Currently, the CBD market is completely unregulated. Almost anyone with some capital can get into the CBD business, and there’s been a glut of raw materials (raw hemp extract) available at falling prices over the past year, especially if you’re not too picky about the quality. 

The result? Consumers struggle to know whether the CBD products they’re buying are legitimate or effective. Between completely fake products, and those that are misleadingly advertised, lots of people get turned off of CBD entirely, even if they might benefit from it. That’s unfortunate because, while there are a lot of overinflated claims out there, there’s ample evidence that CBD helps a lot of people.

While we normally focus on the positive aspects of the industry, and the highest quality CBD products, we also think it’s important to warn our readers … and put pressure on the hemp industry to do better.

Table of Contents

• Why are CBD scams such a big problem?
• CBD-infused clothing, pillows and bedsheets
• “Immune Boosting” claims about CBD & CBD hand sanitizer
• Multi-Level Marketing (MLM) and CBD
• Fake CBD Products
• Lead-filled & Impure CBD Supplements
• How do we fix this? A call for transparency & quality

Why are there so many CBD oil scams?

Once an obscure supplement of dubious legality, CBD has gone completely mainstream. A survey published in August 2019 by Consumer Reports suggested that 40% of people in their 20s have tried CBD, and even 15% of people 65 or older have tried it. Many more people are curious about CBD, or at least have heard of its potential. And an amendment to the 2018 Farm Bill fully legalized hemp-derived CBD products, removing much of the remaining reluctance consumers had about trying it.

Unfortunately, when you combine unprecedented popularity with a lack of regulations, it leaves the market open for grifters, scammers, and a lot of people just looking for a quick buck. We frequently hear from readers that have purchased or considered purchasing scammy products from fly-by-night CBD brands.  

At the time we’re writing this, the FDA is preparing to present its guidelines for consumer CBD products, after receiving approval from the White House. However, we expect these guidelines to be imperfect in their first draft and require a lot of tweaking and negotiation with the industry before the market is truly stable and safe. 

Beyond that, greedy brands are forever looking for loopholes that let them continue to exploit undereducated CBD buyers. The FDA simply does not have the resources or the power to shut down every problematic or misleading product on the supplement market — powerful lobbyists have ensured that. 

In other words, even FDA regulations won’t make all these CBD scams and bad ideas disappear.

#1 Scam: CBD-infused pillows, mattresses, and clothing

A CBD-infused mattress. It’s something that would have seemed like a joke a few years ago, that someone might have used to make fun of the tendency to stick CBD in everything.

Now it’s a reality. A very expensive reality! In a way it’s almost ingenious: mattress brands struggle to differentiate themselves from one another since most use almost identical technology. The same is true for CBD oil. So why not combine the two?

Except it’s completely ridiculous. In the case of a mattress, consumers are meant to believe that CBD inside it can not just penetrate your skin, but any bedsheets, mattress covers, and pillowcases you might use. Even if the products did work as advertised, they’re costly and short-lived. One brand charges $60 for a CBD-infused pillow and $900 (or more) for a twin mattress. For that price, you could buy a regular mattress online and still have money left over for multiple bottles of high strength CBD tincture. 

Speaking of which, you can simply look at a bottle of tincture to see how much you have left. How would you know when the product has become “depleted” and what are you to do with them then? Throw the whole mattress away?

CBD-infused clothing or plastic “CBD bracelets” are a similar scam, with many of the same problems. Even if these products did work, they seem to encourage a culture of disposability and conspicuous consumption that we can hardly afford during our climate emergency.

#2 Scam: Making ‘immune-boosting’ claims and selling CBD hand sanitizer during a pandemic

We covered this topic in more detail in our article on CBD and the novel coronavirus. 

While some (very preliminary) research that suggests certain cannabinoids might be beneficial in treating some symptoms, there’s no scientific evidence that everyday use of over-the-counter CBD supplements will do any good.

We think CBD can be extremely helpful during this stressful time. Cannabidiol can ease symptoms of anxiety or stress, help us sleep better, among other ways it might benefit us. But it’s very, very unlikely that it can keep you from getting sick if you’re exposed to the virus. 

We’re revisiting it here because these shady products didn’t disappear as shortages on regular sanitizer ended and we learned more about COVID-19. Instead, they’ve proliferated.

Target sells an 8oz bottle of hand sanitizer for $5.00. That’s the fancy kind with added nice-smelling essential oils. Meanwhile, a typical 8oz bottle of CBD-infused hand sanitizer sells for $19.99. Even “on sale” for $9.99, it’s still twice the price.

It’s true that CBD hand sanitizer is unlikely to hurt anyone, as long as it’s made using safe ingredients. It’s still a waste of money. Frankly, it seems like an excuse to sell surplus CBD during a pandemic.

All that aside, a number of reputable CBD brands now make regular hand sanitizer available for cheap or for free. We applaud those companies for taking a small step that may actually help folks stay healthy.

#3 Bad Idea: Multi-level marketing (MLM) CBD brands sell the American dream, but can they deliver?

Multi-level marketing CBD brands make our industry look bad.  

If you’re wondering what multi-level marketing (also known as direct sales) is … remember Amway or Tupperware Parties? Maybe someone in your family sells essential oils or tights from a popular MLM brand. Now apply this same business model to CBD. 

These brands sell a product, but they’re also selling the idea of becoming a salesperson. People pay a fee to join and then more money to buy CBD supplements to sell. Members are encouraged to not just sell supplements, but also get friends and family to join too. 

The MLM business model is not ethical or sustainable.

Unfortunately, there are only so many people in the world who can, or should sell CBD. Mathematically speaking, it’s impossible to keep recruiting forever. In almost every MLM, members spend far more money buying products than they make selling them, or from recruiting others. Many MLMs resemble cults more than they do legitimate businesses, putting immense pressure on members to keep spending money instead of leaving.

