The U.S. Food and Drug Administration (FDA) has the power to inspect, detain, and refuse all imported food, drugs, biologics, cosmetics, and medical devices under its jurisdiction that enters the United States. These imported products must comply with the appropriate FDA rules and regulations and may be detained or refused entry into the United States if the product appears to be violative.
Fuerst Ittleman has experience helping companies take a more proactive role and avoid detentions by the FDA by ensuring fully compliant products prior to entry. For those companies that are already in detention through an Import Alert or other reason, we work with the agency and assist with submitting appropriate testing or documentation to remove the appearance of the violation that resulted in the detention and have the product entered into the United States.
It is important for any importer to be in compliance with the FDA rules and regulations. Once the product is refused entry by the FDA, the importer must export or destroy the products, which results in losses that impact the corporate bottom line. For example, detentions of a perishable item that is not dealt with promptly can result in that item being non-saleable at the end of the detention period or if the product is seized then the result is complete forfeiture of the goods. That translates to a loss of profit, loss of time, loss of product and even loss of customers who went elsewhere to fulfill their need of your imported product.
Products are detained and refused for many reasons including an existing Import Alert. Import Alerts result in automatic detention of any product that is included on the Import Alert. The importer must then demonstrate that the products are compliant and not violative. Import Alerts are issued for all types of products, ingredients, manufacturers, country of manufacture, and many other reasons. We have worked successfully with the FDA Division of Import Operations and Policy (DIOP) to have clients removed from Import Alert or placed on an exemption list to the Import Alert so that their imported products are no longer automatically subject to FDA detention.
For more information how Fuerst Ittleman can help your business with importation into the United States, please contact us at contact@fuerstlaw.com or (305) 350-5690.
