FDA WARNING_LETTER - Awesome Foods, Inc. - May 07, 2009

On December 15, 2009, the FDA issued a Warning Letter to Awesome Foods, Inc. following an inspection from May 6-7, 2009. The inspection and a review of product labels and the company website revealed multiple misbranding violations under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

Key violations include: 1. **Raw Essene Bread** is misbranded under section 403(w) of the Act because its label fails to declare "wheat" as a major food allergen, despite containing "Sprouted Kamut" (Triticum polonicum L.). 2. **Raw Coconut Spread** and **Raw Zucchini Bread** are misbranded under section 403(q) of the Act due to non-compliant nutrition information. The Raw Zucchini Bread's serving size is incorrect (declared as two servings for a single-serving container per 21 CFR 101.9(b)(6)), leading to incorrect nutrient values. The Raw Coconut Spread's serving size is not declared in a common household measure (tablespoons) as required by 21 CFR 101.9(b)(1) and (b)(5)(i). Both products also fail to declare cholesterol content (21 CFR 101.9(c)(3)) and percent Daily Values