FDA WARNING_LETTER - Noni Connection - September 18, 2013

On September 4, 6, 12, 16, and 18, 2013, the FDA inspected Noni Connection dba Puna Noni. The inspection and subsequent review of product labels and the company website (www.nonialoha.com) revealed significant violations.

The products "Puna Noni 100% Pure Hawaiian Noni Fruit Capsules" and "Puna Noni 100% Pure Hawaiian Noni Juice" are deemed unapproved new drugs under section 505(a) and misbranded under section 502(f)(1) of the Act due to disease claims on their labels and website. Examples of these claims include statements about "healing and cancer fighting properties," "less pain," "stronger immune system," and uses for "diabetes, high blood pressure, abnormal growths," and various testimonials for conditions like arthritis, cancer, and high blood pressure. These claims establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease, making them "new drugs" without FDA approval. Furthermore, they are misbranded as adequate directions for use cannot be provided for self-treatment of these conditions.

Additionally, "Puna Noni 100% Pure Hawaiian Noni Fruit Capsules" is adulterated under section 402(g)(1) due to significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations