2024 Call to Action for the Natural Products Industry

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success? We asked industry associations to weigh in. Read on for:

2023 Year in Review + 2024 Forecast

Federal Hurdles, State-Level Restrictions & New Challenges on the Horizon

by Steve Mister, President & CEO, Council for Responsible Nutrition (CRN)

Industry Challenges and Opportunities: A Trust-Based Perspective

by Duffy MacKay, Consumer Healthcare Products Association (CHPA) SVP, Dietary Supplements

Remember Our Roots

by Pat Sheridan, President & CEO, Independent Natural Food Retailers Association (INFRA)  

Focusing on Accountability

Securing the Future: A Call to Action for Sustainable Practices & Transparency

by Karen Howard, CEO & Executive Director, Organic & Natural Health Association

Supporting Emerging Leaders in Natural to Transform the Industry

by Debra Short, Executive Director, SENPA

Michael McGuffin, President of the American Herbal Products Association (AHPA)

2023 Year in Review + 2024 Forecast

by Michael McGuffin, President, AHPA

Compliance with complex compliance requirements can be challenging for the natural products industry, both as new statutes and regulations come into effect in 2024 while other, existing requirements still need modernizing to meet the needs of the current market. Manufacturers and marketers of cosmetics, for example, will be subject to new requirements under the federal Modernization of Cosmetics Regulation Act (MoCRA) in 2024, including new serious adverse event reporting requirements and significantly expanded government access to manufacturer records. 

Consumer interest in dietary supplements and natural products peaked during the COVID-19 pandemic and remains high as health interests have expanded from just immune health to also include support for mood, focus, and performance. Although the category is diversifying and growing to meet demand, responsible industry is hampered by both restrictions on what ingredients companies may use and how they may communicate to consumers.

The FDA's prior drug exclusion clause, invoked in decisions related to CBD, NAC, and NMN, bars products from qualifying as "dietary supplements" if they contain substances initially approved or studied as drugs before their use in the conventional food or dietary supplement industry, despite meeting other criteria for "dietary ingredients." This legislation permanently prevents consumer access to dietary supplements with such ingredients. In contrast, if an ingredient debuts in the dietary supplement market, the pharmaceutical industry can later develop a drug with the same ingredient, which may coexist in the market. This disparity constrains consumer options, persisting long after pharmaceutical incentives for ingredient development have diminished or disappeared.

Further, consumers would also benefit from the removal of current legal restrictions that require certain scientific publications to be “physically separate” from dietary supplements. In practice today, with many consumers buying their health products online, this law limits the ability of responsible companies to share truthful and not misleading information with the public. The companies investing resources into studying ingredients should be able to provide the results of scientific research to consumers to assist them in making the most informed decisions about the products they buy to support their health.

AHPA closely engages with FDA to influence and encourage improvements to the regulation of dietary supplements. Our advocacy is especially important considering FDA’s history of imbalanced treatment of dietary supplements—especially when compared to the agency’s attitude toward pharmaceuticals—and perceived inattention to the regulation of food overall. For the agency’s part, FDA plans to reorganize and create a unified Human Foods Program (HFP) to improve the agency’s regulation of food, including dietary supplements. The reorganization would move the Office of Dietary Supplement Programs (ODSP) under a new Office of Food Chemical Safety, Dietary Supplements & Innovation, and AHPA has been assured ODSP will retain the same staffing, scope, and responsibilities with new organizational structure.

With the FDA reorganization on deck, new regulations coming into effect, and more work to do to modernize regulations to better serve our family members, friends, and neighbors, it will be crucial in 2024 for industry to stay engaged with representatives in Congress and support trade associations, including AHPA. Outreach to lawmakers is crucial as it allows industry members to have their voices heard and contribute to the shaping of policies that directly impact their businesses and the wellbeing of the public. Additionally, supporting trade associations helps to amplify the industry's influence and ensure that it remains well-represented in discussions about regulating our health-promoting products. By fostering collaboration and maintaining a proactive stance, industry members can play a pivotal role in shaping a regulatory environment that aligns with the evolving needs of the community.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from CRN, CHPA, INFRA, NPA, Organic & Natural Health, and SENPA!

