11th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements - WEB

presents:

11th Annual Legal, Regulatory and Compliance Forum on

DIETARY SUPPLEMENTS

June 28–29, 2023 • New York City Bar Association, New York, NY

Pre-conference workshops: June 27, 2023

Post-conference workshop: June 29, 2023

Distinguished Co-Chairs:

Megan Olsen

Senior Vice President & General Counsel Council for Responsible Nutrition

Insights from Leading Industry Stakeholders:

» Alkemist Labs

» Amazon

» ChromaDex

» Consumer Brands Association

» Cronos Group

» Haleon

» NAD

» Nestlé Health Science

» OmniActive Health Technologies

» Reckitt Benckiser

» The Vitamin Shoppe

» Unilever

» Validcare

» VITAQUEST International

» Vytalogy

Taneesha Routier Director of Regulatory Affairs

Fireside Chats with:

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

Gerie Voss

Director of the Division of Policy and Regulations Implementation Office of Dietary Supplement Programs (ODSP)

U.S. Food & Drug Administration

2023 Program Highlights:

ĉ Focus Session on FTC’s New Health Products Compliance Guidance

ĉ Spotlight on FDA’s Proposed New Definition of “Healthy”

ĉ Industry and FDA Collaborative on Increasing Inspection Efficiency

ĉ Critical Updates on FTC Green Guides and New State Packaging and Sustainability Laws

ĉ Think Tank on the Future of Personalized Nutrition

ĉ Strategy Sessions on Avoiding Drug Preclusion and Navigating New IND Requirements

ASSOCIATE SPONSOR:

ACI and CRN are excited to welcome you back to New York City this June for our 11th annual Legal, Regulatory & Compliance Forum on Dietary Supplements.

In the year since we last met, there have been numerous important developments influencing the dietary supplements industry’s state of play. With new areas of concern garnering attention from FDA and FTC, and changes to agency regulations and guidance now upon us, this year’s conference will deliver critical updates on the latest policy, regulatory and business developments keeping the supplements industry up at night.

Significant New Developments at FDA Are Shaping the Future of the Industry

At the close of 2022, the FDA issued a proposed rule setting forth new criteria for the labeling of food products with the claim “healthy.” While the proposed rule does not directly prohibit the use of the term “healthy” on dietary supplements, the Agency’s silence on the matter is eliciting concerns about whether and when supplement companies may use the term “healthy” in any context on their labels in the future.

FDA has also proposed a reorganization of the Human Foods Program leaving industry wondering how this will impact the future of dietary supplements. There are also proposed new amendments to regulations on IND applications creating uncertainty about what clinical studies will look like in the years ahead.

What’s more, at the start of this year, the Agency issued an announcement stating that the future regulation of CBD lies with Capitol Hill and a new regulatory pathway. In the wake of this announcement, industry is left contemplating the hurdles that lay ahead to clearing a legal pathway for CBD.

Updated FTC Guidance Will Impact the Future of Dietary Supplement Advertising

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 new guidance has doubled down on the FTC’s gold standard for claims substantiation and has left supplement companies pondering what exactly substantiation requirements will look like going forward. In addition, FTC has announced forthcoming updates to the Green Guides which will impact the future of environmental marketing claims made by supplement companies.

The States Have Been Active on the Environmental Front, the Plaintiffs’ Bar Remains a Constant Threat

At this year’ conference we will additionally explore the latest trends in state activity impacting the industry, including new developments in state packaging and sustainability laws. We will also strategize on combatting the latest class action activity targeting the supplements industry, and will help you to design and implement class action preparedness protocols at our newly added Class Action Defense Boot Camp

Industry Continues to Push for Strides in Personalized Medicine and Product Integrity

Finally, this summer’s conference will provide unique opportunities to collaborate on the future role of dietary supplements in personalized nutrition, as well as how industry can work together towards increasing product integrity by addressing counterfeits, fraud and third-party product testing challenges.

Learn About This and More at This Year’s Conference

Do not miss the chance to join leading industry stakeholders and explore how the changing legal and regulatory landscape will impact industry policies and practices for the remainder of 2023 and beyond.

We look forward to seeing you in New York this June!

