Drug Topics®: E-Alternative Solutions (EAS) is a leader in regulation and compliance in the CBD industry. In the rapidly evolving health and wellness landscape of cannabis- and hemp-derived products, Stephanie Rech and Chris Howard from EAS dive into the biggest questions related to CBD use, safety, and marketing to customers – including pharmacy patients. Take a look.
Rech: My name is Stephanie, I work at EAS as a regulatory specialist, so part of my responsibilities are to research and help analyze the rules and regulations as they relate to CBD. This is definitely a topic that is near and dear to what I do.
Howard: Right, and my name is Chris Howard, I am general counsel and chief compliance officer at EAS. I’ve been working in the CBD space, now, for several years.
EAS actually markets its own line of CBD products. And, as Stephanie noted, we both spend quite a bit of time analyzing the various regulations, both federal, which are very few, but state that impact the category. I will highlight, one caveat is that I am obviously a lawyer, and the information that I share here today should not be taken as legal advice. This doesn’t create an attorney client relationship between me and the viewer, so if you do have legal questions or questions regarding some of the opinions that either Stephanie or I provide, I encourage any listener viewer to bring it up with their own independent counsel that helps them with issues.
Drug Topics®: So recently, we’ve see a really big boom in CBD products – I’ve seen CBD products in pharmacies, but also offered really everywhere: grocery stores, gas stations, liquor stores are selling CBD. So, can you give us a little bit of an understanding of why we’re seeing the CBD space boom recently?
Howard: Yeah, why don’t I kick things off here. CBD isn’t necessarily what I would call new. But we did have some significant changes towards the end of 2018 regarding the Farm Bill and what it did for the category.
Related: A Look at the CBD Legal Landscape
So back in the 2014 Farm Bill, CBD was permissible. What it did was it establish an industrial hemp pilot program that enabled people to manufacturer, to grow, to cultivate CBD hemp-based products for research. And in addition, it had some other criteria regarding what hemp products and CBD products could be. In fact, it limited THC content, which is the threshold level of not necessarily CBD, but the other compounds derived from cannabis plants – limited to that to 0.3% of the product.
And it said that states have the right to develop their own research programs. And so, there were some states back in 2014 that facilitated the growth of CBD manufacturing and cultivation. And a lot of people took this research program idea, they stretched it, and even included marketing research. So that’s why there were some areas that enabled the sale, or marketing or both of CBD even before the significant event in 2018.
Well, 2018 rolled around the Farm Bill was revised. It still kept the 0.3% THC threshold, which is good, but it expanded the definition of hemp to include more products. Most significantly, it removed hemp from the Controlled Substances Act. Now it was no longer federally illegal. And it’s allowed for interstate transportation of hemp products.
In other words, without getting into all the details of the 2018 Farm Bill versus 2014 Farm Bill, in 2018, late 2018, it really opened things up. In other words, it facilitated more and more people being comfortable entering the market, especially in light of the fact that FDA hasn’t provided what I will call a “formal structure” for regulation of the category but that’s really the reason for the boom as you call it.
Drug Topics®: And the FDA has been cracking down on some who have been marketing CBD products. Can you talk about the FDA’s position on these currently marketed products?
Howard: When you ask FDA’s position, FDA doesn’t really have a position on many aspects of CBD, and hemp sales, so let me tell you what we do know.
Right around that time that the Farm Bill came out, obviously FDA realized that we better start directing some attention to this category and let consumers and the channel know that they’re going to oversee the future of manufacturing, marketing, sales, cultivating, all these aspects of CBD. So, in December of 2018, former commissioner Gottlieb actually issued a statement – and you can find this statement online, just type in FDA 2018 Gottlieb statement on CBD. And in that statement, he highlighted several FDA priorities about the category. There were a lot of positive messages there.
In fact, he said that they’re going to explore pathways for lawful marketing of CBD-based products, of hemp products. He said we’re going to establish a working group that’s dedicated to helping develop a regulatory scheme for the products. And then they said they’re going to prioritize enforcement, which we’ll talk about in a minute, when I say enforcement, I mean that in the broadest sense. But then he gave some positions on the various form factors of CBD as they’ve existed, or they currently exist in the market today, is really much of them were on the market back in 2018.
