Virtual Conference Login

Co-Chairs’ Welcoming Remarks

Scott Bass
Partner & Head, Global Life Sciences
Sidley Austin LLP (New York, NY)

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

State of the Industry Address: The New Normal for Supplements

Scott Bass
Partner & Head, Global Life Sciences
Sidley Austin LLP (New York, NY)

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

Over the last few years, the dietary supplement industry has invested considerable energy and resources to promote consumer confidence in its products. At the same time, companies are facing increased legal threats from consumer class actions – which are not only costly for the industry, but stand to undermine public trust. Innovation, increased transparency, and attention to science have been key factors in building confidence and should also be harnessed to combat these legal threats.

New products, innovative modes of product delivery, development of robust industry audit standards, and a voluntary registry program coupled with a greater number of scientific studies that support the benefits of these products are indicative of the industry’s new era of responsibility, as well as responsiveness. These measures, against the backdrop of robust discussions on potential DSHEA amendments, are inspiring industry stakeholders to envision a bright future for dietary supplements.

At the same time, the unexpected and unprecedented COVID-19 pandemic is wreaking havoc on supply chains, threatening worker safety, and challenging companies to continue to provide safe, quality, and beneficial health products in ways that have never been seen before. Now more than ever supplement companies have a responsibility to ensure compliance across all parts of the manufacturing process and continue to provide products that support consumer health during these challenging times.

This opening session will provide attendees with a view on the state of the dietary supplement market, a forecast for the future, and the industry’s continued commitment to promote good health with good products.

Break

FDA Fireside Chat**

Steven Tave
Director, Office of Dietary Supplement Programs
U.S. Food and Drug Administration
(Washington, DC)

INTERVIEWED BY:

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

Morning Break

Defining a “Dietary Supplement” as Intended by DSHEA: Examining Questions Surrounding Synthetic Botanical Constituents, Drug Exclusions, and Other Inconsistent Interpretations of the Dietary Supplement Definition

Paul Bolar
VP, Regulatory Affairs
Pharmavite, LLC
(West Hills, CA)

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

Stan Soper
Outside General Counsel
Nutraceutical Corporation (Park City, UT)

The introduction of novel ingredients and new technologies over the years have tested how a “dietary supplement” is defined under DSHEA — thus, presenting companies with a variety of complex challenges as to what truly can be classified as a supplement. Industry has spent a lot of time debating how these issues could be fixed with changes to DSHEA, but what’s a company to do now? This panel will explore how a company can navigate these challenges while living in a DSHEA 1.0 world.

Topics of discussion include:

• Determining whether the definition of a dietary supplement leaves room for synthetic copies of botanical ingredients?
  • Understanding the FDA’s position on synthetic botanical constituents
• Comprehending how the drug exclusion provision of DSHEA impacts dietary supplements
  • Comparing drug exclusions for food vs. drug exclusions for dietary supplements
  • Assessing how the drug exclusion provisions impact FDA enforcement actions
  • Analyzing how the drug exclusion provisions affect innovation for new dietary ingredients
• Surveying how the clause “dietary substance for use by man to supplement the diet by increasing the total dietary intake” has been interpreted by FDA
  

Morning Break

CASE STUDIES

NDI Notifications vs. GRAS Determinations: Are Exceptions Swallowing the Rule?

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

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

Ashish R. Talati
Partner
Amin Talati Wasserman

As talks of improving DSHEA continue, stakeholders seek clarity on how to comply with new ingredient safety requirements in an efficient and commercially viable manner. Companies struggle with questions about FDA engagement in the NDI notification process, whether an ingredient’s safety needs to be established through an NDI notification or whether it can be considered GRAS, and how to protect confidential, proprietary data throughout the process.

In this session, our speakers will discuss the process for NDI notifications vs. GRAS determinations, all the while providing concrete real-word examples of outcomes, success stories, and lessons learned.

Topics of discussion will include:

NDI

• Pinpointing challenges with submitting an NDI notification without a final NDI guidance from FDA
• Outlining the steps needed to notify FDA of an NDI, data necessary to demonstrate that an ingredient will reasonably be expected to be safe, and commercial considerations companies should be aware of during this process » Tools to help protect confidential data from public disclosure » Tips to engage with FDA and solicit meaningful feedback from the agency to help ensure a successful NDI filing • Assessing the reasons why a company might not submit an NDI notification
  • Examining manufacturers’ hesitancy to share proprietary information
  • Assessing consequences of other companies “piggybacking” on initial NDI filers data
• Creating master files and evaluating IP protections for NDI notifications
  • Lessons learned from the pharmaceutical industry that can be applied to the dietary supplement process » Considerations for FDA to incentivize development, notifications, and protect responsible companies

