As the FDA begins its first round of public hearings on the future of the Dietary Supplement Health and Education Act, and industry leaders ponder what “DSHEA 2.0” might look like, it is worthwhile to consider how medical practitioners—especially those who use supplements—view this peculiar piece of legislation.

With its insistence on structure-function (S/F) claims, and its prohibition of disease language in supplement marketing, DSHEA has a unique impact on medical professionals. 

Putting it simply, the law precludes supplement makers from communicating with clinicians in exactly the sort of language to which practitioners are accustomed.

That, of course, was part of the compromise on which DSHEA was built: it was specifically designed to ensure that disease terminology—and by extension, mainstream medical thinking—remain the province of prescription pharmaceuticals only.

One can certainly make good arguments for a sharp distinction between drugs and supplements. But in the real world—and especially in the clinical real world—the line is blurred. People take supplements to prevent and mitigate diseases, and practitioners—especially naturopathic, holistic, and functional medicine doctors—often recommend them for those purposes. 

Yet most such practitioners would agree that herbs and nutraceuticals are not drugs; they work differently, and they are seldom monotherapies for specific diagnoses.

DSHEA’s prohibition of disease-oriented language for supplements fosters misunderstanding in the clinical world. To many mainstream physicians, S/F claims sound cloudy at best, and bogus at worst. For nutrition-focused practitioners, S/F language is often imprecise, ambiguous, and less than helpful. They often have to read between the lines to understand how a particular product should be used, and for whom.

There were very few—if any—medical professionals involved in the development of DSHEA back in 1994. That’s not surprising. At that time, the number of physicians who utilized supplements was very small.

Today, with major medical establishments like Cleveland Clinic and Mayo Clinic establishing functional medicine centers, and the sale of supplements via practitioners growing at a steady 7-9% annually, it’s a very different story.

Practitioner Perspectives
So how do practitioners feel about DSHEA and the peculiar language games it obliges supplement companies to play?

This spring, Holistic Primary Care sought to find out. Our 2019 practitioner survey, which fielded in April, included a series of questions about supplement industry regulation. The findings are interesting.

As of this writing, we obtained responses from 208 practitioners, 32% of whom are MDs, with 16% being naturopaths; 13% osteopaths; 9% nurses; 7% chiropractors; and a number of acupuncturists, nutrition counselors, wellness coaches, and psychotherapists.

Women outnumbered men (68% to 32%), and most are in solo (51%) or small group practices of 2-10 practitioners (21%).

The survey included the following question: Earlier this year, the FDA announced plans to review and revise DSHEA, which has not been changed since it was first passed in 1994. Which statement best reflects your perspective on this regulatory move?

• DSHEA is fully adequate and effective to protect public safety. The FDA should leave it alone.
• DSHEA would be adequate if properly enforced. FDA should concentrate on better enforcement rather than revision.
• DSHEA is flawed and needs major revision. I support the FDA’s intention to review and revise it.
• DSHEA has problems, but I do not trust the FDA’s intention for revising it.
• I do not know what DSHEA is.

The first finding that jumps out is that one-third of respondents (34%) do not know what DSHEA is. That number may seem high, but it’s actually an improvement over 2016 (the first year we asked questions about DSHEA) when 57% did not recognize what DSHEA was.

Only 16% of the respondents feel the law is adequate to protect public safety, with another 16% holding that DSHEA would be adequate if properly enforced.

While 28% see DSHEA as problematic, they do not trust the FDA to revise it. Notably, only 6% of the respondents chose the statement fully supportive of FDA’s intention to revise the regulation.

Interestingly, conventionally trained MDs tracked very closely with the general cohort in their attitudes about DSHEA: 38% don’t know what it is; 25% see the law as problematic but do not trust the FDA to revise it; 17% believe it would be adequate if properly enforced; and 12% view the current law as fully adequate. Eight percent fully support the FDA’s intention to review and revise DSHEA.

The verbatim comments are indicative of practitioners’ complex, sometimes conflicting, sentiments about regulation. One clinician wrote: “I’m concerned on both ends of this dilemma. There needs to be some review and enforcement. However, I am not sure when it comes to pharmacy lobbyists among others and their influence on the FDA to limit less expensive preventative, supportive and/or treatment options.”

Another pointed out: “FDA approved a lot of the conventional medicine, which is killing thousands of people every year or damaging their health even. For me FDA approved doesn’t mean it is good.”

Communication Standards
Our survey showed practitioners are not fans of S/F based marketing language. Or, put another way, the vast majority would like it if supplement companies could use disease terminology in their practitioner-focused communications.

