FDA knows or reasonably should have known when it accepted GRN-778 allowing hempseed oil as Generally Recognized As Safe (GRAS), that hempseed oil usually contains small amounts of cannabinoids in the resin stuck to the outside of the shell, including THC, and CBD at 20 times higher levels than THC.
FDA knows or reasonably should have known that many CBD products were on the market before GW Pharmaceutical’s IND application in 2015, thus is improperly using the Exclusion Rule.
FDA knows or reasonably should have known that its application of the Exclusion Rule is in opposition of its stated reason for the Rule, “to encourage new product development;” few products in history have had as much interest for new products as CBD.
FDA allowed CVSI and CW to self-certify its CBD products as GRAS.
FDA solicited comments on “Development of a List of pre-DSHEA Dietary Ingredients” a list of ingredients pre-DSHEA, CBD should be on it, and it’s own FAQs state: “added” CBD.
If FDA still maintains it is Schedule 1 and of no medical value, then how is it a conflict to rule it is a food existing before 1994?
FDA knew or reasonably should have known CBD in foods and other products in the US is older than FDA itself (from my submission)
FDA’s single-molecule fetish is on a collision course with Cannabinoid products makers’ multi-molecule ethos. It would be wrong to force the industry to conform to an anti-scientific and impractical set of rules written in the last century.
Like they did with DSHEA for dietary supplements, we need a new protective law and an Office of Cannabis Products.
FDA knew or reasonably should have known that Cannabis has medical value since 1970, with 24,000 studies on U.S. government-funded PubMed; 47 of the United STATES found medical value
FDA knew or reasonably should have known that Congressional intent was for Cannabis to be in Schedule 1 only temporarily, awaiting the Shafer Report. Once Nixon buried the report, FDA should have acted to deschedule in order to maintain its scientific credibility.
As even DEA once said: “marijuana is the safest therapeutically active substance known to man,” elimination of all risk is not the goal and never has been the goal. After all, FDA allowed 500,000 over 5 years to die from Vioxx before pulling it off the market.
FDA was an active participant in giving scientific cover for a purely racist and unconstitutional law for over 51 years.