Court Orders Georgia Defendants to Stop Selling Vitamin D Products as Treatments for COVID-19 and other Diseases
Matthew Ryncarz, owner and operator of Fusion Health and Vitality LLC (doing business as Pharm Origins) was halted from continuing to sell Vitamin D products that he claimed were certified treatments for the COVID-19 virus and other diseases. This permanent injunction from the U.S. District Court of the Southern District of Georgia comes just months after Ryncarz pleaded guilty to claiming the same products prevented consumers from contracting COVID-19 at all.
Ryncarz and his company are charged with violating the Federal Food, Drug, and Cosmetic Act (FDCA) “by introducing unapproved new drugs into interstate commerce.” By not providing “well-controlled clinical studies or other credible scientific evidence,” the product became “misbranded.” The Alpharetta, Georgia-based company sold products like “Immune Shot,” “Immune Boost,” and “Core” that “purportedly contained vitamin D3” which Ryncarz and his company “claimed would cure, mitigate, or treat COVID-19 and other diseases.” However, the federal court alleges that “none of the products were generally recognized as safe and effective by qualified experts for any of the uses promoted.”
The federal court, through their complaint filed on January 8, 2021, orders the company to hire a “Drug Expert” and a “Dietary Supplement Expert” that have no “personal or financial ties (other than a retention agreement) to Defendants and/or their families.” These experts will be hired based on their knowledge and experience and will be expected to conduct comprehensive reviews of the defendant's products, marketing, and all labeling. Furthermore, the company has fifteen days from the date of the injunction to provide the FDA with a plan as to how they will recall and destroy “all of the Defendants’ Vitamin D Products and Hordenine HC1 Products that were manufactured, processed, packed, labeled, held, and/or distributed by Defendants from January 1, 2020, through and including the date of entry of decree.”
If the defendants fail to comply with any of the regulations or timelines in the court’s complaint, they will be fined $5,000 “in liquidated damages for each violation of the Act, its implementing regulations, or decree.” Additionally, they will be fined $3,000 “in liquidated damages per day, per violation.”
Moving forward, before the company can publish a new website or link to their products, they must notify the FDA in writing. They also must post a copy of the complaint on all websites concerning the Vitamin D or Hordenine HC1 products created after the entry of the complaint into court.
Chief Counsel of the U.S. Food and Drug Administration (FDA), Stacy Amin, commented on the permanent injunction saying, “Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases, including COVID-19, places consumers’ health at risk.”
Matthew Ryncarz, the author of “The Metabolic Loophole Diet,” an autobiographical account of his weight loss journey, promotes his company and products to individuals over 40 years of age. In March 2020, when many were still uncertain as to how COVID-19 can spread, he released the Immune Shot for $19 a bottle and claimed it would “lower your risk of COVID-19 by nearly 50%.” On September 29, 2020, the defendant, Ryncarz, pleaded guilty to a “separate but related criminal case” involving the same products. He had reportedly falsely labeled his “Immune Shot” product as a certified way to “lower the risk of contracting COVID-19.”
President Roosevelt signed the FDCA in 1938 after the 1906 Pure Food and Drugs Act failed to enable the FDA with the authority needed to protect consumers. After the law passed, the FDA could “regulate medical devices and cosmetics, and to establish standards” where they didn’t have the authority to do before. The Act mandated drugs and devices for medical use to provide directions and correct labeling.
The FDA recently issued Emergency Use Authorization for two COVID-19 vaccines produced by Pfizer and Moderna. The vaccine developed by Pfizer-BioNTech was authorized for use on December 11, 2020. One week later, the FDA issued the same authorization for the Moderna COVID-19 vaccine. Shortly after authorizing the two vaccines, the FDA published a caution to American consumers on fraudulent tests, vaccines, and treatments for the Coronavirus, warning buyers that “Fraudulent COVID-19 products can come in many varieties, including dietary supplements and other foods.” The FDA has already removed dozens of fraudulent products from the marketplace; however, many still exist through social media, independent websites, and stores.
