The FDA held a public hearing on May 31 to solicit oral presentations and comments in order to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived products. Although the public hearing is finished, FDA is soliciting electronic and written comments until July 2.
Though there are more than 80 biologically active chemical compounds related to cannabis, the most commonly known names are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Since 1970, parts of the Cannabis sativa plant have been federally controlled by the Controlled Substances Act under the drug class marijuana, primarily because of the THC content, which has psychoactive effects.
Plus, the legality of cannabis has been changing over time at federal and state levels, and there has been inconsistency in regulations from one governing body to the next. Currently, 33 states and Washington, D.C., allow medical marijuana, and 10 states and Washington, D.C., permit recreational use.
The federal Agriculture Improvement Act of 2018 (aka the 2018 Farm Bill) allows the production and marketing of hemp (Cannabis sativa L) products and derivatives as long as they contain no more than 0.3% of THC on a dry-weight basis. These new regulations include removing these products from the Controlled Substances Act, which means that cannabis plants and derivatives that contain less than 0.3% of THC by weight are no longer controlled substances under federal law.
While the Farm Bill allowed the use of CBD and nonpsychoactive compounds derived from cannabis—whether or not they’re considered hemp products—they still fall under FDA regulations, either as a drug or a nutraceutical ingredient in foods or beverages. FDA is aware of companies improperly marketing products containing cannabis and cannabis-derived compounds. Marketing CBD products that the FDA hasn’t approved for use as a drug violates the FD&C Act.
For example, FDA issued warning letters to companies illegally selling without drug approvals CBD products that were intended to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer. Unapproved drug products are a violation of the law and could put patients at risk.
FDA’s warning letters also cited food products with CBD and CBD products marketed as dietary supplements. These products also violate the FD&C Act, though the FDA approved a drug (Epidiolex) that contains CBD to treat two rare forms of epilepsy.
The public meeting and ongoing request for comments represent a fact-finding mission, not necessarily aimed at creating new regulations. More so, the explorations seek to answer several questions. For example:
- What levels of cannabis and cannabis-derived compounds cause safety concerns?
- How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety of cannabis and cannabis-derived compounds?
- How do cannabis and cannabis-derived compounds interact with other substances or drug ingredients?
- Are there certain groups (e.g., children, adolescents, pregnant women, etc.) that should be considered when assessing the safety of products containing these compounds?
- What are the characteristics of a successful system to collect representative safety information at the national or state level about products containing cannabis/derived compounds?
- Are there systems that currently exist for the collection of this information (other than FDA’s systems)?
- Are there particular safety concerns related to the overlap of therapeutic dose levels of approved drug products, cosmetics, foods and dietary supplements?
- What margin of exposure would represent an appropriate and safe level from anticipated cumulative exposure?
- What data are available about residues of cannabis-derived compounds in human foods? What levels can be tolerated?
- How does the existing commercial availability of food products containing CBD affect the feasibility of drug-development programs involving such compounds?
FDA is also looking for input regarding manufacturing methods and product quality. For example, what steps are being taken to ensure consistency and dosing? What validated analytical testing is needed to support the manufacturing of safe and consistent products?
Other concerns involve the marketing, labeling and sales of cannabis products. What information should be on the labels, and should there be conditions, restrictions or other limitations on the manufacturing and distribution of these products, particularly with respect to food products containing cannabis-derived compounds such as CBD, allowed in some states but not federally?
For more information, see the Federal Register or visit the FDA website and search for FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.
