Herman's Bakery – FDA Warning Letter, Sep 29, 2011

On February 22, 2012, the FDA issued a Warning Letter to Herman's Bakery following an inspection from September 14-29, 2011. The inspection revealed multiple misbranding violations under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101 for products including Long Johns, Raspberry Bismarks, Snowballs, and Glazed Raised Donuts.

Key violations include: 1. **Misbranding due to undeclared major food allergens (Section 403(w)):** Labels failed to declare wheat and soy, present in ingredients like "Flour" and "milk powder." Long Johns with nuts did not specify "peanuts" as a major allergen, only stating "With Nuts." 2. **Misbranding due to undeclared sub-ingredients (Section 403(i)(2)):** Product labels did not list all component ingredients for "Flour," "milk powder," Bavarian Creme filling, Apple-Black Raspberry Pastry filling, and ground peanuts. 3. **Misbranding due to undeclared artificial coloring (Section 403(k)):** Long Johns (Cream Filled) and Raspberry Bismarks contained artificial colors (Yellow 6, Blue 1, Red 40) that were not declared on labels. 4. **Misbranding due to undeclared artificial flavors (Section 403