The U.S. Food and Drug Administration detailed its concerns regarding the safety of CBD on Tuesday while issuing warnings to 15 companies the agency says are illegally marketing products containing the cannabinoid. In a consumer update posted to its website, the FDA said that only one pharmaceutical, Epidiolex, has been approved by the agency for the treatment of patients with two rare forms of epilepsy. For others, the potential risks may outweigh the benefits.
“The FDA is concerned that people may mistakenly believe that trying CBD ‘can’t hurt,’” the update reads. “The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered.”
The update noted that it is currently illegal to add CBD to foods or label CBD products as dietary supplements. The FDA also detailed several potential risks of CBD that have been discovered through scientific research, including the possibility of liver damage and interactions with other drugs. The agency also warned that studies of laboratory animals revealed a risk of male reproductive toxicity from CBD in males and the male offspring of females that had been given CBD, such as a decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone.
The FDA also warned consumers that products with CBD were being marketed with unproven medical claims and could be produced with unsafe manufacturing practices. The update also noted that CBD was being added to products for animals, another use that has not yet been approved by the agency.
Warnings Issued to 15 CBD Companies
Also on Tuesday, the FDA announced in a press release that is has issued letters to 15 firms warning them that they are marketing CBD products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA said that the companies had been marketing CBD products illegally, including adding the cannabinoid to foods, labeling CBD products as dietary supplements, or advertising the products as a treatment for diseases. The federal regulator also announced that it could not “conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
“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,” said FDA principal deputy commissioner Amy Abernethy. “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.”
Attorney Dave Rodman, the founder of The Rodman Law Group in Denver, said in a statement that Tuesday’s actions by the FDA change little and seem to be an attempt to buy the agency time and stifle the explosive growth of an emerging industry.
“Yesterday’s actions were an attempt to throw cold water on the red-hot CBD market, but it’s likely a case of ‘too little, too late,’ as the industry has already priced-in this information,” said Rodman. “There is nothing new or previously unknown in the warning letters or the Consumer Update. This is just a restatement of existing policy, albeit in a dramatic fashion. Nothing has changed from FDA, except possibly a slight indication of increased likelihood of intervention in the industry.”