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FDA Reopens Public Docket Seeking Data on the Safety and Potential Benefits of CBD

On March 5, 2020, the U.S. Food and Drug Administration (FDA) announced an expansion of its effort to comprehensively evaluate cannabidiol (CBD) products, including an opportunity for stakeholders and other members of the public to continue submitting “high-quality data” for FDA review on the safety and potential benefits of CBD.  FDA’s update – issued by FDA Commissioner Stephen M. Hahn M.D. – also describes several new steps FDA is taking in related areas of education, research and enforcement. 

In May 2019, FDA held a full-day public hearing to obtain scientific information about issues associated with food and other products that contain cannabis and cannabis-derived compounds, such as CBD.  Simultaneously, FDA opened a public docket to accept comments on the issue, which closed on July 16, 2019.  FDA’s most recent update announces that FDA continues to seek high quality data on the safety and potential benefits of CBD, and thus FDA will reopen the public docket in the coming days – and keep it open indefinitely – as a conduit to accept data. 

FDA restated in its update that only one prescription drug containing CBD has been approved by FDA to date.  No other CBD products have been evaluated or approved by FDA, and thus FDA encourages members of the public to consult with their health care providers before using CBD products.  Moreover, FDA emphasized that it continues to enforce against unlawful CBD products that pose a risk to public health.  

FDA Seeks Data to Close the Knowledge Gaps in Both CBD’s Safety and Potential Benefits

The Agriculture Improvement Act of 2018 (known commonly as the “2018 Farm Bill”), legalized industrial hemp, resulting in increased interest in drug development from CBD and other compounds found in cannabis.  To benefit from this increase in data development, FDA is re-opening its public docket. 

FDA’s notice identifies several categories of data in which FDA is interested, including: 

  • 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; and

  • the processes by which “full” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

Significantly, FDA also included in the docket a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential.  FDA noted that it is taking this approach to enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with FDA – including information about specific products, which could help inform FDA’s next regulatory steps.

In addition to seeking data from stakeholders, FDA is working to generate data. For example, FDA’s Office of the Chief Scientist recently awarded a grant to FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. In addition, 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. 

Only One CBD Product Has Been Approved by FDA

FDA expressed concerns in the update that there are myriad CBD products on the market, which the public may wrongly perceive as having been evaluated and determined safe by FDA.  FDA strongly reiterated that except for one prescription drug that FDA approved to treat two rare, severe pediatric epilepsy disorders, no CBD products have been evaluated or approved by FDA.  Therefore, one of FDA’s priorities is educating the public and health care professionals regarding the number of questions that remain regarding CBD’s safety. 

FDA recently updated the public on its concerns about potential harm from CBD products, which include potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. 

FDA is Monitoring the Marketplace for Unlawful CBD Products

FDA indicated that it is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.

Simultaneously, FDA warned that it continues to monitor the marketplace and will take appropriate action against unlawful CBD products that pose a risk of harm to the public.  In particular, FDA notes that it will continue to enforce against 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, which have not gone through FDA’s drug approval process and thus pose a risk to the public. 

FDA has serious concerns about products that put the public at risk in other ways, such as products that contain contaminants such as “heavy metals, THC or other potentially harmful substances.”  Moreover, FDA expressed 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.”

FDA plans to continue to update its online resources on CBD as new information becomes available. 

Update: Following publication of this news alert, on March 11, 2020, FDA published in the Federal Register a notice that it has reopened the public docket for high-quality data on the safety and potential benefits of CBD.  The docket is available here.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 72
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About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Mackenzie S. Schoonmaker Environmental Litigation Attorney Beveridge & Diamond New York, NY
Principal

Mackenzie’s practice includes both litigation and regulatory matters arising under FIFRA, the Clean Water Act, and related environmental laws.

She is passionate about conserving air, water, wildlife, and land for future generations, and enjoys helping clients navigate and enforce the detailed framework of environmental law because she believes compliance is key to preventing adverse impacts to the environment.

Mackenzie is a co-chair of Beveridge & Diamond’s Industrial Hemp & Cannabis industry team. She advises clients, and regularly writes and presents, on federal and state environmental regulations impacting this thriving industry. 

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Mackenzie represents pesticide companies in data compensation arbitrations, focusing on defending the rights of data owners against follow-on registrants of pesticides. She has also worked extensively with task forces comprised of national and multinational companies of all sizes that operate as joint ventures or limited liability companies to generate data and other information to meet government requirements under FIFRA.

Among the wide range of issues under the Clean Water Act that Mackenzie has handled are assisting companies with responses to Clean Water Act Section 308 information requests and Clean Water Act Section 404 compensatory mitigation requirements.

Mackenzie also defends public utilities against toxic tort claims. She was part of the team that obtained a defense judgment after a three-week trial regarding claims alleging that the client supplied corrosive water to apartment buildings. The case, Cormier v. D.C. WASA, 2011 D.C. Super. Lexis 7, 84 A.3d 492 (2013), was successfully upheld on appeal.

212-702-5415
Christopher D. Strunk Environmental Litigation Attorney Beveridge & Diamond San Francisco, CA
Of Counsel

Christopher D. Strunk has more than 20 years of experience litigating complex environmental and toxic tort disputes.  

He focuses on the defense of large, multi-party environmental matters, including mass tort and products liability litigation involving alleged toxic injury arising from asbestos, lead, mold, solvents, and other contaminants. He has represented microchip and technology companies, chemical and petrochemical companies, heavy equipment manufacturers, and the pesticide and fertilizer industry. Over the past five years, he has also developed a significant industrial hemp...

415-262-4016
Kathryn E. Szmuszkovicz Litigation Attorney Beveridge & Diamond Washington, DC
Managing Principal

Kathryn E. Szmuszkovicz litigates and provides strategic regulatory counsel.

Kathy litigates on behalf of individual companies, groups of companies and trade associations in federal and state courts across the country. She also provides alternative dispute resolution (ADR), compliance, strategic planning, and commercial services focused on the regulatory aspects of her clients’ businesses. Kathy’s practice focuses on clients who manufacture, sell, and use products regulated by EPA, USDA, FDA, DOI, DOC, and analogous state agencies under the environmental, health, and safety laws...

202-789-6037
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