Food Requirements and FSMA 101712

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Food Requirements and FSMA 101712 Powered By Docstoc
					 FDA Regulatory
 The Food Safety
Modernization Act
 Presented by Anna Benevente,
  Senior Regulatory Specialist
         Registrar Corp
         October 2012
                Seminar Overview

1.   FDA: Background & Jurisdiction
2.   U.S. Agencies Regulating Food Products
3.   Key Food Regulations
4.   FDA Food Safety Modernization Act (FSMA)
5.   FSMA Requirements Currently in Effect
6.   FSMA and Inspections
7.   Detentions
FDA: Background &
            U.S. Regulation Overview

 The Constitution authorizes Congress to pass laws, which
  are then signed by the President.
 Acts of Congress, e.g. Food, Drug and Cosmetic Act, are
  codified in the “United States Code,” which is cited as
 The executive departments and agencies like FDA may
  promulgate “regulations.”
 Regulations are promulgated through a lengthy process
  called "Notice and Commentary," to satisfy the requirements
  of the Due Process Clause of the U.S. Constitution.
           U.S. Regulation Overview

 Proposed regulations, notices, public commentaries,
  agency responses to the commentaries, and eventually
  the final regulations are published in the “Federal
  Register” as they occur.
 Final regulations are codified in the “Code of Federal
  Regulations” (C.F.R.).
 Guidance Documents are non-binding recommendations
  that contain U.S. FDA’s current thinking about a subject.
         Code of Federal Regulations

 The Food, Drug, and Cosmetic Act is detailed in what
  we call the “CFR” or Code of Federal Regulations.
 The CFR is a codification of the general and permanent
  rules published in the Federal Register by the Executive
  departments and agencies of the Federal Government.
 Title 21 of the CFR is reserved for rules of the Food and
  Drug Administration.
  Food, Drug, and Cosmetic Act (FDCA)

 President Franklin Delano
  Roosevelt signed into law the
  Food, Drug, Cosmetic Act
  in 1938.
 That law remains today the
  principal law regulating all food,
  beverages, drugs, cosmetics and
  medical devices in the USA.
                  FDA Regulates:

 Food, Beverages, Health Supplements
 Cosmetics
 Veterinary Drugs
 Medical Devices
 Radiation-Emitting Products
 Drugs: OTC, API, Prescription
 Biologics: blood, tissues, vaccines
 Tobacco
FDA Structure
                Dual Role of FDA

FDA really plays two roles:

   Gatekeeper: licensing body that decides what drugs,
    medical devices, food additives, etc, are appropriate
    for the marketplace. They set product standards, often
    with public & industry input.
   Police: enforcer of regulations. They issue “Warning
    Letters,” work with CBP on seizures, and with the
    DOJ on criminal prosecutions.
     U.S. Agencies
Regulating Food Products
      Food, Beverages, & Supplements

Center for Food Safety and Applied Nutrition (FDA)

   Jurisdiction encompasses most food products (other
    than meat and poultry)
   Agricultural products, processed food, canned foods,
    seafood, alcoholic and non-alcoholic beverages
    (including bottled water), seafood, etc
       Other Agencies Regulating Food

 U.S. Department of Agriculture
   Food Safety and Inspection Service (FSIS)
   Animal and Plant Health Inspection Service (APHIS)
   National Organic Program
 Department of Justice
   Alcohol and Tobacco Tax and Trade Bureau (TTB)
 Department of Homeland Security
   U.S. Customs and Border Protection (CBP)
                    USDA/FDA Overlap

USDA and FDA often both regulate a product:
   If you grow and pack fresh fruit and vegetables for export, you fall under
    FDA and USDA;
    • USDA, along with FDA, controls for pesticide residues.
   If you produce canned juice from the fruit,
    you fall under FDA alone;
    • Facility Registration, LACF regulations, etc.
 Products with 3% or more raw meat or 2% or more cooked meat
  or 30% or more fat, tallow or meat extract regulated by USDA
 Products containing 2% or more cooked poultry; more than 10%
  cooked poultry skins, giblets, fat and poultry meat in combination
  regulated by USDA
     Department of Homeland Security:
     Customs and Border Patrol (CBP)

CBP is responsible for enforcing import and export laws
in our approximately 317 official ports of entry.
           What is FDA’s Entry Role?

