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In a statement last week on CBD regulation, FDA emphasized the need for clinical research, with no new details on a possible regulatory pathway for CBD food and dietary supplements.
FDA issued a statement on June 14 from Amy Abernethy, MD, PhD, the agency’s principal deputy commissioner, and Lowell Schiller, JD, FDA’s principal associate commissioner for policy, on the agency’s approach to cannabidiol (CBD) following a public hearing on CBD that the agency held on May 31. The hearing brought more than 100 stakeholders to Washington, DC, to testify on the subject of cannabis and cannabis-derived compounds like CBD to help FDA make informed policy decisions.
The takeaway from representatives of the dietary supplement industry at that meeting was that, given the volume of CBD products already on the market, there needs to be a regulatory pathway for CBD now, not later. The concern among members of the industry is that while there are responsible CBD manufacturers, FDA’s inaction on CBD has left the category’s growing consumer base vulnerable to many unscrupulous manufacturers selling questionable products who are taking advantage of the high demand for CBD products.
FDA’s June 14 statement does not provide any official details about what the agency intends to do, but acknowledges the concerns expressed at the meeting and outlines the agency’s own concerns. For example, FDA still holds that CBD is prohibited from being used in food or marketed as a dietary supplement because it was subject to clinical investigations for its potential medical uses and subsequently approved by FDA as a drug as the active ingredient in the prescription drug Epidiolex for the treatment of epilepsy. However, the agency does acknowledge that it has the power to create an exception allowing the legal status of CBD in foods and dietary supplements through regulation, something the dietary supplement industry is lobbying for.
Here, the statement reads: “The statutory provisions that currently prohibit marketing CBD in these forms also allow the FDA to issue a regulation creating an exception, and some stakeholders have asked that the FDA consider issuing such a regulation to allow for the marketing of CBD in conventional foods or as a dietary supplement, or both. This raises important and challenging questions of regulatory policy and public health.”
These concerns, the statement explains, include the safety risks found during clinical investigation of Epidiolex, such as the potential for liver injury. FDA is also concerned about the number of unsubstantiated claims being made about CBD’s therapeutic benefits because these claims could lead consumers to first turn to CBD products in food and dietary supplements instead of getting important medical care. Finally, the agency pointed out that legalizing CBD in food and supplements could reduce commercial incentives to study CBD for further potential drug uses.
On the other hand, FDA concedes that the 2018 Farm Bill’s removal of hemp from the definition of marijuana in the Controlled Substances Act may streamline the process for researchers to study hemp and cannabis derivatives such as CBD. In fact, a major concern expressed by researchers at FDA’s public hearing on May 31 was that the bureaucracy surrounding cannabis has made CBD more difficult to study, resulting in a lack of reliable research and knowledge.
For FDA, some of the major unanswered questions regard safety of CBD consumption outside of an approved drug context. The agency wants to know how much CBD is safe to consume on a daily basis; whether there are drug interactions that need to be monitored; the impacts of consumption by children, elderly, and pregnant women; as well as the risks of long-term exposure. These are valid concerns, but just how and when these questions will be answered is unknown. FDA says in its statement that it must take a scientific approach to CBD policy, and that means collecting available data to determine where there are knowledge gaps so that additional research can be conducted. Unfortunately, the agency does not provide any kind of timeline for discovery, instead pointing to a potentially protracted process.
FDA’s language in the statement also points to the lack of a nuanced understanding of cannabis-derived products, and a preference for drug development.
“While the Agency continues to believe that the drug approval process is the best way to ensure the safety of new drugs, including those made with CBD, the Agency is committed to evaluating the regulatory frameworks for non-drug uses, including products marketed as foods and dietary supplements,” states FDA. “We remain steadfast in our effort to obtain research, data, and other safety and public health input to inform our approach and to address consumer access in a way that protects public health, maintains incentives for cannabis drug development, and creates a robust administrative record needed to support the initiation of any rulemaking.”
Until FDA indicates otherwise, it appears for now that, in the eyes of the FDA, the pharmaceutical industry has the only legitimate claim to CBD because Investigational New Drug applications were submitted for the ingredient prior to any New Dietary Ingredient Notifications (NDIN) for dietary supplements, and now the ingredient is an FDA-approved drug. Also, while FDA does acknowledge the need for consistent terminology related to CBD-containing products, nowhere in this statement does FDA differentiate between hemp-derived products such as tinctures that contain naturally occurring CBD, and CBD isolate products.
Ultimately, the overwhelming amount of feedback FDA received at the public hearing, and that the agency will likely receive in public comments, has left the agency with more questions than answers, and it has a lot of catching up to do while it wades through the available research. In the meantime, many CBD manufacturers are not waiting on FDA to make a decision. CBD products will likely continue to proliferate as FDA, given its limited resources, continues to inch towards cementing its stance on CBD.