The FDA Crackdown on Coronavirus Medical Claims: CBD Companies, Take Note!

Unfortunately, in times of crisis and hardship there will always be companies attempting to take advantage of people, playing off of fear and desperation. Earlier this month, the FDA sent out a round of warning letters to companies that were selling fraudulent COVID-19 products. We’ve written extensively about what CBD companies should not do if they want to avoid FDA scrutiny, as well as the scrutiny that CBD companies have already received. And although none of the letters sent out in this round of FDA enforcement specifically referenced CBD products, at least one of the companies targeted does sell CBD products, and we have heard anecdotal reports of CBD companies making dubious statements related to the coronavirus that may or may not rise to the level of medical claims.
In light of the foregoing, we thought it would be helpful to lay out the nature of the claims being made related to COVID-19 that the FDA will not tolerate, and to review the basics of labeling and advertising related to medical claims as they pertain not just to CBD companies, but to any company in the health and wellness space. Here’s what the FDA had to say in its March 9, 2020 news release:
The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” said FDA Commissioner Stephen M. Hahn, M.D. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their health care providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness. We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”
“There already is a high level of anxiety over the potential spread of coronavirus,” said FTC Chairman Joe Simons. “What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
One of these letters was issued to Herbal Amy Inc., a company out of Idaho that also sells CBD products online. Herbal Amy was selling “Coronavirus Protocol” products including “Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core Tincture, Coronavirus Immune System, and Elderberry Tincture.” This is some of the language included with the products that the FDA deemed unlawful:
Corona virus treatment. Stephen Buhner has analyzed how corona viruses infect tissues, what tissues they infect, and the herbs that are useful to interrupt that process, as well as the herbs useful to shut down the cytokine cascade they create. Here is his protocol.… [T]his is a rather extensive protocol because the particular corona virus that is now spreading world wide is exceptionally potent in its impacts. 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 ….”
Stephen Buhner has used this with other corona virus infections, including SARS, it works well.”
These types of statements are extremely misleading, and illustrate the purpose for which the FDA was created. Our blog archives contain a multitude of resources for companies in the CBD space regarding what you can and cannot say in marketing your products. Generally speaking, products that are not approved by the FDA for the “diagnosis, cure, mitigation, treatment, or prevention of any disease” cannot be marketed as drugs, meaning that these products cannot be marketed with health claims or structure/function claims. If you make health claims regulated by the FDA related to CBD or other cannabis products, you are risking federal enforcement action.
If you are unsure as to whether or not your labels, websites, social media, or other marketing materials contain statements that could be construed as health claims (and it’s important to remember that even vague or general statements could constitute health claims), you should consult with your attorney. We advise many clients on these very issues. And in closing, a reminder from the FDA:
There are currently no vaccines or drugs approved to treat or prevent COVID-19. Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness.”
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