Inspections, Compliance, Enforcement, and Criminal Investigations

February 9, 2011: Rhode Island Woman Pleads Guilty to Smuggling Misbranded Drugs from China

OCI Small Clear Seal
 

Food and Drug Administration
Office of Criminal Investigations

U.S. Department of Justice Press Release

 

For Immediate Release
February 9, 2011
http://www.usdoj.gov/usao/ri

United States Attorney
District of Rhode Island
Contact: Jim Martin
(401) 709-5357
Email: USARI.Media@usdoj.gov

 

PROVIDENCE, R.I. - A Providence woman pleaded guilty Tuesday in U.S. District Court in Providence to smuggling erectile dysfunction drugs from the People's Republic of China which were falsely labeled as herbal dietary supplements. Anny L. Puello, 32, the owner of JMM LLC, pleaded guilty to importing thousands of Durasex and Super Sense One capsules from a Chinese supplier which were mislabeled.

The guilty plea, which was accepted by U.S. District Court Chief Judge Mary M. Lisi, was announced by U.S. Attorney Peter F. Neronha; Mark Dragonetti, Special Agent in Charge of the Food and Drug Administration (FDA), Office of Criminal Investigations; and Bruce M. Foucart, Special Agent in Charge of ICE's Homeland Security Investigations in Boston.

At Tuesday's change of plea hearing, Assistant U.S. Attorney Sandra R. Hebert told the court that on numerous occasions, between November 2006 and October 2008, JMM LLC, through the efforts of Puello, ordered Durasex and Super Sense One capsules from a Chinese supplier, Chengdu Kang Quan Health Product Company (CKQHC). These capsules were imported in packages bearing false shipping labels or invoices. CKQHC falsely described the packages of Durasex and Super Sense One as "Cinnamon Extract," "Ginseng Extract," or "Multivitamin samples" on the shipping labels or invoices.

JMM LLC obtained a machine that Puello and an employee used to package the capsules for distribution. The packaging for the Durasex and Super Sense One capsules distributed by JMM LLC falsely proclaimed that the capsules were "Made in the USA." After packaging the capsules, JMM LLC distributed the capsules to various retailers and distributors in Rhode Island, Connecticut and elsewhere.

In October 2008, the R.I. FDA/OCI Task Force, comprised of agents from ICE - Homeland Security Investigations; Internal Revenue Service - Criminal Investigations Division; U.S. Postal Service Inspectors; Rhode Island State Police; North Providence Police; East Providence Police; and the Rhode Island Department of Attorney General, executed federal search warrants at Puello's business and residence, and seized thousands of pills, pill packaging materials including a labeling machine, computers, and business and shipping documents. Puello was arrested in June 2010.

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