May 20th, 2015 – The FDA has concluded that products containing cannabidiol (CBD) derived from hemp cannot be marketed as dietary supplements. On the Q & A section of its web site, the FDA has posted to following:
Q. Can products that contain cannabidiol be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
This opinion will certainly deal a blow to the CBD industry which has grown rapidly over the past few years. San Diego-based CannaVest has annual sales of CBD products in excess of $10 million annually, and HempMedsPX had sales in excess of $14 million last year. This growth is due to the public learning about the health benefits of CBD for treating epilepsy and many other conditions.
In the Q&A section the FDA is asserting that an investigation of new drug trial (IND) was authorized by the FDA and preceded the availability of hemp-based cannabidiol dietary supplement products being made available to the public and then therefore, cannabidiol does not qualify as a dietary supplement. They do however leave the door open for industry players to provide evidence to the contrary. The FDA has not indicated when the IND was issued, although is likely refers to trials being conducted by GW Pharmaceuticals of their CBD drug known as Epidiolex to treat rare forms of childhood epilepsy known as Dravet syndrome and Lennox-Gastaut syndrome.