Ask Our Experts 6/2/2019: FDA Holds Public Hearing About CBD, What Happened?


By J.J. McCoy, Senior Managing Editor, New Frontier Data

 

Q: I did not have time to sit through all 120 speakers scheduled for the FDA’s public hearing about cannabis and CBD products on Friday, but can you share some of the key takeaways?

 

A: While the market for CBD products has gained massive momentum in recent years, so too have questions swirled around potential safety issues revolving about marketing claims, quality standards, concentrations, drug interactions, and dosing, particularly regarding products for ingestion by humans or animals.

The FDA is also interested in protecting the efforts and investments made by companies conducting research and developing products. Last year, the agency approved GW Pharmaceuticals’ Epidiolex as the first CBD drug derived from cannabis.

Given such, Friday’s FDA hearing sought to cover a broad array of topics: Representatives from the scientific community, the agriculture industry, manufacturers, and retailers participated alongside health-care professionals, lawyers, and consumer and patient advocates.

The hearing also drew keen attention from stakeholders and speculative investors. According to New Frontier Data’s Hemp Business Journal, CBD-related sales increased more than 3x between 2014 and 2017, to $367 million. It estimates that the market will grow to be worth $2.1 billion by 2020.

Big players like Canadian cannabis producer Canopy Growth is building a hemp production facility in New York, and big pharmacy retailers like Walmart and CVS Health are stocking topical items (but not foods) on their shelves. Others like Ben & Jerry’s are expecting to join in as soon as federal policy may allow it.

Those estimates won’t be achieved, though, without regulations in place to remove uncertainties related to making and selling hemp CBD products.

But do not expect any fast resolutions. The FDA plans to accept more public comments this month through July 2. Then the agency will begin to develop draft regulations and seek input on them before any finalization.

So, while the meeting was a notable first step, there remains a long way to go in determining the next directions for players in the U.S.’s massive CBD market.

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