By Sean Moloughney, Editor12.04.23
Part 1: FDA Restructuring and FTC Activity
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation
Suzanne Shelton, Founder, The Shelton Group: A significant portion of my work involves communicating best practices advocacy to the industry. I’m fortunate to have, over the past 30+ years, developed long-standing relationships with clients that are fierce advocates for industry best practices. It’s gratifying to contribute my communications skills to these efforts, and interesting to observe over time whether the industry is adopting better practices, or not.
NOW, a client of mine since dinosaurs roamed the earth, has been testing products they purchased on Amazon for the last several years and sharing the dismal results with the selling platforms, FDA, and the industry. More recently NOW revealed their discovery that counterfeit products were being sold on Amazon as well. Amazon and government agencies have been far more responsive in acting on the counterfeiting than on the mislabeled and sub-par products.
I was disappointed in the answer Cara Welch (Director of FDA’s Office of Dietary Supplement Programs) gave during the recent AHPA (American Herbal Products Association) Regulatory Congress to a question about what FDA plans to do about the mislabeled products identified through NOW’s testing program. I like and respect Cara, but her non-answer was deeply disappointing. It’s clear FDA has no plans to utilize the regulatory tools at their disposal to protect consumers from these bad actors.
"We’re seeing progress in transparency, with companies not just saying they make quality products, but showing it."
Another long-time client, Sabinsa, has been advocating for legitimate scientific research to support product safety and efficacy for the entire 35 years since Dr. Majeed founded the company. Over the years, more industry suppliers have invested in quality research to support product benefit claims and demonstrate safety.
They have also staunchly protected their patents, repeatedly winning in court, which of course protects their customers that build products around them, and consumers looking for products made with ingredients used in published clinical trials. Stealing IP from the companies that developed it seems to be far less common than it once was, although the fact that “borrowing” science still happens at all is ridiculous.
We’re seeing progress in transparency, with companies not just saying they make quality products, but showing it. An example is the growing momentum of Alkemist Labs’ Alkemist Assured quality transparency program launched in 2022 to help ingredient suppliers and finished products companies practice test-result transparency. And kudos to Elan Sudberg for being relentless in getting the industry to see the value in making testing CofAs (Certificates of Analysis) public, because we’re seeing a lot more of that.
I’ve been working with the mushroom supplier Nammex on their advocacy to ensure consumers are given accurate product information, which is timely considering the massive growth in this category. The company filed a citizen petition asking FDA to correct ambiguity in the regulation and clarify that the requirement in place for botanical products to specify the part of plant, along with the common name, clearly applies to fungal ingredients.
More recently, Nammex commissioned a survey of 10,000 people in the U.S. on mushroom terminology that makes the consumer’s definition of what a mushroom is clear: it’s a mushroom ... I love my job.
"For-profit healthcare is, increasingly, an oxymoron. The system is designed to deal with advanced problems that are expensive to treat and accessible to a shrinking percent of citizens. Rather, a return to fundamentals of sound nutrition education, making healthier foods available, together with education on how to both store, prepare, and grow your own food—now those are things we should subsidize."
NW: Congress’ Health Care Task Force is looking for examples of “evidence-based, cost-effective preventive health measures or interventions that can reduce long term health costs.” What role can or should dietary supplements and natural health products play in reducing healthcare spending and/or improving outcomes. And how do we get from here to there?
Loren Israelsen, President, United Natural Products Alliance (UNPA): Well, for starters, Congress should stop subsidizing crops that make fast food and ultra-processed food cheap and abundant—which also makes people fat and sick.
For-profit healthcare is, increasingly, an oxymoron. The system is designed to deal with advanced problems that are expensive to treat and accessible to a shrinking percent of citizens. Rather, a return to fundamentals of sound nutrition education, making healthier foods available, together with education on how to both store, prepare, and grow your own food—now those are things we should subsidize.
Finally, functional/integrative medicine is a far more effective and inexpensive way to meet public health goals. This requires a different kind of medical education as well as an openness from states to recognize and license naturopaths and other functional medicine practitioners who, in great numbers, wish to learn such skills.
How do we get from here to there? The fastest way is to move to Okinawa, one of the blue zones where people live long and healthfully. Why don’t we look at how they do it?
