FDA CBD Hearing Key Talking Points: Main Cannabidiol Lessons Learned So Far

The CBD Hearing held by the Food and Drug Administration took place on Friday, May 31, 2019. On the morning of the hearing, FDA Commissioner Ned Sharpless tweeted about it, stating, There are lots of questions, including many related to safety we will need to answer to ensure that FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.” For the most part, the tweet represented some of the major points at the hearing.

There are lots of questions, including many related to safety we will need to answer to ensure that FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.

— Dr. Ned Sharpless (@FDACommissioner) May 31, 2019

A major highlight of the hearing was that there are too many products on the CBD market that raise cause for concern due to their lack of accurate labeling. For instances, lab data was presented that bottles of CBD products labeled as having 300 mg of CBD oil actually contained a mere 22 mg or none at all. Not only are consumers negatively affected by such products, but companies that actually do present quality products on the market with accurate labeling may be adversely affected by the negative press. The FDA is concerned about these types of products and companies that put such products out can expect to be regulated in the future.

Another issue that arose during the hearing is how the lack of regulation is affecting consumers. Currently, consumers have no way of validating whether the products they purchase are legitimate. As a result, there may be regulation that enables consumers to purchase products that they can be certain are legitimate and accurately labeled. In addition, also related to consumers, is the lack of consumer knowledge as to what CBD actually is.

Moreover, the FDA is concerned about side effects that could arise from using CBD. The issue is that there is not enough data as to what the side effects are. As a result, the FDA is looking to hear from those who have data that can provide insight into adverse reactions and negative side effects that arise from CBD use.

Relatedly, the FDA is not looking for anecdotal evidence. While heartfelt stories on how CBD has helped so-and-so are certainly moving and influential, they do not constitute scientific evidence, which is what the FDA is looking for. Scientific evidence includes research studies and data that provide true insight into just how effective – or ineffective – CBD is.

There are also those who pushed for FDA regulation. For example, Jonathan Miller, U.S. Hemp Rountdable’s General Counsel, stated that the hearing that there is “an urgent need for an efficient regulatory framework for CBD.” Also, Andrew Kline of the National Cannabis Industry Association said, “we strongly recommend [that] FDA act quickly to clarify the regulatory environment.” Not only was his reasoning that many businesses do not know what is legally permissible, but also, “Most significantly, banks and payment processors don’t understand [the regulatory rules] and as a result many CBD companies are at risk of losing financial services.”