The U.S. District Court for the Southern District of Georgia issued a permanent injunction barring Matthew Ryncarz and his companies, Fusion Health and Vitality LLC (d/b/a Pharm Origins) and Fusion Ionz LLC (also d/b/a Pharm Origins), from selling unapproved drugs.  The unapproved drugs were marketed as treatments for COVID-19, according to a U.S. Department of Justice (DOJ) press release.  The defendants, who entered into a Consent Decree of Permanent Injunction, must also take additional actions, such as retaining a drug expert to comprehensively review the defendants’ product labeling, retaining a dietary supplement expert to comprehensively inspect the defendants’ facility and manufacturing process, and complying with various reporting requirements.

According to the DOJ, the defendants sold products, purportedly containing Vitamin D3, that the defendants claimed would cure, mitigate, or treat COVID-19 and other diseases.  These products were sold through the defendants’ websites, labeled “Immune Shot,” “Immune Boost,” and “Core.”  The DOJ alleged the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by introducing unapproved drugs into interstate commerce.  The DOJ also noted that the defendants’ claims lacked credible scientific evidence and “none of the products were generally recognized as safe and effective by qualified experts for any of the uses promoted by the defendants.” 

In a separate but related action, DOJ criminally charged Mr. Ryncarz and his companies for violating the FDCA.  The defendants’ charges stemmed from allegedly selling drugs claiming to treat COVID-19, which the government claims constituted misbranding under 21 U.S.C. § 352(a)(1).  According to the DOJ, during the height of the COVID-19 pandemic in March 2020, Mr. Ryncarz sold “Immune Shot” for $19 per bottle through his company’s websites.  The websites marketed the “Immune Shot” by touting to prospective consumers, “YOU will learn in JUST MINUTES … how to LOWER your risk of COVID-19 by nearly 50%.”  The DOJ also alleged that Mr. Ryncarz targeted individuals age 50 and older with heavy-handed sales pitches, such as: “Immune Shot is Not a Luxury, It is a Necessity Right Now,” and “Is Your Life Worth $19? Seriously, Is It?”  Mr. Ryncarz and his company were charged by way of Information.  On September 29, 2020, Mr. Ryncarz and his company pled guilty and admitted that labeling for the “Immune Shot” product amounted to misbranding under the FDCA, as it falsely claimed it would lower the risk of contracting COVID-19.  

These actions resulted from cross-agency collaborations between the DOJ, FBI, and the Food and Drug Administration.  CG attorneys have written about the government’s continued use of cross-agency collaborations and how such collaborations have resulted in significant takedowns.  Related to unproven drug claims, Deputy Assistant Attorney General Daniel J. Feith made the DOJ’s intentions clear:  “[t]he 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 … [w]e will continue to work closely with the Food and Drug Administration to halt such conduct.” 

The attorneys at Chilivis Grubman represent both companies and individuals in connection with criminal and civil government investigations.  If you have any questions related to such matters, please contact us today.