Why CBD sales may be banned at any moment in the US

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CBD oil ban is closer than you think

Many people may be surprised by this,  but the US government is still sees unlicensed CBD oil or Hemp oil, as controlled drugs ; which should only be supplied on a legal prescription.   

The reason you may be surprised is because you can still buy CBD oil products from thousands of online shops,   and even from High Street vendors.  And in tens of formulations, from oils, tinctures, to balms and gels.  Some states have even legalised them.

The FDA ( food and drug administration agency) ,  who control all licensing of drugs in the US,  can order the removal of all CBD products from shelves at any moment.  So far they have not taken this drastic step.

Yes, they can order every shop and internet vendor to clear their shelves and cease trading tomorrow!

And not only that, i think we are far closer to the removal of CBD products from shelves then we are to their full legalisation.

 To understand how we reached this critical junction, you have to understand the agenda of all  those who are involved in the medicinal cannabis industry.

Meet the players

The Pharmaceutical Companies

At the time of writing this article,  the FDA has approved only four drugs that are based  on cannabis ingredients. They are:

  • Epidiolex ; for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older    
  • Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients
  • Cesamet

By “approved” we mean these drugs have a licence from the FDA and can be supplied on a prescription.  No other CBD or Cannabis-based product has a licence from the FDA.

The companies who have developed these four drugs had to go through  years of clinical trials,  which cost millions of dollars. They had to demonstrate the safety and the efficacy of their drugs to the FDA – and eventually they were granted a licence to market.

This licence is not indefinite,  The company who launched the drug, usually gets about 10-15 years of exclusivity.   This helps them recoup the money they spent on developing and researching the drug, and of course it helps them break into profit.

So, companies are extremely protective of their drugs because they have a relatively short window to recoup their investment and make some profit.

They would fight tooth and nail to stop a rival product, especially one without a licence, flooding the market selling from shops and internet sites.

The reason they haven’t done this already, is probably because they have enough profits in their own niche for now, that they don’t have to worry about CBD oil supplements being sold in health shops and internet sites.  And a costly legal battle and class actions, that would follow such a drastic move, isn’t particularly appealing either.

  As we mentioned earlier the FDA can remove CBD oil supplements from the market with the stroke of a pen.   This is fully within their legal power. but they will only do this on the request of one of the companies who already hold a licence for a CBD-based drug.  

Any of these companies can get the ball rolling on this and get the FDA to act almost immediately.   And you can bet your bottom dollar they will do this, once the sales of CBD products become a threat to them, or their own niche market becomes unprofitable.

The FDA

The FDA ((US Dept of Food and Drug Administration)) are there to ensure licensed drugs are safe and effective for patients. it’s a simple and clear objective.

They require every licensed drug to demonstrate that it is safe AND effective before giving it a licence.  

And if you think about it,  we should be grateful for this.  Because we all want safe and effective drugs.

One of their key rules is that all licensed drugs go through safety and efficacy experiments to prove themselves. They have already granted licences for 4 drugs based  on cannabis ingredients. So the FDA will struggle to justify legalising other  CBD products without all the usual safety and efficacy trials. it will just seem inconsistent with their own policies.

  Why put the four aforementioned companies ,with licensed CBD-based drugs, through all the trials and expense of developing their drugs,  then legalise CBD products for everyone? to sell as they wish.

The FDA would probably get battered in the courts.  And it’s a hard to see a defence for them.

DEA

The DEA (Drug enforcement adminstration) still view all CBD/hemp products as controlled substances (apart from those with a licence from the FDA). So in their eyes, possession and supply of these products is still a federal offence

Some people believe the DEA “de-regulated” CBD oil.  Absolutely not!!

But, why haven’t they swooped in on the millions of people who openly use CBD products, and the thousands of sellers?

Well, in a rare interview in 2018, a senior DEA official confirmed they are after large traffickers and not individual users.  So it seems it’s a question of priorities for them.

Off course, if the FDA decide they want all unlicensed CBD-based products off the shelves, the DEA will probably enforce this immediately.  But for now, the DEA have bigger fish to fry, than pursuing individual users and high street vendors of CBD.

Having said that, if an individual is in possession of a very large quantity of CBD/Hemp products; the DEA can suspect them of being distributors.  This is something the honest user should bear in mind.

Vendors

These are the small health shops and internet sites who sell CBD products that aren’t licensed by the FDA.  

Some of these are genuinely passionate and knowledgeable about the topic and some are simply jumping on the CBD gravy train for a quick buck. 

Vendors in states with CBD-friendly laws, may even be confident they are in the clear. Not fully realising the threat to their business from the federal branch.

Sellers face an uncertain future.  They could be shut down at any moment.   So building a long term business based on CBD or Hemp products is risky – but lucrative for now. 

“Make hay while the sun shines” might be their motto.

Some of the more strategic vendors may choose to expand internationally to countries with more stable and clearer laws, such as the UK.

Conclsuion

We are many years away from having all CBD products on the shelves without a legal cloud over them in the US. 

Pressure from the big pharmaceuticals, FDA and DEA will not ease any time soon without enormous legal changes which could take decades.

Either the unlicensed CBD sellers will have to do the necessary trials and get their products licensed by the FDA (and spend millions), or they’ll have to find a legal loophole to get their product fully compliant with the law.  But it will be a very clever lawyer who can pull this off.

For users, there will be always be products out there.  The supply won’t be an issue, but the quality of the supply will be varied. 

The system of licensing by the FDA gives reassurance that medicinal products are safe and effective for the intended purpose.  And the fact remains, the vast majority of CBD products have not been through this process.

So, for now, there is an uneasy truce.  And uncertain future.

Glossary:

Cannabis : Cannabis refers to a group of three plants with psychoactive properties, known as Cannabis sativa, Cannabis indica, and Cannabis ruderalis

Marijuana: made from the shredded and dried parts of the cannabis plant, including the flowers, seeds, leaves, and stems

Hemp/Industrial Hemp : A strain of Cannabis grown industrially, typically it is lower in THC and higher in CBD content.

CBD (Cannabidiol) : A compound in Cannabis thought to have medicinal benefits and no psychoactive side effects.

THC: The main psychoactive compound in marijuana that gives the high sensation

 

Do you agree with this analysis? Do you disagree?

Tell us in the comments below!!

A comprehensive review of CBD oil brands in the US

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