Byline: Laura Culberson Farr, Executive Director, American Association of Naturopathic Physicians
Since the novel coronavirus (COVID-19) pandemic began in March, the U.S. Food and Drug Administration along with the Federal Trade Commission have sent over 300 warning letters to physicians, clinics, individuals, pharmacists, and manufacturing and retail companies reprimanding them for making false and misleading claims about the ability of products or services to prevent, mitigate, treat, or cure COVID-19. Dozens of these warning letters have gone to practitioners in the integrative healthcare space, including functional medicine physicians, naturopathic physicians, chiropractic doctors, and acupuncturists, many of whom often recommend natural approaches to care through diet and lifestyle changes, and the use of herbs and/or supplements.
The American Association of Naturopathic Physicians conducted an analysis of the warning letters and providers who received them, and found that many of the offending communications were discussions about ways to “boost the immune system,” methods for how to stay healthy, and natural protocols that may be helpful in mitigating COVID-19 symptoms or that have been successfully deployed to treat other acute respiratory distress syndromes. Most of the warning letter recipients sell products through their clinic or online dispensary or advertise services like intravenous (IV) Vitamin C therapy.
The warning letters usually begin by citing language from a clinic’s website or newsletter that regulators determine makes a misleading claim, requesting that the offending language be removed and that the FTC be notified within 48 hours that the recipient has come into compliance.
However, there can be a cascade of downstream consequences from receiving one of these warning letters. Some integrative medicine providers have reported one or several of the following:
- Negative media about the practitioner or their clinic
- Merchant service accounts frozen upon a bank learning of the warning letter, and can only be reactivated after establishing proof of compliance
- Fraud investigations by the Oregon Department of Justice for violations of the Oregon Unlawful Trade Practices Act
- Reports from recipients that their state licensing board was notified
While there are no known cases of disciplinary action by licensing boards on any practitioner, the risk is possible and the anxiety and legal defense fees are even more real for providers who genuinely thought they were sharing important information about potentially beneficial, low-cost, low-risk ways to stay healthy or mitigate COVID-19 symptoms.
Providers at the Crossroads of Commercial and Free Speech
Warning letters are triggered when the FTC perceives that there is advertising or marketing language that violates the FTC Act. For integrative medicine providers, the AANP’s research found that this is almost always the nexus of discussing treatment protocols, services, or research related to COVID-19 with either a direct or implied marketing reference to selling products through a clinic store, online dispensary, or services such as IV therapy. This is considered “commercial speech,” and is highly regulated.
In the middle of this crossroads stands the Dietary Supplement Health and Education Act (DSHEA), which strictly prohibits supplement producers and marketers from making disease-related claims. A disease-related claim, such as stating a product can be used to treat COVID-19, can only be legally made for FDA-approved drugs and medical devices.
Supplement manufacturers and marketers are limited to making what are called structure and function claims and must include a disclaimer that the statements have not been evaluated by the FDA.
Here is a simple example of the difference between a structure/function claim and a disease claim. “Calcium can help build strong bones” is a structure/function claim. “Calcium can help treat osteoporosis” is a disease claim.
Under DSHEA, marketing a product associated with a disease like COVID-19, whether directly, as in “buy my vitamin C to boost your immune system to protect you from COVID-19,” or indirectly, as in “vitamin D deficiency may increase the risk of contracting COVID-19,” is considered making a false and misleading disease claim that a supplement can prevent, cure, mitigate, or treat COVID-19.
Providers who sell products and advertise the availability of products in newsletters, websites or social media are generally viewed by regulators as marketers, but have not usually been the target of FDA and FTC regulatory actions. The combination of heightened consumer fear with the explosion of consumer scams, has led to a regulatory environment that supplement industry consultant Michael Levin has called “a radioactive recipe waiting to explode.”