Steve Mister, President & CEO, Council for Responsible Nutrition (CRN) Federal Hurdles, State-Level Restrictions, and New Challenges on the Horizon

by Steve Mister, President & CEO, CRN

To predict what’s in store for our industry in 2024, it’s a helpful exercise to quickly reflect on what happened over the last year. Understanding the challenges and changes we just faced obviously offers some insights as to where we are headed. 

As CRN turned 50, our annual Consumer Survey showed that 74% of U.S. adults reported taking dietary supplements, with 55% identifying as regular users, and 92% viewing these products as essential to maintaining their health. This data underscores the mainstream status of dietary supplements in American life, reflecting a deep-rooted place in the health and wellness routines of the majority of consumers. 

Meanwhile, on the regulatory front, arguably the biggest story was FDA's proposed restructuring of its Human Foods Program (HFP), and specifically the elimination of ODSP in favor of a “super office,” which lumped supplements in with food additives. CRN was openly critical of the proposal, in part because it seemed to signal an even greater lack of focus on dietary supplements by the agency. In 2024, we will continue to seek assurances that supplements get the robust attention at FDA that a $60 billion industry deserves. 

The agency also made “drug preclusion” – or as we like to call it “supplement exclusion” – a front-burner issue when it determined that NMN (beta-nicotinamide mononucleotide) was precluded from being sold in dietary supplements because it had been previously studied for drug use. This ruling led to Amazon's decision to ban dietary supplements containing NMN from its platform, and left many in the industry wondering what ingredient will be targeted next. And, speaking of exclusion, let’s not forget CBD, an example of an entire class of products FDA decided to exclude from their regulatory remit. In 2024, CRN will continue to press for restoring the balance between incentives for drugs and supplement innovation, through both regulatory and legislative approaches. 

Federal hurdles were unfortunately matched by unreasonable restrictions at the state level. In 2023, various states considered legislation that would impose age restrictions on the purchase of certain dietary supplements, attempting to connect dietary supplement use with eating disorders in young people. CRN actively opposed these legislative efforts by refuting the unfounded correlation through scientific research. But the passage of the bill in New York means even more likely introductions in 2024 and the industry will have to collectively and vigorously oppose this legislation wherever it arises.  

New challenges will present in 2024, too. But after half a century of providing guidance and stewardship to our members, we do know this: The winning formula to overcome much of the adversity we have faced, and will face, is our ability to work collaboratively with regulators and to passionately advocate for our members by showcasing the science and integrity behind their products. It’s why we will be invited back to the table on mandatory product listing and expansion of FSAs/HSAs to include supplements. And it’s why I predict that 2024 will mark the beginning of another 50 years of CRN championing this ever-evolving and dynamic industry. For our members, success in 2024 will come from a well-founded reliance on CRN to act reasonably and responsibly on their behalf, as we faithfully have for five decades. 

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from AHPA, CHPA, INFRA, NPA, Organic & Natural Health, and SENPA!

Duffy MacKay, CHPA SVP, Dietary Supplements

Industry Challenges and Opportunities:
A Trust-Based Perspective

by Duffy MacKay, CHPA SVP, Dietary Supplements

In the dynamic landscape of the dietary supplement industry, building and maintaining trust is an ongoing challenge that requires years of dedication. As Warren Buffett wisely noted: “It takes 20 years to build a reputation and five minutes to ruin it"—a statement that also holds true for the dietary supplement industry. For nearly three decades, industry has enjoyed a commendable reputation under the Dietary Supplement Health and Education Act (DSHEA) of 1994. However, this standing is consistently challenged by the actions of some “bad actors” in the marketplace who prey on the fact that regulations have not kept pace with rapid growth—posing a threat to consumer trust.

As we reflect on 2023, industry has certainly made strides in bolstering its reputation through advancements in science and innovation, thriving on a growing scientific evidence base and showcasing exciting breakthroughs through recent studies, including those revealing that multivitamins may contribute to improved memory and slow cognitive decline in older adults. This scientific evidence not only promotes safe and affordable habits to support health, but it positions the industry as a positive force impacting the quality of life for many Americans, a benefit to both consumers and the entire U.S. healthcare system overall.

