FDA WARNING_LETTER - Bob's Red Mill Natural Foods, Inc. - December 14, 2011

On December 13-14, 2011, the FDA inspected Bob's Red Mill Natural Foods, Inc. in Milwaukie, Oregon, and found significant food labeling violations under 21 CFR Part 101. A sample of "Whole Grain Low-Carb Bread Mix" was collected and analyzed, revealing it was misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act.

The product's label declared 11 grams of protein per 21-gram serving, but FDA analysis found 8.15 grams (74.1%) and a check analysis found 7.67 grams (69.7%). This misbranding falls under Section 403(a)(1) as the protein content was less than 80% of the declared amount, violating 21 CFR 101.9(g)(4)(ii).

Further misbranding under Section 403(q) was identified due to incorrect nutrition facts formatting. The declared serving size of "1 Slice (21 g dry mix)" was incorrect; the Reference Amount Customarily Consumed (RACC) for bread is 50 grams, requiring the serving size to be the amount of mix needed to make 50 grams, declared in an appropriate household measure (21 CFR 101.12(c)(2)). Additionally, sodium content and percent