"Collaboration between the nutraceutical industry, healthcare professionals, and policymakers is crucial to establish evidence-based guidelines, educate the public on proper supplement use, and help integrate these products into a broader health-promotion and disease-prevention framework."
Shaheen Majeed, CEO, BGG Americas: We need to get people to understand the “supplement” side of supplements. Our industry is literally supposed to be part of their daily food habit, but we do a poor job of addressing and educating this. There also must be a shift in the mentality, or thinking, of how the U.S. takes care of its people. Our industry is meant to be preventative rather than taking a drug to try “curing” a disease.
The majority of ingredients sourced around the world are primarily used as daily food items, where over hundreds of years those items have been consumed, and relatively far fewer diseases have occurred. Why doesn’t our education system teach this to doctors? Most doctors dismiss supplements as not being effective enough, not enough science, etc. They fail to tell about the little to no side effects that dietary supplements have, versus all that we have to lose by taking pharmaceutical drugs.
I do believe the dietary supplement industry needs a bigger say at the highest levels of government to help implement programs for the under-nourished, malnourished, those in poverty, etc. I was heartbroken to learn that nearly 12 million kids living in the U.S. are living in poverty. Begin somewhere, begin at something.
Collaboration between the nutraceutical industry, healthcare professionals, and policymakers is crucial to establish evidence-based guidelines, educate the public on proper supplement use, and help integrate these products into a broader health-promotion and disease-prevention framework.
NW: What’s your impression of innovation in the dietary supplements market?
Shaheen Majeed: If I span over the last 5 years, sure there have been some notable growth areas, especially with ingredients like adaptogens, probiotics, and botanical extracts. The microbiome marketplace is its own industry, and it has an important role to play. There are companies that developed personalized nutrition supplements a few years back, and this is an area I’m excited to see grow more in the near future. Clean-label supplements, those free from additives and fillers, continue to gain popularity. Ingredients that are sustainably and ethically sourced will be the norm soon.
However, looking back these past 2 years, I haven’t seen nor experienced much innovation in the products that we as consumers should have had. Without a doubt, the pandemic halted many innovations, and getting back to somewhat of a norm meant finding a safe zone with those that we are familiar with. But now is the time—now we must take on those projects, those new product ideas, those new ingredients, new research, and much more to show ourselves and consumers out there that supplements can be more vital than ever for our health.
NW: Can you speak to the role that contract manufacturers play in today’s dietary supplement industry? What does transparency mean in the context of contract manufacturing and why is it so important?
Scott Steinford, Founder, Trust Transparency Center: Brands and consumers are expressing their desire to see more transparency from contract manufacturers (CMs). The contract manufacturers have an increasing awareness of responsibility to provide guidance to their customers at a deeper level of education to cGMP (current Good Manufacturing Practice) requirements affecting the entire manufacturing process.
It is my belief the CMs have an opportunity to go further and provide resources to educate their customers, especially the new startups, on requirements over and above the manufacturing process, including items such as AER (Adverse Event Reporting) compliance, retained sample requirements, etc.
NW: What strategies and tools can companies use to ensure transparency within their own operations and organizations?
Scott Steinford: The primary indication of transparency to the customer starts with the leadership team and their commitment to transparency to all components of the organization, internally and externally. For transparency to exist within an organization, it should be part of the core culture. Education of the boundaries and guidelines of transparency should be a proactive conversation and not a reactive conversation. Transparency “mistakes,” either permitting or prohibiting the organization’s exchange of information, should be the exception instead of the rule.
"Overall, the industry has become more resilient, adaptable, and consumer-focused. Successful companies have embraced change, leveraged technology, and fostered strong partnerships across the supply chain."
NW: The last few years have been extremely disruptive and volatile for businesses and consumers. What lessons have you learned and applied? What lessons should industry
take away?
Scott Steinford: The last few years of disruption have reinforced the belief in relationship creation versus a purely economic relationship. Contract manufacturers experienced a surplus of demand that created service shortages. How organizations handled the transparency and communication of service challenges has a direct correlation to the level of customer satisfaction both during and after the surplus of demand has subsided. Customers remember how they were treated when they were disadvantaged.
Shaheen Majeed: I never forget that we are consumers as well, both in terms of what this industry offers and in general for goods and services. Over the last few years, there have been many changes, and many things, as consumers, we’ve had to adapt to. There is a resurgence to get back out in the world, and with that, more people are traveling, more consumer goods are being consumed, more deals are being sought out. Certainly, there’s been friction with rising interest rates these last few years and we’ve had to fend off inflation.
