News feeds for the natural products and integrative health practitioner fields have in recent weeks included a drumbeat of alerts on actions of the Food and Trade Commission (FTC) on what the agency considers inappropriate COVID claims. A major natural health organization blasted the FTC’s efforts as practitioner gagging and censorship and is mounting a campaign to stop the activity. Others in these fields point to bullseyes some practitioners and companies have painted on their foreheads via gross over claims (“this mushroom will cure your COVID”) that laser-guide FTC’s actions. At a sober center amidst a tangle of issues – state/federal jurisdiction, free speech, provider-patient relationship, and the peculiar institution of in-office sales of natural products – sit Laura Farr and Rob Kachko, ND. They are the executive director and president, respectively, of the American Association of Naturopathic Physicians (AANP). Among the multiple questions is whether naturopathic doctors and others in integrative medicine are “canaries in the coal mine” of a new, potentially widening push by the FTC and other federal and state agencies into the regulation of integrative and functional medicine practitioner offices.
The AANP represents a profession in which the orientation of the therapeutic philosophy is toward strengthening the host and to “treat disease by restoring health.” They often do this by working with patients on lifestyle choices and encouraging the use of dietary ingredients, nutraceuticals, and botanicals over pharmaceutical drugs. By this definition, the naturopaths would appear to be in the bullseye of an agency that is targeting claims of products and perhaps practices that might “prevent, mitigate and treat” – especially when compounded by the sales of natural products in many clinics.
Early in the pandemic, the AANP quickly acted to help guide its members on how to discuss natural approaches to, as Farr put it, “improve immune resiliency and mitigate COVID-19 symptoms above and beyond social distancing or showing up at the hospital in crisis.” The AANP’s present strategy, as each new announcement of FTC’s regulatory actions seems to further restrict discussion of natural approaches to healthcare, includes seeking a meeting with the FTC. The organization is seeking to further clarify how to effectively communicate these appropriate public health messages.
The most recent FTC action was a June 4, 2020 FTC letter that announced action against “35 more marketeers nationwide to stop making unsubstantiated claims that their products and therapies can treat or prevent COVID-19.” The areas of interest range from IV Vitamin C, to dietary supplements, ozone, essential oils, homeopathic medicines and more. The announcement brought to over what AANP has estimated as 200 practices and companies sent warning letters by the FTC.
In response, the Alliance for Natural Health began Paul Revering with an e-letter entitled Doctors Gagged as FTC Launches Censorship Campaign. They urge their members to sign on to an Open Letter to the president:
The FDA, FTC, Department of Justice, and some state attorneys general have launched a coordinated censorship campaign that prevents medical doctors and other healthcare providers from communicating their extensive knowledge about how to stay healthy during the pandemic using natural medicine. The actions of these federal agencies will lead to more COVID-19 infections and death. We have to fight back to preserve our right to stay healthy, naturally.
Selected Egregious Marketing Pitches Targeted by FTC
The AANP’s Farr and Kachko have a more sober perspective that has put them in the clash of conventional and integrative practices and paradigms since the virus caught the nation’s attention. In their initial rapid response and ongoing effort to serve their members in the COVID era, the AANP created one of the first membership COVID-19 resource sites. They’ve watched as naturopathic leaders played seminal roles in two early initiatives related to the suggestive evidence for natural health therapies including the “Integrative considerations during the COVID-19 pandemic” from the University of Arizona Andrew Weil Center for Integrative Medicine. More recently, two other naturopathic doctors were key authors in a highly touted phased protocol for COVID-19 involving natural agents.
The AANP’s initial guidelines for the appropriate language naturopathic physicians can use in speaking of their services and products led to a good deal of “push-back” from some of their own members. These argued that the association’s cautious stance amounted to self-censorship:
All healthcare providers should refrain from making health claims or proclamations about a “cure” or product that can “prevent” or successfully treat COVID-19. There are currently no nutrients, botanicals, vaccines, pills, lozenges or other prescription or over the counter products available to prevent, treat or cure COVID-19 specifically. Web-based/email marketing that promote potentially false and misleading statements about prevention and cures of COVID-19 hamper efforts to safeguard public health and may create liability for healthcare providers making such claims. [AANP bolding]
Despite the AANP’s early warning, a set of naturopathic doctors found themselves in FTC’s cross-hairs. Farr and Katchko are present seeking to untangle all of FTC’s potential motivations and causes of action. They quickly concluded that many of their targeted practitioners are not without blame. Said Farr: “We have definitely seen providers – not just naturopathic doctors but from all provider categories – making direct marketing claims that are inappropriate. We definitely support the FTC efforts against false claims.” Kachko, the organization’s elected president, offers broader context:
Some of our members have been worried that we are trying to limit our medicine. But our responsibility at the AANP is not just to our member. It is also to the public health. We need to both defend our members’ practice rights and to educate our doctors to how they can speak about what they do. Just the same, we are actively working to gain clarity as to how our providers can safely and effectively support their communities and honor the doctor-patient relationship while abiding by the need to avoid unfounded claims.
