FDA Basics FDA s Import Operations: How FDA Regulates Imported Products

Transcription

1 FDA Basics FDA s Import Operations: How FDA Regulates Imported Products Carlos W. Hernandez Compliance Officer U.S. Food and Drug Administration Global Regulatory Operations and Policy Office of Regulatory Affairs

2 Office of the Commissioner Office of Foods Office of Medical Products & Tobacco Office of Global Reg. Ops & Policy Center for Food Safety & Applied Nutrition Center for Veterinary Medicine Center for Devices & Radiological Health Center for Biologics Evaluation & Research Center for Drug Evaluation & Research Center for Tobacco Products Office of Regulatory Affairs

3 5 FDA Import Divisions Structure 3

4 Products Regulated by FDA It is estimated that more than 20% of the nation s gross domestic product is regulated by the FDA. Human foods (exceptions: most meat and poultry) Animal feeds Cosmetics Drugs (both human and animal) Biologics (including human cells and tissues) Medical devices Electronic products that emit radiation Tobacco Imported products are required to meet the same standards as domestic goods 4

5 The Bioterrorism Act of 2002 Official Title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Title III. Protecting Safety and Security of Food and Drug Supply Regulations Relating to Prior Notice: Sec. 305 Food Facility Registration Sec. 307 Prior Notice of Imports (12/12/2003) Final Rule Effective 5/6/09* *Currently operating under the Food Safety Modernization Act (FSMA) linked Interim Final Rule (IFR) for Prior Notice 5/4/11 5

6 How does FDA decide to take regulatory action? Repeat 483 Points Prior Warning Letter Public Health Threat Positive Samples 6

7 Regulatory Action (continued) FDA provides consumer protection by enforcing the Federal Food Drug & Cosmetic Act (FFD&CA) Imports are addressed in FFD&CA section : Allows for refusal of imported FDA-regulated products for appearing to be adulterated or misbranded based on evidence Adulteration: content of a product (such as the addition of a substance which makes a product inferior, impure, not genuine, etc.) Misbranding: statements on labels or labeling that are false or misleading 7

8 Food Drug & Cosmetic Act FDA RPM Chapter 9 Imports and Exports or otherwise allows FDA to make admissibility decisions using: Historical data Examinations (vs. sample collections) Information from other sources Other evidence 8

9 Food Drug & Cosmetic Act FDA RPM Chapter 9 Imports and Exports shall be refused admission directs FDA s action The intent of the law is to deny importation of violative articles Articles are expected and required to be in compliance at the time of entry Compare to other sections of FDA law (seizure) 9

10 The Import Process US Customs and Border Protection (CBP) is the initial authority for all imported products: Entry is made to CBP If FDA regulated, CBP forwards to FDA FDA then begins its admissibility process 10

11 The Import Process: Entry Review Entry Reviewers FDA has trained individuals who review entry declarations and evaluate the admissibility of a product. Entry reviewers have several options: Release the product Request examination of the product Request additional information or documents Recommend detention of the product 11

12 The Import Process: Examinations Investigators/Inspectors Go out to the port or destination and conduct an examination of the shipment, which may include a physical exam, label review, sample collection. If a sample is collected, it is packaged and shipped to the appropriate laboratory for analysis. The appropriate documentation is completed and data recorded in FDA s database. 12

13 The Import Process: Release Product may be distributed FDA still has jurisdiction Does not preclude FDA action if a problem is found later 13

14 The Import Process: Detention FDA detention is an administrative process NOT a physical hold of the product Importer has the right to take possession of the articles FDA can detain based upon appearance of a violation Importer has the right to give evidence to refute this appearance This is known as the Detention and Hearing Process Based on the evidence, the detention will either stand (refusal) or be overturned (release) 14

15 The Import Process: Detention Importer can also petition to recondition the goods to bring them into compliance Relabeling a misbranded product Cleansing an adulterated product Making a product not FDA regulated Reconditioning must be approved by FDA 15

16 Detention Without Physical Examination (DWPE) Products subject to DWPE are listed in Import Alerts Notice of FDA Action indicating the detention Legal charge(s) for the Detention Division to contact with name and/or phone number Importer of Record and entry Filer (aka Broker) In order to obtain release, the apparent violation has to be overcome 16

17 Import Alerts Provide information to the field offices Field can use this information to detain goods without examining them Keep FDA from having to sample over and over again Products stay on an Import Alert until the firm proves it can produce a compliant product FDA Import Program Website: 17

18 The Import Process: Refusal Final admissibility decision of prohibited merchandise (FDA/CBP Joint Notice) 90 days rule or time-frame to avoid further enforcement action (3x Liquidated Damages) Destruction - CBP form 3499 (FDA Supervision) Exportation - CBP form 7512 (CBP Supervision) Forms 3499 or 7512 must be signed by a CBP or FDA Officer upon supervision 18

19 References CFR Title 21 Part CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 21 CFR Part 1, Subpart J - Recordkeeping Federal Food, Drug, and Cosmetic Act (FFD&C Act) Title 21 of the Code of Federal Regulations (21 CFR) Food Safety Modernization Act (FSMA) Regulatory Procedures Manual (RPM) Investigations Operations Manual (IOM) FDA Import Program 19

20 Questions? 20