Justice Department Files Complaint to Stop Distribution of Unapproved, Misbranded, and Adulterated “Poly-MVA” Products
(STL.News) The United States filed a civil complaint to stop a California company from distributing unapproved and misbranded drugs and adulterated animal drugs, the Department of Justice announced today.
In a complaint for permanent injunction filed Dec. 2, 2020, the United States alleged that AMARC Enterprises Inc.; Albert Lee Sanchez Jr.; and Gary L. Matson Sr. sold and distributed “Poly-MVA” and “Poly-MVA for Pets,” which the defendants claim can cure, mitigate, treat, or prevent disease, including cancer. According to the complaint, defendants’ Poly-MVA products are not generally recognized as safe and effective by qualified experts for the uses intended by the defendants in the products’ labeling. The complaint also alleges that the defendants intend for Poly-MVA to be administered intravenously. The U.S. Food and Drug Administration has previously warned defendants to cease making such claims.
“Marketing purported dietary supplements with unproven disease claims jeopardizes the public health,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division. “We will continue working with the FDA to stop the illegal sale of such products.”
“Patients suffering from cancer or any other disease should not be deceived into relying on unproven treatments. The sale of such unapproved products has the potential to cause delays in getting proper diagnosis and treatment,” said FDA Chief Counsel Stacy Amin. “Patients need to have confidence that the available drug products have been shown to be safe and effective for their intended use. The FDA is committed to taking decisive action against those who disregard the law and risk the public’s health by distributing unapproved drugs for their personal financial gain.”
The complaint alleges that that the disease claims defendants make for Poly-MVA and Poly-MVA for Pets lack support from published, adequate, and well-controlled clinical studies. The complaint also asserts that, because Poly-MVA’s labeling does not have adequate directions for lay users, the product is misbranded. Additionally, the complaint alleges that Poly-MVA for Pets is an adulterated new animal drug because it lacks an approved application. The Department of Justice filed the complaint in the U.S. District Court for the Southern District of California at the request of FDA.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
The case is being handled by Trial Attorney Shannon Pedersen of the Justice Department Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Seth I. Heller of the FDA’s Office of Chief Counse.