10th Anniversary Legal, Regulatory & Compliance Forum on Dietary Supplements - DS

Live and In-Person

In Collaboration with the

presents:

Legal, Regulatory and Compliance Forum on

EARN CLE

Distinguished Co-Chairs:

CREDITS

DIETARY SUPPLEMENTS

Steve Mister President & CEO Council for Responsible Nutrition

Tara Falsani General Counsel, Vice President and Secretary Nature's Way – Schwabe North America

June 29–30, 2022 | InterContinental Times Square Hotel, New York, NY

A comprehensive guide to the latest developments affecting “products intended to supplement the diet”

Fireside Chats with: Cara Welch Director, Office of Dietary Supplement Programs U.S. Food & Drug Administration

Insights from Leading Industry Stakeholders: y American Botanical Council

Serena Viswanathan Associate Director for Advertising Practices Federal Trade Commission

2022 Program Highlights: ĉ Drug Preclusion Case Study

y Bodybuilding.com

ĉ Industry/Retailer Think Tank on Harmonized Product Testing

y ChromaDex

ĉ Focus Session on Mandatory Product Listings

y Cronos Group y Garden of Life, Inc. y IADSA

ĉ Working Group on Supply Chain Disruption Mitigation ĉ ESG Best Practices Collective ĉ Spotlight on “the New Enforcers”

ĉ Brainstorm on Solving the CBD Stalemate

June 28: Pre-Conference Workshops

y NAD y Nestle Health Science y Reckitt y The Vitamin Shoppe

A

Working Group on Successful International Commercialization of Dietary Supplements (with the USTR)

B

Claims Substantiation Working Group

y XYMOGEN Associate Sponsor:

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Luncheon Sponsor:

AmericanConference.com/DietarySupplements • 888 224 2480

Sponsored By:

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In Collaboration with the

ACI and CRN are so excited to welcome you back to New York for the “return to live” reunion that the dietary supplement industry has been waiting for.

W

ith the dietary supplement industry currently witnessing unprecedented growth, it is imperative that we understand how the changing legal and regulatory landscape will impact industry policies and practices for the remainder of 2022 and the future.

At this year’s conference, we will explore the latest FDA priorities for dietary supplements under new Commissioner, Dr. Robert Califf and we are delighted that Dr. Cara Welch, the newly appointed permanent director of FDA’s ODSP will be our Keynote.

We will examine new strategies that companies can employ to avoid drug preclusion when developing and introducing new ingredients. We will also examine pending legislation supporting mandatory product listings and approaches to making harmonized product testing a reality. We will explore new concerns and interests related to botanicals, tactics for substantiating health and immunity product claims, and effective approaches for addressing supply chain disruption and ingredient shortages.

We will also be taking a closer look at the latest trends in state activity impacting the industry, including age restriction legislation for access to certain supplement products.

We will examine offensive tactics and novel defenses that supplement manufactures can employ in defending class actions. Finally, we will look at the concept of “the New Enforcers” and explore how the industry, plaintiff’s bar, and consumer protection groups are taking on the yoke of the regulators.

Do not miss the chance to reunite with your industry peers and engage in meaningful discussion about the most pressing concerns facing supplement companies today as well as the impact the latest developments will have on your business.

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

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

Tara Falsani General Counsel, Vice President and Secretary Nature's Way – Schwabe North America (Green Bay, WI)

FDA KEYNOTE

FTC KEYNOTE

Cara Welch Director, Office of Dietary Supplement Programs U.S. Food & Drug Administration (Washington, DC)

SPEAKERS Katie Bond Partner Lathrop GPM (Washington, DC) Jennifer Boyd Senior Director, Regulatory Affairs, US & International Nestle Health Science (Sudbury, MA) Jeff Brams Chief Innovation & Legal Officer Garden of Life, Inc. (West Palm Beach, FL) Ricardo Carvajal Director Hyman, Phelps & McNamara, P.C. (Washington, DC) Thomas Cohn Global Head Of Regulatory & Product Cronos Group (New York, NY) Andrew Devine Director Strategic Affairs, China Office of the U.S. Trade Representative Executive Office of the President (Washington, DC) Mike Finamore CEO Gemini Pharmaceuticals, Inc. President of Governance Board Global Retailer and Manufacturer Alliance (GRMA) Cassie Folk Founder & President Cassie Folk & Associates (Washington, DC) Anthony Fontana Laboratory Director Alkemist Labs (Garden Grove, CA)

