Podcast 215: Don’t Let the Feds Get You Down

There’s a basic rule when it comes to herbal businesses in the US: “Don’t tell and sell.”

Due to rules and regulations set forth by the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC), there are many limits on what one can say about herbal products. You may already know that it is not allowed to make “disease claims” on product packaging or promotional materials, only “structure & function” claims – that’s why a garlic supplement will says it “supports heart health” rather than “lowers cholesterol”. But you may not be aware that this prohibition extends also to any website, social media presence, or other materials you produce – including as a clinical herbalist or a teacher.

The long and short of it is, you can’t realistically maintain an herbal products line and a teaching or clinical herbal practice.

A lot of herbalists get frustrated with the tell & sell rules, but in reality they’re not as constraining as it seems. They’re part of doing business, and there are actually good reasons things are set up this way. So in this episode, we’ll go through some examples to make this clearer – and find some silver linings along the way!

Referenced in this episode:

Would you like to know more? We’ve got just the thing! The Herbal Business Program has all the nitty-gritty details about setting up your herbal business – whether that’s products, clinical herbalism, or another variety of herbal pursuit. From GMPs and labeling laws, to marketing, to taxes & insurance, to the technology you’ll need to make it all happen, this course has everything. You can do this! We can help.

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Episode Transcript

Katja (00:14):
Hi, I’m Katja here at Commonwealth Holistic Herbalism in Boston, Massachusetts. Today, Ryn is working with the pharmacy students, and I wanted to take this opportunity to talk to you myself a little bit about some business concerns. Lots of people want to start herbal businesses or already have herbal businesses. And lately there’s been a lot of buzz about the tell and sell rules from the FDA and also the FTC. And I just wanted to take a little bit of time to dig into that, so that you could feel a little bit more comfortable about it and understand a little bit more about the issue. How to stay compliant with what the guidelines are. But most importantly, how to get yourself in a really good head space about it. Because a lot of people feel discouraged by those rules or even mad about it. And when you’re in business, the rules are the rules. That’s the game, and that’s what we have to play by. But in this case, honestly, I think that the rules are coming from a pretty decent place. I think it would be challenging to make a better version of the rules. Not necessarily that I think they’re perfect, but I see that it’s hard to make them. I see what they’re trying to do. I appreciate that. All of that I can think about rationally and say yeah, okay. I get it. But what it really comes down to in my mind is that actually these rules aren’t really the impediment that they feel like when you first hear about them. And in the end, basically what it comes down to for me is that it’s not really as bad as it sounds when you first hear it. And honestly, it’s kind of in line with what’s going to happen naturally anyway, in terms of what you can do as just one person while running a business and avoiding burnout.

Katja (02:19):
So, I kind of like to just reframe it in my mind, since we have to follow the rules anyway, right? That’s what we have to do. I like to reframe it in my mind of well, it’s just preventing burnout actually. And so it’s fine, right? Now listen. I am kind of a Pollyanna. And I do like to see the bright side of things. But in this case, like when you’re in business, there’s a lot of stuff that’s just sort of dumb, and you have to do it. And if this feels like one of those dumb things, then this or any of the other dumb things that you don’t like but you have to do, I just find it’s much better to sort of find a way in your mind to be able to just be at peace with it. And say well, actually that’s better for me anyway. Because it’s just going to save you a lot of frustration. So yes, it is looking with rosy glasses at the situation. But in this situation, looking with rosy glasses is going to save you from a lot of frustration and also going to save you from a lot of burnout.

