On April 25, the Department of Justice (DOJ) announced the conviction of Georgia physician, Dr. Audrey Arona. Dr. Arona pleaded guilty to charges related to the sale of drug that contained human chorionic gonadotropin (HCG), marketed as a weight lost product. 

HCG is a hormone produced by the human placenta. According to the DOJ, the U.S. Food and Drug Administration (FDA) has only approved certain injectable HCG drug products for the treatment of specific cases of female infertility and for hormone treatment in males. The issue here is that the FDA has not approved any oral or sublingual HCG drug products for any use, and the FDA has never approved any HCG drug product for weight loss. Notably, the FDA has specifically warned consumers to avoid HCG weight-loss products, urging those who possess any HCG products for weight loss to “quit using it, throw it out, and stop following the dieting instructions.”

According to court documents, Dr. Arona admitted to selling a sublingual HCG-for-weight-loss drug product to patients around the country. She further admitted that she represented to patients that the HCG-for-weight-loss drug product was FDA-approved. Dr. Arona pleaded guilty to “causing the introduction into interstate commerce of a misbranded drug product containing HCG and marketed under the name ‘Releana.’” Pursuant to her plea agreement, a judge ordered Dr. Arona 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, head of the Justice Department’s Civil Division. “The Department will continue to work closely with our law enforcement partners to stop the distribution of misbranded HCG drugs and other misbranded drugs, including through criminal enforcement where appropriate.”

The attorneys at Chilivis Grubman represent clients of all types and sizes in connection with criminal healthcare matters and government investigations. If you need assistance with such a matter, please contact us today.