A Georgia physician has pleaded guilty to causing the introduction into interstate commerce of a misbranded drug product containing human chorionic gonadotropin, or HCG.
Dr. Audrey Arona, 64, of Gainesville, Georgia, pleaded guilty to the charges related to the sale of a purported weight loss drug product that contained HCG marketed under the name “Releana.”
According to court documents, Dr. Arona admitted to selling a sublingually administered HCG-for-weight-loss drug product to patients around the country. Dr. Arona further admitted that she represented to patients that the HCG-for-weight-loss drug product was FDA-approved and that it could assist with weight loss.
The U.S. Food and Drug Administration (FDA) has specifically warned consumers to avoid HCG weight-loss products, advising, “If you have HCG products for weight loss, quit using it, throw it out, and stop following the dieting instructions.”
Dr. Arona was the third defendant to plead guilty in connection with the marketing and sale of Releana. In September 2022, Hoschton, Georgia, resident Maurice Bailey also pleaded guilty to causing the introduction into interstate commerce of a misbranded drug product containing HCG.
According to court documents, Bailey admitted to preparing the Releana sold by Dr. Arona in a facility that was not properly registered with FDA, and to inaccurately labelling that Releana.
Dr. Arona was ordered by Magistrate Judge J. Clay Fuller of the United States District Court for the Northern District of Georgia to forfeit approximately $65,000.
“Doctors who distribute drugs must comply with federal law designed to ensure these products are safe and effective,” said Principal Deputy Assistant Attorney General Brian M. Boynton.
The FDA Office of Criminal Investigations investigated the case.
Senior Litigation Counsel Patrick Runkle and Trial Attorney Michael Wadden of the Justice Department’s Consumer Protection Branch prosecuted the case against Dr. Arona, with assistance from Assistant U.S. Attorney Jennifer Keen for the Northern District of Georgia.
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Key Facts
- State: Georgia
- Category: Drug Trafficking|Fraud & Financial Crimes|Violent Crime
- Source: DOJ Press Release â†â€â€
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