Let’s be clear: we’ve no reason to believe that MLM CBD brands are creating bad CBD products. Many of them seem to buy quality raw materials and perform the kind of quality testing we look for in a brand. We simply don’t believe their profit model is ethical, or sustainable.

This is likely to be the most controversial section of the article. MLM CBD brands are commonplace. Some belong to influential lobbying groups in our industry. We think it’s important to say this anyway. Amid record-breaking unemployment, we think it’s irresponsible to sell people this very expensive but elusive dream of financial freedom.

If you want to learn more about MLMs and how they hurt their members, we strongly recommend the first season of The Dream podcast.

#4 Fraud: A flood of fake CBD products on Amazon & beyond

Hardly a week goes by without us hearing from someone asking about a CBD brand. Many of them seem reputable, and it’s just impossible for us to review every single brand out there. But some of them are clearly frauds.

Brands that spam people by email to buy questionable products. Some don’t even have a stable website. They just put up a crude storefront, make a quick profit, and disappear. 

The problem is widespread. Even Amazon.com is full of fake CBD products. Most of them are simply hemp seed oil, a substance that is nutritious but lacks the concentrated cannabinoids found in a hemp extract supplement. Many of these fake CBD products claim to contain literally impossible amounts of CBD, like 50,000 milligrams inside a one ounce bottle.

You also see these kinds of CBD products in gas stations, pipe shops, we even heard of a food truck that also sold CBD on the side. You should leave selling CBD to the experts: experienced, reputable brands that prioritize transparency.

Even major CBD brands sometimes go wrong. One study by Leafly found numerous products that under-delivered on their CBD. A few didn’t contain any CBD at all. Some had too much!

We only partner with CBD brands that offer third-party lab results, so customers can verify the product’s contents. Whenever possible, we’ve also run our own third-party lab tests on the CBD products we review. You’ll find the results in each review.

#5 Fraud: Lead-filled CBD products put consumers at risk

And then there are products that can actively harm consumers. In July 2020, the FDA recalled a lengthy list of CBD products, for both humans and animals, because they were high in lead. Unfortunately, there are probably other harmful products out there that slipped through the cracks. 

The FDA recalled dozens of lead-tainted CBD products for both humans and animals in summer 2020.

Hemp is known to be especially effective at absorbing heavy metals and other toxins from the soil. That’s great if you want to clean up pollution, but bad if the hemp you grow is going to end up in people’s bodies. Lead can also end up in products in other ways, both through other tainted ingredients and during the manufacturing process.

Lead exposure is serious. According to the FDA, “lead is poisonous to humans and can affect people of any age or health status,” but is especially dangerous to vulnerable populations like children, pregnant people, and people with pre-existing conditions. Lead builds up in your system over time, so even low-level exposure can be dangerous down the road.

While most people selling lead-tainted products probably aren’t doing so maliciously, there’s simply no excuse for putting your customers at risk of serious health problems, even permanent neurological damage.

CBD brands and buyers must put quality and transparency first

It’s true that the FDA may soon impose new regulations on the CBD industry. But that won’t absolve the industry of the responsibility to put extra care into making the best possible supplements.

Anytime a product becomes as popular as CBD, there’s a great temptation to use it to turn a quick profit without worrying about the quality of your product. With increasing competition and a saturated market, there’s a lot of pressure to cut corners. 

The CBD industry can and must do better. Hemp returned to the U.S. starting in 2014, and it’s been fully legal since the end of 2018. When it comes to CBD, it’s past time to develop best practices and stick to them rigorously.

In the long term, we are sure that the brands which prioritize quality, transparency and care for their customers will survive, while others fall away.

What consumers can do to hold hemp brands accountable & stay safe

CBD consumers need to keep being careful and doing their research before buying any products. We suspect this will remain true even after the FDA releases their guidelines for CBD.

Fortunately, there are resources available — like our website — to help you make more informed purchasing decisions. If you use these tools, you’ll be able to avoid CBD scams and find the right, safe CBD product for your needs.

Here’s a small selection of some of the resources we’ve created to help you make informed purchasing decisions:

• Our complete introduction to CBD outlines a lot of vital, basic information on this supplement.

One way to help improve the CBD industry is to “vote with your money”: only buy quality products from brands that make it easy to find information or get more help.

The post CBD Oil Scams Run Wild: A Look At 5 CBD Scams, Frauds & Bad Ideas appeared first on Ministry of Hemp.

First off, our podcast host Matt talks about the difficulties of reading and understanding CBD labels. The good news is MOH’s new videographer, Desiree Kane, just dropped a fantastic short video about How to Read CBD labels.

This episode’s conversation is with Ed Donnelly of AmourCBD. Ed has 35-years of experience in healthcare as everything from a burn unit nurse to a CEO. Donnelly got into the CBD business after his wife was injured and found pain relief in topical CBD but it was stinky and slimy. So Ed decided to start his own line of CBD for pain relief and make a better FDA registered product.

You’ve got hemp questions? We’ve got hemp answers!

Send us your hemp questions and you might hear them answered on one of our Hemp Q&A episodes. Send your written questions to us on Twitter, Facebook, matt@ministryofhemp.com, or call us and leave a message at 402-819-6417. Keep in mind, this phone number is for hemp questions only and any other inquiries for the Ministry of Hemp should be sent to info@ministryofhemp.com

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FDA Registered Topical CBD Products: Complete episode transcript

Below you’ll find the complete transcript of episode 49 of the Ministry of Hemp Podcast, “FDA registered topical CBD products”:

Matt Baum:
I’m Matt Baum, and this is the Ministry of Hemp podcast, brought to you by ministryofhemp.com, America’s leading advocate for hemp and hemp education.

