FDA WARNING_LETTER - Healthy World Distributing

The FDA issued a Warning Letter after reviewing promotional websites (www.oxysilver.com, www.healthyworldambassadors.com, www.healthyworldstore.com) and labeling for products including "Oxysilver," "PrimoLife," and "Green Harvest." The FDA determined that therapeutic claims made for these products, such as destroying viruses, eliminating vaccines, beating cancer, and treating various diseases, cause them to be unapproved new drugs under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act. The marketing of these products with such claims violates section 505(a) of the Act. Additionally, specific products (Oxysilver, Green Harvest, ElectrOEnzymes, OxySilver Immune Support Hydrosol Concentrate) are misbranded under section 502(f)(1) because they lack adequate directions for use, as their conditions are not amenable to self-diagnosis. The introduction of these unapproved new drugs and misbranded drugs into interstate commerce violates sections 301(d), 505(a), and 301(a) of the Act. The firm is required to take prompt action to correct these violations and prevent recurrence, notifying the FDA within fifteen working days. Failure to comply may result in enforcement actions, including product seizure and injunctions.