Online Marketer of Homeopathic H1N1 Remedies Receives Warning

WASHINGTONIn a June 8, 2010, joint letter, FDA and FTC warned an Internet marketer of homeopathic products for treating the H1N1 flu virus that such marketing is out of regulatory compliance. The agencies found the company, Homeopathy for Health, offering a variety of homeopathic remedies via its Web site from companies including Celletech/Micro-Nutrition Plus, Heel Inc., NaturalCare, Hylands Homeopathic, Standard Homeopathic Company and Boiron Borneman (all of which were ccd on the warning letter). The products were marketed with quite specific claims relating to the current swine flu concern or H1N1 virus.

FDA and FTC note homeopathic products can be manufactured and distributed without FDA approval or authorization under FDAs Compliance Policy Guide, Conditions Under Which Homeopathic Drugs May Be Marketed (CPG 7132.15). However, the agencies determined the enforcement discretion under which the remedies are marketed is not unlimited. They reason because the Secretary of Health and Human Services (HHS) considers H1N1 flu a public health emergency with the potential to affect national security, the enforcement discretion does not apply to any product, homeopathic or not, that has not been approved or authorized by FDA.

The agencies were seeking response within 48 hours regarding how Homeopathy for Health will address the violations cited in the warning letter. Until the claims or products are cleared, the products and Web sites remain on FDAs special Web site listing firms that have received warning letters related to H1N1 Flu Virus products.