1. 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

2. FDA Southwest Import District 28 Field Offices Aligned with U.S.- Mexican Ports of Entry 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 FDA Laws and Regulations are Enforced using U.S. Customs & Border Protection Agency Authorities

3. 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. 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. When a FDA regulated product is offered for entry into the U.S., it is subject to sampling and examination.

4. Entry Review FDA has trained individuals who review electronic entries to make admissibility decisions. FDA has trained individuals who review electronic entries to make admissibility decisions. Entry Reviewers have several options: Entry Reviewers have several options: Release the productRelease the product Request examination or a sample of the productRequest examination or a sample of the product Request additional information or documentsRequest additional information or documents Recommend detention of the entryRecommend detention of the entry Sample Collection and Analysis Sample Collection and Analysis Only About 2% to 3 % are examined or testedOnly About 2% to 3 % are examined or tested Targeted exams of high risk or known violatorsTargeted exams of high risk or known violators Headquarters or Field Directed Surveillance SamplingHeadquarters or Field Directed Surveillance Sampling

5. Importers Responsibilities… Hold the shipment intact until released by both Customs and FDA. Hold the shipment intact until released by both Customs and FDA. Bond monies may be confiscated if not held Bond monies may be confiscated if not held FDA may also prosecute or ask for recall if violative products are distributed.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. Assure products being offered for importation comply with U.S. laws and regulations.

6. 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 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. 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. 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. 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.NOTE:Product is allowed to be held under detention at owner’s location, not normally held at border port.

7. 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. 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. Refused product must be exported or destroyed. Allowed 90 days by U.S. CustomsAllowed 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.As a general rule FDA will not allow product that is considered a significant health hazard to be exported.

8. Detention Without Physical Exam (DWPE) Import Alerts have been developed to communicate guidance to FDA personnel and allow for DWPE of products listed. 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. 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.FDA is given authority to refuse entry based on “appearance” of a violation.

9. 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. 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.

10. 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. 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.htmlGo to www.fda.gov : http://www.fda.gov/ora/fiars/ora_import_ia33 10.html http://www.fda.gov/ora/fiars/ora_import_ia33 10.html 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.Current list of products may grow when new proposed FDA guidance limit of 0.1 ppm lead is enforced.

11. 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 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. 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.

12. 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. 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. If this cannot be demonstrated FDA may refer to CPSC.

13. Questions?