FDA WARNING_LETTER - Zone Of Natural Remedies

On May 18, 2010, the FDA reviewed www.zoneofnaturalremedies.com and issued a Warning Letter concerning the marketing of unapproved products for the H1N1 Flu Virus during a nationwide public health emergency. The firm offers "FluGo" and "BaniFlu" with claims to diagnose, mitigate, prevent, treat, or cure H1N1. These products are not approved or authorized by FDA for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act) and/or the Public Health Service Act (PHS Act), specifically 21 U.S.C. §§ 331, 352, 355, and 42 U.S.C. § 351(a). Furthermore, "BaniFlu" is classified as an unapproved biologic. Although labeled as homeopathic, these products do not qualify for enforcement discretion under FDA's Compliance Policy Guide (CPG 7132.15) due to the H1N1 public health emergency. The FDA requires the firm to immediately cease marketing all unapproved H1N1-related products and review all labeling and promotional materials for compliance. The firm must email FDA within 48 hours detailing corrective actions. Failure to comply could lead to enforcement actions like seizure, injunction, or criminal prosecution, and the firm will be added to FDA's public list of non-compliant entities.