Dietary Supplements

With shifting regulatory priorities and leadership changes, the dietary supplements industry faces new challenges and opportunities. This session will explore the evolving landscape, compliance considerations, and strategies for businesses to stay ahead in an era of change.  Points of discussion include:  

• Taking stock of legislative priorities, regulatory shifts and enforcement trends impacting the supplements industry  
• Understanding how the current administration’s policies and confirmation of RFK Jr. as HHS Secretary could reshape FDA oversight, labeling, and marketing regulations
• Navigating emerging regulatory frameworks, mitigating risks, and ensuring adherence to evolving compliance requirements
• Rethinking market opportunities: Identifying growth areas, innovation trends, and ways to position your business for success amidst regulatory uncertainty
• Exploring the role of industry stakeholders in shaping future policies and maintaining a competitive edge  

As the Trump administration implements new tariffs and has signaled that more could be forthcoming, dietary supplement companies face heightened challenges in sourcing key ingredients and maintaining efficient supply chains. This panel will explore how companies can mitigate risks, manage costs, and ensure compliance while maintaining product quality and market competitiveness.  Points of discussion include:  

• Understanding the scope of new tariffs: which ingredients and raw materials are affected, and how these tariffs could reshape the global supply chains for supplement companies
• Supply chain diversification strategies: exploring alternative sourcing options, reshoring possibilities, and supplier negotiation tactics to minimize cost impacts
• Maintaining regulatory and trade compliance: navigating import regulations, potential exemptions, and risk mitigation tactics
• Exploring how dietary supplement companies can adjust pricing models, contracts, and operational efficiencies to offset tariff-driven cost increases  

This session will provide key insights into recent FDA developments and what they mean for compliance, labeling, and future industry practices.  Key topics include: 

• Examining RFK Jr.’s recent criticisms of the Generally Recognized as Safe (GRAS) framework: projections for possible future GRAS reform and the potential impacts on food and supplement regulation and practices
• Assessing the FDA’s Proposed Rule on Front-of-Package Nutrition Labeling: the latest developments, potential challenges, and implementation timelines 
• Projected implications of Loper Bright on FDA regulatory authority: understanding potential shifts in agency deference and the implications this may have on the dietary supplements industry
• Examining broader FDA enforcement trends – lessons and takeaways from recent warning letters, inspections, detentions and enforcement activity  

As the dietary supplements industry continues to evolve, innovation is driving new product development and improved efficiencies.  From AI-powered R&D to advancements in manufacturing and supply chain optimization, companies are embracing cutting-edge technologies to stay competitive. However, these innovations also introduce complex regulatory, intellectual property, and compliance risks that must be carefully navigated.  Join industry leaders and experts as they explore: 

• AI’s role in dietary supplement R&D and product development: how artificial intelligence is transforming ingredient discovery, formulation, and clinical research 
• Understanding the applicable guidelines for using AI to support regulatory submissions/documents (GRAS, NDI, claims registrations, etc.) focused on safety, quality and efficacy of ingredients
• Navigating evolving FDA oversight and safety considerations when utilizing AI in product development
• Understanding the IP and competitive risks: navigating issues that can arise regarding the patentability of AI-discovered ingredients and formulations

State governments are ramping up regulatory oversight of dietary supplements, introducing new age restrictions, ingredient bans, and testing requirements that could reshape the industry. Companies must navigate a growing patchwork of laws to ensure compliance, avoid enforcement actions, and maintain market access. This panel will break down the latest state legislative trends and share projections on future areas of rulemaking where the states may fill in the gaps.  

• An overview of the latest developments in state age restriction laws and legislation, ingredient bans, testing requirements, and other laws impacting the supplements industry
• Compliance strategies for multi-state operations: best practices for tracking legislative changes and adapting compliance programs accordingly
• Understanding how to manage ingredient sourcing, packaging adjustments, and claims practices to comply with new laws
• Best practices for avoiding penalties, lawsuits, and reputational damage through proactive compliance and advocacy efforts
• Forecasts on future areas of rulemaking that may have implications for the supplements industry  

While dietary supplement companies are not bound by the same stringent health privacy laws as healthcare providers, evolving state regulations on consumer health data are creating new compliance challenges.  As many supplement companies collect, store, or share health-related information, they must stay informed to mitigate risk and ensure compliance with emerging legal frameworks. This panel will break down key state regulations and provide practical strategies for staying ahead of evolving privacy laws.  Key points of discussion include:   

