FDA Clears the Air on CBD Reform Efforts

The U.S. Food and Drug Administration (FDA) began its comprehensive evaluation of cannabidiol (CBD) nearly a year ago, with a focus on educating the public of the risks and unknowns, and to gather scientific evidence to inform the agency's approach to regulation. In a recent update, the FDA outlined these efforts. 

"Today, 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 the public health and working to provide market clarity," the agency reported, in its official statement. Following are select highlights from the full report.

Educating the Public

"We’re seeing CBD being marketed in a number of different products, such as oil drops, ... food products such as chocolate bars and teas, cosmetics and other topical lotions and creams... and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons. ... But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe...

See related: Will CBD Cosmetics Face Greater FDA Scrutiny?

"In addition, there is still much we do not know about other potential risks; . . . [i.e., the] 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 ... We encourage Americans to consult with their health care providers before using CBD products.

"We will continue to expand our educational efforts on this front ... [and] continue to update our online resources for consumers, researchers and industry..."

Closing Knowledge Gaps

"The marketplace for CBD-containing products is quickly evolving and it is critical that we work 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, as well as further evaluate any potential benefits ... 

"To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data. This includes data on, among other things: 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) ... and 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 agency has iinitiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products.

"Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. ... given all the research and activity in this space, we are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available. To this end, in the coming days we are re-opening the public docket we established for our May 2019 public hearing. ...

"We also are working to generate data to help inform our work in this area. For example, ... we’ve 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.

"As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine–and, perhaps in some cases, revise–our thinking and approaches."

Monitoring the Marketplace

"As we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public. ...

See related: Is the Hemp Market Oversaturated?

"We also have serious concerns about products that put the public at risk ... For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk."

Conclusion

"Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. ..."