Download - US FDA Regs & Modernization Act 2012
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Exporting Food and Beverages to the U.SA? Overview of U.S. FDA Regulations & the
new Food Safety Modernization Act
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Seminar Overview
U.S. FDA: Background & Jurisdiction Food, Drug, and Cosmetic Act FDA Food Safety Modernization Act About Registrar Corp Questions & Answers
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U.S. FDA Overview Background and Jurisdiction
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FDA Structure
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Code of Federal Regulations
The Food, Drug, and Cosmetic Act is detailed in what we call the Code of Federal Regulations or “CFR”.
The CFR is a codification of the general and permanent rules published in the “Federal Register”
Title 21 of the CFR is reserved for rules of the Food and Drug Administration.
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Food, Drug, and Cosmetic Act
President Franklin D. Roosevelt signed into law the Food, Drug, Cosmetic Act in 1938.
Remains today the principal law regulating all food, beverages, drugs, cosmetics, and medical devices in the USA.
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Food, Beverages, & Supplements
Center for Food Safety and Applied Nutrition Jurisdiction encompasses most food
products (other than meat and poultry) Agricultural products, processed food,
canned foods, seafood, alcoholic and non-alcoholic beverages, ingredients, etc
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What is the Entry role of CBP?
The U.S. importer of record will hire a Customs Broker, who is licensed by CBP, to submit an “Entry Filing” The entry is filed using the documents you
supply to your U.S. importer (BOL, commercial invoice, packing list)
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What is U.S. FDA’s Entry Role?
If FDA-regulated product, FDA is notified via the entry system.
U.S. FDA will then: 1. Release the product for entry 2. Further review the entry 3. Physically inspect / test the
shipment 4. Refuse entry of the shipment
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U.S. FDA’s Entry Process
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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?)
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PREDICT
PREDICT establishes a risk score by analyzing importer’s shipment information using sets of FDA-developed risk criteria.
Allows FDA to better use limited resources by targeting import inspections
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Key Food Regulations
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Food, Drug, and Cosmetic Act Bioterrorism Act
Registration, U.S. Agent, Prior Notice
Labeling Formats, language
LACF Hazard Analysis and Critical Control
Points (HACCP) Good Manufacturing Practices (GMPs)
Requirements
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Bioterrorism Act of 2002
The Public Health Security and Bioterrorism Preparedness
and Response Act of 2002
=
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Bioterrorism Act of 2002
Effective starting in October 2003 Require companies to register if they
“manufacture, process, pack, or store” Requires designation of a U.S. Agent
for FDA communications Require companies to file Prior Notice
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Registration
FDA provides only a number.
As a private company, Registrar Corp provides a certificate to confirm the registration
Certificate can be provided to prospects, buyers, etc.
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Quick Numbers
FDA estimated 420,000 firms should register worldwide, with 50% outside the U.S.
418, 574 registered as of December 1, 2010 (252,414 foreign; 166,160 U.S.)
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Registered Food Facilities as of December 2010
Japan: 26,326 China: 24,314 Mexico: 20,989 Italy: 16,509 Canada: 15,667 France: 14,796 Korea: 7,290 Vietnam: 6,160 Thailand: 3,601
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Prior Notice (Section 307)
Notify FDA before shipments arrive in U.S. instead of after arrival
Allows FDA to better target imports before they arrive in a U.S. port
Best use of limited resources
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Example of a Prior Notice Confirmation
Prior Notice is NOT an “approval” (FDA
could still inspect) Bar-coded confirmation number issued for each product
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Food Labeling & Ingredients
A top reason product is detained: Incorrect labeling, unapproved ingredients, prohibited health claims
Common errors in trying to avoid problems: Copy other wrong labels Only follow part of the regulations
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Examples of Products Recently Detained due to Labeling Violations
• Cookies • Noodles • Sauces • Canned seafood • Energy drinks
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Bulk Pack versus Retail
FDA Inspectors are given significant freedom in deciding what should appear on “Bulk Pack” formats Common name of the product Latin name if applicable Gross Weight / Net Weight Country of Origin Name/Address of Manufacturer Lot or Tracking Number
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Labels for Retail
Will consumers see your product label? If so, then retail labeling rules apply: Basic Panels
Principal Display Panel (PDP) Information Panel (IP)
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Principal Display Panel (PDP)
Two required elements Statement of Identity (name of food) Net Contents Declaration
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Information Panel (IP)
Three required elements Nutrition Facts Chart Ingredients List Manufacturer Identity
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Nutrition Facts Chart
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Examples of Other Formats
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Other Regulated Elements
Serving Sizes Ingredient List Trans fat & allergens Manufacturers Identity Country of Origin
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Bilingual Labeling
All labels must be in English but may also be in additional languages;
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Product Claims
Four types Nutrient claims Relative Claims Structure/Function Claims Health Claims
Unapproved new drug or dietary supplement? Exporters of dietary supplements often encounter
claim-related detentions
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Before & After
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Low-Acid Canned Food
• Low-Acid, Acidified, Thermally Processed Foods
• Typically produced in Cans, Bottles, Jars, or Tetra Paks
• Food Canning Establishment (“FCE”) Registration required
• Process Filings (“SID”) for each product, each size
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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) Meat and Poultry (9 CFR 417) Juice (21 CFR 120)
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cGMP – 21 CFR Part 110
Guidelines and conditions which must be met to ensure production of safe and wholesome foods.
