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American Society for QualityAmerican Society for Quality
Food, Drug, and Cosmetic DivisionFood, Drug, and Cosmetic Division
Fall Midwest Fall Midwest ConferenceConference
Scott MacIntireScott MacIntire
District Director, Chicago, ILDistrict Director, Chicago, IL
Office of Regulatory AffairsOffice of Regulatory Affairs
Food and Drug AdministrationFood and Drug Administration
U.S. Food and Drug Administration UPDATEU.S. Food and Drug Administration UPDATE
FDA Strategic PlanFDA Strategic Plan
Efficient Risk ManagementEfficient Risk Management ---- Searching for new and better Searching for new and better
ways to reduce risks to public healthways to reduce risks to public health
Better Informed ConsumersBetter Informed Consumers ---- Helping consumers get truthful Helping consumers get truthful
information about products they use so they can make informed information about products they use so they can make informed
decisionsdecisions
Patient and Consumer SafetyPatient and Consumer Safety ---- Preventing adverse events Preventing adverse events
involving FDAinvolving FDA--regulated productsregulated products
CounterterrorismCounterterrorism ---- Responding quickly to terrorist acts and Responding quickly to terrorist acts and
enhancing food securityenhancing food security
A Strong FDAA Strong FDA ---- Maintaining a strong science base to support FDA's Maintaining a strong science base to support FDA's
risk management responsibilities.risk management responsibilities.
2
3
Laws Enforced by FDALaws Enforced by FDA
1906 1906 –– Federal Food, Drug, & Cosmetic Federal Food, Drug, & Cosmetic
Act Act prohibits interstate commerce in prohibits interstate commerce in
misbranded and adulterated foods, drinks and misbranded and adulterated foods, drinks and
drugs (1938 et al). drugs (1938 et al).
(1906 (1906 -- MEAT INSPECTION ACTMEAT INSPECTION ACT enforced by USDA, passed the enforced by USDA, passed the
same day) same day)
Celebrating 100 Years of Public ServiceCelebrating 100 Years of Public Service
Laws Enforced by FDALaws Enforced by FDA
Additional Laws:Additional Laws:
�� 1997 Modernization Act1997 Modernization Act
�� Administrative Procedures ActAdministrative Procedures Act
�� Animal Drug User Fee Act of 2003Animal Drug User Fee Act of 2003
�� Best Pharmaceuticals for Children ActBest Pharmaceuticals for Children Act
�� Bioterrorism Act of 2002Bioterrorism Act of 2002
4
Laws Enforced by FDALaws Enforced by FDA
�� Congressional Reports Elimination Act of 1982Congressional Reports Elimination Act of 1982�� Controlled Substances ActControlled Substances Act�� Controlled Substances Import and Export ActControlled Substances Import and Export Act�� Delegations of Authority to the Commissioner of Food Delegations of Authority to the Commissioner of Food and Drugsand Drugs
�� Department of Education Organization ActDepartment of Education Organization Act�� Dietary Supplement Health and Education Act of Dietary Supplement Health and Education Act of 19941994
�� Egg Products Inspection ActEgg Products Inspection Act�� Fair Packaging and Labeling ActFair Packaging and Labeling Act�� Federal Advisory Committee ActFederal Advisory Committee Act�� Federal Advisory Committee AmendmentsFederal Advisory Committee Amendments
Laws Enforced by FDALaws Enforced by FDA
�� Federal AntiFederal Anti--Tampering ActTampering Act�� Federal Fines and Sentencing LawsFederal Fines and Sentencing Laws�� Federal Import Milk ActFederal Import Milk Act�� Federal Meat Inspections ActFederal Meat Inspections Act�� Federal Trade Commission ActFederal Trade Commission Act�� Filled Milk ActFilled Milk Act�� Food Quality Protection Act of 1996Food Quality Protection Act of 1996�� Foods and DrugsFoods and Drugs�� GATT Uruguay Round Patent ProvisionsGATT Uruguay Round Patent Provisions
