FDA WARNING_LETTER - Cedar’s Mediterranean Foods Inc. - March 01, 2022

The FDA issued a Warning Letter to Cedar’s Mediterranean Foods Inc. following a recall initiated on October 25, 2021, for Cedar’s Organic Mediterranean Hommus. The product was misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act because its labels, intended for Organic Everything Hommus, failed to declare a major food allergen: tree nuts (Pine Nut).

The root cause, as identified by the firm in a November 15, 2021 email, was an employee's failure to follow label changeover procedures and performing an unauthorized label change. The firm stated they retrained employees involved in labeling, took disciplinary action, and plan to develop a label reconciliation program.

The FDA noted that the firm appears to have failed to implement adequate allergen preventive controls, a requirement under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Failure to comply with these provisions is prohibited by section 301(uu) of the Act.

Cedar’s Mediterranean Foods Inc. is required to respond in writing within 15 working days, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure, injunction, or suspension of food facility registration.