GMPs required for all food, beverages, and dietary supplements
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Voluntary Certifications
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FDA Food Safety Modernization Act
“FSMA” signed by President Obama 01/04/2011
Phased in over time Most significant update to food safety laws since 1938
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Motivators for FSMA
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food borne diseases
Public health burden that is largely preventable.
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High Profile Cases
Imports in the spotlight Melamine in pet food Illegal antibiotics in aquaculture Better detection of common pathogens,
and strains of new pathogens.
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Burden on Manufacturers and Importers
Port-of-Entry inspection cannot handle increase in imported foods (9,900,000 shipments in 2010 / 27,000 per day; 796,000 inspected)
FSMA makes Importers more responsible for quality of products from foreign manufacturers
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Vision of FSMA
Prevention
Inspections, Compliance,
and Response
Import Safety
Enhanced Partnerships
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Key Components
1. Prevention Mandatory preventive controls for food
companies - Final rule due July 2012 Mandatory produce safety Standards -
Final rule due January 2013
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Key Components
2. Inspections, Compliance, and Response Mandated inspection frequency - Immediate Records access – Immediate Each food facility must renew its U.S. FDA registration
every two years (4th quarter of every even-numbered year). October 2012
Mandatory recall - Immediate Expanded administrative detention - Effective July 2011 Suspension of registration - Effective June 2011
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Key Components
4. Import Safety Voluntary Qualified Importer Program -
Implementation due June 2012 Foreign Supplier Verification Program
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Key Components
5. Enhanced Partnerships Reliance on inspections by other agencies,
including foreign governments Third Party certification - System due
January 2013
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New User Fees New FDA User Fees: 10/01/2011 FDA Hourly Rates:
$224 per hour, domestic $325 per hour, foreign travel
Charged for DWPE Petition Review Reconditioning Re-Inspections
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New User Fees Reinspection Fees
Will be charged to the facility’s U.S. Agent listed in Section 7 of the food facility registration module
That could be your importer who you listed in your registration as your U.S. Agent
The person or company listed will likely be unwilling to continue to serve as your U.S. Agent for FDA communications
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U.S. Agent Responsibilities
US Agent is designated in Section 7, FFRM
US Agent must:
Reside in USA
Be available 24/7
Answer questions as though they are answering for registrant
Should know how to deal with FDA.
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New User Fees Reinspection Fees include:
Traveling to and from the facility Preparing reports Analyzing samples Examining labels
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Registration Suspension FDA may suspend a food facility’s
registration. Effectively stops any foreign manufacturer from exporting to the U.S.
Registration may be held in suspension until FDA determines the cause to be rectified and that no further health consequences exist.
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Administrative Detention Allows FDA to proactively detain food for 30
days if suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern.
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Inspections and Detentions
FDA’s inspection or reinspection of a facility, or detention of a shipment, can have serious impact on business Warning Letters DWPE OASIS
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FDA Inspection Notice
Notice of inspection is sent by email to the U.S. Agent listed in the FFRM
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Reasons for Inspection
Routine schedule Response to reported problem Fulfillment of FSMA mandate
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FSMA Foreign Facility Inspection Schedule
2011- 600 Foreign Inspections 2012- 1,200 Foreign Inspections 2013- 2,400 Foreign Inspections 2014- 4,800 Foreign Inspections 2015- 9,600 Foreign Inspections 2016- 19,200 Foreign Inspections
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Detentions in Port of Entry
“Adulteration”: filth, e.coli, salmonella, etc. “Misbranding”: improper label or claims Failure to make required electronic filings
Registrations Process Filings Prior Notices
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“Notice of FDA Action” Example
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OASIS http://www.accessdata.fda.gov/scripts/importrefusals
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What’s Next with FSMA?
U.S. FDA must now promulgate the regulations:
Federal Register Notice: Proposed Rules
Comment Period Final Rules
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One Big Challenge…
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Proactive versus Reactive
Investing in compliance is much cheaper than reacting to a failed inspection or detention in the U.S.
Detentions mean demurrage, laboratory testing fees, warehousing fees, cost to “recondition” product, return freight, possible FDA fees, and loss of a customer.
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How can you prepare now?
Do you have your 11-digit registration number and 8-character PIN?
Verify that the information in your FDA registration is up-to-date, especially your contact details (phone, fax, email)
Determine who is listed as your U.S. Agent in your FDA Food Facility Registration (does their email work? Are they still in business?)
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How can you prepare now?
Make sure your U.S. Agent is aware of FSMA and is a reliable communications link between FDA and you
Will they forward emails from FDA? Will they answer the phone if FDA calls?
Will they know how to answer an FDA question?
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Food & Beverage Services - FDA Food Facility Registrations - Registration Renewals in 2012 - U.S. Agent / Pre-Inspection Audits - Food Labeling Reviews - Low-Acid & Acidified Canned Food Registrations - Prior Notice Filings - Detention Assistance - All services are fixed fee, no hourly rates
P: +757-224-0177 F: +757-224-0179 E: [email protected]
www.registrarcorp.com