First up we have……
How long is the FDA review going to take?
Dr. Amy Abernethy, FDA deputy commissioner and head of CBD working group, via Twitter:
“We are reviewing available databases and medical literature about CBD’s safety. Thus far, the data appear insufficient.
“We will communicate lessons learned and next steps as quickly as possible after each step. … As we learn more, our goal is to update stakeholders about our path forward and provide consumers with the information needed to make smart choices about CBD products.”
Now.. what the lawyers say
Emily Leongini, attorney in the FDA practice at law firm Arent Fox
“The FDA understands what an important issue this was for Congress. There are a number of statements where they said, ‘Look, we heard you loud and clear that hemp and hemp derivatives are very important legislative priorities. But here we are, we’re stuck here with (regulatory protocols) that say this.’
“And so we understand that hemp is a big priority for you, Congress. So, if it really is, then you can go ahead and issue the fix much more quickly than we are able to.’”
Marc Press, corporate finance and cannabis attorney, Cole Schotz law firm
“You cannot, should not make any therapeutic claims. That will clearly raise the ire of the FDA and (bring) the potential to receive a cease-and-desist letter.
“This is hard to predict, but I would expect that that approach will probably not change very much. Especially given the breadth of the market. …
“If the FDA says, ‘It’s going to take us 2½, three years to come up with a set of regulations, and in the meantime you have to stop selling this stuff,’ hopefully Congress would then act.
“My advice to clients is, ‘I can’t give you absolute assurance that what you do is not unlawful.’
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