And, and but that I mean, he said that, look, topicals, the products including lotions and the rubs and the creams are pretty much – and these are my words, not his, you should read the statement on online – but he said they’re pretty much fine. Be sensitive to not making false claims and things like this, but we’re not going to enforce on those particular products, not without cause, which we’ll get into what cause means in a minute.
But he said that ingestible products are really not compliant. They don’t really fit within the federal Food, Drug and Cosmetic Act primarily because they’ve already licensed drugs which contain the active ingredients, so they can’t now just say that these products are fine without additional scrutiny. FDA’s position was generally that ingestible products are not compliant. I should highlight here, especially if there’s any questions, that FDA hasn’t really acted on this in isolation. In other words, if for example, a manufacturer is selling a chocolate cake with CBD in it, or more likely a gummy or chew with CBD in it, FDA hasn’t come after them because these products are noncompliant. Rather, and I’m not saying that means it’s okay. But it does appear that they’re looking at some discretion here. They’re not ready to act on those kinds of products standing alone.
But what they have acted on, and what former commissioner Gottlieb emphasized in his statement, was that FDA is not okay with companies going out and marketing CBD products with therapeutic claims, with drug claims. In other words, at the time in late 2018, there were all kinds of websites and product packaging and advertisements which said things along the lines of “CBD cured my cancer,” “CBD kept me from another heart attack,” “CBD got rid of my diabetes,” whatever, you name it, the medical claim the drug claim, and they were out there. And FDA former commissioner Gottlieb indicated that that was not okay and that FDA intended to act on that.
And that’s exactly what has happened. Let’s break that down a little bit. FDA defines a drug claim as a statement that says something along the lines of the product containing CBD, diagnoses, cures, or treats or prevents a certain disease or a medical condition in man or other animals. So, things like pain relief. Some of the extreme examples that I gave like cures cancer, but anti-inflammatory effects are reduced is another one. It helps promote sleep; all of these things are considered drug claims by FDA.
And since late 2018, FDA has sent multiple warning letters to companies that are doing exactly this, most of them are more extreme in terms of their therapeutic claim-making that they’ve been doing, but FDA has taken action, and FDA has explained further why they’re taking action.
First of all, there’s no scientific basis, no evidence. And by that, I mean formal evidence built by peer reviewed study and all that which supports these claims of therapeutic effects. And that’s important for FDA because they do make decisions based on science. And the science isn’t there, at least not at a level they deem acceptable. There’s plenty of anecdotes, but not formal science that supports these claims.
And just as importantly, what FDA fears is that consumers would see these marketing messages about therapeutic claims and say, “This is a pathway to me curing my whatever,” and as a result, they might forego other pathways that are scientifically proven. For example, someone with cancer might say, “I got a big decision to make here. Do I go forward with radiation and chemotherapy, or do I trust this claim? I just heard and use CBD to cure my cancer?” Well, FDA doesn’t want that. Of course not. That’s probably not good for public health overall.
The bottom line is this. FDA acknowledges that there’s some benefits to CBD, and they’re dedicating resources to the category. And we know that’s true. But they don’t want people making drug-based claims, therapeutic claims. And they have actively acted on that ever since December 2018, all the way through as recently as today. And I think they’ll continue to do that.
Drug Topics®: You mentioned that FDA is really looking for the science. Have they been investing in clinical trials to show that CBD can be beneficial?
Rech: Yes. The FDA is continuing to work alongside drug developers and investing in clinical trials and real-world data as well to try to help support their decisions and test the safety of CBD for the public.
Howard: FDA is certainly involved in this area. And I’ll tell you, it’s not just them.
There’s dozens of researchers that are now dedicating more resources and effort to this category. And so, while it seems like we’ve been in this period of uncertainty since December 2018, and that’s back when they said, we don’t have more than anecdotal evidence to support these claims. It’s not for lack of trying. A lot of this evidence can only be built over time. We need longitudinal data that shows some consistency with regard to various form factors, CBD content, etc. So, it does take time, it’s not to suggest that FDA isn’t doing or that third parties aren’t doing it. It’s just look, this is a pretty unique product, and it impacts or affects people in different ways, depending on who you are. And as a result, these studies are going to take a lot of resources and effort to come to some real conclusions.
