FDA WARNING_LETTER - Amarc Enterprises, Inc.

On December 11, 2012, the FDA issued a Warning Letter to Amarc Enterprises, Inc. concerning the marketing of their products, Poly-MVA and Poly-MVA for Pets. The FDA reviewed the firm's websites (www.polymva.com, www.polymva.net, www.polymva4pets.com, www.polymvaforpets.com) and product literature, including a book titled "Poly-MVA A New Supplement in the Fight Against Cancer" and a "Testimonials" document.

The FDA determined that Poly-MVA and Poly-MVA for Pets are promoted for conditions that cause them to be unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. Claims, including numerous testimonials, suggest the products are intended for the cure, mitigation, treatment, or prevention of diseases such as various cancers, diabetes, Alzheimer's, heart disease, stroke, arthritis, psoriasis, and endometriosis in humans, and tumors, leukemia, lymphoma, and other cancers in animals.

These products are considered "new drugs" and "new animal drugs" because they are not generally recognized as safe and effective for their claimed uses. They lack prior FDA approval, which is required under section 5