Legal cannabis companies are sprouting up like weeds—each one backed by a compliance expert.
Marty Marion, one of the country’s leaders in FDA compliance and compliance period for the CBD industry.
He is the creator of the Master Positioning Insiders training program, teaching executives, brand and company owners, consultants, and agencies on how to master the science of brand positioning.
In today episode, Marty Marion shares with us some of the key things that you need to know as an existing or new CBD business and the big warning coming from the FDA.
Enjoy and listen in.
So, we’re not coming after CBD marketers based on the law that says CBD cannot be sold as a supplement because we’ve approved that as a prescription drug. At the same time what they did say very clearly, they said, “However, while we’re not going to get aggressive about the drug exclusion rule, we are going to get very aggressive about violations of the DSHEA regulations. -Marty Marion
Some Topics We Discussed Include:
[01:44] – Marty’s introduction, how he started. His background and how he got to healthcare and health product advertising and marketing industry. And how he got involved in working with the FDA, FTC, and the regulatory agencies.
[04:33] – A big reveal on FDA’s operating budget in connection with big Pharma.
[07:59] – Marty talks about the shift in the mentality of doctors, and how they are under pressure and spend less time with patients in a day. And how he got disheartened in guiding and advising major pharmaceutical companies.
[11:32] – Marty talks about the farm bill in late 2018 and how the people expected the bill to allow CBD and extraction of legalized hemp to be a legal product to sell.
[13:56] – Marty’s factual speaking on what the federal law says about CBD.
[22:33] – The FDA’s mandate
[23:22] – Marty talks about what the FDA has done, stepping back and not actively enforcing the drug exclusion rule.
[24:31] – Marty talks about supplements and why they are legal. And how anybody marketing CDB is technically out of compliance by the letter of the law.
[30:46] – Marty’s simple example of how to comply with the law.
[35:28] – Marty talks about how the FDA gives this industry a breathing space on the drug exclusion rule but are aggressive about violations of the DSHEA regulation. He discussed what you are allowed and not allowed to say in marketing your brands and products.
[43:29] – The cohorts: FDA and FTC and NAD. FDA warning letter and why you do not want to receive one.
[44:46] – Marty talks about the 10 page FDA warning letter received by Cura Leaf of curaleaf.com
[50:31] – Marty begs the industry and marketers that go out there and do acquisition legally and compliantly.
[52:51] – Marty’s final message to the CBD industry, “We need to police ourselves.”
References and Links Mentioned:
NAD – National Advertising Division
Scott Gottlieb – FDA administrator who stepped down.
Connect with Marty Marion
Connect with Sonia Gomez
Sonia Gomez: Today we are going to be talking to one of the country’s leaders in FDA compliance and compliance period for the CBD industry. No introduction could do this justice, so I’m going to introduce you to my good friend Marty Marion who will share with us some of the key things that you need to know as an existing or new CBD business and the big warning coming from the FDA is coming here at the end of the episode, so make sure that you stay tuned. Marty, thanks so much for joining us this morning. How are you?
Marty Marion: Completely my pleasure to join you Sonia. I’ve been excited about doing this with you. Doing great this morning and a lot of interesting things going on in the supplement and particularly the CBD space lately, things are changing.
Sonia Gomez: Oh Man, I’m so excited to get into the ever-expanding and evolving industry. This is just like, this is like watching a fine painting unfolding before your eyes. Like it’s a beautiful industry. It’s one of the fastest-growing cash-rich industries in the world right now. Many, many people from all walks of life are both benefiting from the product and the evolution of this industry. But there are also many businesses who are extremely challenged and in some ways threatened because of the, how can we say, instability in compliance and how this is still sort of working itself out. So before we dive into the nitty-gritty of all of that stuff, why don’t you take a second and tell us a little bit about who you are, what you’ve done, what makes you a superhero in the compliance space?
Marty Marion: Well, I don’t have the cape, but I do have a lot of interest in credentials. So my career started in the big Madison Avenue Advertising and Marketing Agency world. And for those of you that might be familiar with the TV series Mad Men, I was a mad man. I’m still a mad man in many ways. I’ve been called worse. But the TV series was based around one of the agencies that I was a senior executive of in New York on Madison Avenue. And when I was involved in the agency world, healthcare as an industry was evolving very quickly, particularly the insurer and payer side. And the agency that I was an executive of wasn’t very deeply involved in the healthcare business at the time. And they wanted to be, they saw the writing on the wall. And rather than organically build a healthcare practice, we decided that we were going to acquire a boutique health advertising and marketing agency, rebrand it under our name.
How Marty Got into Healthcare
Marty Marion: And so we did that. And I was part of a team that built that in a year to become the third-largest health and health product marketing and advertising agency in the world. And you can imagine thinking about the big Madison Avenue agencies that the clients were all the giant pharmaceutical companies, all the ones you could possibly name, right? Merck and Pfizer and Glaxo and Smith Kline. And you just went on and on and on. And after a couple of years, I got headhunted away to another giant agency, which at the time was the world’s largest healthcare and health product advertising and marketing agency. And they have even bigger clients. And my responsibility was to develop a strategy to help these clients take their products out of the pipeline and bring them to market and have a competitive advantage and working with all of the major pharmaceutical players. I had the opportunity to get very deeply involved in working with the FDA and the FTC and the regulatory agencies because that’s really the key of getting new drugs approved. Right. And getting them on the shelf and getting doctors to prescribe them. So I learned a long time ago how the FDA works, how it thinks, what they look for. And I also learned who their best friends are, which are obviously the big Pharma companies because, and most people don’t know this, 80% approximately of FDA’s entire operating budget is paid for by big Pharma.