Drug Topics®: And going forward, what actions can we expect or that you hope to see from the FDA?
Howard: We can probably throw a lot of things out here. Here’s what I want. I think and we need a regulatory scheme. By that I mean, of course, there is a drug side of FDA – another example is the Center for Tobacco Products that regulates vapor, for example, and combustible cigarettes. We need – and there’s obviously a dietary supplement arm where they look at dietary supplements – and we need FDA to either decide where CBD fits in terms of an existing regulatory scheme, or to create a new, separate regulatory scheme, so that’s my personal view that I wish they would do.
I’m also encouraged by the fact that they continue to sort of crack down on therapeutic claims. And that, to me, shows that they learned some of the lessons from the vapor industry, which 10 years ago suffered from sort of a wild west-type culture, where people were just kind of running wild with vapor products, making claims saying that vapor products can help you quit smoking and things like this. As a result, it took FDA longer to get their arms around. In fact, they’re still trying to get their arms around that product category. It seems as though they’ve learned from that and they’re trying to be proactive with regards to handling CBD products. But the first step to get there is actual adoption of a scheme that provides some concrete guardrails for manufacturers and other selling and marketing products.
Rech: Exactly. We need the FDA to provide more details, not only from a business standpoint, but also at the consumer level and the state level. And some of these states are just in limbo right now without clear guidance; they’re not formulating regulations to be able to expand the hemp market within their state. It’s a trickle-down effect and I think if the FDA, like Chris said needs to put out more clear detailed guidelines that it would trickle down all the way to the consumer.
Howard: If I could build on something because Stephanie raises a great point here. While we wait for FDA, and again, not suggest it’s taking like too long or anything, these things take time and obviously FDA got their hands a little full with other issues like COVID-19 and things like this, but while we wait for FDA, what what’s really happening here, it’s exactly what Stephanie said, is that states are taking matters into their own hands. And as a result, we’ve got sort of an inconsistent patchwork or framework of laws that are different from one state to the next. And that’s obviously a disadvantage to the category because it prevents manufacturers from selling more broadly, because now they have to make sure their package complies with, for example, 10 different states laws that are all different. And that’s not easy.
Most companies can’t handle individualized geographic distribution. They need something that they could sort of rely on that would facilitate national distribution on a broader scale. And without the guidance from FDA, well, states aren’t just sitting there waiting, they’re doing it their own way. And the more states that do that, the harder it’s going to be to get everyone in line to simply adopt the federal view, if and when that day comes. So that’s the second thing, which I think is just as critical, that clarity isn’t just important so we all know what FDA’s expectations are with approval or acceptance of a product, but it will help us get states in line, facilitate enabling these products to reach more consumers via the pharmacy or otherwise.
Drug Topics®: And given this big area of confusion at the state level for selling CBD, how can pharmacists kind of understand and have an approachable understanding of whether they able to sell CBD at their stores and clarifying those state regulations?
Howard: Well, look, it’s not just it’s not just pharmacist, right? I know this is important for this audience, but just in case people are out there thinking, “Can I buy it at a gas station or a convenience store?” The same rules apply to everyone. And understanding the rules of your location is critical, because you might live in a state that pretty much said, no ingestible products, regardless of therapeutic claims or otherwise; we’re going to come after you if you do it. And so that’s important.
And so, being familiar with the laws in your own state is step 1. And I wouldn’t advise you to try to do that on their own. I mean, you could, there are resources online you could turn to to learn about your particular state. But then there are also companies like EAS. What we do is we advise those that we work with our view – we don’t go so far as saying legal advice, but we show them the legal analysis that we’ve done to assess the risks associated with each state. And that’s really what a pharmacist or other retailer needs to do, is to either find a way to build their own knowledge base, which could be expensive, and having to hire outside lawyers, and nobody really wants to do that, or find a partner that you can trust. And by that, I mean a partner that is dedicating resources to staying on top of these laws.
