FDA updates Congress on CBD regulation efforts, industry requests imminent action

06 Mar 2020 --- The US Food and Drug Administration (FDA) has released an update on its cannabidiol (CBD) regulation efforts which are focused on key areas such as consumer education, gathering scientific evidence and addressing products that violate current regulation. Amid a complicated regulatory environment on CBD, the update was instigated by request of the US Congress, after FDA’s US$5 million dollar budget plea. FDA says it is also taking steps to provide a transparent way for stakeholders to communicate new information on CBD as it becomes available. Despite FDA’s efforts however the new report offers little clarity and no imminent change in CBD’s legal status and the move elicited responses from industry-oriented organizations.

In response to the update the Natural Products Association (NPA) asked for a limit to be set on daily CBD consumption. “This is more of the same from FDA: All words and no action. The longer FDA waits to regulate the CBD industry the greater chance we have of risking another public health crisis. Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers,” comments Dr. Daniel Fabricant, President and CEO of NPA.

The Council for Responsible Nutrition (CRN) also called for imminent action on CBD regulation and deemed the update “disheartening.” CRN’s CEO and President, Steve Mister notes that the time for consideration and evaluation has passed and action was needed more than a year ago. “Today’s report amounts to bureaucratic can-kicking and Congress should recognize it as such and take action now to declare CBD a lawful dietary supplement,” he underscores.

Congress requested that FDA provides a comprehensive update on its efforts in regulating the CBD industry, after President Trump signed the 2020 spending bill back in December 2019. The federal agency was supposed to provide the update within 60 days, but missed the deadline by two weeks. Moreover, last month, the US President requested US$5 million from the FY2021 budget to regulate the CBD industry to allow the FDA to continue enforcing protection laws safeguarding patients and consumers. The money would also provide potential regulatory pathways for products containing cannabis and cannabis-derived compounds. 

The Council for Responsible Nutrition (CRN) also called for imminent action on CBD regulation and deemed the update “disheartening.”“We are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect public health and working to provide market clarity,” the FDA update states.

However, the FDA says that, over the past year, it embarked on a comprehensive evaluation of CBD products.The agency has focused on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits. In addition, it has steps when necessary to address products that violate the law in ways that raise a variety of public health concerns. 

Concerns on CBD safety
The FDA says it is seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams. But as the agency has stated before, it is concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and have been determined as safe, or that using CBD causes no health issues. 

Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA. (LINK)

“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 healthcare provider,” FDA notes.

FDA will work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality.“We will continue to expand our educational efforts on this front. This broadly includes consumers as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry,while sustaining multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives,” FDA adds.

Closing knowledge gaps
The marketplace for CBD-containing products is quickly evolving and it is critical that FDA works together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, the update says.

“Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging industry and researchers to share new data with the agency,” FDA notes.

Monitoring the marketplace
The agency will also continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.

“We have seen many CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life,” FDA further highlights.

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

“We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards,” the report concludes.

By Kristiana Lalou