FDA WARNING_LETTER - Feel Good Natural Health

On May 18, 2010, the FDA reviewed www.feelgoodnatural.com and found it offering unapproved products, "Thymo Immune Booster" and "Influenzinum 9c," for sale in the U.S., claiming to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. "Influenzinum 9c" is also classified as a biologic. These actions violate 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).

Examples of violative claims include "Increased protection from H1N1 Swine flu" for Thymo Immune Booster and "Flu Shot Alternative for 2009/2010 Flu Season – Includes H1N1 Swine Flu Protection" for Influenzinum 9c. The FDA emphasizes that due to a declared public health emergency for H1N1, the usual enforcement discretion for homeopathic drugs under CPG 7132.15 does not apply to these unapproved products.

The FDA demands immediate cessation of marketing these products to U.S. customers. The company must email FDAFLUTASKFORCECDER@fda.hhs