Katja (03:25):
So, let’s talk a little bit about the rules as they are. Let’s talk a little bit about what that really means for you if you have a product business, if you want to see clients, if you want to teach, different things that you might want to do. And then we can also think about sort of the mindset that we want to go into all of this with, so that you can just look at things as positive as possible and not have to feel a lot of frustration about it. Now, I’m not going to get into every single rule about GMP labels, marketing, what you can say on your website, all that stuff. I’m going to give some examples. But if I get super nitty gritty, this episode would be 10 hours long. So, you would never be able to sit through all that. Well, you might be able to, but not in one sitting. Your butt would get numb. So, all of that nitty gritty stuff is in the Herbal Business program, which you can find at online.commonwealthherbs.com. And it has literally every single thing that you need to know to start any herbal business. Everything from how to register as an LLC or a DBA or an S-Corp or a whatever type you’re going to do. How to collect your taxes. What taxes do you have to collect. How to do all of your GMP compliance, no matter what kind of business you want to start. How to market, also, no matter what kind of business. How to find clients. How to find customers. How to wholesale your products. How to all that stuff. How to build your website. Literally every part of starting a business is in this course.

Katja (05:06):
And there’s lots of interactions. So, you can literally ask me to check every single step of the way. And I’m so excited to do that for you. And if anything comes up that isn’t addressed in the course, you can also just be like hey, Katja. What about this? And then we’ll figure it out. And we’ll work it out, and we’ll move forward. So, everything that you need is in there. And go grab it. It’s online.commonwealthherbs.com. And you’ll find the Herbal Business program – sort of scroll down – in the catalog. But in this episode, I’m just going to sort of do the overview to give you some ideas about how these tell and sell rules apply, where they apply, and how that’s going to impact the kind of business that you have. Now, before I get started, I have to do the thing that says that I am not a doctor. I’m an herbalist. I’m an herbal educator. And in this case, I’m also going to educate a little bit about business. I’m not a lawyer, but I have studied this quite a bit. And there are lots more resources for how to study it in the Herbal Business program. Plus you can find the actual guidelines themselves. You can just read the guidelines. They’re a little complicated to read, but not that bad. It’s pretty close to plain language. So, if you’re like but I don’t want to read a bunch of legal documents. It’s not as bad as reading a bunch of legal documents. It’s reasonably clear.

Katja (06:40):
So, don’t feel intimidated about it. You’re looking for the small entity guidelines for the GMP on the FDA website. That’s fda.gov. And also you need to check the FTC website. That’s ftc.gov. And the FTC does not make a distinction between large businesses and small businesses. They have the same rules for everybody. And the FDA does make a distinction. If you are a small herbal business, which is most of you. If you’re not urban moonshine, if you’re not Gaia or HerbFarm, then you probably are falling under the small entity guidelines. And so those are the ones you want to look at. Those will all be linked in the show notes. And good. Okay. I think those were all the things I’m supposed to say. You know, when Ryn’s here we always say it the right way that we’re supposed to do it. But it’s just me today, so the shorty short version is going to be fine.

Tell & Sell Rules

Katja (07:37):
All right, let’s dig in. So, the first is what do we mean when we say tell and sell, right? So, you can’t tell and sell. You will not find the words tell and sell in the FDA or the FTC actual guidelines. That is a phrase that people have just come up with to sort of paraphrase what they’re talking about. But what it basically means is that you cannot make any health claims at all if you are selling products. And if you are making health claims, you cannot sell products. So, okay, now the next question is what is a health claim? And that’s, I think, where the tell part is actually a really good paraphrase. Because basically it means you can’t say anything about what a product can do. You can’t say anything about what an herb can do if you are selling products. If you are a person who is making a business by telling people what herbs can do, then you cannot sell products, right? You can either tell, or you can sell, but you can’t do both. Okay. Now I’ll get a little bit more specific. But before we launch into a lot of specifics, let’s sort of just think about why do they care?