Laws Enforced by FDALaws Enforced by FDA
�� Generic Animal Drug and Patent Term Restoration Generic Animal Drug and Patent Term Restoration Act of 1988 (Summary)Act of 1988 (Summary)
�� Government in the Sunshine ActGovernment in the Sunshine Act�� Laws Delegating Authority Laws Delegating Authority ---- PatentsPatents�� Lead Based Paint Poisoning Prevention ActLead Based Paint Poisoning Prevention Act�� Mammography Quality Standards Act (MQSA)Mammography Quality Standards Act (MQSA)�� Medical Device User Fee and Modernization Act Medical Device User Fee and Modernization Act (MDUFMA) of 2002(MDUFMA) of 2002
�� Miscellaneous Provisions Relating to Orphan DrugsMiscellaneous Provisions Relating to Orphan Drugs�� The National Environmental Policy Act of 1969The National Environmental Policy Act of 1969�� Pediatric Research Equity Act of 2003Pediatric Research Equity Act of 2003�� Poultry Products Inspection ActPoultry Products Inspection Act
5
Laws Enforced by FDALaws Enforced by FDA
�� Prescription Drug User Fee ActPrescription Drug User Fee Act
�� Project Project BioShieldBioShield Act of 2004Act of 2004
�� Public Health Service ActPublic Health Service Act
�� Reorganization Plan 1Reorganization Plan 1
�� Sanitary Food Transportation ActSanitary Food Transportation Act
�� Sentencing GuidelinesSentencing Guidelines
�� Tea Importation Act Tea Importation Act The Tea Importation Act was The Tea Importation Act was
repealed in 1996 by repealed in 1996 by Public Law 104Public Law 104--128128
�� Trademark Act of 1946Trademark Act of 1946
FDA Centers & FDA FieldFDA Centers & FDA Field
Commissioner
FOODS DRUGS DEVICE VET BIOLOGIC
ORA (FIELD)
6
FDA’s Central RegionFDA’s Central Region
Central Region’s District OfficesCentral Region’s District Offices
�� Baltimore District (MD, VA, WV, DC)Baltimore District (MD, VA, WV, DC)
�� Chicago District (IL)Chicago District (IL)
�� Cincinnati District (OH, KY)Cincinnati District (OH, KY)
�� Detroit District (MI, IN)Detroit District (MI, IN)
�� Minneapolis District (MN, WI, ND, SD)Minneapolis District (MN, WI, ND, SD)
�� New Jersey District (NJ)New Jersey District (NJ)
�� Philadelphia District (PA, DE)Philadelphia District (PA, DE)
7
OFFICE OF REGULATORY AFFAIRS190 OFFICES IN FY 2005
NORTHEASTPACIFIC CENTRAL
SOUTHEAST
SOUTHWEST03-04
Division of Planning, Evaluation, & Mgmt
ORA Offices.ppt
REGIONAL OFFICES - 5DISTRICT OFFICES - 20RESIDENT INSPECTION POSTS - 140OCI FIELD OFFICES - 6OCI RESIDENT OFFICES - 6OCI DOMICILES - 13
CA
NV
WA
MT
OR
ID
AK
HI
AZ
UT
WY
CO
NM
TX
OK AR
MO
IANE
KS
TN NC
GAALMS
LA
FL
SC
PR
MEVT
NY
NH
MA
CTRI
MN
WI
IL
MI
INOH
PA
WV
KYVA
NJ
ND
SD
MDDE
VI
Responsibilities of Regional OfficeResponsibilities of Regional Office
�� Manage the RegionManage the Region
�� Cooperative ProgramsCooperative Programs
�� MilkMilk
�� Retail FoodRetail Food
�� ShellfishShellfish
�� Radiological HealthRadiological Health
Responsibilities of District OfficeResponsibilities of District Office
Regulatory Activities:Regulatory Activities:�� Inspections Inspections –– Domestic and ForeignDomestic and Foreign
�� InvestigationsInvestigations
�� Sample collections Sample collections –– Domestic and ImportDomestic and Import
�� Sample analysis Sample analysis
�� Field Exams Field Exams –– Domestic and ImportDomestic and Import
�� Consumer ComplaintsConsumer Complaints
�� RecallsRecalls
