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The FDA takes on CBD oil as a ‘new’ drug: how ‘new’ is it?

Published on: 07/5/16

CBD oil

The status of CBD oil with the FDA can be pretty hard to get one’s head around as a report in the Portland Mercury shows. The reporter started off by scoffing at Facebook users who said the FDA was going to “outlaw CBD” and went on to say that CBD oil is not a controlled substance. After all, it couldn’t make you high even if you drank a whole bottle of it, right?

Right! CBD couldn’t make stoners happy if they tried – but CBD is a Schedule 1 controlled substance – at least, so the DEA would like us to believe. Could they be wrong about that?

Can the DEA say CBD oil is a controlled substance?

Legal expert Robert Hoban says the matter has gone to court. To find the answer to this question, you have to look at the Controlled substances Act (CSA). What does it say? Absolutely nothing about CBD! The Hemp Industries Council actually won a 2003 court battle with the DEA. The verdict said that the DEA stance on CBD was “invalid and unenforceable”. So much for that…

Yes CBD oil is a medicine and no, it isn’t!

The author of the Portland Mercury article then struggled to get to grips with yet another confusing set of facts. In warning letters to CBD oil companies, the FDA advised that no drug claims should be made. In the same letter, CBD oil companies were told that their products can’t be marketed as ‘health supplements’. Why? Because the FDA currently considers CBD to be a new drug.

For a news reporter struggling to understand the FDA’s stance on CBD oil, this is clearly confusing. He has obviously read about seizure prevention and all the other things people say CBD helps with, and many of those stories are pretty dramatic. The FDA also says CBD oil is a “new drug” while in the same breath saying that it can’t be sold – either as a drug or a health supplement. What on earth?

Why no medical claims for CBD oil?

It’s easy to understand what the FDA’s problem with CBD oil medicinal claims is. A lot of the things people are saying it does are backed only by their personal stories, and yes, there could be 100 personal stories, and even doctors who say CBD oil works – but this is what is known as ‘anecdotal evidence’. It’s not the same as scientific evidence that comes from large ‘double blind’ clinical trials.

Oh, sure, there have been some scientific trials too, and some of them have even been conducted on people as opposed to test tubes or mice. But if you read the bit that says ‘Conclusion’, the best you’ll get from most of them is “shows promise” and “further trials are needed”. That’s the point where one really does understand what the FDA is trying to do. They’re waiting for that all-important, irrefutable proof.

You can’t go around telling people you’ve got a cure for cancer when cancer occurs in hundreds of forms and you don’t have actual proof for anything you say. That’s called ‘unethical’, at least from a medical and scientific perspective.

However, calling CBD a “new” drug is a joke. People are known to have used hemp as a medicine for thousands of years. OK, so they didn’t know about CBD as such. Molecular biology hadn’t been invented yet. They didn’t even know what a molecule was. But ‘new’? Hardly!

Not a health supplement? Isn’t CBD oil healthy?

The “health supplement” prohibition is even harder to understand. Hemp oil is healthy. Nutritionists are calling hemp a ‘superfood’. It’s loaded with all the things health enthusiasts say you should have: antioxidants, fatty acids in just the right balance, complete protein, you name it – what’s not healthy about that?

Here’s where it all comes from. The FDA can stop people from taking up new drugs and marketing them as dietary supplements – but only if they weren’t sold as dietary supplements or ingredients before the clinical investigations begun.

Hemp Industries Association has the last word

The Association wrote to the FDA saying that people have been using hemp both as a food and a dietary supplement for ages, certainly long before someone decided CBD oil should be submitted to the FDA as a “new drug”.

At this point you’re probably asking yourself what the DEA and the FDA have against CBD oil anyway. You won’t be alone. Most experts say it’s just a matter of confusion and bias. Even newspapers report CBD oil news under headlines such as “Parents give children pot”.

CBD oil isn’t pot, even if it does come from cannabis plants, but it seems that as soon as people see the distinctive five-leafed plant, they associate it with something that will make you high – even when it doesn’t.

CBD oil

Still confused?

Yes. It is very confusing, and we haven’t even started looking at state laws yet. But we hope that this article clarifies these issues somewhat. What’s really needed is action from Congress to settle CBD oil’s status once and for all. Many believe that the draft hemp farming law will do just that.

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Disclaimer: Views expressed here do not necessarily reflect those of Endoca and its staff. This article is not intended to provide medical advice, diagnosis, treatment or cure. Endoca CBD products have not been approved by the US Food and Drug Administration (FDA).

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