Katja (09:04):
Like when we think about I’m going to be an herbalist. I’m going to have an herbal business. We have some ideas in our minds about what that might look like. And some of those ideas might be based on some fantasy, or some kind of ideas about the past, and about village life, and cottages, and history times, whatever. We get these ideas in our heads about how things were. And sometimes they really were that way, and sometimes they weren’t. That’s all fine. But regardless of what things were, we have to operate in what they are today. And so we can be frustrated, because we’re not allowed to do the thing that’s in our mind. And I just find that it’s a lot easier to deal with that kind of frustration if we understand why the government agencies are making these kinds of rules at all. They’re not making these rules to ruin our fun, or to try to ruin our businesses, or any of that stuff. In fact, when you read the guidelines, I personally find that the guidelines have been written in such a way to actually allow a lot of leeway for individuality, for diversity, for having your unique way of doing things. They do not impose certain steps that you have to take. They do say you must document your steps, but they do not tell us how to make our products. They do not tell us what products we’re allowed to make and what products we’re not allowed to make. At least mostly they don’t. Cannabis is a little bit more regulated if you’re going to make those kinds of products. But even those regulations are lessening.

Katja (11:04):
But there’s very little even kind of rules in the U.S. About what herbs we’re allowed to work with. There’s a lot more rules about that in the EU. And so, on the flip side, if you are in a sort of telling field, there are actually very few rules about what you’re allowed to say. You’re not allowed to practice medicine without a license. But educationally you are allowed to speak from your experience. You are allowed to teach traditional methods from any of the traditions. There’s so much leeway about what we are permitted to do. Really, the only kind of imposition that they’re making is in this combination of telling and selling at the same time. So, the first thing just to recognize is that even though this one aspect can feel very constraining, actually across the board, there’s very little constraint. They want documentation of what we are doing. They want to make sure that if you’re making products, your space is clean, for example. That the products are safe for consumption and stuff like that. But they do not want to tell you how to run your business. So, that part is really fantastic and awesome.

Why The FDA/FTC Has These Rules

Katja (12:22):
But they care about the tell and sell part because that’s where fraud comes in. Now, we can think about this in terms of diet products. And we can think about like, I don’t know. I feel like who hasn’t looked at one of those diet pills at some point, and thought maybe that would be a good idea, right? Because that’s our culture. Our culture is like, you have to be skinny. That’s the only thing that’s important. And so I feel like diet products are something that lots of people are very familiar with. Now I just want to be clear that diet products can fall under a couple different regulatory guidelines. So, not all diet products are regulated as herbal supplements. In fact, most of them are not. So, just as you’re thinking about, as I’m going to talk about the outrageous claims that diet products make, they are not actually being regulated by the same rules that our products are regulated by. And so when you’re thinking about well, how come they’re making those ridiculous claims? We’re not allowed to make those claims. It’s because they fall under different guidelines. And hopefully those claims will be updated soon. Our guidelines have been updated very recently. And so hopefully theirs will be too. Because honestly, the things that those diet pills tell you are absurd. They’re like oh, you’ll lose all this weight, and it’s totally safe, and this and that and the other. You’ll be beautiful. Your life will be great. But if you look at the products, they’re not really safe, actually. They’re usually filled with tons of caffeine and maybe very strong laxatives or whatever else. And also, they don’t really work.

Katja (14:13):
They can be harmful. And even if you take them, you might lose some water weight. And maybe with a ton of caffeine, okay, you kind of lose some of your appetite, so you maybe don’t eat as much. But it’s not like a healthy way to treat your body. It is a very extreme approach to take that can be harmful. But those products are preying on people who live in this culture. Where we are being told from day one that if you’re not skinny, you aren’t valuable. And if you’re not skinny, you’re not healthy. And neither one of those things is true. So, you know, they’re using that cultural pressure to make money. And so that’s just gross on many levels. But you know, it does feel very scammy, right? Sort of like preying on that cultural pressure.

