FDA does not recognize full spectrum CBD as a dietary supplement
The decision clearly demonstrates the attitude of FDA experts towards hemp extracts as those whose therapeutic properties are insufficiently proven or questionable. In particular, in the correspondence published by the Office with & ldquo; Charlotte's Web & rdquo; and & ldquo; Irwin Naturals & rdquo; data was requested on the effects of full spectrum CBD use associated with male reproductive toxicity as well as adverse effects on the liver.
The US Food and Drug Administration (FDA) has rejected applications to sell full spectrum CBD as a dietary supplement to two US companies. The FDA informed about this kind of decision in letters from CBD to manufacturers - & ldquo; Charlotte's Web of Colorado & rdquo; and Irwin Naturals, which have requested permission from the above government agency to sell their full spectrum extract as a 'new dietary ingredient'.
The FDA has identified two reasons for denial:
1. Cannabidiol (CBD) is an active ingredient in pharmaceuticals and cannot be sold without a prescription;
2. Insufficient data on the safety and effectiveness of CBD.
Commentary of the specialists of the Association & ldquo; Ukrainian technical hemp & rdquo;
According to information published on the FDA website, companies' applications for the sale of full spectrum CBD as a dietary supplement will not be considered due to the management's own preliminary decision to consider cannabidiol as a drug. This kind of decision clearly demonstrates the attitude of FDA specialists towards hemp extracts as those whose therapeutic properties are insufficiently proven or questionable. In particular, in the correspondence published by the Office with & ldquo; Charlotte's Web & rdquo; and & ldquo; Irwin Naturals & rdquo; data was requested on the effects of full spectrum CBD use associated with male reproductive toxicity as well as adverse effects on the liver.