 If FDA-regulated product, FDA is notified via the entry

 U.S. FDA will then:
      1. Release the product for entry
      2. Further review the entry
      3. Physically inspect the shipment
      4. Refuse entry of the shipment
FDA’s Entry Process
             FDA Review of Entry

What U.S. FDA does depends largely on:
  The history of the country,
   the manufacturer, and the importer
   (have they had other violations?)
  The product category: drug, food,
   medical device, or cosmetic? (risk level)
  Nature of the product: fresh juice,
   fresh seafood, canned fruit? (risk level)

 PREDICT = Predictive Risk-based Evaluation for
  Dynamic Import Compliance Targeting
 Risk-based screening system that quantifies the risk of
  imported food shipments
 First tested for seafood products in the
  port of Los Angeles in 2007
   Pilot program was generally considered a success
   Since been expanded

 PREDICT establishes a risk score by analyzing
  importer’s shipment information using sets of
  FDA-developed risk criteria.
 Risk criteria include:
   Violative histories of the product, importer, manufacturer,
    consignee, and country of origin;
   Results of laboratory analysis and foreign facility inspections;
   General intelligence on recent world events
    that may affect the quality of a particular food.
                  A Complex Web

 The U.S. food agencies have over the years become a
  complex web, making it very confusing for foreign
  exporters, and even for U.S. companies.
 Each agency has their own jurisdiction, and their own
  set of regulations to enforce.
 And in the end, a balance between industry self-
  regulating (if you sell me bad product…) and
  government enforcement.
Key Food Regulations

 Food, Drug, and Cosmetic Act
  Bioterrorism Act
   • Registration, U.S. Agent, Prior Notice
  Labeling
  Formats, language
  LACF – Low Acid Canned Food
  HACCP – Hazard Analysis and Critical Control Point
  GMP – Good Manufacturing Practices
            Bioterrorism Act of 2002

 The Public Health Security and Bioterrorism
  Preparedness and Response Act of 2002
 Effective starting in October 2003
   Who, What, Where, When, and How
 Requires companies to register
 Requires designation of a U.S. Agent for foreign
  companies for FDA communications
 Require companies to file Prior Notice
              United States Agent

 Foreign Establishments
 must notify FDA of the
 name, business name,
 address, phone number,
 and email address of
 their United States
 Agent. The US Agent
 must reside or maintain
 a place of business in
 the US.
               United States Agent

 U.S. Agents have been designated since 2003, and
 foreign companies have not had to update that
 information since the initial designation

 Since 2003, many customs brokers and importers have
 allowed foreign companies to designate them as the
 required “U.S. Agent”
           Registration (Section 305)

 Can’t register suppliers…they need to register on their
 Can’t “share” numbers… each factory or storage
  location has its’ own number
 Technically the law does not require exporters, brokers,
  traders, or transporters to register, but many do simply
  to have their own number
           Prior Notice (Section 307)

 Must 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
         Food Labeling & Ingredients

Strict regulations concerning:
   Formatting (font size, etc.)
   Specific Required Declarations (Manufacturer, Net
    Quantity, Statement of Identity, Ingredients)
   Nutrition Fact Charts
   Supplement Facts Charts
   Permitted Ingredients
   Health Claims
Standardization = Comparison
         Principal Display Panel (PDP)

 The Principal Display Panel (PDP) is the primary side
  of the label that the consumer will view --- this is
  usually the front of the package
 Two required elements
   Statement of Identity
    (common or usual name of food)
   Net Quantity Declaration
            Information Panel (IP)

 The Information Panel (IP) is the label panel
  immediately to the right of the PDP
 Three required elements
  Nutrition Facts/Supplement Facts Chart
  Ingredients List
  Manufacturer Identity
  Must be presented with no
   intervening information
Nutrition Facts Chart
Examples of Other Formats

