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As CBD oils become more popular, the FDA considers setting new rules: Shots




Cannabidiol, or CBD, is a compound that can be extracted from marijuana or hemp. It does not get people 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 get people 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 rapidly grown to a billion dollar industry. Today's hearing will help officials decide how to regulate CBD products.

The compound can be extracted from marijuana or hemp. It is promoted as a way to ease anxiety and inflammation – and people don't get loud because it doesn't contain THC, the psychoactive component of the cannabis plant.

People use cannabidiol or CBD oils to help with anything from menstrual cramps to insomnia. While the hype around the CBD has come before science, there is an increasing number of small studies pointing to some health benefits. But the FDA has concerns about how these products are marketed and is seeking more data on their safety.

"The question remains regarding security considerations widespread in the widespread use of these products," FDA officials wrote at a Federal Register notice of today's hearing. "These issues can affect the approaches we consider in regulating the development and marketing of products."

Regulators are expected to hear from many players in the CBD industry eager for the agency to enter and make some clear rules because there has been a cloud of uncertainty over the legality of the marketing and sale of CBD products.

The agricultural bill from 2018 lifted long restrictions on hemp, which means that hemp should no longer be regulated as a controlled substance. The shirt industry saw this as a green light to move forward with marketing CBD products.

"When the farm rained last year, we were astounding. This ended a multi-year hemp ban," said Jonathan Miller, who serves as General Counsel for US Hemp Roundtable, 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. For example, the agency has said that cannabidiol products cannot be sold as supplements.

So the industry is asking for a more definite set of rules, and the FDA hearing is a first step.

"We really need the FDA to join and help us make a way towards a regulated legal product, Miller said. This is the main message he says he will deliver during today's hearing.

But the FDA has many questions His industry, and researchers studying cannabis say there is still a lot to be learned about cannabidiol.

"We are really in childhood understanding cannabadiol's physiological effects right now," said Ziva Cooper, research director of the UCLA Cannabis Research Initiative.

Cooper says there are important questions to answer, for example: What doses are safe? And what happens when people use it for long periods?

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

You need a doctor's prescription to get this medicine and it contains a much higher dose of CBD than what people usually come from oils sold online or in dispensaries or markets.

Clinical studies of Epidiolex found that the high dose of CBD was generally safe, but that caused some side effects in some people, including lethargy and gastrointestinal distress. The FDA also pointed out concerns about possible liver damage.

"This is a potentially serious risk that can be dealt with when the product is taken under medical supervision in accordance with FDA-approved labeling for the product," wrote Office Regulators in the Federal Register Notice. "But it is less clear how this risk can be controlled if this drug is used far more without medical supervision."

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

The hemp industry has signaled its support for this approach. The lower dosage products can be sold "over-the-counter" in natural food stores, pharmacies and grocery stores, "said Miller in US Hemp Roundtable.

The FDA has not set any timeline to regulate CBD products, and its evaluation is likely to continue in the coming months.



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