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Greg Fortsch Associate General Counsel for Regulatory Affairs Nestle Health Science (Bohemia, NY) Stefan Gafner, PhD Chief Science Officer American Botanical Council (Burlington, VT) Anastasia Gilmartin Director of Regulatory Compliance, Counsel Bodybuilding.com (Seattle, WA) Andrea Golan Attorney Vicente Sederberg LLP Day Gooch Vice President, Quality and Commercialization The Vitamin Shoppe Julia Gustafson Vice President Council for Responsible Nutrition (CRN) Jay Hawkins Principal Alpine Group (Arlington, VA) Livia Kiser Partner King & Spalding (Chicago, IL) Mohamed Koroma Director, R&D Pharmavite (Valencia, CA) 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)

Serena Viswanathan Associate Director for Advertising Practices Federal Trade Commission (Washington, DC) Emily Lyons Partner Husch Blackwell

Partner Keller & Heckman LLP (San Francisco, CA)

Donnelly McDowell Partner Kelley Drye & Warren LLP

Andrew Shao, Ph.D. Senior Vice President, Global Scientific & Regulatory Affairs ChromaDex (Los Angeles, CA)

Diane McEnroe Partner Sidley Austin LLP Amy Ralph Mudge Partner BakerHostetler (Washington, DC) Jessica O’Connell Partner Covington & Burling LLP Simon Pettman Executive Director IADSA (International Alliance of Dietary/ Food Supplement Associations) (London, UK) Raqiyyah Pippins Partner Arnold & Porter Kaye Scholer LLP (Washington, DC) Lauren Quinn Vice President and Head, US Regulatory Affairs GSK (New York, NY)

Meghan Stoppel Member Cozen O'Connor (Denver, CO) Michelle Stout Regulatory Policy Director Amway Chair of IADSA (International Alliance of Dietary/Food Supplement Associations) (Buena Park, CA) Ashish Talati Partner Amin Talati Wasserman, LLP (Chicago, IL) Xin Tao Counsel Hogan Lovells LLP (Washington, DC) Suzie Trigg Partner Haynes and Boone LLP (Dallas, TX)

Alistair Anagnostou Reader Trial Attorney U.S. Department of Justice, Consumer Protection Branch

Eric Unis Senior Attorney National Advertising Division (NAD)® – BBB National Programs, Inc.

Harry Rice V.P., Regulatory & Scientific Affairs Global Organization for EPA and DHA Omega-3s (GOED) (Osseo, MN)

Jasmine Wetherell Counsel Perkins Coie

Taneesha Rogers, J.D. Director of Regulatory Affairs XYMOGEN (Orlando, FL)

Will Woodlee Partner Kleinfeld, Kaplan & Becker, LLP

Rohit A. Sabnis

AmericanConference.com/DietarySupplements • 888 224 2480

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PRE-CONFERENCE WORKSHOP DAY

TUESDAY, JUNE 28, 2022

A

9:00 am–12:30 pm

orking Group on Successful International W Commercialization for Your Dietary Supplement Product

Microphone-alt Jennifer Boyd, Senior Director, Regulatory Affairs, US & International, Nestle Health Science

B

1:30 pm–5:00 pm

laims Substantiation Working Group for the Dietary C Supplement Industry: Developing a Playbook for Compliant and Effective Social Media Usage

microphone-alt Thomas Cohn, Global Head Of Regulatory & Product, Cronos Group

Andrew Devine, Director Strategic Affairs, China, Office of the U.S. Trade Representative, Executive Office of the President

Greg Fortsch, Associate General Counsel for Regulatory Affairs, Nestle Health Science

Simon Pettman, Executive Director, IADSA (International Alliance of Dietary/Food Supplement Associations)

Amy Ralph Mudge, Partner, BakerHostetler

Harry Rice, V.P., Regulatory & Scientific Affairs, Global Organization for EPA and DHA Omega-3s (GOED) Moderator: Michelle Stout, Regulatory Policy Director, Amway, Chair, IADSA In today’s global marketplace, it is imperative that dietary supplement manufacturers have at the very minimum, a working knowledge of product commercialization in international markets. Supplement manufacturers must develop strategies which are internationally compliant, but also have commercial appeal for both developed and emerging foreign markets.