         STRICT rules govern when each can be used
Supplement Facts Chart
Examples of Other Formats

                   Use dictated by the
                   package configuration
                   and type of dietary
                   ingredients found in the
                    Serving Sizes

 The serving sizes that appear on food labels are based
  on FDA-established lists of "Reference Amounts
  Customarily Consumed Per Eating Occasion."
 The reference amounts, which are part of FDA
  regulations, are broken down into 139 FDA-regulated
  food product categories (e.g., “cookies 30g”)
 Dietary supplements must use the “the maximum
  amount recommended… per eating occasion.”
                  Ingredients List

 Must appear with the Nutrition Facts or Supplement
  Facts Chart, no intervening information
 Ingredients must be listed in descending order of
  predominance by weight by common/usual name
  (no “E” designations or trade names)
 Must be at least 1/16 of an inch
 Specific requirements for the
       listing of colors
Manufacturer/Distributor/Packer Identity

 Must give actual corporate name
 Must appear with Chart and Ingredients, no intervening
 If not the actual manufacturer, company name must
  have a qualifying phrase that states the relation to the
  product, e.g., "manufactured for" or “distributed by”.
 Must be at least 1/16 of an inch
 Requires the firm name, street address, city or town,
  country, and a postal code
   Street address not required if found in a local directory
                 Country of Origin

 The Tariff Act of 1930 requires that the country of origin
  statement be placed on the label in a conspicuous
 If a domestic firm's name and address is declared as the
  firm responsible for distributing the product, then the
  country of origin statement must appear in close
  proximity to the name and address and be at least
  comparable in size of lettering.
 “Product of Mexico” or “Made in Mexico”
   Food Allergen Labeling and Consumer
     Protection Act of 2004 (FALCPA)
 FDA estimates that:
   Approximately 2 percent of adults and about 5 percent of
    infants and young children in the United States suffer from
    food allergies; and
   Each year, roughly 30,000 individuals require emergency room
    treatment and 150 individuals die because of allergic reactions
    to food;
 Eight major foods or food groups--milk, eggs, fish,
  Crustacean shellfish, tree nuts, peanuts, wheat, and
  soybeans-- account for 90 percent of food allergies

 If your product contains ingredients that are any of the
  allergens specified by FALCPA, they must be declared
  either immediately after the ingredients list in a
  statement that reads, “Contains Wheat, Eggs…” or in
  the ingredients list by listing the source allergen of the
  ingredient in its common name, e.g. “Flour (from
 FDA is currently considering comments related to
  “advisory labeling” such as “produced on machinery
  that also processes [allergen]”
                   Bilingual Labeling

 All labels must be in English
 Common reason for detention
 If the label, boxes, or inserts contain any representations
  or declarations in a foreign language, then all required
  statements must also appear in that language on that
  particular label (excluding mottos)
 You may choose to include:
   Two Nutrition Facts charts, or
   A bilingual Nutrition Facts chart.
                     Product Claims

 Nutrient Content Claims
 • “high in calcium,” “good source of vitamin C”
 Relative Claims
 • “light sour cream,” “reduced sodium potato chips”
 Structure/Function Claims
 • “calcium supports bone strength,” “fiber maintains regularity”
 Health Claims
 • Specifically reference disease, must be approved by FDA:
 • Ex. “Development of cancer depends on many factors. A diet low in total
   fat may reduce the risk of some cancers.” Must meet FDA definition for
   “low fat”
                    Product Claims

 Unapproved new drug or dietary supplement?