A Big Reveal On Fda’s Operating Budget In Connection With Big Pharma
Sonia Gomez: Well I’m not surprised about that. I was doing, I remember doing a video, sorry to interrupt, but I just wanted to dive right in here cause you’re describing a trifecta here that I don’t think a ton of. I think we are aware, but we don’t really truly understand the intricacies of how each one of these buckets spills into the other. And how we’re just supposed to, you know, conduct ourselves business as usual at while all of these things are happening in the background that is quite literally infiltrating our subconscious and we’re seeing the effects of that in our communities, in our families, in our homesteads. And I was doing this video about, this was a little over a year ago even and I was reading some statistics that said over $500 billion have been spent to advertise. Yeah. $5 billion has been spent. 5 billion, something like that has been spent to advertise new pharmaceutical medications to Middle America. So the commercials that are being developed and advertise the amount of air time that’s being put out, you know, the companies that are behind the messaging and the advertising, the length of time and the speed in which they share the side effects of these new medications. All of these different things are just absolutely incredible and they play them after school.
Sonia Gomez:: When the kids are watching their afterschool programming or on Saturday mornings while the kids are watching their afterschool cartoons, eating their cereal on the couch. And these are the people who are being advertised to. So when a mom or grandma or grandpa gets a diagnosis, the kid is the first one to say like, why don’t you try this? I saw it on TV. Right? And so now it’s this like it’s just woven into our fabric and we have already been taught and told that the medical system is the one that we are supposed to have all of our faith and trust in that that is going to be where we can achieve our healing. When in fact it’s a system that’s built on financial gain, right? Like we as patients are not the priority. The paycheck is the priority.
Sonia Gomez: And there was another story I heard yesterday from a patient who was literally having after surgery, had cancer removed from his neck. Well, you guys can check it out on another episode cause I’ll be interviewing him on the podcast. But he has about an eight-inch incision here. And you’ll see in the photos the incision coming open with infection. Quite literally some events, you know, anatomy falling out of the incision and the doctor’s telling him it’s okay, let’s just start radiation. So it’s interesting to hear you speak of it from the advertiser’s perspective because you guys were the ones crafting the message and finding out, you know, what you can say how you can say it and more importantly, what not to say so that you can get these things approved. Now you’re on the other side of it and working with CBD companies who are transforming people’s lives. So can you talk to me a little bit about the industry secrets that you gained and how you’re using them in this industry?
Marty Marion: Sure. So when I was younger and you went to the doctor, the doctor was most interested in finding out what was really wrong with you. And doctors were like detectives, right? Because you can’t really fix something if you don’t know what’s wrong, right. Otherwise, you’re just throwing bandaid at it, literally. And in the last several decades, we’ve seen a shift in the mentality that doctors are now under pressure to spend less time with each patient so they can see more patients in the day and they’re under pressure to prescribe more drugs for specific products because doctors actually get a report card based on how well they meet certain quotas. Now, this isn’t really public, it’s not an official program. But doctors actually are rewarded based on how frequently they will write scripts for specific products. They get more free samples, the reps bring more pizza for the office staff, et cetera.
Marty Marion: And so doctors have become less and fewer diagnosticians and more and more prescription writers. And I had a problem with that and that’s one of the factors that led me to move away from being involved with and guiding and advising the big Pharma companies. And I had been in my career, a consultant to almost every major pharmaceutical company you could possibly name. And went through clinical trials and went through FDA approvals and all of that process. But I got very disheartened with it, to be honest. And I started to understand that a more basic fundamental healthy approach to staying healthy was better than an approach to, “Oh, who cares, we’ll fix it with drugs”. So I started to get very, very involved with companies that we’re investigating, developing and marketing, nutritional supplement, dietary supplement products. And I was able to bring my experience of having worked with FDA and understanding all the regulatory issues to the supplement space and helping a lot of supplement companies stay compliant, get compliant, and kind of do it the right way.
Marty Marion: And this is a good point to a transition, Sonia, into what’s going on in this wild west world of particularly CBD. So if you take the wild west analogy a little more, literally, when gold was discovered in California back in the mid 18 hundreds there was the huge gold rush, right? Okay. So everybody was going to become a millionaire and find a stream and pan for gold and well, that’s the good side of it, right? Lots of great opportunities and millions of people rushing out to become the next gold billionaire. But at the same time, you had claim jumpers and they were gunfights and people got killed and they, you know, had their $6 worth of gold nuggets that they found stolen from them on the way into town to sell it. And we’re seeing an exact replication of that on a much larger scale.
Marty Marion: When the Farm Bill was passed in late 2018 there was a lot of misinformation out there in the marketplace. People had been expecting it, people had been looking for the farm bill to get passed and it got passed and everybody expected and kind of convinced themselves that the farm bill allowed CBD as an extractor of legalized hemp to be a legal product to sell. The farm bill actually didn’t do anything like that at all. And so everybody say, “Yey, the farm bill is signed, we’re going to be the next CBD millionaires”. Right? Like the gold rush, the green rush. And they started building websites and white labeling products and finding manufacturers and putting a product out there in the marketplace. And what they didn’t understand was that there was going to be a huge backlash and a pushback from big Pharma and as I said before, 80% of FDA’s operating budget is funded through big Pharma.
Marty Marion: So when it comes down to it and you’ve got to pick who your best friend is to stand behind. FDA is not your friend in the CBD industry. o matter what they say, all the new hearings that are going on, their promise to reevaluate and come out with potentially revised regulations. I think that’s going to take two or three years at least.
