Background
A food is misbranded under section 403(w) of the Food Drug and Cosmetic Act (FFDCA) if it contains any of the major eight food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) unless the allergen is identified in the ingredient statement or in a contains statement that follows or is immediately adjacent to the ingredient statement. Further, the FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (HRPC Rule) require manufacturers to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented. Labeling that fails to correctly identify the allergens present in a given product renders the food misbranded.
Warning Letters citing inadequate allergen controls
These recent FDA Warning Letters all follow a similar pattern. Each company conducted a voluntary Class I recall for food containing undeclared allergens, provided certain information to the Recall Coordinator regarding the root cause of the misbranding and corresponding corrective actions, and the FDA has not yet (as of the dates of the Warning Letters) conducted a facility inspection to verify implementation of corrective actions.
All five of the Warning Letters note that the FDA “will verify implementation of any corrective actions during FDA’s next inspection of your facility.”
These Warning Letters are significant because they signal that the FDA is strongly focused on the measures facilities can take to manage allergen misbranding issues. In particular, the FDA is placing a high emphasis on developing and effectively implementing allergen preventive controls. Food companies should expect that allergen preventive controls will continue to be a key area of interest for the agency, particularly as part of facility inspections.
Finally, these letters also highlight that a facility inspection is not necessary to trigger a Warning Letter. Each of these actions was premised on information provided to the Recall Coordinator as part of the recall, reinforcing the importance of such communications and the need to engage with legal counsel throughout the recall process.
Please let us know if you have any questions.
Authored by Maile Gradison Hermida and Mary B. Lancaster