�� Compliance activities (seizure, injunction, prosecution)Compliance activities (seizure, injunction, prosecution)
�� Public AffairsPublic Affairs
8
Food Safety is a Compelling and Food Safety is a Compelling and
Real Public Health ProblemReal Public Health Problem
�� 76 Million Foodborne Illnesses76 Million Foodborne Illnesses
�� 325,000 Hospitalizations325,000 Hospitalizations
�� 5,000 Deaths5,000 Deaths
EACH YEAR in the US:
55%
6%
21%
7%
11%
Foods Biologics Human Drugs Animal Drugs Devices
Allotment of FTEsAllotment of FTEs
in all Regions in all Regions -- FY05FY05
9
FDA History of Food Safety and FDA History of Food Safety and
Nutritional QualityNutritional Quality
�� Early 1900’s Early 1900’s –– Food Sanitation/Consumer Food Sanitation/Consumer DeceptionDeception
�� 1950’s 1950’s –– Pesticides and food additivesPesticides and food additives
�� 1970’s 1970’s –– Botulism in canned foodBotulism in canned food
�� 1980’s 1980’s –– Food tamperingFood tampering
�� 1990’s 1990’s –– Nutrition LabelingNutrition Labeling
Food Safety TodayFood Safety Today
Food Safety and SecurityFood Safety and Security
`
Sound Science
Food Safety Programs
Food Security
Enhancements
10
PartnershipsPartnerships
�� Build on a solid Build on a solid
foundation of a national foundation of a national
partnership with other partnership with other
entities involved in food entities involved in food
safety and security.safety and security.
FDA Strategic Action PlanFDA Strategic Action Plan
�� Five StrategiesFive Strategies
�� Enabling Technology Development and Enabling Technology Development and
InnovationInnovation
�� Improving Patient and Consumer Protection Improving Patient and Consumer Protection
�� Protecting the Homeland Protecting the Homeland -- Counterterrorism Counterterrorism
�� Improving Manufacturing Practices Improving Manufacturing Practices
�� Improving FDA’s Business Practices Improving FDA’s Business Practices
FDA Strategic Action PlanFDA Strategic Action Plan
�� Protecting the Homeland Protecting the Homeland -- CounterterrorismCounterterrorism
�� We have developed crisis management plans We have developed crisis management plans and have strengthened our readiness by and have strengthened our readiness by partnering with state and federal agencies in partnering with state and federal agencies in conducting emergency response exercises that conducting emergency response exercises that simulate chemical, biological, and radiological simulate chemical, biological, and radiological events.events.
11
FDA Strategic Plan and HSPDFDA Strategic Plan and HSPD--99
Go Hand and Hand
HSPDHSPD--99
�� Establishes national policy to defend Establishes national policy to defend
the agriculture and food system the agriculture and food system
against terrorist attacks, major against terrorist attacks, major
disasters and other emergencies.disasters and other emergencies.
Bioterrorism Act 2002Bioterrorism Act 2002
�� Directed FDA to take aggressive steps Directed FDA to take aggressive steps
to protect the public health from to protect the public health from
deliberate and accidental deliberate and accidental
contamination of our food supply.contamination of our food supply.
12
Final RulesFinal Rules
1. Registration of Food Facilities1. Registration of Food Facilities
�� Requires all foreign and domestic facilities Requires all foreign and domestic facilities
that manufacture, process, pack or hold that manufacture, process, pack or hold
food for human or animal consumption in food for human or animal consumption in
the United States to register with FDA.the United States to register with FDA.
