FDA WARNING_LETTER - Herbal Papaya - July 31, 2013

The FDA issued a Warning Letter to Herbal Papaya, LLC, following a July 2013 review of their website, www.herbalpapaya.com. The FDA determined that products like "Papaya Seed Extract," "100% Papaya Leaf (Paw Paw Twig)," and "Papaya Leaf with Rooibos Tea" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

The therapeutic claims on the website, including those on product pages, blog posts, YouTube videos, Facebook, and testimonials, indicate the products are intended for disease cure, mitigation, treatment, or prevention. Examples include claims about eliminating intestinal parasites, aiding malaria and dengue fever, reducing cancer risk, regulating blood sugar for Type 2 diabetes, and reducing Alzheimer's risk. The company also cited scientific publications to market products for disease treatment.

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 uses and lack prior FDA approval. Additionally, "100% Papaya Leaf (Paw Paw Twig)" and "Papaya Leaf with Rooibos Tea" are