Sonia Gomez: Or as long as Big Pharma wants it.
Marty Marion: Yeah, I do not believe at all that at the end of that process, the regulations that come out will either be really be revised or that they will be friendly to the CBD marketers outside of Big Pharma. But there are some very specific things going on that I think your audience really should hear and understand a little bit. So let me take it from the top and at the beginning of this is going to sound a little alarmist and it might sound like bad news and just stick with it for a minute because there’s a better. There’s a happier ending hopefully at the end.
Sonia Gomez: Like all things, there’s a light at the end of the tunnel.
Marty Marion: That’s right. And it doesn’t have to be a train.
Sonia Gomez: Good. That’s good news.
Marty Marion:So, slowly at the beginning. Today, factually speaking, according to federal law, all and I mean all CBD, regardless of its source, regardless of its format. Regardless of whether it’s isolate, broad-spectrum, full-spectrum, multi-spectrum, spectrum, doesn’t matter. Regardless of its format, oils drops, beverages, chocolates, doesn’t matter, right? All CBD is 100% illegal to sell in the United States period. Full Stop. No exceptions. Now the reason for that is called the drug exclusion rule. A pharmaceutical company called GW Pharmaceuticals, which I’m sure you’re familiar with, Sonia.
Sonia Gomez: Yes, I am.
Marty Marion: Submitted an IND, an investigational new drug application to the FDA to use CBD as the active ingredient in a prospective new drug for the treatment of juvenile epilepsy. And that IND application was approved
Sonia Gomez: Epidiolex right?
Marty Marion: Epidiolex, correct. And subsequently, the FDA then approved epidiolex as a drug for the treatment of juvenile epilepsy. Well, in the FDA regulations, it says very clearly that any substance that is approved to be used as a prescription drug may no longer legally be marketed without a prescription, period. That’s it. Game over. And because CBD, GW pharmaceuticals was very clever, very smart, they included CBD as the active ingredient. They didn’t go down the road and specify a very particular type of CBD or a very particular derivative of CBD. They said CBD. So according to the letter of the law, CBD is now illegal to sell as a supplement, period.
Sonia Gomez: Cannabinoids in general has, this is, and you know, this is an interesting conversation for me because I do quite a bit of research in this space. Being a part of, you know, legislative development here in Colorado and also fighting both the medical and legal system in California as a teenager and as a young adult for my rights to safe access. Being a patient who chose to use holistic remedies and you know, including nutritional and health supplements and all of this other stuff. Mind, body, and spirit multipronged approach. That’s how I wanted to get well. And I believe that many people want that and just don’t know how or don’t feel like they have the time and are looking for simple ways to do it. And CBD and cannabis, depending on the delivery system that you select have offered not only a variety but a sustainable way to alleviate challenges like this. Including the symptoms or side effects of medications that they’re on.
Sonia Gomez: So in this subject of cannabinoids, or in particular CBD, the US government has actually had a patent on cannabinoids, period. Derived from cannabis or industrial hemp for quite some time now, nearing a decade or more. And so it’s interesting that now that GW pharmaceutical comes out with, you know, epidiolex and all of a sudden it’s this revolutionary medication that’s gonna, you know, change the way that children suffering from epilepsy are, you know, living with their disease or with their diagnoses. Which by the way is not alleviate the parents’ stress or concern, nor the symptoms anywhere near as effectively as cannabis or hemp products. But that’s neither here nor there. You know, what is the difference between what GW pharmaceutical did in specifics with CBD and what the patent 6630507 did for cannabinoids? Why is there this sort of gray area from what GW pharmaceutical is doing and what that patent allows the industry to do right now? Because as we all know, the cannabis industry is booming and it is spreading like wildfire across the United States, around the world, actually. Likewise, for CBD, it is a global empire and many people from all walks of life are participating in one way or another.
Marty Marion: Well, that’s an excellent question. As a matter of fact, a number of years ago, I was giving a presentation in northern California. In the Humboldt region, which was the…
Sonia Gomez: Emerald Triangle area
Marty Marion: Emerald Triangle. And I thought that I was presenting to Emerald Grower’s association and to the people from harborside. And we were talking about the 07 patent and we were going down the road. We were laughing and having a good time at that, you know, during the conversation. But you know, the tin foil conspiracy presence starts to come out. And we were saying, “Oh yeah, well you know, the US government holds the patent on cannabis for medical uses”. All the while, while they’re saying cannabis has no medical benefits, right? But they have a patent on it that says, “Well, if there are any medical benefits, we own it”. And what we had thought at the time was that the government was going to let all these people start marketing cannabis, build an industry, get tens of millions of consumers excited about the benefits of cannabis and its derivatives. And then one day us government was going to jump out from behind a tree and say, “Aha, we own the patent. It’s all ours”.
Marty Marion: And that hasn’t happened. But the interesting part is that a patent gives the patent owner an intellectual property right that has asset value, right? Most of the big pharmaceutical companies are publicly traded. They have investors, they have shareholders and their objective. They have a fiduciary responsibility to make as much money as possible. I have no problem with that. We live in a society and in a country where we are allowed to go out and make a profit based on the work that we do and the inventions that we create. So good for them. On the other hand, I think there’s a number of components that are floating around that. When you put the pieces together, you finally see what the jigsaw puzzle really looks like. And if you only look at one piece, you’ve really can’t tell. So is it good that there are more drugs out there, whether they’re prescription drugs or supplement products or cannabis that can help kids that are suffering from serious problems like juvenile epilepsy?
