Co-Chairs’ Opening Remarks

In-House Counsel Think-Tank on Balancing the Business Priorities of the Food Industry with Key Regulatory Requirements

• Balancing the need to be innovative and in-step with consumer preferences with legal and regulatory requirements
• Preparing for a post-January 2020 world: what is the expected outlook once these regulations go live
• Understanding the state of the union of FDA’s regulatory priorities given the current administration’s deregulatory stance
• Devising best practices for counseling sales and marketing teams when responding to consumer requests
  • Advising regulatory teams on claims challenges

Practical Guidance on the Present State of Food Labeling: Examining the Status of the Nutrition Facts Panel Requirements

• Deciphering the current status of labeling requirements
  • Assessing compliance with the FDA’s nutrition facts panel
    • What do the enforcement initiatives look like?
    • On what areas is FDA expected to focus?
• Examining state and local initiatives on labeling sugar, sodium, antibiotics, hormones, and pesticides
• Interpreting new rules on menu labeling, cultured food products, and the use of dairy names for non-dairy products
• Understanding clean labeling
• What claims are currently high-risk claims and what can be done from a labeling perspective to reduce them?

Networking Luncheon

Is it Natural? Is it Healthy? Interpreting the FDA’s Silence on the Definition of These Terms

• Assessing the current status of FDA’s defining “natural,” “healthy” and other similar terms
• Understanding the repercussions for the industry if FDA does not define these terms soon
• In the interim, should companies steer clear of these terms?
• Examining cases involving:
  • “natural” “all natural,” “healthy”
  • sugar content and “no added sugar”
  • “wholesome,” and “organic”
• Latest on the use of terms “real” and “simple”

Preparing for the Implementation of the GMO Content Disclosure Rules: Who Needs to Disclose and Why?

• Examining the current state of the rule
• Identifying implementation challenges that food companies have been encountering
• What can industry expect with respect to FDA’s anticipated view of the regulation?
• Assessing which circumstances require GMO disclosure under the rule
  • E.g., If GMO ingredients do not appear in a final product after processing, does a manufacturer need to disclose their prior presence?

Afternoon Refreshment Break

What Exactly Can You Say?: Steering Clear of Problematic Claims – A Townhall with the FTC and NAD

Hear directly from the FTC and NAD on how they evaluate various claims in food advertisements and criteria they use to make these assessments. Topics of discussion will include:

• Examining the types of claims that have recently been challenged
• Lessons learned from recent regulatory actions
• Forecasting the likely direction the new administration may take on substantiation

Assessing Current Class Action Challenges and Potential Ways for the Industry to Thwart Them

• Examining developments with the latest claims involving fumaric and malic acids
• Slack fill”: What is it, how to defend against “slack fill” class actions and safeguard a product from slack fill challenges
• Analyzing the recent onslaught of pet food claims: could this be a new avenue for litigation?
• What do manufacturers need to understand about potential liabilities regarding healthy “auras” surrounding their products?
• What to do from a regulatory perspective to avoid litigation?
• Developing best strategies for speedy resolution, if a class action law suit arises

Conference Adjourns to Day Two

Continental Breakfast

Co-Chairs’ Remarks and Recap of Day One

Prop 65: Successfully Moving Forward in the Face of Ever-Increasing Challenges to Food Manufacturers

• Examining the latest overhaul of Prop 65 and its safe harbors as well as their potential effect on the food industry
• Exploring changes in the maximum daily levels
• Reviewing new chemical listings
  • Addressing the practicalities of setting up testing and compliance programs in view of these numerous listings
  • What to focus on and how to communicate these efforts to customers and suppliers?
• Devising safe harbor strategies in view of recent amendments
  • How should products now be labeled?
• Developing protocols for handling 60-day notice
• Addressing indemnification demands from retailers
• Understanding how developments in California are impacting the rest of the country and fueling litigation
  • How does Prop 65 align with FDA policies
• What is the Prop 65 litigation risk with respect to glyphosate at this time?
  • Should products be tested for this chemical at this time
• Weighing defense options against recall strategies
• Is there any way to avoid being targeted – i.e., can manufacturers ensure that no trace amounts of Prop 65-listed chemicals exist in their food products?

