Natural Products Insider

SEP-OCT 2018

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4 INSIDER September/October 2018 In the News FDA this summer approved a drug containing cannabidiol (CBD) derived from marijuana, a seminal development that could lead to a years-long court battle between the government and natural products industry over the legality of CBD in foods and supplements. Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least 2 years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now. Justin Gover, GW's chief executive offi cer, described FDA approval of Epidiolex as "a historic milestone, offering patients and their families the fi rst and only FDA-approved CBD medicine to treat two severe childhood-onset epilepsies." Douglas Throckmorton, M.D., an FDA offi cial, confi rmed with reporters on a conference call that DEA will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act (CSA). "This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," FDA Commissioner Scott Gottlieb, M.D., said in a news release. "And, the FDA is committed to this kind of careful scientifi c research and drug development. Controlled clinical trials testing the safety and effi cacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients." Meanwhile, FDA remains "concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims," Gottlieb said in a separate statement. "The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases." Companies selling CBD in different formulations, and targeted by FDA in enforcement actions, "have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientifi c evidence to support such claims," Gottlieb added. "We'll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims." Unapproved CBD products, Throckmorton told reporters, haven't demonstrated evidence of effectiveness or safety. He also said FDA is "concerned about the lot-to-lot variability" that may occur in such products. Rend Al-Mondhiry, senior counsel to Amin Talati Upadhye LLP, whose clients include marketers of dietary supplements, recommended companies review their marketing claims and the safety of their products. Putting consumers at risk, for example, by failing to follow GMPs (good manufacturing practices), the lawyer said, "would obviously be another trigger for FDA to target a company." Beginning in 2015, FDA opined on its website and in subsequent warning letters that CBD cannot be lawfully sold in a dietary supplement because, in part, it was the subject of substantial clinical investigations by GW that were made public. Nonetheless, several hemp advocates said they remained bullish about the market for CBD following FDA approval of Epidiolex. They see a pathway for CBD to thrive in several different product categories, including as a dietary supplement. "We think that this is the evidence, the proof, the data, that the phytocannabinoids in hemp do have profound benefi t," said Stuart Tomc, vice president of human nutrition of CV Sciences Inc., commenting on FDA approval of GW Pharmaceuticals' medicine, "and hopefully now we can have a more sober, adult conversation about which product, which market, which customer." Tomc added, "Our hope is with this drug approval process that we'll be able to see these clear lines that will be delineated: the pharma products, the health food store products (and) the farmer's market products. They're all different markets, different customers, and hopefully we'll come to that realization." The U.S. Hemp Roundtable, a coalition of hemp companies, retained Amin Talati Upadhye, largely to take legal action if FDA attempted to prevent the sale of CBD in products like supplements and food, said Brandon Beatty, founder and CEO of Bluebird Botanicals. Bluebird is a member of the U.S. Hemp Roundtable's board of directors. "We believe it [CBD] should be permissible in pretty much all FDA categories, including pharmaceutical," he noted. The hemp industry has contested FDA's position that CBD can't be lawfully sold in a supplement. Companies have argued, for instance, that the compound was marketed in a supplement before GW's clinical investigations commenced and were publicized. Another argument: the clinical investigations referenced by FDA in warning letters were not "substantial," and consequently, the drug-related exclusionary clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA) doesn't apply to CBD. In a letter in April to the Texas Department of State Health Services, the U.S. Hemp Roundtable expressed disagreement that GW's clinical trials referenced by FDA "are in fact 'substantial,' as the trials were extremely limited in scope, and funding and the publication of these trials has been limited." But regulatory attorney Todd Harrison doesn't expect FDA to sit on the sidelines now that Epidiolex has been approved. "FDA has painted itself into a corner and must enforce," said Harrison, a partner in Washington with Venable LLP. If FDA doesn't enforce, it will make "a farce" of its "interpretation of the Federal, Food, Drug & Cosmetic Act," the lawyer opined, "and at some point, the agency has to be true to its word." Hemp Industry Reacts to FDA Approval of CBD Medicine by Josh Long

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