The Food and Drug Administration is beginning to examine whether cannabidiol, the cannabis extract also known as CBD, is safe in food and supplements, according to a report from the Wall Street Journal.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” FDA Principal Deputy Commissioner Janet Woodcock told the outlet. Patrick Cournoyer, who leads the agency’s Cannabis Product Committee, told the Wall Street Journal that officials want to determine whether CBD can be ingested during pregnancy, referencing concerns about future fertility among users.
CBD is created in a laboratory or derived from hemp, a plant related to marijuana, according to a report from Harvard Medical School. The FDA nixed regulations on CBD with respect to research trials in 2015 before hemp was legalized in the United States three years later.
The compound is presently utilized to decrease the severity of anxiety, insomnia, and chronic pain, according to Harvard Medical School. Side effects, however, may include nausea, fatigue, and irritability, as well as blood thinning. The FDA does not currently regulate CBD due to its classification as a dietary supplement rather than a medication.
The worldwide market for legal cannabis is expected to grow from more than $33 billion to $57 billion within the next four years, according to a projection from cannabis market researcher BDSA. The company forecasts that cannabis products intended for medical use will become available in Alabama, Kentucky, North Carolina, and South Carolina next year.
President Joe Biden recently signed the Cannabidiol and Marihuana Research Expansion Act, which is intended to “encourage valid scientific and clinical research on marihuana and its compounds, expand sources of research-grade marihuana, and promote the commercial production of FDA-approved drugs derived from CBD or other marihuana compounds,” according to a fact sheet from the Senate Caucus on International Narcotics Control. Among other provisions, the law will permit accredited medical schools and research institutions to manufacture cannabis.
The increased acceptance of medical marijuana products occurs as proponents of criminal justice reform encourage decreased sanctions for offenses related to the substance. Biden recently issued a mass pardon of individuals convicted of simple possession.
The specter of regulation on CBD products also comes after the FDA placed a marketing denial order earlier this year on e-cigarette products manufactured by Juul Labs, claiming that the vapes create exposure to toxic chemicals. The company, which submitted more than 110 studies in an application with the agency, said in filings that its e-cigarettes contained at least 82% fewer harmful substances than IQOS, a tobacco device sold by Philip Morris International.
“We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” former FDA Commissioner Scott Gottlieb said in 2018. “While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine.”