Erik Goldman, Holistic Primary Care10.01.15
It is becoming apparent that—like it or not—the dietary supplements industry will face significant regulatory changes in the not-too-distant future.
A perfect storm of declining retail sales, eroding consumer trust, high-profile regulatory action by state attorneys general, attrition of the industry’s political allies, and increased scrutiny by high-profile critics is forcing the industry to recognize that the Dietary Supplement Health and Education Act (DSHEA) may be reaching the limit of its utility.
What a revised regulatory framework would look like, and who would be involved in the revising, is anybody’s guess at this point.
But in recent months, key players in the field have been floating the previously unthinkable notion that DSHEA needs an overhaul.
Industry leaders, including United Natural Products Alliance President Loren Israelsen—one of the original architects and champions of DSHEA—are calling on the industry’s brain trust to take a proactive role in defining what “DSHEA 2.0” ought to be.
The prevailing view is that if industry does not come forward with a new vision for more effective regulation, unfriendly legislators will do so in the next few years, and the industry won’t like the way it fits.
Facing the Critics
For the first time, industry leaders seem willing to reckon with outspoken critics like Sen. Dick Durbin, who has publicly demanded that the industry—and those charged with regulating it—do a better job of guaranteeing that:
1) What is on a product’s label is actually in the bottle.
2) Consumer safety is assured when a product is used as directed.
3) There is meaningful science supporting a product’s claims.
4) There is traceability and transparency in manufacture.
The critical voices are only getting stronger, and unfortunately, one need not look too hard to find companies within our gates that are flagrantly defying reasonable standards of business ethics, to say nothing of GMPs.
As a first step in demonstrating proactivity on the regulatory front, Mr. Israelsen’s group, along with the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), issued a joint letter to the Food and Drug Administration urging the agency to elevate its Division of Dietary Supplement Programs to the status of “Office,” and to fund it accordingly.
This, the trade groups said, would, “enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency,” and “could help to increase FDA’s abilities to take more aggressive enforcement action” against companies marketing spiked or adulterated supplements.
UNPA and other groups have also supported a recent citizen’s petition forwarded by the Organic and Natural Health Association requesting that FDA extend GMP compliance requirements to include raw materials suppliers.
Such steps are good as far as they go, in that they do demonstrate the industry’s willingness to engage constructively with regulators. But this is low-hanging fruit. Deconstructing and redesigning DSHEA is another matter.
Some thought leaders looking into this believe that fundamentally, the DSHEA framework is sound, and with a little tweaking and more thorough enforcement the law would be fit for purpose for years to come.
Others hold that DSHEA needs a top-to-bottom overhaul, and that the entire premise of structure-function claims needs to be re-thought.
It remains to be seen which approach the industry ultimately takes, and how the industry’s vision jibes with that of legislators.
Engaging Clinicians
My sincere hope is that industry leaders bring physicians and other healthcare practitioners into the dialogue, and that the needs and concerns of medical professionals are included in any serious discussion about regulatory revision.
Clinicians had very little to do with the development of DSHEA and with the implementation of regulations governing supplements and natural products. That’s totally understandable.
Twenty-plus years ago, when the law was written, few healthcare professionals used supplements in their practices. Those who did were largely outside the mainstream and for the most part, they were comfortable in the margins.
Likewise, in the early 1990s there were only a handful of nutraceutical companies playing to practitioners—primarily chiropractors and naturopaths. Some of those companies (think Standard Process) actually had long historical legacies dating back to the earliest days of the nutrition industry. But, like the practitioners they served, most were well below the radar of conventional medicine.
In short, there was no such thing as the Practitioner Channel for dietary supplements back in the early 1990s.
While there were a number of outspoken nutra-friendly doctors who added their voices to the swell of consumer advocacy supporting DSHEA, practitioner involvement did not go much beyond that.
Honestly, I’d hazard a bet that even today, many practitioners do not really know what DSHEA is about.
That’s problematic, because the rules established under DSHEA have very specific implications for practitioner channel brands, and for the practitioners themselves.