One of the biggest business lessons learned from my perspective has been to focus on your core competency rather than branching out for something far too new, or less researched, to promote for your customers. The brands are finding consumers who buy products they are familiar with rather than something totally new. However, “totally new” could also mean a change in the delivery format of that same existing product. Case in point, a multivitamin tablet we were once taking, now comes in a gummy … okay, six gummies.
When I say focus, I also mean in terms of the supply chain—our customers, be it the contract manufacturer and/or the brand company, want to be sure they can receive our ingredients on time, every time. The last few years, several customers overstocked items because they were unsure of product availability, but that’s disappearing. Now, we’re seeing an emphasis on partnerships, long-term contracts, even new product development programs, all of this leading to better communication and a better outlook for the industry.
Overall, the industry has become more resilient, adaptable, and consumer-focused. Successful companies have embraced change, leveraged technology, and fostered strong partnerships across the supply chain.
"The industry must collaboratively work on addressing climate change together because without us doing something, things will get worse. I believe that short-term thinking is always unwise, but with climate change it’s a metaphorical and literal death sentence.”
Francesca de Rensis, Marketing Director, Indena: Today, more than ever, we are certain that a stronger commitment to sustainability has become unavoidable and we work to face some very urgent challenges, such as biodiversity loss, food waste, climate change, health issues, and social vulnerability. Indeed, our strategy implements circular economy in product design to reduce our environmental footprint up and down the value chain and increase our efforts to upcycle food waste.
What does it mean actually? It’s about transforming what is usually considered “waste” into raw material or energy. Through business models such as reuse, companies can reduce greenhouse gas emissions, pollution, and biodiversity impacts. Indena considers waste and pollution as design flaws, rather than inevitable byproducts of the products it makes.”
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation
Suzanne Shelton, Founder, The Shelton Group: A significant portion of my work involves communicating best practices advocacy to the industry. I’m fortunate to have, over the past 30+ years, developed long-standing relationships with clients that are fierce advocates for industry best practices. It’s gratifying to contribute my communications skills to these efforts, and interesting to observe over time whether the industry is adopting better practices, or not.
NOW, a client of mine since dinosaurs roamed the earth, has been testing products they purchased on Amazon for the last several years and sharing the dismal results with the selling platforms, FDA, and the industry. More recently NOW revealed their discovery that counterfeit products were being sold on Amazon as well. Amazon and government agencies have been far more responsive in acting on the counterfeiting than on the mislabeled and sub-par products.
I was disappointed in the answer Cara Welch (Director of FDA’s Office of Dietary Supplement Programs) gave during the recent AHPA (American Herbal Products Association) Regulatory Congress to a question about what FDA plans to do about the mislabeled products identified through NOW’s testing program. I like and respect Cara, but her non-answer was deeply disappointing. It’s clear FDA has no plans to utilize the regulatory tools at their disposal to protect consumers from these bad actors.
"We’re seeing progress in transparency, with companies not just saying they make quality products, but showing it."
— Suzanne Shelton, The Shelton Group
Another long-time client, Sabinsa, has been advocating for legitimate scientific research to support product safety and efficacy for the entire 35 years since Dr. Majeed founded the company. Over the years, more industry suppliers have invested in quality research to support product benefit claims and demonstrate safety.
They have also staunchly protected their patents, repeatedly winning in court, which of course protects their customers that build products around them, and consumers looking for products made with ingredients used in published clinical trials. Stealing IP from the companies that developed it seems to be far less common than it once was, although the fact that “borrowing” science still happens at all is ridiculous.
We’re seeing progress in transparency, with companies not just saying they make quality products, but showing it. An example is the growing momentum of Alkemist Labs’ Alkemist Assured quality transparency program launched in 2022 to help ingredient suppliers and finished products companies practice test-result transparency. And kudos to Elan Sudberg for being relentless in getting the industry to see the value in making testing CofAs (Certificates of Analysis) public, because we’re seeing a lot more of that.
I’ve been working with the mushroom supplier Nammex on their advocacy to ensure consumers are given accurate product information, which is timely considering the massive growth in this category. The company filed a citizen petition asking FDA to correct ambiguity in the regulation and clarify that the requirement in place for botanical products to specify the part of plant, along with the common name, clearly applies to fungal ingredients.
