FDA Conducts Hearing on CBD Products, Concerns Remain Unresolved

FDA

In the first public hearing of FDA on the cannabidiol or the CBD products, mixed opinions and varied perspective on the rules and regulations to be imposed and the approach to manage the products were shared.

The prime objective of the hearing was to notify about the perspective of the Food and Drug Administration as it looked for creating a different course of action to manage CBD. At the moment, it is illegal to use CBD in the food supply or dietary supplement.

Various business owners, researchers, hemp farmers and consumer advocates testified in the hearing, and urged the FDA to develop and establish regulations on the products containing cannabidiol.

One of the opponents Jonathan Miller, general counsel at U.S. Hemp Roundtable, advocated for regulating CBD and legalizing its use in various products. He said that at the moment, there is “an urgent need for an efficient regulatory framework for CBD.” He also claimed that following the approval of 2018 Farm Bill, the Congress also planned for the promotion of CBD products obtained from hemp.

He also suggested help on building a blueprint for regulating the CBD, if the Food and Drug Administration experiences issues on fulfilling the task without any help.

Andrew Kline, director of the public policy of the National Cannabis Industry Association, said “We strongly recommend [that] FDA act quickly to clarify the regulatory environment. Because there are significant confusions in the market, businesses don’t know what is legally permissible and some are making health claims in the absence of clear regulatory guidance.”

“Most significantly, banks and payment processors don’t understand [the regulatory rules] and as a result many CBD companies are at risk of losing financial services,” he added.

NCIA and the others were opposed by the Smart Approaches to Marijuana (SAM) Canada and the Marijuana Victims Alliance. SAM Canada’s Pamela McColl pressed on the fact that marijuana is not only addictive, but also harms the DNA of the user and sometimes, under its influence people hurt themselves.  

The Alzheimer’s association and the American Epilepsy Society in the hearing by FDA said that the current research is not enough to verify the claims on how CBD can help in the treatment of Alzheimer, dementia and epilepsy.

In the recent years, there has been an increase in the demand of the CBD products as various industries presses on the fact that the CBD products can be used to reduce anxiety, pain and insomnia and treat conditions from Parkinson’s disease to cancer.

Yasmin Hurd, a psychiatry professor at the Icahn School of Medicine at Mount Sinai in New York said, “It’s a wild West kind of environment right now. I’m inundated every day with patients wanting to know how much CBD they should take, which ones to buy. But we don’t know what’s in the stuff now being sold. . . . We’ve had this explosion without guidance to the public or regulation.”

Following the public hearing, Dr. Amy Abernethy, principal deputy commissioner of FDA, was able to identify the issues that arose during the hearing. According to her series of tweets on the hearing, there is a need “to further clarify the regulatory framework to reduce confusion in the market” and to create and establish the unavailable information on the usage.

A public hearing like this by the FDA on the usage and availability of the CBD products might help the appropriate authorities to come to a proper conclusion.

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