However, these commendable efforts and achievements have not completely shielded the industry from its challenges. One notable threat to consumer trust stems from the long-standing issue of illegal, counterfeit, and tainted and/or adulterated products masquerading as dietary supplements. Although the issue remains primarily isolated to online sales, the responsibility ultimately falls on industry to collaborate with retailers, regulators, and law enforcement to ensure consumers’ safety. The reputational risks arising from the availability of counterfeit and illegal products highlights a need to remain vigilant in the New Year, as well as the need for current regulations to be modernized, a topic which is poised to be significant in 2024.

DSHEA has served as the cornerstone of the FDA's regulation of dietary supplements, balancing consumers access to diverse products with safety considerations. However, as we envision the next 30 years of growth and innovation, it’s crucial to consider the voices of influential stakeholders across the regulatory and medical community who are advocating for the modernization of current regulations in order to give FDA the tools it needs to enhance safety and product integrity—key tenets to building consumer trust. 

While industry has modernization priorities of its own, such as granting FDA authority for third-party audits, amendments to the drug preclusion provision, and improvements to rules around claims and evidence dissemination, FDA has also outlined several legislative priorities to enhance its insight into manufacturing facilities. As these regulatory changes are debated and negotiated, legitimate concerns have been raised about advocating for modernization while FDA is in the process of reorganizing its Human Foods Program. Whether this is an opportunity, or an obstacle, will depend largely on FDA and industry working cooperatively to ensure quality, safety, and consumer needs at the forefront of discussions.

With millions of Americans relying on these products each day, establishing trust is not just a preference—it's a necessity. And when it comes to navigating these challenges and opportunities, ongoing collaboration among industry stakeholders, regulators, legislators, and the medical community is critical. As we approach 2024, industry should closely evaluate and consider regulatory developments and legislative measures that can enhance trust, increase innovation, and ensure continued success on behalf of U.S. consumers.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from AHPA, CRN, INFRA, NPA, Organic & Natural Health, and SENPA!

Remember Our Roots 

Pat Sheridan is President & CEO of INFRA, a purchasing and services cooperative of over 350 independent grocery and wellness stores across the United States

by Pat Sheridan, President & CEO, INFRA

Well, we made it through the first full post-pandemic year and supply chains are stronger, inflation is cooling, people are gathering again, and there is hope in rebuilding the good that strong communities bring to us. But some things haven’t come back, and many believe they never will. The norms that guided working in the office are in flux, the wholesale commandeering of healthy products by the largest re- and e-tailers to fill their otherwise empty shelves appears to be permanent. And why not? Some of them learned that consumers actually care about what they put in, and on, their bodies, and celebrated higher margins to boot. Consumers who were compelled to stay put were inundated with so many more channels of access to the groceries and supplements they love. The prices were competitive, and the products showed up on our front porches in two hours. What magic is this? It was, and remains, an enticing proposition.

But, as we know, there are downsides to these changes. Massive growth in the sale of high-quality healthy food and supplement products is attracting new players who are skirting the rules (e.g., fraud in organics and low-quality ingredients in supplements) in order to tap into the growth. New brands are trying to break into a product supply chain that reaps ever-dwindling margins. Consumers have reduced their store visits by as much as a third compared to 2019. Locally owned retailers are struggling. Let me say that once again— locally owned retailers are struggling!

My call to action to all of us in this lovely industry is to slow down, be thoughtful, and remember our roots.

The Native and Indigenous communities that protect the earth while growing food, the farming communities of India that practice Vedic agriculture, the individuals too numerous to mention that championed the sanctity of our ingredients and supply chains, and the “mom and pop” health food store owners that won DSHEA all have some things in common. They all support the production of healthy foods, they all take a community-based approach to getting healthy foods to consumers, and they all represent the roots of who we are and why we’re here thriving in this post-pandemic world. Remember our roots. 

Remember our roots when we sell our products by prioritizing locally owned retailers for quality over the retail and e-tail giants for volume. Remember our roots when we launch new products because the most loyal customers prefer their local stores. Remember our roots when we provide pricing to the supply chain to prioritize local over national. And remember our roots when we shop, realizing that an extra five minutes to get there and a few percentage points in cost can make the difference in keeping local economies thriving.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from AHPA, CRN, CHPA, NPA, Organic & Natural Health, and SENPA!