Marty Marion: Absolutely. Nobody wants to see kids suffer. Whatever it is that’s going to do something good for them is a good thing. However, the process of getting there has been a little nefarious and a little underhanded in my opinion, so that the powers that be the government, the FDA, the FTC, the NAD, there are multiple three-letter agencies, it’s not just FDA. That has allowed the industry to go crazy where we now have, we had a dozen that we had several dozens that we had hundreds. Now we have thousands of companies out there, marketing CBD and the FDA saw the public demand. They saw the response after the farm bill was signed. And they said, “Wow, there really is a large component of the public that’s interested in this”. And to the FDA’s credit they said, we need to take a step back for a moment and reevaluate.
The FDA’s mandate
Let's give them at least the benefit of the doubt that they meant it at the time that they were going to take a step back and reevaluate what's going on and should they find a way to allow CBD to be legally marketed as a supplement. - Marty Marion Click To Tweet
Marty Marion: Now was that a genuine gesture? Let’s give them at least the benefit of the doubt that they meant it at the time that they were going to take a step back and reevaluate what’s going on and should they find a way to allow CBD to be legally marketed as a supplement. The FDA is charged with one thing, and that is the safety of the public period. That’s their mandate is to make sure that the foods people eat, the cosmetics people put on their bodies, the products they put in their mouths are safe. And you’re not going to die or suffer because you take some snake oil, right? That could be dangerous. And that’s a great thing to have that there’s a watchdog to prevent charlatans from coming out and you know, potentially hurting consumers just to make a fast buck. So what the FDA has apparently done, which they’ve said, we’re going to step back and we’re not actively enforcing against the drug exclusion rule.
Stepping Back And Not Actively Enforcing The Drug Exclusion Rule
Marty Marion: So we’re not coming after CBD marketers based on the law that says CBD cannot be sold as a supplement because we’ve approved that as a prescription drug. But at the same time, you know, they gave with one hand and they took away with the other. And at the same time what they did say very and very loudly and multiple times they said, “However, while we’re not going to get aggressive about the drug exclusion rule”, right now. Wink, wink, “We are going to get very aggressive about violations of the DSHEA regulations”, the dietary supplement health education act. And so, therefore, this is where we get into the issue of CBD marketers making claims, right? So here are the basics in a nutshell, and this is a much longer conversation, but I want to give you and your readers, your listeners. I know you know 99.9% of this, but I think it’s good for everybody to hear it from the ground up.
Marty Marion: So a supplement is intended and legally allowed to be exactly what it says, a supplement to the normal human diet. Many people do not get enough nutrients in their diet to stay healthy and that’s why supplements exist. And that’s why supplements are legal. Because for example, if you’re a vegetarian or Vegan, perhaps you’re not getting enough iron or enough B12 in your normal diet to maintain proper health. So you are allowed to take various supplements. If you’re a woman and you’re getting older and going through menopause and potentially having calcium deficiencies. To maintain strong, healthy bones and hair, you may need a calcium supplement or a magnesium supplement to your diet. So supplements are allowed to supplement the diet, period. But there’s a nuance chair. A supplement is only legally allowed to help you maintain a normal, proper state of health. It is not allowed to be marketed to take you from a non-normal state of health, meaning you’re suffering from something and reverse it back to a state of health.
Marty Marion: So for example, and I’ll pick on two quick examples here. One is insomnia. Right? Now there’s a lot of CBD marketed out there today to help with sleep issues and insomnia and so on and so forth. And it may be factually true that it does. That doesn’t matter. According to the letter of the law, insomnia is an official disease because it’s a chronic repeated pattern of an inability to fall asleep. And that could signal that there’s something wrong in your body that might need a doctor’s attention. However, occasional sleeplessness, everybody experiences that. You have a fight with your spouse, your kids are sick, you’re worried about finances. How are you going to pay the rent tomorrow? You had to fight with your boss at work. You got a big interview coming up. A lot of reasons why you get stressed out and can’t get a good night’s sleep.
Sonia Gomez: Yeah, that’s 90% of the households around the world,
Marty Marion: Right. So a supplement is allowed to help you maintain your ability to get a good night’s sleep. It is not allowed to help you reduce or relieve or deal with insomnia because insomnia is a disease. Occasional sleeplessness is not a disease. So it depends on not only what you’re saying, but what the intent is. But how you’re saying it. Let’s use another one. Pain. Most CBD is marketed in some degree or another to deal with pain. Well, there are lots of different types of pain, right? I could smash my elbow on the edge of my desk and wow, it’s going to hurt. I’m going to be in pain, but that pain is not caused by a disease. That pain is caused by stupidity. I banged my elbow. Right. However, FDA shows that if you’re in pain and you’re not a professionally trained doctor, if you’re not medically trained, FDA says you are not qualified to adequately shelf diagnose why you are in pain. So if you have headaches or back pain or stomach pain or chest pain or aches and pains in your shoulders and muscles all through your body, FDA says you’re not a doctor. You’re not qualified to diagnose whether that pain is serious or not serious. So you are allowed to help someone maintain a normal pain-free state of being. Okay. You are not allowed to use a supplement or to market a supplement to reduce pain, relieve pain, treat pain, help with pain, ease, pain, none of that. Those are treatment claims.
Sonia Gomez: What you’re saying basically, sorry to interrupt, is that 90% of the brands that are in the market right now are out of compliance for two reasons. Number one. Or actually for three reasons, and you haven’t mentioned this yet, but I’m just going to go ahead and throw it in there.
Marty Marion: Go for it.
