Federal health regulators have rejected the sale of full-spectrum CBD as a dietary supplement, a signal that CBD products will remain legal under federal law only by prescription in the U.S.
The Food and Drug Administration announced the decision this week in letters to CBD makers Charlotte’s Web of Colorado and Irwin Naturals, which sought agency clearance to market its extract as a “new dietary ingredient.”
The FDA pointed to two reasons for the rejections:
- CBD is the active ingredient in a pharmaceutical drug and therefore should not be available over the counter.
- Insufficient data about CBD safety and efficacy.
Charlotte’s Web said in a response to FDA that its full-spectrum extract is distinct from pharmaceutical CBD, which is an isolate that doesn’t contain other cannabinoids.
Charlotte’s Web said in a press release that its business would be unaffected but called on Congress to intervene and designate hemp-derived CBD as a dietary supplement. A bill to do that is pending in the Senate but has yet to see a vote.