Matt Baum:
Welcome back to the Ministry of Hemp podcast. My name is Matt Baum. I’m your host, and today on the show, we are going to talk to Ed Donnelley of Amor CBD. Now, I apologize for this. When I talked to Ed months ago, but there was some audio problems and I want to thank my friend, Ben, who helped me out with this one and rescued the audio. So we’ll get to that in a little bit. But before we do talk to Ed, we should talk about labels for a minute. Because there is no current FDA rules on CBD, there’s no hard and fast rules on what the labels need to say to let you know what you’re getting, and that can be very confusing.

Reading CBD product labels

Matt Baum:
I just got sent a sample today. It’s a CBD tincture that’s supposed to help with sleep, and it says it’s 25 milligrams per dose, which that’s very cool. I like that. As opposed to a label that just says, here’s 1500 milligrams of CBD or here’s 200 milligrams. Well, that’s tough when it comes down to how much is the dosage? It’s hard to read. It’s hard to know what you’re getting. Like I said, there’s no hard and fast rule from the government that says, you need to make it say this so people know exactly what they’re getting. Now we’re moving towards that. It’s going to happen. But for now CBD labels can be a little tough to read. Fear not, we have a new videographer. She’s awesome. Her name is Desiree Kane, and she just put out a video on how to read CBD labels.

Matt Baum:
She talks about what to look for, what to avoid, and all kinds of other stuff in a new video we’ve done up on ministryofhemp.com. I’ll have a link to it in the show notes for this episode, but you’ll be able to find it featured on ministryofcom.com right now. Desiree is awesome. We’re thrilled to have her as a part of the team, and she does such a fantastic job just breaking down how to read different labels on different CBD products. She does a great job touching on a few of them and helps you to understand what they’re saying.

Matt Baum:
It sucks that we even have to make a video like this right now, but until the FDA rules exactly how these labels should look and what they should say, good to have someone like the Ministry of Hemp and Desiree to help you navigate the wilds of these different CBD labels.

Meet Ed Donnelly

Matt Baum:
My conversation today is with Ed Donnelly. He’s the founder and CEO of Amor CBD. Ed worked in healthcare for 35 years. He’s been the CEO of three different related companies as well. He was a registered nurse, worked in a burn unit for five years. Ed first discovered CBD not too long ago when his wife was injured and he decided that he wanted to make the product even better. I spoke to Ed in his home city of Chicago. Here is my conversation with Ed Donnelly.

Matt Baum:
Ed, so your story starts back on September 11th, 2001, if I’m correct?

Ed Donnelly:
There is a story that starts there, yeah. No, that was a bad day. My brother was a fireman. He was with Ladder Company 3, 20, 21 years on the job, and he got killed in the Trade Center.

Matt Baum:
Wow.

Ed Donnelly:
So if you go to the museum, the ladder truck that’s crushed in the center of the museum?

Matt Baum:
I’ve been there.

Ed Donnelly:
[inaudible 00:03:53] truck. That’s his, and he was the senior officer.

Matt Baum:
Wow. Wow. That is …

Ed Donnelly:
It was a Green Beret company.

Matt Baum:
They were all military guys is what you’re saying?

Ed Donnelly:
Yeah. This was a heroic group of guys. My brother had three department medals.

Matt Baum:
Wow.

Ed Donnelly:
Not unit citations, three personal medals. They give out 12 a year, and he had three.

Matt Baum:
You couldn’t have kept these guys out of there if you wanted to.

Ed Donnelly:
Absolutely. Then my brother, we got a report that he was on the 65th floor of the North tower and a woman coming down offered him a Diet Coke, and he smiled at her and said, “That would just be a tease, dear.” She remembered his smile, but absolutely he was going up to the floor.

Creating a better CBD topical

Matt Baum:
Wow. After that, you basically create your own CBD company.

Ed Donnelly:
I’ve been in healthcare for 35 years, the last 25 as CEO of three different companies, one being a public company. So, 2017, my wife takes a fall, hurts her back, doesn’t want opioids, so I go out and I find CBD and it works tremendous for her, but the problem is, it had a terrible odor, the cream, and it contained THC. So I looked at this and, again, with my background as a medical company CEO with FDA experience, I said, this could be done better.

Ed Donnelly:
So I went out and did Amour. It’s odorless, it has zero THC, and it’s not greasy. So that was our pain relieving cream, and as I dove into it, I realized this needs to be registered with the FDA.

Matt Baum:
Absolutely.

Ed Donnelly:
But nobody’s doing it.

Matt Baum:
That’s the biggest problem we’re facing right now.

Ed Donnelly:
Nobody’s doing it. So I took a year and spent a lot of money and a lot of time to get Amour CBD cream FDA registered, which in my view, it’s not FDA approved-

Matt Baum:
It’s registered.

Ed Donnelly:
It’s registered. It gives people the Good Housekeeping Seal of Approval that they know that this is a safe product manufactured to standards. Because you can buy CBD today in a gas station, and you don’t know if that CBD oil is coming from China, from Russia, they have THC, they have solvents in them.

Matt Baum:
Or do they even have CBD in them at all? You have no clue.

Ed Donnelly:
100% right. We do all the independent third party testing, and I told somebody in one other interview one time, my goal, I guess, was to do CBD right. I was very successful in my career as public company CEO, and if I’m going to do it and put my name to it and we have no outside funding, I’m funding it all, I’m going to do it right.

Getting FDA registered CBD products

Matt Baum:
Tell me real quick about FDA registration. So this is not approval. This is registration. That basically means, what kind of hoops did you jump through? You said, you laid out this is how we will create it. This is how it’s made. This is what goes into it. Is it stuff like that?

Ed Donnelly:
Yeah. If you go to Walgreens, CVS, wherever, Target, and buy cough syrup, buy Tylenol Cold and Flu, whatever you buy, there is an NDC number, National Drug Code, and it’s given a number, meaning that they’ve gone through the FDA registration process. You’ve told them what’s in it. You’ve done an independent analysis. You’ve told them that it’s being manufactured in an FDA certified facility, not in the back of some guy’s garage or basement. So you go through all these FDA good manufacturing standards to prove that the product is what you say it is.

