The FDA Issues Hemp-CBD Warning Letters and a Consumer Update

Rather than providing guidance to or issuing regulations concerning manufacturers of Hemp-CBD products, the FDA has focused on telling consumers and Hemp-CBD businesses that most Hemp-CBD products are not legal and not safe. On November 25, the agency issued warning letters to 15 businesses selling hemp-derived CBD (“Hemp-CBD”) products as unapproved drugs. These letters warn Hemp-CBD companies that are making health claims about Hemp-CBD products. The FDA also released updated consumer guidance on Hemp-CBD. Warning Letters The recent batch of warning letters appear to turn on the marketing of Hemp-CBD products as unapproved drugs. This could include changes in alertness, most commonly experienced as somnolence (sleepiness), but this could also include insomnia; gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite, but could also include abdominal pain or upset stomach; and changes in mood, most commonly experienced as irritability and agitation.