The FDA Provides an Update on CBD Legalization

CBD remains the talk of main street. The non-psychoactive component in Cannabis, and often referred to as the ‘sibling’ of THC, is claimed to have a myriad of health benefits and analyst backed forecasts in the billions. However, the pent up demand cannot be released as the substance remains to be sold state by state. Over two separate meetings in the past month, the U.S. Food and Drug Administration (FDA) shed some light on their regulatory framework for potential CBD legalization.

After promising a hearing in the upcoming month of April, the FDA continues to work rigorously on reviewing all aspects of CBD. FDA commissioner Dr. Scott Gottlieb continuous to worry about the mass amounts of products going to market that make unproven claims and advertise therapeutic benefits that could cause a shattering disrupt to the world of professional medical care. Many patients may forgo their proven care for these so-called ailments. “We’ll continue to warn consumers and take enforcement action to protect public health,” Gottlieb told the National Association of State Departments of Agriculture (NASDA).

At this time CBD in food and dietary supplements remains unlawful. This is mostly due to a similar drug named Epidiolex, which has active compounds similar to CBD. The FDA must issue new changes to re-evaluate these substances as pharmaceutical or not. But it’s not a “straightforward process,” Gottlieb told the U.S. House Appropriations Committee. Although the U.S. passing of the Farm Bill loosened restrictions on growing industrial hemp, only oils used from the stalk remain federally legal. These oils rarely include levels higher than 0.02% of THC and CBD, which is considered non-negligible. “We’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches, to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products,” Gottlieb said.

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The Public Wants Action

A letter from several members of Congress sent to Gottlieb last week called for the FDA to provide direction on CBD. The public also grows anxious, as the consumer craze around the benefits of the substance is applied to all kinds of products. We are seeing an influx of products including CBD oils, beauty products, sports recovery creams, and food & beverage products.

“We’ve got to work through what that regulation would look like,” Gottlieb said. The exact date for an April public meeting is expected to be announced soon.

He goes on to state that the agency will solicit comments to establish a framework to allow CBD to be put into the food supply and laid out “theoretical frameworks” for CBD regulations. He then gives examples where a variety of concentration limits would be placed on the amount of CBD placed into foods depending on the purity of the CBD and the type of edible.

CBD remains a high priority for the FDA, and in the meantime, as they mull through a multi-year process, the public is accessing the substance through prescriptions, legal States, or grey markets. In many State rulings, CBD has been separated from THC and runs by a completely separate playbook. The FDA seems to be far behind the common sense practices that are already put in place. We only hope the wait isn’t too long for the prosperous CBD market to expand with federal oversight. Until then America at large sits on the sidelines.

Stay Connected to the Story! Happy Investing!

Alex S.

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