FDA WARNING_LETTER - Stewart Brothers, Inc. - November 08, 2012

On November 5-8, 2012, an FDA inspection of Columbia Gorge Organic's manufacturing facility in Hood River, Oregon, revealed significant violations. The "SuperBerry Fruit Juice Drink Blend" was found to be adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) because it contains Ginkgo biloba leaf extract (Ginkgo), an unapproved food additive. Ginkgo is not authorized by any food additive regulation, nor is it generally recognized as safe (GRAS) for use in conventional foods, with scientific literature raising safety concerns, including carcinogenic activities in animals.

Additionally, several products were misbranded under Section 403 of the Act. The "Pomegranate Blueberry Cherry with Superfruits" product was misbranded because its "Antioxidant-rich in Plant Polyphenols & Anthocyanins" claim is a nutrient content claim for which no Reference Daily Intake (RDI) has been established, violating 21 CFR 101.54(g). "Protein CoGo 20g Soy Protein Fruit Juice Drink Blend" was misbranded for bearing an unauthorized health claim regarding heart disease risk reduction, as it does not meet "low saturated fat" requirements (21 CFR 101.82(c)(2)(iii)). Furthermore, "Blueberry B'Mega," "Strawberry Super C," and "Super C"