FDA WARNING_LETTER - Polydna - March 31, 2011

The FDA and FTC issued a Warning Letter to Tal Davidson of PolyDNA following a March 2011 review of their websites, www.polyDNA.com and www.gene-eden.com. The product "Gene-Eden" is promoted with therapeutic claims for conditions such as flu, Epstein-Barr, Herpes, Hepatitis, and HPV, causing it to be an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act). Marketing this product without prior FDA approval, as required by section 505(a) of the Act, is illegal. Additionally, the product is misbranded under section 502(f)(1) of the Act because its labeling lacks adequate directions for use. The FTC also cited violations of the FTC Act (15 U.S.C. § 41 et seq.) for advertising disease prevention, treatment, or cure claims without competent and reliable scientific evidence. PolyDNA must take prompt action to correct these violations, review all marketing materials, and ensure compliance. The firm is required to notify FDA and FTC in writing within fifteen working days of the specific corrective steps taken. Failure to comply may result in FDA enforcement actions like product seizure and injunctions, and FTC actions including injunctions or orders for consumer repayment.