Facts

Defendants AMARC Enterprises Inc. and Albert Lee Sanchez Jr., its owner, sold and distributed products called "Poly-MVA" and "Poly-MVA for Pets." These products claimed to cure, mitigate, treat or prevent disease, including cancer and were intended to be administered intravenously. The products were not generally recognized as safe nor effective by qualified experts, for the uses intended on the products' labels.

PLAINTIFFS' CONTENTIONS: Plaintiffs alleged that defendants made claims regarding their products that lacked support from published, adequate and well-controlled clinical studies. They also asserted that because the products' labeling did not include adequate directions for lay users, the product was misbranded. The complaint alleged that Poly-MVA for Pets was an adulterated new animal drug because it lacked an approved application. Finally, despite previous warnings, defendants continued violating the law.

DEFENDANTS' CONTENTIONS: Defendants denied all contentions.

Result

Defendants agreed to be permanently enjoined to cease distribution of their products until they come into compliance with the Federal Food, Drug, and Cosmetic Act.