Fake Cancer Cures: California Company Busted for Selling Unapproved Treatments
A California company and its owner have been ordered to stop distributing unapproved and misbranded drugs and adulterated animal drugs, the FDA announced.
AMARC Enterprises Inc. and its owner, Albert Lee Sanchez Jr., were accused of selling and distributing products called “Poly-MVA” and “Poly-MVA for Pets” that they claimed could cure, mitigate, treat or prevent disease, including cancer. However, the products are not recognized as safe and effective by qualified experts, and the defendants intended for Poly-MVA to be administered intravenously.
The FDA complaint also alleged that the defendants’ claims regarding Poly-MVA and Poly-MVA for Pets lacked support from published, adequate and well-controlled clinical studies. Additionally, the product labelling did not include adequate directions for lay users, making it misbranded. Poly-MVA for Pets was also found to be an adulterated new animal drug because it lacked an approved application.
“Companies that market products with unproven claims endanger the public health,” said Acting Assistant Attorney General Brian M. Boynton. “The court’s order ensures that the defendants uphold their obligation to comply with the law.”
Judith McMeekin, FDA’s associate commissioner for regulatory affairs, added, “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.”
The court ordered AMARC and Sanchez to cease distribution of their products unless they come into compliance with the Federal Food, Drug, and Cosmetic Act (FDCA). Trial Attorneys Sarah Williams and Shannon Pedersen handled the case with the assistance of Associate Chief Counsel Jaclyn Martinez Resly of the FDA’s Office of Chief Counsel.
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Key Facts
- State: California
- Category: Drug Trafficking|Fraud & Financial Crimes|White Collar Crime
- Source: DOJ Press Release â†â€â€
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