DISTINGUISHED FACULTY

CHAIRS

Megan Olsen

Senior Vice President & General Counsel

Council for Responsible Nutrition (Washington, DC)

Taneesha Routier Director of Regulatory Affairs

XYMOGEN (Orlando, FL)

FDA KEYNOTE

Gerie Voss Director of the Division of Policy and Regulations Implementation Office of Dietary Supplement Programs (ODSP)

U.S. Food & Drug Administration

FTC KEYNOTE

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

SPEAKERS

Rend Al-Mondhiry Partner

Amin Talati Wasserman LLP (Washington, DC)

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

Meryl Bartlett Attorney

Latham & Watkins LLP (Washington, DC)

Keval Bhoola Business Manager Regulatory & Medical Affairs RNI Consulting (UK)

Katie Bond Partner Keller & Heckman LLP

Brigid Bondoc Partner

Morrison & Foerster LLP (Washington, DC)

Ricardo Carvajal Partner

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

Jacqueline J. Chan Assistant General Counsel, Regulatory & Marketing Unilever (Washington, DC)

Christopher Cole Partner

Katten Muchin Rosenman LLP (Washington, DC)

Tara Couch Owner

TLC Regulatory and Laboratory Consulting (Woodland Park, CO)

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

Kelly Fair Partner Dentons (San Francisco, CA)

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

Garrett Graff Partner Moye White LLP

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

Todd Halpern Assistant General Counsel Haleon (Richmond, VA)

Kristen R. Klesh Partner Loeb & Loeb LLP

Greer Lautrup Partner Sidley Austin LLP (Washington, DC)

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

Claudia Lewis Partner Venable LLP (Washington, DC)

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

Nate Matusheski Chief Science Officer Hologram Sciences

Sharon Lindan Mayl Partner

DLA Piper (Washington, DC)

Theodora ("Teddy") McCormick Partner Epstein Becker & Green PC (Princeton, NJ)

Cynthia Meyer Partner Kleinfeld, Kaplan & Becker (Denver, CO)

Russ Michelson Global Head of Regulatory, VMS Reckitt

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

Amy Mudge

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

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

DISTINGUISHED FACULTY (CONT.)

Trenton H. Norris Partner Hogan Lovells LLP (San Francisco, CA)

Stuart Pape Senior Partner Polsinelli

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

Raqiyyah Pippins Partner Arnold & Porter

James R. Prochnow Shareholder Greenberg Traurig LLP

Deshanie Rai Vice President, Global Scientific and Regulatory Affairs

OmniActive Health Technologies (Mountain Lakes, NJ)

Amy Rinaldo Attorney Ward Law Office LLC

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

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

Jennifer Santos Attorney National Advertising Division (New York, NY)

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

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

Elan Suderb CEO Alkemist Labs (Garden Grove, CA)

Léa Trichelot Regulatory Affairs Consultant RNI Consulting (France)

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

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

I look forward to this conference each year with the great lineup and terrific topics.

Barbara Davis Regulatory, Nuseed Nutritional (2022 attendee)

Every presentation this year was on-point and relevant in terms of the current regulatory environment.

Carri Matthieu Church & Dwight Co., Inc. (2022 attendee)

Topics were relevant and informative. Speakers were knowledgeable, clear and concise.

Liz DesJardins Director Regulatory, Santa Cruz Nutritionals (2022 attendee)

Pre-Conference Workshops TUESDAY, JUNE 27, 2023

A9:00 am–12:30 pm

Strategy Session for Successful International Commercialization for Your Dietary Supplement Product

microphone-alt Deshanie Rai, Vice President, Global Scientific and Regulatory Affairs, OmniActive Health Technologies

Keval Bhoola, Business Manager, Regulatory & Medical Affairs, RNI Consulting (UK)

Léa Trichelot, Regulatory Affairs Consultant, RNI Consulting (France)

Russ Michelson, Global Head of Regulatory, VMS, Reckitt

In today’s highly competitive global marketplace, it is essential that dietary supplement manufacturers ensure cross-border commercial success while remaining compliant with complex international rules and regulations. This can be a challenging endeavor, particularly as evolving politics, supply chain challenges, ingredient safety concerns, and other issues continue to impact and modify the rules and processes governing market entry and post-market surveillance.

Our workshop leaders will provide you with comprehensive strategies for tackling the myriad challenges that global commercialization presents and provide solutions for success. Points of discussion will include:

• What to know before you go: an examination of different regulations governing dietary supplements across key foreign jurisdictions

» What are critical distinctions to be aware of?

» What countries are currently changing or expanding their laws?

