FDA says CBD is “not safe,” requires more research
The U.S. Food and Drug Administration (FDA) issued a statement to consumers on Monday saying more research must be done before cannabidiol (CBD) can be considered safe. The agency also issued warning letters to 15 companies for illegally selling products containing CBD as dietary supplements and adding CBD to human and animal foods.
In June, the FDA held a public hearing to get feedback on regulations for CBD. The hearing featured more than 100 individuals and ten hours of testimony, after which the status of CBD products remained unclear. The agency seemed to recognize a need for urgency but emphasized taking the time to ensure the regulatory path is scientifically sound and in the best interest of public health.
Then, in October, the FDA along with the Federal Trade Commission, issued a joint warning letter to a company for illegally selling unapproved products containing CBD online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease.
In the consumer update, the FDA reminded companies and consumers that it has only approved one CBD product, Epidiolex, a drug used to treat rare and severe forms of epilepsy. It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement, the agency said.
The FDA said it has only seen limited data about CBD safety, and data point to risks that must be considered before taking CBD for any reason. Further, some CBD products are being marketed with unproven medical claims and are of unknown quality.
Despite the 2018 Farm Bill removing hemp, defined as cannabis and cannabis derivatives with very low concentrations tetrahydrocannabinol, from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance, the agency said.
Following the hearing, the FDA said it became concerned that many people are using CBD products without considering the potential harm, even though only limited data exist. The agency is calling on consumers to use caution with CBD products. “CBD has the potential to harm you, and harm can happen even before you become aware of it,” the statement said.
The FDA said CBD can cause liver injury, affect metabolism of other drugs causing serious side effects, and use of CBD with alcohol or other central nervous system depressants increases the risk of sedation and drowsiness. It can cause side effects, including changes in alertness, gastrointestinal distress, and changes in mood. Additionally, many unanswered questions remain, including the long-term effects of daily CBD use and how CBD interacts with other herbs and botanicals.
Unlike Epidiolex, unapproved CBD products, including drugs, cosmetics, foods, and products marketed as dietary supplements, have not been subject to FDA evaluation regarding whether they are effective to treat a disease or other condition. They have also not been evaluated to determine proper dosage, drug or food interactions, or side effects and safety concerns, the agency said.
The FDA said its top priority is to protect public health, including making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. The agency also said it will hold companies accountable for illegally selling CBD products. The agency will continue to monitor the marketplace and evaluate regulatory frameworks.
“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,” said Amy Abernethy, MD, PhD, FDA Principal Deputy Commissioner in a statement. “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.”
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