The use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, and questions loom large about the health and safety of these products. In my May blog, I wrote about the quiet revolution occurring in the cannabis industry as agricultural opportunities intersect with the drug approval process.
Recently, the FDA held a much-anticipated public hearing, “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.” The May 31 hearing drew an estimated 1,300 interested stakeholders, both in person and remotely, along with roughly 100 speakers.
The FDA has already received more than 3,000 comments from individuals and organizations, ranging from the National Cannabis Industry Association to the American Medical Association to veterans with service-related injuries, and many others. Attendees heard from supporters, who touted the benefits of CBD products, and those who expressed concerns, including the potential for abuse and liver toxicity, as well as the challenges surrounding the ability to conduct scientific research due to the lack of legal availability of the product. The current regulatory environment was described as “The Wild West” with impassioned pleas to develop a regulatory pathway for these products.
To understand the enormity of developing a regulatory framework for CBD products, it helps to understand this complex agricultural commodity. Cannabis is a plant belonging to the Cannabaceae family, which consists of three primary species: cannabis sativa, cannabis indica, and cannabis ruderalis. Cannabis contains more than 80 biologically active chemical compounds, the best-known being delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Since 1970, parts of the cannabis sativa plant have been controlled under the Federal Controlled Substances Act (CSA). However, the passage of 2018 Farm Bill removed industrial hemp — defined as the plant cannabis sativa L. with a THC concentration of less than 0.3 percent — from the CSA. As a result, industrial hemp is no longer classified as a controlled substance under Federal law.
The 2018 Farm Bill, however, unequivocally preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds. If any one of these compounds, or the plant itself, is marketed as a drug or is added to a food, cosmetic, or any FDA-regulated product in interstate commerce, it falls within the FDA’s jurisdiction. The FDA will issue — and has issued — warning letters to companies that illegally sell CBD products that claim to prevent, diagnose, mitigate, treat, or cure serious diseases.
Currently, there is a tangled web of confusion surrounding CBD products because the product category dictates the regulatory pathway. For example, for a CBD product to be marketed as a drug to treat a disease or have a beneficial effect on the body, the safety risks and therapeutic benefits of a specific formulation, dosage form, and strength for a particular population need to be evaluated by conducting clinical trials.
Cosmetics are subject to a set of regulations that enable the FDA to take action if a cosmetic has been adulterated or misbranded.
Food, including dietary supplements, have their own set of regulations, but with the same overarching goal of protecting consumers. A new food additive, for example, needs to be approved as safe by the FDA before being put in the food supply, unless it is generally recognized as safe, or GRAS.
Nutraceuticals are monitored as “dietary supplements.” Regulations, however, may need to evolve since nutraceuticals are products containing a food component that claims to have health benefits, including treating and preventing disease.
It is abundantly clear there is an urgent need to develop robust regulatory pathways for the many different CBD products flooding the market today. To help address the minefield of questions surrounding the safety of these products, the FDA formed an internal working group following the May 31 hearing. Some of the questions currently being looked at include:
- How much CBD is safe to consume in a day?
- What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes CBD oil?
- How will CBD interact with other drugs a person might be taking?
- Is CBD safe for pregnant women?
- What if children access CBD products, like gummy edibles?
- What happens when someone uses CBD for prolonged periods?
The FDA intends to keep the public updated on the regulatory pathways being developed. In the meantime, the public is encouraged to submit comments to the FDA by July 16, 2019: httpss://www.regulations.gov/docket?D=FDA-2019-N-1482.
Stay tuned as this issue continues to progress and evolve.