Washington, DC: The outgoing commissioner of the US Food and Drug Administration, Scott Gottlieb, has reaffirmed his stance that it could take several years for the agency to create regulations specific to the marketing of certain CBD-infused products.
Gottleib insisted that regulating CBD requires a "highly novel rulemaking process" that could take years to finalize. He further suggested that this process could be expedited if Congress enacted explicit legislation addressing the issue.
His statements echo comments he made earlier this month when he cautioned it could take up to four years for the FDA to create a regulatory pathway for the retail sale of CBD-infused food products or health food supplements.
Gottleib advised that the agency is putting together a working group to study the issue, and that it could have initial recommendations by as early as this summer.
In December, Congress enacted legislation removing industrial hemp (defined as cannabis containing less than 0.3 percent THC) and products containing cannabinoids derived from hemp from the federal Controlled Substances Act. However, the following day, the FDA stated, “[I]t’s unlawful under the FD&C Act (US Food Drugs and Cosmetics Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” That announcement led to regulatory agencies in several states pulling certain CBD-infused products from the retail market.
An archived video of the FDA commissioner’s comments is online.