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Smokable hemp regulations likely won’t come before FDA’s broader CBD rules, attorneys say

December 11, 2020 By Laura Drotleff



Hemp flower growers and smokable hemp manufacturers impacted by state laws that have banned or restricted smokable hemp flower production and sales are worried that federal regulators could echo state-level restrictions on a national scale.

But according to cannabis industry attorneys, industry members can put those fears to rest, as it’s unlikely that the industry will see any federal regulations on smokable hemp products until the U.S. Food and Drug Administration – or Congress – issues regulations for hemp-derived CBD as a category.


“Right now, it’s arguably not under FDA’s jurisdiction,” said Ashish Talati, a partner with Chicago law firm Amin Talati Wasserman.

“It’s not nicotine; it’s not tobacco; so where does it really fall under? I don’t see them regulating it any time soon at all,” Talati said during the Hemp Industry Daily Forum at MJBizCon 2020.


California-based cannabis attorney Emily Leongini, an associate with Arent Fox and former FDA attorney agreed, saying the agency has “too many other things on their plate right now.”


“Even if they wanted to exercise jurisdiction creatively … I can’t imagine it will be anytime soon,” Leongini said.

To date, at least seven states including Texas, Iowa, Indiana, Kentucky, Louisiana, Hawaii and New York have banned smokable hemp. At the end of its 2020 legislative session, a CBD regulation bill in California included language that would have banned smokable hemp; however, that legislation did not make it to the floor for a vote in time.

State bans on smokable hemp products don’t necessarily mean federal authorities will institute bans or restrictions on the sector, according to hemp industry insiders. But it doesn’t mean federal food and drug authorities won’t try to regulate them, either.

Smokable hemp flower in its raw form is most closely monitored by the U.S. Department of Agriculture. As long as crops remain compliant with the federal limit of 0.3% THC, it’s unlikely the U.S. Drug Enforcement Administration will take notice of the category, cannabis industry attorneys say.

“Once the product transitions from the harvested commodity to a smokable product intended for human consumption, it would arguably transfer over to the FDA’s jurisdiction,” said Garrett Graff, a cannabis attorney for Denver-based Hoban Law.

Thus far, the FDA has not made any policy statements or enforced any existing regulation under the Food, Drug and Cosmetics Act against smokable hemp products, according to cannabis attorney Shawn Hauser, a partner with Denver-based law firm Vicente Sederberg.

“The FDA has cited the need to further study various methods of intake of CBD, including smoking and vaping, as a necessity in determining its ultimate regulatory approach for hemp-CBD products, indicating that it may ultimately exercise regulatory authority over these product types,” Hauser said. “The FDA has also recently prioritized regulation and enforcement of e-nicotine devices.”

But a federal smokable hemp ban isn’t likely anytime soon, according to Jonathan Havens, a cannabis attorney and partner with the Saul Ewing Arnstein & Lehr law firm in Washington, DC.

“In fact, even federal product restrictions could be a ways off, unless the FDA considers such products to be drugs or tobacco products,” Havens said.

Down the road, the FDA will likely provide further clarity around smokable and inhalable hemp products, he said.

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