Matt Baum:
Fair enough.

Ed Donnelly:
Then they approve the labeling, they approve the claims, which generally there are no claims. We’re able to say advanced pain relief, but you can’t say that it cures cancer.

Matt Baum:
Of course, which is good. We shouldn’t be.

Ed Donnelly:
We shouldn’t. Absolutely, we shouldn’t.

Matt Baum:
Correct me if I’m wrong. But your cream includes lidocaine, which is typically used for burn victims. This comes from your background working with burn victims. Is this correct?

Ed Donnelly:
That is correct. As scary as it seems, I’m a registered nurse. I had training. You wouldn’t want to get sick in front of me, but I am a registered nurse. I’m clinically trained and I did work in burn unit for five years. Lidocaine is using in burn centers, but lidocaine is used every place. Novocaine in the dentist office is a form of lidocaine. Lidocaine is absolutely the number one topical pain reliever on the market. Lidocaine. It’s in Neosporin. They sell Neosporin with lidocaine. So it’s, without a doubt, the best pain reliever. But yes, I’m a nurse in my undergrad. It’s very important to me.

Matt Baum:
Absolutely.

Ed Donnelly:
It’s who I am. I’ve got a patient sensitivity.

Matt Baum:
Absolutely. So you took your nursing undergrad and from there, you went straight into opening businesses? Or you said, “You know what, I’m tired of this nursing thing. I need to make some money?”

From nurse to CBD entrepeneur

Ed Donnelly:
I was working as a nurse in a burn unit, working all the overtime I could get because back in 1980, nurses didn’t pay that great. But I went to business school at the same time. So I was taking care of the sickest people in the burn unit with the curtains drawn and read some books there. I was reading and I was typically one to one patient care. Got out of a business school. I worked as a nurse for five years, so it’s not like I just did it part time. Then I went and worked for big Fortune 100 medical companies, so I didn’t just go out and start businesses. I went and started as a sales rep, ran a region, moved to Dallas, ran half the country, moved to the headquarters, ran the whole country, big company, and then recruited away to be a president of a good sized company, which I made a big company. There’s another one that I took public on the NASDAQ.

Matt Baum:
Tell me how you came to find CBD and hemp. You said your wife had an accident.

Ed Donnelly:
My wife fell. My wife fell and hurt her back and she had chronic back issues to begin with. So again, she didn’t want opioids. Again, dangerous nurse medical guy. I’ll go find something, and I found CBD. Now, we put this greasy, smelly stuff on her, but it worked. It absolutely worked for her.

Matt Baum:
It just didn’t smell good.

Ed Donnelly:
We also had her taking some drops too. She would take the drops under her tongue and maybe even chew some gummies. Suddenly she was getting comfort and relief, not a cure, but able to get through her day. Then I said, “This could be done better.” These products, thank you for being there, but they’re not as good as they could or should be. The THC. There are horrible stories here in Chicago about a bus driver taking CBD, takes a urine test and fails it.

Matt Baum:
Then blacklisted forever.

Ed Donnelly:
Yeah, and then she got fired. Terrible.

Matt Baum:
It’s just ridiculous.

Ed Donnelly:
There’s no reason to have the THC. It takes another couple hours of processing per tube to get rid of the THC. So in some ways, like everything else, it’s all about money. Guy wants to be selling it cheap in a gas station, so he’s giving you China grown marijuana with THC, might not be tested, but they get it out there and they put it out for 9.99. CBD, it’s the old story. You get what you pay for it.

Matt Baum:
Absolutely. Tell me about the hemp that you’re using.

Ed Donnelly:
Ours is US grown only. Colorado grown, but it’s absolutely US grown. We use independent third party labs-

Matt Baum:
Nice. That’s important.

Working with the FDA

Ed Donnelly:
… To test for THC and everything. So we’ve got all of the necessary proofs to demonstrate exactly what we say. Then again with the FDA, you darn well better do what you say. Otherwise, they’re going to be ringing your doorbell.

Matt Baum:
Was that difficult when you came to the FDA and you said, “Look, I want to register.” I would guess their first reaction would be to say, ‘No, we don’t deal in that.” What was that conversation like?

Ed Donnelly:
It’s interesting. It’s a great question. The conversation was easy because the FDA registration part is not difficult. It’s laborious and time consuming and expensive. Everything you’d expect from a government process.

Matt Baum:
Of course. Yeah. It wouldn’t be a government process otherwise.

Ed Donnelly:
That’s right. Fill out this long form and then take close to a year, submit multiple drafts. So that wasn’t hard. What was interesting was then going to the trademark office and trying to trademark Amour CBD. The government trademark office wouldn’t even listen to it because CBD is illegal, they say.

Matt Baum:
You may as well trademark heroin! What, are you crazy?

Ed Donnelly:
Yeah. But the FDA process wasn’t difficult. It was just it’s normal, tell us what you have. We have a pain relieving cream. Tell us what’s in it. Lidocaine and CBD. Okay, lidocaine, it’s a regulated drug, so it needs to be registered. So it was all just checking the boxes and taking the time, being patient and paying fees.

Matt Baum:
Fair enough. So as long as you are-

Ed Donnelly:
We’re the only one that does it. We’re the only one that’s done it. Why? Because it takes nine to 12 months and tens of thousands of dollars to do it.

Matt Baum:
You’re the first person I’ve talked to that has done it. I didn’t even know it was possible before I spoke to you about this, honestly.

Ed Donnelly:
For me, it’s because, again, as a previous CEO of medical companies, I dealt with the FDA all the time. So maybe for me, it was easier to get done, because the first thing I did was go to a FDA lawyer who was an expert on this and paid his ridiculous fee. But I knew the straight path.

