As CBD oils become more popular, the FDA plans to set new rules: shots

The Food and Drug Administration is holding its first public hearing on the CBD, the cannabis extract that has quickly become a billion dollar industry. Today 's hearing will help officials determine how to regulate CBD products.

The compound can be extracted from marijuana or hemp. It is presented as a way to relieve anxiety and inflammation – and it does not wake people because it does not contain THC, the psychoactive component of the cannabis plant. .

People use oils containing cannabidiol, or CBD, to relieve everything from menstrual cramps to insomnia. Although the hype around the CBD is ahead of science, there are a growing number of small studies that indicate health benefits. But the FDA is worried about how these products are being marketed and is looking for more data on their safety.

"Questions remain regarding safety considerations raised by the widespread use of these products," FDA officials wrote in a Federal Register notice regarding today's hearing. . "These issues could affect the approaches we plan to take to regulate the development and marketing of products."

Regulators should hear from many CBD industry players wanting the agency to intervene and set clear rules, as the legality of marketing and selling CBD-based products is tainted by ## 148 ## # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # 39; uncertainty.

The 2018 Farm Bill lifted the long-standing restrictions on hemp, which means hemp would no longer be regulated as a controlled substance. The hemp industry has seen the go-ahead to promote CBD products.

"When the agriculture bill was passed last year, we were more than happy to end a ban on hemp for several decades," said Jonathan Miller, General Counsel for Agriculture. the American round table on hemp, a coalition of dozens of hemp companies. "It was a historic moment."

But the FDA quickly intervened to say that it had regulatory power over the CBD. For example, the agency said that products containing cannabidiol can not be sold as food supplements.

The industry is asking for a more definitive set of rules and the FDA hearing is a first step.

"We really need the FDA to join us and help us chart the way to a regulated legal product," Miller said. This is the main message that he says he will convey to today's audience.

But the FDA has a lot of questions to ask its industry, and researchers who study cannabis say that there is still a lot to learn about cannabidiol.

"We are really in the process of understanding the physiological effects of cannabadiol," said Ziva Cooper, director of research at the UCLA Cannabis Research Initiative.

Cooper says that there are important questions to answer, such as: Which doses are safe? And what happens when people use it for long periods?

The FDA has already approved a purified CBD drug, called Epidiolex, used to treat two rare and serious forms of epilepsy.

To get this medicine, you need a prescription from your doctor. This contains a much higher dose of CBD than that usually obtained from oils sold online, in clinics or in markets.

Clinical trials of Epidiolex have shown that the high dose of CBD is generally safe, but that it causes side effects in some people, including lethargy and gastrointestinal disorders. The FDA has also raised concerns about possible liver damage.

"This is a potentially serious risk that can be managed when the product is taken under medical supervision in accordance with the FDA-approved labeling for the product," agency regulators said in a statement. the opinion of the Federal Register. "But it is less clear how this risk could be managed if this substance was used much more widely, without medical supervision."

A potential strategy for regulating the CBD could be to set a threshold. High dose products may be limited and require a prescription, while low dose products similar to many CBD oils currently on the market would be widely available.

The hemp industry has shown support for this approach. The lower dose products could be sold "over the counter in health food stores, pharmacies and grocery stores," Miller said of the hemp round table in the United States.

The FDA has not set any deadline for regulating CBD products and its assessment is expected to continue in the coming months.