U.S. FDA Regulations for Exporting Food to the United States. Presented by: David Lennarz President, Business Development & Operations

Transcription

1 U.S. FDA Regulations for Exporting Food to the United States Presented by: David Lennarz President, Business Development & Operations

2 Overview FDA Overview Food Facility Registration Prior Notice Food Canning Establishment Requirements Labeling Rules FDA Inspections FSMA HARPC Food Safety Plans (and Importer s FSVP) Qualified Facility Attestation Finding Customers Questions & Answers 2

3 How does the FDA work? Common myths FDA approves facilities FDA approves products FDA requires submissions of labels or an inspection before marketing products For food and beverages Regulator / Rule-maker Enforcer / Police 3

4 How does FDA work? Enforcement Inspections Import Refusals Import Alerts Warning Letters Suspension of registration Civil and criminal penalties 4

5 Registration, U.S. Agent, & Prior Notice Basic FDA Requirements 5

6 FDA Food Facility Registration and the Biennial Registration Renewal 6

7 Food Facility Registration Registration required under the Bioterrorism Act of 2002 for facilities that manufacture, process, pack or store food (including beverages and dietary supplements) Foreign facilities must designate a U.S. Agent 7

8 Food Facility Registration Exemptions Trading companies Personal residences Transportation only Farms Retail Food Establishments Fishing Vessels USDA-regulated facilities 8

9 Food Facility Registration Information Facility Information (name, corporate entity type, physical location, trade names used to do business) Contact Information (telephone, address, emergency contact, preferred mailing address) Product Information (general product categories) 9

10 Food Facility Registration Renewal Every two years, on even-numbered years Facilities must consent to FDA inspection Failure to renew results in invalidated registration, is a prohibited act

11 Next Renewal Period: October 1 to December 31, 2018! Failure to Renew = Cancelled Registration FDA removed thousands of food facility registrations that were not properly renewed for 2016 from its registration database on February 1,

12 Registration Statistics January 2016 Malaysia 639 Singapore 227 Indonesia Myanmar - 90 Thailand 1492 Vietnam 1485 Cambodia -36 Philippines February 2017 Malaysia (46% decrease) Singapore 117 (48% decrease) Indonesia 601 (41% decrease) Myanmar 49 (46% decrease) Thailand 849 (43% decrease) Vietnam 806 (46% decrease) Cambodia 24 (33% decrease) Philippines 373 (50% decrease) 12

13 Verification Steps 1. US Agent verification 2. 3 rd party authorization Both verification steps apply to new registrations, renewals, and cancellations. FDA will not confirm any of these transactions until both the US Agent and the authorizing individual for a 3 rd party submission has submitted a receipt code to agree to their respective designations. 13

14 Prior Notice Notification to FDA NOTE: Required even for samples Detention in port if not filed Includes information about the shipment and the facility May be filed by exporter, importer, or third party 14

15 An Additional Requirements Food Canning Establishment (FCE) Registration 15

16 Typical Products 16

17 Food Canning Establishment Low-Acid Canned Food Final ph > 4.6 ( certain tomato products > 4.7) Water activity (a w ) > 0.85 Common examples: green olives in brine, artichokes, figs in syrup, roasted peppers, etc. Acidified Food Final ph 4.6 Water activity (a w ) > 0.85 In cans, glass, semirigid and flexible pouches 17

18 FCE Wizard & SID Verifier Identify whether your products are subject to FCE-SID regulations Receive and share a PDF report detailing the possible requirements Verify if a particular SID is currently on file in FDA s database Avoid time-consuming detentions and entry errors at port 18

19 New Nutrition Labeling Requirements 19

20 Regulatory History 2014: Based upon new research and nutritional data, FDA issued two Proposed Rules to modify the current Nutrition Facts Label 2015: Supplemental proposed rule addressed "added sugars May 27, 2016: Two Final Rules issued that mandate new Nutrition Facts Label 20

21 New Content Changes New mandatory declarations: vitamin D, potassium, added sugars Vitamin A and C now voluntary Calories from fat may no longer be declared New definition for dietary fiber New units for vitamin D, niacin, vitamin A, vitamin E, folate/folic acid 21

22 Standard Label Format Changes Changes made to the order of nutrients Changes made to the footnote Changes made to the font sizes of the declarations Quantitative amounts of certain vitamins/minerals required 22

