Isis Navarro Reyes Allegedly Sold Misbranded Adulterated Weight Loss Drugs to Customers Without a License to Administer Such 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.
U.S. Attorney Damian Williams said: “As alleged, Isis Navarro Reyes used her social media following to sell weight loss drugs unapproved for distribution in the United States. Reyes’s alleged unlawful dispensing of these drugs caused significant, life-threatening injuries to some victims and put all of her victims in harm’s way. Recently, public interest in semaglutide and weight loss drugs has skyrocketed, and criminals have sought to take advantage of this interest for their ends. With this, the first misbranding and adulteration charges brought pertaining to semaglutide, Reyes will be held accountable for her conduct, and criminals should think twice before trying to sell weight loss drugs without a license to do so. This case makes clear that extreme caution and physician consultation should always be taken when purchasing medications, especially on social media.”
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.”
As alleged in the Complaint:[1]
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.[2] Photos of packaging containing the purported Ozempic that REYES mailed the UC are below:
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.
The maximum potential sentences are prescribed by Congress and are provided here for informational purposes only, as any sentencing of the defendant would be determined by a judge.
Mr. Williams praised the outstanding investigative work of the FDA Office of Criminal Investigations, the U.S. Postal Service Office of the Inspector General, and the Task Force Officers assigned to the U.S. Attorney’s Office for the Southern District of New York.
This case is being handled by the Office’s Narcotics Unit. Assistant U.S. Attorney Brandon C. Thompson is in charge of the prosecution.
The charges contained in the Complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
[1] As the introductory phrase signifies, the entirety of the text of the Complaint and the description of the Complaint set forth herein constitute only allegations, and every fact described herein should be treated as an allegation.
[2] To date, there is no evidence that the Ozempic that REYES sold the UC is not genuine.
No comments:
Post a Comment