Interim Final RulesInterim Final Rules
2. Prior Notice of Imported Foods2. Prior Notice of Imported Foods
�� Requires food importers to provide FDA Requires food importers to provide FDA
with prior notice of human or animal with prior notice of human or animal
food shipments imported or offered for food shipments imported or offered for
import.import.
New Final RuleNew Final Rule
3. Administrative Detention3. Administrative Detention
�� FDA may detain an article of food on FDA may detain an article of food on the strength of credible evidence or the strength of credible evidence or information resulting from an information resulting from an inspection, examination, or inspection, examination, or investigationinvestigation
13
New Final RuleNew Final Rule
4. Establishment and Maintenance of 4. Establishment and Maintenance of
RecordsRecords
�� Identify immediate previous source and Identify immediate previous source and
immediate subsequent recipients of foodimmediate subsequent recipients of food
Monitoring and SurveillanceMonitoring and Surveillance
�� Methods Methods –– developing and validating developing and validating
methods that can be used to detect, methods that can be used to detect,
enumerate and identify potential nonenumerate and identify potential non--
traditional agents that may threaten the food traditional agents that may threaten the food
supply.supply.
FOOD/AGENT SCENARIOSFOOD/AGENT SCENARIOS
�� Assess risk for specific productAssess risk for specific product--agentagent--activity activity
combinations covering harvest, production combinations covering harvest, production
and delivery and delivery -- farm to table:farm to table:
�� Farm/dairy farm/orchard/apiary/fishing vesselFarm/dairy farm/orchard/apiary/fishing vessel
�� Bulk transportationBulk transportation
�� Manufacturing (including packing houses)Manufacturing (including packing houses)
�� Finished product transportationFinished product transportation
�� WarehousingWarehousing
�� Retail/food serviceRetail/food service
14
Vulnerability AssessmentVulnerability Assessment
�� Evaluating the public health consequences of Evaluating the public health consequences of
a range of producta range of product--agent scenarios agent scenarios
associated with potential tampering, associated with potential tampering,
criminal, malicious, or terrorist activity.criminal, malicious, or terrorist activity.
�� Implement “shields” for protecting those Implement “shields” for protecting those
identified food/agent combinations.identified food/agent combinations.
ResearchResearch
�� Assessing the abilities of nonAssessing the abilities of non--traditional traditional
microbial pathogens to survive and grow in microbial pathogens to survive and grow in
foods during processing and storage, or the foods during processing and storage, or the
stability and activity of chemical agents while stability and activity of chemical agents while
present in foods, and the potential for their present in foods, and the potential for their
inactivation during food processing.inactivation during food processing.
FY 05 Food Security AssignmentFY 05 Food Security Assignment
�� Exercise the planning and implementation Exercise the planning and implementation
for responding to a period of increased for responding to a period of increased
food security risk and identify gaps in the food security risk and identify gaps in the
systemsystem..
�� Deter intentional contamination of food Deter intentional contamination of food
through heightened and targeted through heightened and targeted
preventative activities.preventative activities.
15
FY 05 Food Security AssignmentFY 05 Food Security Assignment
�� Identify foods of concern using ORMIdentify foods of concern using ORM�� Raw milkRaw milk
�� Fruit and vegetable juiceFruit and vegetable juice
�� Spring and mineral waterSpring and mineral water
�� Liquid and powdered infant formulaLiquid and powdered infant formula
�� Fresh leaf and stem vegetablesFresh leaf and stem vegetables
�� Inspect firms processing that foodInspect firms processing that food
�� Take samplesTake samples
FY 05 Food Security AssignmentFY 05 Food Security Assignment
�� Ship and test samplesShip and test samples
�� Chemical CT agents (e.g. CN)Chemical CT agents (e.g. CN)
�� Microbiological CT agents (e.g. Microbiological CT agents (e.g. BotBot toxin)toxin)
�� Test infrastructure for handling presumptive Test infrastructure for handling presumptive
and confirmed positives.and confirmed positives.
