Update: The Legal Status of CBD in the US
- CBD is the nonpsychoactive component of cannabis and hemp.
- Unlike the THC in cannabis, CBD does not induce a high, but has many clinical benefits, including the control of seizures and pain
- Federal drug laws stipulate cannabis is an illegal Class 1 narcotic
- In states where cannabis has been legalized, buyers and sellers of cannabis rely on federal authorities not enforcing federal drug law
- The US Drug Enforcement Agency (DEA) considers CBD to be cannabis and has scheduled it as a Class 1 narcotic. Hemp growers have sued DEA to deschedule CBD. The case is currently pending before the Ninth Circuit of Appeals
- There is a limited time left for CBD companies to petition FDA to market CBD as a dietary ingredient.
- Once FDA approves GW Pharmaceuticals’ (NASDAQ:GWPH) CBD medicine as a new drug, CBD can no longer be legally sold or marketed as a supplement
- FDA has issued a draft document in which they state they intend to exercise enforcement discretion on homeopathic products, but made it clear they believe homeopathic medicines are unapproved new drugs.
Legal Update on CBD Oil
Cannabidiol (CBD) is the nonpsychoactive component of cannabis. Unlike tetrahydrocannabinol (THC), it does not induce a “high,” but has many clinical benefits, including the control of seizures and pain.
With projections suggesting somewhere between 50,000 and 60,000 Americans will die from opioid overdoses this year there is a dire need of nontoxic pain relief.
CBD oil is one of them.
But, cannabis is classified as a Class 1 narcotic, which makes the legalities surrounding CBD complex.
Here is why
What people must know is that cannabis and hemp are the same plant. It is just the amount of THC that’s in that plant.
The status of cannabis is very clear.
Under federal law, it’s a controlled substance. It cannot be marketed or sold regardless of what the states have done.
The federal government may, might, could clamp down on the states that have legalized cannabis and take action against individuals in those states.
In states where they have legalized cannabis, it depends upon the good will of the federal government not to enforce the US drug laws.
CBD is a different and complex issue.
CBD is part of the hemp plant, and it could also be part of the marijuana plant. It comes from the resin of the plant/s.
CBD is considered by the Drug Enforcement Administration (DEA), to be a controlled substance. It is considered to be marijuana.
There is a case now pending before the Ninth Circuit of Appeals. Oral hearings were argued on whether DEA’s scheduling of CBD is appropriate. We expect a decision of the Ninth Circuit from a DEA perspective probably sometime mid-Summer, no later than September 2018.
The lawsuit was brought by several hemp growers against the DEA. It has been going on for a while, and now at the Court of Appeals stage.
The arguments look very strong that the DEA has overstepped its bounds.
From a controlled substance point of view, that decision of the Ninth Circuit will either be a game changer, or it will be the homeopathic industry’s worst nightmare.
And of course there is the Supreme court…and then there is Congress, the ultimate decider for The People nationwide.
Considering CBD is nonpsychoactive, there is nothing for DEA to be concerned about. One cannot get high on it, it is not addictive.
Taking these facts alone, it makes no sense to regulate CBD as a Class 1 narcotic, a possible motive to do so may have to with Big Pharma.
The Big Q: Why?
The Big A: By eliminating CBD, drug companies stand to make more money from drug sales.
But, Big Pharma may want CBD to be descheduled too, as companies have started developing CBD-based drugs.
And, they are not going to want it to be a controlled substance.
Now if the Ninth Circuit case goes badly, I believe that when the FDA approves GW Pharmaceuticals’ new drug, there will ultimately to be a recommendation to deschedule CBD from the FDA.
The future of homeopathic remedies in the US
I expect they will remain under assault, and doubt the FDA will ever finalize its draft guidance document because it knows that when you finalize things, it has other repercussions.
On Homeopathic companies
So, homeopathic companies will likely continue to be sued until or unless the FDA admits that homeopathic remedies are appropriate and legal.
Companies must also take care to be consistent with the materia medica to ensure their claims are not misleading the public.
We believe that if a person feels that a homeopathic is helping, that person should be allowed to use it, especially when you consider all the other things people allowed to use that come with significant if not extreme risks, be it cigarettes, alcohol or over-the-counter medications.
The FDA’s public comment period expired on 30 March, so we wait, watching for the coming developments.
The FDA has issued a draft document where in it states it intends to exercise enforcement discretion on homeopathic products, making it clear they believe homeopathic medicines are unapproved new drugs.
|NASDAQ:GWPH||132.43||20 April 2018||-1.66||136.14||136.25||127.8||686,935|
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|Neutral (0.21)||Neutral (0.17)||Bullish (0.32)||Neutral (0.14)|
Have a terrific week
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