According to a press release from the U.S. Department of Justice, Isis Navarro Reyes, 36, was charged 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 November 2023, 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, she 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 Reye’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.  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 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, 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 for a total of 25 years 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.

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, 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,” said U.S. Attorney Damian Williams in a statement.

Mr. Williams praised the outstanding investigative work of the FDA Office of Criminal Investigations, the U.S. Postal Inspection Service, the New York City Police Department, the Customs and Border Protection Task Force Officers of the Drug Enforcement Administration, and the Special Agents and Task Force Officers of the U.S. Attorney’s Office for the Southern District of New York.