Georgia physician pleads responsible to distributing weight reduction drug that’s not federally accredited

A Georgia doctor has pleaded responsible to the introduction into interstate commerce of a misbranded drug product, a supposed weight reduction medication marketed as “Releana.”

Audrey Arona, 64, of Gainesville, Georgia, pleaded responsible Monday. Arona was ordered to pay $65,000 as a part of a plea settlement. She admitted to promoting Releana nationwide and to saying that the drug was federally accredited despite the fact that it was not.

Arona can be listed by the Georgia Department of Public Health as a director for well being district 3-4, which covers the state’s Gwinnett, Rockdale, and Newton counties. The Justice Department didn’t specify whether or not or not her responsible plea impacts her employment with GDPH.

Releana accommodates human chorionic gonadotropin, a hormone produced by the placenta. While the Food and Drug Administration has accredited the hormone’s use for infertility remedy in girls and hormone remedy in males, HCG has not been accredited for weight reduction.

In reality, the FDA warns customers in opposition to HCG weight reduction merchandise. Diets that function it, the FDA says, get their efficacy from the extreme restriction of caloric consumption, versus any results HCG could have.

The label of accredited HCG-containing medicine even state 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 FDA notes.

Doctors should not allowed to distribute misbranded, non-approved medicines.

Arona was the third defendant to plead responsible in relation to the distribution of Releana, based on the Justice Department.

In September 2022, Georgia resident Maurice Bailey pleaded responsible to introducing a misbranded drug containing HCG into interstate commerce, which concerned getting ready the Releana in an unregistered facility earlier than it was then bought by Arona.

In August 2021, a Colorado resident and fellow Releana distributor, Sarah Alberg, pleaded responsible to introducing the misbranded drug product containing HCG with the intent to mislead or defraud. Alberg smuggled HCG into the U.S. from India, and distributed Releana utilizing bottles and provides uncovered to rodent droppings.

“Doctors who distribute drugs must comply with federal law designed to ensure these products are safe and effective,” Principal Deputy Assistant Attorney General Brian Boynton mentioned.