The US Food and Drug Administration (FDA) has said it cannot conclude that cannabidiol (CBD) is generally recognised as safe (GRAS) for use in food due to a lack of scientific information supporting its safety.
The agency said many unanswered questions and data gaps about CBD toxicity exist, and some of the available data “raise serious concerns about potential harm from CBD”.
A revised consumer update has also been published by the FDA, outlining specific safety issues related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhoea and changes in mood.
“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,” said Amy Abernethy, FDA principal deputy commissioner.
“Aside from one prescription drug approved to treat two paediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety.”
She added: “We recognise the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
The FDA has also issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the US Federal Food, Drug, and Cosmetic Act (FD&C Act).
Some of the products outlined in the warning letters are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added.
Some of the products are also marketed as dietary supplements. CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
The Council for Responsible Nutrition (CRN), the trade association representing the dietary supplement and functional food industry, said the FDA’s move has unnecessarily alarmed consumers.
“FDA’s inaction for the past year has facilitated an unregulated marketplace – which is bad for consumers and bad for business,” said Steve Mister, president and CEO, CRN.
“It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements.”