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These links on self-affirmed GRAS are NEARLY WORTHLESS.

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MartyTamreau Member Level  Saturday, 11/09/19 10:17:08 AM
Re: Richard Roper post# 60768
Post # of 61165 
These links on self-affirmed GRAS are NEARLY WORTHLESS. When you include a link from "StopKillingMyKids", well, as a science major and physician, the scientific validity of this link is worthless. Also you included a couple of law firm looking for business.

Thanks for reminding us that GRAS is complicated (not being sarcastic). It is. Here's the thing about the supplement industry (CBD is not regulated like that YET, but wait till the interim rule comes out - IMO, that's the route). So supplement companies by DSHEA are expected to assure the safety of their products. How? By studies, by quality standards, by having an adverse event monitoring system in place. Getting GRAS, either self-affirmed or FDA blessed, requires toxicology studies, which CVSI has already completed (and published). I don't believe there are other tests they need to conduct to satisfy that requirement. IMO, they will file an NDI (new dietary ingredient) application, and include the toxicology data. Then FDA can review both. I assume CVSI will announce that as soon as it's done, and I suspect they would have done it earlier, but the regulatory framework is still far from clear. Why do you think hiring Duffy was such a brilliant coup? Because he's a star in the space and has decade long relationships with FDA regulators in the food and dietary supplement space.

Self-Affirmed GRAS worthless? Far from it. Not the panacea, but part of a very complicated end game that CVSI, under Dowling's leadership, is executing.

And putting stuff in all CAPS is a way to get less attention on this board rather than more attention. I'm sharing that because I'm such a magnanimous guy.

All the best.

MT

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