Matt Baum:
This is all part of the game, right?

Ed Donnelly:
It’s a game of sorts. Absolutely.

Matt Baum:
Yeah.

Ed Donnelly:
It’s just checking the box and doing it right. It’s funny. Before this pandemic, I had interviews going where people asked me to make predictions for 2020 and what CBD was going to be all about, and every other person who was interviewed said it’s going to be a $20 billion business.

Matt Baum:
It’s going to be huge.

Ed Donnelly:
[crosstalk 00:16:11] billion-

Matt Baum:
Farmers are going to be millionaires!

Ed Donnelly:
All I said to the interviewer, because I’m sort of a regular guy. I said, “It’s going to be big. But the news flash for 2020 is, watch the FDA get involved.” Because the end of last year was when Juul and the vaping companies had already issues of people dying of respiratory problems and they tied it all back to THC.

Matt Baum:
Right, and that it’s the same thing as CBD, right? Must be the same. I guess that’s [crosstalk 00:16:47] people too.

Ed Donnelly:
Absolutely. THC is THC. They were just smoking it and ingesting it. That was why, when that happened, I was sickened for the individuals. I wasn’t happy because it cast a shadow on the CBD climate.

Matt Baum:
Yeah. It was really too bad.

Ed Donnelly:
But I was very happy that I had the foresight to go no THC in any of my products, either the cream, the liquids, the gels, or the pills. No THC whatsoever.

What’s next for AmourCBD?

Matt Baum:
So let’s say, tomorrow the FDA, best case scenario of course, tomorrow the FDA says, “All right, we’ve got rules in place. We get it, and full spectrum is fine. If you want to have THC, it has to be below whatever, but it’s fine.”, are you going to switch or are you going to stay the way you are?

Ed Donnelly:
I’m going to stay the way I am. I’m going to say we’re broad spectrum, and I’m also going to take the position, which is the one I’ve been taking, is we’re a medical grade. We are a medical CBD. We’re not recreational. If people want the best, if they’re having difficulty with chronic pain in their shoulder, knee, I use it on my rotator cuff, it’s great. If people are having anxiety related issues due to COVID, they take the drops. I’m making sure my wife takes them twice a day.

Matt Baum:
Fair enough.

Ed Donnelly:
Because she’s stir crazy with this. I’m not going to change. We’re doing broad spectrum, no THC, medical grade. We’re not trying to compete with the 9.99. We’re putting out the best, safest, FDA product.

Matt Baum:
It’s sounds to me, the way that you’re talking. And I’m not demonizing anyone, I don’t think, but it sounds to me like you see your products in a pharmacy, not so much in a specialty CBD shop.

Ed Donnelly:
I think that’s a fair description with one caveat. I think we’re really looking for that educated consumer that does their homework, because our website is our number one source of getting it, amourCBD.com. But pharmacies are absolutely carrying our products.

Matt Baum:
Oh really?

Ed Donnelly:
Pharmacies, pro shops in the golf courses. They carry it because they know it’s the high quality. But certainly we’re not looking for that person who’s just experimenting with trying to be recreational with gummies. We have gummies, they’re broad spectrum and they’re more expensive than the other gummies.

Matt Baum:
Right now, you do the drops, you do the cream, and you do the gummies. What’s next for Amour? Where are you guys going?

Ed Donnelly:
And pills.

Matt Baum:
Pardon me, and the pills, capsules.

Ed Donnelly:
We do pills for those that don’t like it. I can see it evolving into patches.

Matt Baum:
Oh really?

Ed Donnelly:
Pain relieving. You can embed it in a patch. Right now, we’re not going there, but there are many other personal products that can have CBD infused in them. So right now, we’re trying to stay that high road of medical grade. I think we might find ourselves taking the cream into different sizes. So this is 1.5 ounces. We might go to seven or eight ounces or we might go down to one ounce.

Matt Baum:
That cream that you’re holding up, let me stop you real quick. How many milligrams of CBD are in there? What’s the dosage like?

Ed Donnelly:
It’s 1.5 ounces of cream, and there’s 200 milligrams of CBD.

Matt Baum:
That’s a good amount.

Ed Donnelly:
Yeah. We don’t cut corners. It’s not placebo. It’s a good amount. Then our pills, we’ve got them in 500 and 1500 milligrams. So again, those are the most popular. My son has a business, he’s been selling competitive CBD products and those were the most popular sizes. Then the gummies, the gummies are the gummies. 10 milligrams in a gummie.

Matt Baum:
Right. You take a couple of them when you need them and you’re good.

Ed Donnelly:
Some people say they help with the putting.

What’s coming next from the FDA with CBD

Matt Baum:
Fair enough. Yeah, I can see that. So I’m not going to ask you to speculate here, but you are a guy that’s been in the business for awhile, and I think you’ve got some insight that a lot of people working in CBD right now might not have coming from the drug world. We’re in a very weird place with the USDA and the FDA right now. How do you see this shaking out as far as government action, national action? Right now, there’s a bunch of different statewide regulations that are making it very difficult for people in other states everywhere because your labels got to look like this in one state, and it’s got to say this in a different state and it can only have this in one state. How do you see this shaking out, and how long do you think it’s going to take before we have real federal guidelines behind this?

Ed Donnelly:
When the vaping crisis took place in, what was that? Fourth quarter of last year, October, November, December, when that horrific thing was going on, I was fully expecting the FDA to come cracking down. In fact, I had heard that some of the bigger companies had gotten FDA letters.

Matt Baum:
That was the rumor.

Ed Donnelly:
[crosstalk 00:22:27] they’ll publish that there were letters, cease and desist, et cetera. So I expected 2020 to be the year of the FDA and I was going to sit back and enjoy it because we had done the work. I expected it to be very beneficial to my business. Then the pandemic hit and the FDA went completely a whole different direction.