• Identifying country-specific legal and regulatory resources to help you navigate complex international regulatory issues

• Exploring how key nations are currently approaching risk assessments of certain dietary supplement ingredients

• Analyzing recent developments creating import challenges in other foreign jurisdictions and best practices for US manufacturers and suppliers in navigating them

B1:30 pm–5:00 pm

Claims Substantiation for Social Media

Master Class: A Comprehensive Guide for Making Compliant Claims on Social Media in a Time of Evolving Agency Guidance

microphone-alt Jacqueline J. Chan, Assistant General Counsel, Regulatory & Marketing, Unilever

Cynthia Meyer, Partner, Kleinfeld, Kaplan & Becker

Jennifer Santos, Attorney, National Advertising Division

In an era where Facebook, Instagram TikTok, and product user reviews are major sources of information for consumers, dietary supplement brands are wise to include social media in their marketing strategy. However, when dealing with non-traditional tactics such as influencer marketing, online celebrity endorsements or consumer reviews, supplement companies must be diligent in ensuring that claims about their products are thoroughly substantiated, appropriate disclosures are made, and compliance teams are aware of the latest regulatory guidance and concerns. This panel will explore topics including:

• Determining how to compliantly promote your product and win consumer confidence while staying out of trouble with the regulators

• Examining how new FTC substantiation guidance, endorsement disclosure guidelines, and enforcement activity around use of consumer reviews are impacting social media and other online marketing by supplement companies

• Determining the scientific evidence necessary to meet FTC claim substantiation standards

• Examining how the latest regulatory guidance and enforcement activity impacts influencers and advertisers on platforms like TikTok, Instagram stories, Snapchat, and online retailers like Amazon.

• Developing best practices for:

» Consumer endorsements and consumer reviews

» Expert, celebrity, and influencer endorsements

» Reviews on third-party websites

» Repurposed reviews

» Disclosures of material connections to the brand or seller of the advertised product

• Influencing your influencers: preventing rogue influencers from touting unsubstantiated claims and implementing safeguards against influencer campaign liabilities

7:30 Registration and Continental Breakfast

8:30

Co-Chairs Opening Remarks

microphone-alt Megan Olsen, Senior Vice President & General Counsel, Council for Responsible Nutrition

Taneesha Routier, Director of Regulatory Affairs, XYMOGEN

8:45

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

microphone-alt Todd Halpern, Assistant General Counsel, Haleon Carlos Lopez, Vice President & General Counsel, The Vitamin Shoppe

Tanaz Dietz, Chief Legal Officer, Vytalogy

Moderator: Claudia Lewis, Partner, Venable LLP

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

FDA Focus Sessions

10:00

Fireside Chat with FDA

Gerie Voss

10:45 Morning Coffee and Networking Break

11:15

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

microphone-alt Ricardo Carvajal, Partner, Hyman Phelps & McNamara, P.C.

Brigid Bondoc, Partner, Morrison & Foerster LLP

Stuart Pape, Senior Partner, Polsinelli

• 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?

12:00

Examining FDA’s Proposed New Definition of “Healthy” and How it Will Impact the Supplement Industry

microphone-alt Barry Ritz, VP and Head Regulatory, Scientific & Medical Affairs, Nestlé Health Science

James R. Prochnow, Shareholder, Greenberg Traurig LLP

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

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

• 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

12:30

Networking Luncheon for Speakers and Delegates

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

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

Rend Al-Mondhiry, Partner, Amin Talati Wasserman LLP

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?

2:00

microphone-alt Miriam Guggenheim, Partner, Covington & Burling LLP

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?

2:45

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

microphone-alt Taneesha Routier, Director of Regulatory Affairs, XYMOGEN Greer Lautrup, Partner, Sidley Austin LLP

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

3:30 Afternoon Break

3:45

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

microphone-alt Nate Matusheski, Chief Science Officer, Hologram Sciences

Meryl Bartlett, Attorney, Latham & Watkins LLP

• 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

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

Navigating the Sale of CBD and Other HempDerived Cannabinoids in the Wake of FDA’s Recent CBD Announcement

microphone-alt

Sharon Mayl, Partner, DLA Piper

Former Senior Policy Advisor, FDA

Christina Phelps, Senior Director of Regulatory Affairs, Cronos Group

Kelly

Fair, Partner, Dentons

Garrett Graff, Partner, Moye White LLP

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

5:15 Conference Adjourns

Main Conference Day 2 THURSDAY, JUNE 29, 2023

8:30

Co-Chairs’ Opening Remarks

Spotlight on FTC

8:45

Fireside Chat with FTC

Christine L. DeLorme Attorney, Division of

Federal

Advertising Practices

Trade Commission

Interviewed By: Megan Olsen, Senior Vice President & General Counsel, Council for Responsible Nutrition

9:15

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

microphone-alt Gregory Fortsch, Assistant General Counsel for Regulatory Affairs, Nestlé Health Science

Mark Brian Levine, Associate General Counsel, Reckitt Benckiser

Katie Bond, Partner, Keller & Heckman LLP

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

• 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?

