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Donald S. Stein focuses his practice on federal regulatory issues, and in particular U.S. Customs law, trade remedies and trade policy issues. From dealing with imports and the myriad of laws enforced by the U.S. Customs and Border Protection ("CBP"), he has also developed experience in practicing before other federal regulatory agencies, including the U.S. Food and Drug Administration, the U.S. Federal Trade Commission, and the U.S. Fish and Wildlife Service. He is also experienced in working with the U.S. International Trade Commission, the U.S. Department of Commerce, and the Office of the U.S. Trade Representative in connection with trade law and trade policy issues.

In the Customs area, Don has wide-ranging experience representing clients in the apparel and agriculture sectors, as well as in many other industries, in tariff classification, valuation, country of origin and country of origin marking matters, as well as defending clients against Customs detentions and seizures, and claims for penalties, liquidated damages, and/or the redelivery of goods. He has also worked closely with U.S. intellectual property owners to help protect their intellectual property against unauthorized and infringing imports. Under the CBP’s regime of "informed compliance," Don has worked with his clients to advise and ensure that they structure their import operations in a manner that is fully compliant with all CBP rules and regulations. He has also worked with clients to design and implement Customs compliance programs. Additionally, Don assists clients who are subject to CBP audits.

In the trade policy area, Don has represented the interests of clients in trade preference matters (free trade agreements and special trade programs), as well as in matters pending before Congress which may affect their interests. He also provides advice to clients on World Trade Organization related issues.

Don provides advice and assistance to foreign exporters and U.S. importers of foods, cosmetics and other products regulated by the U.S. Food and Drug Administration. He has developed deep knowledge of the FDA’s implementation of the Food Safety Modernization Act ("FSMA"), and has been a featured speaker on FSMA implementation in the U.S. and abroad. In addition to his Customs and FDA-related practices, Don counsels clients with respect to certain matters regulated by the FTC (textile and apparel labeling and "Made in USA" claims) and the U.S. Fish and Wildlife Service.

Concentrations

  • Customs law
  • Trade remedies
  • Trade policy issues
  • Food safety/bioterrorism

Capabilities

Recognition & Leadership

  • Team Member, a Law360 “Product Liability Practice Group of the Year,” 2021-2022
  • Named, Client Service All Star, BTI Client Service All-Stars Report, Federal Regulations, 2014

Credentials

Education
  • J.D., American University Washington College of Law, 1981
  • M.A., The George Washington University, 1979
  • B.A., The George Washington University, 1976
Admissions
  • District of Columbia
  • Supreme Court of the United States
  • U.S. Court of Appeals for the District of Columbia Circuit
  • U.S. Court of International Trade
  • U.S. District Court for the District of Columbia
Languages
  • Hebrew
  • Spanish

Related Capabilities

Customs International Trade Latin America Practice Pharmaceutical, Medical Device & Health Care Litigation Regulatory & Compliance Pharmaceutical, Medical Device & Health Care Retail Manufacturing & Supply Chain Industry Complex Torts