Donuts Deluxe – FDA Warning Letter, May 26, 2011

An FDA inspection of Donuts Deluxe's facility in Vadnais Heights, Minnesota, on May 23-26, 2011, revealed significant deviations from food labeling regulations (21 CFR Part 101), causing their "French Bread" product to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Undeclared Major Food Allergen:** The French bread is misbranded because its label fails to declare wheat, a major food allergen, despite "flour" (derived from wheat) being an ingredient. This violates section 403(w) of the Act. 2. **Undeclared Sub-ingredients:** The French bread is misbranded under section 403(i)(2) because sub-ingredients of "enriched bromated flour" and "yeast" (containing sorbitan monostearate and ascorbic acid) are not declared on the label, as required by 21 CFR 101.4(a)(1) and 101.4(b)(2). 3. **Missing ZIP Code:** The French bread label lacks the ZIP code, violating 21 CFR 101.5(d).

The FDA acknowledged a June 10, 2011, response to the Form FDA-483 but noted that the response