Federal Court Orders California Company and Owner to Stop Distribution of Unapproved, Misbranded and Adulterated ‘Poly-MVA’ Products | OPA

A federal court ordered a California company and its owner to stop distributing unapproved and misbranded drugs and adulterated animal drugs.

In a complaint filed in the U.S. District Court for the Southern District of California in December 2020 at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that AMARC Enterprises Inc. and Albert Lee Sanchez Jr. sold and distributed products called “Poly-MVA” and “Poly-MVA for Pets” that defendants claimed could cure, mitigate, treat or prevent disease, including cancer. According to the complaint, the 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’ labelling. The complaint also alleged that the defendants intended for Poly-MVA to be administered intravenously.

AMARC and Sanchez agreed to be bound by a consent decree of permanent injunction. The order entered by the court permanently enjoins the defendants from violating the Federal Food, Drug, and Cosmetic Act (FDCA) and requires them, among other things, to cease distribution of their products unless and until they come into compliance with the FDCA.

“Companies that market products with unproven claims endanger the public health,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The court’s order ensures that the defendants uphold their obligation to comply with the law.”

“Marketing products that claim to cure, mitigate, treat or prevent cancer in both humans and animals without adequate scientific support poses serious safety risks to consumers and their pets,” said Judith McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA). “The unlawful distribution of these types of products is particularly concerning as they have the potential to derail consumers from seeking and receiving proper treatment from qualified health care providers. Despite previous warnings, AMARC Enterprises Inc. continued violating the law. The FDA will continue to take action to protect the American public when companies knowingly violate the law and put consumers or their pets at risk.”

The complaint alleged that the claims defendants made regarding Poly-MVA and Poly-MVA for Pets lacked support from published, adequate and well-controlled clinical studies. The complaint also asserted that, because Poly-MVA’s labelling did not include adequate directions for lay users, the product was misbranded. Additionally, the complaint alleged that Poly-MVA for Pets was an adulterated new animal drug because it lacked an approved application.

Trial Attorneys Sarah Williams and Shannon Pedersen of the Civil Division’s Consumer Protection Branch handled the case with the assistance of Associate Chief Counsel Jaclyn Martinez Resly of the FDA’s Office of Chief Counsel.