Multimmunity, Inc. – FDA Warning Letter, Jul 31, 2014

The FDA issued a Warning Letter to Multimmunity, Inc. after reviewing their website in July 2014, determining that the product "Multimmunity" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The website's therapeutic claims, including "heart health," "immune boost," "concussion prevention/recovery," and targeting individuals with family histories of heart disease, cancer, or diabetes, or those with hearing loss, establish the product's intent for disease cure, mitigation, treatment, or prevention. Research claims and personal testimonials further support this intended use for conditions like high cholesterol, high blood pressure, stroke recovery, and Type I Diabetes.

As a "new drug" under section 201(p) of the Act, Multimmunity lacks FDA approval, violating section 505(a). Furthermore, the product is misbranded under section 502(f)(1) because it addresses conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use. Even if not classified as a drug, the product is misbranded as a dietary supplement under section 403(s)(2)(B) because its label omits a "dietary supplement" statement of identity as required by 21 CFR 101.3(g). The FDA requires a written response within