U.S. FDA won't issue regulations on CBD

After 4 years of work, the Food and Drug Administration, the U.S. Food and Drug Administration, has concluded that it will not regulate CBD foods or supplements.

At the same time, it rejected three petitions aimed at authorizing the marketing of CBD products as a dietary supplement, and said the agency would «work with Congress» on a regulatory path for the cannabinoid.

The statement was issued by Senior Assistant Commissioner Dr Janet Woodcock.

«CBD consumption raises a variety of safety concerns, particularly with long-term use. Studies have shown that it could be harmful to the liver, interact with certain drugs and harm the male reproductive system. CBD exposure is also of concern when it comes to certain vulnerable populations such as children and pregnant women,» Woodcock wrote in his statement.

Woodcock said the decision would allow policymakers to develop «a new regulatory pathway for CBD [...] that balances the desire of individuals to access CBD products with the regulatory oversight needed to manage risk.»

Woodcock also stated that there are concerns about the potential risk of CBD to animals and that «people could be unknowingly exposed to CBD through the meat, milk and eggs of animals fed CBD.»

«Because it is not clear how CBD products would meet the safety standard for substances in animal feed,» she writes, «we also do not intend to pursue rulemaking to allow CBD use in animal feed.»

It adds that the agency «has not found sufficient evidence to determine how much CBD can be consumed, and for how long, before causing harm» and, therefore, «does not intend to pursue rulemaking permitting the use of CBD in dietary supplements or conventional foods.»

On the other hand, shelled hemp seeds, hemp oil and seed-based protein powder are approved by the FDA as ingredients for human consumption.

The US Congress has already considered CBD, by drafting a bill in 2021 which would have ensured that hemp-derived CBD and other non-intoxicating hemp ingredients could be marketed as dietary supplements.

«The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021» would also have required manufacturers of CBD products and hemp extracts to comply with existing safety rules for dietary supplements. The bill stalled in a House committee earlier this month.

CBD could be processed in the Farm Bill 2023 to be negotiated this year. Stakeholders have urged legislators to include in the Farm Bill a text that would designate CBD and other non-intoxicating cannabinoids as dietary supplements.