Workshop leaders will help you with the challenges that global commercialization presents and provide solutions for success.

Points of discussion will include:

The Practicalities and Details for Entering Foreign Markets – Established and Developing • Detailed discussions around key markets, such as China, the European Union, and the UK » Foreign laws and regulations governing dietary supplements » Evaluating a regulatory pathway for dietary supplement product entry » Identifying foreign approvals and registration processes » Preparing for premarket approval and notification systems

Current Factors Impacting Import – Focus on China and Europe • Analyzing ground-breaking challenges in China related to the General Administration of Customs China (GACC) regulations » What the regulations mean and why they were developed? » How are U.S. regulators trying to bring clarity to U.S. companies? » What solutions can a U.S. company explore for compliance? » Where are the regulations still ambiguous?

• Spotlight on the European Union » Animal Product Certifications in the EU What products and ingredients are impacted?

For example, popular ingredients like Vitamin D could be affected – what can companies do to comply?

Discussion around significant changes to requirements affecting exemptions » EU and Risk Assessments How are EU countries approaching risk assessments of ingredients?

Exploration of examples of shifting risk assessment paradigm, such as EU’s approach to titanium dioxide • Other Significant Actions Affecting Foreign Commerce » Discussion of the decision by the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program (SIP) to discontinue export certifications for fishery product oil supplements » Hear from the Global Organization for EPA and DHA Omega-3s (GOED) on the impact on fishery product oil supplement exportation and possible pathways forward

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Eric Unis, Senior Attorney, National Advertising Division, (NAD)® – BBB National Programs, Inc. Ensuring proper claims substantiation for a dietary supplement product is often a complex, fact-specific process. Even with substantial, welldesigned, studies, claims and their support may still draw scrutiny from regulators and increasingly, plaintiff’s attorneys. If that were not, enough, the changing nature of advertising to use more non-traditional marketing, such as influencers, endorsements, and consumer reviews, and emerging social media platforms, presents new challenges for ensuring claims are communicated in a manner that the substantiation supports.

In this working group, we will take a closer look at the use of influencers, consumer reviews, and new forms of social media used to promote products—all with the goal of determining how to compliantly promote your products, stay out of trouble, and win consumer confidence. Points of discussion, include: • Exploring how COVID-19 has changed claims substantiation for dietary supplements and understanding how this impacts direct and implied claims through various social media platforms • Predicting how anticipated updates to FTC advertising guidelines (e.g., environmental, endorsements/testimonials) will impact the supplement industry • Determining the scientific evidence necessary to meet FTC claim substantiation standards • Examining the role of claims’ language, disclosures, and images in advertising on class action risk and how a claim should be substantiated to reduce class action risk • Taking a closer look at how the FTC and FDA view product claims made via social media and influencers • Exploring recent FTC enforcement activity in the dietary industry space regarding false and misleading social media claims and endorsements » Understanding the significance of this activity in view of the landmark Supreme Court case AMG Capital Management, which significantly limited the FTC’s ability to collect monetary penalties for deceptive advertising • Examining how regulatory guidance and enforcement activity impacts the influencers and advertisers on newer social media platforms like TikTok, Instagram stories, Snapchat, etc.

• Developing best practices relative to: » 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 • Preventing rogue influencers from touting unsubstantiated claims • Implementing safeguards to ensure that influencer campaigns do not create legal liabilities for your company

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DAY 1 – MAIN CONFERENCE

WEDNESDAY, JUNE 29, 2022 8:15

Co-Chairs Opening Remarks

microphone-alt Steve Mister, President & CEO, Council for Responsible Nutrition Tara Falsani, General Counsel, Vice President and Secretary, Nature's Way – Schwabe North America

• Establishing the true intent of the of § 321” drug preclusion” clause and educating regulators as well as the industry on its meaning • Developing strategies to avoid drug preclusion when developing and introducing new ingredients • Finding ways to engage with FDA on current determinations and future ingredients of concern • Getting support from the scientific community for classifying your product as an old “grandfathered” ingredient versus a new dietary ingredient » If a new dietary ingredient, understanding the benefits of establishing stringent research and due diligence protocols for new dietary ingredient notifications that may help negate preclusion findings 10:15

Networking Break

10:45

Fireside Chat

8:30

Cara Welch Director, Office of Dietary Supplement Programs U.S. Food & Drug Administration

A View from Capitol Hill: Monitoring the Latest Activity in Washington Impacting the Supplement Industry

microphone-alt Jay Hawkins, Principal, Alpine Group Donnelly McDowell, Partner, Kelley Drye & Warren LLP Diane McEnroe, Partner, Sidley Austin LLP One year into the Biden administration and the 117th Congress and two years plus into the COVID-19 pandemic, many questions remain about how certain priorities and policies may affect the supplement industry.

