Food Law and Regulation Boot Camp

Co-Chairs Opening Remarks

Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies

• Understanding how the responsibilities and jurisdiction of FDA, USDA, FTC and local health agencies intersect and overlap
• Deciphering the organizational structure of each agency and their respective roles in food regulation
  • DHHS: FDA – CFSAN (Center for Food Safety and Applied Nutrition); (ODSP) Office of Dietary Supplement Programs; CDC (Center for Disease Control)
  • USDA – FSIS (Food Safety Inspection Service), AMS (Agriculture Marketing Service), APHIA (Animal Plant Health Inspection Service)
  • FTC – Bureau of Consumer Protection
  • State and local health agencies
• Defining the scope of each agency’s jurisdiction and authority
  • labeling
  • marketing, promotion and advertising
  • product recalls
• Examining how each agency exercises its jurisdiction and regulatory authority
  • rule making
  • product decisions
  • enforcement
• Exploring proposed changes at FDA for the Human Food program
• Addressing preemption challenges between state and local authorities
  • understanding when federal laws preempt state regulation
  • examining how state authorities exercise their authority despite preemption

FDA Food and Food Ingredient Classification: Examining GRAS, Premarket Review and the Approval Process for Food Additives

• Defining food, food ingredients and food additives
• Exploring the GRAS process and understanding its role in the premarket and approval process for food additives
• Distinguishing GRAS classification made through scientific procedures vs. food additive safety determinations made by a sponsor
• Understanding when a GRAS determination can be made based on “common use in food”
• How to outline a substance’s intended condition of use in the food product

Morning Break

An Overview of Food Labeling Laws, Regulations, and the Components of a Compliant Label

• Defining “labeling” and the “label”
  • identifying the role of packaging, package inserts, websites and advertisements relative to the label and to labeling
• A summary of applicable laws and regulations applicable to food labeling and labels
  • 21 CFR parts 100-199
  • FDCA Chapter IV
  • Fair Packaging and Labeling Act of 1966
• Identifying the FDA’s responsibility for food labeling and labels
• Understanding the USDA ‘s role in food labeling and labels
• the scope of authority of FSIS and AMS
• labels approved under the prior label approval system vs. the generic label approval
• Defining the product “label”
  • front-of-pack, information panel, package insert
  • label requirements – contents, ingredients, allergens
  • how to list label information posted on websites and advertisements
• How to avoid allegations of misrepresentation and misbranding

A Practical Guide to The Revised Nutrition Facts Label

In 2016, the FDA overhauled the Nutrition Facts label and gave most large Food manufacturers until 2022 to comply with the new requirements. This session will explain what the new label requires and some still outstanding points of controversy.

• Percent daily value classifications
• Serving size revisions
• Sugar and fat content information
• Nutrient updates

Label Bonus Round: Examining the FDA’s New Proposed Rule on Healthy and Allergen Label Guidance

FDA’s New Proposed Rule on Healthy

• Comparing the current definition of healthy to the definition under the proposed new Rule
• Understanding how the definition of healthy under the proposed new Rule would affect food labels
• Examining the “specific nutrient-related criteria to use the nutrient content claim “healthy” under the proposed new Rule
• Exploring how the new definition would expand the healthy food category

FDA’s New Guidances on Allergen Labeling requirements

• Analyzing the FDA’s two new guidance documents on Allergen Labeling requirements – what are the differences:
• Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry
  • Draft Guidance
  • Final Guidance
• Examining ingredients on the new allergen list under the guidances

Label Status Updates on:

• Bioengineered/ GMO
• Organic
• Gluten-free
• Natural

Lunch Break

Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliancy and Meeting Substantiation Standards Relative to Health, Nutrition, Structure and Function

• Examining the relationship between the food product label and advertising and promotion
• Distinguishing “claims made” from “claims substantiated”
• Understanding what you can and cannot say in food advertising and promotion
• Overview of food product claims and the regulatory requirements for making each:
  • nutrient and health
  • structure/function – dietary supplements vs. conventional foods
  • mental performance and focus
  • disease
  • comparative
  • calories/ingredients
• Distinguishing FDA and FTC jurisdiction and authority relative to claims substantiation in food advertising and promotion
• Identifying proofs required to substantiate product claims under FDA and FTC expectations
  • clinical studies
  • scientific evidence and testing
  • consumer surveys
  • taste and internal expert panels
  • market research firms
• When are social media and websites can be viewed as a means of advertising and promotion
• Understanding what recent enforcement actions reveal about food and beverage marketing and advertising vulnerabilities
• Monitoring of food advertising by National Advertising Department of Better Business Bureau (NAD)
• Exploring Lanham Act challenges relative to false and misleading claims for competitor products
• Assessing when health claims for a food product which have been cleared through FDA’s pre-market clearance procedures can be deemed unauthorized under the FDCA
• Identifying circumstances under which disease prevention claims for a food product may relegate that product to the status of an unapproved new drug

