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As CBD Oils Become More Popular, The FDA Considers Whether To Set New Rules : Shots



Cannabidiol, or CBD, is a compound that can be extracted from marijuana or hemp. It does not make people so high because it does not contain THC, the psychoactive component of the cannabis plant.

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Cannabidiol, or CBD, is a compound that can be extracted from marijuana or hemp. It does not make people so high because it does not contain THC, the psychoactive component of the cannabis plant.

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The Food and Drug Administration holds its first public hearing on the CBD, the cannabis extract that has quickly become a multi-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 promoted as a way to relieve anxiety and inflammation, and it does not make people so high because it does not contain THC, the psychoactive component of the cannabis plant.

People use oils with cannabidiol or CBD to help with everything from menstrual cramps to insomnia. While the exaggeration around CBD has been ahead of science, there is a growing number of small studies that point to some health benefits. But the FDA is concerned about how these products are marketed and is looking for more information about their safety.

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"There remain questions about the safety considerations raised by the widespread use of these products," FDA officials wrote in a Federal Register notice about today's hearing. "These questions could impact the approaches we consider adopting to regulate the development and commercialization of products."

Regulators are expected to listen to many actors in the CBD industry anxious for the agency to intervene and establish some clear rules, because there has been a cloud of uncertainty about the legality of marketing and selling CBD products.

The agricultural bill of 2018 removed the long-standing restrictions on hemp, which means that hemp would no longer be regulated as a controlled substance. The hemp industry saw this as a green light to advance the promotion of CBD products.

"When the farm bill was pbaded last year, we were more than excited." This ended with a decades-old ban on hemp, "says Jonathan Miller, who serves as general counsel for the Hemp Roundtable. the United States, a coalition of dozens of hemp companies. "It was a historic moment."

But the FDA quickly stepped in to make it clear that it has regulatory authority over the CBD. The agency has said, for example, that cannabidiol products can not be sold as dietary supplements.

So, 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 come together and help us find the path to a regulated legal product," says Miller. This is the main message he says he will deliver during today's hearing.

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

"We are really in our infancy to understand the physiological effects of cannabadiol at this time," says Ziva Cooper, research director of the Cannabis Research Initiative at UCLA.

Cooper says there are important questions to answer, such as: What dose are safe? And what happens when people use it for long periods of time?

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

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You need a prescription to get this medication, and it contains a much higher dose of CBD than people normally get from oils sold online or in dispensaries or markets.

Epidiolex clinical trials found that the high dose of CBD was generally safe, but that it caused side effects in some people, such as lethargy and gastrointestinal disorders. The FDA also noted 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 FDA-approved labeling for the product," the agency's regulators wrote in the Federal Register notice. "But it is less clear how this risk could be managed if this substance is used much more widely, without medical supervision."

A possible strategy to regulate the CBD may be to establish a threshold. High-dose products may be restricted and require a prescription, while low-dose products similar to many of the CBD oils currently on the market would be widely available.

The hemp industry has expressed its support for this approach. The lower-dose products could be sold "over-the-counter at health food stores, pharmacies and grocery stores," says Miller of the US Hemp Round Table.

The FDA has not established a schedule to regulate CBD products, and its evaluation is likely to continue over the next few months.


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