u.s. fda regulations
TRANSCRIPT
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U.S. FDA Regulations:Exporting Food to the United States
David Lennarz | President, Business Development & Operations
Overview
How Does FDA Work?01
02
03
06
04
05
07
PREDICT: Your Reputation with FDA
Food Facility Registration
Prior Notice
Food Canning
Labeling
FSMA
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How Does FDA Work?
Myth vs Fact
Common Myths
• FDA “approves” facilities
• FDA “approves” products
• FDA requires submissions of labels or an inspection before marketing products
For food and beverages
• Regulator / Rule-maker
• Enforcer / Police
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How does FDA work?
Enforcement
• Inspections
• Import Refusals
• Import Alerts
• Warning Letters
• Suspension of registration
• Civil and criminal penalties
Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting
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PREDICT
PREDICT: System for determining which shipments to examine or sample at the port
Prioritize higher risk shipments, considering:
• Inherent product risk
• Shipper’s FDA compliance history
• Also uses randomization for an additional level of security
Factors that can alter PREDICT score:
• Invalid registration number
• Labeling errors
• Failed FDA facility inspection
• Consumer complaint
Basic FDA RequirementsRegistration, U.S. Agent & Prior Notice
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Food Facility Registration
- Bioterrorism Act of 2002
- Facilities that manufacture, process, pack or store food (including beverages and dietary supplements)
- Foreign facilities must designate a U.S. Agent
- Facility Information
- Name
- Corporate Entity Type
- Physical Location
- Trade Names Used
- Contact Information
- Product Information
INFORMATION & REQUIREMENTS
Requirements Information
FDA Registration
Exemptions
- Trading Companies
- Personal Residences
- Transportation Only
- Farms
- Retail Food
- Fishing Vessels
- USDA-Regulated Facilities
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Renewal
Food Facility Registration Renewal
- Every two years, on even-numbered years
- Facilities must consent to FDA inspection
- Failure to renew results in invalidated registration, is a “prohibited act”
2020
Failure to Renew = Cancelled Registration
1. US Agent verification
2. 3rd party authorization
Both verification steps apply to new registrations, renewals, and cancellations.
FDA will not confirm any of these transactions until both the US Agent and the authorizing individual for a 3rd party submission has submitted a receipt code to agree to their respective designations.
Verification Steps
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Prior Notice
Notification to FDA
- Detention in port if not filed
- Includes information about the shipment and the facility
- May be filed by exporter, importer, or third party
NOTE: Required even for samples
Food Canning Establishment (FCE)Registration
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Food Canning Establishment
• Final pH > 4.6 ( certain tomato products > 4.7)
• Water activity (aw) > 0.85
Examples: green olives in brine, artichokes, figs in syrup, etc.
• Final pH ≤ 4.6
• Water activity (aw) > 0.85
In cans, glass, semi-rigid and flexible pouches…
Low-Acid Canned Food Acidified Food
www.fcewizard.com
• Identify whether your products are subject to
• FCE-SID regulations
• Receive and share a PDF report detailing the possible requirements
www.sidverifier.com
• Verify if a particular SID is currently on file in FDA’s database
• Avoid time-consuming detentions and entry errors at port
FCE Wizard & SID Verifier
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Food Labeling
2014:
Regulatory History
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
2016:2015:
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Changes to other formats permitted for special packaging:
Additional Label Formats
Simplified Linear
Tabular
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Compliance Dates
Compliance Dates
• FDA allows industry time to incorporate the new rules into their packaging
• Based upon the annual food sales of the manufacturer
• Sales > $10 Million: Jan 01, 2020
• Sales < $10 Million: Jan 01, 2021
1. Products made with 100 percent organic ingredients may use the USDA Organic Seal or the term “100 percent organic.”
2. Products made with at least 95 percent organic ingredients may use the USDA Organic Seal or the term “organic”.
3. Products made with 70 to 95 percent organic ingredients may use the phrase “made with organic _____________.”
4. Products made with less than 70 percent organic ingredients may only disclose individual organic ingredients in the ingredient statement.
Labeling Food as “Organic”
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FSMA: FDA’s Shift to Being Proactive
FSMA Rules & Dates
January 4, 2011Food Safety Modernization Act (FSMA) signed into law
2011
November 27, 2015Foreign Supplier Verification Program (FSVP)Third Party VerificationProduce Safety
2015 2016 2016
04JAN
17SEP
27NOV
06APR
27MAY
April 6, 2016Sanitary Transportation
November 14, 2016Voluntary Qualified Importer Program (VQIP)
14NOV
May 27, 2016Intentional Adulteration
September 17, 2015Preventive Controls for Human & Animal Food
SHIFTING FDA FROM REACTIVE TO PROACTIVE
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Preventive Controls Rule21 CFR 117 & 21 CFR 507
Applicability
How?
