FDA Rejects Treating CBD as a Dietary Supplement, Will Work With Congress on New Regulations

By | Updated on January 27, 2023

Evidence Based 4

Big news coming from the Food and Drug Administration (FDA) today: it rejected three citizen petitions to allow CBD to be treated as a dietary supplement and announced that its existing framework is not sufficient enough to regulate CBD.

In the FDA’s words, “…a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks…we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”

That’s pretty negative news as hemp industry stakeholders and a growing number of politicians have been putting pressure on the FDA to regulate CBD since people have already been accessing it for many years and issues with product quality and safety continue to exist.

But there is a positive bit of news. The agency, which is tasked with protecting public health by regulating drugs and supplements, did say that it’s “prepared to work with Congress” on new CBD regulations. Perhaps this will coincide with the 2023 Farm Bill, which should also address other issues with hemp, such as the delta-8 THC legality loophole and raising hemp’s THC limit to 1%.

The FDA explained its decision by arguing that we don’t know enough about the safety of CBD, specifically its potential to harm the liver and the male reproductive system, its effects on children, pregnant women, and animals, as well as drug interactions.

The statement also said that a new regulatory framework would help with clear labels, CBD content limits, minimum purchase age, and making sure there are no contaminants. Meanwhile, the existing framework is not enough to manage CBD products:

“The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.” 

The FDA closed by reiterating that the agency will continue to monitor the CBD market and take action (like warning letters) against companies and products that pose risks or break the FDA’s rules, such as making claims about CBD products treating health conditions.