Over the past few years, CBD has been receiving a lot of attention. The development of CBD-based products is a result of this growing interest in CBD as a form of therapy. Both federal law and California law currently prohibits CBD from being added to any food or drink product. On July 22, 2019 the FDA took steps to further spread the CBD ban by issuing formal letters determining that certain CBD products such as pain relief products and vape pens were sold in violation of the Federal Food, Drug and Cosmetic act (FD&C Act).
Companies are claiming that products, including CBD pain relief patches and CBD vape pens, are being advertised for cures and treatments that are not amenable to self-diagnosis. The FDA warns that these type of health claims are not appropriate. If the recommendation is not given by a certified person (aka a doctor), the FDA claims that it is unsafe to recommend adequate doses and directions for these CBD products. Ultimately, only doctors are capable of recommending a product for pain relief or other conditions.
The FDA warned Curaleaf Inc., a top marijuana company, for making claims in its advertising and labeling that CBD can help cure illnesses. These type of health claims are not appropriate because CBD is not approved by the FDA. Therefore, to say that cannabidiol products can treat minor pain to cancer, is unfair and misleading for consumers.
The FDA gathered numerous claims from Curaleaf’s website and social media accounts that give credibility to CBD for being able to cure debilitating diseases and deadly illnesses such as, “CBD was effective in killing human breast cancer cells.” The warning letter can be accessed here.
In the warning by the FDA issued to Curaleaf, some of the products considered unapproved are: “CBD Lotion,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 Versions) and “Bido CBD for Pets” (3 versions).
The FDA rejected these CBD products from Curaleaf Inc. for two main reasons.
- It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded or unapproved new drug under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
- Marketing CBD products as dietary supplements is not appropriate because CBD is the active ingredient in the FDA-approved drug product Epidiolex, and thus they do not meet the definition of a dietary supplement under the FD&C Act.
Are there any CBD drug products that are FDA-approved?
Yes, but only one… Epidolex. Therefore, we recommend to be wary of all of the CBD products that are on the market. Manufacturers and sellers could incur civil or even criminal liability for selling unregulated, unapproved products, and buyers could be buying products with impurities or toxic additives that could cause side effects or health concerns.
The violation of CBD products is not limited to products sold for humans. The FDA has also come to the conclusion that some products labeled CBD for pets are unapproved and unsafe under the FD&C Act.
Margolin & Lawrence has published other blogs in relation to the confusion of CBD over the years. To read more about these blog posts on our website, press here.
We recommend taking prompt action if you believe you are a business that sells CBD products that might not fall under “approved” by the FD&C Act. If you would like assistance or clarification regarding this issue, please contact one of our attorneys.