The Food and Drug Administration (FDA) said Thursday that updated regulations are needed for cannabidiol (CBD) and congress should create a path for such rules.
In a statement on Thursday, FDA Deputy Commissioner Dr. Janet Woodcock said that new regulations are necessary for CBD, which is a chemical in marijuana and does not include tetrahydrocannabinol (THC), which causes users to experience a high.
Woodcock said that the agency is ready to work with the United States Congress to establish a new regulation process for CBD. The agency also refused to accept three petitions from people that had asked the FDA to create rules to permit CBD items to be sold as dietary supplements.
The FDA regulates the medication Epidiolex, which has CBD in it and was the first medicine that the agency approved that had active drug material that came from marijuana. However, the agency said that a group looked at studies connected to Epidiolex, as well as other research, and decided that it is not clear how CBD items “could meet safety standards for dietary supplements or food additives.”
“For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” the statement noted.
The Washington Post reported that federal law holds that the active compounds used in prescription medication can’t also be food supplements. The FDA does not have much capability to increase the spread of CBD because of the existence of the medication, according to Peter Lurie, executive director at the Center for Science in the Public Interest.
Using CBD, especially for a long amount of time, brings up questions about its safety, Woodcock’s statement noted. Research has revealed that it can possibly damage the liver, and could damage the male reproductive system. It can also react with specific medicines and could be an issue if pregnant women or children come into contact with it.
The agency is not planning to attempt to make regulations for CBD to be used in foods or dietary supplements. It also pointed out that the substance could be harmful to animals and consumers could accidentally come into contact with CBD through food products that are made from animals that eat CBD. The agency is also not going to make rules permitting CBD to be used in feed for animals.
State regulations differ on the substance. Some states allow it to be used entirely, whereas others put certain parameters on it.
“I’m sure the FDA probably concluded that no matter which way they went, it would involve trying to fit a very big genie back into a very small bottle, and create a political firestorm,” Brian Ronholm, Director of Food Policy for Consumer Reports, said. “It’s not surprising that they would want to seek some cover from Congress.”