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Re: Mithras post# 89493

Sunday, 05/26/2019 4:38:42 PM

Sunday, May 26, 2019 4:38:42 PM

Post# of 186029
I come from the food/dietary supplement space with a heavy FDA regulatory background and can chime in here.

Although Verus would be distributing the product and not manufacturing, both functions within the supply chain of the product are heavily regulated and are expected to remain compliant with FDA standards.

CV Sciences has a self-affirmed GRAS status on their hemp ingredient, which is completely allowable in food products. However, the noncompliance comes from how they're claiming CBD on their labels. They haven't gotten in trouble yet due to uneven enforcement in the FDA.

The FDA has only issued 2 rounds of Warning Letters to CBD companies since 2017 (as far as I know, for example Stanley Brothers being one). Recently, FDA commissioner stated that they're using discretion for targeting these companies with over-the-top claims that revolve around curing/treating diseases. Things like relaxation, stress, improved sleep, etc. are not considered over-the-top.

May 31ST, FDA is holding a public hearing to discuss the direction of CBD-containing products in the industry, with a docket outlining these findings due to be published in July.

All in all, if Verus were to release CBD-containing products, and if their claims are reasonably within the confines of the FDA's current thinking, there would be no problem whatsoever unless something drastic happens during the public hearing. CBD-containing products are NOT fully out of the question at the moment.