Keeping the Food Supply Safe: Developing Strategies for Supply Chain Risk Minimization

• Developing a sound risk minimization plan to ensure supply chain integrity
• Understanding the importance of including mitigation protocols into your plan blueprint
• Addressing recalls within the parameters of risk preparedness
  • What’s the scope of the recall?
  • Handling challenges surrounding anticipated claims
• Managing supply chain mishaps without jeopardizing relationships with suppliers
  • Recovering costs incurred as a result of implementing recalls
  • Paying for claims
  • Assessing brand damage
  • Estimating lost profits
• Addressing challenges relative to products that cannot be sold as a result of a recall
• Suggested ways to protect yourself contractually and through insurance
• Recovering from insurance for losses and liabilities without disrupting the supply chain

Morning Coffee Break

Containing Imported Food Contaminants to Protect Supply Chain Integrity

• Addressing the problem of pesticides and other contaminants that regularly find their way into the supply chain through imported products
• How does a producer protect against this and when needed, defend against it?
• Understanding when supplier verification of “no contaminants” is not enough
• Examining FDA’s standards for evaluating imports
• Reviewing FDA’s protocol for when a contaminant is found in food
• What do manufacturers need to know about import compliance relative to the Foreign Supplier Verification Program?
• Establishing an effective Voluntary Qualified Importer Program

What Lies Ahead for Hemp and Cannabis-Related Ingredients

• Examining the latest developments with the emergence of state cannabis laws
• Exploring developments under the new Farm Bill and whether cannabis-derived ingredients could be used in foods
• Analyzing anticipated state and federal issues
• What is the distinction between hemp, industrial hemp and CBD oil?
• At this time, what hemp or cannabis-related ingredients can be placed into foods legally?
• Evaluating practicalities and liabilities with respect to paying vendors for ingredients

Networking Lunch

Allergens 360: What You Need to Know from Labeling to Litigation

• Complying with the Food Allergen Labeling and Consumer Protection Act (FALCPA): what needs to be on the label and where?
• Voluntary allergen disclosures and statements: regulatory and liability implications
• Allergen controls and CGMP in manufacturing
• Recalls: when does an undisclosed allergen trigger a recall?
• Emerging allergen regulatory and liability issues

CRN Keynote Address

Finalizing FSMA Implementation: Assessing What Has Worked, What Has Not, and What’s Coming Next

• Examining the status of the implementation of each major rule and remaining challenges
• Finalizing manufacturers’ intentional adulteration plans: implementing the final FSMA rule on intentional adulteration
• Exploring the latest developments with FSMA inspections
  • Examples of lessons learned during inspections
• Developing real-time strategies for responding to investigators
• Handling inspections by state and local health departments

Afternoon Refreshment Break

Effectively Managing Recalls While Preserving a Company’s Reputation

• Ensuring that manufacturers do not ignore the warning signs or recall too quickly
• Managing a response to FDA food safety investigation
• How to effectively cooperate during investigations
• Developing best strategies for speaking with the FDA
  • What is the best timing for speaking with the FDA?
• How does FDA view a company’s decision-making process on product recalls?
• How does FDA decide whether or not to investigate and what test data they are using to get a sense of what the risks are?
• How to determine what microbiological tests should be performed?
• If after performing a test there is a positive result, is a recall required immediately or should a producer try to correct the issue first?
• Working with outside experts and PR firms while maintaining attorney-client privilege

Innovations in Food Technology: Examining How Innovative Food Products Are Evaluated, Approved, Labeled, and Named

• Analysis of how novel foods are developed, brought to regulatory process, and eventually sold
• Exploring the latest developments with test-tube-produced meat products and plant-based foods
• Assessing the viability of 3D printing of food
• Evaluating liabilities associated with the testing and production of marijuana edibles
• Understanding the use of block chain for traceability

Main Conference Adjourns