Tuesday, February 19, 2019 5:14:51 PM
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Sent: Tuesday, February 19, 2019 3:17 PM
One other question on the status of self-affirmed GRAS please: is it CV Sciences contention that Self-Affirmed GRAS will be lead to FDA approval of only the CVSI proprietary CBD because of the CVSI process?; or would the FDA approval of our Self-affirmed GRAS mean that CBD would then be approved as GRAS for anyone to use the status? There is a lot of confusion out there about the use and value of the research we did and whether it will uniquely benefit CVSI, or if all companies will gain.
Thanks,
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Answer from IR:
"Generally, a GRAS application comes from the ingredient supplier, not the finished product supplier like CVSI and we aren’t selling to other finished supplement producers. So, I do not believe that GRAS status will apply to any other CBD producer, as has historically been the case. The FDA doesn’t approve research on supplements, yes on the drug development side, but for supplements, the FDA doesn’t approve efficacy, just weighs in on safety."
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