Afternoon Break

FDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination

• Overview of essential food safety regulations
• Defining “adulteration” and “adulterants” under the FDCA and the Federal Meat Inspection Act
  • poisonous or deleterious substances
  • added vs. non-added substances
  • chemical contaminants and carcinogens
  • filth and extraneous materials
  • pesticides
  • metals
• Update on STECs and E. coli prevention protocols
• Differentiating allergens from pathogens
  • understanding how they differ
  • FDA vs. USDA
• How to establish effective food safety guidelines, protocols and screening measures – traceback, HACCP, sanitation SOPs and testing procedures
• Update on the Reportable Food Registry and how the FDA has used information provided in the Registry to address food safety issues

Food Safety Modernization Act: An Overview of the Law, Subsequent FDA Guidances and Common Compliance Pitfalls to Avoid

The Food Safety Modernization Act (FSMA) is one of the most sweeping laws in the history of FDA and dramatically changed food safety standards. FSMA shifted the focus of food safety from a reactionary approach to a preventative one. This session will provide an in-depth overview of the FSMA as well as significant subsequent FDA Guidances and common compliance pitfalls to avoid.

• FSMA Overview
• Title I – prevention of food safety hazards
• Title II – detection and response to food safety problems
• Title III – improving safety of imported food
• Title IV – Miscellaneous
• Final FSMA Rules recap
  • Preventive Controls for Human Food Final Rule
  • Preventive Controls for Food for Animals Final Rule
  • Standards for Produce Safety Final Rule
  • Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Final Rule
  • Accredited Third-Party Certification Final Rule
  • Sanitary Transportation of Human and Animal Food Final Rule
  • Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule
• An overview of relevant FDA Guidances for FSMA Compliance

Day 1 Adjourns

Co-Chairs Remarks and Recap of Day 1

Current Good Manufacturing Practices (cGMPs): Understanding their Unique Role in Food Safety Requirements

• Defining cGMPs and the scope of their importance to food commercialization
• Understanding how cGMPs factor into the scope and authority of the FDA
• Changes to food cGMPs under FSMA’s Preventive Controls for Human Food Final Rule
• Deciphering HACCP/ HARPC applicability as per the rule and its relationship with cGMP compliance
• Validation and proofs of preventative controls
• Examining requirements for qualified individuals

Inspections: What to Do if the Government Shows Up at Your Door

• Examining inspection mandates under FSMA
• Defining the jurisdiction and authority of each agency to conduct inspections – FDA, USDA – FSIS, Department of Public Health
• Assessing how these agencies work together in the context on an inspection
• Knowing what the Government will be looking for during an inspection
  • how to prep your records and employees for an inspection
  • how to handle a “surprise” inspection
  • how to respond to agent’s requests on-site
  • distinguishing a valid investigation from a fishing expedition and how your staff should react to each
• Formulating a Form 483 response post-inspection
• Understanding the Government’s recourse when a response is not received at the end of the 15-day response period

Morning Break

Food Imports: Analyzing Safety Requirements Pursuant to FDA’s Final Guidance on Foreign Supplier Verification Programs (FSVPs)

On January 11, 2023, FDA released its final guidance on foreign supplier verification program (FSVP) requirements for importers of food for humans and animals. This session will provide an overview of the laws and regulations relative to food imports in the U.S, as well as an analysis of the core elements and notable changes reflected in FDA’s final guidance on FSVPs.

• Overview of laws and regulations relative to food imports in the U.S.
• Understanding how the FDA USDA and other US regulatory bodies monitor food import/export activity outside the US
• Analyzing the requirements of the Final FSVP Rule, as well as FDA’s 2018 guidance intended to help importers develop and implement an FSVP
• Examining FDA’s recent Final Guidance on FSVPs, including clarification on issues such as:
  • The FSVP “importer” definition and the scope of FDA’s FSVP requirements;
  • FDA’s enforcement discretion policies;
  • FSVP compliance, approval, and verification requirements;
  • FSVP documentation and audit procedures;
  • Requirements regarding hazard analysis, hazard reports, and controls for identified hazards
  • FSVP requirements for importers of dietary supplements
• Identifying circumstance under which a foreign supplier verification program is required and when it is not

Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority

• Exploring FDA’s recall and detention authority and how this changed under FSMA
• Tips on how to effectively remove products from the marketplace once an issue is discovered – making the decision when and how to recall
• Identifying and correcting regulatory and compliance mishaps that led to the recall
• Working with state and federal government to streamline the recall process
• Maintaining proper documentation during a recall in anticipation of litigation that may result from the recall
• Developing a strategy to address publicity issues that arise as the direct result of a recall

Main Conference Adjourns