The FDA’s latest comments about CBD were irresponsible, but it won’t stop where we are heading…
The FDA updated its page on CBD yesterday. It was not helpful to the industry, and it contained a lot of unproven and even bad science.
The FDA’s update is not an official regulation – it has no force of law. But it trotted out a host of unproven claims about the potential harm of CBD and it couched the update in just enough imprecise language to induce some panic among people.
The biggest claim is that CBD “can” cause liver injury. That’s might even be true – at some doses. And there’s an old saying – the dose makes the poison. Too much of anything can be harmful.
People periodically die simply from drinking too much water.
So let’s take a closer look at the CBD doses.
The FDA’s warning about liver injury are based on testing that GW Pharmaceuticals PLC (Nasdaq: GWPH) did for its CBD medicine, Epidiolex.
In that testing, children received up to 25 milligrams per kilogram of body weight. For a 5 year old who is 40 pounds, that would be about 450 milligrams. Scaled up to a 150-pound adult, it would be about 1,700 milligrams. By comparison, the amount of CBD in the new line of gummies from Charlotte’s Web Holdings Inc. (OTC: CWBHF) is 10 milligrams per 2-gummy serving.
An adult would have to eat 340 gummies to get to the dosage the FDA used for its update.
Liver damage is also a risk with alcohol, acetaminophen, and a host of other things that people use every day. And yet millions of people have a glass of wine with dinner and take two Tylenol when they have headaches with no ill effects at all.
Because they aren’t taking 340 Tylenols and they aren’t drinking a case of wine. Putting out that statement without more qualifying language was, frankly, irresponsible.
And there’s more.
Drug interactions, male reproductive toxicity in animals, drowsiness (which is why some people use it in the first place!) and irritability (which was measured among toddlers taking a drug) all rated a mention and all are just not supported by good science at this time, particularly for the low doses seen in consumer products.
In some respects, this is not a surprise.
The FDA generally regulates drugs, like Epidiolex.
However, this entire episode is just a tiny bit of off-noise in a symphony of excitement about CBD. It has enthusiastic support among users and a bi-partisan group of boosters in Congress. If the FDA can’t see its way clear to help the CBD industry grow, Congress will help them along.
The One Thing the FDA Did Right
How the FDA presented this information was irresponsible, and it’s leaving a lot of folks with more questions than answers today.
Unfortunately, it’s also hitting our cannabis stocks.
But the bigger picture is the FDA also announced it had written warning letters to 15 companies that are making unproven claims about CBD.
Unlike the last batch, when a real public company called Curaleaf Holdings Inc. (OTC: CURLF) was among the culprits, this batch went exclusively to smaller operators.
If a company wants to last, it will not rely on gimmicky claims or trying to trick people. In that regard, the FDA provided some support to legitimate operators, like the members in our model portfolio.
Millions of people who use CBD can tell you how it has helped them, but the science for making specific, testable claims is behind the experience of the people in the case of CBD. The smart CBD companies are letting the press, which is not regulated by the FDA, to make the public aware of the specific uses for CBD and letting consumers make their own decisions.
And because of the benefits people experience, I’m here to tell you that the CBD industry is here to stay, no matter what the FDA says.
Executive Director, National Institute for Cannabis Investors
P.S. We’ve been calling 2019 the “Year of CBD” for months now. And we don’t believe that these unfounded claims by the FDA are going to stop this market from growing – and growing rapidly. Fact is, this market has the potential to grow 3,622% over the coming months. That’s 15 times faster than the cannabis market as a whole. You don’t want to miss your opportunity to place a stake in this market before it takes off.
8 responses to “Why I’m Not Worried About the FDA’s Latest Statement on CBD”
November 26 2019