Dietary Supplements

Key dietary supplement company leaders will share and address their top regulatory and policy concerns for this year as well as 2025. At the end of the segment, participate in an interactive Q+A that will allow you to ask your most pressing questions and add to the dialogue.

• Analyzing the parts of DSHEA that have allowed the dietary supplements industry to thrive, and examining the parts of DSHEA that may be stifling innovation or putting the industry at risk
• What parts of DSHEA might need a present-day reset?
• Addressing inadequacies in FDA tools to handle and address bad actors in the industry
• What does the industry want FDA to do about chronic, flagrant law violators of DSHEA?
• How can FDA be given morel tools and authority to marginalize bad actors and keep dangerous products out of the market?
• Weighing the risks and benefits of giving FDA more authority to stifle criminal activity and the sale of fraudulent products
• Evaluating how industry can combat irresponsible actors in the absence of initiatives to do so by the FDA
• What types of industry initiatives already exist?
• Assessing the pros and cons of proposed legislative updates to DSHEA

• Understanding the full scope of implications of the creation of the Unified Human Foods Program (HFP) and New Office of Regulatory Affairs (ORA) Model
• Analyzing CRN’s concerns about the proposal to include supplement oversight under a new Office of Food Chemical Safety, Dietary Supplements, and Innovation
• Examining how the new Office of Critical Foods will interact with the OFCSDSI
• Understanding what will and will not change with the agency’s Reorganization
• Are the agency’s areas of focus going to change?
• Will FDA supplement activity increase or decrease after the Reorganization?
• Could certain types of activity increase, such as inspection frequency?
• FDA insights on the agency’s latest guidance and enforcement initiatives:
• Updates to the new dietary ingredient notification (NDIN) guidance
• Analyzing enforcement priorities, including inspections and keeping fraudulent products off the market
• Focus on manufacturing issues under scrutiny, such as ingredient overages
• Exploring how collaboration with CRN and FDA bolsters the industry and protects consumers

As part of the FDA’s initiative to strengthen its oversight of human food, the agency is unifying inspection and compliance programs under the new Unified Human Foods Program – which includes dietary supplements. This session will explore topics, including:

• Analyzing changes to FDA inspection processes resulting from the Human Foods Program and Office of Regulatory Affairs Reorganization
• What will the proposed Office of Inspections and Investigations (OII) look like and how will FDA’s field operations dedicated to human food change?
• Examining the latest tools and methods that FDA is using to increase inspection efficiencies
• Understanding the pros and cons of remote regulatory oversight and assessments
• Navigating the challenges that can arise in the use of remote inspection tools and processes
• What FDA enforcement functions are being shifted from ORA to compliance offices in FDA centers?
• What impact will this have on future FDA inspections and compliance actions?
• How will reorganization impact inspections and compliance programs covering international entities?
• Practical tips for handling inspections, such as getting your facility prepared for your inspections, managing responses to inspections and understanding when you might need to get outside counsel involved

• Lessons and takeaways from the latest trends in FDA enforcement and warning letters
• Analysis of FDA’s 2024 updates to NDIN guidance and what’s to come
• Strategies for complying with FDA’s updates and anticipating changes to other parts of the NDIN guidance
• Examining the status of FDA’s final rule governing “healthy” nutrient content claims
• Contemplating FDA’s next steps and tips for preparing to comply with a final rule
• Status update on FDA’s proposed amendments to regulations on Investigational New Drug applications (INDs)
• Analyzing the impact of recent developments on the design of clinical studies, IND requirements, and dietary supplement research

• Breaking down New York’s new supplement age restriction law
• Examining other newly introduced and proposed state bills placing age restrictions on the purchase of certain supplement products
• Addressing the challenges of navigating conflicting cross-state standards
• Examining the recent trend of states and local governments interest in food and supplement safety and what this means for FDA authority
• Overview of other state legislation that would impose additional restrictions on food and supplement practices, such as state ingredient bans and sustainable packaging laws
• Analyzing how industry can combat emerging state-level restrictions on the supplement industry: battling the narrative that the FDA does not have appropriate authority to deal with the purported harms targeted by state legislation and laws
• Would a national standard be preferrable in certain situations and what would that look like?
• Should industry support efforts for additional FDA authority to minimize state activity?

• Analyzing the latest trends in class action activity impacting the dietary supplements space
• Examining the latest advertising and labeling practices triggering class action claims
• Identifying key lessons and takeaways from the latest litigation activity
• Insights on what the plaintiff’s bar may target next
• Assessing how current class action activity will impact future labeling and marketing practices as well as your bottom line
• Identifying new and continuing class actions risks:
• Technical label compliance, such as calorie calculations, net contents statements, DSHEA disclosure placement
• Ingredients for which safety has been questioned, such as titanium dioxide and PFAS
• Reemergence of slack fill cases
• “Green” claims and other claim categories at highest risk for class actions

• Designing thorough internal class action prevention and preparedness protocols
• Understanding how offensive strategies such as sound advertising claims substantiation practices can be your best defense and nip a class action in the bud
• Tracking government and consumer protection group enforcement activity on which the plaintiff’s bar might try to piggy-back
• Predicting when you may be a class action target and developing pre-suit defense strategies

Ingredient overage practices are drawing increasing attention from consumer products testing labs, the media and the plaintiffs’ bar. This panel will discuss:

• The latest legal, compliance and litigation concerns surrounding ingredient overage practices
• The regulatory and marketing considerations related to ingredient overages
• Industry best practices that can help ensure consumer safety and consumer confidence
• Analyzing best practices for manufacturing and labeling to avoid risks associated with product degradation and claims related to overages
• trategies for reducing your overages
• Tips for changing or improving the messaging around ingredient overages