  Exporters of dietary supplements often encounter
   claim-related detentions
   • Does it “cure cancer” or
   • Does it “support immunity”
           Correcting Existing Labels

 Correcting label mistakes in any manner may be
  acceptable if the final label is correct and complies with
  all regulations at the time of retail sale.
 Stickers should not cover other mandatory labeling, and
  should adhere tightly.
 Be sure to follow stringent Nutrition Facts Chart/
  Supplement Facts Chart formatting guidelines.
            Common Misconceptions

 There is no “licensing” or “approval” process for labels
 (except for meat & poultry and alcoholic beverages)
   Common mistake – copying other wrong labels
 Just because it is approved for use in the EU does not
  mean that it is permitted in the US
 Bar codes, lot numbers, and expiration dates on food are
  not regulated by FDA
 Labeling compliance does not mean just the label
  affixed to product – applies to websites, brochures,
  advertising, etc.
             Common Misconceptions

 Use of the “®” for a Trademark
   In order to use the registered trademark symbol “®”on your
    labeling, your product must be a registered trademark in the
    U.S. U.S. Customs and Border Protectiono may seize any
    goods which violate this rule and subject the violator to
 "TM" is used for marks that are not yet registered in the
  U.S. Patent and Trademark office and puts the public on
  notice of your claim of ownership.
Food Labeling Example - Before
Food Labeling Example - After
           Additional Requirements

 Low-Acid Canned Food Regulations

 Hazard Analysis and Critical Control Point

 Good Manufacturing Practices
   FDA’s Office of Low-Acid & Acidified
         Canned Foods (LACF)
 In the 1970’s several life-threatening botulism outbreaks
 occurred due to
   Inadequate thermal processing of commercially prepared low-
    acid foods packaged in hermetically sealed containers
   improper acidification of commercially prepared acidified
                FDA LACF Office

 FDA’s office of Low-Acid Canned Food oversees the
 registration of factories that produce low-acid or
 acidified canned foods.
         What Is Required for LACF?

 Registration of the facility that produces the product as
  a Food Canning Establishment (FCE)
 Filing of processing information for all low-acid or
  acidified foods produced in the factory (SID)
 Coding on the packaging that identifies
   the establishment where the product was packed
   the product contained therein
   the year, day, and period during which it was packed.
                   What is FCE?

 Registration of the physical location that produces the
  product (note: not the office, not the importer,
  not the warehouse, etc)
 The factory is assigned a 5 digit number (e.g. FCE #
 Only one number is assigned per factory
 Traditionally, this process takes 5-10 weeks
      What Is a “Process Filing” (SID)?

 An SID is a number assigned to the filings
  of your scheduled process information for
  Low-Acid or Acidified canned food with the FDA.
 Process Filings are required for each product produced
  at the factory that falls under LACF regulations.
 Each Process Filing is assigned an SID number
  (“Submission Identifier”).
             Low-Acid Canned Foods

 Have an equilibrium pH value greater than 4.6 and
  water activity greater than 0.85,
 Are sealed in a hermetic, air-tight container (i.e., secure
  against the entry of microorganisms),
 Receive a heat treatment for the purpose of achieving
  commercial sterility, and
 Are normally stored and distributed under non-
  refrigerated conditions.
                  Acidified Foods

 Are low-acid foods to which acid(s) or acid food(s) are
  added for the purpose of reducing the pH to a finished
  equilibrium pH of 4.6 or below,
 Have a water activity greater than 0.85, and
 Are stored and distributed under non-refrigerated
                Fermented Foods

 Are naturally fermented whereby the pH of the food is
 reduced to 4.6 or below by the production of acid from
 the growth of acid-producing microorganisms.

 May be “excluded” from FCE/SID
Common FCE-SID Detained Products

        Coconut Milk
        Herbs in Oil
        Peppers in Vinegar
        Hot Sauce
        Sweet Custard
        Mango Juice
          Is a Process Filing Needed?

 Registrar Corp uses a variety of factors to determine if a
  product needs a Process Filing.
 Important factors include pH, water activity,
  fermentation, carbonation, etc.
 We provide clients a questionnaire, which helps us begin
  to make the determination.
        You might need FCE-SID if…

 Acidified and Low-Acid food will almost always
 require FCE and SID registration.

 A product with a pH > 4.6 and water activity > 0.85
 requires an FCE and SID registration.

