Food Law and Regulation Boot Camp

This session will explore the current structure of key agencies and discuss anticipated changes on the horizon.

• Understanding how the responsibilities and jurisdiction of FDA, USDA, FTC, EPA and state and local health agencies intersect and overlap
• Deciphering the organizational structure of each agency and their respective roles in food regulation
• DHHS: FDA – HFP (Human Foods Program), (Dietary Supplements) CDC (Centers for Disease Control and Prevention)
• USDA – FSIS (Food Safety Inspection Service), AMS (Agriculture Marketing Service), APHIA (Animal Plant Health Inspection Service)
• FTC – Bureau of Consumer Protection
• EPA (Environmental Protection Agency)
• Food and Nutrition Service (FNS)
• State and local health agencies and agriculture departments
• 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
• Guidance documents
• Addressing preemption challenges between state and local authorities
• Understanding when federal laws preempt state regulation
• Examining how state authorities exercise their authority despite preemption
• Assessing the implications of Loper Bright for agency rulemaking concerning food, and addressing new challenges to the tenets of the Administrative Procedures Act (APA)

• Defining “labeling” and the “label”
• Identifying the relationship of packaging, websites, and advertisements to the label and to labeling
• Examining Country of Origin labeling regulated by Customs and Border Patrol
• FTC’s voluntary “Made in USA” claims
• 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
• FDA’s Uniform Compliance Date
• Nutrition Labeling and Education Act
• 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
• FDA’s Front-of-Pack labeling proposal
• Label requirements – statements of identity (standards of identity and common or usual names), net quantity of contents, ingredients, allergens, organic health claims, and nutrient content claims
• How to list label information posted on websites and advertisements
• Nutrition Facts Label
• Percent daily value classifications
• Serving size revisions
• Sugar and fat content information
• Nutrient updates
• How to avoid allegations of misrepresentation and misbranding

FDA’s final rule on labeling food ‘healthy’

• Understanding the updated criteria for the ‘healthy’ claim
• How food manufacturers can voluntarily claim that a product is ‘healthy’
• Exploring FDA’s partnership with Instacart to help consumers identify products with the ‘healthy’ claim in a virtual storefront
• Updates to FDA guidance on voluntary sodium reduction targets 

Front-of-Pack (FOP) Nutrition Labeling

• Understanding FDA’s proposal for front-of-pack nutrition labeling
• Exploring ways that FOP impacts food manufacturers’ approaches to marketing
• Devising next steps for food manufacturers under FOP, including potentially costly reformulations and repositioning of products
• How FOP may work to reduce sodium in the food supply 

Allergen labeling

• Examining FDA’s latest guidance on allergen labeling
• Developing best practices on food allergen labeling requirements
• Exploring labeling errors associated with major food allergens and undeclared allergens
• Addressing problems related to “sesame”
• Understanding the pros and cons of “may contain” and “processed in a facility” statement
• Enforcement activities related to allergen labeling failures

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 Guidance and common compliance pitfalls to avoid.

• FSMA Overview and Final Rules Recap
• Preventive Controls for Human Food Final Rule
• Preventive Controls for Food for Animals Final Rule
• 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
• Voluntary Qualified Importer Program (VQIP)
• An overview of relevant FDA Guidance for FSMA Compliance

Plant-Based “Proteins” and “Milks”: Examining the Standards of Identity

• Exploring the latest developments on naming products where standards of identity exist for:
• Plant-based “proteins” products
• Plant-based dairy alternatives
• Analyzing the FDA’s January 2025 draft guidance on labeling of plant-based alternatives to animal-derived foods
• What can we gleam from the comments
• Analyzing the various states’ approaches to plant-based “proteins” and “milks”
• Questions of preemption
• Understanding the process for developing and labeling of protein-alternative foods
• Exploring labelling and usage requirements by plant-based food companies
• Assessing the impact of GRAS changes on these categories

Cell Cultivated Meat, Alternative Proteins, Precision Fermentation

• Understanding the industry significance of FDA’s First (2022) Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology, and subsequent Pre-Market Consultations in 2023 and 2025
• Examining various state bans on cell cultured foods
• Differentiating FDA and USDA responsibilities for cell cultured foods
• Distinguishing between cell cultured foods and precision fermentation
• Comprehending the industry significance of GRAS Notices for alternative proteins and use of precision fermentation

• Defining processed vs ultra processed food
• Exploring the findings of discussions between the FDA and NIH on ultra-processed foods—what are the implications of these talks in the current environment?
• Understanding the FDA’s position on ultra processed foods under the current administration
• State level actions
• Examining how other countries are addressing the “ultra-processed foods” conundrum

• Examining the relationship between the food product label and advertising and promotion
• Differentiating “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
• Avoiding puffery
• When 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 Division of the Better Business Bureau (NAD)
• Children’s Advertising Review Unit (CARU)
• Exploring Lanham Act challenges relative to false and misleading claims for competitor products
• Assessing when health claims for a food product that have been cleared through FDA’s pre-market clearance procedures can be deemed unauthorized under the FD&C Act
• Identifying circumstances under which disease prevention claims for a food product may relegate that product to the status of an unapproved new drug

• Defining Current Good Manufacturing Practices (cGMPs) and the scope of their importance to food commercialization
• Understanding how cGMPs factor into the scope and authority of the FDA
• Deciphering HACCP/ HARPC applicability as per the rule and its relationship with cGMP compliance
• Examining requirements for qualified individuals

• Examining inspection mandates under FSMA
• Defining the jurisdiction and authority of each agency to conduct inspections – FDA, USDA – FSIS, Department of Public Health; State inspections under contract with FDA
• Determining if state’s authority or FDA’s apply
• Assessing how these agencies work together in the context of 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
• Understanding the difference between a “for cause” inspection and a “routine” inspection
• Samples and records access; authority to take photographs
• Evaluating an FDA 483; preparing an effective response
• Understanding the Government’s recourse when a response is not received at the end of the 15-day response period or is deemed inadequate

This session will provide an overview of the laws and regulations relative to food imports in the U.S., including prior notice and FSVP.

• Overview of laws and regulations related to food imports in the United States
• Understanding how the FDA USDA, CPB, 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 2023 guidance intended to help importers develop and implement an FSVP
• Prior notice
• Import detentions
• Import alerts
• 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 circumstances under which a foreign supplier verification program is required and when it is not

• Overview of essential food safety regulations
• Defining “adulteration” and “adulterants” under the FDCA and the Federal Meat Inspection Act and Federal Poultry Inspection Act
• Poisonous or deleterious substances
• Added vs. non-added substances
• Chemical contaminants and carcinogens
• Chemical contaminants transparency tool
• Filth and extraneous materials
• Pesticides
• Metals
• Update on STECs and E. coli prevention protocols
• Listeria mono prevention guidance documents for refrigerated foods
• 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
• Facility registration under the bio-terrorism act

• 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 a direct result of a recall