With the second half of 2022 before us, we will look back at how food manufacturers navigated recent shifts in FDA requirements to help better prepare for compliance deadlines later this year. Join Eric Edmunds, Food Safety Director at The Acheson Group, as he walks through FDA enforcement discretion for labeling issues caused by supply chain disruptions and new FDA sesame declaration requirements, how the FDA is enforcing FSVP after COVID, what food manufacturers can learn from the recent Delta 8 ruling impacting the 2018 Farm Bill, and how to become more “recall ready” in line with FDA’s recent guidance for voluntary recalls.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Supply Chain Controls:
Ensuring Regulatory Compliance and Consumer Safety
Eric Edmunds
Food Safety Director
The Acheson Group - TAG

2. Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
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FSMA FRIDAYS

3. Casual but Professional Format
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Watch prior FSMA Friday recordings at
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Before We Get Started
FSMA FRIDAYS

4. Featured FSMA Friday Speaker & Host
FSMA FRIDAYS
Jim Albright
FSMA Friday Host
Eric Edmunds, JD
Food Safety Director
Eric is a food industry expert on food safety, risk
management, regulatory compliance, and operational
excellence. He regularly works along the farm to fork
continuum to help address food safety and regulatory
concerns for his clients. He holds a Juris Doctor degree
from Willamette University College of Law in Salem,
Oregon, and was previously an attorney for farmers,
retailers, producers, processors and restaurants. Eric is
heavily involved in FDA regulatory issues, the Food Safety
Modernization Act (FSMA) and worked with NASDA’s FSMA
Technical Working Group with the Oregon Department of
Agriculture Food Safety and Animal Health Program.

5. FSMA FRIDAYS
FDA Updates
● FDA Guidance: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting
● FDA Guidance: FDA Oversight of Food Covered by Systems Recognition Arrangements
● White House Office of Management and Budget
○ Labeling of Plant-based Milk Alternatives
○ Inorganic Arsenic in Apple Juice: Action Level
○ Action Levels for Lead in Food Intended for Babies and Young Children
○ Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation
○ Dietary Guidance Statements in Food Labeling
○ Conducting Remote Regulatory Assessments, Questions and Answers, Draft Guidance for Industry
○ Nutrient Content Claims, Definition of Term: Healthy

6. FSMA FRIDAYS
May 2020: Started with COVID-19 Public Health Emergency
Temporary Policy for Food Labeling
When not feasible:
Consumer transparency: Use websites; point-of-sale labeling
• Ongoing supply chain disruptions
• Addresses minor formulation changes
• Printing new labels is ideal, or use of alternatives (e.g., stickers)
• Ingredient substitutes should not cause SAFETY concerns (e.g., allergens, gluten)
• QUANTITY: Ingredient is 2% or less of finished food by weight
• Ingredient is not PROMINENT or part of a label statement (e.g., “made with real butter”)
• Ingredient is not CHARACTERIZING or in INGREDIENT NAME (e.g., raisins in raisin bread)
• Substitution does not affect CLAIMS
• Change does not have significant impact on NUTRITION or FUNCTION of finished product

7. FSMA FRIDAYS
● Sesame is now the 9th major food allergen
FASTER Act (Sesame Allergen Labeling)
● Compliance date: JANUARY 1, 2023
● Must be included in the “contains” statement or named
in ingredient list
● Food introduced or delivered for introduction to interstate
commerce after compliance date must be in compliance
● FDA encouraging labeling NOW!
● No action required for products on retail shelves
before compliance date
● “We believe manufacturers have ample time to have
the correct labels on their products.”
● Consider how this may affect your other products (e.g., allergen cross-contact)

8. FSMA FRIDAYS
Foreign Supplier Verification Programs (FSVP)
Foods-21 CFR 1.502(a)-Develop FSVP
Foods-21 CFR 117.35(c)-Pest control
Foods-21 CFR 117.130(a)-Hazard Analysis - Identification
Foods-21 CFR 117.80(c)-Manufacturing process
Foods-21 CFR 117.35(a)-Sanitary operation
Foods-21 CFR 117.40-Equipment
Foods-21 CFR 117.10-Personnel
Foods-21 CFR 1.505(a)(2)-Evaluation-performance
Foods-21 CFR 1.506(b)-Supplier verification
Foods-21 CFR 1.504(a)-Hazard analysis written
Top 10 Citations
Fiscal Years: 2021, 2022

9. FSMA FRIDAYS
● IMPORTER
FSVP (continued…)
● All foods covered unless exempt:
● Can comply by meeting supply chain requirements in Preventive Controls Rules
● Starting July 24, 2022: The symbol “UNK” is no longer an acceptable facility identifier
○ “The U.S. owner or consignee of an article of food that is
being offered for import into the United States.”
○ Can designate an agent or representative if no “U.S. owner
or consignee”
○ Someone physically located in U.S.
○ Exemptions:
USDA regulated foods, HACCP regulated foods,
personal consumption, R&D use, transhipped goods,
exported then returned without further processing

10. FSMA FRIDAYS
1) Conduct a hazard analysis of the food (hazard ID & risk evaluation)
General Requirements of an FSVP
FSVP must be completed before any food enters the U.S.
2) Evaluate the foreign supplier’s food safety performance and risk posed by the food
3) Based on #2, approve the foreign supplier
4) Establish written procedures to ensure the food is imported only from approved foreign suppliers.
5) Determine and apply appropriate verification activities (assess results).
6) Implement corrective action(s), if needed.
7) Re-evaluate foreign supplier (at least every 3 years)
8) Identify the FSVP importer at entry
9) Records and documentation!

11. FSMA FRIDAYS
● What is it?
Delta-8 THC and CBD
● 2018 Farm Bill made hemp and its derivatives legal, but preserved FDA’s
authority in regard to FD&C Act enforcement
● 9th Circuit found it to be a legal product in a trademark dispute case
● Does that make it legal for use in food?
● Is there a way forward for either product?
○ Psychoactive substance found in cannabis/hemp
○ There had been ongoing confusion as to the legality of delta-8 THC
○ NO. The FDA still considers this an illegal food ingredient
○ FDA recent warning letters for delta-8 THC and CBD
○ Maybe
■ It is a derivative of hemp
■ It is commonly produced from CBD, which ran afoul of DEA regulations

12. FSMA FRIDAYS
FDA Guidance: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
Recall Readiness
• Identify the recall team (and backups)
• Make sure the recall team is trained up on their responsibilities
• A clear recall communication plan (internal and external)
• Outline of reporting requirements (i.e., reportable food registry)
• Product coding for traceability (ingredients, in process, and finished product)
• Current contact information for customers/direct accounts, FDA recall coordinator
• Communication templates for customers/direct accounts, public notices

13. FSMA FRIDAYS
• Food formulation changes and product label
compliance subject to FDA enforcement discretion
Summary
• Update labels and food safety programs for
sesame allergen
• FSVP enforcement is a continued focus for the FDA
• Delta-8 THC and CBD face an uphill battle for
inclusion in food
• FDA has provided additional guidance on what it
considers “recall ready”

14. Q & A
FSMA FRIDAY
Eric Edmunds, JD
Food Safety Director

15. ✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
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Resources & Future Events
FSMA FRIDAYS
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