FDA issues warning letters to companies selling unproven mpox treatments

The agency identified several companies allegedly selling unproven products.

February 1, 2023, 11:18 PM

A new warning from the Food and Drug Administration urges consumers to beware of marketers attempting to sell illegal and unproven mpox "medication" and "cures" in order to swindle scared, vulnerable people and bilk them out of their money.

The agency also shared a series of pictures of the alleged illegal products for sale.

These products, often sold online, have not been reviewed by FDA, the agency says, and are not proven safe or effective to treat mpox and other health conditions that they claim to address.

Several warning letters have been sent by FDA to the companies allegedly peddling these products.

PHOTO: In this Aug. 19, 2022, file photo, a man receives the monkeypox vaccine from a registered nurse at the Arlene Cooper Community Health Center at the LGBTQ Center in Las Vegas.
In this Aug. 19, 2022, file photo, a man receives the monkeypox vaccine from a registered nurse at the Arlene Cooper Community Health Center at the LGBTQ Center in Las Vegas.
K.M. Cannon/Las Vegas Review-Journal via TNS via Getty Images, FILE

One company's website falsely claims that an "herbal natural remedy" for mpox comes from the carnivorous purple pitcher plant, Sarracenia Purpuria, the agency said.

"For decades, research has shown the effectiveness of Sarracenia Purpurea (Pitcher Plant) against past outbreaks of small pox [sic] in the 19th Century, found to halt viral replication in viral, derived from the Variola Virus also associated with Monkey Pox," the company's site says, according to FDA's warning letter.

FDA notes that site also uses additional metatags and social media posts with key terms like "Monkey Pox," "Herbal Natural Remedy" and "remedy coming soon!" to bring consumers to their site for purchases.

Another company's site, which appears to target young parents, allegedly falsely claims that colloidal silver can help fight viral infections -- not only mpox, but also COVID-19, RSV and other upper respiratory tract infections.

PHOTO: A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020.
A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020.
Manuel Balce Ceneta/AP, FILE

The FDA quotes this company as saying on its website, "What Can Colloidal Silver Treat? … As an antiviral, silver can kill the virus that causes COVID-19 and may be an effective adjunctive treatment. There is also evidence that it may be effective against other viruses of interest including monkeypox, herpes, RSV, and viruses that cause upper respiratory tract infections (like influenza)."

Claims like these are particularly concerning in light of their appeared marketing toward infants and children, the agency says -- with marketers allegedly preying on parents' scrambling to take care of their kids after a difficult fall and winter when pediatric patients were slammed hard with the tripledemic of RSV, Covid, flu and other viruses -- amid notable shortages of the cold, fever and cough medications which are actually approved to help their symptoms.

The FDA said it's "particularly concerned" that the second company marketed their colloidal silver product "for use in infants and children," the letter says. The agency singled out a blog post for parents that advertised the product as tasting "like water and is easy to give to even the pickiest kids."

"The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children and infants who may be at greater risk for adverse reactions," the FDA said, since their bodies absorb and metabolize drugs differently.

Health experts say the best way to get medical care for mpox -- or any other malady -- is to speak with your healthcare provider. Wellness products aren't rigorously tested and don't have great oversight, especially on the internet -- something which marketers know they can take advantage of, according to experts.

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