Legal? FDA to Focus More on CBD Regulations in April

Legal? FDA to Focus More on CBD Regulations in April
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CBD is a $1 billion-a-year industry that is projected to grow to $16 billion by 2025 as the cannabinoid continues to make its way into everything from lotions to candy. But the CBD industry has been begging for regulation as it tiptoes around the various medical marijuana laws across the U.S. In April, FDA Commissioner Scott Gottlieb will discuss the agency’s approach to regulating foods and supplements made with CBD, he announced February 27.

CBD, the acronym for cannabidiol, is non-psychoactive, so it doesn’t get users high. It has proven health benefits, including anti-anxiety, anti-inflammatory, and pain-relieving properties. In 2018, the FDA approved the first CBD-based drug for the treatment of 2 types of severe epilepsy.

CBD derived from hemp could be legal, but that’s far from certain. Food and supplements sold across state lines and products that make health claims fall under the FDA’s regulatory reach. Analysts and investment firms expect the agency to only crack down on CBD in these 2 circumstances. That level of flexibility could allow the CBD industry to thrive, but it is predicted that the CBD market will be in a state of uncertainty for the next 6 months.

In December, shortly after President Donald Trump legalized hemp farming, Gottlieb said:

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products – meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”

During the upcoming April meeting, Gottlieb is expected to specify what that means. Analysts say the agency head will most likely prioritize ensuring that some forms of hemp-derived CBD could be sold legally in food and supplement form, while also guarding pharmaceutical CBD applications.

The commissioner hinted that high concentrations of CBD might be regulated as a drug that has more regulatory strings attached, while lower concentrations could be categorized as food products that come with an easier review process. [2]

Survey: 42% of People Replaced Pharmaceuticals with Marijuana Compounds

Gottlieb said he has heard Congress “loud and clear” when it legalized hemp products, including CBD. The commissioner added that he is in the process of assembling a group of senior officials to work on the new rules, though he warned that it will not be a “straightforward” process.

He commented:

“There is not a good proxy for us doing this through regulation, and if we get comments back and find this is sufficiently complicated for the agency, we will come back and have a conversation with Congress on how we might be able to work together on this.”

Currently, companies are technically prohibited from adding CBD to food, drinks, and dietary supplements, but that hasn’t stopped many of them from doing so anyway.


[1] Business Insider

[2] CNBC