Inspections, Compliance, Enforcement, and Criminal Investigations

April 15, 2015: Owner of Harrisburg Diet Supplement Business Charged with Selling Misbranded Drugs

 

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Food and Drug Administration 
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             U.S. Department of Justice Press Release

 

 

For Immediate Release
April 15, 2015

United States Department of Justice

Middle District of Pennsylvania

The U.S. Attorney’s Office of the Middle District of Pennsylvania announced today that a criminal information was filed in U.S. District Court in Harrisburg, Pennsylvania, charging Cheryl Floyd, 52, Harrisburg, owner of Floyd Nutrition LLC, with introducing misbranded drugs into interstate commerce and money laundering.

 

According to U.S. Attorney Peter Smith of the Middle District of Pennsylvania, Floyd, aka Cheryl Floyd Brown, is owner and operator of an internet-based business known as Floyd Nutrition LLC, based at her Harrisburg residence and warehouse facilities in the Harrisburg area.

 

The items offered for sale between 2010 and 2014 were allegedly purported all-natural dietary supplements sold as weight loss products.  They allegedly contain the drugs sibutramine and phenolphphthalein which are not listed as ingredients in the product labels.

 

According to U.S. Food and Drug Administration (FDA), sibutramine was the active pharmaceutical ingredient in Meridia, a prescription weight loss drug removed from the market in 2010 following studies that showed increased heart attack and stroke in the studied population.  Phenolphphthalein was an over-the-county drug until 1999 when FDA reclassified it as not generally safe because it posed a carcinogenic risk.

 

The FDA has detained shipments of the products coming from China intended for Floyd’s business.  In July 2014, search warrants executed at locations used by Floyd’s business resulted in seizure of a large quantity of the products.  The products were sold over the internet under the names such as Slim Trim U, ZXT Slim Bee Pollen, Magic Slim, ZXT Bee Pollen, ZXT Gold Infinity, Lean Body Extreme, Bnew Beauty and Body and Natural Body Solutions.

 

“When individuals knowingly sell misbranded drugs to the general public and generate significant profits from these sales, IRS Criminal Investigation will diligently work with our fellow law enforcement partners to dismantle the operation and trace the proceeds of the criminal activity, which in this particular matter where seven properties valued at over $2 million,” said Special Agent in Charge Akeia Conner of the Internal Revenue Service Criminal Investigation.

 

“The manufacturing and selling of products marketed as all natural dietary supplements that actually contain dangerous pharmaceutical ingredients places consumers at risk of serious injury or death,” said Special Agent in Charge Antoinette V. Henry of the FDA Office of Criminal Investigations’ (FDA OCI) Metro-Washington Field Office.  “FDA OCI will continue working with the Department of Justice to protect consumers from public health risks and fraud and commends the USAO MDPA and our law enforcement partners for the resolve and commitment they demonstrated in investigating and prosecuting this case.”

 

The criminal information also charges Floyd with money laundering of the proceeds of the sales of the misbranded products and the government is seeking forfeitures of properties in Harrisburg owned by the defendant, a truck and nine bank accounts.

 

The government filed a plea agreement with the defendant that included an agreement to forfeit the properties listed in the criminal Information.  The agreement is subject to the approval of the U.S. District Court of the Middle District of Pennsylvania.

 

This case was investigated by the FDA Office of Criminal Investigations, Internal Revenue Service Criminal Investigations and the Dauphin County Drug Task Force.  It is assigned to Assistant U.S. Attorney Christy H. Fawcett of the Middle District of Pennsylvania.

 

Introduction of misbranded drugs in interstate commerce carries a maximum penalty of three years’ imprisonment, a $10,000 fine and a one-year term of supervised release.  The maximum penalty for conducting financial transactions with criminally-derived property in excess of $10,000 is ten years’ imprisonment, a $250,000 fine and a three-year term of supervised release.

 

An Indictment and criminal Information are only allegations.  All persons charged are presumed to be innocent unless and until found guilty in court.

 

A sentence following a finding of guilt is imposed by the judge after consideration of the applicable federal sentencing statutes and the Federal Sentencing Guidelines.        

 

Under the Federal Sentencing Guidelines, the judge is also required to consider and weigh a number of factors, including the nature, circumstances and seriousness of the offense, the history and characteristics of the defendant and the need to punish the defendant, protect the public and provide for the defendant’s educational, vocational and medical needs.  For these reasons, the statutory maximum penalty for the offense is not an accurate indicator of the potential sentence for a specific defendant.

 

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:  Complete and submit the report Online: www.fda.gov/MedWatch/report.htm - download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Page Last Updated: 04/20/2015
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