Our panel will look at developments at key agencies as well as Congress that will have an impact.

• Understanding the role that the pandemic is continuing to play in political developments impacting the supplement industry • Anticipating new FDA priorities for the dietary supplement industry under new Commissioner, Dr. Robert Califf » What can we glean from Dr. Califf’s prior tenure at FDA? » What changes can we expect at FDA’s Office of Dietary Supplement Programs?

• Exploring FTC priorities relative to dietary supplements » What should we expect from legislation that could give FTC greater monetary penalty authority? » How could FTC’s other priorities effect supplements?

• Analyzing the status and probable impact of key proposed federal legislation » H.R. 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 » S. 1654/H.R. 5214: allowing HSAs/FSAs to be used for supplements » Mandatory product listing legislation • Forecasting what a Republican flip of Congress in the midterms would mean for the supplement industry • Examining how PDUFA or other legislation could be used as a vehicle for DSHEA reform

Focus on FDA 9:15

NAC Case Study: How to Prevent Your Supplement from Becoming the Next Target of Drug Preclusion

microphone-alt Andrew Shao, Ph.D., Senior Vice President, Global, Scientific & Regulatory Affairs, ChromaDex

Xin Tao, Counsel, Hogan Lovells LLP • Examining FDA’s most recent interpretations of the scope of the 21 U.S.C. § 321(ff)(3)(B) “drug preclusion” provision » Findings, status, and consequences of FDA’s July 2020 warning letters and subsequent actions

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DSHEA — Past, Present, and Future 11:45

Sound Strategies to Employ While Waiting for Updated New Dietary Ingredient (NDI) Guidance

microphone-alt Anastasia Gilmartin, Director of Regulatory Compliance, Counsel, Bodybuilding.com

Lauren Quinn, Vice President and Head, US Regulatory Affairs, GSK Ricardo Carvajal, Director, Hyman, Phelps & McNamara, P.C. The industry has been waiting for updated NDI guidance for the better part of a decade. This panel will discuss which new ingredient strategies have worked in this regulatory environment and how to anticipate and prepare for any future FDA guidance.

• Anticipating what updated NDI guidance from FDA will look like • Examining NDI submissions that have been successful in the last decade and what can we learn from them with future filings • Recognizing “safety” as the cornerstone of any NDI filing • Looking at whether other pathways for regulatory compliance exist for a new ingredient, such as whether a GRAS evaluation is appropriate to establish safety and compliant use in supplements • Reviewing the status of proposed “Master Files” as part of the NDI notification process and how FDA enforcement of existing NDI requirements would protect consumers and support public health 12:30

Networking Luncheon

1:30

Preparing the Way for Mandatory Product Listings

microphone-alt Julia Gustafson, Vice President, Council for Responsible Nutrition (CRN)

Jessica O’Connell, Partner, Covington & Burling LLP Will Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP FDA and many industry stakeholders continue to support mandatory product listing for the dietary supplement Industry. With pending legislation and FDA support, mandatory product listing could become a reality in the next few years. This panel will discuss how mandatory product listing authority could be granted to FDA, what the authority and requirements could look like, and how companies can prepare.

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• Identifying the path by which mandatory listings could come into effect: legislation or rulemaking » Senator Durbin’s proposed legislation » Could PDUFA or other legislation be used a vehicle to establish mandatory listing authority? » Does FDA have rulemaking authority to impose mandatory product listing?

• What will mandatory listing authority look like? » Comparison to NIH Dietary Supplement Database and industry tools, like the Supplement OWL » What elements is FDA likely to want to include in mandatory listing legislation and could the new FDA Commissioner appointment effect FDA’s requests? » What elements would industry likely oppose? Could other stakeholders, such as consumer watchdog groups, try to impose new requirements on dietary supplements through mandatory product listing legislation?

