Tag Archives: CBD

CBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from cannabis and its components, including cannabidiol (CBD). Recognizing the need to provide clarity on the authority of FDA to regulate these products, and what pathways are available for marketing them, the agency outlined its next steps:

  • A¬†public hearing¬†will be held on May 31, and written comments are being sought from the public.
  • FDA is forming a high-level internal agency working group to explore potential

FDA Approves Marijuana-Derived, CBD-Containing Drug Epidiolex to Treat Certain Epilepsy-Associated Seizures

On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, an orally administered drug derived from the marijuana plant, Cannabis sativa. The drug is approved for use for patients two years and older, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, both of which are rare and severe forms of epilepsy. It is the first drug that FDA has approved for Dravet patients.…

LexBlog