Seller of supplements diluted with fillers pleads guilty, agrees to pay more than $1 million

By Hank Schultz contact

- Last updated on GMT

Seller of supplements diluted with fillers pleads guilty, agrees to pay more than $1 million

Related tags: Food and drug administration

The owner of a dietary supplement company has pleaded guilty of conspiracy to commit wire fraud in connection with the sale of diluted and adulterated ingredients and supplements.  The plea deal comes with an agreement to pay a fine that exceeds $1 million.

Barry Steinlight, 69, of Hackettstown, NJ, pleaded guilty to the single count that charged him with selling products that did not meet label claim or were adulterated under the brand name of his company, Raw Deal, Inc. The company had sales of $7 million to $20 million during its years of operation.

“Barry Steinlight diluted his products, cheated his customers and lied to the Food and Drug Administration when they came to inspect his company,”​ said U.S. Attorney Paul J Fishman.  “This scheme went on for four years and essentially became the business model at his company.  People who sell and use dietary supplements have the right to expect that the ingredients are listed and they get what they paid for.”

Deliberate adulteration

According to documents filed in this case and statements made in court:

Steinlight was the president and owner of Raw Deal Inc., located in Flanders, NJ.  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.  Further during an U.S. Food and Drug Administration (FDA) inspection of Raw Deal in February 2012, Steinlight instructed Raw Deal employees to alter a document before providing it to the FDA.

FDA sent Steinlight at least two warning letters, one in 2012​ and another in 2013​.  The second letter specifically mentioned the substitution of ingredients on the label with fillers.  Batch records indicated that maltodextrin and/or white rice powder was used in the manufacture of the products but were not listed on the labels.  For example, in a product identified in the 2013 letter​ by FDA as “Pre-mix” (part of the product’s name was redacted from the public posting of the warning letter),  FDA said that its own testing revealed that only 4.4% of the product consisted of the ingredients on the label, whereas maltodextrin and white rice powder made up the remainder.  Other products specifically mentioned in the warning letter were diluted to lesser degrees, with one product consisting of 77% unlabeled fillers and another 28%.

Related topics: Regulation, GMPs, QA & QC, Adulteration

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