The U.S. Food and Drug Administration (FDA) treats products containing CBD or cannabis-derived compounds as it does any other FDA-regulated products — meaning they are subject to the same authorities and requirements as any other substance.
This guidance was issued near the end of January 2023, whereby the FDA said it is unable to regulate CBD products under its current structure because the hemp- or marijuana-derived ingredients have not been shown to be safe enough for food or supplements.
Instead, the FDA called on Congress to create new rules for the massive and growing market for CBD, which has become increasingly popular in lotions, tinctures, and foods and is projected to reach sales of $22 billion by 2030.
However, the FDA already has oversight over CBD because it is the active ingredient in an approved prescription drug, Epidiolex, which is used to treat two rare seizure disorders. Under current FDA regulations, a drug cannot be added to food or sold as a dietary supplement if officials have not determined if it is safe or effective for other conditions.
What are the Next Steps for the FDA to Regulate CBD?
The FDA has indicated that it wants to create a regulatory pathway for certain CBD products to be legally marketed to balance consumer access and regulatory oversight.
After denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements, the agency is apparently prepared to work with Congress on the matter to establish new rules.
Essentially, a new regulatory path for CBD would mandate specific safeguards and oversight specifically targeted to CBD products. The FDA has indicated that these safeguards could include items, like clear labels, prevention of contaminants, CBD content limits, and a minimum purchase age.While some lawmakers consider the FDA’s partnering with Congress to develop a regulatory solution a step forward, it has largely disappointed the businesses and stakeholders within the industry who have been waiting for FDA regulations on CBD for over four years.
As more information becomes available, or the next steps are taken by lawmakers, we will continue to update this post.
If you have questions about your existing CBD business operations, or obtaining a CBD license in California, contact one of our California cannabis law firm specialists today by phone at (310) 912-2960 or online to learn more about how we can help.