More recently, Nammex commissioned a survey of 10,000 people in the U.S. on mushroom terminology that makes the consumer’s definition of what a mushroom is clear: it’s a mushroom ... I love my job.
"For-profit healthcare is, increasingly, an oxymoron. The system is designed to deal with advanced problems that are expensive to treat and accessible to a shrinking percent of citizens. Rather, a return to fundamentals of sound nutrition education, making healthier foods available, together with education on how to both store, prepare, and grow your own food—now those are things we should subsidize."
— Loren Israelsen, United Natural Products Alliance
NW: Congress’ Health Care Task Force is looking for examples of “evidence-based, cost-effective preventive health measures or interventions that can reduce long term health costs.” What role can or should dietary supplements and natural health products play in reducing healthcare spending and/or improving outcomes. And how do we get from here to there?
Loren Israelsen, President, United Natural Products Alliance (UNPA): Well, for starters, Congress should stop subsidizing crops that make fast food and ultra-processed food cheap and abundant—which also makes people fat and sick.
For-profit healthcare is, increasingly, an oxymoron. The system is designed to deal with advanced problems that are expensive to treat and accessible to a shrinking percent of citizens. Rather, a return to fundamentals of sound nutrition education, making healthier foods available, together with education on how to both store, prepare, and grow your own food—now those are things we should subsidize.
Finally, functional/integrative medicine is a far more effective and inexpensive way to meet public health goals. This requires a different kind of medical education as well as an openness from states to recognize and license naturopaths and other functional medicine practitioners who, in great numbers, wish to learn such skills.
How do we get from here to there? The fastest way is to move to Okinawa, one of the blue zones where people live long and healthfully. Why don’t we look at how they do it?
"Collaboration between the nutraceutical industry, healthcare professionals, and policymakers is crucial to establish evidence-based guidelines, educate the public on proper supplement use, and help integrate these products into a broader health-promotion and disease-prevention framework."
— Shaheen Majeed, BGG
Shaheen Majeed, CEO, BGG Americas: We need to get people to understand the “supplement” side of supplements. Our industry is literally supposed to be part of their daily food habit, but we do a poor job of addressing and educating this. There also must be a shift in the mentality, or thinking, of how the U.S. takes care of its people. Our industry is meant to be preventative rather than taking a drug to try “curing” a disease.
The majority of ingredients sourced around the world are primarily used as daily food items, where over hundreds of years those items have been consumed, and relatively far fewer diseases have occurred. Why doesn’t our education system teach this to doctors? Most doctors dismiss supplements as not being effective enough, not enough science, etc. They fail to tell about the little to no side effects that dietary supplements have, versus all that we have to lose by taking pharmaceutical drugs.
I do believe the dietary supplement industry needs a bigger say at the highest levels of government to help implement programs for the under-nourished, malnourished, those in poverty, etc. I was heartbroken to learn that nearly 12 million kids living in the U.S. are living in poverty. Begin somewhere, begin at something.
Collaboration between the nutraceutical industry, healthcare professionals, and policymakers is crucial to establish evidence-based guidelines, educate the public on proper supplement use, and help integrate these products into a broader health-promotion and disease-prevention framework.
NW: What’s your impression of innovation in the dietary supplements market?
Shaheen Majeed: If I span over the last 5 years, sure there have been some notable growth areas, especially with ingredients like adaptogens, probiotics, and botanical extracts. The microbiome marketplace is its own industry, and it has an important role to play. There are companies that developed personalized nutrition supplements a few years back, and this is an area I’m excited to see grow more in the near future. Clean-label supplements, those free from additives and fillers, continue to gain popularity. Ingredients that are sustainably and ethically sourced will be the norm soon.
However, looking back these past 2 years, I haven’t seen nor experienced much innovation in the products that we as consumers should have had. Without a doubt, the pandemic halted many innovations, and getting back to somewhat of a norm meant finding a safe zone with those that we are familiar with. But now is the time—now we must take on those projects, those new product ideas, those new ingredients, new research, and much more to show ourselves and consumers out there that supplements can be more vital than ever for our health.
NW: Can you speak to the role that contract manufacturers play in today’s dietary supplement industry? What does transparency mean in the context of contract manufacturing and why is it so important?
