Saturday, November 09, 2019 10:17:08 AM
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
Recent CVSI News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 08:54:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 01:28:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 01:10:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/12/2023 02:36:49 PM
Lingerie Fighting Championships Signs Broadcast Deal With Maybacks Global Entertainment • BOTY • Sep 26, 2024 9:00 AM
Maybacks Global Entertainment and Lingerie Fighting Championships Enter Into Broadcast And Revenue Sharing Agreement • AHRO • Sep 26, 2024 8:30 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM