The cat is out of the bag and so are CBD and other cannabis products.  You can find CBD in almost anything (creams, ointments, lotions, foods, supplements) and almost everywhere, including gas stations, 7-Elevens, supermarkets, flea markets, and fairs, etc.  I am certain that Amazon drones will be dropping it off at your front door soon.

In addition, with the number of states legalizing cannabis products and the ubiquity of CBD, the future of regulation lurks in the shadows, just waiting to pounce onto the public stage.  The FDA, in a pre-publication Federal Register Notice (here), announced an extensions of the “comment period for the notice that appeared in the Federal Register of April 3, 2019.  The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”  The extension is for an additional two-week period (ending July 2, 2019) albeit that during the public hearing some of the attendees asked for a thirty-day extension.

As of the date of this blog, the Agency has received 1,458 comments and counting.  Most of the comments give testimonial accounts of the benefits of these products and many ask the FDA to leave the arena alone from a regulatory perspective.  Some indicate that the different products do different things and, thus, the Agency should let the public, on its own, decide which products to use and how to treat their ailments.  Some comments call the current situation the wild, Wild West!  So how does the Agency corral the beast and provide not only some order to the burgeoning industry, but also provide knowledge to consumers to allow them to make appropriate choices and provide some expectation of the effectiveness and quality of the products?  That is question number one!

Question number two is how does the Agency employ its scarce resources to take on this potentially massive market segment in an orderly and fair manner?

We will leave these questions and this argument to simmer in the pot of public opinion until the FDA decides to take whatever bold steps it may decide to pursue, and will leave you with a couple of more questions to ponder:  When will the Agency actually take action?  Who will it invite to help (as the task may be too large for it to handle on its own – remember the DESI review)?  And what will the regulatory landscape look like when the FDA finally emerges after wading into this pond full of aligators?