Strictures on Science
For one, because DSHEA only permits structure/function claims, it imposes severe restrictions on the scope of clinical research on vitamins, herbs and other types of supplements.
Simply put, the law makes it difficult in the U.S. to study supplements in people with diseases.
In the eyes of the regulators, a trial designed to assess a supplement as a potential treatment for a disease is, de facto, a disease claim. And that, as we all know, is prohibited by DSHEA.
This means U.S. studies of supplements can only enroll healthy people, and that makes it very hard to show a meaningful effect size. Give painkillers to people without pain and you’re not likely to see a measurable effect.
There are many examples of studies that do show specific supplements might mitigate specific disease states. But these are based either on epidemiological correlations or on changes in biomarkers and other indirect disease indicators—a regulatory gray area with ever-changing boundary lines.
Trials looking at supplements as treatments for various diseases do exist, but they’re almost always done outside the U.S.
In all these cases, it is easy for U.S. doctors to dismiss evidence: epidemiological correlations are not considered “gold standard” data; biomarkers can be easily challenged as irrelevant; and data from other countries is, well, foreign.
In aggregate, the research restrictions imposed by DSHEA contribute to a general sense often voiced by doctors that there’s little research to support supplements, and that the research that does exist is vague or flimsy.
Even when research is solid and significant, it often comes out sounding like flim-flam once it goes through the structure/function transducer.
The reality is that medical practitioners see sick people and they treat or try to prevent diseases. They don’t think of their work as “supporting healthy function.” It is a major challenge for marketers to get their messages across in terms that physicians understand but don’t run afoul of DSHEA.
All of this adds up to a perception among some healthcare professionals that the supplement industry is less-than-honest.
The robust growth of the practitioner channel—generating more than $3 billion annually, and rising at a steady 7-8% per year despite these restrictions and the major retail downturns—is a testament to the value of many supplement products, the commitment of practitioner channel brands, and the open-mindedness of a growing number of clinicians.
Practitioners deeply engaged in natural medicine and who use many supplements generally understand the restrictions DSHEA imposes, and they can read through the language-games. Other practitioners, including those who guard the gates of the major academic medical centers and the managed care plans, are less familiar with the regulations and less forgiving of the double-speak.
Practitioner Views on Regulation
Holistic Primary Care’s 2015 Practitioner Survey, which gathered data from more than 650 primary care physicians, 125 specialists and 90+ nurses, included questions gauging practitioner attitudes toward regulation.
While 17% of the primary care respondents felt that the existing system is adequate to ensure the quality and safety of supplements, and 48% agreed that existing regulations would be adequate if properly enforced, 35% believed that a total regulatory overhaul is needed.
The latter position was particularly strong among MDs (compared with NDs, DCs and other non-MDs) and among those in insurance-based versus insurance-free practices. It is important to note that these survey respondents were generally friendly toward nutritional medicine and supplements.
Verbatim comments in response to the regulatory questions revealed that while these clinicians see the value of supplements in their practices, they are also mistrustful of industry and of regulators alike.
As one primary care doctor put it: “Quality control needs to be implemented and enforced, but not by the FDA, who have an anti-nutrition stance.”
Others hold that the existing regulatory system has not been able to prevent a flood of questionable products making dubious claims and lacking quality control. This can make it difficult for them—and for their patients—to feel secure knowing they are purchasing safe and effective supplements. Still others echo the oft-heard view that the nutrition industry is entirely unregulated.
An Opportunity for Evolution
In the 20 years since passage of DSHEA, the supplement industry has experienced remarkable growth, and some of the strongest and most consistent growth has been in the practitioner channel. Clearly many more medical professionals have become interested in supplements, and have begun using them in their practices.
Mainstream institutions that once scoffed at the very notion that nutrition was part of “real” medicine, are championing functional medicine and lifestyle change as the keys to a healthy future. For the most part, the industry as a whole has done little to cultivate allies within healthcare, and to develop stronger relationships with the medical community.
