Editor's note: This article was updated Jan. 13 with comments from the defendant.
A federal court has permanently barred a company from selling vitamin D products as treatments for COVID-19.
On Jan. 7, U.S. District Court Judge William T. Moore Jr. entered a consent decree of permanent injunction against Matthew Ryncarz and his companies, Fusion Health and Vitality LLC and Fusion Ionz LLC.
The defendants claimed their products would cure, mitigate or treat COVID-19 and other diseases, according to the U.S. Department of Justice (DOJ) in a civil complaint filed Nov. 23 in the U.S. District Court for the Southern District of Georgia. While the defendants sold many products online that purportedly contained vitamin D3, such as “Immune Shot,” “Immune Boost” and “Core,” no qualified experts considered them effective or GRAS (generally recognized as safe) for the uses that the products were promoted for, the complaint alleged.
The government alleged the marketers introduced unapproved new drugs into interstate commerce, in violation of the Federal Food, Drug and Cosmetic Act (FD&C). The products also were misbranded because the defendants’ disease-related treatment claims were not supported by any well-controlled clinical studies or other credible evidence, according to the complaint.
"Fusion Health and Vitality no longer sells any Vitamin D products and has not sold any since the middle of 2020," Ryncarz said in an email after this article was first published. "We do not sell anything else related to COVID-19."
He also said the claims targeted by the government referenced "emerging and copious recent scientific data regarding Vitamin D and COVID-19" and were not specific to his products. He nonetheless acknowledged the references violated FDA labeling laws.
After being "contacted by the government," Ryncarz added, "we moved swiftly with counsel to correct any errors by removing products from the market, offering refunds and hiring FDA experts to ensure compliance moving forward."
The case against Ryncarz and his companies reflects ongoing efforts by multiple federal agencies, including FDA, to crack down on unsupported claims that non-FDA-approved products cure, treat or prevent COVID-19.
“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,” Deputy Assistant Attorney General Daniel J. Feith said in a DOJ news release. “We will continue to work closely with the Food and Drug Administration to halt such conduct.”