U.S. FOOD AND DRUG ADMINISTRATION
REGULATIONS (FDA)
Dr. DONALD A. PRATER, DVM
Deputy Director (Foods), US FDA Europe Office
Presented at: How to do business in the USA
May 24, 2011, Thessaloniki, Greece
Organized by the American-Hellenic Chamber of Commerce
FDA’s Mission
• Protect public health by assuring the safety and
efficacy of
–
–
–
–
–
human drugs
biological products
medical devices and products that emit radiation
animal feed and veterinary drugs
food and cosmetics
• Advance public health by facilitating innovations
that make medicines and foods more effective,
safer and more affordable
• Provide the public with accurate, science-based
information on medicines and foods
Challenges of Globalization
Globalization has fundamentally changed the environment
for regulating food and medical products and has created
unique regulatory challenges for FDA:
– More foreign facilities supplying the U.S.
– Increasing volume of FDA-regulated imported products
– $2 Trillion worth of products enters the U.S. from more than
150 countries, with 130,000 importers of record, and from
more than 300,000 foreign facilities
3
4
Number of Foreign Sites Making FDA-Regulated Drugs
Has More Than Doubled Since 2001
Official FDA Data – ORA/DIOP
3,000
Foreign Facilities
2,820
Foreign Facilities Inspections
2,595
Number of Active Sites
2,500
2,323
2,046
2,000
1,780
1,507
1,500
1,282
1,000
500
249
211
189
260
255
212
325
0
CY01
CY02
CY03
CY04
CY05
Note: Number of foreign facilities inspections are scaled in fiscal year.
Calendar Year
Number of foreign facilities are scaled in calendar year. Numbers approximate due to data limitations.
CY06
CY07
5
FDA Foreign Offices
6
6
U.S. Food Safety System
Department of Health and Human Services (HHS)
– Food and Drug Administration (FDA)
– Centers for Disease Control and Prevention (CDC)
Department of Agriculture (USDA)
– Food Safety and Inspection Service (FSIS)
– Animal and Plant Health Inspection Service (APHIS)
– Foreign Agricultural Service (FAS)
Environmental Protection Agency (EPA)
Department of Commerce – (NOAA NMFS)
Bureau of Customs and Border Protection (CBP)
Alcohol and Tobacco Tax and Trade Bureau (TTB)
State and local health and agricultural agencies
Bioterrorism Act Regulations
• Took effect December 12, 2003
• FDA and Border Patrol/Customs collaboration
• Facility Registration (foreign 226,373; total 382,866)
– Domestic and foreign facilities engaged in manufacturing,
processing, packing and holding of food
– Greece has 1,166 registered facilities
– The EU has 54,181 registered facilities
• Prior Notification of imported foods
– 2 hours by land
– 4 hours by air or by rail
– 8 hours by sea
Major FDA Center for Food Safety and
Applied Nutrition (CFSAN) Programs
- Food facility registration and prior notice for imports
– Minimization of health risks due to chemical and
biological contamination
– Safety of dietary supplements, infant formulas and
medical foods
– Pre-market safety of substances added to food,
including colors
– Safety of food and ingredients developed through
biotechnology
Major CFSAN Programs
– Food and allergen labeling, health claims
– Seafood and juice HACCP regulatory programs
– Low Acid Canned Food/Acidified Food (LACF) process
registration
– Post-market surveillance and compliance
– International food standard and safety harmonization
(Codex, WTO)
– Technical cooperation and assistance
Reportable Food Registry
• Portal opened September 2009
• All registered food facilities (domestic and
foreign) required to report in 24 hours
• When there is reasonable probability that food
or feed will produce serious adverse health
consequences to humans or animals (equivalent
to Type 1 Recall)
• Served by HHS Safety Reporting Portal
Food Defense Approach
• Detect and identify harmful organisms and toxins in food
(Awareness)
• Train industry and state officials on “CARVER” vulnerability
assessments (Prevention)
–
–
–
–
–
–
Criticality
Accessibility
Recuperability
Vulnerability
Effect
Reconcilability
• Develop effective strategies to protect the food supply from
terrorist threats (Protection)
• ALERT, FIRST
How to Export Food to the U.S.
