Registration and Continental Breakfast

Co-Chairs Opening Remarks

Coffee and Q&A with Dietary Supplement Industry Leaders: What’s Keeping You Up at Night?

Tanaz Dietz
Chief Legal Officer
Vytalogy (Los Angeles, CA)

Todd Halpern
Assistant General Counsel
Haleon (Richmond, VA)

Carlos Lopez
Vice President & General Counsel
The Vitamin Shoppe (New York, NY)

Moderator:

Claudia Lewis
Partner
Venable LLP (Washington, DC)

Key dietary supplement company leaders will share and address their top regulatory and policy concerns for this year as well as 2024. At the end of the segment, participate in an interactive Q+A that will allow you to ask your most pressing questions and add to the dialogue.

Topics to be discussed will include:

• Addressing the latest policy, regulatory, and business developments and priorities which are affecting the supplement industry’s state-of-play
• Analyzing areas of concern garnering attention from the FDA and FTC
• Contemplating the future of dietary supplement regulation, such as the fate of mandatory product listing
• Anticipating what industry changes and regulations will have the biggest impact on the supplement industry

Fireside Chat with FDA

Gerie Voss
Director of the Division of Policy and Regulations Implementation
Office of Dietary Supplement Programs (ODSP)
U.S. Food & Drug Administration

Interviewed By:

Steve Mister
President & CEO
Council for Responsible Nutrition (Washington, DC)

Morning Coffee and Networking Break

It’s a Matter of Interpretation: What Can the Industry Glean About the Future of Dietary Supplement Regulation Based on Recent FDA Activity

Brigid Bondoc
Partner
Morrison & Foerster LLP (Washington, DC)

Ricardo Carvajal
Partner
Hyman Phelps & McNamara, P.C. (Washington, DC)

Stuart M. Pape
Senior Partner
Polsinelli P.C. (Washington, DC)

• Assessing how the FDA’s reorganization of the Human Foods Program will impact the future of dietary supplements and functional foods
• Examining FDA’s recent Final Guidance on Best Practices for Convening a GRAS Panel and how this affects the industry
• Lessons and takeaways from the latest trends in FDA enforcement and warning letters
• What assumptions can we make about when FDA will release an updated NDI guidance and what will that guidance include?

Examining FDA’s Proposed New Definition of “Healthy” Nutrient Content Claims and How It Will Impact the Supplement Industry

James R. Prochnow
Shareholder
Greenberg Traurig LLP

Barry Ritz
VP and Head Regulatory, Scientific & Medical Affairs
Nestlé Health Science (Hazleton, PA)

At the end of 2022, the US Food and Drug Administration issued a proposed rule setting new criteria for the labeling of food products with the nutrient content claim “healthy.” While the proposed rule does not directly foreclose the use of a “healthy” nutrient content claim on dietary supplements and functional food, the updated criteria would make it very difficult for these products to qualify. This panel will closely examine the FDA’s new proposed rule and its implications on the dietary supplement and functional foods industry.

• Understanding the new criteria proposed to qualify for “healthy” nutrient content claims
• Examining what the new rule will require with regard to label changes, modifications to product formulations and new recordkeeping obligations
• Assessing the industry’s response to the new proposed rule, including proposed modifications and potential First Amendment challenges
• Exploring the challenges associated with using the term “healthy” in any context on dietary supplement and food labels in light of FDA’s proposed updates and lack of clarity around what is a “healthy” nutrient content claim
• Discussing challenges FDA’s updated “healthy” criteria could create from non-FDA parties, like the likelihood of class action challenges
• Contemplating FDA’s next steps and tips for preparing to comply with a final rule

Networking Luncheon for Speakers and Delegates

Solving the IND Conundrum: Analyzing Recent Developments Impacting the Design of Clinical Studies, IND Requirements and the Effect on Dietary Supplement Research

Rend Al-Mondhiry
Partner
Amin Talati Wasserman, LLP (Washington, DC)

Yasmeen Nkrumah-Elie, Ph.D.
Global Director for External Research
ChromaDex

The FDA recently issued a proposal to amend its regulations on Investigational New Drug applications (INDs). Pursuant to the proposed amendments, certain clinical investigations of dietary supplements and food would be exempt from the IND requirements. If finalized, these new regulations could help clear a major roadblock for the supplement industry when designing clinical studies, but questions still remain about the scope of IND requirements. This panel will explore the new IND proposal and its implications.

