FDA WARNING_LETTER - E-holistic Health /Hanna Cooper - December 18, 2009

On December 18, 2009, the FDA reviewed the website http://shop.e-holistichealth.com and determined it offered "Flu Nosode" for sale, claiming to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. This product is unapproved and unauthorized by the FDA for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 352.

The website displayed the claim: "Flu Nosode may provide homeopathic aid in support of improving resistance to or recovery from of [sic] H1N1 (Swine Flu) Virus . . .." Although this specific claim was removed, the site continued to use metatags like "H1N1 Swine Flu Nosode Remedy" and "homeopathic remedy for swine flu."

The FDA emphasized that a nationwide public health emergency exists for H1N1. While homeopathic drugs may ordinarily be marketed under FDA's Compliance Policy Guide (CPG 7132.15), this enforcement discretion does not apply during a public health emergency for products claiming to address the emergency disease without FDA approval or authorization.

The FDA demanded immediate cessation of marketing unapproved H1N1-related products. The firm must email FDAFLUTASKFORCE-CDER@fda.hhs.gov within 48 hours,