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 Notice 05 05 Food Canning 06 06 Labeling 07 07 FSMA

Ho How w Doe oes s FD FDA A Work? ork?

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

PREDIC DICT PREDICT: System for determining which shipments to examine or sample at the port Prioritize higher risk Factors that can alter shipments, considering: PREDICT score: • Invalid registration • Inherent product risk number • Shipper’s FDA compliance • Labeling errors history • Failed FDA facility • Also uses randomization inspection for an additional level of • Consumer complaint security • History of detentions

How How does FDA work rk? 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 sic FD FDA A Req equirem irements ents Registration, U.S. Agent & Prior Notice

Food d Facil ilit ity y Reg egis istra rati tion on Require uirement nts s Inform rmati ation on - Bioterrorism Act of 2002 - Facility Information - Facilities that manufacture, - Name process, pack or store food - Corporate Entity Type (including beverages and - Physical Location dietary supplements) - Trade Names Used - Foreign facilities must designate a U.S. Agent - Contact Information - Unique Facility Identifier - Product Information beginning October 2020 (e.g., DUNS)

FDA Regist istration ration 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)

Ren enewal Food Facility Registration Renewal 2020 - 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 Failure to Renew = Cancelled Registration

FDA Regist istration ration FDA Registrations by Country - Canada - 2018: 6,721 Difference: 21% - 2019: 5,299

Prio ior r Notice ice Notification to FDA NOTE: Required even for samples - Detention in port if not filed - Includes information about the shipment and the facility - May be filed by exporter, importer, or third party

Foo ood d Canning ng Es Esta tabl blish ishment ment (FCE) Registration and Process Filing

Food d Can anni ning ng E Establ ablishme ishment nt Low-Acid cid Canned ed Foo ood Acidi dified ied Food ood • Final pH > 4.6 ( certain • Final pH ≤ 4.6 tomato products > 4.7) • Water activity (a w ) > 0.85 • Water activity (a w ) > 0.85 Examples: hot sauces, baby Examples: coconut water, food puree, juices tuna, UHT milk

Low-Acid cid / A Acid idif ifie ied d Foods ds Food Canni ning ng Establi blishm hment ent (FCE) and Subm bmission ssion Identi ntifi fier er (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

FCE Wi Wizar ard d & SI SID Ver erif ifier ier 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

Food Labeling

Regulatory History 2016: 6: 2014: 14: 2015: 15: Supplemental Two Final Based upon new proposed rule Rules issued research and addressed that mandate nutritional data, "added sugars“ new Nutrition FDA issued two Facts Label Proposed Rules to modify the current Nutrition Facts Label Enforcement Date: 2020

Add ddit itio ional l Label el Forma mats ts Changes to other formats permitted for special packaging and/or certain products: Simplified Linear Tabular

Complian liance ce Da Dates es 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

Labeling Food as “Organic” 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.

FS FSMA MA : FDA’s Shift to Bei o Being ng Proactive

FS FSMA MA Rul ules es & Da Dates es SHIFTING FDA FROM REACTIVE TO PROACTIVE April il 6, 2016 06 06 04 14 17 Sanitary Transportation APR JAN NOV SEP September 17, 2015 November 14, 2016 Preventive Controls for Voluntary Qualified Human & Animal Food Importer Program (VQIP) 2011 2016 2016 2015 January 4, 2011 November 27, 2015 May 27, 2016 Food Safety Modernization Act Intentional Adulteration - Foreign Supplier Verification (FSMA) signed into law Program (FSVP) 27 - Third Party Verification 27 Produce Safety NOV MAY

Pr Preventiv entive e Co Contr ntrols ols Rul ule HARPC PC (Food od Safet ety y Plan) 21 CFR 117 & 21 CFR 507

Applic plicabil bilit ity Preventive Controls - Reduce risks associated with FDA- Registered Human & Animal Food Facilities Including: How? - Food additives - Sanitations Controls - GRAS Substances - Supply Chain Controls - Dietary Ingredients - Recall Plans [21 CFR 117] Human Food [21 CFR 507] Animal Food

HACCP CCP vs s HARPC HARPC 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”

Hazard Assign PCQI Analysis Re-Analysis Preventive Controls Food Safety ty Record Monitoring Keeping Procedures Plan Correctiv ective e Recall Plan Actions ions MUST BY DEVELOPED BY A Preven entiv ive Controls ols Qualif lified ied Indiv ividu idual al (PCQI) Supply Chain Verification Program Qualified Through Education & Training

Exem empt pt 01 02 Facilities Foods - Juice - Retail Establishments Restaurants and Stores - Seafood - Dietary Supplements - Stored Packaged Foods - Alcoholic Beverages No exposure to environment - USDA-Regulated Products - Farms Includes animal feed

Modi difie ied d Requi equiremen rements ts Qualified Facility In 3 preceding calendar years, business: - Must average annual sales of <$500,000 - At least 50% of sales to local consumers Very Small Business In 3 preceding calendar years, company: - Must average <$1,000,000 in annual sales - Market value of unsold food inventory is <$1,000,000 - Attestation Applicability A Qualified Facility attestation must be submitted and accepted by FDA. (Exempt from Subpart C & G)

31 For orei eign gn Suppli upplier er Ver erif ificat ication ion Progr ogram am (F (FSVP) VP) 21 CFR 1.500-1.514

U.S. Impor mporter r FSVP Requ quireme rements ts • 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

*For each food category per foreign supplier FSVP Compon onen ents

FS FSVP Require equireme ments ts Supplier 1 Food Safety Plan Supplier 2 Food Safety Plan Importers need to check supplier’s Food Safety Plans in order to be in compliance with FSVP requirements Supplier 3 Food Safety Plan