FY 06 Strategic Partnership Program FY 06 Strategic Partnership Program
AgroterrorismAgroterrorism (SPPA) Initiative(SPPA) Initiative
�� Joint effort to assess and identify vulnerabilities in the Joint effort to assess and identify vulnerabilities in the agricultural and food sectorsagricultural and food sectors
�� FDA, FBI, USDA and DHS will collaborate with states FDA, FBI, USDA and DHS will collaborate with states
and private industry to protect the nation’s food and private industry to protect the nation’s food
supply from terrorist threatssupply from terrorist threats
�� Focus from farmFocus from farm--toto--tabletable
�� Goal Goal -- SPPA intends to provide government and SPPA intends to provide government and
private industry the tools to refine its efforts and to private industry the tools to refine its efforts and to seek better technology or steps to protect the food seek better technology or steps to protect the food
and agriculture infrastructure with research and and agriculture infrastructure with research and
developmentdevelopment
16
CT Guidance for IndustryCT Guidance for Industry
1.1. RETAIL FOOD STORES AND FOOD SERVICE RETAIL FOOD STORES AND FOOD SERVICE ESTABLISHMENTSESTABLISHMENTS
2.2. FOOD PRODUCERS, PROCESSORS, AND FOOD PRODUCERS, PROCESSORS, AND TRANSPORTERSTRANSPORTERS
3.3. IMPORTERS AND FILERSIMPORTERS AND FILERS
4.4. COSMETICS PROCESSORS AND TRANSPORTERSCOSMETICS PROCESSORS AND TRANSPORTERS
5.5. MILK PROGRAMMILK PROGRAM
“Firewalls” Against BSE “Firewalls” Against BSE
TransmissionTransmission
�� Joint USDA FSIS, USDA APHIS, FDA notice asks for Joint USDA FSIS, USDA APHIS, FDA notice asks for public comment on additional preventive actions public comment on additional preventive actions
being considered on BSEbeing considered on BSE
�� An interim final FDA rule prohibits use of certain An interim final FDA rule prohibits use of certain
cattlecattle--derived materials in human food, dietary derived materials in human food, dietary
supplements, and cosmeticssupplements, and cosmetics
�� Proposed FDA rule on recordkeeping for the interim Proposed FDA rule on recordkeeping for the interim
final rule relating to this ban final rule relating to this ban
IMPORTSIMPORTS
17
Growth of Imported FDA Growth of Imported FDA
Regulated EntriesRegulated Entries
0
1
2
3
4
5
6
7
8
9
10
11
12
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
IMPORT LIN
ES
(MIL
LIO
NS)
IMPORT LINE DATA SOURCES:
1986 - 1993: CENSUS
1994 - 1996: U.S. CUSTOMS
1997 - 2004: FDA OASIS
What types of goods are imported?What types of goods are imported?
10%
20%
2%
<1%
2%
65%
Devices and Rad Health
Foods
Biologics
Animal Drugs and Feed
Human Drugs
Cosm
etics
Size of International MarketSize of International Market
�� 224 countries exporting FDA regulated goods 224 countries exporting FDA regulated goods
�� 221,100 foreign manufacturers221,100 foreign manufacturers
�� 196,224 Shippers196,224 Shippers
�� 127,896 importers of record127,896 importers of record
�� 3,700 active OASIS filers3,700 active OASIS filers
�� 134,433 consignees (includes overlap)134,433 consignees (includes overlap)
Source : OASIS (2004)Source : OASIS (2004)
18
Predictive RiskPredictive Risk--based Evaluation & Demonstrative Import Compliance Trackingbased Evaluation & Demonstrative Import Compliance Tracking
The Automated RiskThe Automated Risk--based Import based Import
Entry Examination SystemEntry Examination System
“PREDICT”“PREDICT”
What is What is PREDICT ?PREDICT ?
