Shortly after Natural Products ExpoWest, I received a call from one of Holistic Primary Care’s key advertisers. She told me her company—among the largest and most ethically conscious in the practitioner space—had received an FDA Warning Letter demanding that the company desist in making product claims related to inflammation.

It turns out that upward of 150 companies—many in the practitioner channel—received similar warnings over the last few months. The deluge of warnings about inflammation claims indicates an all-out FDA effort to define “inflammation” —a bodily process and not a specific diagnosis—as a disease state, and to prohibit supplement companies from stating that their products can modify or  “balance”  inflammatory responses.

It appears that FDA now considers inflammation to be a disease, and any claim that a product can modulate inflammation is now considered, de facto, a drug claim.

Industry insiders are taking this development very seriously. Loren Israelsen, executive director of the United Natural Products Alliance, said his organization is keeping a close eye on it. On May 7, the Council for Responsible Nutrition teamed up with Virgo Publishing to produce a webinar on the current “Dos and Don’ts” of inflammation claims. It is safe to say that at this point the Don’ts definitely outnumber the Dos.

The matter was on the minds of many of the natural products executives who gathered in Long Beach, CA, early in April for the inaugural Health Practitioner Marketing Forum, produced by Holistic Primary Care and Windrose Partners (www.HPMForum.com). Some attendees said they see FDA’s efforts as the beginning of a strict enforcement campaign in which companies will be held to the most constrained definitions of structure and function as outlined in the Dietary Supplement Health and Education Act (DSHEA).

In and of itself, FDA’s move against inflammation claims throttles an important and growing segment of the product spectrum: the number of natural products and nutraceuticals marketed for quelling inflammation has soared in recent years, especially in the wake of the Vioxx withdrawal late in 2004.

However, the issue has much broader implications: executives fear the agency is widening its definition of  “disease” in a way that could make it difficult for marketers to say anything meaningful about what their products do. If inflammation—a non-specific physiological process—is now interpreted to be a disease, what’s next? Congestion? Swelling? Itching? Oxidation?

The possibility of a greatly broadened definition of disease is worrisome to many in the field, as it would give regulators a much bigger net to cast out over a much wider area of the market.

This is certainly not the first time that FDA has targeted inflammation claims. Isolated companies have received Warning Letters as early as 2006. However, this is the first time there has been such a concerted and rapid effort around inflammation. Industry insiders fear it is only the beginning of a much larger regulatory sweep against a variety of different claims.

The issue has particular significance in the practitioner channel because most clinicians—including naturopaths, chiropractors and other “alternative” caregivers—are trained to think in terms of disease diagnoses. Specific disease claims are explicitly prohibited under DSHEA, but the possibility of creating messages around regulation of physiological processes like inflammation gave marketers some degree of latitude to speak in a way that practitioners understood without directly violating the law. That latitude, if not welcomed or encouraged, seemed to be at least tolerable to regulators. Not any more.

Growing Practitioner Interest
FDA’s move against inflammation claims comes at a point in time when practitioner interest in nutrition, dietary supplements and non-pharmaceutical therapies are at an all-time high.

Evidence of this growth is everywhere. The Institute for Functional Medicine, an organization that has pioneered the interdisciplinary education of a wide range of practitioners, will host more than 1,000 clinicians at its upcoming annual meeting—a doubling of its audience size 3-4 years ago.

Over the last 13 years, the American Board of Integrative Holistic Medicine has certified more than 1,500 physicians in a comprehensive spectrum of holistic therapies and preventative modalities. The University of Arizona’s Program in Integrative Medicine will soon graduate its thousandth physician-fellow. To complete this program, physicians must complete 1,000 hours of training over a 2-year period.

Holistic Primary Care’s new 2013 Physician Survey—a questionnaire-based survey of 2,000 practicing primary care doctors that fetched a 9% response rate—showed a near tripling of the number of clinicians who dispense dietary supplements in their offices since 2010. The number of MDs who dispense almost quadrupled.

More than 40% of all respondents said they are seeking new revenue streams for their practices. Dispensing supplements is the top option they are considering.

There has been a 50% increase in the number of practitioners who recommend supplements and nutraceuticals to their patients, as well as major growth in the number of primary care practitioners who identify as “Holistic/Functional” in their practice style. This is despite the fact that the overwhelming majority of respondents are conventionally trained MDs and DOs. Clearly, primary care engagement with nutrition-based medicine is growing.

The survey contains a wealth of detailed information about practitioners’ interests, preferences and aversions with regard to nutrition and natural medicine. The signals are quite positive for companies interested in reaching the medical community. (The 2013 Survey Report, as well as slide presentations from HPC’s Health Practitioner Marketing Forum are available on www.HPMForum.com.)

One of the most intriguing findings was that more than two-thirds of the respondents—and again, we’re talking mostly MDs here—said they are in agreement with the following statement: “Diseases and conditions can be treated or ameliorated with the use of dietary supplements and/or natural products.”

More than one-third agreed strongly, a major increase in buy-in since 2010. This is noteworthy because the statement represents precisely the sort of message that DSHEA prohibits supplement marketers from sending. Regulations or not, doctors are getting the message that nutrition and nutraceuticals can be used in a therapeutic context.

I’m speculating here, but this sort of thing may very well be what is spurring regulators toward greater action. Simply put, in the eyes of the law, supplements should not be used like drug therapies to treat diseases. Insinuating a therapeutic effect by highlighting the fact that an ingredient can modulate a physiological process that sometimes causes diseases would encourage just this kind of therapeutic thinking among clinicians.

As one HPM Forum participant pointed out, the situation with inflammation claims only underscores a nasty Catch-22 that has always lurked beneath the surface of DSHEA: If a company makes claims without having any scientific back-up, that company can be nailed for making unsubstantiated claims. But if a company does have data showing meaningful effects on a potentially pathogenic physiological process (no alliteration intended), then this can easily be interpreted as a drug claim in the eyes of the regulators.

These days, it seems that FDA is moving in that direction. The inflammation claims clampdown is very much a moving target, and I’m sure we’ll be hearing more about it in the future.