Katja (15:14):
Okay. So, you can look at that and say well, okay. The FTC and the FDA want to avoid that kind of thing. But then let’s take an example that’s a little bit less related. Let’s take an example of those emails that you get that are like dear sir or madam. I have this bank account. And I need to transfer the money to you for some kind of reason. You remember these emails? I haven’t seen one in a while. I guess the spam filter catches them. But you remember the ones I’m talking about, right? Where it’s just like please send me your name and address and some other kind of detail, and I will forward you all this money. Like whatever. And now those kinds of scams fall… They’re still happening. They’re just happening in different ways, where people are trying to get you to give them money. This happens a lot to elders. That people will call up elders. And they will sound very professional. And they will say that they’re raising money for some kind of a thing that doesn’t exist. And they will convince elders to donate money. And then it’s just a total scam. The thing never existed. None of it existed. The person just wanted the money. And they knew that this is a group of people that are easy to manipulate, are often easy to manipulate. And so they prey on them. So, you can think about your experience with this kind of scam or other similar scams that you have experienced. Especially if you have cared for an elder who has been in this kind of situation, and maybe didn’t know that that thing wasn’t real, and maybe sent a lot of money. And that was more money than what they could really afford, but they were doing it out of kindness and compassion. And now you feel like you’re trying to care for this person’s situation. And you’re like, if they keep sending their money away, this isn’t good for them. It’s not actually healthy for them. I have a lot of friends who are caring for elderly parents who have had these kinds of problems.

Katja (17:32):
So, you may also have experienced this kind of problem. And when this sort of thing happens, people are like well, why doesn’t somebody do something about it? They are actually. The FTC is trying to do things about it. It’s just that fraudulent people are very frequently a step ahead. So, when we think about these tell and sell rules, that is the FTC and the FDA trying to do something about it. And they are trying to prevent scams from happening. So, none of you who are watching this, listening to this, would ever just outright lie to somebody. You would not be like oh yeah, this apple juice extract is going to make your cavities go away. You wouldn’t say that to somebody. But some people would, and some people do, and some people have. And you would not set up a website to sell your products. And then set up 10 fake websites that all link to your products in a fraudulent manner saying oh, I’m just this blogger. And I love this product that this person makes. It’s so fantastic. But it’s all the same person, right? You would not set up a ton of fake social media accounts to put comments on your business social media account saying how wonderful your own products are, right?

Katja (19:07):
First off, you don’t have that kind of time. But also you wouldn’t do that, right? You’re making great products, and you’re not going to do that. Your products stand for themselves. But there are people who do. And the FTC is trying to say listen, herbal products are becoming very, very popular. There’s not enough education in the general population for people to know what a lot of these things do. And so we want to impose some kind of rule that will as best as possible reduce the likelihood of fraud. So, they’ve come up with these rules by observing what fraudulent businesses have done. And so that example about setting up a ton of fake social media accounts who then write comments on the real social media account. That is a thing that happens frequently. And that’s why that’s part of the rules for the FTC and the FDA. Because they have seen this thing happen. And they’re like okay, this is how this fraudulent company was selling their scammy products to so many people. And so we’re going to say that’s not permitted. You can have an honest business, but you can’t do that. So, that’s where these tell and sell rules are coming from. From things that scammy people have done in the past that you probably would never have done. But those people kind of ruined it for everyone. And again, on one hand there is some constraint here. But on the other hand I kind of applaud both of these agencies for only putting constraint in the one place where they really felt like it was necessary and keeping their hands off all the other stuff. That part is at least really awesome. We’re going to take our positives where we can get them. And hopefully by the end of this you’re also going to feel much more positive about the tell and sell constraints as well.

Take Care With Your On-Line Posts

Katja (21:12):
So again, they want you to run your business. Honestly, they want you to be successful, because that’s more taxes for them, right? But they just want to regulate enough so that there’s not a bunch of fraud going on in the marketplace. So, let’s talk a little bit about some of the things that are specifically not permitted. And some of them might seem a little weird, but again, remember these are all rules that are coming from things that actually happened and caused problems. And so then they say all right, well then you can’t do that. Because people who were making problems, people who are making trouble did that. So, we’re going to say that’s what bad actors do, so you can’t do that. So, a lot of this stuff is focused on internet stuff, right? Your social media, your website, YouTube, or other video products you have out there. And part of the reason is because that is the easiest part to enforce. Both the FDA and the FTC have gotten a lot more funding for enforcement. And so physical enforcement, like actual people doing actual physical inspections, that is ramping up. But the place where it’s easiest to find problems is online. And that has a twofold impact, right? The first is it’s really easy for them to find problems online, especially now as AI is coming into the picture. Also, there has been some special software, like some custom software that has been written that allows both government agencies and also businesses who help people with compliance to automate the let me find things that are wrong process.