23 Additional Format Label Changes Changes to other formats permitted for special packaging Simplified Linear Tabular 23

24 Compliance Dates Compliance Dates FDA allows industry time to incorporate the new rules into their packaging Based upon the annual food sales of the manufacturer Sales > $10 Million: Jan 01, 2020 Sales < $10 Million: Jan 01,

25 Labeling Food as Organic Regulated by USDA There are four ways that foods may be labeled as organic: 1. Products made with 100 percent organic ingredients may use the USDA Organic Seal or the term 100 percent organic. 2. Products made with at least 95 percent organic ingredients may use the USDA Organic Seal or the term organic. 3. Products made with 70 to 95 percent organic ingredients may use the phrase made with organic. 4. Products made with less than 70 percent organic ingredients may only disclose individual organic ingredients in the ingredient statement. 25

26 Prop 65 California requires clear and reasonable warning on products that contain chemicals known to cause cancer or reproductive toxicity. Warnings must be prominently displayed Format and content depends on the nature of the toxin and the type of exposure (e.g. consumer product, food, alcoholic beverage) List of Subject Chemicals: 65/proposition-65-list 26

27 FDA Food Facility Inspections 27

28 Foreign FDA Food Facility Inspections FDA inspections are designed to: Identify food safety problems before products arrive in the U.S. or enter interstate commerce Determine compliance status of facilities Help FDA make admissibility decisions Ensure that food products meet U.S. requirements under the FD&C Act. Note: An FDA establishment inspection is a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA. 28

29 Foreign Food Facility Inspection Facility s risk profile: Product Risk Process Complexity Selection Facility compliance history (refusal rates, previous inspection results, etc.) New exporters shipping large volumes Convenience typically FDA inspects 4-8 facilities on one trip 29

30 Inspection Process: Notice of Inspection Notice is sent by to registrant s as indicated in the food facility s FDA registration Notice is also sent to U.S. Agent via will come 30

31 Key Points: Inspection Process : Notice of Inspection 5 Days to Respond Provide additional data Refusal to respond or refusal to allow an inspection may cause increased sampling, refusal of admission, or other regulatory action. 31

32 Inspection Process: Factory Profile Information Form Once you reply, FDA s Office of Regulatory Affairs will contact you: May take days, weeks, or months (or never) Coordinate inspection date Ask you to complete and return a Factory Profile Information form to FDA FDA will then come back with name of investigator, their flight info, ask you to make hotel reservations, and maybe even ask you to provide ground transportation. 32

33 FDA Inspections FDA inspection are more than just routine GMP reviews Some may be targeted at specific industry issues If the facility handles any major food allergens, the inspection may also focus on: Allergen control plan Potential cross-contact Cleaning and sanitation protocols Use of rework Production sequencing Traffic patterns Factory separation Labeling 33

34 Applicable FDA Regulations A single inspection may focus on multiple requirements For example, a canned tuna product may be inspected for compliance with: Seafood HACCP (21 CFR 123) Low Acid Canned Foods (21 CFR 113) Current GMP (21 CFR 110) / (21 CFR 117) Food Labeling (21 CFR 101) Emergency Permit Control (21 CFR 108) 34

35 Inspection Process: Day 1 Inspection is typically 2 days Day 1: Introductions Opening Meeting Quick Tour Document Review 35

36 Day 2: Inspection Process: Day 2 Most time spent in factory Closing meeting with management Delivery of form 483 Inspectional Observations 36

37 After the Inspection FDA will eventually classify the inspection: No Action Indicated (NAI) Voluntary Action Indicated (VAI) - Official Action Indicated (OAI) FDA discloses the final inspection classification in an online database 37

38 OAI Actions Warning Letter (which you could respond to) and perhaps a Close Out Letter Detentions at the port Registration suspension Re-inspection under FSMA 38

39 Recommendations Preparedness is critical Most companies think they are prepared, but they re not. Having a review by an external expert is often highly beneficial Immediately address simple issues found during the inspection process Respond to the 483 with evidential solutions, not with vague answers 39

40 The biggest change in 70 years Food Safety Modernization Act 40

41 What is FSMA? The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. 41

42 Seven Rules of FSMA Preventive Controls for Human Preventive Controls for Animals 3rd Party Accreditation FSVP Produce Safety Sanitary Transport Intentional Adulteration 42

43 Preventive Controls Food Safety Plan 43

44 Preventive Controls Hazard Analysis Recordkeeping Preventive Controls Corrective Action Food Safety Plan Supply Chain Program Monitoring Procedures Verification Recall Plan 44