Why do I say it’s difficult for an individual to do it on their own? Because you might wake up the next day, and the laws have changed, and you won’t even know. But if you’ve got a partner that’s put resources on it, like for example, we have Stephanie here who specializes in tracking these laws every day. Well, it could give you a little bit more peace of mind in terms of making sure that what you’re doing is compliant under your particular state.
Rech: As far as CBD products and pharmacies, there does seem to be a general consensus across the states with some familiar form factors like topicals and tinctures and capsules. And those are products that consumers and patients do lean toward, so that is something that I would say familiarize yourself with those form factors, because those are great options.
Drug Topics®: How can pharmacists effectively counsel on these topicals and ingestibles in their pharmacy with their patients who may have heard that these products could possibly or potentially help their ailments, but they want to learn more about it?
Howard: Pharmacists don’t really get a free pass on making therapeutic claims, either. So, Stephanie is about to tell you how to counsel some specifics that pharmacists or other retailers could provide in terms of guidance, but I will highlight that just because they’re not the manufacturer of the goods doesn’t mean they can go out and tell people that a topical CBD or an ingestible cures their ailment, right? That’s still really against the spirit of FDA’s rules.
Rech: And that’s why you have to be very careful with your language. You would never use the word “guarantee” or anything like that. But the best advice really to start with is to follow the package’s suggested use, so guide them in that. A good rule of thumb for topicals, they can apply as needed. And tinctures, they can use the recommended dose, but they can start off small too and then titrate up. But it’s really important to engage with the patient, what they’re looking to achieve, ask open-ended questions – is it something they want to use during the day or at night? Is it a concentrated area or all over relief that they’re looking for? So just having these open-ended questions will really help guide them to make a decision.
Howard: The pharmacist also has an obligation to make sure that the products they’re recommending are compliant or legitimate, for lack of a better word. In other words, there are some established brands that have a good reputation that are clear on their websites and on their packaging, regarding expectations. Those are the are the good ones. There are plenty of other products out there like “Joe Bob’s Mudflap CBD,” which obviously I made up, but it could be a fly by night organization trying to make a quick buck just playing in the cowboy way. And they might put “Cures cancer” on their label.
The pharmacist should be very careful, especially given the state of this category now, with so many offerings out there, to truly pick the ones that they believe in. In other words, that they know that these guys are following the rules as best as they can, manufacturing the products according to some set of standards that’s meaningful, and trying to play within the limited rules that FDA has provided so far. If I was a pharmacist, or someone who’s a doctor or anyone recommending CBD, you want to make sure you recommend the one that that you would take yourself.
Drug Topics®: I know the legislative space is still very early with CBD, but are there labels that you can look for that shows that they went through regulatory process of developing those products?
Rech: That’s a great question. Look to the outer package first, see how detailed that is. Companies that have a high bar for compliance will have a detailed package, it’ll follow a similar format that you would see on other regulated products. If it had an ingredient list, or Best By date, all ingredients listed on it, contact information. So those are items to look for on packages that could point you in a quality product.
Howard: It’s funny, because just to build on that, when you mentioned is there some certification they could look for, or some indicator of FDA approval or something like that? Well, the irony here is that if it does say FDA approved, or includes almost any certification, that’s probably one you need to watch out for, because we know that FDA isn’t approving the majority of these products besides the drug Epidiolex, and those sorts of things. And that there really isn’t a standard certification that that you would expect to see on every compliant product, it’s just not there. So, when you do see it, it might be a red flag for you.
If anyone’s interested in learning more about some of the activities that are going on, there were a couple of FDA public sessions in the last 24 months where, these are sort of like town halls, I’ll say for those of you who’ve never seen one. But it actually invites participation of what I’ll call experts or influencers in the field, researchers, things like that. And the researchers then tell FDA, “Hey, here’s what we need,” or “Here’s where you’re not doing enough of, FDA,” but they talk about some of the programs that they put together themselves, the educational institutions or otherwise, and you could hear a lot about the ongoing activities that most of those are probably still ongoing even though the last town hall was over a year ago. You can find those on the FDA website.
Source: drugtopics.com
