Call for Comments: FDA Wants Your Opinion on CBD

Do you have anything to say about CBD that you want the FDA to hear?

The Food and Drug Administration is asking everyone to submit their comments about CBD as the agency prepares to issue legal marketing regulations. The comment period is not the first time that the FDA asked for feedback regarding CBD. It was initially open from April to July of 2019 and aimed to help address uncertainties related to the safety of CBD. Since its reopening on March 11th of 2020, the FDA has received over 4,450 comments about CBD. Expect that number to grow as the comment period will be open indefinitely.

So, why is the FDA gathering more data?

There is a lot of pressure coming from lawmakers to speed up the process of implementing regulations on CBD. In the United States, as much as 70% of CBD products are not what they claim to be. Misleading and outright lies on product labels are abundant in the market. With such a high demand for CBD because of the numerous potential therapeutic benefits, along with the lack of FDA regulations, companies are putting out CBD products left and right. It is difficult to determine if a product stays true to its claims.

 It is up to companies, just like, to serve as CBD product watchdogs. We use third-party blind laboratory testing and data algorithms to test and analyze products. Our Advisory Board of cannabis scientists and doctors determines what is safe and effective versus all the marketing fluff and snake oil.

The FDA is optimistic that the results of the comments collection will help address gaps, especially the ones related to nonclinical data. Stakeholders are encouraged to submit comments, data, and information about CBD. The FDA wants your comments fast and in real-time. They reopened the public docket to provide a public and transparent way for stakeholders to provide new and emerging information.”

As mentioned, the FDA wants your comments fast. To expedite the collection of high-priority data with regards to CBD safety, they identified areas that needed the most help. There are data gaps in specific clinical studies and the development of systematic surveillance, and the FDA is working to address these. With limited funds for research, the agency will only be able to address these data gaps through collaboration with stakeholders.

Clinical Studies* - Some clinical studies will require the submission of an Investigational New Drug Application (IND)

  1. Safety and Tolerability Study
    • Include diverse populations, including potentially vulnerable populations, but not specifically powered to look at any subgroup
    • Acute and long-term outcomes related to:
      • Male reproductive toxicity (e.g., semen analysis, laboratory markers, such as testosterone, FSH, LH)
      • Liver toxicity (e.g., laboratory markers)
  1. Driving Impairment Study
  2. Alcohol Interaction Study
  3. Dermal Penetration Study”

*See Information on CBD Data Collection and Submission

The FDA sees an opportunity to create safety systematic surveillance measures that will capture data related to CBD, especially data that are not feasible to generate using traditional clinical trials or studies. Other studies may also be useful on findings, dependent on the design to meet specific goals.

“While FDA recognizes that there are many study designs that can be appropriate, ranging from randomized controlled trials conducted in a clinical trial setting to observational studies leveraging real world data, it is important that studies and/or trials be designed in a way that produce data that can inform regulatory decision making. This includes careful consideration of not only study design, but also study endpoints and any statistical considerations. FDA welcomes the opportunity to review and provide feedback on protocols for studies intended to address any of the data gaps identified above.”

There is a lot of data to collect on CBD alone. Other cannabinoids, terpenes, and other cannabis-derived compounds and extracts need data as well. With formulations and claims from different CBD companies, the FDA issued guidance documents applicable to each specific cannabis-derived ingredient. From the data collection, the agency can form the basis for ensuring CBD products are safe. These will be useful to understand the safety of other cannabis-derived compounds apart from CBD.

CBD as Dietary Supplements?

The reopening of the comments docket will hopefully provide the data needed by the FDA to regulate CBD sales as dietary supplements. There is a lot of confusion with regards to consumer products containing cannabis or cannabis-derived compounds in food, cosmetics, and drugs, including dietary supplements. Marketed in different forms, CBD comes in oils, creams, pills, and the list goes on.  Companies are churning out products, casually riding the CBD boom.

With this lack of regulation, and products sold mostly online, legality and safety are questionable. While the collection of comments may hint that regulations are forthcoming, the FDA reminds companies that they will not tolerate the illegal sales of CBD as dietary supplements at the moment. Whether CBD is hemp-derived or not, it can not be an ingredient in dietary supplements. CBD companies are also not allowed to say that their products can prevent, diagnose, treat, or cure disease (claims that can legally be made only by FDA-approved drugs).

The efforts of the FDA related to CBD are in line with their mission, and that is to protect the public, foster innovation, and promote consumer confidence. There is a lot of interest in CBD at the moment for the myriad of therapeutic benefits. Hopefully, by working with stakeholders and getting valuable data, the agency will be able to create regulation that can uphold rigorous public health standards.