 A product with acid added to pH < 4.6 and water
 activity > 0.85 requires an FCE and SID registration.
     You might NOT need FCE-SID if…

 A product with a pH > 4.6 but with a low water activity
  will not require FCE or SID.
 Fermented foods not covered by regulations will not
  require FCE or SID.
 Carbonated or Alcoholic beverages generally will not
  require FCE or SID.
 Foods that are stored, distributed and retailed “under
  refrigeration” do not require FCE or SID.
    Hazard Analysis and Critical Control
             Point (HACCP)
 Management system: a systematic approach to the
  identification, evaluation and control of food safety
 Based on common sense application of science and
  technology to
   Plan,
   Control, and
   Document
  the safe production of foods.
 HAACP Is (Currently) Mandatory for…

 Seafood Products (21 CFR 123)

 Meat and Poultry Products (9 CFR 417)

 Juice Products (21 CFR 120)
  Current Good Manufacturing Practices

 Guidelines and conditions which must be met to ensure
 production of safe and wholesome foods.

 Found in 21 CFR 110
                  cGMP Includes:

 Personnel (cleanliness, training, disease control)
 Plants & Grounds (construction and design
 Sanitary Operations (pest control, sanitizing, storage,
  handling of equipment
 Sanitary Facilities and Controls (water supply,
  plumbing, sewage disposal, handwashing facilities)
                 cGMP Includes:

 Equipment and Utensils (properly maintained, nontoxic,
  bonded seams, calibrated)
 Processes and Controls (handling of raw materials for
  safety, manufacturing operations conducted to prevent
 Warehouse & Distribution (storage and transportation
  designed to prevent contamination)
 Natural / unavoidable defects that present no health
  hazard: can contact FDA for “defect action levels”
FDA Food Safety and
 Modernization Act
    FDA Food Safety Modernization Act

 “FSMA” signed by President Obama 01/04/2011
 Phased in over time thru 2016
 Most significant update to food safety laws since 1938
              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.
                 High Profile Cases

 Imports in the spotlight

   Melamine in pet food and infant formula
   Illegal antibiotics in aquaculture
   Better detection of common pathogens, and strains of
   new pathogens.
Imports of FDA-Regulated Food Have
    Almost Doubled Since 2002
           Burden on Manufacturers
                and Importers

 Port-of-Entry inspection cannot handle increase in
 imported foods

 FSMA makes Importers more responsible for quality of
 products from foreign manufacturers
               Vision of FSMA


                                 and Response

                 Import Safety

 Mandatory preventive controls for food companies -
 Final rule was due July 2012 (not published yet)

 Mandatory produce safety Standards -Final rule due
 January 2013
               Preventative Controls

 Scientifically- and risk-based practices that facilities use
  to address hazards to which their products might be
 “Preventive Controls” may incorporate HACCP, food
  defense plans, and other prerequisite programs
  (Employee Training, etc.)
 Seafood and Juice facilities are exempted from FSMA’s
  “Preventive Controls” if following HACCP
 LACF exempted from requirement of preventative
  controls of microbiological hazards if following HACCP

 Food Facility Registration Renewal
      Oct 1 – Dec 31, 2012
 Mandated inspection frequency - Immediate
 Records access - Immediate
 Testing by accredited laboratories –
  (Establishment of accreditation program due
  January 2013)

 Mandatory recall - Immediate
 Expanded administrative detention - Effective July 2011
 Prior Notice refused entry in other countries- Effective
  August 2011
 Suspension of registration - Effective June 2011
 Enhanced product tracing abilities - Implementation
  of pilots due September 2011
 Additional Record Keeping of high risk foods -
  Implementation due January 2013
           Enhanced Partnerships

 Reliance on inspections by other agencies,
 including foreign governments

 Third Party certification - System due January
              Registration Renewal

 Each food facility must renew its U.S. FDA registration
  every two years (4th quarter of every even-numbered
  year). Starting October 1 through December 31, 2012
 System not currently online
 No indication from FDA of when it may become
 No indication of whether the Dec 31, 2012 deadline will
  be extended
                    Prior Notice

