FDA WARNING_LETTER - Le Natural, Inc. - April 30, 2011

The FDA issued a Warning Letter to Le Natural, Inc. and 9-12 Corp. regarding their Elevate enhanced fiber water (lemon and orange flavor) products, based on a review of product labels and the website www.elevatewaters.net in April 2011.

The FDA determined that the products are misbranded under section 403 of the Federal Food, Drug and Cosmetic Act (the Act) and are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act. The website, considered labeling, includes therapeutic claims such as "Helps manage diabetes," establishing the products as unapproved new drugs under section 201(p) of the Act, as they are not generally recognized as safe and effective for this condition and lack FDA approval.

Furthermore, the products are misbranded under section 403(r)(1)(B) of the Act due to unauthorized health claims on the website, including "A diet rich in fiber can reduce the risk of cardiovascular disease, obesity, an (sic) high blood pressure" and "The direct benefits of fiber. .. Helps to reduce the risk of cancer." The cancer claim specifically fails to meet requirements under 21 CFR 101.76, as the products are not grain products, fruits, or vegetables. Additionally, the products are misbranded under Section 403(i)(1)