On March 5, 2020, the Food and Drug Administration (FDA) submitted an updated report to Congress communicating their progress and efforts to clarify the regulations and the proposed enforcement actions for Cannabidiol (CBD) based products.
The report, which can be downloaded here, outlines the actions that FDA has been working on to advance their efforts to develop a regulatory pathway for FDA oversight of Cannabis and its components including CBD.
Overview of FDA Report
The report includes the enforcement activities that the agency has implemented and those that are in the process of being implemented over the next 12 months. The report communicates the FDA’s concerns about the safety risks of currently marketed CBD products under their jurisdiction. Among the many problems that FDA has identified includes the mislabeling of contents and potential adulteration of products which contain delta-9-tetrahydrocannabinol (THC), pesticides, and heavy metals. Obviously, CBD products containing higher than permissible levels of THC can results in unexpected psychoactive effects that the consumer may not have been expecting. Furthermore, CBD products that are adulterated or contaminated with either pesticides or heavy metals can result in serious injuries.
Unexpected Consumer Risks and Consequences
Although THC may not be harmful when its willingly and knowingly consumed, it can result in potential negative consequence when its consumption is unanticipated. For example, the unexpected consumption of THC after ingesting a product that a consumer may have thought only contained CBD, could lead to unanticipated consequences such as being cited for driving while under the influence of a controlled substance. The legal ramifications would be very serious for any consumer caught in this situation. Other FDA concerns include products which are contaminated or adulterated with pesticide or heavy metals, which both can lead to very serious adverse reactions, poisoning and/or serious long-term health problems. The FDA has raised these concerns as being very serious and justified. This safety threat has only increased the urgency and need for the FDA to establish and implement federal regulations and controls over the manufacturing, distribution, and marketing of CBD products. Therefore, the FDA is making this as a very high priority over the next 12 to 18 months.
The FDA’s Enforcement Focus
The report identified the following key areas that the FDA would focus on with its enforcement efforts
Safety - Currently available clinical data demonstrate that CBD is associated with some potential risks and the potential for drug interactions. FDA is working to better understand the safety profile of CBD, especially for sustained and/or cumulative exposure, co-administration with other medicines, and for vulnerable populations like children, pregnant and lactating women, the elderly, and unborn children.
Human and Animal Drugs - For human and animal drugs, there are clear regulatory pathways available for CBD drug development and the review of new drug applications (NDAs), or new animal drug applications (NADAs). In 2018, FDA approved the NDA for a CBD drug, Epidiolex, for the treatment of two rare and life-threatening seizure disorders in children. FDA encourages and supports continued research to explore the therapeutic potential of CBD, as well as all other compounds in cannabis, and will continue to make available regulatory mechanisms to expedite cannabis and CBD drug development as appropriate.
Dietary Supplements – The FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements. Under current law, CBD products cannot lawfully be marketed as dietary supplements, but the FDA has the authority to create an exemption through notice-and-comment rulemaking procedures that would allow products containing CBD to be sold legally as dietary supplements. A new congressional bill H.R.5587, which was introduced in January 2020, calls for an amendment to the Federal Food, Drug and Cosmetic Act to classify CBD as a Dietary Supplement. The Agency is actively evaluating what data, and how much data, under certain conditions would be required to support a conclusion that CBD can safely be permitted within dietary supplements. To further advance and expedite the FDA’s progress, the agency is taking steps which include evaluating the issuance of risk-based enforcement practices that would provide greater transparency and clarity regarding FDA’s enforcement priorities, while the FDA continues to advance the processes of rulemaking.
Human and Animal Food - There are already established pathways for introducing new substances into the human or animal food supply, which also apply to hemp-derived substances in the same way as they do to any other substances. Under one such pathway, certain hemp seed-derived products such as dehulled hemp seeds, hemp seed protein, and hemp seed oil, which contain very minimal amounts of CBD, currently can be lawfully marketed in human food without the need for any further FDA approval. This is permissible provided that such products do not make any drug claims or any claims that may be false or misleading and that they comply with all other applicable requirements. Because the same ingredient can present different risks to humans and animals, these ingredients would need to be separately evaluated before they could be introduced into an animal food or feed. It is not currently lawful to add CBD to human or animal foods, and the data currently available to FDA raises some safety concerns about the use of CBD in foods.
Cosmetics - Cosmetic ingredients do not generally require premarket approval, with the exception that most color additives do require premarket approval. Those firms marketing a cosmetic product are responsible for ensuring the safety of the product. The FDA is aware of only limited data available on CBD when used topically. No ingredients, including CBD can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.
The FDA’s enforcement activities will cover the full range of CBD based consumer focused products as defined above. The FDA will continue its aggressive efforts working towards developing more clearly defined regulatory requirements for the lawful marketing and distribution of CBD products. They will be collecting more data on the safety and applicable uses of CBD derived products. They intend to issue more policy guidance regarding their risk-based enforcement practices over the coming months. This is an effort to provide greater transparency and clarity to the industry. Their policy enforcement objectives are intended to protect the public health and welfare, while providing clarity to industry regarding their enforcement priorities based on the known risks of CBD products. The FDA will be more strictly enforcing regulatory actions against any violations that they identify as putting the public at risk. Firms who operate within the cannabis and CBD industry should be proactive in understanding and aligning their operational practices with the FDA’s evolving regulatory oversight.
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About the Author
Chris Merriam-Leith is a Program Manager with USDM who has 20 years’ experience working with regulated life sciences companies. He holds a M.S. degree in Regulatory Affairs of Drugs, Biologics and Medical Devices from Northeastern University. He is also Regulatory Affairs Certified (RAC) for the U.S. and Globally. He is completing a second M.S. degree in the Quality Assurance of Biopharmaceuticals. He is available to consult with your company to help you navigate the complex regulatory challenges that your firm may be navigating.
 Reference: Report to the U.S. House Committee on Appropriations and the U.S. Senate Committee on Appropriations, Cannabidiol (CBD). Report in Response to Further Consolidated Appropriations Act, 2020. U.S. Food and Drug Administration.