• What can companies do now to prepare for mandatory product listing? » CRN Supplement OWL roadmap • Assessing FDA’s current and future authority to enforce mandatory listing » How should the FDCA be amended to ensure FDA has authority to enforce listing? » Does FDA need other tools for meaningful enforcement, such as additional funding?

2:15

In Perfect Harmony: Industry/Retailer Think Tank on Adopting Harmonized Supplement Testing Requirements

microphone-alt Mike Finamore, CEO, Gemini Pharmaceuticals, Inc., President of Governance Board, Global Retailer and Manufacturer Alliance (GRMA)

Anthony Fontana, Laboratory Director, Alkemist Labs Mohamed Koroma, Director, R&D, Pharmavite • Exploring efforts between industry and major retailers—including e-retailers, such as Amazon—to work together to achieve a harmonized supplement testing standard • Comparing the search for a harmonized testing standard to efforts that lead to the creation of harmonized audits for good manufacturing practices • Examining the GRMA Product Integrity Committee’s efforts to find a path toward a harmonized testing standard • What would a harmonized testing standard look like? » Discussion of current retailer testing standards » How can in-house labs demonstrate that their testing should be accepted by retailers? » What metrics can be used to create a harmonized standard?

3:15

Networking Refreshment Break

3:30

Solving the CBD Stalemate

Microphone-alt Emily Lyons, Partner, Husch Blackwell Andrea Golan, Attorney, Vicente Sederberg LLP It has been over 3 years since the passage of the 2018 Farm Bill that legalized the production and sale of hemp, and we are still not any closer to finding a legal path forward for hemp-derived CBD as a dietary supplement ingredient. This panel will look at current state and federal activity and how the industry, legislators, and regulators can move forward.

• Status and significance of H.R. 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 » Discussion of other federal CBD legislation and how it could help or hinder CBD supplement legalization efforts • Examining various state activity on CBD and whether any patterns are emerging • Does it make sense to produce CBD supplements in the current environment? » Risk benefit analysis of manufacturing CBD in the current environment, including navigating the patchwork of state laws, handling the risk from federal uncertainty, retailer concerns, and other issues 4:15

And Now a Word About Botanicals

microphone-alt Stefan Gafner, PhD, Chief Science Officer, American Botanical Council

Ashish Talati, Partner, Amin Talati Wasserman, LLP • Examining how consumer demand for botanicals such as ashwagandha and echinacea have brought new attention to the regulation and sourcing of these products • Understanding the unique regulatory framework surrounding botanical ingredients and how it differs from synthetically derived ingredients » When do EPA rules govern? » How do third-party bodies, like USP and the American Botanical Council (ABC) play a role in botanical compliance?

• Differentiating between rules for organic and nonorganic botanical ingredients • Addressing concerns about pesticide use and contaminants • Devising safeguards to ensure authenticity and integrity of botanical sourcing • Addressing supply chain concerns with botanical sourcing 4:45

Media Partners:

Supply, Demand and Disruption in the Supplement Industry: Devising Strategies to Address Supply Chain Disruption of Raw Materials

microphone-alt Day Gooch, Vice President, Quality and Commercialization, The Vitamin Shoppe

Suzie Trigg, Partner, Haynes and Boone LLP • Assessing the current state of ingredient shortages, their causes, and impacts • Examining the trickle-down repercussions of not being able to obtain ingredients for product manufacture • Drafting contracts to allow flexibility in instances of supply shortage and non-fulfillment • Developing strategies to find new compliant suppliers 5:30

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Conference Adjourns to Day Two

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DAY 2 – MAIN CONFERENCE

THURSDAY, JUNE 30, 2022 8:10

Co-Chairs Opening Remarks

microphone-alt Steve Mister, President & CEO, Council for Responsible Nutrition Tara Falsani, General Counsel, Vice President and Secretary, Nature's Way – Schwabe North America

10:30

Developing Strategies for Making Scientifically Substantiated Product Claims Without Running Afoul of the Regulators

microphone-alt Taneesha Rogers, J.D., Director of Regulatory Affairs, XYMOGEN

8:15

Analysis of Recent State Activity Impacting Dietary Supplements

microphone-alt Carlos Lopez, Vice President & General Counsel, The Vitamin Shoppe