Ed Donnelly:
I don’t think the FDA is at all focused on CBD now, and I think some of the bad behavior is going to be allowed to continue probably for this full 2020, if not most of 2021. I think they’re just elsewhere directed. Will they get back on it? Probably. They should. God forbid, there’s an incident like THC, where somebody gets injured or hurt. I don’t want to see that. But I think unfortunately the FDA’s eyes are off the ball. They’re elsewhere directly now.

Matt Baum:
If you have to guess, how long do you think we have? Just shot in the dark. No one’s going to hold you to this.

Ed Donnelly:
End of 2021, second half of 2021 or 2022, unless something happens.

Matt Baum:
That’s a ways off too. But guys like you, it sounds like you have taken the steps you need to, to get ahead of the curve by making sure you’ve stood in line and you paid the money and you showed them I’m doing it the way you want it done. I’m putting this in it.

Ed Donnelly:
It would have been happening now, if not for this whole COVID issue.

Matt Baum:
It sure does seem like that.

Ed Donnelly:
Yeah. Because they were like … You obviously were aware that some companies had gotten letters and there were things happening, but now that’s not the priority.

Matt Baum:
Yeah. Ed, before I let you go, can I ask, where does the name Amour come from?

Ed Donnelly:
The name Amour came from my 10 year old granddaughter who had two heart transplants.

Matt Baum:
Oh my God.

Ed Donnelly:
She’s 10 years old, and she’s had two heart transplants, the most recent one this past Christmas. But I think of her all the time, every day, and Amour just came. That’s her.

Matt Baum:
That’s beautiful.

Ed Donnelly:
[crosstalk 00:25:02] her name, and that’s how I came up with the name Amour.

Matt Baum:
That’s beautiful. Is she doing okay?

Ed Donnelly:
She’s doing great.

Matt Baum:
That’s great. That’s really good news.

Ed Donnelly:
Doing great. She’s a miracle, but I’m not trying to … I’ve been very lucky in my life. I’m having fun with these products. We’re doing good, but I’m not trying to cheat, borrow, and steal. We’re making good medical grade products that are helping people. The FDA thing is a big deal.

Matt Baum:
Yeah. Now that I know that and when people start asking me about it, I’ll definitely push that. It’s just sounds like, even if you’re not approved, at least you have everything done. You’ve got 90% of what they need done, and then when they do say, “Okay, you can have approval,” you got 10% more work to go as opposed to 100.

Ed Donnelly:
Yeah. The guys that don’t have it, when the FDA gets annoyed, they crack down, they take you off market. I don’t know how CVS’ of the world and Walgreens can be selling these products that are not FDA registered.

Final thoughts from Matt

Matt Baum:
I want to thank Ed for coming on the show. He was a lot of fun to talk to, and FDA registration was not something that I have heard of, but it sounds important and extremely beneficial. I would hope that more smaller CBD companies are looking into this, because FDA regulation is coming and it is going to affect every aspect of this industry. Just like I talked about earlier, from the labels all the way to how this stuff is made and what goes into it and what is allowed and what is not and what we can and can’t say that it does. That’s good, and people like Ed, it sounds like he’s ready. He’s done the hard work. He’s done the research. He’s putting out a quality product, and when the FDA does come knocking, he’s going to be ready for them. You’ll be able to find links to Amour CBD and all their products in the notes for this episode.

Matt Baum:
That brings us to the end of this episode, but there is still so much more Ministry of Hemp to keep you busy while you wait for the next one. Head over to ministryofhemp.com, and we have got some new CBD reviews from Well Care Botanicals Hemp about their new extract. It’s a high potency CBD without the hempy flavor if you don’t care for that earthy, hempy flavor. Personally, I like it, but some you don’t and that’s fine. Check us out on medium.com, at Ministry of Hemp, where you can find a new article we have about the science of mixing CBD and caffeine. Back in episode 43, I interviewed Alan Mortada of Ott Coffee out of Austin, Texas, and we both gushed about how much we like CBD and caffeine mixed together. Turns out it works pretty well, and there doesn’t seem to be many side effects.

Matt Baum:
If you need even more than that, follow us on all your favorite social media at Ministry of Hemp/ministry of hemp, and speaking of /ministry of hemp, if you go to Patreon/ministryofhemp, you can become a Ministry of Hemp insider, and directly help us to spread the good word of hemp to other people. Any amount you can give makes you a Ministry of Hemp insider, gets you access to podcast extras. We’ve got a great video up right now featuring the Harney brothers, who I interviewed a couple episodes ago, planting their own hemp. It’s actually pretty hilarious. You get early access to articles. You get Patreon exclusive articles and stuff too, but best of all, you’re helping us help spread the word of hemp. So if you care about this and you want to hear more, become a Ministry of Hemp insider. I can’t stress how cool it is and how much it really helps us.

Matt Baum:
Here at the Ministry of Hemp, we believe that an accessible world is a better world for everyone, so you can find a full written transcript of the show in the notes as well. It’s time for me to get out of here. I like to end the show the same way every time. I like to say, remember to take care of yourself, take care of others, and make good decisions, will you? This is Matt Baum with the Ministry of Hemp signing off.

The post FDA Registered Topical CBD Products, With Ed Donnelly of AmourCBD appeared first on Ministry of Hemp.

What this means is that the FDA isn’t monitoring the ingredients, purity, or methods used to make CBD products. Instead, they have been using their authority to warn certain “bad actors” in the industry that claim their products can treat or cure illnesses. In official FDA terms, these are known as “disease claims.”

This distinction is understandably lost on a lot of people. An October 2019 survey by the Grocery Manufacturers Association found that most Americans falsely believe CBD products are regulated.

In December, the FDA issued a “consumer update” about the safety CBD. The administration also sent 15 warning letters to CBD brands around the same time. This only added to the tension and confusion. Is CBD safe? Is it legal?

