It is a prohibited act to fail to meet the requirements of section 418 of the FD&C Act, related to preventive controls, and to fail to comply with the requirements under section 419, related to produce safety. Depending on the nature of the violation, and whether the food is adulterated or misbranded, FDA may consider different regulatory actions. These include:
• the issuance of advisory letters;
• court actions, such as seizure or injunction; and
• Administrative actions, such as administrative detention to gain control of adulterated or misbranded products, mandatory recall of violated food, or suspension of a facility’s food registration to prevent the shipment of food.
For imported food products, FDA may detain and refuse violated entries, or place imported food products on import alerts to inform FDA field staff that they may detain (i.e., initiate a refusal of admission) future shipments of a food without physical examination.
