In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel coronavirus.  This follows the seven warning letters jointly issued by the agencies in early March.

  • Gaia’s Whole Healing Essentials LLC was warned for selling colloidal silver products with claims that the products can build immunity and possess anti-viral properties for the treatment or prevention of COVID-19.
  • Homeomart Indibuy was warned for claiming that its homeopathic drug products treat respiratory illnesses and act as a prophylactic to protect from COVID-19 infection.
  • Health Mastery Systems DBA Pure Plant Essentials was warned for selling essential oils with claims that the products are safe and/or effective for the treatment or prevention of COVID-19. In addition to identifying improper claims made on the manufacturer’s website, the warning letter also scrutinized the express and implied claims made in social media posts including the following hashtags: “#coronavirus #covid #prevention #preventativehealth #symptoms #essentialoil #aromatherapy.”
  • NeuroXPF was warned for advertising that its cannabidiol (CBD) product prevents and treats COVID-19. Given the existing regulatory scrutiny on the growing CBD industry, we expect particularly aggressive enforcement against CBD manufacturers who make unsubstantiated and/or unapproved claims regarding COVID-19.

States have also begun enforcement actions.  Last month, the Missouri Attorney General sued televangelist Jim Bakker and his company, Morningside Church Productions Inc., for claiming, on a broadcast featuring a naturopathic doctor, that the product Silver Solution can cure coronavirus.  This spurred an FDA/FTC warning letter against the company in early March.  Similarly, California Attorney General Xavier Becerra issued a consumer alert warning the public:  “Do not be hustled by opportunistic tricksters claiming to have a miracle cure. There is not a cure for COVID-19. . . .  I encourage anyone who has been the victim of a snake oil scam or who otherwise has information about products that are falsely touted as coronavirus treatments, tests, or cures to immediately file a complaint through my office’s website[.]”

As we discussed in an earlier blog post, companies may advertise structure/function claims without pre-approval by the FDA if the statement is substantiated by competent and reliable evidence, and is truthful and not misleading.  Disease claims, by contrast, are not permissible without FDA pre-market review and authorization under the rules for health claims or drugs, as appropriate.

While the FDA has relaxed other requirements during the COVID-19 public health crisis, the existing framework for structure/function and disease claims remains in full effect.  By asserting that their products treat, cure or prevent the novel coronavirus, these companies are, according to FDA and FTC, asserting unapproved disease claims that violate federal law.

Furthermore, it is unlawful under the FTC Act to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.  No such study is currently known to exist for COVID-19.  Thus, any coronavirus-related prevention or treatment claims are not currently supported by competent and reliable scientific evidence.  This may soon change; FDA has created the Coronavirus Treatment Acceleration Program (CTAP), which is intended to expedite the development of prevention and treatment approaches, and has accelerated the process by which developers and scientists may use investigational products and evaluate new treatment options.  As of March 31, 2020, FDA reported there are 10 therapeutic agents in active trials and another 15 therapeutic agents in planning stages.

To some extent, the industry predicted this surge of purported COVID-19 products even before the virus had spread widely across the United States. In February, nutraceutical industry trade groups reminded consumers and retailers that dietary supplements cannot claim to treat, prevent, or cure the novel coronavirus. In a joint statement, the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) affirmed their support for the responsible sale and use of vitamins, minerals, herbs, and other dietary supplements that provide many positive benefits promoting better health and wellness. The joint statement noted: “While research supports the use of certain dietary supplements to maintain immune system health, we are not aware of clinical research that demonstrates using a dietary supplement specifically to prevent or to treat the Novel Coronavirus.”  The statement also cautioned that even if competent and reliable research is conducted and published, the Dietary Supplement Health and Education Act of 1994 (DSHEA) prohibits marketers of dietary supplements from promoting any dietary supplement product that makes disease prevention or treatment claims.

Takeaways

Until a reliable human clinical study is published, supplement manufacturers should avoid making claims regarding COVID-19, and should scrutinize all of their advertising statements, including those broadcast over social media or using influencer marketing, to ensure they are not making unapproved disease claims.