An automated screening system that:An automated screening system that:
•• Associates disparate data to reveal “risk Associates disparate data to reveal “risk
statements” about specific importsstatements” about specific imports
•• Is selfIs self--learning learning ---- “rules evolve with “rules evolve with
experience” experience”
•• Augments FDA scienceAugments FDA science--based risk based risk
decisionsdecisions
PREDICTPREDICT
Algorithms
Decision
Support
Internal FDA
Data(OASIS, ORADDS,
FACTS, MARCS, …)
External
Regulatory Data (Prior Notice,
Customs, USDA, …)
Supply Chain
Data (Transactional,
Transportation,
Business Practices, …)
Exogenous
Data (Political Risk,
Disease, Weather,
Intelligence, …)
Data Merge
“PREDICT”“PREDICT”Components of Components of PREDICTPREDICT
Disparate Data
Sources Science-based Risk Analysis
Shipment-specific
Output Reporting
Defined by broad
sets of data and
advanced analysis
methods, each
shipment has a
snowflake-like
uniqueness
19
FERNFERN
�� Food Emergency Response Network Food Emergency Response Network ––
nationwide network of Federal and State nationwide network of Federal and State
laboratories capable of testing the safety of laboratories capable of testing the safety of
thousands of food samples and enabling us thousands of food samples and enabling us
to respond to a terrorist attack.to respond to a terrorist attack.
eLEXNET: eLEXNET: What is it?What is it?
�� An integrated, secure An integrated, secure
system designed for system designed for
multiple government multiple government
agencies involved in agencies involved in
food safety activitiesfood safety activities
�� The necessary The necessary
infrastructure for an infrastructure for an
early warning system early warning system
that identifies potentially that identifies potentially
hazardous foods and hazardous foods and
enables health officials enables health officials
to assess risks and to assess risks and
analyze trendsanalyze trends
eLEXNET’s GIS Reporting FunctionseLEXNET’s GIS Reporting Functions
Report Parameters:
Salmonella
Cheese/Cheese Products
All Laboratories
All States
August 2002 to present
20
FDA Retail Food Program FDA Retail Food Program
�� Federal, State, Local Federal, State, Local Gov’tGov’t and Industryand Industry
�� One of several Cooperative ProgramsOne of several Cooperative Programs
�� Program is in FDA Regional OfficesProgram is in FDA Regional Offices
�� Field Retail Food SpecialistsField Retail Food Specialists
“Measuring the Effectiveness of the Nation’sFood Service and Retail Food Protection System”
�� Randomly Selected:Randomly Selected:
�� DelisDelis
�� Full service restaurantsFull service restaurants
�� Fast food restaurantsFast food restaurants
�� Schools Schools
�� Nursing homesNursing homes
�� HospitalsHospitals
“Measuring the Effectiveness of the Nation’sFood Service and Retail Food Protection System”
�� Risk FactorsRisk Factors
�� Food from unsafe sourcesFood from unsafe sources
�� Inadequate cookingInadequate cooking
�� Improper holding temperatures Improper holding temperatures
�� Contaminated equipment andContaminated equipment and
�� Poor personal hygienePoor personal hygiene
21
“Measuring the Effectiveness of the Nation’sFood Service and Retail Food Protection System”
�� Food Code public health interventions:Food Code public health interventions:
�� Demonstration of KnowledgeDemonstration of Knowledge
�� Employee health controlsEmployee health controls
�� Controlling hands as a vehicle of contamination Controlling hands as a vehicle of contamination
(No bare hand contact with ready to eat food)(No bare hand contact with ready to eat food)
�� Time and temperature parameters for Time and temperature parameters for
controlling pathogens andcontrolling pathogens and
�� Consumer advisoriesConsumer advisories
Voluntary National Retail FoodVoluntary National Retail Food
Regulatory Program StandardsRegulatory Program Standards
1. 1. Regulatory Foundation Regulatory Foundation
2. 2. Trained Regulatory StaffTrained Regulatory Staff
3. 3. Inspection Program Based on HACCP Inspection Program Based on HACCP PrinciplesPrinciples
4. 4. Uniform Inspection ProgramUniform Inspection Program
5. 5. Food borne Illness Investigation and Food borne Illness Investigation and ResponseResponse
6. 6. Compliance and EnforcementCompliance and Enforcement
7. 7. Industry and Community RelationsIndustry and Community Relations
8. 8. Program Support and ResourcesProgram Support and Resources
9. 9. Program AssessmentProgram Assessment
CURRENT ENROLLMENTCURRENT ENROLLMENT
�� NationallyNationally –– >118>118 State, local State, local
and tribal jurisdictions are and tribal jurisdictions are
enrolledenrolled
WE WANT YOU!WE WANT YOU!