- Sanitations Controls- Supply Chain Controls- Recall Plans
Preventive Controls - Reduce risks associated with FDA-Registered Human & Animal
Food Facilities
[21 CFR 117]
Human Food
[21 CFR 507]
Animal Food
Including:
- Food additives- GRAS Substances- Dietary Ingredients
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Exempt
- Retail Establishments
Restaurants and Stores
Facilities01
- Juice
- Seafood
- Dietary Supplements
- Alcoholic Beverages
- USDA-Regulated Products
Foods02
- Farms
- Stored Packaged Foods
No exposure to environment
Includes animal feed
Assign PCQI
Supply Chain Program
Record Keeping
VerificationMonitoring
Procedures
Preventive Controls Qualified Individual (PCQI)- Qualified Through Education & Training
MUST BY DEVELOPED BY A
Corrective Actions
Food Safety
Plan
Re-Analysis Hazard Analysis
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Modified Requirements
In 3 preceding calendar years, business: - Must average annual sales of <$500,000 - At least 50% of sales to local consumers
Qualified Facility
In 3 preceding calendar years, company:- Must average <$1,000,000 in annual sales- Market value of unsold food inventory is <$1,000,000
-
Very Small Business
A Qualified Facility attestation must be submitted and accepted by FDA. (Exempt from Subpart C & G)
Attestation Applicability
HACCP vs HARPCThe 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”
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Foreign Supplier Verification Program (FSVP)21 CFR 1.500-1.514
• Perform risk-based foreign supplier verification activities to verify that :
• Food is produced in compliance with the applicable FDA regulations • Food is not adulterated
• Food is not misbranded (concerning food allergens)
• Aligns with the requirements for the Supply Chain Program in the HARPC regulation
U.S. Importer FSVP Requirements
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*For each food category per foreign supplierFSVP
Components
• Importers must monitor their suppliers for FDA compliance
• Registrar Corp’s FDA Compliance Monitor tracks compliance status of manufacturers and importers all in one place
• www.fdamonitor.com
Compliance Monitoring
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FSVP Requirements
Importers need to check supplier’s Food Safety Plans in order to be in compliance with FSVP requirements
Supplier 1Food Safety Plan
Supplier 2Food Safety Plan
Supplier 3Food Safety Plan
FDA Food Facility Inspections
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Facility Inspections
FDA inspections are designed to:• Identify food safety problems before products arrive in the U.S. or
enter interstate commerce
• Determine compliance status of facilities
• Help FDA make admissibility decisions
• Ensure that food products meet U.S. requirements under the FD&C Act.
Note: An FDA establishment inspection is a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA.
Facility’s risk profile:
• Product Risk
• Process Complexity
• Facility compliance history (refusal rates, previous inspection results, etc.)
New exporters shipping large volumes
Convenience
• Typically FDA inspects 4-8 facilities on one trip
Inspection Selection
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Inspection Process: “Notice of Inspection”
• Notice is sent by email to:
• Registrant’s email as indicated in the food facility’s FDA registration
• U.S. Agent via email
• Email will come from: @fda.hhs.gov
• 5 Days to Respond
• Provide additional data
• Refusal to respond or refusal to allow an inspection may cause “increased sampling, refusal of admission, or other regulatory action.”
Inspection Process: “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.
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FDA Inspections
FDA inspection are more than just routine GMP reviews
Some may be targeted at specific industry issues
If the facility handles any major food allergens, the inspection may also focus on:• Allergen control plan
• Potential cross-contact
• Cleaning and sanitation protocols
• Use of rework
• Production sequencing
• Traffic patterns
• Factory separation
• Labeling
Applicable FDA Regulations
A single inspection may focus on multiple requirements
For example, a canned tuna product may be inspected for compliance with:
• Seafood HACCP (21 CFR 123)
• Low Acid Canned Foods (21 CFR 113)
• Current GMP (21 CFR 110) / (21 CFR 117)
• Food Labeling (21 CFR 101)
• Emergency Permit Control (21 CFR 108)
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Inspection Process
01 Day 02 Day
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
After the Inspection
- FDA 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
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OAI Actions
Warning Letter (which youcould respond to) and perhaps a “Close Out Letter”
Detentions at the port
Registration suspension
Re-inspection under FSMA
Recommendations
Preparedness is critical
Most companies think they are prepared, but they’re not. Having a review by an external expert is often highly beneficial
Immediately address simple issues found during the inspection process
Respond to the 483 with evidential solutions, not with vague answers
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Finding Customers
Registrar Corp’s Solutions
Registrar Corp provides a full range of fixed-fee compliance services:
• Registration & U.S. Agent Service• Prior Notice Filings• Labeling, Ingredient, and Product Review• LACF
• FCE Wizard, SID Verifier
• Food Safety and FSMA Compliance Services• Mock Inspections, FDA Compliance Monitor, FSMA Wizard
• Detention Assistance• DWPE Petition Submissions• “FDA Compliance Monitor” (www.fdamonitor.com)
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Questions & Answers
CONTACT US
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +1-757-224-0177
F: +1-757-224-0179
International Offices: www.registrarcorp.com/offices