Katja (23:13):
And so because of that, it is so much easier for them to find stuff online. And then they use that information to say okay, these people are screwing up online. Let’s also maybe put them on a list, and see if they’re screwing up in person also, right? So, if you get caught online, you are much more likely to be bumped up in the list to have a physical inspection. If you are super solid online, you’ll probably get inspected at some point, but it’s probably going to be a while. Because there are a lot of herbal companies out there, and there are a growing number but still not enough physical inspectors. So, I’m not going to say like you’ll never get inspected, but it’ll take a while, right? Whereas if you do something online that breaks the rules, you’re going to get bumped up in that queue. Now, if you do something online that breaks the rules, please do not panic. Because for the most part, nothing… I don’t want to say nothing will happen, but I want to say nothing bad will happen, right? They’re not going to put you in jail. Most of the time you will not have any kind of fine. The FTC guidelines now do have a fine to impose, but that is not a guarantee. So, if you just made a mistake and fix it fast, it’s unlikely that that fine would apply to you. They just have the ability to impose a fine, and the fine is pretty high. It’s like, you know, a $50,000 kind of a target. But again, they have the ability to impose that. They’re not automatically going to impose it on every person who made one mistake, right?

Katja (25:00):
So, what is going to happen is that you will receive a letter. And you will be told what the problems are on your social media, on your website, on whatever, your blog, your YouTube. And you’ll be told that you have a certain amount of time to fix it. You’ll be required to submit proof that you fixed all of it. And then you will go on your way. They will not shut your business down. They will not take your business away from you. They will not take your house away from you. They won’t do any of that stuff. You will just have to fix it. But now you’re on their radar. Eh, that’s not awesome, right? You would rather be on the list of people that they looked at and said oh, good job. You’re fine. That’s the list you really want to be on. Plus, if they tell you you have to make changes, what a hassle. Now you have to put aside whatever work you were doing, deal with all this stress of making all the changes online to your website. And that’s a pain in the butt if you run your own website. But a pain in the butt plus dollars if somebody runs your website for you, and you have to pay them to make those changes. Plus you may have to change your labels, and then just throw away whatever labels you already had, and pay to have labels reprinted, and all that kind of stuff. Like ugh, just a big honking hassle. So, it’s best to avoid it if possible for both reasons, right? Not because oh my God, I’m going to lose my business. I’m going to go to jail. You are not going to go to jail. You are not going to lose your business. But it’s a hassle. It’s a ton of stress. It might be some dollars. And none of that stuff is stuff you need. So, it’s better to just stick right to it even when it feels kind of constraining or frustrating.

Social Media & Blog Content Missteps

Katja (26:50):
So, some examples are on your social media presence, let’s say you have a product business, and you have beautiful labels. And they are compliant. They do not have any claims on them at all. And it’s just your elderberry syrup with a picture of some elderberries next to it. And that’s it. And in the text of your social media post you wrote, I gathered these elderberries myself. And I made this elderberry syrup with love. And my store is restocked, so go get it while the supplies last. Perfect. You are 100% compliant. And then you put #coldandflu. Now you’re in trouble. That is against the rules. And they are really beefing up their attention to hashtags. So, every other thing was perfect, and the hashtag got you. Let’s say you did not put a cold and flu hashtag. You had that beautiful perfect post. Your hashtag was madewithlove. #herbal. Not herbal medicine, herbal. #elderberry, #elderberry syrup. #Ilovefall. Great, okay. All of those are fine. Everything is perfect. And somebody comments on your post and says oh my God. I got this elderberry syrup. And I didn’t have the flu all year, and I never got a cold. And it’s great. I love it. I can’t wait to get more. And you did not write it. A real person wrote that as a comment on your social media. Now you’re in trouble, right? Now, if a real person wrote that, obviously it’s going to take you a minute to find it. But you must, immediately when you find it, you must delete it. And the reason is because literally truly scammers out there have made a ton of social media accounts, and then commented on their own posts. And that person in that comment made a health claim.

