The U.S. Food and Drug Administration (FDA) objected to an application made by Charlotte’s Web, the top-selling CBD brand in the U.S., to sell its full-spectrum hemp extract as a dietary supplement. Charlotte’s Web Chief Executive Officer Deanie Elsner reported that despite providing extensive scientific evidence, the FDA’s objection to the application was partly based on its prior approval of Epidiolex, a CBD drug to reduce seizures.
The cannabinoid’s prior approval as a drug precludes the FDA from authorizing CBD for dietary purposes. The agency also articulated concerns about the adequacy of safety evidence that Charlotte’s Web submitted, requiring more data on potential liver damage and reproductive toxicity. The company responded with further correspondence suggesting that the conclusions drawn by the FDA did not appear to be based on the data provided in its application. In a separate letter to the FDA dated Aug. 3, Charlotte’s Web said its submission included data that showed no effects on reproductive organs or liver damage.
According to Elsner, the decision suggests that the path to achieving regulatory clarity for CBD must come from Congress. Los Angeles-based supplement retailer Irwin Naturals also filed applications with the FDA that were rejected.
The FDA’s ruling on the Charlotte’s Web and Irwin Naturals applications won’t disrupt the companies’ efforts to continue selling their hemp products containing CBD. Similar to many brands retailing CBD, the products retail in a legal gray area. CBD is currently sold in a climate of regulatory uncertainty, rendering its manufacture, advertising, and retail challenging for all involved with the industry. Nonetheless, the agency periodically comes down hard on companies that make unsubstantiated health or therapeutic claims.
There are currently a number of initiatives underway to encourage Congress and the FDA to adopt a clear stance with respect to FDA regulation, such as Regulate CBD Now, which is backed by the U.S. Hemp Roundtable.