Chronicity Inc. – FDA Warning Letter, Aug 31, 2011

The FDA reviewed Chronicity Inc.'s website, www.chronicityinc.com, in August 2011 and determined that several products, including "Anti-Viral," "Artemisinin," "Cellular Health," "Chol-Less," "GastroHealth," "Leuko-Stim," "Omega 3," and "Selenium," are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The website's therapeutic claims, such as treating chronic fatigue syndrome, fibromyalgia, various infections, cancers, and reducing cholesterol, establish these products as intended for the cure, mitigation, treatment, or prevention of disease.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses. Marketing unapproved new drugs violates section 301(d) of the Act. Furthermore, since these products address conditions not amenable to self-diagnosis and treatment by laypersons, their labeling lacks adequate directions for use, rendering them misbranded under section 502(f)(1) of the Act. Introducing misbranded drugs into interstate commerce violates section 301(a) of the Act.

Chronicity Inc. must take prompt action to correct these violations and prevent recurrence. Failure to comply may result in enforcement actions, including product seizure