Sonia Gomez: Number one, GW pharmaceuticals have claimed, staked claim, put the flag in the dirt around CBD, so anybody marketing CBD is technically out of compliance by the letter of the law. Second, the way that they are marketing based off of functionality and repair versus support makes them out of compliance. So if they say, you know, pain cream and their marketing that you’re going to alleviate your pain using a cream or a tincture that eliminates your neck pain or headaches, that’s out of compliance. Third-tier to that is even with testimonials, if you have a testimonial where one of your clients or purchasers is saying, I took this and before I was this way and now I’m sleeping like a baby. Even that is pushing the borders of compliance almost to the point of saying that you’re out of compliance.
Marty Marion: I’m going to add another one to that, Sonia.
Sonia Gomez: Oh, there’s even a tier four?
Marty Marion: Ooh, there’s, there’s six or seven of these.
Sonia Gomez: Oh sh*t.
How to Comply with the Law
Marty Marion: Yeah, it gets, I’m telling you, it gets really crazy. And even marketers of supplements and CBD products that want to be compliant, the nuances are very complicated. For example, and everything you said is 100% spot-on correct. So you can call a product Bob’s CBD pain cream, but you can’t in context talk about treating or relieving pain. You can talk about helping someone maintain a normal pain-free body.
Sonia Gomez: Okay. I feel like that’s good. And all of you guys who are existing CBD brands, rest assured that the information that you’re getting right now offers you a framework and a bridge to get from where you are right now. Maybe perhaps with the question in your mind to where you want to be, which is skating on smooth ice. And I through that, I think through understanding these nuances and really looking at the weave of the fabric, right? We want to really look at the full picture of the jigsaw puzzle and not just one piece. Many businesses right now, and excuse me, Marty, while I just bridged this gap here, but I think a lot of the challenge in the industry right now, and I know because I’m working with many top-level brands and brand new beginning startups inside of the Emerald Circle, which is a business mastery mastermind specific to the cannabis and hemp space.
Sonia Gomez: Because as you guys know, there are many nuances as we’re describing here that make us individual and different from any other industry in the world. Starting with the fact that we are brand new. So if you are an existing brand or you are looking at joining the green rush as either an ancillary business or a direct relationship with any process that has to do with hemp cannabis or any of its derivatives, it’s important for you to understand the top-level compliance rules so that we can find the gray areas that you can operate in that will avoid you getting a letter from any one of these three-letter agencies and there is a gray area. Marty, I can’t wait to hear about this letter that you have in your hand right now, but there is black and white and then there’s a gray area.
Sonia Gomez: In that gray area you are safe to assume that what you are doing and how you are doing it will keep you from receiving one of these letters. Now, unless you’re operating in full Blanca, unless you’re in the full white, there is no guarantee and honestly, in this industry, there’s never a guarantee. Nobody guaranteed a new farmer or a new gold rusher that they were going to strike it rich, right? As a matter of fact, in the entrepreneurial world, there are many references to watching somebody pick, pick, pick, pick, pick away at the dirt and walking away right before they strike the vein, right? Or continuing through the vein instead of following it down because gold grows linear. The point of all of that is saying is that there, this is not a hopeless conversation. This is meant to bring you to hope and more importantly, bring you to awareness so that you understand the inevitable obstacles that are a part of any business, but specifically this business. Now, because the rules have not been written yet, being a part of this industry, whether you’re brand new or well-established, being a part of this industry, you are a part of writing the rules and you have a specific responsibility to leveling what we do as an industry.
Sonia Gomez: So watching, listening, paying attention to and complying with to the best of your ability, without limiting your capability of doing or growing your business is really important because to make the impact, the income is inevitable. This is the biggest, fastest-growing cash-rich industry in the world. Whether you’re selling, you’re basically selling popcorn to elephants right now. There’s no way they’re going to turn you down like so. There’s, it’s inevitable that you will find success here, but if you do not understand these nuances in compliance and business building, these specific practices that you must follow in order to start, build, grow, scale a business, you’re going to be looking at the doomsday device. And really you’re just playing Russian roulette and putting too much on the betting, too much to win too little, you know? So I suggest that you take a second look here. Take your time to understand the compliance by the letter of the law because in that there are loopholes and gray areas that you can operate in comfortably without compromising your investment of time, money, energy or team.
Marty Marion: Sonia, I love your analogy that the smooth ice, right? We all have to understand that all the ice is very thin, to begin with because of the drug exclusion rule. FDA has given this industry a breathing space where they’re not coming after you right now about the drug exclusion rule, but they are being very aggressive and getting more so about violations of the DSHEA regulations in terms of making claims. I’m going to throw a couple of things out at you and then I’m going to give you a piece of news that happened yesterday. So number one, you are not allowed, not only to say you are not even allowed to imply that a supplement, particularly CBD can diagnose, treat, cure or prevent any disease or any symptom of a disease. Now pain by itself is not a disease but it is a symptom of many diseases. So you are not allowed to relieve, treat, eas, reduce, pain nor inflammation. In fact, anti-inflammatory is a specifically prohibited phrase.
FDA has given this industry a breathing space where they're not coming after you right now about the drug exclusion rule, but they are being very aggressive and getting more so about violations of the DSHEA regulations in terms of making claims. Click To Tweet
Sonia Gomez: I’m so happy that I’m a media company cause I can say whatever the f*ck I want. Now I’m just kidding.
