A piece in Cannabis Wire offers some insight into the FDA’s decision to reject CBD’s use as a dietary supplement. Essentially, the agency doesn’t want to approve CBD as a additive to mainstream products when it’s also the active ingredient in Epidiolex, a pharmaceutical the agency has approved to treat severe pediatric epilepsy disorders.
- In rejections to brands Irwin Naturals and Charlotte’s Web, the agency argued “The term ‘dietary supplement,’” … does not include “an article that is approved as a new drug,” or has been “authorized for investigation as a new drug.”
- It added that Irwin’s application was for a product that “delivers a relatively high amount of CBD per day, comparable to a drug product.”
- The agency also told Charlotte’s Web that it had concerns about evidence of CBD’s safety.
- According to Charlotte’s Web, “this response from the FDA indicates to Charlotte’s Web that without legislation by Congress, this market will remain unregulated.”
- (Disclosure: I’ve done a small amount of indirect consulting work for Charlotte’s Web.)