FDA Public Hearing About CBDs Prescribes Caution, Bearishness, and Deliberation

By William Sumner, Contributing Writer for the Hemp Business Journal

Last Friday, the U.S. Food and Drug Administration (FDA) held its first public hearing about the safety and regulation of cannabis and cannabis-derived products. At the heart of the hearing were issues of how the FDA should regulate CBD, which has been growing in popularity as both a nutritional supplement and as a patented pharmaceutical ingredient.

Though nongovernmental organizations like the World Health Organization regard pure CBD and CBD preparations (containing no more than 0.2% THC) as generally safe and nonaddictive, by the FDA’s standards there remains insufficient clinical data to allow itself to confidently issue an informed verdict.

As Garrett Graff, managing attorney with Denver-based Hoban Law Group, previously told Hemp Business Journal, stakeholders and speculators should not expect any immediate answers.

“I would fully expect to see some interim additional guidance sometime this year, though I would not expect finalized guidance until 2020 and perhaps years beyond,” he said. Rather, interested parties should look for common themes, and ways for stakeholders and the FDA to build from consensus and compromise to find any bridges for determining what parameters should be.

As Acting FDA Commissioner Ned Sharpless put it during the hearing, “there are important reasons to generally prohibit putting drugs in the food supply.”

Similarly, CBD’s legal status is likewise unclear in the EU, where the substance is classified as a “novel food” under well-defined regulations, …

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