Boyer Law Firm assists businesses and individuals who are subject to the regulatory authority of the U.S. Food and Drug Administration (FDA) and related agencies. Our attorneys are knowledgeable and prepared to assist you in obtaining the proper licensing, inspections, FDA Agent and permits to properly import your products to the United States.
FDA Agent and Inspections
Anyone who sells a food product in the U.S., whether from abroad or domestically, must comply with the same FDA requirements. Before entry to the U.S., imported products must undergo FDA inspection to determine whether the products meet the standards as domestic products and are admissible to the U.S. commerce or if they violate any provision of the rules and regulations that apply. Some of these requirements include registering the foreign food facility with the FDA, giving the FDA proper notice before offering a food product for import to the U.S., and using appropriate packaging and food labels.
Additionally, for importers of food products, the FDA requires any foreign entity that is engaged in the manufacturing or processing of any products (not just food products) that are imported to the United States to assign a U.S. FDA Agent for the entity. The U.S. Agent must be a disinterested party that is not involved in your business or the import of your business’s products. You may only designate one U.S. Agent, and that agent must either reside in the U.S. or maintain a place of business in the U.S. and must be available to answer the phone during normal business hours. We can be this Agent.