The Lie of FDA’s Exclusion Rule

Someone please sell a phytocannabinoid product containing all the minor cannabinoids so that a Big Pharma company can’t “pull a GW” and get a monopoly on that cannabinoid from the corrupt FDA.

And do it soon please: the corruption is polluting FDA daily with their Exclusion Rule (ER), used to the exact opposite of its stated mission. If it won’t Congress certainly can; see (ll) in the statute.

The mission of the rule, it’s entire reason for existence FDA says, is to encourage the development of new medicines thereby superseding any dietary supplement from being put on the market with the same ingredient, in this case Cannabidiol from a plant.

However, few compounds in history have had the avalanche of interest as CBD today. Therefore, FDA is using the ER not to encourage development of new medicines, but rather to stymie them for the benefit of just one company.

It’s unfair to the public, to patients, to the market, to good governance, to FDA’s reputation, and ultimately to society to continue this charade. It even has impacts far beyond our borders as the global community of patients is stuck with very few options, some as expensive as $42,000 or more annually. Meanwhile, there are thousands of eager quality qualified cannabinoid companies willing to serve them with safe, effective, standardized medicines made in a certified, GMP factory.

But wait, it gets worse: to invoke the Exclusion Rule, GW’s Epidiolex had to be the first CBD product ever sold legally in the U.S. before its IND application in 2015, and it wasn’t. One example is a CBD nasal spray for Dravet’s Syndrome marketed as Cannatol, which was made in Colorado and sold legally in 2011. There are other prior products legally marketed as CBD before 2015, which is somewhat late to the CBD game. I consider 2010 to be when the U.S. CBD industry as we know it started, Lawrence Ringo‘s genetics work driving it, and a number of CBD products were coming out of Colorado, Michigan, and Humboldt even before 2015.

Plus there are the hundreds of patent medicines made by many of today’s drug companies and dispensed by pharmacists, which even pre-date FDA’s existence by 80 years. Those that contained Cannabis also invariably contained CBD, especially the hemp products using “Cannabis Americana.” Dr. Roger Adams’ patent on CBD in 1942 even mentions that the best source is “wild Minnesota Hemp.”

FDA has done this before, to red yeast rice extract and more recently, to N-acetyl-L-cysteine (NAC). That it invoked the ER against selling of dietary supplement NAC in the middle of a global pandemic is cruelly criminal, as NAC is very effective against virii and was sold over the counter. It’s been almost 60 years since NAC was tested as a drug, and is not on the market today as one.

This rule is costing lives. Demand Congress and FDA do the right thing… for once.

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