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FDA Says CBD Products Are 'Potentially Harmful'

Nov 29, 2019

FDA Says CBD Products Are 'Potentially Harmful'

The US Food and Drug Administration (FDA) has released a new consumer update advising the public that cannabidiol (CBD) and CBD-containing products “have the potential to harm” consumers.

The FDA also announced the issuance of 15 warning letters to various American CBD companies for illegally selling products containing CBD “in ways that violate the Federal Food, Drug, and Cosmetic Act,” and the decision to not include CBD as a produce generally recognized as safe for use in human or animal food.

The warnings come at a time where the FDA is re-evaluating its regulatory framework for CBD and CBD-containing products. In the summer, more than 4,400 individuals and organizations responded to an FDA open comment period seeking feedback on potential reforms.

 

What does the FDA have to say on CBD?

In their latest consumer update, the FDA re-iterates their position that CBD should not be added to food as a dietary supplement, nor should it be advertised with associated unproven or misleading medical claims.

The update advises that CBD “has the potential to harm you” and that those harms “can happen even before you become aware of it.”

The update specifically references the possibility of liver injury and adverse drug interactions, leading to serious side effects. Also mentioned are potential changes in alertness and mood, and gastrointestinal distress.

The concern over liver health comes from the clinical trials for the oral CBD solution Epidiolex, which was approved by the FDA last summer to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Those trials noted elevated liver enzymes in participants and cautioned that Epidiolex patients be made aware that mild liver injury was a potential side effect of the treatment.

The FDA notes that while the risk of liver injury can be managed when taking CBD-based drugs under medical supervision, this may be harder to manage outside of that supervision, which is why it’s now cautions the public to stay clear of non-prescription CBD products.

The federal agency also highlights animal several studies linking CBD use to decreasing male fertility and the potential for unpredictable drug interactions between CBD and prescription medicines or dietary supplements.

“The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD,” the agency wrote in the update. “However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket."

 

Guidelines for companies selling CBD

The FDA has now officially indicated that it cannot conclude CBD to be generally recognized as safe (GRAS) to use in human or animal foodstuffs. This means that CBD is now an “unapproved food additive” under federal law, and that its inclusion in human or animal food would be a violation of the Federal Food, Drug, and Cosmetic Act.

It appears that hulled hemp seed, hemp seed protein powder, and hemp seed oil, which were given GRAS notices last winter, will continue to be GRAS as the ingredients contain only trace amounts of CBD.

In light of the new GRAS decision, and in keeping with previous rules restricting the advertising of CBD with unproven or misleading medical claims, the FDA issued 15 warning letters to CBD companies in ten different states.

Some of the companies’ offences included marketing “unapproved new human and animal drugs,” selling CBD products as dietary supplements, and adding CBD to foodstuffs. Some products were also marketed for infants and children, who are “a vulnerable population that may be at greater risk for adverse reactions,” according to the FDA. One product was also intended for food-producing animals and the FDA expressed concern over the safety of milk, meat, or eggs for human consumption that came from animals fed CBD.

The FDA has given all the companies 15 working days to respond with their plans to rectify the violations listed in their warning letters. A failure to correct their operations “may result in legal action, including product seizure and/or injunction.”

 

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