Food Law and Regulation Boot Camp

• 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

• 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

• 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

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

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

• 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

• 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

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