The Food and Drug Administration (FDA) is tasked with protecting consumers from harmful foods, drugs, vaccines, cosmetics, medical devices, and more. On May 31, 2019, the agency held a public hearing on cannabidiol (CBD), the non-intoxicating chemical compound found in cannabis and hemp. Consumers, health professionals, scientists, manufacturers, and more industry insiders called for regulation on CBD in food and dietary supplements.
Opening Remarks
Acting FDA Commissioner Ned Sharpless gave the opening remarks expressing hesitation about CBD’s effectiveness and safety. The lack of research into CBD has prevented the FDA from developing a regulatory framework based on facts. During the remarks, Sharpless said that “when FDA approves a drug, [they] carefully examine the risks and benefits of a specific formulation, dosage form, and strength for a particular population.”
Food and Drug Safety
Currently, the FDA does not allow CBD to be included in food products or marketed as a dietary supplement. In June 2018, however, the agency approved Epidiolex, a treatment for severe forms of epilepsy Lennox-Gastaut syndrome and Dravet syndrome. During the trials, researchers found that liver damage was one of the serious side effects of the drug. Coupled with unsubstantiated health claims from CBD brands, the safety of CBD was under heavy scrutiny during the hearing.
Proponents for CBD cited a World Health Organization report on CBD and its lack of dependence issues. Some of the most pressing questions about CBD food and dietary supplements included the following:
- What should be a safe daily dose? Should this depend on product type?
- Are there any CBD and drug interactions?
- How does CBD affect children, seniors, or pregnant women?
- Are there any long-term effects of CBD consumption?
Cannabis Research
Researchers and health practitioners who spoke at the public hearing presented research on the minimal side effects of CBD. Most of them expressed concerns with the obstacles related to current cannabis-related research. Cannabis’ Schedule I designation makes it difficult for the DEA to issue cannabis research permits. In addition, researchers brought up the low-quality of cannabis they receive from the only source in the country, the University of Mississippi.
Public Docket
The FDA is also seeking public statements on their experience with CBD and how it has affected them. CBD users are encouraged to submit a comment to the public docket by July 16, 2019. The original cut-off date for public comments was June 20, 2019, but the comment period was extended.
In particular, the FDA is looking for anecdotal evidence about threshold levels for CBD-containing foods and insight into other key topics like marketing, manufacturing, labeling, and more. The information will be used to determine what areas of research are needed to address the effectiveness of CBD.
Congress Pushes for More CBD Research
The U.S. House recently approved a budget allocating $100,000 for the FDA to set a “safe level for conventional foods and dietary supplements.” Democratic Rep. Jerry McNerney of California filed the amendment to set up a framework that could protect consumers from the wide array of CBD products that currently exist. Once the House approves the entire bill, the bill would have to go through the Senate.
For now, hemp-derived-CBD tinctures, cartridges, topicals, edibles, and other products are not approved by the FDA. CBD brands have to be very careful not to make unsubstantiated health claims. Customers must still perform their due diligence when researching CBD safety and dosage and consult with a physician before considering starting a CBD regimen.
