Worldwide, the age of COVID-19 has ushered in a plethora of medical claims concerning the use of natural products to prevent and/or treat the pathogen.
Here in the U.S., the Federal Trade Commission (FTC) has been clamping down on bad actors, and those well-intentioned but under-informed about the current, and sometimes opaque, rules of the road.
Federal responses have been accelerated by a perniciously persistent pandemic that lacks an approved drug-based prophylactic therapy, a vaccine, or treatment, other than one repurposed COVID-19 treatment therapy, Remdesivir.
We are all in pursuit of reasonable solutions to prevent, manage, and overcome this virus. Traditional therapies across cultures and provider disciplines are being explored and observed clinically, if not studied in large randomized placebo-controlled trials.
Back to the Basics: Know the Law
If you are an integrative health practitioner or your organization markets and sells natural products of any kind, now is the ideal time to revisit how to best communicate the benefits of your goods and services to existing and prospective patients and clients.
Proactivity begins with returning to the basics of focusing on structural and functional characteristics.
Any discussion of COVID-19 mitigation, prevention or cure using dietary ingredients or herbs, connected to the sale of those products, is a direct violation of the prohibition against disease claims for dietary supplements. ~AANP Fact Sheet on Regulatory Agency Warning Letters During COVID-19 Pandemic
Serious consequences can result upon receiving a warning letter from the FTC and other regulatory agencies. There is a risk of fines, censure, negative publicity, and other punitive actions, including those from:
- State Investigations
- Federal Actions
- Medical Licensing Boards
- Bank/Merchant/Processing Gateways
- Potential Challenges from Malpractice Insurers
Limited Science is Merely Observational and Anecdotal
Natural products and infusions such as high-dose Vitamin C may be incredibly useful to help develop a stronger immune system response, reducing the cytokines storm, or increasing antiviral activities through other unknown mechanisms at various stages of infection.
Though vitamin D deficiency was recently shown to be prevalent among those with COVID-19, this does not prove that dosing vitamin D and reaching a specific blood serum level will prevent the virus.
Until ‘if and when’ natural agents, or combinations thereof, are tested under large and rigorous randomized control trials to prove their efficacy and become approved as a drug, no medical claims can be made.
[Handpicked Related Content: Integrative Health Must Lead on COVID-19 and Immune Resiliency]
AANP Offers Valuable Resource for Integrative Health and Functional Medicine Community
The leadership of The American Association of Naturopathic Physicians (AANP), in coordination with integrative health professionals, dietary supplement manufacturers, and longtime industry attorney Alan Dumoff, has created an important and prescient Fact Sheet on Regulatory Agency Warning Letters During COVID-19 Pandemic.
Whether you are a credentialed health provider, manage a supplement company or retail operation, manufacture natural products—or otherwise make recommendations, market/sell supplements, IV nutrients, or functional foods—this Fact Sheet is comprehensive and timely; it is required reading for your practice, company, or organization.
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Access the Fact Sheet to learn about:
- Avoiding “direct” or “implied” claims regarding a nutrient ingredient supplement.
- Allowable immune claims for dietary supplements in the context of COVID-19.
- Areas where the law is unclear, such as advertising intravenous vitamin C—which typically requires a clinical evaluation to ensure appropriate care delivery.
- Legal risk versus benefits of sharing information, especially in the context of COVID-19 support and the importance of not overstating the evidence.
- Specific disclaimers to incorporate immediately.
You do not have to be a naturopathic physician to find solid, actionable value from the guidance provided by AANP’s Fact Sheet on Regulatory Agency Warning Letters During COVID-19 Pandemic.
Currently, more than ever, there is a responsibility and an opportunity for those in the integrative health and functional medicine community to positively impact population health. As a member, your role is critical in the education and support of patients and clients specific to lifestyle and natural products that strengthen host immune resiliency.
Let’s ensure we step forward and participate in a responsible, safe way with a heightened understanding of the legal and regulatory constructs in place. Full stop.
FON is a leading integrative health and medicine business development and strategy consulting firm. FON specializes in custom solutions for growing patient volume, developing programs, and increasing product sales. Our practical business models are driven by innovative marketing, clear messaging, and customer engagement via branded storytelling.
Image credit: BigStockPhoto.com/nature78