Beyond feeding on the retail buzz generated by high-profile media medicos like Mehmet Oz, Mark Hyman and David Perlmutter, and beyond support of conferences and educational events in the holistic/functional medicine space, the industry has not done much to engage practitioners in the broader issues.
I believe practitioner channel companies need to take a lead role in the process of revising and redefining the regulations, and they need to engage practitioners in that process.
Because they are playing in the healthcare arena, practitioner-focused brands have a greater stake in science, and a stronger imperative for maintaining the highest standards of quality in manufacture, and the highest ethical standards in marketing.
Pro lines should be setting the quality bar for the industry as a whole, and should be willing to stand up—and stand out—as examples of how to combine innovation with integrity.
They are also in the best position to create meaningful relationships with physicians, nurses and other healthcare stakeholders, and to identify common ground between the industry and the practitioner groups that are reshaping how medicine is practiced in this country.
These relationships will be extremely important for the future of the practitioner channel specifically, but also for the industry as a whole.
Medical opinion leaders who understand what the industry has to offer and who recognize the constrictions under which the industry has had to operate can become valuable allies in the coming contentions over supplement regulations.
It’s not about identifying which clinician might be the “next Dr. Oz.” It’s about engaging prominent as well as unknown practitioners, as well as practitioner groups, in the discourse about regulation and the role of supplements in healthcare at large.
The industry has plenty of critics within the ranks of healthcare. It is high time to invest in cultivating medical allies.
Erik Goldman
Holistic Primary Care
Erik Goldman is co-founder and editor of Holistic Primary Care: News for Health & Healing, a quarterly medical publication reaching about 60,000 physicians and other healthcare professionals nationwide. He is also co-producer of the Practitioner Channel Forum, April 6-8, 2016, at the Marriott Coronado Island in San Diego. The Forum is the nation’s leading conference focused on opportunities and challenges in the practitioner segment of the dietary supplement industry. A comprehensive 48-page Executive Summary of findings from Holistic Primary Care’s 2015 survey of primary care practitioners, as well as five categories of medical specialists, is available for purchase at http://tpcforum.com/physician-survey.
A perfect storm of declining retail sales, eroding consumer trust, high-profile regulatory action by state attorneys general, attrition of the industry’s political allies, and increased scrutiny by high-profile critics is forcing the industry to recognize that the Dietary Supplement Health and Education Act (DSHEA) may be reaching the limit of its utility.
What a revised regulatory framework would look like, and who would be involved in the revising, is anybody’s guess at this point.
But in recent months, key players in the field have been floating the previously unthinkable notion that DSHEA needs an overhaul.
Industry leaders, including United Natural Products Alliance President Loren Israelsen—one of the original architects and champions of DSHEA—are calling on the industry’s brain trust to take a proactive role in defining what “DSHEA 2.0” ought to be.
The prevailing view is that if industry does not come forward with a new vision for more effective regulation, unfriendly legislators will do so in the next few years, and the industry won’t like the way it fits.
Facing the Critics
For the first time, industry leaders seem willing to reckon with outspoken critics like Sen. Dick Durbin, who has publicly demanded that the industry—and those charged with regulating it—do a better job of guaranteeing that:
1) What is on a product’s label is actually in the bottle.
2) Consumer safety is assured when a product is used as directed.
3) There is meaningful science supporting a product’s claims.
4) There is traceability and transparency in manufacture.
The critical voices are only getting stronger, and unfortunately, one need not look too hard to find companies within our gates that are flagrantly defying reasonable standards of business ethics, to say nothing of GMPs.
As a first step in demonstrating proactivity on the regulatory front, Mr. Israelsen’s group, along with the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), issued a joint letter to the Food and Drug Administration urging the agency to elevate its Division of Dietary Supplement Programs to the status of “Office,” and to fund it accordingly.
This, the trade groups said, would, “enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency,” and “could help to increase FDA’s abilities to take more aggressive enforcement action” against companies marketing spiked or adulterated supplements.