GRAS

• Examining ways dietary supplement manufacturers use GRAS determinations to legally market a dietary supplement
• Determining when a GRAS determination vs. NDI notification is appropriate
• Understanding the practical differences between GRAS determinations vs. NDI notifications
  

Lunch Break

CASE STUDIES

CBD – Hemp State of the Union: Threats Caused by Government Inaction and Current State of a Legal Path for CBD in Dietary Supplements

Martin Hahn
Partner
Hogan Lovells US LLP (Washington, DC)

Melody Harwood
Head, Scientific and Regulatory Affairs
Neptune Wellness Solutions
(Los Angeles, CA)

Kelly Shea
Senior Vice President of Government Affairs & Corporate Communications
Charlotte’s Web (Boulder, CO)

• Clarifying the latest information on FDA’s position on CBD use in dietary supplements and food
• Anticipating whether FDA will consider an approval pathway for CBD in supplements and food, and possible restrictions on that pathway
• Understanding the significance of FDA warning letters issued to companies that sell CBD products as dietary supplements
• Comprehending how government inaction has significantly increased class action threats for CBD and could threaten the viability of the industry moving forward
• Analyzing Congressional positions and recent legislation to exempt CBD from the drug exclusion provisions currently preventing CBD use in supplements and food
• Examining state regulation and legislation for CBD and how these actions could impact the federal regulatory landscape, e.g., California’s pending assembly bill AB228 allowing the sale of hemp-derived CBD in food – could this put additional pressure on FDA?
• Exploring steps industry can take to mitigate risk and put pressure on legislators and regulators to clear a legal pathway for CBD
  

Break

The Impact of Increased State Consumer Protection Activity on the Dietary Supplement Industry: Analysis of Pending and Recent State Initiatives and How These Actions Could Affect Your Company

Christopher Allen
Member
Cozen O’Connor (Washington, DC)

Amanda Darlington
Amanda Darlington
Council for Responsible Nutrition (Washington, DC)

Gregory W. Fortsch
Associate General Counsel/ Privacy Officer
The Nature’s Bounty
(Ronkonkoma, NY)

• Analyzing the potential impact of regulatory initiatives that could increase class action risks
  • How industry can combat these, such as the risk posed by recent regulatory changes proposed in Oregon
• Understanding how sale limitations that state legislators have proposed for dietary supplements, such as age and ingredient restrictions, would make it harder to distribute dietary supplements and create a slippery slope of patchwork state regulations
• Examining ways in which state privacy laws, such as California’s Consumer Privacy Act (CCPA), are uniquely affecting dietary supplement companies
  • Comprehending the impact of privacy laws and legislation on the dietary supplement industry’s efforts to innovate through e-commerce and digital marketing
  • Assessing unique considerations for dietary supplement companies, such as how consumers’ “right to be forgotten” may affect future safety concerns (e.g., what if a consumer needs to be notified of a recall)
• Exploring how broad state environmental legislation and consumer concerns could change how supplements are sold

Afternoon Break

Examining New Trends in Claims Substantiation: A Study of Innovative Claims, Ever Increasing Use of Influencers to Promote Products, and Risk

Richard Cleland
Assistant Director; Advertising Practices, Bureau of Consumer Protection
Federal Trade Commission (Washington, DC)

Kathleen Dunnigan
Senior Attorney
National Advertising Division (NAD)®
BBB National Programs, Inc.
(New York, NY)

Raqiyyah Pippins
Partner
Arnold & Porter Kaye Scholer LLP (Washington,DC)

Ryan Bradley, ND, MPH
Director of Research, Helfgott Research Institute
Program Director, Building Research across Inter-Disciplinary Gaps (BRIDG) Clinical Research Training Program
Associate Professor, College of Naturopathic Medicine and School of Graduate Studies
National University of Natural Medicine

Innovative Claims

• Exploring the latest trends in claims and developing substantiation for these claims
• Assessing claims related to packaging and waste reduction • Evaluating newer claims related to probiotic and prebiotic products
• Reviewing various types of environmental (“green”) claims and substantiation challenges surrounding their use • Understanding the benefits and pitfalls of making complicated structure/function claims
• Reviewing recent FTC activity concerning performance, efficacy, and comparative claims
• Comprehending what the FTC’s increased scrutiny over sales claims made by direct-selling companies could mean for your business