AANP’s Fact Sheet on Regulatory Warnings
I spoke with Farr and Kachko hours before the AANP’s planned publication on June 5, 2020 of a new Fact Sheet on Regulatory Agency Warning Letters During COVID-19 Pandemic. The 6 page fact sheet, backed up by a useful appendix from long-time integrative health attorney Alan Dumoff, can be useful to any integrative professionals in the field. The document was developed after consultation with multiple lawyers and with members of the dietary supplement industry who are familiar with past FTC actions. The AANP Fact Sheet hits on 5 main themes:
- Possible Consequences of Agency Warning Letters The AANP ticks off a cascade of negative consequences that can flow from an FTC warning: other federal actions, state action, licensing board activity, bank/merchant services freezes, and action from malpractice carriers.
- Patterns and Trends in FTC Activities This segments enters the weeds of how the FTC web-crawler algorithms are set to find those who are targeted. (The AANP concludes that “most of [the FTC] claims appear to be valid” but highlighted in my interview that some legitimate educational content was flagged by “flawed algorithms” from the FTC that associated COVID-19 with unrelated material.))
- Understanding the Laws This segment includes a focus on the application of the Dietary Supplement Health and Education Act (DSHEA) to practitioners. Farr shares that dialogue with industry has made clear that industry members are uniformly surprised by how little practitioners who sell products in their practices are aware of the marketing restrictions in the 1994 legislation.
- Areas Where the Laws are Less Clear The AANP’s consultations have uncovered that some of the actions against practitioners have cracked open a “novel area” of legal interpretation in which providers may be “targeted for services [AANP bolding] that are only performed with patients after an evaluation, such as IV Vitamin C.” This, they have concluded, “exposes serious concerns about jurisdictional overreach by the FTC into areas typically defined at the state level by licensure and scope of practice, and regulated by state medical licensing boards.”
Suggestions for Practice to Mitigate the Risk See below. The Fact Sheet offers specific examples.
Concerns about Infringement on Scope of Practice [my bolding] Included here is the significant concern that FTC may be infringing on a practitioner’s “discussion of immune enhancement, when explained in a straight forward manner, and not associated with product sales.”
A Portion of the AANP COVID-19 Fact Sheet
I asked Farr and Kachko via our zoom interview if they believed that their profession was in any way being targeted by the FTC. I shared that I’d not heard of as many challenges related to integrative and functional medical doctors who also have in-office pharmacies. The AANP leaders shared that while there have been some FTC actions against integrative MDs, most have targeted licensed acupuncturists, NDs, nutritionists, chiropractors, and lay alternative health practitioners. They also wonder why mainstream institutions that are known to be advertising use, for instance, of intravenous Vitamin C – such as Eastern Virginia Medical School and New York’s Northwell Health – do not seem to be taking heat. Yet while there appears to have been relatively little activity against conventional medical and academic institutions, Kachko suggested that recipients of the recent surge in FTC warning letter may be the “canaries in the coal mine” for what may be yet to come for other integrative practitioners.
Next steps – “novel applications” and meet with the FTC
Farr provided some useful summary notes from our exchange, that included, in part:
- There is a heightened state of concern and need for consumer safety which is leading to unprecedented regulatory activity stepping into areas of clinical practice previously unseen.
- Application of laws previously reserved to the dietary supplement industry is now aggressively being applied to the healthcare practitioner realm of all provider types: MD, DO, ND, DC, LAc, lay practitioners, nutritionists.
- FTC getting involved in the advertising of services which require establishment of a doctor/patient relationship, evaluation, and patient-specific protocol, is a very unusual jurisdictional reach historically reserved for state regulatory agencies responsible for scope of practice.
The AANP’s next step is to seek to dialogue with the FTC. “We support the need for regulation,” notes Farr, and “we seek to educate them about naturopathic doctors specifically, and about our role as physicians and physician educators and learned intermediaries. We need to clarify the boundary between education and commercial speech.”
The naturopathic canaries in the present coal mine of FTC motivations may have already -through the balanced exploration evident in this Fact Sheet – produced value for the entire integrative community. The meetings with the FTC, if the agency will consent to the request, will likely produce further useful clarity.
In fact, the clarity can have a meaning that goes far beyond the COVID-19 and even the FTC context. The present challenges have common denominators with two other major issues facing the broader integrative community: the Google “censorship” of natural health content and the heightened scrutiny of the Accreditation Council on Continuing Medical Education (ACCME). Each surfaces the distinctive relationship to evidence of those whose practices, in contradistinction to the dominant school’s attack-the-virus mode, seek to support the host so it is less hospitable. Naturopathic doctors and other integrative practitioners need to be educated to the ins-and-outs of the FTC’s culture and requirements. At the same time, FTC’s regulators need own the pharma-centric imbalance in the medical industry and awaken to the value in treating disease by educating, engaging, preventing, mitigating, and restoring health.