Marty Marion: Anti-anxiety, same thing. Now you can say helps maintain a state of calm. You cannot say to reduce anxiety. You see the difference. It’s a way, it’s the way you say it. Now to go back to what you said before, Sonia, a lot of companies say, well okay, I’m going to stay clean. I won’t make any of these horrible mistakes but I’m going to include social proof. So I’ve got 15 testimonials on my side from verified users. Let’s assume they actually are really verified users and Suzy from Chicago says, “Oh my God, I tried Bob’s CBD tincture and for the first time in years I am absolutely free of my arthritis pain”. Boom, illegal. Now Suzy has the right to say whatever she wants to say, right? The minute you put it on your website, you are saying it. So the use of testimonials and the use of reviews that include treatment or prevention claims that are in violation of DSHEA, you are in violation of DSHEA.
Marty Marion: So Suzy can say on your website, “I love this product. This is wonderful. I use every day”. But she cannot say on your website to help me with my arthritis pain. Okay. Number two, number three, wherever we are. You are not allowed to include citations even from legitimate third party peer-reviewed scientific studies from the most reputable institutions in the world. You cannot include an excerpt, a citation, or even a link on your website to the study by the Harvard Medical School that showed that CBD was able to reduce arthritis pain by 48%, the minute you put that on your website, you are saying it in context, it’s called a nexus to the selling of your product. Therefore it becomes illegal. But let me jump over to the, to the news from yesterday.
Sonia Gomez: Wait, I want to just say one thing before you open up this news from yesterday. And for those of you guys who are just tuning in right now, what Marty is about to share with you is the newest information from the FDA, the newest warning letters. So tune in, make sure that you stay focused here. There’s going to be a lot of value in what (a) to avoid and what (b) to look out for. But I wanted to just give one little caveat because what you said right now, Marty, about what people say, how people say it, what could potentially compromise you. There’s one caveat to this, okay? And why I’m over here smiling like it’s Christmas dinner. Okay. If you are a brand, those things are true. If you are a product company, those things are true. Here is my secret and if you guys want to know more about how I’ve been able to run compliant advertising for cannabis and hemp brands for the last three and a half years.
Sonia Gomez: I’m one of the veterans in the area. My husband and I have 30 years in this industry. We’ve literally been a part of weaving this fabric, creating the industry, pioneering this movement along with a few of the others that you’ve seen inside of this podcast here, but we have some industry trade secrets that have allowed us to run compliant advertising and build a massive movement, a massive audience and an internal traffic system for CBD and cannabis brands. Now if you want to know more about that, click on the link, shoot us an email, check us out on our Facebook communities because there are ways around what he is saying and we are actually showing specific brands exactly what we have done and are doing to reach a massive community of people who are actively searching for the result-oriented products that I know that you are producing.
Sonia Gomez: Now, if you are a new entrepreneur and you want to understand more of the intricacies of how you can get started and be compliant from the start and not have to go back and spend a lot of time and money fixing avoidable mistakes, we can also help you with that. Just check out, shoot us an email, let us know a little bit about you and where you are and we would be happy to get in touch with you, but I want you to know that this is not a blanket statement for the industry. If you are a physical brand, Bob’s CBD, these are the things that are governing you, but if there are some secrets, for instance in the lane that I’m playing in, I am a media company, so I get the great pleasure of talking to both the industry leaders and professionals as well as the people whose lives are being transformed by this. And by using this platform, this type of media, I’m able to expose the results and inform the community of the different happenstances that are happening. And I’m governed by the FTC, which I’m far and away from any of the claims that would put me in danger. But those are different governing municipalities. FDA, DSHEA, all of the Disha? Desha?
Marty Marion: Yup. Dishey.
Sonia Gomez: Dishey, that’s how you say it, the DSHEA, that’s one bank. That’s one Bank of the governing municipality. The FTC is completely different and in my experience, not so scary when it comes to being able to share stories and talk about the results that people are getting and really do investigative journaling. That’s what this is. And we have the, we are protected by the freedom of speech. Just throwing that out there. Excuse me for interrupting. Marty, take it away. Let me know.
Marty Marion: No, no, no. everything you shared is exactly correct. I will add however that FTC and FDA work together.
Sonia Gomez: Well, they’re all in cohorts.
Cohorts: FDA and FTC and NAD
Marty Marion: Right? When the marketing is making FDA violation claims, that could be misleading or untruthful to the public, then FTC steps in. And there’s also the NAD, the national advertising division, which you absolutely don’t want to run afoul of because they’re one of the three-letter agencies you don’t hear about a lot and that’s a good thing. But here’s the big news and I’ve been saying this for months actually since the farm bill was signed that FDA is kind of gathering their docs, putting them all in a row, figuring out what to do and at some point, FDA is going to start issuing warning letters. You do not want an FDA warning letter. It’s like getting audited by IRS once you’re audited IRS one year, they’re looking at you the next year and the next year and the next year.
Marty Marion: Right. It’s almost like being a registered sex offender. All eyes are on you from that moment forward. So you do not want an FDA warning letter. Yesterday the FDA started to issue warning letters and…
Sonia Gomez: Is this the first set of warning letters that have been issued?
The 10-paged Fda Warning Letter Received By Cura Leaf Of Curaleaf.Com
Marty Marion: It is actually the first warning letter that has been issued in a number of months this year. But it signifies that FDA is now ready and unafraid of issuing warning letters. They’ve kind of, they have a new administrator, rights? Scott Gottlieb stepped down, there are a new administrator and FDA on July 22nd that’s yesterday, sent an FDA warning letter by overnight delivery. So it arrived this morning to a accompany in Massachusetts called Cura Leaf, C-U-R-A-L-E-A-F.com and this is about a 10 page FDA warning letter. This is what it looks like and you really don’t want to get one of these. I have gone through the entire warning letter word for word for word and I’ve highlighted a few things that are very telling about what’s going on.