Scott Steinford, Founder, Trust Transparency Center: Brands and consumers are expressing their desire to see more transparency from contract manufacturers (CMs). The contract manufacturers have an increasing awareness of responsibility to provide guidance to their customers at a deeper level of education to cGMP (current Good Manufacturing Practice) requirements affecting the entire manufacturing process.
It is my belief the CMs have an opportunity to go further and provide resources to educate their customers, especially the new startups, on requirements over and above the manufacturing process, including items such as AER (Adverse Event Reporting) compliance, retained sample requirements, etc.
NW: What strategies and tools can companies use to ensure transparency within their own operations and organizations?
Scott Steinford: The primary indication of transparency to the customer starts with the leadership team and their commitment to transparency to all components of the organization, internally and externally. For transparency to exist within an organization, it should be part of the core culture. Education of the boundaries and guidelines of transparency should be a proactive conversation and not a reactive conversation. Transparency “mistakes,” either permitting or prohibiting the organization’s exchange of information, should be the exception instead of the rule.
"Overall, the industry has become more resilient, adaptable, and consumer-focused. Successful companies have embraced change, leveraged technology, and fostered strong partnerships across the supply chain."
— Shaheen Majeed, BGG
NW: The last few years have been extremely disruptive and volatile for businesses and consumers. What lessons have you learned and applied? What lessons should industry
take away?
Scott Steinford: The last few years of disruption have reinforced the belief in relationship creation versus a purely economic relationship. Contract manufacturers experienced a surplus of demand that created service shortages. How organizations handled the transparency and communication of service challenges has a direct correlation to the level of customer satisfaction both during and after the surplus of demand has subsided. Customers remember how they were treated when they were disadvantaged.
Shaheen Majeed: I never forget that we are consumers as well, both in terms of what this industry offers and in general for goods and services. Over the last few years, there have been many changes, and many things, as consumers, we’ve had to adapt to. There is a resurgence to get back out in the world, and with that, more people are traveling, more consumer goods are being consumed, more deals are being sought out. Certainly, there’s been friction with rising interest rates these last few years and we’ve had to fend off inflation.
One of the biggest business lessons learned from my perspective has been to focus on your core competency rather than branching out for something far too new, or less researched, to promote for your customers. The brands are finding consumers who buy products they are familiar with rather than something totally new. However, “totally new” could also mean a change in the delivery format of that same existing product. Case in point, a multivitamin tablet we were once taking, now comes in a gummy … okay, six gummies.
When I say focus, I also mean in terms of the supply chain—our customers, be it the contract manufacturer and/or the brand company, want to be sure they can receive our ingredients on time, every time. The last few years, several customers overstocked items because they were unsure of product availability, but that’s disappearing. Now, we’re seeing an emphasis on partnerships, long-term contracts, even new product development programs, all of this leading to better communication and a better outlook for the industry.
Overall, the industry has become more resilient, adaptable, and consumer-focused. Successful companies have embraced change, leveraged technology, and fostered strong partnerships across the supply chain.
"The industry must collaboratively work on addressing climate change together because without us doing something, things will get worse. I believe that short-term thinking is always unwise, but with climate change it’s a metaphorical and literal death sentence.”
— Wilson Lau, NuHerbs
Climate and Sustainability
Wilson Lau, President, Nuherbs: The biggest challenge now, and probably for the rest of our lives, is climate change. The impact on botanicals is huge because the frequency and unpredictability of extreme weather events make supply a top concern and creates pricing instability. The herb industry has been seeing the effects of climate change on supply for years, but it’s escalating and will continue to do so. The industry must collaboratively work on addressing climate change together because without us doing something, things will get worse. I believe that short-term thinking is always unwise, but with climate change it’s a metaphorical and literal death sentence.Francesca de Rensis, Marketing Director, Indena: Today, more than ever, we are certain that a stronger commitment to sustainability has become unavoidable and we work to face some very urgent challenges, such as biodiversity loss, food waste, climate change, health issues, and social vulnerability. Indeed, our strategy implements circular economy in product design to reduce our environmental footprint up and down the value chain and increase our efforts to upcycle food waste.
What does it mean actually? It’s about transforming what is usually considered “waste” into raw material or energy. Through business models such as reuse, companies can reduce greenhouse gas emissions, pollution, and biodiversity impacts. Indena considers waste and pollution as design flaws, rather than inevitable byproducts of the products it makes.”
