1. The U.S. Food and Drug
Administration:
FDA in Latin America:
Overview, Goals, Objectives, Opportunities
Michael Rogers, M.S.
Director, Latin America Office
Food and Drug Administration
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2. FDA in Latin America
• Overview:
– FDA’s organization and Mission
• Office of International Programs
– History and overview of FDA offices
overseas
• structure of the FDA Latin American Office (LAO).
– Challenges of Globalization
• The triggering factors → International
• Roles and Responsibilities of LAO
– Ongoing Activities
– Future Opportunities
• Identifying sources and ways to obtain
information about FDA regulated products within
the Region
• Working with industry and foreign governments. 2

3. FDA Mission
FDA Mission
• FDA is charged with protecting the public health by ensuring the safety,
effectiveness, and security of human and veterinary drugs, biological
products, and medical devices; ensuring the safety of foods, cosmetics, and
radiation-emitting products; and regulating tobacco products.
• Specifically, FDA is responsible for advancing the public health by:
– Helping to speed innovations that make foods safer and make medicines and
devices safer and more effective;
– Ensuring the public has accurate, science-based information they need to use
medicines, devices, and foods to improve their health;
– Regulating the manufacture, marketing, and distribution of tobacco products and
reducing tobacco use by minors; and,
– Addressing the Nation’s counterterrorism capability and ensuring the security of
the supply of foods and medical products.
Vision
• FDA is dedicated to world-class excellence as a science-based regulatory
agency with a public health mission. We aim to provide effective and
innovative leadership — both domestically and internationally — to protect
health, prevent illness, prolong life, and promote wellness.
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4. 4 4

5. Mission and Vision of OIP
Vision
• The FDA's Office of International Programs (OIP) advances the
mission of the FDA and public health worldwide in partnership with
other FDA components, other U.S. agencies, foreign governments
and international organizations.
Mission
• OIP's mission is to lead, manage, and coordinate all of FDA's
international activities, with the following goals.
• Effect an affirmative public health agenda in the international area;
• Enhance and maximize FDA's communications and interactions
globally, to assure they reflect the Agency's policies and best
scientific, legal, and policy thinking;
• Assure that FDA international communications and interaction are
consistent with the U.S. Department of Health and Human Services
public health objectives, and,
• Leverage resources with counterpart agencies to meet our public
health missions.
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6. 6

7. FDA Resources Compared Imports
25,000
20,000
Lines∗ in Thousands
15,000
10,000
5,000
0
1995 1997 1999 2001 2003 2005 2007 2009 2011
est
Fiscal Year
FTEs LINES
∗Lines are shipments of a certain type of product (i.e. if a container includes 1 million bottles of water
and 5 million bottles of club soda, that would be one entry containing two lines).
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8. Foreign Inspections
2500
2000
1500
1000
500
0
2008 2009 2010 2011
Fiscal Year
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9. Principales países latinoamericanos
exportadores de productos regulados por
FDA 2011*
PAIS ENTRADAS
Mexico 7,970,177
República Dominicana 137,520
Chile 121,529
Guatemala 113,100
Costa Rica 108,364
Colombia 89,774
Brasil 88,380
El Salvador 81,114
Perú 74,662 9
*Fuente: ORADSS (Datos no Oficiales)

10. Principales causas de rechazos de
productos colombianos 2011
 Medicamentos no aprobados
 Colores no inocuos
 Etiquetado: no en inglés, ingredientes no
listados y errores en general
 LACF: sin FCE ni SID
 Plaguicidas
 Falta etiquetado nutricional
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11. Algunas alertas de Importación que afectan
productos alimenticios colombianos
http://www.accessdata.fda.gov/CMS_IA/countr
y_CO.html
 Quesos: contaminación  Violaciones a NLEA
microbiológica  Aflatoxinas en alimentos general
 Aletas de tiburón: suciedad  Frutas y vegetales frescos:
 Pez espada: metil mercurio contaminación con patógenos
 Tamarindo: suciedad  Plaguicidas en alimentos frescos
 Hojas de Stevia y procesados: lulo, mora, fresa,
uchuva, albahaca
 Colores: ilegales o no declarados
 Salmonella: te de manzanilla,
 Pescado a vacío: C. botulinum
albahaca
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12. Changing Nature of Risk in Global Supply Chains
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13. Latest wakeup calls
• Melamine in pets foods and in infant formula
• Listeria in cheese, guacamole, etc.
• DEG in toothpaste, in glycerin used in teething
gel and in cough syrup
• Salmonella in mamey pulp, peppers,
cantaloupes, etc.
• Counterfeit diabetic test strips
• Gentamicin pyrogenic reactions
• Heparin (Condroitin Sulfate adulterant?)
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14. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/Glo
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15. History of FDA’s Latin American
Office
• OIP’s Foreign Offices
– 7 foreign offices
– Asia Pacific, China, India, Europe, Middle East and North
Africa, and Sub-Saharan Africa, Latin America Office (LAO)
• administrative offices in Maryland
• LAO
– January 6, 2009
• First office officially dedicated at the US Embassy in San José,
Costa Rica
• Ceremony attended by Leavitt, Von Eschenbach, Valdez and
Seligman.
• Trip includes a visit to the Gorgas Research Institute in Panamá
City, Panamá.
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16. FDA Foreign Offices
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17. 17

18. Regulatory Challenges for FDA
• more imported products
• more international providers of these products
• more international sub-contractors being used
for manufacturing and clinical trials
• more complex supply chains
• imports coming from countries, whose regulatory
systems are not fully developed
• more opportunity for economic fraud,
counterfeiting, acts of bioterrorism
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19. Today’s Reality
• Import Statistics
• Borders can no longer be a first line of defense
• It is very difficult to detect harmful products at
the border
• Products grown, processed, manufactured,
tested, transported to standards of safety & high
quality – best defense
– primary prevention
– build in safety & quality at the source
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20. Ongoing Activities
• Country profiles
• Validating contacts within the Region
• Build capacity and an understanding of foreign
regulatory systems
• Environmental Scans
• Project to enhance the class 1 recall process
• Analytical Papers
• Presentations and Translating documents
• Training on FSMA
• Collaboration with industry
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21. Future Activities
• Pathway to Global Product Safety and Quality
• Inspections
• Product mapping
• Recalls
• Identifying sources of information within the
Region that have a direct impact on FDA
regulated products or firms shipping to the U.S.
• Leverage information generated by foreign
governments
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22. Contact Information and
Questions
• US-FDA-LAO@fda.hhs.gov
• US Embassy Costa Rica
(506) 2519-2224
• Michael Rogers, (506) 2519-2223
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