Furthermore, the DOJ alleged that AMARC Enterprises and Sanchez failed to provide adequate directions for consumers. Therefore, the defendants misbranded their Poly-MVA products.
Finally, the Justice Department accused the defendants of unlawfully selling and disbributing an adulterated new animal drug. The defendants violated FDCA.
In a statement, DOJ Civil Division Acting Assistant Attorney General Brian Boynton said, Companies that market products with unproven claims endanger the public health. The court’s order ensures that the defendants uphold their obligation to comply with the law.”
On the other hand, FDA Office of Regulatory Affairs Associate Commissioner Judith McMeekin, said, “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 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,” she added.
