Posted on: May 01, 2024 04:00 PM

Share : Facebook Twitter Email Whatsapp

Long Island woman busted for selling misbranded weight loss drugs

Damian Williams, the United States Attorney for the Southern District of New York, and Fernando P. McMillan, the Special Agent in Charge of the New York Field Office of the Office of Criminal Investigations of the U.S. Food and Drug Administration (“FDA”), announced the unsealing of a criminal Complaint in Manhattan federal court charging ISIS NAVARRO REYES, a/k/a “Beraly Navarro,” with receipt of misbranded drugs in interstate commerce, dispensing misbranded drugs while held for sale, conspiracy to introduce and deliver for introduction misbranded drugs in interstate commerce, dispensing of misbranded drugs while held for sale, and smuggling.  As alleged in the Complaint, from about November 2022 through about January 2024, REYES marketed, advertised, and sold various misbranded and adulterated weight loss drugs, including Ozempic, Mesofrance, and Axcion, to followers on social media.  REYES, who is not licensed by law to administer prescription medication, obtained the weight loss drugs that she held for sale from Central and South America.  None of the weight loss drugs that REYES sold were approved for sale or dispensing in the United States by the FDA.  REYES was arrested this morning and will be presented in Manhattan federal court later today before U.S. Magistrate Judge Barbara Moses.

FDA Office of Criminal Investigations Special Agent in Charge Fernando P. McMillan said: “Selling misbranded prescription drugs, particularly injectable products that should be sterile, in the U.S. marketplace puts all consumers’ health at risk.  We will continue to pursue and bring to justice those who jeopardize the public’s health by selling misbranded drugs.” 

From about November 2022 through about November 2023, ISIS NAVARRO REYES, using TikTok, posted dozens of videos about weight loss drugs including, but not limited to, Ozempic, Axcion, and Mesotherapy.     

In her videos, REYES showcases the weight loss drugs, instructs viewers how frequently they should be used, describes how they should be taken or injected, and claims to describe her personal experiences — for example, side effects and effectiveness in causing weight loss — in detail.  In several of these videos, REYES tells viewers that they can contact her via an encrypted messaging application on her cellphone (the “Cellphone”) if they would like to order the weight loss drugs that she is selling. 

On about October 11, 2023, REYES posted a video pertaining to Ozempic.  In this video, REYES demonstrates how to inject oneself with the medication and shares her experience using the drug.  Toward the end of the video, REYES instructs viewers to contact her on the Cellphone if they are interested in having her obtain Ozempic for them.  A screenshot from this TikTok post is below: 

In about December 2023, a law enforcement officer acting in an undercover capacity (the “UC”) began messaging REYES on the Cellphone.  From about December 2023 through about January 2024, the UC and REYES exchanged several messages concerning REYES’s supply of Ozempic and the UC’s interest in purchasing Ozempic from REYES.  On about January 7, 2024, pursuant to instructions from REYES, the UC sent $375 to a Zelle account in the name of “Isis Reyes Navarro.”  REYES did not ask the UC to provide a prescription, and the UC did not provide one.  On about January 9, 2024, REYES dropped off a package intended for the UC at a post office located in or around Shirley, New York.

On about January 12, 2024, law enforcement received a package addressed to the UC from REYES (the “UC Parcel”) in Manhattan.  The UC Parcel contained a box containing what purported to be Ozempic

All of the labeling accompanying the Ozempic in the UC Parcel was in Spanish, in violation of FDA regulations.

In about November 2022, a woman who had viewed content posted to REYES’s TikTok account (“Victim-1”) called the Cellphone for the purpose of ordering weight loss drugs.  The individual who answered Victim‑1’s call identified herself as “Isis Navarro Reyes.”  In about February 2023, Victim-1 purchased 30 injections of Mesofrance, an injectable weight loss drug, from REYES.  REYES mailed the Mesofrance to Victim-1’s residence in White Plains, New York.  REYES did not ask Victim-1 to provide a prescription, and Victim-1 did not provide one. 

Between about February 2023 and about June 2023, Victim-1 self-administered 28 injections.  In an audio message that she recorded and transmitted, REYES provided Victim-1 with instructions on how to administer the drug.  REYES told Victim-1, among other things, to inject herself every three days.  All of the labeling of the vials that contained the Mesofrance that Victim‑1 purchased from REYES were in a language other than English, in violation of FDA regulations.

On about July 13, 2023, Victim-1 began developing lesions from administering the Mesofrance.  Victim-1 sent messages to REYES about her injuries and sent photos.  In about October 2023, Victim-1’s physician diagnosed her with a mycobacterium abscessus infection, which is frequently caused by the contamination of medications, medical products, and medical devices with the mycobacterium abscessus bacterium.  In about November 2023, the New York Department of Health tested one of the vials of Mesofrance that Victim-1 purchased from REYES.  The substance tested positive for mycobacterium abscessus, a species of rapidly growing, multidrug-resistant, nontuberculous mycobacteria.

REYES, 36, of Shirley, New York, is charged with one count of smuggling, which carries a maximum sentence of 20 years in prison; one count of receipt of misbranded drugs in interstate commerce, which carries a maximum sentence of one year in prison; one count of dispensing of a misbranded drug while held for sale, which carries a maximum sentence of one year in prison; one count of conspiracy to introduce and deliver for introduction a misbranded drug in interstate commerce, which carries a maximum sentence of one year in prison; and two counts of dispensing of misbranded drugs while held for sale, each of which carry a maximum sentence of one year in prison.

(From the DOJ Press Release)