Lowell Schiller, the FDA Principal Associate Commissioner for Policy, has said that the drug scheduling system of the FDA has hampered the ability of the scientific community to research CBD, and the FDA is now scrambling to fill the knowledge gaps that would have been filled long ago.
Schiller made these remarks while speaking at the 2019 Hemp Business Summit organized by the National Industrial Hemp Council on Tuesday. The FDA official kept repeating that the agency was “excited” about the potential of CBD.
During his speech, Schiller emphasized that the FDA has regulatory authority over hemp and any products made from it. He added that it is currently illegal to add a hemp derivative into the food chain as an ingredient in cosmetics, food or dietary supplements.
Hemp-derived products can only enter the food supply once the FDA makes alternative rules to regulate such uses of hemp products. He admitted that this rulemaking process was more complex because the FDA had already approved a CBD-based drug (Epidiolex).
Speaking about research into hemp, Schiller said that the scheduling of hemp and marijuana as controlled substances had stood in the way of research into cannabis compounds, such as CBD. The legal status of hemp and its products only changed at the end of 2018 when the Farm Bill was passed.
The FDA official revealed that even in their initial stages of considering how to regulate CBD, they realized that they knew so little about this compound and about the possible ramifications of putting it in dietary supplements, food and cosmetics.
Schiller pointed out that research needs to be done to understand how one can be affected by consuming a large amount of CBD, how the substance interacts with other drugs, effects of using CBD during pregnancy and the effects of the long-term consumption of CBD.
Once the FDA gets the answers to those questions, it will be easier to chart the way forward from a regulatory perspective. To that end, the FDA official revealed that the agency had picked interest in their own version of CBD which he explained as “Collect Better Data.”
He also said that as the agency works round the clock to develop hemp and CBD rules in a transparent manner, it will keep in mind the different calls that have been made by lawmakers and industry members to come up with rules that will not interfere excessively in the marketing of CBD.
The official from the regulator ended by asking the CBD industry for support on this journey to help the scientific community to catch up with the pace at which public interest and commercial undertakings in CBD are moving.
USDA Undersecretary Greg Ibach also addressed the hemp and CBD conference. Analysts believe that industry players like Lexaria Bioscience Corp. (CSE: LXX) (OTCQX: LXRP) and Marijuana Company of America Inc. (OTCQB: MCOA) were taking notes during the conference in order to get ideas about the kind of rules the FDA would formulate.
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