Image from FDA A warning letter posted to the FDA website on March 5, 2024 described a case involving hamburger chili macaroni skillet meals that were misbranded because milk, a major food allergen, was in the formulation but not declared on the product label. This was initially discovered by a customer and led to a subsequent recall. The company was involved in three previous recalls due to misbranding. The incident resulted when a line operator mistakenly brought the incorrectly labelled packaging to the production line, and failed to verify that the correct packaging was used. The corrective actions submitted by the product manufacturer to the FDA included retraining employees on the firm’s procedures and verification of ingredients in their packages with every product changeover.
A warning letter posted March 5, 2024, indicated that hamburger buns were misbranded because they contained milk that was not declared on the product label. The error was discovered after a consumer reported an allergic reaction to the Michigan Department of Agriculture and Rural Development. The root cause of the issue was a product formulation change introducing milk powder without updating the package label with the new allergen declaration. In their response to the FDA, the manufacturer stated that they had instituted a sign off by ingredient buyers and the owners to prevent reoccurrence. The FDA stated that more was needed to address the root cause of the undeclared major food allergen.
Another warning letter posted February 13, 2024, indicated that hot dog buns were misbranded because they contained sesame, a major food allergen undeclared on the product label. This was identified when a customer notified the company that a child who consumed the buns had an allergic reaction to sesame. The undeclared allergen resulted when the bun producer reformulated the product to include sesame without indicating the change on the prelabeled packaging. In their response to the FDA, the manufacturer determined “lack of label control” to be the root cause because a receiving associate accepted incorrect packaging into the plant and a bagging operator used the incorrect packaging. The company’s corrective action plan includes retraining employees to check for correct allergen labeling prior to use; visually verifying and documenting the label on bags at receipt; require a new bag number for future allergen labeling changes to prevent receipt and use of unlabeled packaging; and require new packaging proofs to be signed off by the company before new packaging is printed.
To help manufactures, allergen controls and labeling requirements are outlined in FDA’s guidance and Compliance Policy Guide. Deibel Laboratories’ advisory services can provide gap assessments to ensure confidence in such controls or provide expertise when responding to FDA visits, form 483’s, or warning letters.