Dietary Supplements

One year into the current administration, dietary supplement companies are no longer planning for potential change — they are managing it in real time. Join legal, compliance, and business leaders as they discuss how evolving FDA priorities, new HHS leadership, and policy initiatives are reshaping risk tolerance, governance structures, and day-to-day decision-making.

Topics of discussion will include:

• How the dietary supplements industry is adapting to a “new normal” where regulatory and policy shifts seem to be constant rather than episodic — and what that means for long-term compliance planning
• Updates on HHS priorities, impacts of MAHA initiatives, and evolving FDA focus areas
• Have the administration’s policies and priorities evolved as the industry projected a year ago?
• Practical strategies for navigating rules, guidance, and enforcement approaches that may be subject to litigation, court challenges, or future administrative reversal
• Designing internal systems, governance models, escalation pathways, and risk frameworks that can withstand regulatory volatility
• How current regulatory and enforcement dynamics are affecting day-to-day operations, resource allocation, and cross-functional decision-making

As 2026 gets underway, FDA policy, enforcement, and legislative activity continues to evolve in ways that carry meaningful compliance and business implications for the dietary supplements industry.

This session will provide an update on the most significant FDA and legislative developments impacting supplements in 2026, with a focus on what these changes mean in practice for legal, regulatory, and compliance teams.

• Examining drug preclusion after NMN: a breakdown of FDA’s recent decision confirming NMN as lawful for use in dietary supplements and exploring how this decision could impact the agency’s treatment of other ingredients
• An update on FDA’s evolving approach to New Dietary Ingredient Notifications (NDINs): how companies are managing the latest guidance, as well as areas that remain unsettled
• Managing NDIN risk in practice: navigating open questions companies are still grappling with — including:
  • What constitutes “robust” safety evidence?
  • Under what circumstances is FDA enforcement likely?
  • What are your options and best practices if products are detained, seized, or challenged by FDA?
• Taking stock of the newly issued 2025–2030 Dietary Guidelines: will FDA’s Human Foods Program make changes to the criteria for “healthy” claims in order to align with the new guidelines? How will the Front-of-Package Nutrition Labeling final rule look in light of the new Dietary Guidelines?
• Congressional action and transparency initiatives: a survey of proposed supplement legislation, including Senator Durbin’s Dietary Supplement Listing Act of 2026, and what mandatory product listing and public databases could mean for manufacturers and distributors
• How other FDA actions could impact dietary supplements, including the FDA’s DSHEA disclaimer enforcement discretion announcement, anticipated caffeine guidelines, online grocery food labeling guidance, and much more

A newly proposed FDA rule on Generally Recognized as Safe (GRAS) determinations could significantly alter how dietary supplement ingredients are brought to market. This session will examine available details of a proposed GRAS rule, what it means for self-affirmed GRAS determinations, and how the focus on mandatory FDA submission and review could reshape compliance planning, enforcement exposure, and litigation risk for dietary supplement companies.

Key topics of discussion will include:

• What’s changing under the newly proposed GRAS rule?
• Understanding how existing self-affirmed GRAS determinations may be affected, and what companies should be doing now to assess their ingredient portfolios
• Practical implications for product development, reformulation, supply chains, and go-to-market strategies if FDA review becomes a prerequisite for GRAS recognition
• How a new rule could impact FDA enforcement posture, private litigation, and challenges to ingredient safety determinations
• How in-house counsel and compliance leaders can prepare for the transition, manage uncertainty, and mitigate risk as the rule is finalized and implemented

Evolving trade policy and tariff regimes continue to pose unpredictable challenges for dietary supplement companies. As sourcing strategies, ingredient availability, and cost structures remain vulnerable to policy shifts, legal and compliance teams are being asked to help their organizations manage uncertainty while maintaining product quality, regulatory compliance, and market competitiveness.

This session will examine:

• An update on current and potential tariff regimes, policy signals, and what companies should be watching as trade priorities continue to evolve
• Strategies for addressing the mechanics of tariff payment in this current period of uncertainty
• Mitigating tariff-driven cost increases while maintaining quality standards, supplier oversight, and regulatory compliance
• Planning for policy whiplash: how companies are preparing for tariffs to be overturned, reimposed, expanded, or replaced through alternative trade mechanisms
• Navigating import and export risk management: practical approaches to customs compliance, supplier diversification, contract structuring, and risk allocation for both ingredients and finished products
• Lessons learned and forward-looking strategies for building flexibility into sourcing and logistics amid ongoing disruption

While federal oversight continues to evolve, dietary supplement companies are facing a continuing rise in state-level laws that are creating a complex compliance environment for the industry. This panel will examine the most significant state developments impacting dietary supplements and provide practical guidance on how companies are navigating inconsistent requirements, assessing enforcement risk, and making strategic decisions about compliance, reformulation, labeling, and market participation.

Key Topics Will Include:

• Developments in weight-loss and muscle-building supplement restrictions in New York and other states, and how companies are responding
• California’s new prenatal vitamin law: navigating testing and public disclosure requirements for heavy metals, QR-code labeling obligations, and practical compliance challenges
• Examining emerging state ingredient bans and recent prohibitions on alcohol-based extracts, botanicals, food colors, and food additives
• State packaging and sustainability mandates: navigating new laws regarding use of the “chasing arrows” symbol (NJ and beyond) and implications for national packaging strategies
• How companies are evaluating when to comply, adapt formulations or labeling, seek enforcement discretion, or exit certain state markets altogether

In this timely conversation, the General Counsel of the Council for Responsible Nutrition (CRN) joins litigation counsel from Cozen O’Connor to unpack the high-stakes constitutional challenge to New York’s law restricting the sale of certain sports nutrition dietary supplements to minors.

This candid discussion will explore:

• The current procedural posture of the case and what happens next at the Supreme Court stage
• The key constitutional questions CRN is asking the Court to consider
• Broader First Amendment implications for dietary supplement labeling, advertising, and state regulation, as well as the impact across the wider consumer products goods industry
• Why this litigation is important in this era of increasing state scrutiny over food and dietary supplements

Extended Producer Responsibility (EPR) laws have quickly moved from a future concern to a present-day compliance challenge for dietary supplement companies. With multiple states adopting, and continually revising, EPR frameworks for packaging, companies are shifting from understanding the concept to figuring out how to operationalize compliance across jurisdictions with conflicting rules, deadlines, and reporting requirements.

This session will delve into:

• Navigating multi-state EPR regimes: managing overlapping and conflicting rules across CA, CO, ME, MD, MN, OR, WA
• Understanding the requirements set forth in emerging EPR laws in 13 additional states and counting
• Examining the current status of California’s EPR program, recent pauses and reconsideration of requirements, and what companies should be doing while timelines and obligations remain in flux
• Getting the data right: practical guidance on calculating material quantities, distinguishing between packaging components, determining exemptions, and avoiding common reporting pitfalls
• Managing competing reporting obligations: strategies for handling differing definitions, reporting formats, and submission timelines across states
• Building internal workflows, tools and cross-functional coordination models for staying compliant as EPR rules continue to evolve