To clear all this up, we wanted to take a closer look at what the Food and Drug Administration is actually doing and saying about cannabidiol and hemp extract supplements, and what they’re likely to do in the future. First, let’s look at what we know about the safety of CBD.

Is CBD safe? Is CBD legal?

To recap, the 2018 Farm Bill made hemp legal.

That includes hemp products like CBD. The same amendment took hemp out of the control of the Drug Enforcement Administration. It also reinforced the FDA’s power to regulate foods, supplements and medicine made from hemp.

But, so far, the FDA hasn’t issued any clear regulations, leaving the industry metaphorically holding its breath.

“There’s no science behind these scare tactics.”

Jonathan Miller, general counsel to U.S. Hemp Roundtable

Their recent consumer update certainly takes an ominous tone, however. The document warns about numerous potential (but largely unproven) safety risks around CBD. Multiple experts we spoke with pushed back against this document.

“There’s no science behind these kinds of scare tactics,” said Jonathan Miller, general counsel to the U.S. Hemp Roundtable.

The first line of the consumer update should set the tone for the rest:

“The FDA is working to answer questions about the science, safety, and quality of products containing … CBD.”

None of what follows in their document is proven. Rather, the FDA instead is saying these possible issues warrant a closer look.

“In fact, there’s a lot of science — even that the FDA has done — which demonstrates [CBD’s] safety,” Miller noted.

Some global agencies concerned with health agree with that assessment. The World Health Organization ruled that CBD seems safe, with no potential for abuse. The World Anti-Doping Agency ruled CBD safe for use by athletes, and other similar agencies overseeing sports have followed suit.

Of course, CBD can have side effects and, very rarely, drug interactions. Since the drugs involved could include psychiatric medications and heart medications, the FDA is right that more investigation is needed.

You can find more information in our article on CBD side effects. When in doubt, check in with a medical professional before taking CBD.

The FDA is challenging the CBD industry

It’s the FDA’s job to be extremely cautious about new substances. Epidiolex, a prescription epilepsy drug made from CBD, also complicates the administration’s approach.

A clause in the FDA’s policies known as the “IND Preclusion” (IND stands for “investigational new drug”) prevents supplements from including active ingredients in pharmaceutical drugs. That means anyone making CBD-infused edibles, or selling their CBD as a nutritional supplement is technically violating the IND Preclusion.

“We’re trying to get them to use their authority to waive the IND Preclusion,” said hemp advocate Joy Beckerman, president of the Hemp Industries Association.

The FDA “exceedingly overstates the health risks of CBD.”

Joy Beckerman, president of the Hemp Industries Association

There is precedent for drugs appearing both in medicine and consumer products. Caffeine is one obvious example. Beckerman added:

“The public guidance exceedingly overstates the health risks of CBD derived from hemp, and it ignores the vast majority of the scientific evidence of the safety of CBD.”

Research that found potential drug interactions with CBD used dosages far in excess of the amount normal home CBD users are likely to consume. The experts we spoke with saw recent developments as a challenge from the FDA to the industry to prove that CBD is safe at the dosages found in consumer supplements.

“This is an opportunity for the industry to demonstrate that these products are safe and there is the ability to distinguish hemp supplements and hemp foods from CBD prescription drugs,” said Garrett Graff. Graff is managing attorney at Hoban Law Firm, specializing in representing the hemp industry.

“At the end of the day, it comes down to establishing parameters that distinguish between pharmaceutical application and conventional application,” he added.

What the FDA warning letters mean for CBD

What’s most important to note is that the FDA hasn’t actually set any rules about how CBD should be sold. Instead, they only warn brands that make flagrant claims about their products. This leaves the industry on its own to determine how their supplements get made and marketed.

Sending 15 warning letters at once seems like a lot, but the experts we interviewed said it’s just a sign of how bureaucratic agencies like the FDA function. In all, the FDA sent about 70 letters warning CBD brands since 2014.

“There’s nothing new or novel about these letters,” observed Beckerman.

Many aspects of the letters are identical to those the FDA might use about any supplement maker who made unrealistic disease claims. Some of the brands warned in the latest round even implied that their CBD supplements could cure or treat cancer. That kind of claim is wildly irresponsible and not backed up by scientific evidence.

“There’s nothing new or novel about these letters.”

Joy Beckerman, president of the Hemp Industries Association

In general, in the dozens of letters the FDA sent, they’ve never gone after brands that were careful not to make disease claims. At the same time, it’d be easy to cross the line. Even publishing customer testimonials could be considered making a claim.

And none of the warning letters ever resulted in legal action.

“In most cases,” Beckerman said, “the companies are either not around anymore or they’ve come into compliance.”

“So the warning letters did their jobs with those recipients and we’re confident that they’re going to do their job with these 15.”

What’s coming next for CBD & the FDA

Eventually, the FDA is expected to publish regulations for production and sales of consumer CBD products. But that could be months, or even years away.

“We need to put pressure on the FDA,” Miller said, “and put pressure on Congress to put pressure on the FDA to come out with regulations.”

Members of Congress, like Sen. Mitch McConnell, are on the record enthusiastically backing hemp. However, the current political climate puts hemp further down on the list of priorities, despite bipartisan support.

“This kind of environment benefits the bad apples.”

Jonathan Miller, general counsel to U.S. Hemp Roundtable

In the meantime, the industry has already taken action. While approaches vary, many brands now track every aspect of their products from hemp plants to final supplements. Many brands now use “GMP” certified facilities or manufacturing practices to make their CBD. Transparency matters too, and top CBD brands now offer third party lab results showing their products potency and purity. These moves could be a model for final FDA regulations.

“We’re a new industry and name another new industry that calls to the federal government ‘please regulate us,'” said Miller.

The current lack of regulation actually benefits scammers with fake products, he said.

“In this kind of environment where there’s threats being made and no regulations, it benefits the bad apples.”

