Practice Areas

Drugs, biologics, cosmetics, medical devices, electronic products that emit radiation, and many food products are subject to examination by FDA when they are being imported or offered for import into the United States. Most meat and poultry products are regulated by the U.S. Department of Agriculture. All imported products are required to meet the same standards as domestic goods. For example, imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and claims substantiated; radiation-emitting devices must meet established standards; and all products must contain informative and truthful labeling in English.

The Wood Burditt Group provides assistance to clients that face complex importation issues. We advise clients on the legal and practical importation concerns pursuant to the Federal Food, Drug, and Cosmetic Act, the Prescription Drug Marketing Act, and the Medicare Prescription Drug Improvement and Modernization Act. We assist clients with FDA’s Operational and Administrative System for import Support, as well as the Customs Automated Commercial System. We also assist clients with Import for Export issues, pursuant to the FDA Export Reform and Enhancement Act.

The Wood Burditt Group also offers its clients effective counsel concerning import issues related to the U.S. Department of Homeland Security and Customs and Border Protection.