Main Street Cafe Bloomer, LLC – FDA Warning Letter, Apr 29, 2015

On April 17 and 29, 2015, the FDA inspected Main Street Cafe Bloomer, LLC, identifying several labeling violations. The 10" M&M pie was deemed adulterated because it contained FD&C Yellow No. 5, but failed to declare it in the ingredient list, violating 21 U.S.C. § 342(c) and 21 CFR 74.705(d)(2).

Multiple products were misbranded under 21 U.S.C. § 343(w) for failing to declare major food allergens. The 10" M&M, 10" Butterfinger, and 3" Tart Pie Peanut Butter Heath products did not declare wheat (from "Oreo Crumb"). The 10" Butterfinger pie also failed to declare egg (from "Vanilla Silk"). The 3" Tart Pie Peanut Butter Heath product failed to declare egg, almonds, soy, and milk (from "Vanilla Silk," "Chopped Heath English Toffee," and "Graham Cracker Tart shells").

Furthermore, the 10" M&M, 10" Butterfinger, and 3" Tart Pie Peanut Butter Heath products were misbranded under 21 U.S.C. § 343(i)(2) and 21 CFR 101.4 for not declaring