Marty Marion: So first of all, the FDA, when they issue a warning letter, they throw everything and the kitchen sink in the warning letter, right? They cover every base. So they are calling out this company for having claims that are in violation, making those products classified as drugs and thus illegally marketed for CBD vapes, CBD tinctures, CBD creams, CBD oils, and they give literally exact quotes from the company’s website on page so and so, in your article entitled “Can CBD Oil be Used for ADHD”, that’s the title of the article. Can it be used for ADHD? Now to me, that doesn’t sound like it’s making a claim, right? But…
Sonia Gomez: Any content after that has to be making a claim. It’s answering the question yes or no.
Marty Marion: Right? And they use words like relieve, address the symptoms of, chronic pain, anxiety, ADHD. And FDA quote every single instance on their entire website is detailed page after page after page after page. FDA went through every blog article on the website, every page on the website, every product description on the website, every social media reference on the website and found dozens and dozens and dozens of FDA DSHEA violations that are all detailed in painstaking detail in the warning letter, chapter and verse, word by word.
Sonia Gomez: Ooh God.
Marty Marion: And hold on. Here’s where it gets interesting. There are two pieces of interesting news in this. Number one, it’s actually three pieces. Number one, FDA’s also citing in this warning letter, this company’s use of social media, particularly Facebook and Twitter, which means this is one of the first times I’ve actually seen this in great detail. FDA is now evaluating, reviewing and calling you out for what you say on social media, not just on your website, so what you’re posting on your Facebook pages, even if it’s not paid to advertise. What you’re posting on Twitter, what you’re responding to when other people ask questions.
Sonia Gomez: Interesting.
Marty Marion: FDA’s catching all of that now. Next, is this company is also selling CBD products for pets. So this answers the question that FDA absolutely exerts control over veterinary products and supplements for dogs and cats and other animals. And they’re talking about for dogs with arthritis and dogs with joint issues. And they cited the American Kennel Club report about how CBD can help reduce inflammation. Siting that report, put them in violation. Okay. And here’s the last piece of this. Remember I talked about the drug exclusion rule for epidiolex. FDA includes it in the warning letter so that they have a safety net where even if the company fix it, all of the DSHEA violation claims on their website, FDA can come back to them and say, “Yeah, but you’re still in violation of the drug exclusion rule because we gave epidiolex the sole exclusive rights to market CBD”, period.
Go Out There not for the Fast Dollar
Marty Marion: So what’s happening here is FDA is covering their ass there, including the drug exclusion violation in the warning. So at any day, tomorrow, next week, next month, if the FDA wanted to, they could whip out the drug exclusion rule card and shut down every CBD marketer. And this is why I begged the industry. We all know how valuable CBD is. We all know the benefits that it can have and as well as other derivatives of the hemp plant. There are marketers out there who are just shamefully looking for the fast dollar and don’t care and will market anything to make a sale. Okay. I have a problem with that. If you want to destroy your own business, I guess that’s your right. But when marketers go out there and make more and more illegal violation claims that they could easily avoid because I am telling you and Sonia you and I’ve had this conversation, you know there is a right way to say anything you want to say.
Marty Marion: We can talk about issues like pain, we can talk about sleeplessness, we can talk about these things if we say it the right way. Right? And you know better than anybody else in the industry that you can market. You can advertise, you can drive traffic, you can do acquisition legally and compliantly and build a hugely profitable business as you do for your clients today. And I’ve seen Sonia’s work and I can vouch for the fact that it’s absolutely brilliant. There’s very little out there that does it the way Sonia and her husband do it. But that being said where I really have a problem is that there are marketers who know better. I’ve had at least four conversations with the top CBD law firms in the country over the last several months where I’ve literally had to actually educate them because they were misinterpreting FDA regulations and giving their clients wrong advice and it was getting them in trouble.
We Need To Police Ourselves. Go Compliant
Marty Marion: There’s a lot more to talk about, but the point is, let me leave you with this Sonia and your audience. We have a grace period in the CBD Industry today where if you can stay compliant if you can get compliant and they’re all, we talked about a half a dozen or a dozen little nuances today, let me tell you, there’s a hundred of them, a hundred of them, right? If you can get compliant and stay compliant not only on your website, in your blog, in your marketing, on your labels, right? In your packaging, you have an opportunity to survive. What I believe is going to be a continuing wave of more and more and more warning letters that are going to be coming out. And the more FDA has caused issue more warning letters, the longer it’s going to take them to come to a new set of rules and regulations that might allow this industry to finally become legal and blessed and sanctioned for doing things the right way.
Marty Marion: We need to police ourselves and really take it on ourselves to understand that we care about our patients, we care about the consumers that we’re marketing our products to because we believe that this is a benefit to them. Then we have an obligation to help this industry survive and not call down the wrath of the gods in Washington upon us. So that’s my little soapbox speech Sonia, what a pleasure to have this opportunity to talk to you and your and your audience on your podcast today. Thank you. First of all, by the way, for everything you and your husband are doing for the industry, I think it’s absolutely brilliant. And for those of you who haven’t had the opportunity to take a look at what’s Sonia and her husband are offering for CBD and cannabis marketers, you need to take a few minutes and do that because there are a few people out there who do it the way they do and few people who get it the way they do in few people who have had the success for their clients.
Marty Marion: And I’ve seen this with my own eyes that they can bring to you. So you get my highest possible recommendation and Kudos for everything you’re doing for the industry.
Sonia Gomez: Thank you.
Marty Marion: I will put in one little shameless plug.
Sonia Gomez: Do it. Do it.