45 HACCP to HARPC Developed in the 50s Critical Control Points Required for seafood and juice Expansion and industry standard 45

46 HACCP vs. HARPC Hazard Analysis and Critical Control Points Food for astronauts Post-process deterioration Critical control points Hazard Analysis and Risk-based Preventive Controls An ounce of prevention is worth a pound of cure. Supply Chain Program and Recall Plan Individual responsibilities 46

47 Preventive Controls Food Safety Plan Written by a Preventive Controls Qualified Individual (PCQI) Signed by the owner or managing agent of the facility 47

48 Preventive Controls Risk Analysis Identify and evaluate the risks associated with a certain food Naturally occurring Unintentionally introduced Adulteration for economic gain Biological, chemical (including radiological), and physical 48

49 Preventive Controls Preventive Controls Steps to ensure food is handled in a sanitary manner Eliminate or reduce the risks associated with the foods Examples Sanitation Controls Process Controls Allergen Controls Recall Plan Supply Chain Program 49

50 Preventive Controls Supply Chain Program Verify controls applied by your suppliers Put controls in place for uncontrolled hazards Only use approved suppliers Determine adequate supplier verification activities Documentation 50

51 Preventive Controls PC Management Components Verification Validate controls Verify monitoring and corrective actions Calibrate instruments Product sampling and testing Record review 51

52 Preventive Controls PC Management Components Monitoring How to monitor the preventive controls Adequate frequency Recordkeeping 52

53 Preventive Controls PC Management Components Corrective actions What to do in case of a non-compliance Recordkeeping Maintain records for at least two years after their creation 53

54 Preventive Controls Exemptions and modified requirements: Retail establishments (restaurants and stores) Qualified facilities Juice and Seafood HACCP Alcoholic beverages Dietary supplements USDA products Farms Unexposed, packaged food in warehouses 54

55 Compliance Deadlines (Human Food) Compliance deadlines for all covered human food facilities have passed. Facilities with >500 full-time equivalent employees: September 19 th, 2016 Small businesses (<500 employees): September 18 th, 2017 Very small businesses/qualified facilities: September 17,

56 Compliance Deadlines (Animal Food) Facilities with >500 full-time equivalent employees: September 18 th, 2017 Small businesses (<500 employees): September 17 th, 2018 Very small businesses/qualified facilities: September 17,

57 Qualified Facility Attestation Compliance deadline for very small human food businesses passed on September 17, These facilities must either: Submit Qualified Facility Attestation to FDA by December 17, 2018, or Implement a written HARPC Food Safety Plan and Supply Chain Program 57

58 Qualified Facility Attestation Exempts qualified facilities from Preventive Controls requirements to: Maintain a written Hazard Analysis and Risk-based Preventive Controls (HARPC) Maintain a written Supply-Chain Program. 58

59 Who Qualifies for the Exemptions? Very Small Businesses: Businesses (including all subsidiaries and affiliates collectively) that have averaged less than $1,000,000 (adjusted for inflation) in global sales of food for human consumption plus the market value of unsold food inventory per year during the previous three calendar years 59

60 Qualified Facility Wizard Determine whether your facility is eligible to file an attestation at 60

61 Enforcement of Preventive Controls How will FDA enforce this requirement? Audit of importer s Foreign Supplier Verification Program ( FSVP ) Facility inspections What is a Foreign Supplier Verification Program? Another requirement of FMSA, placed on Importer Just like you have to develop a Food Safety Plan, your Importers have to develop a FSVP 61

62 Enforcement of Preventive Controls What are the consequences for failure to comply? FDA Warning Letters Import Alerts Detentions and Refusals in Port Suspension of registration Civil and criminal charges Damage to company image 62

63 Finding Customers 63

64 Finding Customers 64

65 Final Advice 65

66 Registrar Corp s Solutions Registrar Corp provides a full range of fixed-fee compliance services: Registration & U.S. Agent Service Prior Notice Filings Labeling, Ingredient, and Product Review LACF FCE Wizard, SID Verifier Food Safety and FSMA Compliance Services Mock Inspections, Food Safety Plans, FDA Compliance Monitor Detention Assistance DWPE Petition Submissions 66

67 67

68 Let us be your resource on FDA regulations. Questions & Answers 68

69 Contact Us Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA P: F: