Federal food and drug regulators on Tuesday addressed the hemp industry directly for the first time since stakeholders asked for feedback regarding CBD safety back in 2019. But the message was a familiar one. Grail Sipes, acting cannabis-product committee chair with the U.S. Food and Drug Administration, reiterated the agency’s position that it needs additional CBD research and safety data before it can be considered for uses beyond prescription drugs, such as a food additive or dietary supplement.
A Texas judge has put the brakes on a delta-8 THC ban announced last month by the state’s health department. Travis County judge Jan Soifer issued an injunction Monday, barring state officials from enforcing an Oct.15 notice to law enforcement saying that delta-8 THC products are considered controlled substances, the Dallas Morning News reported. The injunction comes after Hometown Hero CBD filed a lawsuit arguing that Texas health officials didn’t follow the correct procedures nor provide proper grounds to initiate the change in the controlled substances list. The same judge had earlier rebuffed the CBD company’s request for a restraining order in the case. Delta-8 THC consumers and sellers in Texas widely believed that delta-8 had been legal since it ramped up in popularity about two years ago, the newspaper reported. But official state documents show that the Texas health department listed the product on its controlled substance list in January. Hemp activists in Texas argue that the January listing wasn’t properly publicized. A hearing to settle the matter hasn’t been scheduled.
A cardiologist with no public comments on cannabinoid therapies, Dr. Robert Califf, has been nominated to take over as commissioner of the U.S. Food and Drug Administration. President Joe Biden made the nomination Friday, calling Califf a “steady, independent hand.” He would replace Stephen Hahn, who headed the FDA from December 2019 until January 2021. Califf briefly led the FDA under President Barack Obama and formerly led the agency’s oversight of medical and tobacco products. It wasn’t immediately clear how the Califf choice could affect the hemp and marijuana industries. The FDA has been reviewing over-the-counter CBD since 2019 but has yet to signal any change from its existing policy – that the cannabinoid is an active ingredient in a pharmaceutical drug and shouldn’t be taken without a doctor’s oversight. Califf has said nothing publicly about cannabinoids such as CBD. The National Industrial Hemp Council lauded the nomination as a needed step toward new leadership at the agency given oversight of consumed hemp products. “Senate-confirmed leadership at the FDA will enhance consumer safety for cannabidiol and prime the pump to grow a hemp economy that works for everyone,” NIHC spokesman Larry Farnsworth told Hemp Industry Daily.
Califf’s nomination now awaits approval by the Senate.
Cannabis operators making or selling delta-8 THC are pointing to two recent comments from officials with the U.S. Drug Enforcement Administration that suggest states lining up to ban the isomer may be going too far. The comments came in little-noticed state advisories about intoxicating THC isomers that are rare in the plant but easily made from extracted CBD. First, DEA liaison Sean Mitchell told a Florida panel of hemp operators on a recorded call in June that “the only thing (in hemp) that is a controlled substance is delta-9 THC greater than 0.3% on a dry-weight basis.” The next consideration came in a September letter to the Alabama Board of Pharmacy, where the head of the DEA’s Drug & Chemical Evaluation Section, Terrence Boos, told regulators that THC “synthetically produced from non–cannabis materials” is controlled. Because delta-8 THC products are commonly converted from CBD first extracted from hemp flowers, some advocates say the Alabama letter suggests that the cannabinoid isomer isn’t federally illegal unless it comes from “non-cannabis materials.” Cannabis attorneys seized on the pair of comments this week as validation that delta-8 THC may not violate federal drug law if it comes from hemp. The nonbinding policy statements come after more than a dozen states banned the THC isomer or limited it to marijuana retailers.