According to The Wall Street Journal, The Food and Drug Administration (FDA) is determining whether legal cannabis is safe in food or supplements and plans to make recommendations for regulating the growing number of cannabis-derived products in the coming months.
“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,” said FDA Principal Deputy Commissioner Janet Woodcock, who has led the agency’s efforts looking at cannabis regulation.
Patrick Cournoyer, who heads the FDA office developing the agency’s cannabis strategy, said the agency wants to know whether CBD can be safely eaten every day for an extended period or during pregnancy, for example. He pointed to concerns about future fertility.
Congress legalized hemp and its resulting products in 2018 but left them to the FDA to regulate. Since then, makers of products such as CBD oil have operated without specific federal rules guiding their manufacture or marketing, while some states have moved ahead with their own rules.
Large companies have held off investing in the space as they wait for the agency to decide whether cannabis-derived products can be treated as food or supplements rather than as drugs. Yet cannabis-derived products have still proliferated: A 2021 report by the FDA said the $4.6 billion market was expected to quadruple by 2026.
Currently, the agency said CBD and similar chemicals cannot be added to foods or marketed as supplements. If companies make therapeutic claims about their products, they must prove with clinical trials that they meet the agency’s standard for new drugs.
After weighing the evidence, the FDA will decide within months how legal cannabis should be best regulated and whether that will require new agency rules or legislation from Congress.