. As part of his plea agreement, Steinlight must forfeit $1,036,834 in profits from the scheme.
Palmer pleaded guilty yesterday to a one-count information charging her with obstructing an FDA investigation. The obstruction charge carries a maximum potential sentence of five years in prison and a $250,000 fine, or twice the gain or loss caused by the offense. Her sentencing is scheduled for Dec. 21, 2015.
The government is represented by Assistant U.S. Attorney Joseph Mack, Deputy Chief of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, Special Assistant U.S. Attorney Shannon M. Singleton from the FDA’s Office of Chief Counsel, and Trial Attorneys Patrick Runkle and David Sullivan of the Civil Division’s Consumer Protection Branch.
U.S. Attorney Fishman reorganized the health care fraud practice at the U.S. Attorney’s Office for the District of New Jersey shortly after taking office, including creating a stand-alone Health Care and Government Fraud Unit to handle both criminal and civil investigations and prosecutions of health care fraud offenses. Since 2010, the office has recovered more than $635 million in health care fraud and government fraud settlements, judgments, fines, restitution and forfeiture under the False Claims Act, the Food, Drug, and Cosmetic Act and other statutes.
Source: U.S. Department of Justice, Office of the United States Attorneys