 Filers need to indicate whether a food product has been
 refused entry to another country
           Latest Developments

 New  User Fees
 Registration Suspension
 Administrative Detentions
 Voluntary Qualified Importer Program
 Foreign Supplier Verification Program
 New Dietary Ingredients Guidance
                  New FDA User Fees

 New FDA User Fees Effective October 1, 2012
 FDA Hourly Rate For Reinspections and
   $221 per hour, domestic
   $289 per hour for foreign travel
            FSMA Reinspection Fees

 Invoiced to the foreign facility’s designated “U.S.
 That could be an importer who agreed to act as the U.S.
 That could be YOU ----- if you have been designated as
  the “U.S. Agent” by a foreign food facility’s FDA

 “Reinspection” is one or more inspections subsequent to
 such an inspection which identified non-compliance
 materially related to a food safety requirement.
                  New FDA User Fees

 Reinspection Fee
   Fee is based on the number of direct hours, including:
   time spent conducting the physical surveillance at the facility,
   whatever components of such an inspection are deemed
   making preparations and arrangements for the reinspection
                   New FDA User Fees

 Reinspection Fees
   traveling to and from the facility
   preparing any reports,
   analyzing any samples
   examining any labels if required
   performing other activities until the facility is in compliance.
                 New FDA User Fees

 “Reconditioning Fees” on Imported Food
   Fees must be paid by owner of food or importer, depending on
   Fees must be paid at the hourly rate for all expenses in
    connection with arranging, conducting, and evaluating the
    results of examinations and additional examinations of product
                  New FDA User Fees

 “Reconditioning Fees” on Imported Food
   Will be charged where reconditioning is required to bring food
    into compliance
   Will be charged even if product is destroyed
Fees Related to Import Alerts (DWPE)

                   Will be charged where
                    food is detained by an
                    Import Alert
                   No charge if food is
                    detained, not subject to
                    an Import Alert, and
                    Shipper or Importer
                    submits satisfactory proof
                    that food is not
  Fees Related to Import Alerts (DWPE)

 Exporters applying for removal from DWPE must pay
 FDA's hourly charges for evaluating the application,
 including the cost of inspecting the foreign facility if
                 New FDA User Fees

 Not Complying with a Recall Order
   (1) Not initiating a recall as ordered by FDA
   (2) Not conducting the recall in the manner specified by FDA
   (3) not providing FDA with information regarding the recall as
    ordered by FDA.
   An importer who does not comply with a recall order is
    responsible for paying the fee
   The party paying the fee would be the party that received the
    recall order.
            Registration Suspension

 FDA’s power to suspend the registration of food
  facilities effectively closes any facility that created,
  caused, or is responsible for food having a reasonable
  probability of adverse health consequences to humans or
 FDA may also suspend registration of facilities
  suspected to have prior knowledge or involvement in
  introducing such food into commerce in the United
             Registration Suspension

 Registration may be held in suspension until U.S. FDA
  determines the cause to be rectified and that no further
  health consequences exist.
 FDA also announced its right to require “corrective
  action plans” from suspended facilities as proof that no
  further health consequences exist.
            Administrative Detention

 Allows FDA to proactively halt food suspected of
  adulteration or misbranding at the border instead of
  being required to wait for a proven health concern.
 If FDA suspects food to have been produced or
  processed in unsanitary conditions, the agency may
  administratively detain food products for up to 30 days.
                Import Safety

 Voluntary Qualified Importer Program

 Foreign Supplier Verification Program
                       Import Safety

 Voluntary Qualified Importer Program(VQIP)
   Implementation was due June 2012
   FDA must establish a user-fee funded VQIP to expedite entry
    into the United States of imported food from eligible, qualified
   To be eligible to participate, an importer must offer food for
    importation from a facility that has a certification by an
    accredited third party.
   FDA will qualify eligible importers to participate in VQIP
    based on risk considerations.
   The new law directs FDA to issue guidance on participation in
    and compliance with VQIP.
                        Import Safety

