Overview of U.S. FDA Regulations for Greek Manufacturers and Exporters of Food & Beverages

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1 Overview of U.S. FDA Regulations for Greek Manufacturers and Exporters of Food & Beverages Coley Anderson, Director of Industry and Government Relations March 20 th, 2016

2 Seminar Overview Advantages of Exporting to the U.S. U.S. FDA and the Import Process Key FDA Regulations Food, Drug, and Cosmetic Act Bioterrorism Act Food Safety Modernization Act Summary and Q&A

3 Advantages of Exporting to the United States Opportunities for Growth

4 Why Export to the United States? The United States is the world's largest economy and the largest exporter and importer of goods and services. GDP of $16.77 trillion USD

5 In 2015, the U.S. imported an estimated Seafood: $17.2 billion Fruits & Frozen Juices: $14.2 billion Vegetables: $9.9 billion Meat products: $11.9 billion Bakery products: $8.7 billion And much more Total U.S.-imported food: $116.8 billion

6 The U.S. Market 317 million consumers Large variety of ethnicities, ages, climates, etc. Diversity of tastes and incomes provides a market for any product 6

7 Multiple Types of Distribution Supermarkets & Grocery Stores

8 Multiple Types of Distribution Niche Grocers & Specialty Food Stores

9 Multiple Types of Distribution E-Commerce

10 U.S. Greek Relations Close political and economic allies Strong commercial ties more than 580 million USD in direct foreign investment in 2014 Both the U.S. and Greece are members of the World Trade Organization

11 U.S. FDA and the Import Process What to Know Before You Export

12 Before you export The U.S. is a regulated market, so many rules apply Not complying with U.S. Food and Drug Administration regulations has negative consequences Prepare in advance to avoid costly mistakes 12

13 FDA Structure

14 Your View of the Export Process Manufacturer/Exporter U.S. Importer/ Distributor Shipping Documents/ Payment Mechanisms Licensed Custom Broker Submits Shipment Info to CBP FDA is Notified FDA Makes Admissibility Decision

15 FDA s View of Import Process

16 FDA Review of Entry What U.S. FDA does depends on: The history of the manufacturer, importer (have they had other violations?) and even the country The risk level of the product: type (seafood?) and presentation (fresh?) PREDICT Risk score

17 Reasons for Detentions in Port of Entry Adulteration = filth, E.coli, salmonella, etc. Misbranding = improper label or claims Failure to make required electronic filings Failure to have renewed your Facility Registration in 2016 Lack of Process Filings for each size product required to have an SID Failure to file Prior Notice

18 Key FDA Regulations Three Important Laws

19 Beginnings Pre-1906: No regulation Upton Sinclair s The Jungle Pure Food and Drug Act of

20 Food, Drug, & Cosmetic Act Elixir Sulfanilamide President Franklin Delano Roosevelt Food, Drug, and Cosmetic Act LACF = Low-Acid Canned Food GMPs = Good Manufacturing Practices Labeling & Ingredients Creation of the FDA 20

21 Requirements for Low-Acid/Acidified Canned Foods (LACF) Low-Acid, Acidified, Thermally Processed Foods Typically produced in Cans, Bottles, Jars, or Tetra-Paks Food Canning Establishment ( FCE ) Registration required Process Filings (Submission Identifiers or SID ) for each product, each size Important factors are ph and Water Activity 21

22 HACCP Focuses on the prevention of hazards Can be applied throughout the food chain From farm to table. Currently required for Seafood (21 CFR 123) Juice (21 CFR 120) 22

23 cgmp 21 CFR 110 GMP requirements include: Sanitation Employee hygiene and hygienic practices Equipment construction, maintenance and calibration Pest Control Facility construction Water quality 23

24 The Bioterrorism Act of 2002 Effective since October 2003 Requires companies to register if they manufacture, process, pack, or store food Requires designation of a U.S. Agent for FDA communications Require companies to file Prior Notice 24

25 Food Facility Registration Greece 1,178 Turkey 1,066 Bulgaria 374 FYROM 89 Albania - 33 Italy 10,125 25

26 Registration Statistics Food Facility Registration by Country United States Japan France Italy China Mexico Canada

27 FSMA 27

28 FSMA: Preventive Control (PC) Rule Food Safety Plan Food Safety Plan Exempt: farms, retail establishments, qualified facilities, and others First deadline: Sept. 17 th,

29 FSMA: Foreign Supplier Verification Program (FSVP) U.S. Importers Verify that foreign suppliers are FDA compliant Foreign Suppliers Show U.S. importers that you re FDA compliant How? U.S. importer must perform supplier verification activities Sampling and testing Review of records Onsite audits 29

30 Summary Registrar Corp s Solutions for your Business

31 How can I prepare to export? Register with U.S. FDA and be sure your Registration is Valid: Renewal is required between October 1, 2016 and December 31, 2016, and every even year thereafter Correct food and beverage labeling File prior notice correctly Prepare and implement a food safety plan Speak with your U.S. importer concerning FSVP

32 Common Misconceptions The FDA reviews each food product on the market for safe ingredients. The FDA reviews each food product label on the market. FDA requires submission of labels for pre-market review. FDA automatically inspects registered facilities. FDA inspects all food products coming into the U.S.

33 Summary The U.S. is a huge potential market for Greece Large, diverse market open to new products Many distribution options to explore But, be prepared: U.S. FDA is a regulator, not a market promoter. Registrar Corp can help!

34 FDA & Your Company s Digital Footprint

35 FDA Compliance Monitor

36 Registrar Corp s Solutions Registrar Corp provides a full range of fixed-fee compliance services: Registration & U.S. Agent Service FSMA Compliance Package (includes FSVP audit) Prior Notice Filings Label, Ingredient, and Product Review LACF and Food Safety Services (Mock FDA Inspections, etc) Detention Assistance DWPE Petition Submissions FDA Compliance Monitor

37 FSMA Compliance Package FDA Foreign Supplier Compliance Package Food Safety Plan Review (up to three products) FDA Compliance Monitoring (up to 50 facilities) Onsite Food Safety Audit (FSVP Audit) (excludes travel and lodging) Food Defense Plan Creation or Review Labeling and Ingredient Review (up to three products) FCE-SID Process Filings (unlimited) Food Facility Registration and U.S. Agent Service (as required under 21 CFR 1.225) Detention Assistance

38 Registrar Corp Worldwide Offices

39 Question & Answers

40 Contact Us Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA P: F: E: Registrar Corp Greece Mesogion Avenue GR Athens Greece P: ext. 25 F: E:

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