• An overview of relevant state health privacy laws and their impact on supplement companies   
• Key risks associated with collecting and sharing consumer health-related data
• Best practices for data protection, consent management, and compliance frameworks
• Strategies to adapt to evolving regulations and avoid enforcement actions  

With the recent rise of Extended Producer Responsibility (EPR) laws, dietary supplement companies must adapt to new packaging, recycling, and sustainability requirements. This panel will break down key EPR obligations, provide an overview of other new environmental requirements popping up across the states, and provide actionable insights for supplement brands navigating this evolving landscape.  Key discussion points include:  

• An overview of new and upcoming EPR regulations and their implications for supplement companies
• Understanding what dietary supplement companies must now do to track, report, and manage their packaging waste obligations under EPR regs 
• Exploring how supplement companies can redesign packaging to meet EPR requirements, and navigate cost and supply chain implications caused by EPRs
• Taking stock of other new state environmental laws affecting dietary supplement companies in the U.S. and globally  

As consumer demand for clean-label, health-conscious products rises, dietary supplement companies must carefully craft their advertising claims to stay compliant with evolving regulations.  From “green” and sustainability claims to health benefit statements, regulatory agencies are keeping a close watch. This panel will provide key insights into the latest trends, compliance risks, and best practices for ensuring truthful and substantiated claims. Discussion points include:  

• Understanding the latest FTC, FDA, and state regulatory standards and enforcement priorities for health claims and environmental/ “green” claims  
• Best practices for substantiating and defending supplement health benefit claims  
• How product composition affects marketer’s legal and regulatory risks, including how the alleged presence of microplastics, heavily scrutinized food additives like food dyes, and heavy metal contaminants could lead to legal trouble and tips for avoiding scrutiny  
• Identifying the latest buzz words and marketing trends, like “ultra-processed”, ingredient emphasis or avoidance claims, quality and sourcing descriptions, and the legal challenges for substantiating such claims
• Strategies to minimize enforcement risk and align marketing with compliance expectations  

With the rising popularity of GLP-1 agonists for weight management and diabetes, dietary supplement companies are increasingly interested in marketing products to support the overall nutrition and wellness needs of these pharmaceutical users. . When promoting these support products, companies should consider the regulatory framework for structure/function claims and any unique substantiation requirements. This panel will explore:  

• Innovative ways that dietary supplements and functional food may support GLP-1 users
• How to navigate structure/function claim requirements and avoid disease claim pitfalls
• Best practices and unique considerations for supporting claims related to nutrition and wellness when marketing products to support GLP-1 users   

Dietary supplement companies operating in the online marketplace face a unique challenge: they must not only comply with rigorous testing and quality requirements imposed by major retailers like Amazon but also act as watchdogs to protect their brands from counterfeit products, and increasingly to raise to identify and challenge non-compliant competitor products. This panel will explore how brands can effectively navigate these dual responsibilities to protect their reputation, maintain consumer trust, and ensure a fair marketplace.  Points of discussion include:  

• Meeting online retailer compliance standards: understanding the testing, quality assurance, and other requirements set by platforms like Amazon and how to stay ahead of evolving policies  
• Policing the marketplace: strategies for identifying and reporting counterfeit, non-compliant, or misleading competitor products and working with platforms to remove them 
• Best practices for challenging fraudulent products while avoiding potential legal and regulatory pitfalls

The dietary supplements industry continues to face increasing scrutiny from the plaintiff’s bar, with evolving class action litigation shaping the regulatory and business landscape.  This panel will explore the latest class action trends and key legal vulnerabilities that supplement companies should be aware of in the year ahead.     

• Examining recent lawsuits alleging misleading claims on ingredient efficacy, structure-function claims, and “natural” product labeling
• The rise of consumer suits targeting supplements over alleged contamination with heavy metals, or other ingredients for which safety has been questioned
• A look at legal challenges against subscription-based supplement sales, including claims of deceptive auto-renewal practices under state and federal laws
• Identifying key lessons and takeaways from the latest litigation activity, and insights on what the plaintiff’s bar may target next  

• Predicting when you may be a class action target and developing pre-suit defense strategies
• Designing thorough internal class action prevention and preparedness protocols 
• Strengthening quality control, testing and substantiation practices to mitigate risks and stay ahead of litigation threats
• Tracking government and consumer protection group enforcement activity on which the plaintiff’s bar might try to piggy-back