 Foreign Supplier Verification Program (FSVP)
   Regulation was due January 2012
   FSVP requires all importers to conduct risk-based foreign
    supplier verification activities to verify that imported food is
    not adulterated and that it was produced in compliance with
    FDA’s preventive controls requirements and produce safety
    standards, where applicable.
       Dietary Supplements Guidance

 FDA issued a draft guidance which reviews the methods
  in which a manufacturer wishing to use a dietary
  ingredient should notify the U.S. FDA before adding
  such ingredients to products.
 Clarifies what a “new dietary ingredient” (NDI) is
 Clarifies the type of data FDA expects to receive in
  support of an NDI
 New requirement aims to protect consumers from
  unnecessary public safety concerns from new dietary
  ingredients with unclear health risks.
FSMA and Inspections

               FDA Registered Facilities

 Domestic registrations: 169,884
 Foreign registrations: 445,884
 Total: 615,768

**As of May 22, 2012
           Inspections and Detentions

 FDA’s review of a facility or product can have serious
  impact on business
 Suspension of registration will result in the inability to
  sell food products in one of the world’s largest markets
            Reasons for Inspection

 Routine schedule
 Survey
 Response to reported problem
 Fulfillment of FSMA mandate
FDA’s Foreign Inspection History
FDA’s 2010 Foreign Inspection Totals
             FSMA Foreign Facility
              Inspection Schedule
 Double the previous year, minimum of:

      Year       Foreign

      2011        600
      2012       1,200
      2013       2,400
      2014       4,800
      2015       9,600
      2016       19,200

                Details, details…

 FDA must now promulgate the regulations:

  Federal Register Notice:
   Proposed Rules
  Comment Period
  Interim Final Rule
  Final Rule
  Inclusion in Code of Federal Regulations
One Big Challenge…
                Shipment Detained?

 Shipment arrives, FDA has options:
  1. Release
  2. Detain –Review – Release
  3. Detain – Review – Test – Release
  4. Detain – Review – Test – Refuse entry
 Phone call in the night
 If an importer advises you of detention,
  ask for a copy of the “Notice of FDA Action.”
                Compliance Issues

 Misbranding: FDA has jurisdiction to ensure that food
  labeling is truthful, non-misleading, and adequate to
  ensure that foods are safe and effective for their
  intended uses.
 Adulteration: FDA has jurisdiction to ensure that foods
  are properly processed, meet their specifications and are
  not contaminated.
Analysis of FDA Detentions
       Common Reasons for Detention

 Failure to label product correctly –
  Most of these detentions could have been avoided by
  pre-shipment label review.
 Failure to make required electronic filings –
  Registrations, Process Filings, Prior Notices…
“Notice of
FDA Action”
 Detention Without Physical Examination

 Products from certain countries, foreign manufacturer, a
  specific product, or shipper may be placed on an
  “Import Alert,” also called Detention Without Physical
  Examination (DWPE).
 Reasons may include:
   article has been manufactured, processed, or packed under
    insanitary conditions
   article is adulterated, misbranded
             Removal from DWPE

 Not easy: FDA must believe the issue(s) causing the
  listing have been resolved (i.e. what have you
 A minimum of five consecutive non-violative
  commercial shipments before the FDA will consider
 Shipments should represent routine commercial entries
  and include certain documentation;
 A written petition with documentation must be
  submitted to FDA for their review/action
             Proactive versus Reactive

 Numerous regulations already exist
 U.S. offers enormous market potential and products will only
  need to comply with specific regulations, not all.
 Best advice: stay informed. Many changes are coming over the
  next 4 years.
 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.
      Compliance to U.S. FDA Regulations

    Determining compliance BEFORE the first shipment to the U.S
              is much cheaper than a single detention.
 Think about the various costs of a detention:
  1. Demurrage:                          $$$ per day
  2. Laboratory testing fees:            $$$ per sampling/test
  3. Warehousing fees:                   $,$$$ ?
  4. Freight cost to return the product: $,$$$ ?
  5. Cost to “recondition” the product
     (re-label, for example):            $,$$$ ?
  6. Cost of loosing a client:           $$$,$$$ ?
  7. FDA Fees                            $$$?

