FDA issued a Warning Letter to a PA bakery operation. The primary issue was putting allergens in the Contains statement, but not including those items in it the formulation.
The "bread loaf products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations. The Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product is misbranded for a similar reason; the product label includes walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements; however, these nuts are not ingredients in the formulation of the product. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls."
The company also tried to say brown sugar was a natural flavor. "Flavor were not declared on the label, and you stated that the Brown Sugar Powder and the (b)(4) ingredients meet the definition of “Natural Flavors” and are considered to be included as that on the label. According to 21 CFR § 101.22(a)(3), the term “natural flavor” means “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR §§ 182.10, 182.20, 182.40, and 182.50 and Part 184, and the substances listed in 21 CFR § 172.510. If these ingredients do not meet the definition of natural flavor contained in 21 CFR § 101.22(a)(3), they may not be declared as such on the label."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bimbo-bakeries-usa-inc-672140-06172024
WARNING LETTER
Bimbo Bakeries USA, Inc.MARCS-CMS 672140 — JUNE 17, 2024