On Tuesday, the Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) issued a Warning Letter issued to Neuro XPF, a company selling CBD products in the U.S., based on claims contained on its website and social media pages that its products can mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA has stated it will continue to issue warning letters to companies for selling fraudulent COVID-19 products as part of the agency’s effort to protect consumers and to pursue those that place public health at risk.
Not surprisingly, the letter cited rather clear disease claims as the reason for action, such as “Crush Corona” and other statements which indicate that taking CBD may help maintain the immune system and potentially help prepare the body to fight a coronavirus infection.
Of course, a claim that a dietary supplement product fights disease or enhances disease-fighting functions of the body is a “disease” claim. Although a claim that a product generally “supports the immune system” may not be specific enough to imply prevention of disease (i.e., since the immune system has both “structure/function” and “disease fighting” roles), if the context of the claim links the supposed effect of the product to disease prevention and/or disease treatment capabilities, as is the case here, the statement would generally be interpreted as a disease claim by the FDA.
As we have understood well before the first CBD products hit the market in this country, making disease claims about products that have not been pre-approved by the FDA as drugs is illegal. Making these types of claims will effectively render the product an “unapproved new drug” under the law, which creates exposure to liability for marketing unapproved new drugs.
The agencies issuing the letter advised the company to review its websites, product labels, and other labeling and promotional materials to ensure all problematic content is removed. The letter also allowed a mere 48 hours for an email response describing the specific steps taken to correct these violations, which is much less than the typical “15 working days” request for a response provided in most other similar letters issued by these agencies.
Additionally, the FDA indicated that the agency is advising consumers not to purchase or use certain products that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19 via a public list, which can be found at: http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products.
Bottom line? Do not make claims that your CBD products may treat or help prepare the body to fight off COVID-19. Even if such claims may be cleverly worded to indicate that CBD could help maintain immune system function that, in turn, may theoretically fight against the disease, the effect of this type of statement is virtually the same as if you had claimed your product cures the virus itself. As evidenced by the swift actions of these federal agencies, it is clear that the FDA and FTC are taking any claims related to COVID-19 very seriously.
If you have questions about FDA regulations or what types of claims you can make about your cannabis products, please contact our attorneys at Hoban Law Group. We are here to help.