 The Food and Drug Administration Safety and
  Innovation Act for Generic Drug Facilities
 Signed into law on July 9, 2012
 Effective October 1, 2012
 Requires additional information to be submitted for the
  registration of domestic and foreign drug facilities

 Unique facility identifiers of each drug establishment
  (FEI & DUNS)
 Point of contact e-mail address
 As of October 1, 2012, the re-registration period for
  domestic and foreign drug manufacturers has been
  changed to October 1st to December 31st of each year,
  instead of the previously more open-ended period of on
  or before December 31st of each year.

 The Generic Drug User Fee Amendments of 2012
 GDUFA allows collection of new fees beginning October 1, 2012

 Includes
  – Application Fees
    • Abbreviated New Drug Applications (ANDAs)
    • Prior Approval Supplements (PASs) to ANDAs
    • ANDA backlog Fee
  – DMF Fees
  – Annual Facility Fees
   GDUFA – Self Identification and Fees

 On October 2, 2012, FDA issued a “Notice of
  Requirement,” notifying operators of generic drug
  facilities/certain sites/organizations that are identified in
  a generic drug submission that they must now provide
  self-identification information to FDA by Dec 3, 2012.
 Self Identification will allow FDA to determine the fee
  that will be paid by certain facilities.
 FAILURE to self-identify may result in generic drug
  products and API’s being deemed misbranded, resulting
  in detention and refusal of shipments
              GDUFA - Facility Fees

 Any person that owns a facility that is identified or in at
  least one generic drug submission that is pending or
  approved to produce one or more generic drug Finished
  Dosage Forms (FDFs) and/or APIs is required to self-
  identify & pay facility fees.
 If a facility manufactures both generic FDFs and APIs,
  Under GDUFA, such a facility will incur annual FDF
  and annual API facility fees.
 An annual facility fee will be due for each facility
  assigned a unique Facility Establishment Identifier
               Sunscreen Labeling

 FDA issued a final rule in June 2011 for sunscreen
  labeling that mandated specific statements and revised
  testing procedures
 Final rule had an initial effective date ofJune 2012
 Was extended to December 17, 2012
 Vast majority of sunscreen labels (including those for
  cosmetic products that have SPF) must comply by that
              About Registrar Corp

 Expertise in Food & Beverages, Medical Devices,
  Cosmetics, Radiation Emitting Devices, and Drugs
 Founded in 2003, based in Hampton, Virginia, USA
  with over 100 employees
 All services are fixed fee, no hourly rates
 25,000 total clients served from more than 150 countries
 “Live Help” on web site
 19 overseas offices.
           Food & Beverage Services

 FDA Food Facility Registrations
 Registration Renewals in 2012
 U.S. Agent Service
 Food Labeling Reviews
 Low-Acid & Acidified Canned Food Registrations
 Prior Notice Filings
 Detention Assistance
 Audit Service starting October 2012
       Pre-Inspection Assistance Service

  • As part of our U.S. Agent service, Registrar Corp will dispatch
    a food safety expert trained in FDA inspections to facilities to
    help prepare if a notice of FDA inspection after October 1,
    2012 is received.
  • This assistance is included at no additional charge other than
    travel and lodging expenses.
             Need Additional Assistance?

US Agent and Detention Assistance Services
 Drug Products
   Establishment Registration, Self Identification
   Product Listing
   Label & Ingredient Reviews
   Drug Master Files (DMF)
 Medical Devices
   Establishment Registration
   Device Listings
   510(k) Administrative Review
   Medical Device Master Files (MAF)
Registrar Corp Overseas Offices

          Registrar Corp Headquarters
          144 Research Drive
          Hampton, Virginia
          USA 23666
          P: +757-224-0177
          F: +757-224-0179
Questions & Answers

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