U.S. FDA Regulations: Exporting Food to the United States Anna - - PowerPoint PPT Presentation
U.S. FDA Regulations: Exporting Food to the United States Anna Benevente | Senior Regulatory Specialist Ov Overvie view 01 01 How Does FDA Work? 02 02 PREDICT: Your Reputation with FDA 03 03 Food Facility Registration 04 04 Prior
Anna Benevente | Senior Regulatory Specialist
How Does FDA Work?
01 01 02 02 03 03 06 06 04 04 05 05 07 07
PREDICT: Your Reputation with FDA Food Facility Registration Prior Notice Food Canning Labeling FSMA
Myth vs Fact
Common Myths
marketing products For products they regulate:
PREDICT: System for determining which shipments
to examine or sample at the port
Prioritize higher risk shipments, considering:
history
for an additional level of security Factors that can alter PREDICT score:
number
inspection
How How does FDA work rk?
Enforcement
BURDEN IS ON YOU TO COMPLY Your $ + Your Reputation
Registration, U.S. Agent & Prior Notice
process, pack or store food (including beverages and dietary supplements)
designate a U.S. Agent
beginning October 2020 (e.g., DUNS)
Require uirement nts s Inform rmati ation
FDA Regist istration ration
Exemptions
Agriculture (most meat, poultry, and some egg products)
Food Facility Registration Renewal
“prohibited act”
each renewal cycle
Failure to Renew = Cancelled Registration
FDA Regist istration ration
FDA Registrations by Country
Difference: 21%
Notification to FDA
the shipment and the facility
importer, or third party NOTE: Required even for samples
Registration and Process Filing
tomato products > 4.7)
Examples: coconut water, tuna, UHT milk
Examples: hot sauces, baby food puree, juices
Low-Acid cid Canned ed Foo
Acidi dified ied Food
Food Canni ning ng Establi blishm hment ent (FCE) and Subm bmission ssion Identi ntifi fier er (SID)
www.fcewizard.com
www.sidverifier.com
2014: 14:
Based upon new research and nutritional data, FDA issued two Proposed Rules to modify the current Nutrition Facts Label Supplemental proposed rule addressed "added sugars“ Two Final Rules issued that mandate new Nutrition Facts Label
2016: 6: 2015: 15: Enforcement Date: 2020
Changes to other formats permitted for special packaging and/or certain products:
Simplified Linear Tabular
Complian liance ce Da Dates es
Compliance Dates
packaging
and single ingredient syrups/sugars due to recent changes to guidance for “added sugars” declaration on such products: July 01, 2021
1. Regulated by the U.S. Department of Agriculture, but applies to FDA- regulated food products as well. 2. Canada and the U.S. have an “equivalency arrangement” for organic certification. 3. Products made with 100 percent organic ingredients may use the USDA Organic Seal or the term “100 percent organic.” 4. Products made with at least 95 percent organic ingredients may use the USDA Organic Seal or the term “organic”. 5. Products made with 70 to 95 percent organic ingredients may use the phrase “made with organic _____________.” 6. Products made with less than 70 percent organic ingredients may only disclose individual organic ingredients in the ingredient statement.
January 4, 2011
Food Safety Modernization Act (FSMA) signed into law
2011
November 27, 2015
Program (FSVP)
Produce Safety
2015 2016 2016 04 JAN 17 SEP 27 NOV 06 06 APR 27 MAY
April il 6, 2016
Sanitary Transportation
November 14, 2016
Voluntary Qualified Importer Program (VQIP)
14 NOV
May 27, 2016
Intentional Adulteration
September 17, 2015
Preventive Controls for Human & Animal Food
SHIFTING FDA FROM REACTIVE TO PROACTIVE
21 CFR 117 & 21 CFR 507
How?
Preventive Controls - Reduce risks associated with FDA-
Registered Human & Animal Food Facilities
[21 CFR 117]
Human Food
[21 CFR 507]
Animal Food
Including:
The Food Safety Plan can also be referred to as a HARPC Plan
Taken from “Hazard Analysis and Risk-based Preventive Controls for Human Food: Draft Guidance for Industry”
Assign PCQI Preventive Controls Record Keeping Verification Monitoring Procedures
Preven entiv ive Controls
lified ied Indiv ividu idual al (PCQI)
Qualified Through Education & Training MUST BY DEVELOPED BY A
Correctiv ective e Actions ions
Food Safety ty Plan
Re-Analysis Hazard Analysis Supply Chain Program Recall Plan
Restaurants and Stores
Facilities
Foods
No exposure to environment Includes animal feed
In 3 preceding calendar years, business:
Qualified Facility
In 3 preceding calendar years, company:
A Qualified Facility attestation must be submitted and accepted by FDA. (Exempt from Subpart C & G)
Attestation Applicability
21 CFR 1.500-1.514
31
activities to verify that:
Program in the HARPC regulation
*For each food category per foreign supplier
Importers need to check supplier’s Food Safety Plans in order to be in compliance with FSVP requirements
Food Safety Plan
Food Safety Plan
Food Safety Plan
in May 2016
being comparable in terms of control measures and monitoring
sharing, collaboration, and more efficient use of resources
where the agency does not have the same level of confidence in their food safety system
covered under the agreement:
verification
(SFCR)
regulatory standing
maintain acceptable traceability documents
food safety controls
consignee of an article of food that is being
Protection’s “importer of record”
importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent
FDA INSPECTIONS are designed to:
in the U.S. or enter interstate commerce
under the Food, Drug, & Cosmetic (FD&C) Act.
inspection results, etc.)
sampling, refusal of admission, or other regulatory action.”
“NOTICE OF INSPECTION”
Insp spect ection ion Proce cess ss
“Factory Profile Information” Form
Once you reply, FDA’s Office of Regulatory Affairs will contact you:
◼ May take days, weeks, or months (or never) ◼ Coordinate inspection date ◼ Ask you to complete and return a “Factory Profile
Information” form to FDA
◼ FDA will then come back with name of investigator, their
flight info, ask you to make hotel reservations, and maybe even ask you to provide ground transportation.
A single inspection may focus on multiple requirements
For example, a canned tuna product may be inspected for compliance with:
Appli plicab cable le FDA Regulat ulations ions
◼ Introductions ◼ Opening Meeting ◼ Quick Tour ◼ Document Review ◼ Most time spent in factory ◼ Closing meeting with
management
◼ Delivery of form “483”
“Inspectional Observations”
TYPICALLY 2 DAY PROCESS
FDA will almost always issue a form “483 Inspectional Observations” at end of visit
◼ Identifies deficiencies ◼ Left with management ◼ Provides contact details for your response
within 15 business days
Helpful tips:
1.
Don’t argue with the inspector;
2.
Fix small issues on site to avoid mention on 483;
3.
When respond to FDA, provide documentary evidence.
After you respond to FDA (or if you never respond), they will eventually classify the inspection:
◼ No Action Indicated (NAI) ◼ Voluntary Action Indicated (VAI) ◼ Official Action Indicated (OAI)
FDA discloses the final inspection classification in an online database: http://www.accessdata.fda.gov/scripts/inspsearch/ Or visit: www.fdamonitor.com
Publicly available to customers and competitors
+ “Close Out Letter”
Recommendati
Preparedness is critical
Having a review by an external expert is often highly beneficial
inspection process
vague answers
Registrar Corp provides a full range of fixed-fee compliance services:
Registrar Corp Headquarters
144 Research Drive Hampton, Virginia USA 23666 P: +1-757-224-0177 F: +1-757-224-0179 info@registrarcorp.com International Offices: www.registrarcorp.com/offices