FDA WARNING_LETTER - Nutrient Synergy, Inc - June 30, 2013

The FDA issued a Warning Letter to Nutrient Synergy, Inc. after reviewing their website (www.nutrientsynergy.com) in June 2013, determining that their product, Nepretin, is promoted for conditions that classify it as a drug under the Federal Food, Drug, and Cosmetic Act. The website and product label contain therapeutic claims, including "revolutionary treatment for diabetic retinopathy and nephropathy," and "designed to control complications of diabetes," indicating intent for use in disease cure, mitigation, treatment, or prevention.

Examples of claims cited include Nepretin slowing, stopping, or reversing diabetic retinopathy symptoms, improving eye grade, glycohemoglobin rates, albumin excretion rates, blood pressure, and reducing insulin needs. Testimonials also describe Nepretin's use for treating advanced diabetes, improving eyesight, and stopping eye bleeding. Metatags like "diabetes nephropathy treatment" further support the drug claims.

Nepretin is deemed a "new drug" because it is not generally recognized as safe and effective for these uses and lacks FDA approval, violating sections 201(p) and 505(a) of the Act. Furthermore, it is misbranded under section 502(f)(1) because adequate directions for use cannot be provided for self-diagnosis and treatment by laypersons.

The FDA previously informed Nutrient Synergy of these violations during a June 6, 2013, conference call, where the