04/11/23

FDA Regulatory Requirements

&The Food Safety

Modernization Act

Presented by Anna Benevente, Senior Regulatory Specialist

Registrar CorpOctober 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 & Jurisdiction

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.

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 SupplementsCosmeticsVeterinary DrugsMedical DevicesRadiation-Emitting ProductsDrugs: OTC, API, PrescriptionBiologics: blood, tissues, vaccinesTobacco

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. AgenciesRegulating 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 AgricultureFood Safety and Inspection Service (FSIS)Animal and Plant Health Inspection Service (APHIS)National Organic Program

Department of JusticeAlcohol and Tobacco Tax and Trade Bureau (TTB)

Department of Homeland SecurityU.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 USDAProducts 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 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

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

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 2007Pilot program was generally considered a successSince been expanded

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;

andGeneral 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

Requirements

Food, Drug, and Cosmetic ActBioterrorism Act

•Registration, U.S. Agent, Prior NoticeLabelingFormats, languageLACF – 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 2003Who, What, Where, When, and How

Requires companies to register Requires designation of a U.S. Agent for foreign

companies for FDA communicationsRequire 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 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

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 ChartsSupplement Facts ChartsPermitted IngredientsHealth 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 elementsStatement 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 elementsNutrition Facts/Supplement Facts ChartIngredients ListManufacturer IdentityMust 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 product

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 inchSpecific requirements for the

listing of colors

Manufacturer/Distributor/Packer Identity

Must give actual corporate nameMust 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 inchRequires the firm name, street address, city or town,

country, and a postal codeStreet 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 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”

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

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]”

Bilingual Labeling

All labels must be in English Common reason for detentionIf 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 TrademarkIn 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.

Food Labeling Example - Before

Food Labeling Example - After

Additional Requirements

Low-Acid Canned Food Regulations

Hazard Analysis and Critical Control Point

Good Manufacturing Practices

In the 1970’s several life-threatening botulism outbreaks occurred due toInadequate thermal processing of commercially prepared low-

acid foods packaged in hermetically sealed containers improper acidification of commercially prepared acidified

foods.

FDA’s Office of Low-Acid & Acidified Canned Foods (LACF)

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 packedthe product contained thereinthe 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 # 18289)

Only one number is assigned per factoryTraditionally, 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, andAre stored and distributed under non-refrigerated

conditions.

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 MilkHerbs in OilPeppers in VinegarHot SauceSweet CustardMango 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 hazards.

Based on common sense application of science and technology toPlan, 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 (cGMP)

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 designSanitary Operations (pest control, sanitizing, storage,

handling of equipmentSanitary 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 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”

Break

FDA Food Safety and Modernization Act

FDA Food Safety Modernization Act

“FSMA” signed by President Obama 01/04/2011Phased in over time thru 2016Most 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 formulaIllegal antibiotics in aquacultureBetter 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

Prevention

Inspections, Compliance,

and Response

Import Safety

Enhanced Partnerships

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

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

Inspection/Compliance/Response

Food Facility Registration Renewal

Oct 1 – Dec 31, 2012Mandated inspection frequency - ImmediateRecords access - ImmediateTesting by accredited laboratories –

(Establishment of accreditation program due January 2013)

Inspection/Compliance/Response

Mandatory recall - ImmediateExpanded administrative detention - Effective July 2011Prior Notice refused entry in other countries- Effective

August 2011 Suspension of registration - Effective June 2011 Enhanced product tracing abilities - Implementation

of pilots due September 2011Additional 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 2013

NEW FDA REQUIREMENTS CURRENTLY IN EFFECT

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 onlineNo indication from FDA of when it may become

availableNo 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 FeesRegistration SuspensionAdministrative DetentionsVoluntary Qualified Importer ProgramForeign Supplier Verification ProgramNew Dietary Ingredients Guidance

New FDA User Fees

New FDA User Fees Effective October 1, 2012FDA Hourly Rate For Reinspections and

Reconditioning: $221 per hour, domestic $289 per hour for foreign travel

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

Reinspection

“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

necessarymaking preparations and arrangements for the reinspection

New FDA User Fees

Reinspection Fees traveling to and from the facilitypreparing any reports,analyzing any samplesexamining any labels if requiredperforming 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

circumstancesFees 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 complianceWill 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 adulterated.

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.

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 feeThe 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 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. 

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 2012FDA 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.

Import Safety

Foreign Supplier Verification Program (FSVP)Regulation was due January 2012FSVP 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) isClarifies the type of data FDA expects to receive in

support of an NDINew requirement aims to protect consumers from

unnecessary public safety concerns from new dietary ingredients with unclear health risks.

04/11/23

FSMA and Inspections

FDA Registered Facilities

Domestic registrations: 169,884Foreign registrations: 445,884Total: 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 scheduleSurveyResponse to reported problemFulfillment 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 Inspections

2011 600

2012 1,200

2013 2,400

2014 4,800

2015 9,600

2016 19,200

04/11/23

Details, details…

FDA must now promulgate the regulations:

Federal Register Notice: Proposed Rules

Comment PeriodInterim Final RuleFinal RuleInclusion in Code of Federal Regulations

One Big Challenge…

Detentions

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 nightIf 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” Example

http://www.accessdata.fda.gov/scripts/importrefusals

OASIS

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 conditionsarticle 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 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

Proactive versus Reactive

Numerous regulations already existU.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 $$$?

Other BREAKING FDA News!!

FDASIA

The Food and Drug Administration Safety and Innovation Act for Generic Drug Facilities

Signed into law on July 9, 2012Effective October 1, 2012Requires additional information to be submitted for the

registration of domestic and foreign drug facilities

FDASIA

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.

GDUFA

The Generic Drug User Fee Amendments of 2012GDUFA 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 (FEI).

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 2012Was extended to December 17, 2012Vast majority of sunscreen labels (including those for

cosmetic products that have SPF) must comply by that date.

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 rates25,000 total clients served from more than 150 countries“Live Help” on web site19 overseas offices.

Food & Beverage Services

FDA Food Facility RegistrationsRegistration Renewals in 2012U.S. Agent ServiceFood Labeling ReviewsLow-Acid & Acidified Canned Food RegistrationsPrior Notice FilingsDetention AssistanceAudit Service starting October 2012

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.

Need Additional Assistance?

US Agent and Detention Assistance Services Drug Products

Establishment Registration, Self IdentificationProduct ListingLabel & Ingredient ReviewsDrug Master Files (DMF)

Medical DevicesEstablishment RegistrationDevice Listings510(k) Administrative ReviewMedical Device Master Files (MAF)

Registrar Corp Overseas Offices

Registrar Corp Headquarters144 Research Drive Hampton, Virginia USA 23666 P: +757-224-0177 F: +757-224-0179 E: info@registrarcorp.com

Questions & Answers

info@registrarcorp.comwww.registrarcorp.com/livehelp