The U.S. Food and Drug Administration (FDA) was quick to address the passage of the 2018 Farm Bill and its legalization of hemp. The same day the law passed, the FDA issued a statement reinforcing the fact that it remains illegal at a federal level to market food or dietary supplements containing added cannabidiol (CBD) or delta-9 tetrahydrocannabinol (THC) nor claim any health-related benefit without going through the established FDA drug-approval process. The agency has continued to reinforce this position via testimony, actions against companies in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and consumer statements. On November 25, 2019, the FDA issued a statement on its website after warning 15 companies of illegally marketing CBD products. The statement reminded consumers that the agency has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.14
In an accompanying statement, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. said, “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ We want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered.”3
The challenge policymakers face amidst the ongoing emergence of state medical marijuana laws is that often they are charged with trying to discern if cannabis products are safe and effective without the scientific or medical evidence necessary to do so. There is no doubt that there are medical benefits derived from the cannabis plant; just as there are known therapeutic benefits of other plants such as the Opium poppy. But using that analogy, imagine if there were different laws at the state and federal level regarding the growth, harvesting, manufacturing and sale of opiates for use by patients.
There are studies that support marijuana’s efficacy as a medicine, but to date most of those studies are preclinical or observational. The highest levels of evidence required by the U.S. Food and Drug Administration (FDA) to deem any product safe and effective for use as medicine are systematic reviews or meta-analyses of randomized, placebo-controlled clinical trials, followed by evidence from well-designed randomized controlled trials to reduce the risk of bias. The FDA has only approved four cannabinoid medicines based on this process: a plant-derived cannabidiol (CBD) oral solution for the treatment of seizures associated with two rare, severe forms of epilepsy, and three formulations of synthetic THC cannabinoid products, dronabinol and nabilone, for the treatment of nausea and vomiting associated with cancer chemotherapy or loss of appetite and weight loss in people with AIDS.
Surprisingly, we still see lower levels of evidence used to sanction the marketing of cannabis products as medicine under state medical marijuana laws. Ultimately this is discouraging the investment by companies into FDA-caliber studies of the plant and its medicinal value, limiting the long-term benefit cannabis therapies could have for so many and putting patients at risk. As policymakers, supporting legislation that encourages investment in the scientific study of Cannabis Sativa L. to ensure the safety of derived products is critical.
3FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety Concerns," FDA News Release, November 25, 2019. Available at https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Accessed 9 December 2019.
14“What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” FDA Consumer Updates, November 25,2019. Available at https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis. Accessed 9 December 2019.