• Examining the specifics of the new proposed IND rule amendments and the implications they will have on industry
• Designing clinical studies — in view of current practices, FDA guidance, and proposed amendments — that do not require an IND and risk triggering drug preclusion
• If supplement and food companies can self-determine if they need an IND going forward, what factors must they consider when making that determination and what conditions must be met?
• If supplement and food companies opt to seek an “FDA-Determined Exemption” from the IND requirements, what must they submit along with their request in order to obtain the exemption?

Understanding FDA’s Interpretation of the Drug Preclusion Clause: Tips for Fostering Innovation, Winning the “Race to Market” and Protecting Your Winning Investment in the Current Compliance Landscape

Miriam Guggenheim
Partner
Covington & Burling LLP (Washington, DC)

Kristen R. Klesh
Partner
Loeb & Loeb LLP

Amy Rinaldo
Attorney
Ward Law Office LLC

• Overview of FDA’s interpretation of the drug preclusion clause and discussion of FDA’s actions related to NAC and NMN
• Understanding how to effectively determine if an ingredient is “grandfathered” versus a new dietary ingredient and developing documentation to support this conclusion
• Best practices for establishing whether FDA would consider a new dietary ingredient precluded and developing support that an ingredient is not precluded
• Formulating strategies to avoid drug preclusion when developing and introducing new dietary ingredients
• Steps for establishing the date a supplement was first “marketed”
• Identifying business and legal practices that could jeopardize a supplement ingredient’s first to market status, including the use of investigational new drug applications in the research process and pitfalls to avoid when preparing patent applications
• Discussion of tools available to protect the intellectual property developed through ingredient research and innovation
• What should regulatory experts know about IP protection to help successful protect investments and avoid creating FDA compliance concerns in the process?
• Understanding how to develop patent applications and using other IP protection tools
• Looking at the bigger picture: Is legislation needed to amend drug preclusion and what should amendments include?
• How can industry work with drug companies and other associations to influence Congress to amend the legislation?

Industry Think-Tank on FDA Inspections: Examining How New FDA Inspection Tools and Remote Regulatory Assessments Will Help Increase Inspection Efficiencies

Greer Lautrup
Partner
Sidley Austin LLP (Washington, DC)

Taneesha Routier
Director of Regulatory Affairs
XYMOGEN(Orlando, FL)

Increasing the frequency, quality, and efficiency of dietary supplement manufacturing facility inspections is a priority for both industry and FDA.

This panel will explore topics including:

• Identifying the latest tools and other methods through which FDA is working to increase inspection frequency and efficiency, such as the use of Remote Regulatory Assessments and increased FDA inspector training
• Exploring possible changes to the FDA inspection processes based on changes to FDA structure and the proposed creation of the “Human Foods Program”
• Understanding what additional changes FDA could make to better facilitate inspections, such as increased coordination between the Office of Regulatory Affairs and other FDA offices
• How can industry collaborate with FDA to identify inspection concerns and increase frequency and efficiency?
• Practical tips for handling inspections, such as getting your facility prepared for your inspections, managing responses to inspections and understanding when you might need to get outside counsel involved
• Understanding ways that non-FDA third-party manufacturing audits could help the inspection process

Afternoon Break

Forecasting the Future of Personalized Nutrition: Examining New Market Opportunities and Legal Risks for the Supplement Industry

Meryl Bartlett
Attorney
Latham & Watkins LLP (Washington, DC)

