FDA WARNING_LETTER - Homeopathy For Health

The FDA and FTC reviewed www.elixirs.com on December 22, 2009, and found the website marketing unapproved products claiming to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. These products, including various "Micro Nutrition Plus Flu" items, BHI Bronchitis, NaturalCare Flu Wellness Kit, Heel Gallium Heel, Standard Homeopathic Nux Vomica, Hyland's Nux Vomica, and Boiron Oscillococcinum, are considered unapproved drugs under the Federal Food, Drug, and Cosmetic Act (FFDC Act), violating 21 U.S.C. §§ 331, 352.

The letter cites numerous specific claims from the website, such as "Supportive help for current H1N1/swine flu concerns," "Seasonal Flu Vaccine 2009-10 is the homeotherapeutic vibration of the current H1N1 flu strains," and "Treatment dose for relief of flu symptoms."

Despite some products being labeled as homeopathic, the FDA states that the enforcement discretion outlined in their Compliance Policy Guide (CPG 7132.15) does not apply during a nationwide public health emergency, such as the H1N1 Flu Virus. The marketing of these unapproved products poses a significant public health threat.

Elixirs.com is required to immediately cease marketing these unapproved products. The