Aloha Medicinals Inc. – FDA Warning Letter

This FDA Warning Letter, dated April 6, 2010, addresses Aloha Medicinals, Inc.'s marketing of "Immune-Assist," "Levolar Forte," "Agaricus blazei Murill," "K-9 Immunity," "K9 Transfer Factor," and "Dog Immune." The FDA determined, based on website statements (www.alohamedicinals.com), that these products are unapproved new drugs and/or new animal drugs, and are misbranded.

Specifically, "Immune-Assist," "Levolar Forte," and "Agaricus blazei Murill" are deemed drugs under 21 U.S.C. § 321(g)(1)(B) due to intended use in human disease diagnosis, cure, mitigation, treatment, or prevention, and new drugs under 21 U.S.C. § 321(p) as they are not generally recognized as safe and effective for their labeled uses. Their introduction into interstate commerce without FDA-approved New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) violates 21 U.S.C. § 331(d).

"K-9 Immunity," "K9 Transfer Factor," and "Dog Immune" are classified as drugs under 21 U.S.C. § 321(g)(1)(B) for intended use in animal disease, and