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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States August 1989

Final
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs

BACKGROUND:

19 CFR 18.21(b) states: "Narcotics and other articles prohibited admission into commerce of the United States shall not be entered for transportation and exportation and any such merchandise offered for entry for that purpose shall be seized, except that exportation or transportation and exportation may be permitted upon written authority from the proper governmental agency and on compliance with the regulations of such agency."

*For example,* a shipment of amygdalin was entered for transportation and exportation and was seized by the U. S. Customs Service as a prohibited article. The importer was notified that consideration for release for export of the article must be obtained from the Food and Drug Administration. The importer wrote us requesting such release for export. In response, we informed the importer that we fully supported the U. S. Customs Service in their action and that we would not authorize the exportation of the article, since the importation, exportation, or other shipment in interstate commerce of amygdalin is prohibited by the Federal Food, Drug, and Cosmetic Act.

POLICY:

FDA supports the use of seizure by the U.S. Customs Service under authority of 19 CFR 18.21(b) of articles regulated by FDA, which are offered under a Transportation and Exportation Entry (T & E), if certain conditions are met. Such conditions may be: the article poses a hazard to health, consists of gross filth, or represents a gross consumer fraud *or we have reason to believe the article may be offered for entry into the U.S. at a later date or that its routing might be deviated during transit.*

If Customs has seized and the importer requests release of the article for export; if Customs inquires whether they should seize; or if we believe Customs should seize under the authority of 19 CFR 18.21(b) articles regulated by FDA offered under a Transportation and Exportation Entry (T & E), the facts should be sent to the appropriate *Center* for action and/or consideration.

*Material between asterisks is new or revised*

Issued: 11/26/76
Revised: 10/1/80, 8/31/89

 

Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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