Nate Matusheski
Chief Science Officer
Hologram Sciences

• Contemplating what the future of personalized nutrition could look like with the implementation of widespread blood testing, advanced diagnostic tools and AI
• Exploring opportunities — as well as the risks and potential legal liabilities — for supplement companies to develop their own blood testing or to partner with diagnostic companies to determine nutritional needs
• Understanding legal requirements for nutritional testing and how FDA medical device laws and guidance govern their use
• Navigating privacy risks, including HIPPA implications
• Working with healthcare practitioners on meeting personalized patient needs, facilitating compliance with DSHEA claims requirements, and navigating recent enforcement actions involving healthcare practitioners

Contemplating the Future for CBD: Navigating the Sale of CBD and Other Hemp-Derived Cannabinoids in the Wake of FDA’s Recent CBD Announcement

Kelly Fair
Partner
Dentons (San Francisco, CA)

Garrett Graff
Partner
Moye White LLP

Sharon Lindan Mayl
Partner
DLA Piper (Washington, DC)

Christina Phelps
Senior Director of Regulatory Affairs
Cronos Group (Los Angeles, CA)

On January 26, 2023, FDA announced that the existing regulatory frameworks for food and dietary supplements are not appropriate for hemp-derived CBD, and that the agency was looking to Congress to establish a new regulatory pathway for the ingredient. Concurrently with this pronouncement, FDA denied three citizen petitions asking FDA to establish a legal pathway for CBD as a dietary supplement.

This panel will address topics including:

• Analyzing the basis for FDA’s determination that regulation of CBD lies with Capitol Hill and a new regulatory pathway
• Understanding FDA’s legal and safety concerns around CBD and the limitations imposed by current supplement regulations
• Forecasting the legislative impact of the FDA’s recent announcement
• Predicting the types of CBD legislation industry could see in 2023, including whether CBD could be a topic for the 2023 Farm Bill
• Exploring the opportunities and hurdles to creating a clear legal pathway for CBD
• Navigating the patchwork of state CBD laws in the absence of federal regulation

Conference Adjourns

Co-Chairs’ Opening Remarks

Fireside Chat with FTC

Christine L. DeLorme
Attorney, Division of Advertising Practices
Federal Trade Commission

Interviewed By:

Megan Olsen
Senior Vice President & General Counsel
Council for Responsible Nutrition (Washington, DC)

Grappling with the Implications of the FTC’s New Health Products Claim Substantiation Guidance

Katie Bond
Partner
Keller & Heckman LLP

Gregory Fortsch
Assistant General Counsel for Regulatory Affairs
Nestlé Health Science (Bohemia, NY)

Mark Brian Levine
Associate General Counsel
Reckitt Benckiser (New York, NY)

On December 20, 2022, the FTC’s Bureau of Consumer Protection issued its new Health Products Compliance Guidance, the Commission’s first revision of its dietary supplement advertising guidance in nearly 25 years.

This panel will take a deep dive into what has changed from the FTC’s original 1998 guidance, what has stayed the same, and what these new guidelines will ultimately mean for industry going forward.

• Examining the key ways in which the new guidance deviates from and expands upon the old guidance
• What expectations has FTC created in the guidance regarding clinical trial quality, practices and analysis, including statistical analysis of clinical trial results?
• Addressing how the new guidelines will impact the use of ingredient clinical studies
• Understanding how court precedent impacts the guidance and what to do where precedent contradicts FTC’s guidance updates
• Analyzing the new guidance’s emphasis on randomized controlled clinical trials (RCTs) How much evidence, and what type of evidence, will be needed going forward to substantiate health-related claims?
• Are there exceptions to using RCTs, what type of evidence can be used in lieu of RCTs, and how do advertisers document the relevance of this evidence?

