On April 6, the Food and Drug Administration (FDA) issued five warning letters chastising companies for their unapproved products related to the novel coronavirus disease 2019 (COVID-19). Two days later, the FDA issued another four warning letters for similar reasons. Two of the five warning letters issued on April 6 were issued to companies in connection with their CBD products, and one of the warning letters issued on April 8 was issued to a CBD company as well. The full text of the letters can be found here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cbd-online-store-606587-04072020, here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indigo-naturals-606423-04062020 and here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/native-roots-hemp-606247-04062020
Reiterating its position toward CBD companies making claims that their products mitigate, prevent, treat, diagnose or cure disease, the FDA stated that by making claims that their products might alleviate or cure COVID-19 symptoms, all three companies’ products were thus unapproved new drugs and also misbranded drugs sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters direct the companies to immediately cease making all such claims, under threat of legal action in a Federal District Court, seeking injunctions as well as penalties such as an order may require that the companies pay back money to consumers.
Besides the negative impact that these kinds of false claims could have on the nascent hemp and CBD industry, the issuance of the FDA’s warning letters are particularly disappointing given the seriousness of the COVID-19 crisis. Indeed, on March 20, 2020, the Department of Justice issued a press release urging the public to report suspected fraud schemes related to COVID-19, and also directing all U.S. Attorneys to prioritize the investigation and prosecution of COVID-19-related fraud schemes.
Hopefully, these public warnings will ensure that no further hemp or CBD companies (or really, companies in any industry) make these type of disease remediation claims.