FDA Import Operations Overview Border Port Operations and Enforcement Vince Iacono, Compliance Officer U.S. Food and Drug Administration Southwest Import District Otay Mesa Resident Post 619-661-3250 X102
FDA Southwest Import District • 28 Field Offices Aligned with U.S.-Mexican Ports of Entry • FDA Laws and Regulations are Enforced using U.S. Customs & Border Protection Agency Authorities
General Import Procedures… • An importer, or his/her representative, must file an entry notice and an entry bond with the U.S. Customs & Border Protection (Customs) pending a decision regarding admissibility. • When a FDA regulated product is offered for entry into the U.S., it is subject to sampling and examination.
Entry Review • FDA has trained individuals who review electronic entries to make admissibility decisions. • Entry Reviewers have several options: • Release the product • Request examination or a sample of the product • Request additional information or documents • Recommend detention of the entry • Sample Collection and Analysis • Only About 2% to 3 % are examined or tested • Targeted exams of high risk or known violators • Headquarters or Field Directed Surveillance Sampling
Importers Responsibilities… • Hold the shipment intact until released by both Customs and FDA. • Bond monies may be confiscated if not held • FDA may also prosecute or ask for recall if violative products are distributed. • Assure products being offered for importation comply with U.S. laws and regulations.
Detention… • Detention may be recommended by entry reviewers based upon past history of a product or failure to comply with FDA laws and regulations based on their own observations. • Detention may be based upon FDA lab results. • A Notice of Detention and Hearing is sent to the owner and/or consignee of the product. • The owner and/or consignee may submit a petition to recondition the product to bring it into compliance. • NOTE:Product is allowed to be held under detention at owner’s location, not normally held at border port.
Refusal… • If a product cannot be brought into compliance, or the owner or consignee fails to act on the Notice of Detention, the product will be refused entry. • Refused product must be exported or destroyed. • Allowed 90 days by U.S. Customs • As a general rule FDA will not allow product that is considered a significant health hazard to be exported.
Detention Without Physical Exam (DWPE) • Import Alerts have been developed to communicate guidance to FDA personnel and allow for DWPE of products listed. • Based upon past history of the product and/or other information indicating the product may be in violation. • FDA is given authority to refuse entry based on “appearance” of a violation.
Private Lab Testing • Importer may request to submit third party private lab testing and/or other evidence to overcome the “appearance” of the violation for products detained without physical exam or subject to the Import Alert.
Import Alert 33-10"DETENTION WITHOUT PHYSICAL EXAMINATION OF CANDY DUE TO LEAD" • Current list of specific products by manufacturer subject to detention without exam. • Go to www.fda.gov : http://www.fda.gov/ora/fiars/ora_import_ia33 10.html • Current list of products may grow when new proposed FDA guidance limit of 0.1 ppm lead is enforced.
Other Import Alerts Related to Lead Listing Mexican Imported Products • IMPORT ALERT #52-08, DETENTION WITHOUT PHYSICAL EXAMINATION OF CERAMICWARE DUE TO EXCESSIVE LEAD AND/OR CADMIUM • New Alerts to be added for a Chocolate Drink product and several salt, sugar, chili based products like “Limon 7” that are consumed by children.
Lead Found in Wrapper Inks • FDA must show that the lead in the wrapper has migrated into the candy or food product before an action can be taken. • If this cannot be demonstrated FDA may refer to CPSC.