Over the last year, Cannabidiol (CBD), the non-psychoactive cannabinoid in cannabis, has undergone an interesting shift with regard to federal legalization. CBD has long been recognized for its wide-range of health benefits which reputedly include being used as a treatment for anxiety, chronic pain and inflammation, epilepsy, and more. Last year CBD was approved for use by the FDA in the prescription drug Epidiolex, and it was later re-scheduled and legalized under the Agricultural Improvement Act of 2018.
As a result of this shift in federal legalization, there has been a proliferation of select CBD products hitting store shelves, such as lotions, creams, patches and other topically applied goods. Our most recent Newsletter explains how CVS plans to bring a line of CBD products to select stores, and there has been recent talk that Walgreens will do the same. Our firm receives inquiries on a near daily basis from CBD startups who are trying to break into the market and need advice on the evolving legal landscape surrounding CBD products.
Currently, CBD can only be used in a few approved products for topical use as it has yet to be authorized as a dietary supplement and its approval as a drug is limited to Epidiolex. With respect to its approved use as a drug, the FDA has stated “Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.” As of today, CBD has not received pre-market approval and there is no “monograph” for CBD as a drug category, which precludes it from being able to conform with any such category. Thus, CBD is not authorized as a drug under current FDA guidelines. The FDA’s FAQ on Cannabis and Cannabis-derived products can be found on its website here.
Aside from not being approved as a drug, the FDA prohibits CBD products from being sold as a dietary supplement in food and beverages. In short, the FDA has concluded CBD products are excluded from the dietary supplement definition under Section 201(ff)(3)(B) of the Food Drug and Cosmetics Act (FD&C Act). Recently, the FDA has sent warning letters to companies illegally selling CBD products that claim to prevent, treat, or cure serious diseases with the added acknowledgment that these companies were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
The FDA’s commissioner Scott Gottlieb recently clarified the FDA’s enforcement priorities with respect to CBD products, stating “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over-the-line claims”. Gottlieb’s comments do not authorize CBD use in dietary supplements, but they do seem to suggest the agency will only be scrutinizing products that make over-the-line medicinal claims as to the efficacy of their products in treating symptoms that CBD has not been proven to cure or alleviate.
For now, it remains unknown as to how the FDA will actually enforce products that feature CBD in food and beverages. The FDA has stated that its priority is to use its resources to prohibit products that pose a threat to public health. Given the recent federal approval of CBD under the Agricultural Improvement Act of 2018, it seems that the FDA is limiting its enforcement scope to target companies making robust medical claims about their CBD products. It is important for companies to remember that lack of enforcement does not equate to legality and that CBD products are still prohibited under the FDA’s guidelines and directives. Further, state agencies, such as California’s Department of Public Health, have authority to regulate CBD products being sold within their jurisdiction, so beyond federal enforcement it is important that companies remain apprised of the rules governing CBD products within their state.
Businesses involved with the manufacturing and sale of CBD products should consult with a qualified legal representative in order to better understand how these rules effect their current or proposed operations. At the very least, CBD companies need to take a serious look at their packaging and labelling and the corresponding health and wellness claims that are being made about their products. The intracate relationship between local and federal CBD laws continues to evolve and it is imperative that CBD companies continue to follow any new developments to ensure they operate with an eye towards compliance.