Next month, the U.S. Food and Drug Administration will be conducting a public hearing focused on the wellness industry's favorite additive: CBD. Health department officials have been cracking down on the use of cannabidiol, a non-intoxicating compound found in cannabis plants that's commonly known as CBD, in products like baked goods and lattes in cities and states from New York to Ohio, citing concerns around the safety of these items. Now, the FDA has unveiled the public hearing as a step towards developing official regulations for the usage of CBD in consumer products like food and drinks.
The hearing, which will be held on May 31, will allow the public to “share their experiences and challenges with these products, including information and views related to product safety,” according to the statement from FDA Commissioner Dr. Scott Gottlieb, released on April 2. The ultimate goal is to create “lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed.”
The agency’s other plans include creating a working group dedicated to finding “potential pathways” that CBD-infused dietary supplements, food, and beverages can be legally marketed, as well as what statutory or regulatory changes regarding CBD may be necessary moving forward. The FDA will also be updating its FAQ on the topic and issuing warning letters to businesses currently marketing CBD products with “egregious and unfounded claims that are aimed at vulnerable populations.” These are claims like suggesting that CBD can cure cancer or other diseases, despite little research showing CBD's efficacy at anything other than managing two rare forms of pediatric epilepsy.
Despite the abundance of CBD-infused products in the market, it exists in legal limbo. The New York Times reported that while the FDA approved the first CBD prescription drug, Epidiolex, for sale last June, the Drug Enforcement Administration still classifies CBD as illegal because it's cannabis-derived. The Brookings Institute also notes that CBD is still a Schedule I substance under federal law.
Dr. Gottlieb stated that “open questions remain” regarding CBD-infused products overall safety, especially when it comes to the potential effects of long-term exposure. He also added that there are “questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”
“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products,” said Dr. Gottlieb. “Especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods.”
Although the FDA has not finalized its stance on these products, the new plan outlines necessary steps towards a framework for regulation. Hopefully, the initiative will help clarify many of the questions surrounding the use of CBD in goods for both consumers and businesses alike.
"This is a complicated topic and we expect that it could take some time to resolve fully," said Dr. Gottlieb. "Nevertheless, we're deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward."
Readers should note that the regulations and data surrounding marijuana, CBD, and other related products are still developing. As such, the information contained in this post should not be construed as medical or legal advice. Always consult with your doctor before trying any substance or supplement.