• 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

This was my first conference of this type. I left with so much knowledge and pertinent information that applies to my role in the legal department. I have a list of items that I want to implement as part of our standard procedures.”

Dawn Stadlin Paralegal, Vitaquest International LLC (2022 attendee)

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

microphone-alt Raqiyyah Pippins, Partner, Arnold & Porter

Frederick Stearns, Partner, Keller and Heckman LLP

Joseph Aquilina, Sr. Director, Associate General Counsel, Consumer Brands Association

• Examining the proposed changes to the Green Guides and the impact that FTC’s contemplated rulemaking could have on environmental marketing claims

• 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”

• 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

10:45 Morning Coffee Break

11:15

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

microphone-alt Amy Mudge, Partner and Co-Chair Advertising, Marketing and Digital Media Team, Baker & Hostetler LLP

Meghan Stoppel, Member, Cozen O’Connor

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

11:45

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

microphone-alt Joseph Wheatley, Senior Corporate Counsel, Counterfeit Crimes Unit, Amazon

Elan Suderb, CEO, Alkemist Labs

Tara Couch, Owner, TLC Regulatory and Laboratory Consulting

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

• 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

ƒ How can labs demonstrate quality and proficiency?

ƒ How does a company refute third-party testing they believe is inaccurate?

12:30

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

microphone-alt Trenton H. Norris, Partner, Hogan Lovells LLP

Jasmine Wetherell, Counsel, Perkins Coie LLP

• 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

1:30 Conference Ends

Post-Conference Workshop THURSDAY, JUNE 29, 2023

C2:30 – 5:00

Class Action Defense Boot Camp: A Comprehensive Guide for Designing and Implementing Class Action Preparedness Protocols for In-House Counsel and Regulatory Executives

microphone-alt Christopher Cole, Partner, Katten Muchin Rosenman LLP

Theodora ("Teddy") McCormick, Partner, Epstein Becker & Green PC

Dietary supplements have been a significant target of class action demands for a number of years and this trend shows no signs of slowing down. As the plaintiff’s bar continues to seek out new ways to challenge supplement claims and labeling as false and misleading, it is no longer a question of “if” you will be sued, but “when” you will be sued.

In response to the continued risk from class action litigation, ACI and CRN have created this workshop to help in-house counsel as well as the regulatory teams that they work with develop a class action defense preparedness plan. Attend to develop comprehensive protocols including offensive tactics and defensive strategies which may help insulate your company from the plaintiff’s bar’s latest maneuvers.

Topics of discussion will include:

• Designing thorough internal class action preparedness protocols

• Understanding how offensive strategies such as sound advertising claims substantiation practices can be your best defense and nip a class action in the bud

• Tracking government and consumer protection group enforcement activity on which the plaintiff’s bar might try to piggy-back

• Predicting when you may be a class action target

• Developing pre-suit defense strategies

• Implementing best practices for navigating pre-suit demand letters and complaints

Media Partners

• Considerations for budgeting and forecasting of litigation costs

• Understanding when and how to enlist outside counsel

• Understanding how to make the “fish or cut bait” decision

» Which actions are worth fighting and which should be settled right away?

» Grasping what types of cases settle, which don’t, and how much should be paid

• Comprehending how to allocate contractual liability in view of class actions

New York City Bar Association

42 West 44th Street, New York, NY

Building Bed

Sofitel New York

45 West 44th Street, New York, NY

Reservations: https://book.passkey.com/e/50507107

ACI is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s Dietary Supplements”.

Please note that the guest room block cut-off date is June 6, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Can’t Attend In-Person?

Attend the livestream from the comfort of your home or office.

Immerse yourself in live presentations, panel discussions, specialized breakout sessions and networking opportunities.

Engage in meaningful dialogue with attendees and speakers in an interactive format.

Meet 1-on-1 with attendees you select and exchange contact information for lasting connections and true engagement.

Expand your network to a global audience.

Visit solution providers and learn about the latest technologies, services and products.

ONLINE: AmericanConference.com/DietarySupplements

Book with confidence!

Register and pay to lock in your early rate and be eligible for a full refund until June 17, 2023. If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to customerservice@americanconference.com by June 17, 2023.

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The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 35 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

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