UNPA and other groups have also supported a recent citizen’s petition forwarded by the Organic and Natural Health Association requesting that FDA extend GMP compliance requirements to include raw materials suppliers.
Such steps are good as far as they go, in that they do demonstrate the industry’s willingness to engage constructively with regulators. But this is low-hanging fruit. Deconstructing and redesigning DSHEA is another matter.
Some thought leaders looking into this believe that fundamentally, the DSHEA framework is sound, and with a little tweaking and more thorough enforcement the law would be fit for purpose for years to come.
Others hold that DSHEA needs a top-to-bottom overhaul, and that the entire premise of structure-function claims needs to be re-thought.
It remains to be seen which approach the industry ultimately takes, and how the industry’s vision jibes with that of legislators.
Engaging Clinicians
My sincere hope is that industry leaders bring physicians and other healthcare practitioners into the dialogue, and that the needs and concerns of medical professionals are included in any serious discussion about regulatory revision.
Clinicians had very little to do with the development of DSHEA and with the implementation of regulations governing supplements and natural products. That’s totally understandable.
Twenty-plus years ago, when the law was written, few healthcare professionals used supplements in their practices. Those who did were largely outside the mainstream and for the most part, they were comfortable in the margins.
Likewise, in the early 1990s there were only a handful of nutraceutical companies playing to practitioners—primarily chiropractors and naturopaths. Some of those companies (think Standard Process) actually had long historical legacies dating back to the earliest days of the nutrition industry. But, like the practitioners they served, most were well below the radar of conventional medicine.
In short, there was no such thing as the Practitioner Channel for dietary supplements back in the early 1990s.
While there were a number of outspoken nutra-friendly doctors who added their voices to the swell of consumer advocacy supporting DSHEA, practitioner involvement did not go much beyond that.
Honestly, I’d hazard a bet that even today, many practitioners do not really know what DSHEA is about.
That’s problematic, because the rules established under DSHEA have very specific implications for practitioner channel brands, and for the practitioners themselves.
Strictures on Science
For one, because DSHEA only permits structure/function claims, it imposes severe restrictions on the scope of clinical research on vitamins, herbs and other types of supplements.
Simply put, the law makes it difficult in the U.S. to study supplements in people with diseases.
In the eyes of the regulators, a trial designed to assess a supplement as a potential treatment for a disease is, de facto, a disease claim. And that, as we all know, is prohibited by DSHEA.
This means U.S. studies of supplements can only enroll healthy people, and that makes it very hard to show a meaningful effect size. Give painkillers to people without pain and you’re not likely to see a measurable effect.
There are many examples of studies that do show specific supplements might mitigate specific disease states. But these are based either on epidemiological correlations or on changes in biomarkers and other indirect disease indicators—a regulatory gray area with ever-changing boundary lines.
Trials looking at supplements as treatments for various diseases do exist, but they’re almost always done outside the U.S.
In all these cases, it is easy for U.S. doctors to dismiss evidence: epidemiological correlations are not considered “gold standard” data; biomarkers can be easily challenged as irrelevant; and data from other countries is, well, foreign.
In aggregate, the research restrictions imposed by DSHEA contribute to a general sense often voiced by doctors that there’s little research to support supplements, and that the research that does exist is vague or flimsy.
Even when research is solid and significant, it often comes out sounding like flim-flam once it goes through the structure/function transducer.
The reality is that medical practitioners see sick people and they treat or try to prevent diseases. They don’t think of their work as “supporting healthy function.” It is a major challenge for marketers to get their messages across in terms that physicians understand but don’t run afoul of DSHEA.
All of this adds up to a perception among some healthcare professionals that the supplement industry is less-than-honest.
The robust growth of the practitioner channel—generating more than $3 billion annually, and rising at a steady 7-8% per year despite these restrictions and the major retail downturns—is a testament to the value of many supplement products, the commitment of practitioner channel brands, and the open-mindedness of a growing number of clinicians.
