FDA to Expedite CBD Rulemaking Process Following Period of Public Input
Following a public hearing held by the FDA regarding regulations for the CBD industry on May 31, 2019, and a period of public comment through July 20, 2019, the acting FDA Chief Information Officer, Amy Abernathy, publicly announced on Twitter that the FDA intends to “expedite” the rulemaking process regarding CBD.
This seems to be a step in the right direction considering former FDA commissioner Scott Gottlieb had stated in June that the rulemaking process could take as long as three to five years.
Unfortunately, many industry experts believe that the FDA’s definition of the word “expedite” might not match up with today’s common usage of the word. According to the FDA, the next steps are to compile the public input and take it into consideration in formulating its plan of action. The FDA anticipates reporting its findings sometime in late summer or early fall of this year. The timeline as to the publication of any meaningful regulations remains unclear.
One can’t really blame the FDA for dragging its feet, however. There is a need to balance the huge potential benefits that CBD may have for consumers with the FDA’s imperative to protect American consumers.
Ms. Abernathy said as much on Twitter when she stated the FDA’s intent to expedite the rulemaking process. But the FDA seems to be neglecting one very important point. The reality is that CBD products are completely legal for sale and are currently available to consumers, with or without FDA approval.
The longer the regulatory process is prolonged, the less information is available to consumers regarding CBD products. And right now, there isn’t much credible information available at all, at least not carrying the FDA’s stamp of approval.
In the meantime, one thing that is clear. The FDA intends to continue cracking down on unsubstantiated claims used by companies in marketing their CBD products.
On Monday, July 29, 2019, the FDA issued another warning letter. This time to CBD producer Curaleaf, warning them that they were selling illegal CBD products containing unsubstantiated claims on their website.
The warning letter informed Curaleaf that they had 15 days to rectify their misconduct or face substantial penalties. As a result, CVS Health pulled out of a contract with Curaleaf to market their products in 800 retail locations across 8 states.
The moral of the story is, even if we know nothing else about how to legally produce, market, and sell CBD properly under FDA regulations, DO NOT make unsubstantiated claims about the effects CBD products have on users. And at least so far (unless your name is Epidiolex, the only FDA approved drug containing CBD), that means don’t make any claims as to CBD’s health effects at all or sell any products that do.