U.S. FDA Regulations:Exporting Food to the United States

Anna Benevente | Senior Regulatory Specialist

Overview

How Does FDA Work?01

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03

06

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PREDICT: Your Reputation with FDA

Food Facility Registration

Prior Notice

Food Canning

Labeling

FSMA

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 products they regulate:

• Congress passes a law

• FDA writes the “regulation” into the CFR

• Educator, but also enforcer

• Inspections in port

• Inspections overseas at factories

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

• History of detentions

How does FDA work?

Enforcement

• Inspections

• Import Refusals

• Import Alerts

• Warning Letters

• Suspension of registration

• Civil and criminal penalties

BURDEN IS ON YOU TO COMPLY

Your $ + Your Reputation

Basic FDA RequirementsRegistration, U.S. Agent & Prior Notice

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

- Unique Facility Identifier beginning October 2020 (e.g., DUNS)

- Facility Information

- Name

- Corporate Entity Type

- Physical Location

- Trade Names Used

- Contact Information

- Product Information

Requirements Information

FDA Registration

Exemptions

- Trading Companies

- Personal Residences

- Transportation Only

- Farms

- Retail Food

- Fishing Vessels

- Facilities Regulated by the U.S. Department of Agriculture (most meat, poultry, and some egg products)

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”

- FDA purges database beginning of odd year following each renewal cycle

2020

Failure to Renew = Cancelled Registration

FDA RegistrationFDA Registrations by Country

- Canada

- 2018: 6,721 Difference: 21%

- 2019: 5,299

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 and Process Filing

Food Canning Establishment

• Final pH > 4.6 ( certain tomato products > 4.7)

• Water activity (aw) > 0.85

Examples: coconut water, tuna, UHT milk

• Final pH ≤ 4.6

• Water activity (aw) > 0.85

Examples: hot sauces, baby food puree, juices

Low-Acid Canned Food Acidified Food

Low-Acid / Acidified Foods

Food Canning Establishment (FCE) and Submission Identifier (SID)

• Each facility that produces a low-acid or acidified canned food (LACF) intended for U.S. market must be registered

• Filing of processing information for all low-acid or acidified foods produced in the factory [submission identifier]

• Each individual product in each distinct container must have its own SID

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

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:

Enforcement Date: 2020

Changes to other formats permitted for special packaging and/or certain products:

Additional Label Formats

Simplified Linear

Tabular

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

• Extension granted to manufacturers of certain cranberry products 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.

Labeling Food as “Organic”

FSMA: FDA’s Shift to Being Proactive

FSMA Rules & Dates

January 4, 2011Food Safety Modernization Act (FSMA) signed into law

2011

November 27, 2015- Foreign Supplier Verification Program (FSVP)- Third Party VerificationProduce Safety

2015 2016 2016

04

JAN17

SEP

27

NOV

06

APR

27

MAY

April 6, 2016Sanitary Transportation

November 14, 2016Voluntary Qualified Importer Program (VQIP)

14

NOV

May 27, 2016Intentional Adulteration

September 17, 2015Preventive Controls for Human & Animal Food

SHIFTING FDA FROM REACTIVE TO PROACTIVE

Preventive Controls RuleHARPC (Food Safety Plan)

21 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

HACCP vs HARPC

The Food Safety Plancan 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

Preventive Controls Qualified

Individual (PCQI)

Qualified Through Education & Training

MUST BY DEVELOPED BY A

Corrective

Actions

Food Safety

Plan

Re-Analysis

Hazard

Analysis

Supply Chain

Program

Recall

Plan

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

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

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Very Small Business

A Qualified Facility attestation must be submitted and accepted by FDA. (Exempt from Subpart C & G)

Attestation Applicability

Foreign Supplier Verification Program (FSVP)21 CFR 1.500-1.514

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• 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

*For each food category per foreign supplier

FSVP Components

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

• Agreement between Canada and the United States, signed in May 2016

• Mutual recognition of each other’s food safety systems as being comparable in terms of control measures and monitoring

• Ensures greater regulatory cooperation, information sharing, collaboration, and more efficient use of resources

• Subject to review and reassessment

• Allows FDA to focus efforts on food imported from countries where the agency does not have the same level of confidence in their food safety system

Food Safety Systems Recognition Arrangement (FSSRA)

• Modified FSVP requirements for U.S. importers of food covered under the agreement:

• Do not have to conduct a hazard analysis• Do not have to conduct supplier evaluation for approval and

verification

• To qualify, a business must:• Be licensed under the Safe Food for Canadians Regulations

(SFCR)• Be on the SFCR list of licensed food manufacturers in good

regulatory standing• Operate with an acceptable Preventive Control Plan (PCP) and

maintain acceptable traceability documents

• Companies on the list will also meet FSVP requirements for food safety controls

Food Safety Systems Recognition Arrangement (FSSRA)

FSVP Agent

• FSVP rule defines “importer” as “the U.S. owner or consignee of an article of food that is being offered for import into the United States.”

• Different from U.S. Customs and Border Protection’s “importer of record”

• FSVP Importer must be in the United States

• What if there is no owner?• US warehouse • Trade show samples

• If there is no U.S. owner or consignee, the importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent

FDA Food Facility Inspections

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 Food, Drug, & Cosmetic (FD&C) Act.

Inspection Selection

• Facility’s risk profile:

• Product Risk

• Process Complexity

• Facility compliance history (refusal rates, previous inspection results, etc.)

• New exporters shipping large volumes

• Convenience (FDA typically inspects 4-8 facilities per trip)

• 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: “NOTICE OF INSPECTION”

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.

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)

Applicable FDA Regulations

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

End of Inspection

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.

Post Inspection

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

OAI Actions

• Warning Letter (which you could respond to)

+ “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

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)

Questions & Answers

CONTACT US

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