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FDA Regulatory Requirements & The Food Safety Modernization Act

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1 FDA Regulatory Requirements & The Food Safety Modernization Act
Presented by Anna Benevente, Senior Regulatory Specialist Registrar Corp October 2012

2 Seminar Overview FDA: Background & Jurisdiction
U.S. Agencies Regulating Food Products Key Food Regulations FDA Food Safety Modernization Act (FSMA) FSMA Requirements Currently in Effect FSMA and Inspections Detentions

3 FDA: Background & Jurisdiction

4 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 “U.S.C.” 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.

5 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.

6 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.

7 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.

8 FDA Regulates: Food, Beverages, Health Supplements Cosmetics
Veterinary Drugs Medical Devices Radiation-Emitting Products Drugs: OTC, API, Prescription Biologics: blood, tissues, vaccines Tobacco

9 FDA Structure

10 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.

11 U.S. Agencies Regulating Food Products

12 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

13 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)

14 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

15 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.

16 What is 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 the shipment 4. Refuse entry of the shipment

17 FDA’s Entry Process

18 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)

19 PREDICT 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

20 PREDICT 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; and General intelligence on recent world events that may affect the quality of a particular food.

21 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.


23 Key Food Regulations

24 Requirements 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

25 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

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

27 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”

28 Registration (Section 305)
Can’t register suppliers…they need to register on their own 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

29 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

30 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

31 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

32 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

33 Nutrition Facts Chart

34 Examples of Other Formats
STRICT rules govern when each can be used

35 Supplement Facts Chart

36 Examples of Other Formats
Use dictated by the package configuration and type of dietary ingredients found in the product

37 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.”

38 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

39 Manufacturer/Distributor/Packer Identity
Must give actual corporate name Must appear with Chart and Ingredients, no intervening information 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

40 Country of Origin The Tariff Act of 1930 requires that the country of origin statement be placed on the label in a conspicuous location. 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”

41 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

42 FALCPA 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 wheat).” FDA is currently considering comments related to “advisory labeling” such as “produced on machinery that also processes [allergen]”

43 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.

44 Product Claims Nutrient Content Claims Relative 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”

45 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”

46 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.

47 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.

48 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 penalties. "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.

49 Food Labeling Example - Before

50 Food Labeling Example - After

51 Additional Requirements
Low-Acid Canned Food Regulations Hazard Analysis and Critical Control Point Good Manufacturing Practices

52 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 foods.

53 FDA LACF Office FDA’s office of Low-Acid Canned Food oversees the registration of factories that produce low-acid or acidified canned foods.

54 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. 

55 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 # 18289) Only one number is assigned per factory Traditionally, this process takes 5-10 weeks

56 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”).

57 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.

58 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 conditions.

59 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

60 Common FCE-SID Detained Products
Coconut Milk Herbs in Oil Peppers in Vinegar Hot Sauce Sweet Custard Mango Juice

61 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.

62 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.

63 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.

64 Hazard Analysis and Critical Control Point (HACCP)
Management system: a systematic approach to the identification, evaluation and control of food safety hazards. Based on common sense application of science and technology to Plan, Control, and Document the safe production of foods.

65 HAACP Is (Currently) Mandatory for…
Seafood Products (21 CFR 123) Meat and Poultry Products (9 CFR 417) Juice Products (21 CFR 120)

66 Current Good Manufacturing Practices (cGMP)
Guidelines and conditions which must be met to ensure production of safe and wholesome foods. Found in 21 CFR 110

67 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)

68 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 contamination Warehouse & Distribution (storage and transportation designed to prevent contamination) Natural / unavoidable defects that present no health hazard: can contact FDA for “defect action levels”

69 Break

70 FDA Food Safety and Modernization Act

71 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

72 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.

73 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.

74 Imports of FDA-Regulated Food Have Almost Doubled Since 2002

75 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

76 Vision of FSMA Prevention Inspections, Enhanced Compliance,
and Response Import Safety Enhanced Partnerships

77 Prevention Mandatory preventive controls for food companies - Final rule was due July 2012 (not published yet) Mandatory produce safety Standards -Final rule due January 2013

78 Preventative Controls
Scientifically- and risk-based practices that facilities use to address hazards to which their products might be exposed “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

79 Inspection/Compliance/Response
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)

80 Inspection/Compliance/Response
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

81 Enhanced Partnerships
Reliance on inspections by other agencies, including foreign governments Third Party certification - System due January 2013


83 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 available No indication of whether the Dec 31, 2012 deadline will be extended

84 Prior Notice Filers need to indicate whether a food product has been refused entry to another country

85 Latest Developments New User Fees Registration Suspension
Administrative Detentions Voluntary Qualified Importer Program Foreign Supplier Verification Program New Dietary Ingredients Guidance

86 New FDA User Fees New FDA User Fees Effective October 1, 2012
FDA Hourly Rate For Reinspections and Reconditioning: $221 per hour, domestic $289 per hour for foreign travel

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

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

89 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 necessary making preparations and arrangements for the reinspection

90 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.

91 New FDA User Fees “Reconditioning Fees” on Imported Food
Fees must be paid by owner of food or importer, depending on circumstances 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

92 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

93 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 adulterated.

94 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 necessary.

95 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.

96 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 animals.  FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States. 

97 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.

98 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.

99 Import Safety Voluntary Qualified Importer Program
Foreign Supplier Verification Program

100 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 importers. 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. 100

101 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.

102 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.

103 FSMA and Inspections

104 FDA Registered Facilities
Domestic registrations: 169,884 Foreign registrations: 445,884 Total: 615,768 **As of May 22, 2012

105 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 105

106 Reasons for Inspection
Routine schedule Survey Response to reported problem Fulfillment of FSMA mandate 106

107 FDA’s Foreign Inspection History

108 FDA’s 2010 Foreign Inspection Totals

109 FSMA Foreign Facility Inspection Schedule
Double the previous year, minimum of: Year Foreign Inspections 2011 600 2012 1,200 2013 2,400 2014 4,800 2015 9,600 2016 19,200 4/6/2017

110 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

111 One Big Challenge…

112 Detentions

113 Shipment Detained? Shipment arrives, FDA has options:
Release Detain –Review – Release Detain – Review – Test – Release 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.”

114 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. 114

115 Analysis of FDA Detentions

116 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…

117 “Notice of FDA Action” Example

118 OASIS 118

119 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

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

121 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.

122 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: Demurrage: $$$ per day Laboratory testing fees: $$$ per sampling/test Warehousing fees: $,$$$ ? Freight cost to return the product: $,$$$ ? Cost to “recondition” the product (re-label, for example): $,$$$ ? Cost of loosing a client: $$$,$$$ ? FDA Fees $$$?

123 Other BREAKING FDA News!!

124 FDASIA 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

125 FDASIA Unique facility identifiers of each drug establishment (FEI & DUNS) Point of contact 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.

126 GDUFA 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

127 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

128 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 (FEI).

129 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 date.

130 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.

131 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

132 Pre-Inspection Assistance Service
COMING SOON 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.

133 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)

134 Registrar Corp Overseas Offices
Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA 23666 P: F: E:

135 Questions & Answers

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