With CBD becoming a billion-dollar industry, there’s immense pressure on the FDA to find a path forward. CBD oil products are unlikely to disappear.

But it’s clear a lot is riding on the FDA, and it’s possible the industry might have to take to the courts if the final regulations don’t meet the needs of CBD consumers and the industry.

The post The FDA & CBD: FDA Warning Letters Hint At Future CBD Regulation appeared first on Ministry of Hemp.

According to predictions in the 2019 Hemp & CBD Industry Factbook from Hemp Industry Daily, CBD sales could reach up to $1.3 billion this year. CBD, short for cannabidiol, is a massively popular supplement made from industrial hemp. Consumers take CBD to relieve a host of diverse symptoms. It’s believed to help balance the human endocannabinoid system when used regularly.

According to the Hemp Industry Daily predictions, CBD sales are up 133% over last year. If growth continues along the same path, CBD sales could reach over $10 billion dollars by 2024.

Of course, while many experts predict increased interest in CBD, the market could also reach a saturation point. Alternately, consumers could be put off by the hype and miss out on CBD’s actual benefits.

In any case, the billion dollar CBD market fulfills an old prediction, in an unexpected way.

From ‘Billion Dollar Hemp’ to billion dollar CBD sales

In 1938, Popular Mechanics famously promised that hemp could become a billion dollar crop. However, the authors of that report could never have predicted how their prediction would come true.

We’re going to see plenty of excitement but it’s not going to keep quality products from getting into people’s bodies and improving their lives.”

Joy Beckerman, president of the Hemp Industries Association

While humans used hemp as medicine as far back as ancient China, scientists didn’t isolate CBD in laboratories until the 1940s. When Popular Science predicted billion dollar in hemp sales, the focus was on hemp’s many other benefits. Hemp makes great paper, clothing, rope and other textiles, even building materials. It can even converted into a fuel source, among almost countless other uses. You can find articles about many of these uses for hemp on our website.

U.S. hemp growing expanded in 2019, as reflected by the massive increase in hemp growing licenses. Almost all of that hemp is grown for CBD. As a result, fiber or other forms of hemp are usually imported from China, Canada, India, or Eastern Europe.

A recent Gallup poll reported that 14% of Americans have tried CBD. Younger people make up the majority of those polled that said they’d tried CBD. However, even 8% of those over 65 reported using CBD products. 40% of CBD consumers said they used CBD products for pain. Another 20% used for anxiety, and 11% to help them sleep better.

What about the FDA?

One unknown factor in the future of the billion dollar CBD industry is how the Food and Drug Administration will rule.

Although many consumers don’t realize it, currently the CBD market is almost entirely unregulated. However, under the terms of the 2018 Farm Bill, which legalized hemp in America, the FDA will regulate the future of over the counter CBD supplement sales.

CBD is in a unique place since it’s both a medication (sold under the brand name Epidiolex as a high-end epilepsy drug) and an over-the-counter supplement, putting the FDA in a challenging position.

As Joy Beckerman, president of the Hemp Industries Association recently told us, members of Congress like Sen. Mitch McConnell would like the FDA to offer guidance as soon as possible, but that guidance could still be months or years away.

“Both congressional chambers are attempting to direct the FDA to take various forms of action via their respective Agriculture Appropriations Bills, but creating a regulatory framework could still take years depending on what directive language makes its way into law.”

A billion dollar CBD industry … and beyond?

At the same time, a billion dollar CBD industry has a lot of weight to throw around when it comes to lobbying. There’s also support in high places (like McConnell) for a path forward. It’s unlikely that this supplement will disappear entirely.

As our understanding of the human endocannabinoid system deepends, we’re likely to increase our appreciation for how CBD and other natural compounds found in hemp can help us live more balanced lives. Discerning consumers are also beginning to educate themselves about what makes a quality CBD product.

“We’re going to see plenty of that excitement,” agreed Beckerman, “but it’s not going to keep … wonderful quality-assured products from marching themselves down the field and getting into people’s bodies and improving their lives.”

The post Billion Dollar CBD: CBD Sales Predicted to Top $1 Billion in 2019 appeared first on Ministry of Hemp.

Ministry of Hemp Editor in Chief Kit O’Connell spoke with Dawn Peacock, host of CBD Talk Podcast about recent hemp news in the U.S., including the 2018 Farm Bill. The Farm Bill, recently signed into law, fully legalizes industrial hemp in the United States.

While the Farm Bill represents a huge win for hemp advocates, there’s still more to do before hemp and CBD are fully accessible to everyone. A recent FDA statement about CBD’s legality after the Farm Bill has left people confused and concerned about the supplement’s future in the U.S. Dawn and Kit talk about what the memo really means, and why it could show the FDA is actually warming up to CBD.

In addition to the video above, this episode of CBD Talk is available as an audio file on Soundcloud:

Some of the links mentioned in the podcast:

• Legal Hemp In The USA: What The 2018 Farm Bill Means For US Hemp & Agriculture (Ministry of Hemp)
• Police Arrest Nebraska CBD Shop Owners Just Days Before Hemp Is Federally Legalized (Ministry of Hemp)
• Support Heather & Dreyson Beguin, Victims of Nebraska CBD Arrests (GoFundMe)
• Marc Grignon: Hemp Can Help Sustain Native Americans (Ministry of Hemp)
• FDA Signals Shift in Rhetoric Towards Hemp Products (LinkedIn/ Hoban Law Group)
• cbdMD Bath Bombs (Ministry of Hemp)
• CBDMEDIC Active Sport Ointment (Ministry of Hemp)
• Holistic Corn CBD Popcorn (Holistic Corn homepage)

CBD Talk is available on all your favorite podcast apps — give them a listen!

The post Kit O’Connell On The 2018 Farm Bill, The FDA, & Nebraska Hemp Arrests appeared first on Ministry of Hemp.