Gainesville doctor, public health official pleads guilty to misdemeanor regarding misbranded weight loss drug. She says she was 'misled'

May 1—A Gainesville doctor pleaded guilty in April to a misdemeanor for selling a product as a weight loss drug despite it not being approved for that purpose, according to court officials.

In a statement through her attorney, the doctor, Audrey Arona, said she was misled by the company who supplied the product. Arona said she stopped selling the product more than two years ago.

Arona serves as the district health director for the counties of Gwinnett, Newton and Rockdale but previously worked in private practice as an OB-GYN.

Arona pleaded guilty Monday, April 24, to causing the introduction into interstate commerce of a misbranded drug product.

She did not receive any custodial time or probation but must forfeit more than $65,000 seized from her bank accounts. She also had a $25 penalty.

According to the plea agreement, the maximum prison sentence was one year, but there is no mandatory minimum sentence. The maximum fine was $100,000.

The case involves human chorionic gonadotropin, a hormone "produced by the human placenta and found in the urine of pregnant women."

The FDA approved certain HCG products for male hormone treatment and female infertility.

"HCG is not approved for use without a prescription for any purpose, and no HCG drug products are FDA-approved for weight loss," according to the plea paperwork. "In fact, the HCG prescription drug label advises that there 'is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or 'normal' distribution of fat or that it decreases the hunger and discomfort associated with calorie-restricted diets."

The government wrote that Arona began supplementing her income as an OB-GYN in 2010 by selling an HCG product, Releana, to patients for weight loss.

"(Arona) would represent that for Releana to work, an individual would need to maintain a very restrictive diet, but that if they did so, they could lose up to 30 pounds in 30 days," according to the plea documents.

Maurice Bailey, of Hoschton, purchased the Releana patent, and Arona began purchasing the product from Bailey, according to the court documents.

Bailey admitted that the facility for the Releana product was not registered with the FDA and that certain ingredients were not disclosed on the label, according to the plea agreement.

Bailey pleaded guilty in September to causing the introduction into interstate commerce of a misbranded drug product containing HCG and was sentenced to three months of probation, according to court records.

According to the court documents, Arona continued her Releana business after taking on her public health role.

The case has not affected Arona's medical license.

Arona said in a statement provided by attorney R. Joseph Burby that she was "misled," saying she did not know that the product was not made in an FDA-registered facility and had an ingredient not disclosed on the label.

"I also did not know that the product at issue — HCG — was not FDA approved for weight loss," Arona said. "The company I purchased the HCG from also misrepresented that fact to me. Although, to be clear, I was not charged with any offense related to the FDA status of HCG or my statements to patients about it, and doctors may prescribe drugs for off-label use, and frequently do."

Arona said she stopped selling the product when she learned it was misbranded in January 2021 and cooperated with the government.

"I am deeply disappointed that the government elected to bring this case against me," Arona wrote. "If the FDA had simply sent me a warning letter about the HCG product, as they routinely do, I would have immediately stopped selling it. I have spent my entire career taking good care of people and helped a lot of people lose weight safely. We all face adversity in this world. My strength comes from knowing that God knows the truth about what happened here."

Emails to the Department of Public Health were not delivered. The Times called twice Monday, May 1, for comment, but no response was received.