Influencer Marketing

• Understanding how influencers are being used specifically to promote dietary supplement products
• Exploring the concept of organic influencers and related risk unique to dietary supplement companies, such as ensuring that influencers not only make statements that can be supported, but do not make disease claims or other inappropriate statements • Devising strategies for monitoring content across different social media platforms
• Drafting legal contracts and developing training to ensure influencers understand what is required of them and know the consequences for violating these requirements
• Assessing options for when influencers make claims about your product without authorization
• Examining the FTC’s latest guidance on influencer marketing • Analyzing legal compliance challenges unique to using influencers to promote FDA-regulated products

Special Focus on: Immune Function Claims – Viewpoints on Substantiated v. Fraudulent in a COVID-19 Environment

• Hear from an immunity expert about the science behind immune support claims and how certain dietary ingredients benefit our immune system
• Learn from advertising law experts how to talk about dietary supplement health benefits in a COVID-19 world
• Understand the FDA’s and FTC’s latest actions against COVID-19 claims

Break

Anticipating Post-Implementation Challenges with the BE Label

Jessica Wasserman
Partner
Greenspoon Marder LLP (Washington, DC)

Chad Weida
Associate Director
Abbott
(Columbus, OH)

Full implementation of USDA’s bioengineered (BE) food label requirements went live on January 1, 2020. This panel will explore post-implementation challenges and address anticipated enforcement activity and other risks.

Points of discussion will include:

• Identifying potential post-deadline challenges relative to proper disclosure of bioengineered foods
• Understanding exceptions to the BE labeling rule
• Assessing the USDA’s position on the use of technology for BE disclosures
• Ensuring proper labeling for known BE Foods
• Anticipating whether consumer litigation will follow that alleges non-compliance with labeling requirements
• Analyzing continued state interest in BE labeling requirements

Conference Adjourns to Day Two

Virtual Conference Log-in

Conference Co-Chairs’ Welcoming Remarks and Recap of Day One

Fireside Chat: FTC Priorities and Enforcement Initiatives

Serena Viswanathan
Acting Deputy Director of the Bureau of Consumer Protection
U.S. Federal Trade Commission (Washington, DC)

Interviewed by:

Megan Olsen
Vice President and Associate General Counsel
Council for Responsible Nutrition (Washington, DC)

Break

International Affairs: Supply Chain Disruptions and Contract Negotiations in the Times of Tariffs and COVID-19

Christine Beltran
Director, Global Product Regulatory Services
doTERRA
(Pleasant Grove, UT)

James McCall Smith
Partner
Covington and Burling LLP (Washington, DC)

Sameer Joshi
Head of Global Business Operations
OmniActive Health Technologies (Morristown, NJ)

• Understanding COVID-19 impacts on supply chain and how to combat them
• Exploring contractual rights and how to draft contracts in an uncertain world
• Examining supply chain risks from COVID-19, such as increased risk of economic adulteration and how to source new suppliers quickly and efficiently
• Examining the status of tariffs and treaties currently impacting the dietary supplement industry
• Exploring the impact of tariffs on raw material and ingredient imports from and exports to relevant countries such as China
• Understanding the possible impact of the new USMCA on the dietary supplement industry
• Assessing the possible Brexit effect on the dietary supplement industry
• Analyzing the long-term effects of tariffs and related costs on the consumer
• Examining the impact of pending legislative initiatives to restore congressional authority over tariffs and taxes

Morning Break

Prebiotics, Probiotics, and Now Postbiotics: Addressing Current Standards and International Guidelines

Lisa Jen
Director, Global Regulatory Affairs & Product Compliance
Herbalife Nutrition
(Torrance, CA)

James Griffiths, PhD
Senior Vice President, International and Scientific Affairs
Council for Responsible Nutrition

• Analyzing new trends associated with prebiotic products in dietary supplements
• Assessing the current debate on probiotic standards and international guidelines
  • Examining current Codex standards for dietary supplements as they apply to probiotics
  • Considering proposed Codex standards specific to probiotics offered by the International Probiotics Association (IPA) and opposition from the International Alliance of Dietary/Food Supplement Associations (IADSDA)
• Understanding FDA’s labeling requirements and industry best practices for probiotics, such as quantity and identity labeling challenges
• Examining the impact of the lactobacillus taxonomy name change
• Exploring the rise of postbiotics and its impact on dietary supplement products
• Revisiting the Bayer case – implications five years later for probiotics and beyond

Break

CASE STUDIES

Focus on Quality Standards: Implementing Winning Strategies for Meeting Retailer and Consumer Demands for Quality

Russ Michelson
Regulatory Director, VMS
RB Health (Parsippany, NJ)

