After 4 years of work, the Food and Drug Administrationthe US Food and Drug Regulatory Authority, has concluded that it will not regulate CBD foods or dietary supplements.
She also dismissed three petitions seeking to allow CBD products to be marketed as dietary supplements and said the agency would “work with Congress” on a regulatory pathway for the cannabinoid.
The statement was released by the Principal Assistant Commissioner, Dr Janet Woodcock.
“The consumption of CBD raises various safety concerns, especially during long-term use. Studies have shown that it can harm the liver, interact with certain medications, and harm the male reproductive system. CBD exposure is also of concern when it comes to certain vulnerable populations like 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 individuals’ desire for access to CBD products with the regulatory oversight needed to manage risk. »
Woodcock also said 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 with CBD. »
“Because it is not clear how CBD products could meet the safety standard for substances in animal feed,” she writes, “nor do we have the intention to pursue the development of rules allowing the use of CBD in animal feed. »
She adds that the agency “did not find sufficient evidence to determine how much CBD can be consumed, and for how long, before causing harm” and, therefore, “did not have the intention to pursue the development of rules allowing the use of CBD in dietary supplements or conventional foods. »
Shelled hemp seeds, hemp oil, and protein powder made from the seeds, on the other hand, are approved by the FDA as ingredients in human food.
The U.S. Congress has already addressed CBD, drafting a bill in 2021 that 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 2021” would also have required manufacturers of CBD and hemp extract products to comply with existing safety rules for food supplements. The project stalled in a House of Representatives committee earlier this month.
CBD could be treated in the Farm Bill 2023 which will be negotiated this year. Stakeholders urged legislators to incorporate into the Farm Bill a text that would designate CBD and other non-intoxicating cannabinoids as dietary supplements.