Practitioners deeply engaged in natural medicine and who use many supplements generally understand the restrictions DSHEA imposes, and they can read through the language-games. Other practitioners, including those who guard the gates of the major academic medical centers and the managed care plans, are less familiar with the regulations and less forgiving of the double-speak.
Practitioner Views on Regulation
Holistic Primary Care’s 2015 Practitioner Survey, which gathered data from more than 650 primary care physicians, 125 specialists and 90+ nurses, included questions gauging practitioner attitudes toward regulation.
While 17% of the primary care respondents felt that the existing system is adequate to ensure the quality and safety of supplements, and 48% agreed that existing regulations would be adequate if properly enforced, 35% believed that a total regulatory overhaul is needed.
The latter position was particularly strong among MDs (compared with NDs, DCs and other non-MDs) and among those in insurance-based versus insurance-free practices. It is important to note that these survey respondents were generally friendly toward nutritional medicine and supplements.
Verbatim comments in response to the regulatory questions revealed that while these clinicians see the value of supplements in their practices, they are also mistrustful of industry and of regulators alike.
As one primary care doctor put it: “Quality control needs to be implemented and enforced, but not by the FDA, who have an anti-nutrition stance.”
Others hold that the existing regulatory system has not been able to prevent a flood of questionable products making dubious claims and lacking quality control. This can make it difficult for them—and for their patients—to feel secure knowing they are purchasing safe and effective supplements. Still others echo the oft-heard view that the nutrition industry is entirely unregulated.
An Opportunity for Evolution
In the 20 years since passage of DSHEA, the supplement industry has experienced remarkable growth, and some of the strongest and most consistent growth has been in the practitioner channel. Clearly many more medical professionals have become interested in supplements, and have begun using them in their practices.
Mainstream institutions that once scoffed at the very notion that nutrition was part of “real” medicine, are championing functional medicine and lifestyle change as the keys to a healthy future. For the most part, the industry as a whole has done little to cultivate allies within healthcare, and to develop stronger relationships with the medical community.
Beyond feeding on the retail buzz generated by high-profile media medicos like Mehmet Oz, Mark Hyman and David Perlmutter, and beyond support of conferences and educational events in the holistic/functional medicine space, the industry has not done much to engage practitioners in the broader issues.
I believe practitioner channel companies need to take a lead role in the process of revising and redefining the regulations, and they need to engage practitioners in that process.
Because they are playing in the healthcare arena, practitioner-focused brands have a greater stake in science, and a stronger imperative for maintaining the highest standards of quality in manufacture, and the highest ethical standards in marketing.
Pro lines should be setting the quality bar for the industry as a whole, and should be willing to stand up—and stand out—as examples of how to combine innovation with integrity.
They are also in the best position to create meaningful relationships with physicians, nurses and other healthcare stakeholders, and to identify common ground between the industry and the practitioner groups that are reshaping how medicine is practiced in this country.
These relationships will be extremely important for the future of the practitioner channel specifically, but also for the industry as a whole.
Medical opinion leaders who understand what the industry has to offer and who recognize the constrictions under which the industry has had to operate can become valuable allies in the coming contentions over supplement regulations.
It’s not about identifying which clinician might be the “next Dr. Oz.” It’s about engaging prominent as well as unknown practitioners, as well as practitioner groups, in the discourse about regulation and the role of supplements in healthcare at large.
The industry has plenty of critics within the ranks of healthcare. It is high time to invest in cultivating medical allies.
Erik Goldman
Holistic Primary Care
Erik Goldman is co-founder and editor of Holistic Primary Care: News for Health & Healing, a quarterly medical publication reaching about 60,000 physicians and other healthcare professionals nationwide. He is also co-producer of the Practitioner Channel Forum, April 6-8, 2016, at the Marriott Coronado Island in San Diego. The Forum is the nation’s leading conference focused on opportunities and challenges in the practitioner segment of the dietary supplement industry. A comprehensive 48-page Executive Summary of findings from Holistic Primary Care’s 2015 survey of primary care practitioners, as well as five categories of medical specialists, is available for purchase at http://tpcforum.com/physician-survey.