Daniel Fabricant, Ph.D. is CEO and President of the Natural Products Association (NPA)

Focusing on Accountability

by Daniel Fabricant, Ph.D., CEO and President, NPA

NPA has an almost 90-year history of action speaking advocacy to power, so of course, we're biased, but it doesn't mean we are wrong. When benchmarked to industries of standard economic scale, our industry lags in association membership (as a percentage of industry participation), lobbying, and campaign contributions.  

In times like these, I cannot stress the need for effective communication between the Natural Products industry and policymakers. With some 4,000-plus associations in D.C., policymakers often need a deeper understanding of practices and the challenges faced by any given industry. Not having a deep bench of advocates for Natural Products in the legislative branch across party lines to value the merits of the industry and ensure that policies are conducive to the industry's growth and sustainability will not result in a future course that exceeds our present reality.

Yet, thanks to the NPA membership, NPA continues to execute effective and impactful initiatives, and this year, we took our efforts a step further to expand our reach. Throughout 2023, we have seen significant accomplishments along with areas of concern that need to be addressed by the entire industry.

In years past, the NPA defeated proposals in California, Illinois, Maryland, Massachusetts, Missouri, New Jersey, Rhode Island, and others. However, this year, despite intense lobbying and grassroots efforts led by the NPA, New York enacted a new law restricting access and making it hard to purchase dietary supplements. This is significant because the state represents billions of dollars for industry and establishes a precedent that other states will follow. The NPA was the only association to recently file a lawsuit, we believe the court will recognize the serious concerns raised and declare it unconstitutional. Independent of outcome, we know ourselves and our enemy; why aren't we more in the fight against such derision?  

In passing the Dietary Supplement Health and Education Act (DSHEA), Congress charged the FDA to protect public health by ensuring foods are safe, wholesome, sanitary, and properly labeled. FDA's change of policy relative to the status of NAC, NMN, and other ingredients is a detriment to the entire dietary supplement industry. The situation with these ingredients is yet another example of the inconsistent way the FDA interprets DSHEA. To that end, we anticipate our lawsuit against the agency for NAC, and future action regarding agency treatment of NMN, will drive the conversation for reforming DSHEA.

The FDA's proposed reorganization package is now under review at the U.S. Department of Health and Human Services (HHS), which begins the formal external review process after more than a year of work following the findings and recommendations of a Reagan-Udall Foundation evaluation, which excluded an examination of how the agency regulates dietary supplements.

This is an alarming proposal, and the industry should not minimize the announcement's significance, especially regarding budgetary allocations. 

It's unclear to NPA why dietary supplements would be placed within the same office as food additives, especially since there is a statutory firewall between dietary supplement and food additive regulations. While the agency continues to communicate that these changes will modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements, the agency is not in the position to have earned the benefit of the doubt from the Natural Products Association. 

As the voice of the natural products industry, the NPA's advocacy work is one of its primary and core functional areas. In 2023, we ensured our members had a seat at the table by advocating, supporting, and opposing policies that broadly affected the natural products industry. Our work enabled our members to maximize their investment and value proposition associated with their membership within our organization. As we head into the new year, we are inspired and without apathy for the work ahead and the path forward in 2024.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from AHPA, CRN, CHPA, INFRA, Organic & Natural Health, and SENPA!

Karen Howard, CEO & Executive Director, Organic & Natural Health Association

Securing the Future: A Call to Action for Sustainable Practices and Transparency in Our Industry

In an era where 74% of Americans actively incorporate dietary supplements into their routines, the natural products industry stands at a critical juncture, teetering on the edge of its own triumphs. Embracing the 'bigger is better' ethos, typical of American business, the industry catapulted to the forefront during the COVID-19 pandemic, as consumers sought refuge in fundamental supplements to fortify their immune systems. The surge in demand, fueled by the pandemic, has inadvertently spotlighted potential pitfalls inherent in any thriving industry. Notably, products catering to weight loss, sexual enhancement, and specific sports nutrition have long been the industry's Achilles Heel. Recent regulatory measures, such as the ban on certain supplements in New York for customers under 18, foreshadow a wave of similar actions across states. As the spotlight intensifies, with the industry now surpassing $60 billion, stakeholders including marketers, legal professionals, and investors closely monitor the trajectory, evident in pharmaceutical companies' persistent acquisition of supplement firms. In this realm where size holds sway, the question persists: Is bigger truly better?