The survey asked: When marketing to medical professionals, should supplement companies be permitted to use language that refers to specific diseases and symptoms?

Eight-five percent of the practitioners responded  Yes; only 15% said No.

Then, we asked: When marketing to the general public, should supplement companies be permitted to use language that refers to specific diseases and symptoms?

Here the response was more subdued, with 43% indicating Yes, and 57% voting No.

Again, the MDs tracked very closely with the general cohort: 83% of MDs believe supplement companies should be permitted to use disease language when marketing to medical professionals, and 35% would support use of disease terminology with the general public.

In essence, the data suggest that practitioners are comfortable with a two-tiered communications standard, with greater latitude for disease claims on the practitioner side.

That’s not entirely surprising. Until the 1990s, when direct-to-consumer pharma advertising became widespread, physicians and patients dwelled in two vastly different info-spheres, with little overlap between them.

Many of today’s older practitioners trained and came of age when access to detailed medical information was much more restricted than it is today. Whether or not they’re conscious of it, they’re used to being privy to certain types of information to which their patients do not have access.

The fact that nowadays many non-practitioners have free access to most of the world’s medical literature—and some have become quite knowledgeable despite a lack of formal medical training—has not changed this expectation too much. 

Pharma marketing is, by its very nature, condition-specific. Disease-based language continues to inform medical thinking. Despite the evolution of the wellness movement, most people—practitioners or not—are still conditioned to think in terms of specific diagnoses (“my diabetes,” “my family history of heart disease,” etc.) when thinking about health.

So, it’s not at all surprising that practitioners would be comfortable with disease claims for supplements.

While DSHEA makes no distinction between practitioner-channel supplements and those sold in retail channels, the S/F restrictions inherent in DSHEA have a disproportionately negative effect on the practitioner side.

The reality is, people go to physicians and other practitioners because they’re seeking treatment for, or prevention of, diseases. The restriction of clear and unequivocal communication about what herbs, vitamins, and other supplements can—and cannot—do in the context of disease management, can be an impediment to truthful medical dialogue.

As a number of industry observers have pointed out, the most DSHEA-compliant marketing materials are the least informative and useful to practicing clinicians.

Prohibition of condition-specific claims has also hobbled clinical research on nutraceuticals. Unlike the situation with prescription drugs, where manufacturers have tremendous incentive to fund research which they can then use (presuming positive data) in their marketing campaigns, nutraceutical companies have far less to gain by investing in clinical studies.

In practice, FDA, FTC, and state attorneys general have largely ignored the practitioner channel supplement brands. Lawyers working in this field explain that regulators recognize that practitioners play the role of “Learned Intermediaries,” guiding and overseeing their patients’ use of supplements. They’re generally more tolerant of the use of disease-specific science in the medical space than in retail.

In short, FDA and FTC have (so far) been reluctant to get deeply involved in regulating the practice of medicine and overseeing clinical judgment. (Insurance company utilization reviewers and state medical boards are another story, but that’s for a different article.)

Still, there’s no question that DSHEA, as it was written in 1994, restricts the supplement industry from utilizing the language that is most common and comfortable to medical practitioners.

I won’t argue that our survey population is fully representative of all medical professionals. This is a decidedly supplement-friendly cohort. Nearly all respondents (95%) take supplements themselves, and 63% dispense (i.e., sell) them in their practices. Even among those who do not dispense, 93% recommend supplements to their patients.

Still, the fact that more than 80% of  the conventionally-trained MDs we surveyed believe supplement makers should be able to use disease terms when communicating with practitioners is highly significant.

It seems very clear that despite the resignation of Scott Gottlieb as FDA commissioner, the agency intends to open DSHEA for revision.

While it is very unlikely that any future version of the law would permit supplement companies to make disease claims, the need for clear and truthful clinical communication should at least be on the table for discussion as DSHEA goes under review.

As one of our survey respondents noted: “I would suggest adding practitioners who use these products to be on the advisory committees.”

The industry would be wise to engage its clinical allies in the dialogue around “DSHEA 2.0.” Supplement-friendly practitioners will be affected—whether they realize it or not—by whatever amendments are made to the law. Their needs and concerns should be part of the discussion.

The absence of medical perspectives was excusable in 1994 when DSHEA was drafted. In 2019, when thousands of practitioners—including some MDs at mainstream institutions—are using supplements, it is not.

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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, the nation’s leading conference focused on opportunities and challenges in the practitioner segment of the dietary supplement industry.