鶹ý

Feds Crack Down on Vitamin D COVID 'Cures'

— Georgia-based companies ordered to stop sales after national recall, DOJ says

MedpageToday
The Pharm Origins Group logo and bottle of IMMUNE SHOT over a court document

Two Georgia-based health and wellness companies were prohibited from selling unapproved vitamin D products after pushing fraudulent claims that they could cure COVID-19, the .

A federal court in Georgia issued a permanent injunction against founder Matthew Ryncarz and his companies Fusion Health and Vitality LLC and Fusion Ionz LLC, both doing business as Pharm Origins, from selling their vitamin D supplements. The companies touted products including "Immune Shot," "Immune Boost," and "Core" as cures for COVID-19, yet provided no clinical data proving their safety or efficacy, officials stated.

The recent civil complaint claims that Ryncarz and his businesses violated the Federal Food, Drug, and Cosmetic Act by introducing unapproved drugs into interstate commerce. Additionally, the complaint noted, the disease-fighting claims made without any scientific evidence resulted in misbranding of these substances.

Ryncarz pleaded guilty in September to separate but related criminal charges after Fusion Health and Vitality claimed that Immune Shot could lower the risk of getting COVID-19 by 50%.

As noted in a from the U.S. Attorney's Office of the Southern District of Georgia, Fusion Health and Vitality promoted Immune Shot mainly to people older than 50, claiming that the product, sold in bottles for $19 each, had life-saving capabilities. Sales pitches said that the supplement was potentially "the most important formula in the WORLD right now due to the new pandemic," and claimed that "the NEXT FIVE MINUTES could save your life," officials said.

Following the guilty plea, Fusion Health and Vitality all 2020 Core and Immune Boost products. Some were also found to contain an unapproved food additive, hordenine HCl, which is potentially unsafe for oral consumption and may cause side effects such as rapid heart rate and high blood pressure, officials said.

In an email to 鶹ý, Ryncarz said that his companies no longer sell any products related to COVID-19. He added that the advertising claims in question were not meant to refer to Fusion Health and Vitality products specifically, but were "direct references to the emerging and copious recent scientific data regarding Vitamin D and COVID-19."

After internal investigation, the company acknowledged violations of the law, providing refunds on all vitamin D products, Ryncarz continued. "We are thankful we are able to put this behind us, comply with current laws, and continue to provide products and services to our customer base."

"The Department of Justice will not allow individuals to take advantage of consumers during a public health emergency by making unproven claims about unapproved drugs to profit from public panic," said Deputy Assistant Attorney General Daniel J. Feith in a about the permanent injunction. "We will continue to work closely with the Food and Drug Administration to halt such conduct."

  • Amanda D'Ambrosio is a reporter on 鶹ý’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system.