Ariel L. Clark, PharmD
Over a decade has passed since the first states, Colorado and Washington, legalized cannabis for recreational use. Another 5 years have gone by since the Farm Bill allowed for the sale of hemp and its derived products. And over the past several years, many states have passed legislation allowing cannabis to be used medically. But questions remain.
Recently, FDA announced plans to begin research into a new regulatory framework for cannabidiol (CBD)-containing products sold over the counter. HHS also issued a new recommendation to FDA to reclassify cannabis from a Schedule I to Schedule III drug. Cannabis, which contains tetrahydrocannabinol (THC) and CBD, has been investigated in the treatment of multiple disease states, yet federally, remains a Schedule I drug and is therefore considered to be a “drug(s) with no currently accepted medical use.”
Both of these potential actions by FDA and HHS could mean major changes for the cannabis industry and pharmacists alike.
CBD-containing products
Today, you can find CBD-containing products, derived from hemp, anywhere from local gas stations to pharmacies to grocery stores. This is because the Farm Bill, legislation passed by Congress in 2014 and reaffirmed in 2018, removed hemp (i.e., cannabis sativa L., with <0.3% w/w ∆-9 THC) from the DEA Controlled Substance Act as a Schedule 1 drug.
After more than 5 years of investigation, FDA remains concerned over the safety of OTC CBD products, particularly with long-term use.
In January 2023, FDA’s Office of the Commissioner made an announcement that the current regulatory framework for OTC CBD-containing products was ineffective. With the aim of ensuring that products are safe, they called for clear product labeling and for products to be unadulterated, which is not guaranteed currently. Epidiolex, the only FDA-approved CBD product, indicates some potential for liver damage, which would likely be a risk in OTC CBD products.
Further, FDA specifically noted that CBD cannot be sold as a dietary supplement. Even though hemp-derived OTC CBD products are available, it is federally illegal for them to be marketed as a food additive similar to a dietary supplement, beverage, or other food, according to Cynthia Solomon, PharmD, and Glen Solomon, MD, from Wright State University Boonshoft School of Medicine in Dayton, OH.
Cannabis reclassification
On September 13, 2023, HHS issued a recommendation to reclassify cannabis as a Schedule III drug. Members of the Congressional Research Service, who authored the recommendation, stated that this reclassification would
“allow for medical use of marijuana while maintaining federal criminal control.”
Reclassification would also result in implications for states that have medical cannabis programs, including compliance with the Controlled Substance Act, and the potential for federal income tax deductions. As cannabis is a Schedule I drug currently, research is inherently limited due to roadblocks in place by DEA.
Blair Curless, PharmD, PhD, who is involved with cannabis education in Georgia, said this is an opportune time for any independent pharmacy to capitalize on reclassification by being among the first to provide prescription cannabis programs.
Reclassification could also open up an avenue for further research.
“Researchers would face less strict regulatory controls in researching cannabis as a Schedule III controlled substance, which may in turn promote further research on cannabis,” noted authors of the HHS recommendation. Next steps toward the change to Schedule III will include a review by DEA, followed by a federal rulemaking process, if rescheduling is to move forward.
Changes to the regulation of CBD products and to the schedule of cannabis may better help pharmacists understand what is safe for patients and how the products can be sold or advertised in an appropriate and legal way. ■