The Latest on State Laws Impacting Dietary Supplement Packaging and Anticipating the Impact of the FTC’s Updated Green Guides

Joseph Aquilina
Sr. Director, Associate General Counsel
Consumer Brands Association (Washington, DC)

Raqiyyah Pippins
Partner
Arnold & Porter Kaye Scholer LLP

Frederick Stearns
Partner
Keller and Heckman LLP (Washington, DC)

• Examining the proposed changes to the Green Guides and the impact that FTC’s contemplated rulemaking could have on environmental marketing claims
• Understanding recent class action risks related to environmental claims
• Analyzing state packaging and sustainability laws, such as California’s SB 54, and their impact on industry
• State law packaging and sustainability trends, such as extended producer responsibility laws and PFAS packing bans
• Exploring differences in FTC’s guidance and state law requirements for the term “recyclable”
• Best practices for how to deal with patchwork state laws regarding environmental claims, such as “recyclable” and “compostable”

Morning Coffee Break

Shining a Light on “Dark Patterns”: What Supplement Companies Should Know About a Rising Area of FTC Advertising Enforcement

Amy Mudge
Partner and Chair Advertising, Marketing and Digital Media Team
Baker & Hostetler LLP (Washington, DC)

Meghan Stoppel
Member
Cozen O'Connor (Denver, CO)

The FTC and other enforcers are rapidly increasing their focus on “dark patterns” in advertisement designs, which are practices that regulators believe can trick or manipulate consumers into buying products or giving up their privacy.

This spotlight session will explore:

• Specific website design and advertising practices that are currently triggering enforcement activity
• The types of allegations being brough by the FTC in cases where dark advertising patterns are alleged
• How dietary supplement companies can avoid being the next target in this rising wave of deceptive advertising enforcement

Dietary Supplement Integrity: Addressing Counterfeits, Fraud, and Product Quality

Tara Couch
Owner
TLC Regulatory and Laboratory Consulting (Woodland Park, CO)

Patrick Runkle
Trial Attorney, Consumer Protection Branch
U.S. Department of Justice

Elan Sudberg
CEO
Alkemist Labs (Garden Grove, CA)

Joseph Wheatley
Senior Corporate Counsel
Counterfeit Crimes Unit
Amazon (Washington, DC)

• Assessing recent risks to the industry from counterfeit products and tips for protecting your products
• Combating supply-chain fraud, supplement purity and identity errors, and trends in recent criminal and civil enforcement actions
• Steps companies can take to protect supplement integrity if they discover counterfeit products or other fraudulent activity
• Taking a look at the most recent developments in third-party testing of supplement products, retailer requirements, and how testing can help combat product quality concerns
• Examining the challenges and benefits of third-party testing
• How can labs demonstrate quality and proficiency?
• How does a company refute third-party testing they believe is inaccurate?

Examining the Latest Class Action and Prop 65 Activity Posing Risks to the Dietary Supplements Industry

Trenton H. Norris
Partner
Hogan Lovells LLP

Jasmine Wetherell
Counsel
Perkins Coie LLP (Los Angeles, CA)

• Analyzing the latest trends in class action activity impacting the dietary supplements space
• Examining the latest advertising and labeling practices triggering class action claims
• Identifying key lessons and takeaways from the latest litigation activity
• Insights on what the plaintiff’s bar may target next
• Assessing how current class action activity will impact future claims practices as well as your bottom line
• Identifying new and continuing class actions risks
• Technical label compliance, such as calorie calculations, net contents statements, DSHEA disclosure placement
• Presence of overages
• Ingredients for which safety has been questioned, such as titanium dioxide and PFAS

• Examining data analytics on class action trends
• Trends in the subject of class actions, cost of class actions, jurisdictions of class actions, etc.
• Exploring the latest Prop 65 activity concerning dietary supplements
• Taking a look at the latest round of Prop 65 chocolate suits and how this could impact supplements containing chocolate
• Assessing Prop 65 activity surrounding contaminants
• Examining Prop 65 trends that are predictors of future class action activity in the supplements space

Conference Ends