David Trosin
Managing Director - NSF Health Sciences Certification
NSF International (Ann Arbor, MI)

• Ensuring compliance with the ANSI/NSF 455-2 good manufacturing compliance (cGMP) certification standards developed by the Global Retailer and Manufacturer Alliance (GRMA)
• Understanding the significance of the Supplement Safety and Compliance Initiative (SSCI) benchmarking guidance documents
• Developing best practices for meeting different retailer-imposed quality requirements and managing retailer expectations
  • Exploring CVS’s “Tested to be Trusted” program for dietary supplements for label accuracy and safety over one year after implementation
• Tips for how to manage differing retailer requirements and streamlining quality-compliance programs
• Understanding the impact of testing done through an independent third-party lab
• Outlining the impact of self-regulatory standards led by industry and consumer stakeholders
  • Building consumer confidence and ensuring safety of dietary supplement ingredients
    

Lunch Break

Ensuring Supply Chain Integrity and Transparency, and Meeting Corporate Social Responsibility Expectations

Christine Burdick-Bell
Vice President & General Counsel
Pharmavite LLC (West Hills, CA)

Claudia A. Lewis
Partner
Venable LLP (Washington, DC)

In this panel, our speakers explore the processes and methods for ensuring supply chain integrity, social and environmental responsibility, as well as improving transparency and managing counterfeit threats.

Topics of discussion will include:

• Understanding how consumer demand is influencing dietary supplement manufacturers to be more transparent about the source of ingredients
  • Determining country of origin, labeling requirements, and how to support claims
  • Resolving challenges with adulterated products caused by supply chain problems
• Managing your own and retailer corporate social responsibility expectations
  • Environmental; adhering to labor laws; other ethical practices • Protecting brand image and integrity by monitoring counterfeit products sold on third-party websites
• Protecting brand image and integrity by monitoring counterfeit products sold on third-party websites
  • How to detect counterfeits
  • Establishing crisis management protocols
• Improving GMP standards to maintain supply chain integrity and ensure the continued quality and safety of dietary supplement ingredients
• Assessing FDA supply chain activity related to supplement manufacturers
  • Debating whether a mandatory product registry will resolve transparency challenges
• Lessons learned from a recent recall related to adulterated dietary supplements
  

Afternoon Break

HYPOTHETICALS

Understanding How Ingredients are Placed on the Prop 65 Lists

Joseph T. Green
Special Counsel
Kelley Drye & Warren LLP (Washington, DC)

Adam Regele
Policy Advocate
California Chamber of Commerce (Sacramento, CA)

Dietary supplement sales practices are significantly impacted by requirements imposed on substances subject to California’s Lists of Known Carcinogens and Reproductive Toxicants, better known as Prop 65. Through the use of hypotheticals, this interactive session will explore the various methods by which a substance gets placed on the Prop 65 lists, what can be done to prevent (or at least reduce the chance of) listing, and if a substance is listed, how to reduce its impact.

Attendees will also benefit from an analysis of new Prop 65 developments.

Topics of discussion include:

• Exploring how an ingredient receives a Prop 65 designation
• Mechanisms and processes
• Understanding the safe harbor provisions and related requirements
• Determining whether once a product is assigned a Prop 65 designation if it can be removed from the list
• Creating internal processes and protocols to ensure you are meeting Prop 65 requirements
• Examining how new substances recently added to the list may affect supplement manufacturers, such as new listings for soluble nickel and THC
• Assessing new warnings related to acrylamide
  

Afternoon Break

Responding to Thorny Class Action Litigation Claims

Julie L. Hussey
Partner
Perkins Coie LLP (San Diego, CA)

Christine McInerney
Deputy General Counsel - Litigation
Nature’s Bounty (Ronkonkoma, NY)

• Comprehending the significance and class action implications of Debernardis v. IQ Formulations, LLC, No. 18-11778 (11th Cir. 2019)
  • If FDA declares that a product is illegal, is its value negated, thereby giving a right to sue based on economic harm?
  • How can companies limit application of this case when selling products that are subject to unsettled FDA positions on legality
• Analyzing new class litigation concerning CBD products
  • Understanding the significance on the recently imposed stay in the Green Roads of Florida LLC case
  • Invoking the doctrine of primary jurisdiction in the absence of FDA guidance on CBD
  • California CBD class action activity: understanding the parallels between California’s Sherman Act, the federal FD&C Act, and how they relate to these lawsuits
• Analyzing recent trends for the type of claims targeted by class action litigation
  

Conference Ends