As it fired off warning letters to 15 companies for illegally selling cannabidiol-based products, the US Food and Drug Administration this week said there should be no presumption of safety about CBD as an ingredient in food and supplements. 

The FDA also published a revised Consumer Update detailing “safety concerns” about CBD products more broadly. Based on what the regulator says is “the lack of scientific information supporting the safety of CBD in food”, the FDA stated that it “cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food”.

This week’s developments come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address “outstanding questions related to the safety” of CBD products.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA principal deputy commissioner Amy Abernethy.

“…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”

“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.’ Aside from one prescription drug approved to treat two pediatric 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 – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize 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 also warns about what is says are the “many unanswered questions and data gaps about CBD toxicity”. Some existing data, it says, “raise serious concerns about potential harm from CBD”. The regulator’s Consumer Update outlines specific safety concerns, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. The FDA also points to studies in animals “that have shown CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behaviour in males”. It adds that “questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women”.