The U.S. Food and Drug Administration (FDA) released a statement last week describing recent efforts in the agency's evaluation of cannabidiol (CBD). The statement is of particular interest to stakeholders in the cannabis industry, as Dr. Stephen Hahn has issued only a few public statements regarding cannabis since being sworn in as the FDA Commissioner on December 17, 2019. Soon after assuming that role, the FDA and the U.S. Drug Enforcement Administration (DEA) issued a press release regarding the seizure of 44 websites advertising the sale of illicit vaping cartridges containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. Last week's statement, as well as the commissioner's remarks at the National Association of State Departments of Agriculture's Winter Policy Conference last month, were generally welcomed by cannabis stakeholders. Besides echoing the theme from the December 2019 press release concerning enforcement against violative products that raise public health concerns, the statement emphasized the importance of gathering the science needed to inform FDA's regulatory approach and educating the public about CBD products.

Closing Knowledge Gaps

Last week's statement highlights several knowledge gaps that drive the FDA's solicitation of scientific data. The FDA states, "…we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use."

To help close these knowledge gaps, the FDA is actively seeking high-quality data on the science, benefits, safety, and quality of CBD products. Among other topics, this includes data on:

• The sedative effects of CBD
• The impacts of long-term sustained or cumulative exposure to CBD
• Transdermal penetration and pharmacokinetics of CBD
• The effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile
• The safety of CBD for use in pets and food-producing animals
• The processes by which "full spectrum" and "broad spectrum" hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

The FDA intends to reopen a public docket to facilitate submission of such information from industry, academic researchers, and other stakeholders. Depending on commenter preference, information submitted to the FDA can be marked as confidential or not. Notably, non-confidential information posted to the docket has the potential to serve as a trove of available data on cannabis and CBD that can benefit stakeholders engaging the agency.

In addition to information collection, the agency intends to generate data on CBD. Specifically, the FDA has initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration. The FDA's plan to dedicate resources to data collection and development appears to signal a commitment to a regulatory approach tailored to CBDs.

Public Education

The information gathering campaign appears simultaneous with the effort to share the information through public education. The education will focus not only on consumers, but also healthcare professionals on whom the FDA intends to rely, in part, for the safe use of CBD. To help guide these conversations, the FDA recently launched a webpage concerning CBD that discusses:

• Potential harm, side effects, and knowns
• Unanswered questions about the science safety, and quality
• Unproven medical claims, unsafe manufacturing practices
• Evaluation of the regulatory frameworks

Beyond outreach to consumers and healthcare providers, the FDA also announced its intent to engage with Congress, industry, researchers, and regulatory partners at the federal, state, local, territorial, tribal, and international levels. The FDA's educational webpages are expected to be revised or overhauled as more information is obtained from these sources.

On example of outreach to industry is the FDA's webpage geared toward cannabis research and the drug approval process, which the agency notes was launched in response to the increased interest in drug development from CBD. The inclusion of CBD in consumer products is also becoming more prevalent. The FDA acknowledged that CBD is 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, as well as products marketed for pets and other animals. One way in which the FDA is adapting to consumer products, particularly cosmetics, is through the research initiated in partnership with the University of Mississippi discussed above. As the CBD demand and market grow, the FDA's research initiatives and regulatory approach are expected to evolve.

In general, the agency appears to be receptive to the responsible development and use of CBD products. The FDA prides itself on being a science-based regulatory agency and this approach is consistent with that principle as it promotes data-driven decisions. A critical step remains, however, which is obtaining the high-quality data on which to base those decisions.

It is important to note that when the FDA solicits input from partners and stakeholders, it can often serve as an opportunity to influence the agency's thinking on regulatory policy with outcomes that affect how products come to, and remain on, the market. Readers are encouraged to consider roles they can play and networks that can be leveraged to help shape the FDA's policy on CBD regulation.