Can products that contain cannabidiol (CBD), a non-psychoactive variety of Cannabis sativa
, be sold as dietary supplements? The short answer is no
, according to FDA’s webpage, “FDA and Marijuana: Questions and Answers.”
But the agency’s justification for that position raises a few additional questions.
In the sentences following its negative opinion, FDA states that CBD products are excluded from its dietary supplement definition because of existing authorizations for investigational new cannabis drugs (INDs)—namely, GW Pharmaceuticals' Sativex and Epidiolex. An exception can only be made, FDA says, if the substance in question (CBD) was marketed as a dietary supplement or conventional food prior to those INDs. Well, according to FDA’s references, the IND authorizations became public on November 26, 2007 and May 24, 2014 for Sativex and Epidiolex, respectively. Those dates appear much too late to fit the IND preclusion to many in the CBD supplements industry, including CBD oil supplier CV Sciences (Las Vegas). Here’s what the firm had to say about FDA’s exclusion of CBD:
“Based on that criteria, notwithstanding the FDA’s Q&A Posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, as the investigations that were publicized were not substantial as they were limited in number and preliminary in nature, thereby rendering the IND preclusion inapplicable.”
Perhaps it’s this lack of clear legal language, coupled with FDA’s lack of resources and extensive safety data, that has CBD sales and demand skyrocketing in spite of the agency’s position. The controversial cannabinoid is now appearing in proprietary oils, energy drinks, and cocktails, among other new markets. On top of that, steady traction behind hemp in food products is only helping CBD’s cause.
Regardless of the mixed opinions surrounding marijuana, CBD has proven to be non-psychoactive and safe for use. Although it might not be for everyone, there’s no question the legal language needs to be made clearer. In the meantime, CBD supporters will continue to push forward with new products and an ever-increasing consumer base. And if you look at the following research on various health conditions, that consumer base is poised to grow even bigger in the years to come.
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1. Food and Drug Administration (FDA), “FDA and Marijuana: Questions and Answers,” Questions #12 and #14, www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm, last accessed September 4, 2016.