From time to time industry inquires whether regulated products can be manufactured in a Foreign Trade Zone (Free Trade Zone) and exported without meeting the requirements of the laws and regulations administered by the Food and Drug Administration.
Foreign Trade Zones are provided in the United States by the U. S. Customs Service for the trade to hold or otherwise manipulate goods for an unlimited period of time awaiting a favorable market in the U. S. or nearby countries without being subject to customs entry, payment of duty, tax, or bond. The location of an establishment in a Foreign Trade Zone has absolutely no bearing on the jurisdiction of the Food and Drug Administration or the applicability of the laws it administers.
For the purposes of the laws enforced by the FDA, Foreign Trade Zones are part of the United States and the movement of regulated products into or out of such zones, including export, constitutes interstate commerce. Therefore, regulated products in Foreign Trade Zones must comply with those laws that come within the purview of FDA.
*Reference: See United States v. Yaron Laboratories, Inc., 365 F. Supp. 917 (N.D Calif., 1972.)*
*Material between asterisks is new or revised*
Revised: 10/1/80, 8/31/89
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.