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 accepted regardless that it was not.
Arona can be listed by the Georgia Division of Public Well being as a director for well being district 3-4, which covers the state’s Gwinnett, Rockdale, and Newton counties. The Justice Division didn’t specify whether or not or not her responsible plea impacts her employment with GDPH.
Releana comprises human chorionic gonadotropin, a hormone produced by the placenta. Whereas the Meals and Drug Administration has accepted the hormone’s use for infertility remedy in ladies and hormone remedy in males, HCG has not been accepted for weight reduction.
In truth, the FDA warns shoppers towards 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 accepted HCG-containing medication even state that there “isn’t any substantial proof that it will increase weight reduction past that ensuing from caloric restriction, that it causes a extra enticing or ‘regular’ distribution of fats, or that it decreases the starvation and discomfort related to calorie-restricted diets,” the FDA notes.
Docs usually are not allowed to distribute misbranded, non-approved medicines.
Arona was the third defendant to plead responsible in relation to the distribution of Releana, in line with the Justice Division.
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.
“Docs who distribute medication should adjust to federal legislation designed to make sure these merchandise are protected and efficient,” Principal Deputy Assistant Lawyer Normal Brian Boynton stated.