Pure Prescriptions Inc. – FDA Warning Letter, Sep 30, 2008

The FDA issued a Warning Letter to Pure Prescriptions Inc. on September 30, 2008, following a review of their website, www.pureprescriptions.com. The FDA determined that five products—"Ellagic Defense," "Immpower," "Pau d’ Arco Extract," "Prostate Elements II," and "N-Tense"—were promoted with therapeutic claims that classify them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

The claims, such as "Slowing the growth of abnormal cells in humans" for Ellagic Defense and "The effects of Active Hexose Correlated compounds as a cancer treatment" for Immpower, indicate the products are intended for the cure, mitigation, treatment, or prevention of disease. The letter cited specific examples of claims and references used to market these products for disease treatment and prevention, including citations to scientific articles.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed conditions. Marketing new drugs without prior FDA approval, as required by section 505(a) of the Act [21 U.S.C