As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

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Perfection Bakeries Inc. dba Aunt Millie’s Bakeries
Fort Wayne, IN

In a Sept. 7, 2023 warning letter, the FDA told the bakery owner that the agency has determined that your recalled “Our Family” brand White Hot Dog Enriched Buns (8 count, 12oz. retail unit, UPC #0-70253-75107-3) manufactured between Feb. 9, 2023, and March 20, 2023, were misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, sesame. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. 

Your firm recalled “Our Family” brand White Hot Dog Enriched Buns on March 21, 2023, after you discovered that the product contained sesame, but the printed packaging did not declare sesame. Your firm became aware of the undeclared sesame after being notified by a customer of an allergic reaction to sesame after a child consumed the buns. In documentation provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator on March 21 and 28, 2023, you indicated that your firm reformulated “Our Family” brand White Hot Dog Enriched Buns in January 2023 by adding sesame to the formulation. On February 9, 2023, you received printed plastic packaging for the buns which did not declare sesame in the ingredients statement. Between February 9, 2023 and March 20, 2023, you manufactured the “Our Family” brand White Hot Dog Enriched Buns using the incorrect label, which resulted in undeclared sesame in the product.

On March 28, 2023, you provided documents which indicated that you determined the root cause to be a “lack of label control,” as the receiver accepted incorrect packaging into the plant and the bagger operator used incorrect packaging that did not contain the correct allergen labeling. 

You stated that your action plan includes retraining “bag operators, break people, and supervisors” to check for correct allergen labeling “before being used at point of use”; updating policy to include the “QA manager or designated back-up visually verifying and documenting every receipt of bags before they can be received in (redacted by FDA) and put in the warehouse”; creating a policy that future allergen labeling changes will require a new bag number, “making it impossible to receive old bag into plant”; and creating policy that will require new packaging proofs to be signed off by your company before new packaging can be printed. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.

As of January 1, 2023, sesame is considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. § 321(qq)]. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

• The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewher in the ingredient list (unless the name of the food source that appears elsewher in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].

Your recalled “Our Family” brand White Hot Dog Enriched Buns are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (sesame).

Your facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].

The full warning letter can be found here.