Our paramount goal is to guarantee uninterrupted access for consumers to the pinnacle of quality, effective, and cost-effective products vital to their well-being. Confronting imminent challenges that jeopardize the essence of our distinctiveness is imperative. We must confront the hurdles hindering access to supplements and foods for all Americans, fortify the faltering domestic and global organic standards, navigate international policies impacting pesticide exposure, and staunch the tide of undisclosed bioengineered ingredients infiltrating our food and supplement supply chain.

A core value of our industry is an enduring sense of community. We must preserve this community spirit as we grow, beginning by championing independent retailers. These frontline educators serve as the authentic influencers, earning trust as proven advocates with direct access to both countless consumers and the legislators representing them. Through collective collaboration and support, we can mobilize a formidable force to extend SNAP benefits, starting with the inclusion of vitamin D3. This serves as an inaugural step toward significantly enhancing the health of those currently lacking access to one of the most potent and cost-effective means of improving overall well-being.

As our community expands globally, active participation on the international stage becomes crucial. This involves safeguarding our organic standard, currently under legal threat, and promoting consistent biodynamic and regenerative practices. Despite the EU's recent commendable step in eliminating glyphosate as a desiccant, challenges persist with its approval for other purposes over the next decade. Our unwavering commitment is essential to address risks to human health and soil vitality. The infiltration of undeclared bioengineered ingredients in our industry demands our diligence. We must use science and legal measures to compel disclosure, ensuring transparency to consumers. Despite challenges, our dedication positions us to shape a healthier, more accountable future.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from AHPA, CRN, CHPA, INFRA, NPA, and SENPA!

Debra Short, Executive Director, SENPA

Supporting Emerging Leaders in Natural to Transform the Industry

by Debra Short, Executive Director, SENPA

As a trade association of 65+ years, SENPA has seen the ebb and flow of the natural products industry. Through those years, we have represented our core membership, the independent retailer, and that continues today.  

Our members are the key to building this industry and the gatekeepers to new products/companies who want to join our industry.  Why? Because they have the staff in the aisle who understand the products they represent, and they prove it every day!

What are the most pressing issues the natural products industry will face in 2024?

We are in a generational transition; many family-owned businesses with legacy retail owners are looking to retire without a succession plan in place. These family-owned businesses, where the determination through the years was to make a difference in their community and the passion to back that up, will be weighing out the options to close their business or offer an opportunity for family members/employees, or 3^rd parties to embrace a new vision, to navigate transitions to profitability, monitor the evolving market trends, and to set themselves and their business up to be unique and profitable.  

What steps would we like to see industry members to help ensure our collective success?

SENPA embraced this generational transition to better understand what the current needs of our membership are. We surveyed independent retailers, brokers, sales in the field, and companies at our SOHO Events and found a touch point to consider.

SENPA engaged a group we call Emerging Leaders in Natural to look at the footprint of our independent retailers, understanding the trends and how their association can support the future of our retail membership.

At the 2023 SOHO Expo, we hosted our first meeting for 14 Emerging Leaders from retailers, brokers, and educators to begin the creative discussions and bring a fresh and dynamic energy to the association. This group has their finger on the pulse of current trends and how to retain the passion from our legacy industry retail owners and supply companies who support them. They are empowered to transform the natural products industry into something better than what we see today.  

Combining their passion and efforts will help more retailers reach their full potential to be sustainable and empower all to recommit to the values that started this industry.

It should go without saying, Independent retailers are essential to the natural products industry.  

They are the source of knowledge, passion, and customer service to their communities. 

Our members bind together by keeping strong relationships and establishing new ones. They support the companies that support their business. 

It should be well noted, partnership is and always will be the key element to build this industry, SENPA and our members prove it every day! As a non-profit trade association, we will engage our members on all levels in education, advocacy and understand business needs to support the longevity of the natural products industry.

As we mark the 30th anniversary of DSHEA, what are the most pressing issues facing the industry, and what steps should industry members take to ensure our collective success?  Read on for more insights from AHPA, CRN, CHPA, INFRA, NPA, and Organic & Natural Health!