On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19.
The warning letters referenced posts on brand websites as well as on social media. For instance, one company’s website quoted people who used CBD oil “as treatment” for various medical conditions, claiming positive effects. Another company marketed the use of CBD oil to treat medical conditions on social media, using several hashtags related to serious medical conditions. The FDA considers these products “new drugs” under section 201(p) of the FD&C Act, and therefore they are not considered safe and effective for treatment of medical conditions as these companies promoted. The warning letters also addressed products that were illegally marketed for pets.
Some of the products were described as “especially concerning from a public health perspective” due to the method of administration. The particularly concerning methods of administration were nasal, ophthalmic, and inhalation. The FDA stated its priority in monitoring this new market is products that “pose the greatest risk of harm to the public.”
The FDA issued 21 warning letters related to CBD products in 2020, 13 of which were also related to COVID-19. The FDA will likely continue to monitor the emerging CBD market throughout 2021, addressing violations with more warning letters and possibly legal action. For further information about the FDA’s efforts to address and pursue improper CBD product marketing, please contact your Dinsmore attorney.
Ashley Durner contributed to this article.[i] See: https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products
© 2020 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume XI, Number 5