Natural Products Insider

JUL-AUG 2019

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4 INSIDER July/August 2019 In the News FDA has many "unanswered questions" when it comes to the safety of CBD, a cannabis-derived compound, the agency's top offi cial said. FDA Acting Commissioner Norman "Ned" Sharpless, M.D., cited "real risks" and "critical questions" that remain regarding the safety of CBD and THC in FDA-regulated products, including food and dietary supplements. During a May 31 public hearing at FDA's campus in Silver Spring, Maryland, more than 100 speakers representing myriad interests addressed CBD and THC issues, including FDA's prospective regulation of cannabis-derived compounds. The hearing was intended to obtain scientifi c data and information about the labeling, manufacturing, marketing, product quality, safety and sale of products containing cannabis or cannabis-derived compounds. Sharpless said FDA has many questions about CBD that remain unanswered. "While we have seen an explosion of interest in products containing CBD, there is still much that we don't know," he said. Sharpless suggested population-based research focused on CBD was scant prior to the passage of the Agricultural Improvement Act of 2018, otherwise known as the Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA). The "lack of evidence to support CBD's broad use in FDA-regulated products— including in food and dietary supplements— has resulted in unique complexities for its regulation," he said, "including many unanswered questions related to … safety." For instance, Sharpless asked a fundamental question about CBD: How much of the compound is safe to consume? "What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil?" Sharpless asked. "How much is too much?" Sharpless also asked how CBD would interact with other drugs taken by a person, and he left unanswered the question of how the compound would impact the health of a pregnant woman. "What if children access CBD products like gummy edibles?" the commissioner asked. "What happens when someone chronically uses CBD for prolonged periods?" FDA has concluded CBD and THC—the psychoactive compound responsible for the high from consuming marijuana—cannot be added to conventional food or marketed in a dietary supplement because the compounds were fi rst studied as drugs. But FDA has authority to create an exception by issuing regulations, a process that could take several years. FDA opened a docket on the public hearing and accepted comments through July 2, 2019. Some speakers said they wanted FDA to extend the deadline. As of late June, FDA had already received more than 2,500 comments, refl ecting substantial interest in a cannabis-derived compound that has proliferated in food, dietary supplements and other FDA- regulated products over the last fi ve years. 'Time Is of the Essence' Several speakers urged FDA to provide clarity to a confused marketplace and do so swiftly. "Time is of the essence," said Andrew Kline of the National Cannabis Industry Association. He added, "We strongly recommend that FDA act quickly to clarify the regulatory environment because there is signifi cant confusion in the market." The debate over safety should not hamper FDA from promulgating regulations to allow for the use of CBD in supplements, Megan Olsen, assistant general counsel of the Council for Responsible Nutrition (CRN), told FDA offi cials during the public hearing. "There is already a regulatory framework in place that is proven to ensure the safety of dietary supplements and food—one that will automatically be implemented should FDA develop a regulation permitting CBD use in food and supplements," Olsen said. Michael McGuffi n, president of the American Herbal Products Association (AHPA), requested FDA do one of two things: | Either "issue a regulation, possibly as an interim fi nal rule with an accelerated effective date, permitting CBD as a lawful ingredient in supplements and foods," with the caveat that all other applicable federal regulations must be followed; | Or release guidance, disclosing FDA's intent to exercise formal enforcement discretion regarding provisions of federal law on which the agency "bases its position that CBD- containing supplements and foods are unlawful." Enforcement Since 2015, FDA has issued more than 20 warning letters to companies selling unapproved CBD products. "Our biggest concern is the marketing of products that put the health and safety of consumers at risk," Sharpless said, "such as those claiming to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, in the absence of requisite approvals." Sharpless said consumers may be using such products instead of proven therapies to treat diseases. But the agency has not made any promises to leave alone marketers of unapproved CBD products who refrain from making claims of treating a disease. FDA, he said, "does not have a policy of enforcement discretion with respect to any CBD products." That seemed to contradict a previous statement from Scott Gottlieb, M.D., who—while FDA commissioner—told members of Congress that his agency was using its enforcement discretion to target CBD products, such as those that purport to treat cancer. Brandon Beatty is the founder and CEO of Bluebird Botanicals, a marketer of hemp-derived products containing CBD. Regardless of the various statements by FDA offi cials, Beatty said FDA's warning letters over the last several years have focused on products that have made claims of treating diseases. "So far, that's been a clear pattern," he said in an interview. "Regardless of what they're saying, they have used enforcement discretion. Hopefully that continues." FDA Acting Commissioner Highlights 'Unanswered Questions' Related to CBD by Josh Long

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