Meghan Stoppel, Member, Cozen O'Connor Cassie Folk, Founder & President, Cassie Folk & Associates • Monitoring state activity affecting the supplement industry » Survey of the most active states: California, Massachusetts, New Jersey, New York, Oregon • Examining various state bills that would impose age restrictions on the sale of weight loss and body building supplements • Exploring Oregon’s CBD legislation and regulations setting limits on THC amounts and how other states may follow suit • Assessing the latest state AG activity against manufacturers and retailers • Discussing sustainability, recyclability, and other environmental legislation trends impacting dietary supplements 9:00 FTC Fireside Chat

A Conversation with the FTC: Agency Views on Enforcement, Endorsements, Testimonials, All Things Green, and Other Priorities Serena Viswanathan Associate Director for Advertising Practices Federal Trade Commission 9:30

» Understanding the importance of consumer education regarding recycling and anti-waste measures as part of ESG commitments » Anticipating how new FTC Green Guides may address ESG claims » Understanding what role states may play in regulating ESG claims • Examining the necessary proofs for regenerative agriculture and other sustainability measures • Assessing legal obligations that may stem from ESG commitments • Identifying potential liabilities that may arise from unsubstantiated or misleading ESG representations

Networking Break

9:45

Environmental, Social, and Governance (ESG) Case Study: What Dietary Supplement Manufacturers Need to Know about Substantiating ESG Claims and Commitments

microphone-alt Jeff Brams, Chief Innovation & Legal Officer, Garden of Life, Inc. Katie Bond, Partner, Lathrop GPM • Defining, establishing, and substantiating ESG commitments for the dietary supplement industry • Appreciating the importance of third-party certifications for ensuring ethical and sustainable practices for supply chain and ingredient procurement, as well as human rights protections • Devising strategies for supplement manufacturers to implement measures and establish proofs for carbon footprint reduction offsets • Implementing substantiation protocols for green claims including recycling and sustainability claims

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Raqiyyah Pippins, Partner, Arnold & Porter Kaye Scholer LLP Alistair Anagnostou Reader , Trial Attorney, U.S. Department of Justice, Consumer Protection Branch • Examining how the ongoing pandemic has and is still affecting the balance between structure function and health claims » COVID claims » Immunity claims • Analyzing the ongoing First Amendment and free speech arguments for scientifically supported claims • How can companies with good research present scientific findings without running afoul of making unauthorized health claims?

• Hedging risk: can claims be qualified to reduce regulatory scrutiny?

• Examining label changes in view claims you wish to make—or not make • Can industry work with regulators, consumer protection groups, and other third parties, such as the NAD, to ensure proper claims and self-police the industry? » What benefit is there to industry to self-police? Does this provide more credibility with regulators, increase consumer trust? » What role does the NAD play in helping the industry police rogue players? » Should the industry be doing more to weed out bad actors?

11:15

Afternoon Break

11:30

Navigating the Latest Class Action and Prop 65 Activity: Keeping an Eye on the Plaintiff’s Bar’s Newest Assaults on the Dietary Supplements Industry

microphone-alt Mark Brian Levine, Associate General Counsel, Reckitt Benckiser

Rohit A. Sabnis, Partner, Keller & Heckman LLP Jasmine Wetherell, Counsel, Perkins Coie Class Actions • Examining recent class action activity in the dietary supplements space » New retailer suits • Analyzing the latest class action precedent and discussing strategies to combat class actions » Are there arguments that appear to be more persuasive to judges to have a class action dismissed in the early stages of litigation? » Can dietary supplement companies prevail in a jury trial? » What other important strategies should you be aware of to navigate a class action demand letter or complaint?

• Discussing claims language, labeling practices, and other actions a company can take to reduce the risk of a class action

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• Exploring the latest class action case trends » Recycling and sustainability » Glyphosates » Green claims » Flavoring – malic and citrus acid » Heavy metals » Structure/function claims » PFAS – forever chemicals

Prop 65 • Examining the latest Prop 65 activity concerning dietary supplements • Status of changes to short form warnings • Examining the latest activity on the Prop 65 coffee litigation and why the supplement industry should be paying attention » Acrylamide 12:45

Introducing the New Enforcers – How Consumer Protection Groups and the Plaintiff’s Bar Are Policing Claims, Labeling, and Other Marketing Practices

microphone-alt Claudia Lewis, Partner, Venable LLP Livia Kiser, Partner, King & Spalding • Examining the plaintiff’s bar’s attempts to police claims and labeling like government regulators » How is the plaintiff’s bar targeting labeling practices governed by the FDCA and other statutes that do not include a private right of action? » What weaknesses in substantiation and claims language has the plaintiff’s bar tried to target?

