FDA Acknowledges Need for New Regulatory Framework for Cannabidiol Products

In a new statement, FDA Principal Deputy Commissioner Janet Woodcock, MD, said officials with the FDA have concluded that existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol (CBD), and they will work with Congress to find alternatives.

The CBD market is growing rapidly and necessitates careful regulatory consideration. To address this, the FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. That working group concluded that a new regulatory pathway for CBD is necessary.

According to the statement, a regulatory pathway for these products should balance individuals’ desire for CBD products with the necessary oversight to manage risks. Officials with the FDA plan to work with Congress to develop this pathway.

The use of CBD, and particularly long-term use, is associated with some safety concerns, according to the statement. Research has found potential harms to the liver, medication interactions, and potential harm to male reproduction. Exposure to CBD is also a concern for some vulnerable populations, such as children and pregnant individuals.

A new regulatory pathway would also benefit consumers by establishing safeguards and oversight to manage and minimize these risks. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures to minimize the risk of ingestion by children, such as minimum purchase age. Additionally, a new regulatory pathway could provide access and oversight for some CBD-containing products for animals.

The existing FDA food and dietary supplement authorities provide 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 marketed as a dietary supplement or food additive. Several citizen petitions have been filed requesting that the FDA allow CBD to be marketed as a dietary supplement, but after reviewing the evidence, those petitions have been denied.

Specifically, the working group examined data regarding the drug Epidiolex. Based on the entirety of the evidence, the working group found that CBD products do not meet the safety standards for dietary supplements or food additives. For example, the group members did not find adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.

In addition to potential safety concerns for human consumption, the working group noted that CBD poses risks to animals, and humans could be unknowingly exposed to CBD through milk, meat, and eggs from animals fed CBD. According to the statement, it is unclear how CBD products could meet the safety standard for substances in animal food, so the officials do not plan to pursue rulemaking allowing for this use.

“The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety,” the statement concluded.

REFERENCE

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward. News release. FDA; January 26, 2023. Accessed January 31, 2023. https://content.govdelivery.com/accounts/USFDA/bulletins/3450d66