• Register facility with FDA
• Register process for canning/aseptic packaging of Low
Acid/Acidified Canned Foods (LACF)
• Give “Prior Notice”
• Use good practices in food production
– Agricultural
– Aquacultural
– Manufacturing
– HACCP
• Assure that the product is safe, wholesome, sanitary,
properly packaged and labeled
FDA Food Safety
Modernization Act
Main Themes of the
Legislation
Prevention Standards
Inspections, Compliance,
and Response
Enhanced Partnerships
Import Safety
Import Safety: Most
groundbreaking shift
• Current reliance on port-of-entry inspection cannot
handle increase in imported food.
• Importers now responsible for ensuring that their foreign
suppliers have adequate preventive controls in place
• Requires food from abroad to be as safe as domestic
Import Safety Mandates
Sec. 301. Foreign supplier verification program
• Requires importers to verify their suppliers use risk-based
preventive controls that provide same level of protection as
U.S. requirements.
Sec. 302. Voluntary qualified importer program
• Allows for expedited review and entry; facility certification
required
Sec. 303. Certification for high-risk food imports
• FDA has discretionary authority to require assurances of
compliance for high-risk foods
Import Safety Mandates
Sec. 304. Prior notice of imported food shipments
• Requires information on prior refusals to be added to prior notice
submission
Sec. 305. Capacity building
• FDA mandate to work with foreign governments to build food safety
capacity
Sec. 306. Inspection of foreign food facilities
• Can deny entry if FDA access for inspection is denied
Sec. 201. Targeting of inspection resources
• Increased inspection of foreign as well as domestic facilities
Import Safety Mandates
Sec. 307. Accreditation of third-party auditors
• FDA can rely on accredited third parties to certify that foreign food
facilities meet U.S. requirements
Sec. 308. Foreign Offices of the Food and Drug Administration.
• Establish offices in foreign countries to provide assistance on food
safety measures for food exported to the U.S.
Sec. 309. Smuggled Food
• In coordination with DHS, better identify and prevent entry of
smuggled food
Role of Third-Party Certification
Programs
• Tool for importers to obtain needed assurances to meet
their obligations for the foreign supplier verification
program (sec. 301)
• A way for importers to participate in the voluntary
qualified importer program to expedite movement of food
through the import process (sec. 302)
• Can be required by FDA to accompany high-risk foods
(sec. 303)
Import Projects Completed
(as of May 2011)
Sec. 304. Prior notice of imported food
shipments
– Requires information on prior refusals to be added to
prior notice submission
– Effective July 3, 2011
Enhanced Partnerships:
Vital to Success
International capacity building
– FDA has mandate to work with foreign governments
to build their food safety capacity
– Allows FDA to rely more heavily on foreign
government oversight
– Capacity building helps to prevent problems before
products reach the U.S. port of entry.
Implementation: FDA is prepared
•
•
•
•
Experience in preventive controls
Implementation process in place
Much work already underway
Projects completed can be found on
www.fda.gov/fsma
But, many challenges
• Enormous workload
- 50 new rules, guidance documents, reports in 3 years
• Tight deadlines
• Changes won’t appear overnight
- Building new system will be a long-range process
• Resources
Implementation
Approach
•
•
•
•
Coalition needed
Transparency a priority
Focus on public health protection
Engage with stakeholders to help determine
reasonable and practical ways to do so
Priorities
•
Prevention
– Mandatory preventive controls for facilities (FR 18 months)
– Produce safety standards (FR 2 years)
– Intentional contamination (FR 18 months)
•
Inspection, Compliance, and Response
– Administrative detention (IFR 120 days)
– Recall (Upon enactment)
– Suspension of registration (180 days)
•
Imports
– Foreign supplier verification program (Guidance and FR 1 year)
– Accredited third-party certification program (FR 2 years)
– Mandatory certification for high risk foods (Upon enactment)
For more information
www.fda.gov/fsma
(Subscription feature available)
Contact Information
Donald A. Prater, DVM
Deputy Director (Foods)
FDA Europe Office
Based at the European Food Safety Authority
Parma, Italy
Telephone: 39 0521 036582
Email: donald.prater@fda.hhs.gov