HWW Enterprise Group – FDA Warning Letter, Mar 31, 2011

The FDA issued a Warning Letter to HWW Enterprise Group following a March 2011 review of their website, http://www.omega-3.us. The agency determined that the product "Omega 3 Salmon Oil Plus" is promoted with therapeutic claims that cause it to be an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Claims such as reducing heart disease risk, lowering blood pressure, improving depression, treating various cancers, alleviating arthritis, and preventing conditions like preeclampsia and erectile dysfunction, establish the product's intent for disease cure, mitigation, treatment, or prevention. This marketing violates the Act. Additionally, the product is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use, as its intended conditions are not amenable to self-diagnosis. The introduction of this misbranded drug into interstate commerce is a violation of section 301(a). As an unapproved new drug under section 201(p), it cannot be legally marketed without prior FDA approval as described in section 505(a). HWW Enterprise Group must promptly correct these violations and notify the FDA within fifteen working days, detailing corrective actions and providing documentation, or face potential enforcement actions like product seizure and injunctions.