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Wednesday, November 01, 2017 10:43:13 PM
http://www.kkblaw.com/lessons-from-red-yeast-rice-factors-to-consider-regarding-fdas-position-on-cbd-supplements/
then here is the cvsi response to the fda feb 2016 where they begin to build the case and attack the timeline of the "substantial clinical trials":
https://www.newcannabisventures.com/cv-sciences-responds-to-fda-warnings-issued-to-8-marketers-of-cbd/
then the "gras" section read page 23 question 2:
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf
2. Am I required to submit an NDI notification for a dietary ingredient that is an NDI, but has been (a) listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food or (b) approved as a direct food additive in the U.S.?
No, as long as the following conditions are met....[read the rest]
Are you confused yet? We still arent done. There is a little thing called the Sherman Act of 1890:
As explained by the U.S. Supreme Court in Spectrum Sports, Inc. v. McQuillan 506 U.S. 447 (1993):
The purpose of the [Sherman] Act is not to protect businesses from the working of the market; it is to protect the public from the failure of the market. The law directs itself not against conduct which is competitive, even severely so, but against conduct which unfairly tends to destroy competition itself.
So does giving the pharmaceutical industry a MONOPOLY over the natural product industry destroy competition unfairly? How can cbd oil from hemp flower have been expected to be marketed as a dietary supplement when per the DEA it was illegal. Perception is reality and DEA sabre rattling prevented cbd oil from being marketed before "substantial clinical trials" regardless of the true legality of cbd oil from hemp flower.
The FDA will come in say; well we are protecting the market.
But if it is self affirmed GRAS (Generally Regarded as Safe) that argument holds no water. The product is safe the public does not need protection; at least from pluscbd that is. cant vouch for the rest.
SEE YOU IN FEDERAL COURT
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