The Food and Drug Administration (FDA) held it’s first public hearing on Cannabidiol (CBD) on May 31, 2019 to address their concerns about the newest product to flood the market. This is not the first time the FDA has addressed CBD, but it is the first time in FDA history that they have held a public hearing to gain scientific information about products containing cannabis or cannabis-derived compounds. The panel included individuals from various roles within the FDA’s organization, as well as the Acting Commissioner, Norman “Ned” Sharpless.
Over 100 speakers participated in the hearing, and more than 1000 people registered to join the discussion. Each of the speakers was given a designated time allotment to present their testimony. Those who were unable to complete their presentation in the set amount of time, or those unable to speak, were instructed to submit comments to an established portal connected to the official docket for the public hearing.
We can only see this as the beginning of something much greater. The FDA is seeking the opinions of citizens to help them reach a final decision regarding the degree of government oversight and regulation that will be dedicated to CBD products in order to protect consumers from questionable products and helping them select reliable ones.
But as of now, many questions are left unanswered.
What Was Covered During This Meeting?
The Importance of Sharing Knowledge
Following the FDA panel introduction and opening statements, a steady parade of individuals came forward to present information about the use of hemp, hemp-derived products and byproducts, and the use of consumer products containing cannabidiol (CBD). This testimony continued for nearly 10 hours. Presenters included representatives of academia, agriculture, public safety, and retail, as well as consumers, patients, and healthcare advocates and professionals.
Many of the individuals presented their opinions or the opinion of their company on how the FDA should regulate this booming industry. Some demanded strict oversight, while others lobbied for looser regulation.
There was a general consensus that the FDA should have some type of control over the CBD industry, but the question remains to what extent?
Working Towards Regulations
On December 20, 2018, President Trump signed the Agricultural Improvement Act, commonly known as the “Farm Bill”. This act legalized the cultivation of hemp in the United States (after specific state regulations are in place) but did not alter the existing rules on the production nor sale of cannabis and cannabis-derived products to consumers.
This Farm Bill expanded on the previous bill that passed in 2014 which clarified the distinction between hemp and marijuana. It also stated that institutions of higher education or state departments of agriculture could cultivate industrial hemp as pilot projects.
This new Farm Bill filled in some of the gaps in the regulations. These include:
- A more precise definition of hemp. The bill eliminated the word “industrial” in the description. Instead, they use the term “hemp” to refer to the plant Cannabis sativa L. They also clarify that any product or byproduct with MORE than 0.3 percent THC will still be considered marijuana under federal law.
- For hemp to be legally grown, each state must develop a U.S. Department of Agriculture (USDA) plan to monitor and regulate production (including tracking all locations), establish procedures for testing THC concentration, regulations for disposing of plants and products that violate the law and take appropriate actions against violators.
- The removal of hemp and marijuana (replaced by Tetrahydrocannabinols) from the list in section 102(16) of the Controlled Substances Act, 21 U.S.C. § 802(16).
That said, this bill did not modify the Controlled Substances Act related to hemp or hemp products. CBD has become a gray area in federal and state laws.
Misconceptions About Cannabis
There are many misconceptions among consumers about CBD. Many individuals have difficulty distinguishing between the terms “hemp.” “marijuana,” and “cannabis.” Some even use these terms interchangeably.
However, cannabis is a family of plants, in which hemp and marijuana are two of the species listed under this family.When you compare these two types of plants side-by-side, they are similar in appearance but very different in their chemical make-up. Hemp and marijuana differ in their levels (concentration) of tetrahydrocannabinol (THC), which is the psychoactive component of the plant. While the Cannabis sativa L. hemp plant contains neglible trace amounts of THC, if any at all.
The confusion happens many times when the botanical names of plants as used, such as Cannabis sativa L. People see or hear the word “cannabis” and automatically associate this word with marijuana. Unfortunately, this is entirely wrong! This is the botanical name for the legal form of hemp that contains little (less than 0.3%) or no TCH and is used in the industry to produce CBD.
Safety Concerns Related to CBD
Most of the safety concerns related to the use of CBD revolve around the lack of published scientific data. Just like other FDA-cleared substances, the consumer needs to know that the product is safe for use, as well as the potential for side effects and drug interactions.
This is particularly true when it comes to children. In 2018, the first CBD-based drug (Epidiolex) was approved by the FDA for the management of two rare forms of epilepsy, but the use of CBD to treat other childhood conditions remains controversial among many health professionals.
This is why the FDA is investigating the need for regulating products containing cannabis or cannabis-derived compounds, and looking to others for information.
The common theme of the public hearing was that there is indeed data from research about the use of CBD, but not enough time was allotted per speaker to delve into the details. As of now, the FDA still claims that they have not received enough data from empirical studies to categorize CBD as an active ingredient.
The FDA panel did, however, asked some individuals specific questions about the production and use of CBD and encouraged other presenters to submit additional data through the portal by July 2, 2019.
The FDA is still in the process of determining how it will choose to regulate this industry. Although they have cautioned that marketing hemp-derived products as dietary supplements or as an active ingredient is unlawful under current federal regulations. This decision is because CBD and THC are active ingredients in FDA-approved drugs, and these drugs underwent mandated clinical investigations before they could be marketed as foods or dietary supplements.
What we do know is that it is likely to be an arduous review process ahead.