• Understanding where legitimate industry players can pick up where plaintiffs class actions end to weed out bad actors • Comprehending the role consumer protection groups and third parties that hold themselves out as consumer protection organizations play in policing claims and labeling » Review of the DC Consumer Protection Procedures Act and precedent allowing third-party consumer protection groups the right to sue for allegedly false or misleading claims » How can companies defend against third-party lawsuits and reduce the risk of these lawsuits? » Understanding how industry can work with regulators and consumer protection groups to ensure proper claims and self-police • How are dietary supplement companies utilizing NAD resources to police rogue players and preserve reputation of legitimate manufacturers • Is Amazon stepping in where the FDA has not through its testing programs and product bans?

1:30

Venue Information HOTEL: InterContinental Times Square Hotel ADDRESS: 300 W 44th St, New York, NY 10036, United States RESERVATIONS: +1 212-803-4500 American Conference Institute 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 CRN Legal, Regulatory, and Compliance Forum on Dietary Supplements".

Please note that the guest room block cut-off date is June 8, 2022. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Conference Ends

As a member of a dietary supplement regulatory affairs department reviewing product content daily for FTC / FDA compliance, it was a valuable experience to be in a room with top minds from around the country who could answer my questions.

Christine Bardsley Regulatory Associate, FoodState

Comprehensive and In-depth review of leading regulatory issues for the dietary supplement industry.

Chad Lewis Chief Operating Officer, Universal Nutrition

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Planning Ahead for Live Conferences: C5’s All Secure Safety Plan

As American Conference Institute and our partners plan for in-person events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or location-specific regulations, and will follow the commitments below.

Attendance Screening All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y Have not experienced any COVID-19 symptoms now or within the last 14 days. y Have not had close contact with any person with or suspected of having COVID-19 within the last 14 days.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference. y A conference room layout with planned seating for appropriate physical distancing. y We continue to work closely with our venue partners to ensure the safety of our attendees. Please check back frequently as we monitor and evolve our plan in the weeks ahead.

y Have not had a positive COVID-19 test within the last 14 days. y Have not been advised by any health authority, government agency or regulatory body, within the last 14 days, to self-isolate due to possible exposure to COVID-19.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/ symptoms.html We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

Enhanced Communication y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more. y Education and training for the team to ensure we provide a safe and secure conference experience. y Distribution of local health-resource information in advance of the event. y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

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y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas.

y Food and beverage options that ensure minimal handling and exposure.

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y Availability of personal hygiene and safety products including facial coverings where available.

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Make Connections Join scheduled “1:1 Networking” sessions. They are an interactive way to expand your network of peers.

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Engage with solution providers of all kinds by visiting the “Expo” to watch videos and live demonstrations, and for face-to-face conversations.

Use the “People” tab to create new relationships and strengthen existing ones within your industry.

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Looking to Register?

Contact our Customer Service Representatives:

Mark Parrish American Conference Institute

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D.Manganiello@AmericanConference.com

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M.Parrish@AmericanConference.com

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1 212 352 3220 x7207

Use Registration Code: B00-999-DMO22

Register & Pay by April 22 2022

PRICING

Register & Pay by May 27, 2022

Use Registration Code: B00-999-MPH22

All Access Pass (Main Conference + Both Workshops)

$2895

$3195

$3295

In-Person Conference

$2095

$2295

$2395

Livestream Conference

$1795

$1995

$2095

Workshops

All program participants will receive an online link to access the conference materials as part of their registration fee.

Additional copies of the Conference Materials available for $199 per copy.

GUARANTEE

3–4

10% Conference Discount

5–6

15% Conference Discount

7

20% Conference Discount

8+

Call 888-224-2480

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

Registration

669L22-NYC

Bringing a Team?*

$600 Each

WORRY FREE

CONFERENCE CODE:

Register & Pay after May 27, 2022

* Team/group registrations are for in-person only and must be from the same organization/firm and register together in one transaction.

Book with confidence!

Register and pay to lock in your early rate and be eligible for a full refund until June 17.

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.

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Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent.

For more information please contact us at: SponsorInfo@AmericanConference.com

Accreditation will be sought in those jurisdictions requested by the CREDITS registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

EARN CLE

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state?

Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

 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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