FDA WARNING_LETTER - Ad-Med Biotechnology, LLC

The FDA issued a Warning Letter to Ad-Med Biotechnology, LLC and A.M.S. Bioteck, LLC following a June 2014 review of their "Immune Active Adult Formula" label and company websites. The agency determined that "Immune Active Adult Formula" and "Immune Active Children's Formula" are promoted for conditions that classify them as unapproved new drugs under section 201(g)(1)(B) of the Act. Therapeutic claims, including "Joint Pain Relief & Inflammatory Disorders," "power antiviral, antibacterial and antifungal," and efficacy against various infections and autoimmune disorders, establish drug intent. As these products are not generally recognized as safe and effective, they are "new drugs" under section 201(p) and are illegally introduced into interstate commerce without FDA approval, violating sections 505(a) and 301(d). They are also misbranded under section 502(f)(1) due to inadequate directions for use for laypersons. Furthermore, the products are misbranded dietary supplements under section 403. Violations include a false claim that "Melaleuca Alternifolia is FDA GRAS-designated as safe" (403(a)(1)), failure to identify the product as a "dietary supplement" (403(s)(2)(B)), omission of net quantity of contents (403(e)(2)), an incorrect serving size (403(q)(1)(A)), and failure to identify the plant part for Melaleuca Alternifolia (403(s)(2)(C)). The company must promptly correct all violations and respond to the FDA within fifteen working days, detailing corrective actions and timelines, to avoid potential legal action.