Marty Marion: If you are really starting out in CBD marketing or if you already have a website and you really want to do the right thing. Get in touch with Sonia. Sonia knows how to get in touch with me. I am very happy to offer reviews or compliance edits for your websites, for your social media, for your product labels. And I’m happy to do so. I want to see this industry survive and thrive. Don’t want to see people getting warning letters and getting shut down. So by all means, if you’re concerned about FDA compliance and FTC compliance and DSHEA compliance, which by the way, you should be. Make no mistake. I’ll just add one little cute thing here. Driving drunk is illegal, right? We all know that. Does it mean that if you drive drunk tonight, you’re going to get caught? No. Does it mean you’re going to get into an accident? No, not necessarily. But if you continue to do it, the odds you’re going to catch up with you. If you are not compliant because you didn’t understand some of the nuances. Let’s fix that for you. Okay.
Sonia Gomez: I always say that Marty. I’m all about, you know, people are really considerate about budgets and you know, everyone wants to look at the bottom line and do we have money for this and do we have money for that and how do we spend the money that we have? And you know, even if you’re well-capitalized, I see this happen too often where people are hesitant to invest into, you know, the big four and for me that’s compliance. For me that’s legal. For me that’s accounting and for me, that’s licensing. If you get those four things right, those are really the pillars of your foundation there. If you can fill in that foundation, you’re going to have a solid structure. If you build a hollow foundation that is not, you know, filled with the meat that you really need or concrete facts that are subject to change.
Sonia Gomez: That’s the one thing about this industry that you have to know that there are concrete facts that are subject to change because it is a new industry. Now if you want to profit from the green rush and you want to be a part of the next wave of millionaires or even billionaires that are being created in this space, by all means, the time is now to jump in. Anybody is fair game right now. There’s so much opportunity. It’s sickening and in some cases blinding because you’re like, which direction do I pick? Ancillary directly related manufacturing pro. It doesn’t matter. There is an entry point for you whether you have the skill sets, need to develop the skill sets or are already operating a business. There is time and space for you. I will advise from the very, very beginning though, understand what the rules are so that you can beat the game.
If You Don’t Know What the Rules Are, You’re Playing Roulette
Marty Marion:If you don’t know what the rules are, you’re playing roulette and that’s okay. If you want to gamble, but I suggest going to Vegas because your odds are going to be better. Your stress is going to be lower and you’re going to lose, drink it off, sleep it off, and then fly home. That’s not the case with the CBD or cannabis industry. You come in to bet at all and you either win big or you’ll lose big. That’s how it’s going here and if you don’t get the stomach for it, don’t join.
Marty Marion:: I think you are two million percent correct. In this industry at this time, there are massive opportunities. However, if you play the game wrong, if you are in violation of FDA and [inaudible] regulations, it is not a matter of if, it’s only a matter of when your business will go bye-bye, with all the dollars you’ve put into it and it will hurt everyone else in the industry. So you have been warned, the FDA is not sitting on their thumbs anymore. There it is. FDA warning letter.
Sonia Gomez: Yup. There it is. Cura Leaf, sorry guys. That’s just, I mean for me that’s the worst.
Marty Marion: Sonia.
Sonia Gomez: For me, that’s the worst and the best news just in your final thoughts and Marty, I’m so super grateful for the work that you do as well. Thanks so much for your stamp of approval on what we do. We work really hard and we definitely skate like this on the fine line. So I’m, I’m not by any means saying that we’re perfect, but we have been a part of this long enough to know what we are comfortable risking. And it’s for us it’s in the name of growth and progress and we really have a mission and a purpose and a passion that we put behind this and every single day is a risk, but there’s an incredible reward for the things and the way that we do things. And how we advise our businesses is to be aware. You have to be self-aware and give yourself permission to use self-care, care enough about yourself to be a part of the evolution and innovation of this industry rather than its demise.
Sonia Gomez: There’s plenty of people playing on all different sides of the spectrum that are contributing to the negative stigma that has haunted this plant and its capabilities for generations. We are in a tipping point right now whereas a community, as a family, as a planet, as a country, we are looking at the largest evolution and wealth growth opportunity of our lifetime. This time period here is going to go down in history similar to the tech revolution, the oil boom, the world wars. I mean any major turning point in history that you can refer back to that is celebrated with national holidays. We are looking at the same type of movement right now and we can either be a part of what makes it great or we can be a part of what makes it f*cked up. And I believe what Marty says, and I preached this myself, we have a responsibility to operate under the pretenses of together as one because we are one industry with many entities and this one industry is making an incredible impact in the communities and consumers that we are serving online, offline, it doesn’t matter.
Sonia Gomez: Your product is touching the hands of people who need and want to believe that there is something else out for them. And our responsibility to greatness starts with self-care and consideration and the way that you build and grow your business and utilize your message to impact your marketplace.
Sonia Gomez: Thank you so much for tuning into another episode of on the rise podcast. I’m your host, Sonia Gomez. This was our guest, Marty Marion, who is one of the country’s leading compliance expert when it comes to cannabis, CBD, FDA, DSHEA, FTC, and all of the others, scary three leather industries. This is definitely a person that you want to have on your side. We will do a part two to this specification for the Emerald Circle Mastermind members who want to dive more into the intricacies of these things, and we will post all of the contact information so that you can directly connect with Marty, his social media platforms, as well as having him work specifically with you, your brand and business, to ensure that you are following the much-needed rules and regulations that are governing and growing this industry. Marty, we’ll see you again and thank you guys for tuning in. Take care.
Marty Marion: Thank you so much, Sonia, have a great day.
Sonia Gomez: You too.
Marty Marion: Bye Bye.
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