It seems like CBD oil is all we talk about, but honestly, it’s almost all that our clients are talking about. If your marketing folks haven’t come to you yet with an idea to add CBD oil to something, they will almost certainly show up soon.
In this latest installment, the FDA giveth, and the FDA taketh away. That’s likely how the cannabidiol (CBD) industry is feeling right now in response to the FDA’ statement from April 2. We expect, however, that most sellers of the hemp-derived substance, which was legalized at the federal level in certain circumstances in the 2018 Farm Bill, will be content with this approach, considering that the agency is seeking to clarify the regulatory status of CBD products.
In a statement by FDA Commissioner Scott Gottlieb, the agency communicated a series of next steps related to its regulation of CBD. It announced a public hearing to be held on May 31 and invited stakeholders to provide input through a public comment period. In discussing this meeting, the FDA acknowledged certain issues that have impeded the CBD industry: namely the safety risks associated with the substance, particularly if used without FDA-approved labeling, and how it may be lawfully incorporated into foods and dietary supplements. As readers of this blog know, the FDA and many states prohibit adding CBD as an ingredient into food and dietary supplements because CBD is the active ingredient in FDA-approved drug products and was part of clinical investigations before being introduced to food. Essentially, this policy prevents certain drugs from being introduced to food or supplements without either notice-and-comment rulemaking or legislation. To resolve this issue, Commissioner Gottlieb also announced that the FDA will form a “high-level internal agency” to consider the issue of how CBD could be legally marketed in conventional foods and dietary supplements, focusing on what statutory or regulatory steps can be taken. Additionally, the FDA also promised to update its website with frequently asked questions (which can be your second stop for CBD news and updates after this blog).
The FDA’s final announced step – this is the “taketh” – was new compliance actions against products that it believes are putting consumers at risk. On the same day as the commissioner’s statement, the agency issued warning letters to three companies that sold CBD products claiming to treat various diseases, including cancer and Alzheimer’s. These letters were sent in conjunction with the Federal Trade Commission and demonstrate a continued commitment by these agencies to crack down on unsubstantiated disease claims related to CBD. As we noted in a previous blog, the FDA has been practicing some level of enforcement discretion and, so far, has largely limited its compliance actions to products making claims for treatment of serious diseases.
However, Commissioner Gottlieb has also expressed concern about retailers selling CBD products making claims that don’t rise to this level. In a Congressional hearing on April 3, Mr. Gottlieb said, “So you now see big-box stores seeking to market CBD products for some uses where the claims seem to be potentially over the line, for the treatment of pain for example.” Commissioner Gottlieb’s comment, however, may reflect use of the “bully pulpit” rather than suggesting that FDA is prepared to more rigorously scrutinize CBD oil claims.
In his statement, Commissioner Gottlieb expresses real concerns about the risks presented by CBD, but he also lays a path forward for the FDA to engage with these issues and hopefully remove some of the roadblocks that the industry faces. There aren’t any solutions on the horizon yet, but there are steps being taken to figure out what those solutions might be. We’ll keep you updated of further developments on this blog.