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)
  • 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

• 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”
  • Reviewing tree-nut updates and exclusions
  • Understanding the pros and cons of “may contain” and “processed in a facility” statement
  • Enforcement activities related to allergen labeling failures
• FDA’s final rule on labeling food ‘healthy’:
  • Understanding the updated criteria for the ‘healthy’ claim
  • Exploring potential changes to the final “healthy” rule under the current administration
  • How food manufacturers can voluntarily claim that a product is ‘healthy’
  • Updates to FDA guidance on voluntary sodium reduction targets
• Front-of-Pack (FOP) Nutrition Labeling:
  • Understanding FDA’s evolving 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

• 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

• Current requirements for approving food ingredients
• Exploring the current GRAS process and understanding its relationship to the premarket and approval process for food additives
  • Assessing the future of self-affirmed GRAS and FDA’s proposed changes to the notification process
  • Distinguishing the criteria and process for GRAS with the criteria and process for food additives
• Understanding the concept of a substance’s intended condition of use
• Taking stock of recent developments regarding the GRAS Pathway and Pre-market Consultations for Novel Food Ingredients
• Examining state-level ingredients ban proposals and GRAS reform initiatives

• Defining processed vs ultra processed food
• Exploring discussions regarding “ultra-processed foods” and its lack of definition and implications for food manufacturers
• Understanding what FDA might do about ultra processed foods
• 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
• Understanding what you can and cannot say in food advertising and promotion
• Overview of food product claims and the regulatory requirements for making each:
  • Puffery vs. Claims
  • Nutrient and health
  • Structure/function – dietary supplements vs. conventional foods
  • Mental performance and focus
  • Disease
  • Health / Qualified Health
  • Comparative
  • Taste and #1 / Favorite
• 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
• 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
• Identifying circumstances under which disease prevention claims for a food product may relegate that product to the status of an unapproved new drug