Tuesday, November 12, 2019
The question in the title of this post is the headline if this notable new editorial in the journal Drug Discovery Today authored by Patricia Zettler and Erika Lietzan. (Disclosure/humble brag: Professor Zettler is on the Ohio State College of Law faculty and a member of our Drug Enforcement and Policy Center.) Here are excerpts from the start and end of the piece:
In the last two years the cannabidiol (CBD) market has exploded. Consumers can purchase CBD-containing oils, lotions, gummies, tea, coffee, water, popcorn, and cereal, on store shelves and online. Celebrities and athletes are touting the benefits of these products, and sales are forecast to exceed $20 billion in the next five years. This market explosion has coincided with the U.S. Food & Drug Administration (FDA)’s 2018 approval of the first CBD drug (Epidiolex), for treating seizures associated with two rare and severe forms of epilepsy in children, as well as the 2018 Farm Bill, which removed cannabis with low levels of delta-9-tetrahydocannabinol (THC) — “hemp” — from the federal list of controlled substances. And it comes on the heels of nearly 40 states enacting comprehensive laws to legalize cannabis for medical use (and sometimes recreational use) within their borders.
Yet significant questions remain about the legal status of these widely available CBD products. Most sales of CBD-containing foods and supplements violate the “drug exclusion rules” in the Federal Food, Drug, and Cosmetic Act (FDCA). But FDA has yet to enforce those rules, apart from sending warning letters to a few sellers. The agency is instead considering what approach to take. Several former agency officials — including former Commissioner Scott Gottlieb — have urged FDA to create a sensible, science-based path forward for consumer products. The time is ripe for the agency, lawmakers, health care providers, the drug discovery community, and the public to consider the purpose of the drug exclusion rules and what a different approach — exempting CBD — might mean for consumer and patient access and safety, as well as innovation incentives....
As a practical matter, CBD-containing foods and supplements may be here to stay. Lawmakers or FDA may decide that the drug exclusion rules are unwarranted for CBD, given the federal descheduling of hemp, state legalization of cannabis products, and (eventually) rigorous evidence that CBD products are relatively safe. But FDA should not default into this position simply because a robust, albeit unlawful, market has already emerged. A decision to give CBD special treatment should be made thoughtfully and with public participation, accounting for possible gains in consumer access and choice, as well as the lost opportunity to learn, and harness, CBD’s full therapeutic potential.