National Bakery Inc – FDA Warning Letter, Feb 10, 2011

An FDA Warning Letter was issued to National Bakery Inc. following an inspection from February 8-10, 2011, identifying multiple misbranding violations under the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101. Key deficiencies include the failure to declare wheat, a major food allergen, on Pumpernickel and Seedless Rye Bread labels (21 U.S.C. 343(w)). Additionally, these products failed to list all common or usual names of ingredients (21 U.S.C. § 343(i)(2), 21 CFR 101.4(a)(1)). Bakery Cinnamon Raisin Bagels were cited for not declaring trans fat on the nutrition facts panel (21 U.S.C. 343(q), 21 CFR 101.9(c)(2)(ii)). Further labeling issues included the Pumpernickel Bread lacking an appropriate household measure, the Cinnamon Raisin Bagel's net weight not being expressed in pounds (21 CFR 101.105(j)(l)), intervening material on Pumpernickel and Seedless Rye Breads (21 CFR 101.2(e)), and a missing footnote on these breads (21 CFR 101.9(d)(9)). The firm is responsible for ensuring compliance and must provide a written response within fifteen working days detailing corrective actions, with potential regulatory action like seizure or injunction if violations are not addressed.