Dietary Supplements

Co-Chairs Opening Remarks

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)

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

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

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

Andrew Shao, Ph.D.
Senior Vice President, Global Scientific & Regulatory Affairs
Chromadex

Xin Tao
Counsel
Hogan Lovells LLP (Washington, DC)

• 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
• 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

Networking Break

Fireside Chat

Cara Welch
Director, Office of Dietary Supplement Programs
US Food & Drug Administration

DSHEA- Past, Present, and Future

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

Anastasia Gilmartin
Director of Regulatory Compliance, Counsel
Bodybuilding.com

Lauren Quinn
Vice President and Head, US Regulatory Affairs
GSK (New York, NY)

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  

Networking Luncheon

Preparing the Way for Mandatory Product Listings

Jessica O’Connell
Partner
Covington & Burling LLP

Will Woodlee
Partner
Kleinfeld, Kaplan & Becker, LLP

Julia Gustafson
Vice President
Council for Responsible Nutrition (CRN)

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. 

• Identify 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?

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

Mohamed Koroma
Director, R&D
Pharmavite

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

Anthony Fontana
Laboratory Director
Alkemist Labs

• 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? 

Networking Refreshment Break

Solving the CBD Stalemate

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

And Now a Word About Botanicals

Stefan Gafner, PhD
Chief Science Officer
American Botanical Council

Ashish R. Talati
Partner
Amin Talati Wasserman (Chicago, IL)

• 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

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

Suzie Trigg
Partner
Haynes and Boone LLP

Day Gooch
Vice President, Quality and Commercialization
The Vitamin Shoppe

• 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

Conference Adjourns to Day Two

Co-Chairs Opening Remarks

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)

Analysis of Recent State Activity Impacting Dietary Supplements

Carlos Lopez
Vice President & General Counsel
The Vitamin Shoppe

Meghan Stoppel
Member
Cozen O'Connor

Cassie Folk
Founder & President
Cassie Folk & Associates (Washington, DC)

• 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

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 (Washington, DC)

Networking Break

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

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
• 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

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

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

Taneesha Rogers, J.D.
Director of Regulatory Affairs
XYMOGEN

Raqiyyah Pippins
Partner
Arnold & Porter Kaye Scholer LLP

• 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? 

Afternoon Break

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

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

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

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

Claudia Lewis
Partner
Venable LLP (Washington, DC)

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?

Conference Ends