FDA Wants More Scientific Data During CBD Regulation Making Process

Players in the cannabidiol (CBD) sector will have to sit tight and wait after the U.S. Food and Drug Administration (FDA) announced that it needs more scientific data before issuing a regulatory framework for the rapidly growing industry.

The sector got a new breath of life after the 2018 Hemp Farming Act removed industrial hemp from the list of controlled substances, paving the way for farmers in all 50 states to plant the cash crop. In the year since hemp cultivation became legal, the market has been flooded with thousands of untested and unregulated products, each claiming to cure certain medical conditions.

The FDA comments period for hemp and cannabis-derived ingredients expired months ago, but the federal agency is still accepting comments. Sharon Lindan Mayl, Senior Policy Advisor for the FDA’s Office of Food Policy and Response, says that despite all the comments the agency has received, more data is still needed. “It’s safe to say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on.”

She says that the agency recognizes the fact that there were few, if any, safety studies on CBD and other cannabis extracts before hemp was descheduled as a controlled substance. Still, she adds, the agency is open to being convinced through scientific data about the safety of CBD as an ingredient.

The FDA especially needs to see total exposure data, as using CBD as an ingredient in consumer products raises health risk concerns. Although there already exists an FDA-approved CBD-based drug, Epidiolex, the agency isn’t considering it in its evaluation of CBD safety for use in non-drug products.

Her comments come after a top FDA official said that the agency won’t make an exception for CBD products when making regulations. Lowell Schiller, the FDA’s Principal Associate Commissioner for policy, told a group of nutritionists that the agency’s biggest concern is whether CBD is safe to consume in food and supplements.

He said that although the FDA is under pressure to move forward with a legal pathway for using CBD as an ingredient, it still doesn’t have enough data to determine whether CBD is safe for long term use, especially among vulnerable populations.

“We look at an FDA-regulated product containing CBD the same as we would look at an FDA-regulated product containing any other substance. We apply the same tools, authorities and statutory provisions,” Schiller added.

Experts believe these comments may put a damper on the hopes of cannabidiol companies like Sugarmade Inc. (OTCQB: SGMD) and Willow Biosciences Inc. (CSE: WLLW) which had hoped that CBD regulations would soon be released by the FDA.

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