The U.S. Food and Drug Administration has issued warning letters to 15 companies for selling products containing cannabidiol (CBD) that are marketed or produced in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act).
The letters, issued on November 25, 2019 to companies in 10 different states, including six in California, warn companies against making unsubstantiated health claims, adding CBD to food, or marketing CBD products as dietary supplements.
“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,’” FDA Principal Deputy Commissioner Amy Abernethy said in a statement.
The agency has previously sent warning letters to companies illegally selling CBD products that claimed to prevent, diagnose, mitigate, treat or cure serious diseases. In 2019 alone, the FDA has issued warning letters to 22 different companies for the illegal sale of products said to contain CBD.
The following 15 companies recently received warning letters:
In July, the agency sent a warning letter to Curaleaf, the world’s largest cannabis company, for labelling products with unsubstantiated claims that the products treated cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety.
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,”
– said Abernathy
Aside from Epidiolex, a CBD-based oral solution approved by the FDA in June 2018, no other CBD products on the market have been approved or tested by the FDA to determine whether they are effective for their intended use, how they might interact with other drugs, what the proper dosage should be, or if they have any possible side effects.
The agency also published a revised Consumer Update, a set of safety guidelines that detail the legality, side effects, and possible long term consequences associated with cannabis-derived consumer products.
These guidelines, which are entitled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” also address the issue of CBD products being marketed with unproven medical claims.
As the title of the guidelines indicates, the FDA and the scientific community in general have limited data on CBD’s safety and its long term effects. The agency says it is working to foster continued CBD research and monitor the marketplace for products that pose a risk to public health.
The FDA has requested that the 15 companies who received warning letters respond within 15 working days stating how they will correct the violations. Failure to alter their business practices in accordance with the FDA’s standards could result in legal action, such as product seizure or injunction.