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FDA Issues Guidance on CBD Products

December 4, 2019

Author

Elizabeth (Izzy) Montgomery, MPA
Policy Analyst
501-526-2244
efmontgomery@achi.net

 

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On November 25, the U.S. Food & Drug Administration (FDA) published a revised Consumer Update regarding safety concerns around products containing cannabidiol, or CBD. CBD is the second most prevalent of the active ingredients in cannabis, derived directly from the hemp plant. CBD does not contain the psychoactive properties often associated with cannabis use, but it has increasingly been marketed as a treatment for a variety of health issues.

The FDA states that much is unknown about CBD, such as its long-term health impacts and interactions with other drugs. The FDA also notes potential harms associated with CBD use, including risk of liver injury and other potential side effects, such as changes in alertness and gastrointestinal problems.

The federal agency has approved only one CBD prescription drug product used to treat two rare forms of epilepsy. In the update the FDA emphasized:

  • It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
  • The FDA has seen only limited data about CBD safety, and these data point to real risks that need to be considered before taking CBD for any reason.
  • Some CBD products are being marketed with unproven medical claims and are of unknown quality.
  • The FDA will continue to update the public as it learns more about CBD.

The FDA also issued warning letters to 15 companies for selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act.