Update Issued By FDA on CBD Rulemaking Status Makes Its Way to Congress

• The FDA is working to establish rules that would allow CBD to be used in supplements for its therapeutic use.
• So far, the only FDA-approved CBD-based drug has been Epidiolex, used for specific forms of pediatric epilepsy.

Congress has been waiting for quite a while for updates from the Food and Drug Administration (FDA) on the matter of rulemaking for CBD. According to a recent news article with Marijuana Moment, the process is still going on, but the agency stated that they are actively looking for ways to allow CBD to be marketed as a dietary supplement. Enforcement discretion guidance is in the works, and a public docket will soon reopen for more scientific details on the potential risks and benefits of the compound.

The FDA was instructed to create an update on the CBD regulations, following the federal legalization of hemp under the 2018 Farm Bill. While the mandate stated that the FDA had 60 days to provide this update, the report and notice were only recently made public on March 5^th, 2020. Lawmakers were told,

“The FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the FDA intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while the FDA takes potential steps to establish a clear regulatory pathway.”

In the past, the FDA has issued warnings to multiple CBD companies in violation of certain regulations, specifically involving false claims about their product’s so-called therapeutic use. Furthermore, the agency is concerned that these types of claims will continue, leading them to take on additional enforcement actions.

With the update, the FDA acknowledges that they still had limited data on CBD, as “cannabis-derived CBD was a Schedule I controlled substance” before the 2018 Farm Bill. This restrictive classification and its impact on research has been a major point of conversation amongst advocates for legalization. However, the agency wrote,

“As more data on CBD becomes available, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.”

Right now, the medical industry is fully capable of creating drugs that are centered around CBD as the active ingredient, and it is even possible to do so with the approval of the FDA, as demonstrated with Epidiolex. However, the FDA states that CBD is still not considered to be “risk-free,” and there is some documentation to indicate that liver health could be compromised. For that reason, the FDA remains concerned over the potential for products to be mislabeled and for adulterants to be included in unregulated formulas.

As it stands, the FDA commented that they are “actively evaluating what and how much data would be sufficient to support a conclusion that CBD can safely be allowed in dietary supplements under certain conditions.” To ensure that this process moves along swiftly, the FDA is also presently,

“evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rulemaking.”

The FDA is prioritizing the safety and protection of the public, and they plan to continue pursuing action against any brand that chooses to violate the protocols. As the agency mulls over the new regulations, there are multiple questions on their minds:

• How will the body react to daily CBD use for a sustained amount of time?
• How much CBD is needed to trigger the risks associated with it?
• How does the method of use impact the user’s intake?
• How does CBD impact a growing brain (i.e. children)?
• How does CBD impact an unborn child or breastfeeding newborn?
• How does CBD interact with the use of botanicals and other herbs?
• Can CBD cause toxicity in the male reproductive system in the same way that it occurs in animals?
• Are the safety concerns different between animal species, breeds, and classes?
• In animals used for their meat that consume CBD, is any residue left behind.

At the moment, CBD cannot be marketed as a dietary supplement, but the FDA stated that it is well within their scope of authority to establish rules that negate the exclusion. By finding the answers to the questions above, the process should be moved along more quickly, and the FDA plans to leave the docket opened “indefinitely” to continue submitting details that are important to the rulemaking process. The FDA noted,

“We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements.”

Still, there are concerns that would arise with the use of CBD in dietary supplements, like the differences in regulating supplement companies and pharmaceutical companies. Due to this lack of regulation, the FDA would have limited “systematic and comprehensive oversight over all CBD products.”

To ensure that the FDA is able to get more product-specific CBD details, the authority plans to establish a system involving proprietary data to be used for the purpose of sharing details with the FDA about different products to influence the regulatory procedure.

One of the other major concerns is the use of CBD vaping products, considering the risk of toxicity and the implied appeal to teenagers. Without FDA approval, vaping products with CBD are not allowed to even be made available as a drug. In a separate notice, which was provided to the public on Thursday, the FDA noted,

“We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”

The FDA further added that their authority is presently looking at information regarding the differences in broad spectrum and full spectrum products, which will be necessary in establishing regulations. While there’s been some progress in terms of new regulations, there’s still plenty of room for change, since the majority of the update simply describes the efforts without any changes in progress.