FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of joint warning letters to several companies claiming their products—teas, essential oils, tinctures, and colloidal silver—could prevent or treat COVID-19.

Warning Letters to Seven Companies

The warning letters were sent to Vital Silver, Quinessence Aromatherapy, Xephyr, GuruNanda, Vivify Holistic Clinic, Herbal Amy, and The Jim Bakker Show on March 6, 2020. The joint letters and separate, corresponding press releases are available here (FDA) and here (FTC).

The companies claimed their products could be curative or healing, claims that were both directly and indirectly targeting coronavirus. For example, Quinessence Aromatherapy marketed “eucalyptus radiate,” an essential oil, as having “a powerful antibacterial, antifungal and anti-infectious action, which makes it extremely useful for all types of infection.” Quinessence Aromatherapy also alluded to COVID-19 in other marketing materials, including claims that it had the “most powerful anti-virus essential oils to provide defence against coronavirus.”

The agencies also addressed products that more directly claimed to treat coronavirus, too. Herbal Amy, which sells teas and tinctures, was targeted by the agencies for the following claims about its product:

“Corona virus treatment . . . All the herbs are specific in one way or another for this virus. A number of the herbs are strongly antiviral for corona viruses . . . . The formulations are preventative as well as specific for acute infections . . . .”

In the jointly issued warning letters, the agencies ordered each company to cease selling products claiming to prevent or treat COVID-19, noting that the products lack competent and reliable scientific evidence, much less regulatory approval, supporting the companies’ claims. FDA stressed that these letters were part of its broader campaign requiring urgent measures to protect consumers from products that claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

FTC stated that, according to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent COVID-19.

Numerous state attorneys general are also taking action against unauthorized and unsupported product claims. For example, Missouri Attorney General Eric Schmitt sued The Jim Bakker Show for selling “Silver Solution,” a dietary supplement, as a “coronavirus cure,” and New York Attorney General Letitia James issued a “cease and desist” order to Bakker for the same. Washington Attorney General Bob Ferguson announced that his office “is investigating price gouging in the wake of the COVID-19 public health emergency.”

Takeaways for Consumer-Facing Product Manufacturers

  • Avoid sales of unapproved products. Avoid selling products that claim to prevent or treat COVID-19 without approval, clearance, and/or authorization under the FD&C Act. The warning letters covered diverse products including teas, essential oils, tinctures, and colloidal silver. In its corresponding press release, FDA also warned consumers that fraudulent COVID-19 products could include dietary supplements and other foods, as well as products purporting to be drugs, medical devices, or vaccines.
  • Avoid making claims without evidence. Avoid claiming that products can prevent or treat COVID-19 without competent and reliable scientific evidence under the FTC Act. FTC may consider a “misbranded” product unlawful. While there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of development and have not completed testing for safety or effectiveness.
  • Be proactive. Review marketing statements contained on websites, social media, and other sales channels. An FDA cross-agency task force was established to closely monitor for fraudulent products related to COVID-19, and it has already worked with major retailers and online marketplaces to remove more than three dozen product listings.
  • Assess potential exposure. With respect to FDA, failure to correct the FD&C Act violations may result in an injunction and seizure. On the other hand, failure to correct the FTC violations may result in an injunction and order to pay back money to consumers. Further, agency warning letters can often spawn consumer lawsuits, adding to companies’ potential legal exposure for unsupported claims.
  • Follow agency guidance. FDA and FTC are motivated to halt production of products with unapproved or unsupported claims because they can cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. Companies should continue to closely track agency-issued guidance.

Conclusion

In the coming days and weeks, we can expect more of these types of warning letters from FDA and FTC relating to COVID-19, as well as from state attorneys general. We will continue to provide updates as the federal agencies and state offices issue more guidance in the face of this rapidly evolving health crisis.