Synonyms, Euphemisms and Syllogisms of COVID-19
What has been particularly confounding for many integrative medicine providers trying to communicate legitimate educational content, research, protocols, tips, and recommendations to patients and the public is the ever-growing list of synonyms and euphemisms that regulators are associating with COVID-19, and asserting that they are syllogisms to making a disease claim to prevent, treat, or cure COVID-19. For example, the term “virus” is often associated with a disease, therefore a statement that a dietary ingredient has shown promise to treat or prevent “viruses” would likely be considered a false and misleading disease claim, and may trigger a warning letter specific to COVID-19.
The legal team of a popular supplement company used by many integrative medicine practitioners has cautioned their marketing team to also avoid using phrases like “during this pandemic,” or “in this new normal,” which may be considered euphemisms for COVID-19 when viewed through a marketing lens. A statement along the lines of, “during this pandemic, we need to make sure our immune systems are strong,” that then recommends a sample protocol to boost immune resilience would be viewed by the FTC as an inference to COVID-19 and a prohibited disease claim.
In a recent call with the FTC task force charged with protecting the public against COVID-19 scams, the Assistant Director of the FTC’s Bureau of Consumer Protection remarked “there is a syllogism between immunity and COVID-19 that is not definitively supported by scientific evidence.” He explained that if there is a communication about the pandemic, immunity, and dietary ingredients that links to a store selling related products, the FTC will view this as marketing and a false and misleading disease claim about the products.
The proliferation of fraudulent COVID-19 cures is a real and significant problem, as is the potential for restricting open communication about potentially beneficial, natural approaches to improve health. Some natural health advocacy organizations have argued that the regulators have gone too far and are stifling the ability of providers to communicate appropriate information about natural approaches to preventing or treating COVID-19.
“Your right to learn from your doctor about natural methods of staying healthy during the pandemic are under threat,” said the Alliance for Natural Health in a May statement. “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…using natural medicine.”
This front is also evolving rapidly, research is changing constantly, and some providers and clinics who have received warning letters are pushing back to defend the ability to educate consumers and market dietary supplements. Ongoing dialogue needs to happen with regulatory bodies to fine-tune the line between what constitutes free speech, which is not regulated, and commercial speech, which is heavily regulated.
Providers must quickly become educated about marketing laws, DSHEA, what constitutes commercial speech, and the domains that have long been the purview of the supplement industry but are now broadly being applied to providers who have become de facto marketers.
Additionally, providers also need to understand the line between free speech and commercial speech. Author Erik Goldman provides an example in his article Words of Warning: “Saying ‘Vitamin D boosts immunity’ on your website is free speech. Saying “Vitamin D boosts immunity and you can buy it at my store” is marketing. Regulators are unlikely to object to the first statement. They very well could target the second.”
To ensure compliance with marketing regulations, practitioners are urged to analyze their marketing communications with the following considerations:
- Educate the public about COVID-19 treatment approaches without any marketing for product sales on websites, newsletters, social media posts, etc; OR
- Market dietary supplements/products without making prevention or treatment claims, including but not limited to COVID-19, antiviral, or other disease properties;
- Do not make claims about COVID-19 treatment approaches with product sales or a link to an online dispensary in either a direct or implied manner;
- Get to know laws around marketing, the FTC Act and DSHEA, and the important distinction between commercial and free speech. The AANP co-hosted a FREE webinar with Holistic Primary Care, with guests from the FTC department issuing warning letters, and several legal and practitioner experts. Please click here to watch and share Your COVID Communications Could Be Illegal: How to Avoid FTC/FDA Trouble When Marketing Your Practice.
Integrative medicine practitioners play an important role in helping consumers understand what are credible, evidence-informed natural approaches to health. Developing a deeper understanding of marketing laws and commercial speech regulations will help providers accomplish this effectively and legally.
About the Author
Laura Culberson Farr
Laura Culberson Farr is the Executive Director of the American Association of Naturopathic Physicians, the national association representing licensed naturopathic doctors, and Board of Director of the Integrative Health Policy Consortium. A health advocate for over 25 years, she has a deep knowledge of the complexities of healthcare reform, and is an expert on how naturopathic and integrative medicine doctors, conventional clinics, and insurers can work together to improve patient care and reduce healthcare costs.