22
RETAIL FOODRETAIL FOOD PROGRAM PROGRAM
RESOURCE DISKRESOURCE DISK
�� PROGRAM STANDARDSPROGRAM STANDARDS
�� FOOD CODE & supplementFOOD CODE & supplement
�� HACCP GUIDESHACCP GUIDES
�� BASELINE DATABASEBASELINE DATABASE
�� STANDARDIZATIONSTANDARDIZATION
�� MANY OTHERSMANY OTHERS
IT’S HERE!!!IT’S HERE!!!
1 COPY FOR EVERY RETAIL FOOD PROGRAM
Eureka! DiskEureka! Disk
�� Free Subscription Free Subscription
�� Over 700 Subscribers!Over 700 Subscribers!
�� ORA’s Eureka DatabaseORA’s Eureka Database
�� Over 12,000 DocumentsOver 12,000 Documents
�� 1,800 Graphics1,800 Graphics
�� A Great Resource!A Great Resource!
�� Use on a Stand Alone or Use on a Stand Alone or LAN ServerLAN Server
New Format (WebNew Format (Web--CD) Technology!CD) Technology!
Eureka! DiskEureka! Disk
�� FDA regulatory references in electronic format :FDA regulatory references in electronic format :
�� Federal Food Drug and Cosmetic ActFederal Food Drug and Cosmetic Act
�� Title 21 CFRTitle 21 CFR
�� Compliance Policy GuidesCompliance Policy Guides
�� Enforcement ReportsEnforcement Reports
�� Talk PapersTalk Papers
�� Import AlertsImport Alerts
�� Investigations Operations Manual, Regulatory Investigations Operations Manual, Regulatory Procedures ManualProcedures Manual
�� Food CodeFood Code
�� Compliance ProgramsCompliance Programs
23
Eureka! DiskEureka! Disk
�� Not available to the publicNot available to the public�� Available to state and local agencies Available to state and local agencies �� Disk is not releasable under FOI Disk is not releasable under FOI
Disks available from:Disks available from:
FDA Division of Federal-State Relations
Call: 301Call: 301--827827--6906 6906
Email: [email protected]: [email protected]
Revitalizing the Nutrition Revitalizing the Nutrition
ProgramProgram
Improving NutritionImproving Nutrition
�� Better InformationBetter Information
�� Consumer Health Information for Better Nutrition Consumer Health Information for Better Nutrition
InitiativeInitiative
�� Supporting ConsumersSupporting Consumers
�� Obesity Working GroupObesity Working Group
24
ClosingClosingWorking together we will rise Working together we will rise
to the challenge of making to the challenge of making
sure Americans continue to sure Americans continue to
enjoy a safe food supply and enjoy a safe food supply and
medical products.medical products.
CONTACTCONTACT
SCOTT J. SCOTT J. MacINTIREMacINTIRE
[email protected]@FDA.HHS.GOV
312312--596596--42004200