FDA Office of Enforcement and Import Operations Division of West Coast Imports

1. FDA Office of Enforcement and Import Operations Division of West Coast Imports Pacific Island Health Officers Association Meeting Honolulu, HI September 5, 2018 Dan Solis Division Director

2. FDA LEADERSHIP Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. “FDA always faces big challenges because of where it sits at the intersection of so many critical concerns. By virtue of the fact that people’s lives – quite literally – depend on what we do.”

3. Topics • FDA Updates • Division of West Coast Imports Organization Changes • Enforcement under Import Operations • Training in Saipan • Island Touch Base Monthly Calls • Moving Forward

4. FDA OFFICE OF POLICY, PLANNING LEGISLATION and ANALYSIS OFFICE OF GLOBAL REGULATORY OPERATIONS & POLICY Office of the Commissioner Jeremy R. Sharp Dara Corrigan, J.D. Scott Gottlieb, M.D OFFICE OF OPERATIONS OFFICE OF FOODS AND VETERINARY MEDICINE OFFICE OF MEDICAL PRODUCTS & TOBACCO Stephen Ostroff, M.D. Center for Drug Evaluation & Research Center for Devices & Radiological Health Office of International Programs OFFICE OF REGULATORY AFFAIRS ORA OIP CDER CDRH Center for Biologics Evaluation & Research Melinda Plaisier. Center for Food Safety & Applied Nutrition Center for Veterinary Medicine Center for Tobacco Products CBER CTP CFSAN CVM FDA Organizational Chart

5. ORA Organizational Chart ACRA OFFICE OF CRIMINAL INVESTIGATIONS OFFICE OF HUMAN &ANIMAL FOODS OPERATIONS OFFICE OF COMMUNICATIONS & PROJECT MANAGEMENT OFFICE OF MANAGEMENT OCI OHAFO OCPM OM OFFICE OF ENFORCEMENT AND IMPORT OPERATIONS OFFICE OF REGULATORY SCIENCES OFFICE OF MEDICAL PRODUCTS & TOBACCO OPERATIONS OFFICE OF PARTNERSHIPS & OPERATIONAL POLICY OFFICE OF TRAINING EDUCATION & DEVELOPMENT ORS OMPTO OEIO OSPOP OTED

6. Office of Enforcement and Import Operations Division of Enforcement (DE) Division of Import Operations (DIO) Division of Food Defense Targeting (DFDT) Todd Cato Acting Director, Office of Enforcement and Import Operations Division of West Coast Imports (DWCI) Division of Northern Border Imports (DNBI) Division of North East Imports (DNEI) Division of South West Imports (DSWI) Division of South East Imports (DSEI)

8. MAIN IMPORT OPERATIONS OFFICE – Long Beach, CA Airports Seaports CENTRALIZED EXAMINATION STATIONS (CES) International Mail Facility (IMF) Division of West Coast Imports • States of: • Washington (Tacoma, Seattle) • Oregon (Rose City) • Nevada (Las Vegas) • California (Offices in Stockton, Alameda, South San Francisco, Woodland Hills, El Segundo, Long Beach, Carson, Torrance, Ontario, San Diego ) • Hawaii (Honolulu)

9. Division of West Coast Imports Org. Structure DIVISION DIRECTOR • INVESTIGATIONS BRANCH • Import Product Review • Inspect Products • Sample Collections • Request Detentions • Investigations • Inspections • Refusal Exams • Recall • Filer Exams • Seizure of Products at the Border • Release or May Proceed your products • COMPLIANCE BRANCH • Import Product Review • Retail Samples Exam • Label Review • Request Investigations • Detain Shipment • Refuse Shipment • Recondition Review • Seizures • Injunctions/Debarment • Initiate a Criminal Case • Release or May Proceed your products

10. What is OEIO responsible for? • Foods manufactured overseas and imported into US • Imported drug and devices • Health fraud investigations and some recalls • Debarment • All of the above • None of the above

11. IMPORT PROGRAM PRIORITIES • Prescription opioids and unapproved drugs coming in through air and mail • Food Importer inspections and supply chain investigations - FSVP • Interdiction efforts at the ports on all FDA regulated commodities • Supply chain investigations • Joint operations with CBP and PGA

12. Training in Saipan/Monthly Touch Base Phone Conference call Training in Saipan (June 13, 2018) • FDA Import Overview • Foreign Supplier Verification Program (FSVP) • Voluntarily Qualifier Importer Program (VQIP) • FDA Safety and Innovation Act (FDASIA) • Counterfeit Drug Detection and IMF Initiative • FDA Food Labeling Requirement Monthly Pacific Island Call • Specific Training Discussion such as labeling, drug training, FSVP training, etc. • Potential Cooperative Agreement Discussion • Island needs survey development • Future joint operation opportunities

13. Burden of Proof for Imports Defined in FD&C Act in 801(a) …if the article “appears” from the “examination of such samples or otherwise”…to be violative…it “shall” be refused admission

14. FDA Refusal • Reconditioning criteria not met • Product remains in violation (e.g.): • SID • NDA • 510(k), PMA • Color • Labeling

15. Imports Data 2012 - 2017 Shipments Refusals

16. FDA Import Operations Moving Forward • Lessons learned from the survey that can be brought back to the different FDA Offices at HQ • Training in Saipan can be used as additional foundational discussing topics • Possible joint work in the Pacific Islands on interdiction operations • Additional Import Training or other FDA commodities training in 2019 • Guam lab visit in 2019?

17. FORMS OF COMMUNICATION WITH FDA in West Coast • Phone Numbers for Division of West Coast Imports Office in Long Beach, Ca • General status line (562) 256-7700 • Compliance status line (562) 256-7707 • Fax line (562) 256- 7701 • General email address: WCID@fda.hhs.gov • Los Angeles District Consumer Complaint Hotline: (949) 608-3530 • FDA National Emergency Operations Number: 1-866-300-4374 or (301) 796-8240 • FDA General Inquiry: 1-888-INFO-FDA • For Adverse Event of illness call 1-800-FDA-1088 or online • For Drug Inquiries: CDERSmallBusiness@fda.hhs.gov or (866)-405-5367 • For Medical Device Inquiries: industry.device@fda.hhs.gov or (800) 638-2041 • To report e-mails promoting medical products that you think might be illegal, forward the email to:webcomplaints@ora.fda.gov. • Food and Cosmetic Information Center by phone and/or e-mail Monday through Friday, from 10 a.m. to 4 p.m. at 1-888-SAFEFOOD (1-888-723-3366). Or, submit questions by filling out the online form. Note: Fastest response is email. www.fda.gov

18. Thank You For Your Attention! Email address: Dan.Solis@fda.hhs.gov Lawton.Lum@fda.hhs.gov Gordon.Chu@fda.hhs.gov or WCID@fda.hhs.gov

19. Thank you!

20. www.fda.gov