Katja (29:16):
They claimed that elderberry fixes the cold or flu, or prevents it, or cures it, or whatever. That was the claim. Even though they didn’t use the word heal, prevent, or cure, that is still the claim that they made. And the FDA and the FTC have no way to know who actually owns that account. And because there have been so many instances of scam that way, they simply said no health claims, even if somebody else makes it as a comment. You have to delete it. Even if they did it two years ago. Even if your social media started off as I’m just learning herbalism, and I’m sharing what I know. And then three years later it became I started a product business. And now I love my herbal products, and you will too. Please buy them. And from the point that you started your herbal business, all of your posts were perfect. But before that they weren’t. You have to delete all the ones before or change the words, right? Every post before has to be in compliance. Wow, how frustrating, right? But what they’re saying is this has been done to scam people, and therefore you can’t do it. So, they’re really serious about this. And for a while it was like okay, well fine. Well then you can just make some YouTube videos. But now AI knows what YouTube videos say and can very quickly scan for health claims. So, if you are giving a webinar. If you are posting a YouTube video, which is fine. You’re allowed to post them. In fact, I encourage you to. Go ahead and make a video of you in the production process. Make sure you are following every single GMP rule but show your process. Show how awesome it is. While you’re doing it, talk about – with your gloves on your hands, and your hairnet, and whatever, your apron – talk about how much you love making these products, and how much you hope that they’re going to help people in the world.

Katja (31:26):
Don’t tell them what you’re going to help with, just that you hope they’re going to help people. You hope that people are going to enjoy them, all that stuff. All that is fine. But you can’t say because this is going to make your asthma go away. Now it’s a problem. But everything up until that point, yes, you are allowed to put that up there. And you should. It’s fantastic. You can teach people how to make the stuff that you make. Nobody has time to make your stuff. They’re not going to steal your stuff. But a lot of times just seeing that part of the process can be a lot of fun for people when they buy herbal products. They are supporting a specific person. They’re not just buying the product. There are 10 million calendula salves out there. They’re buying yours because they like you. And so yes, show people what there is to like. Absolutely. Just don’t tell them what calendula can do because that’s what will get you. And because now the software has advanced so much, it is so much easier for them. They don’t have to sit and watch every single video on your YouTube anymore. They can have it machine analyzed. And that combined with more money for more people all around means more people are being inspected, even if it’s just online inspection, right?

Katja (32:48):
Some people ask about blogs. Like well, can I put it in my blog post as long as my blog post doesn’t link to the product. For a while, people were thinking that would be a way to get away with it. It’s not. It is not. And listen. The way that you know is not just by reading the guidelines, but read all the warning letters. Because when you read the warning letters, you see what is up in their heads, right? What are they focusing on for enforcement right now? And that tells you oh, that’s what I need to be careful about right now. I see how this enforcement is playing out, and I can adjust my strategies based on that. So, read the warning letters. You can find all of them at the FDA website. Also the FTC publishes their warning letters as well. Which means if you receive a warning letter, your name, your business name, your address, all that stuff is going to be in this database of people who have been warned. And anyone can find you for that. So, that’s also not necessarily awesome. Because I mean okay, the only people really searching that database are people who have herbal businesses. But still, you just don’t want to be in that database. And if it happens again, they’re not going to take your business away. Like it happens. It’s fine, it happens. But try to avoid it, right? Because it’s just less hassle if you don’t have to go through it.

What You CAN Say About Products or as an Herbal Educator

Katja (34:21):
All right. So, a lot of people feel well, that’s so frustrating because I can’t have a blog. I can’t say these things on my social media. I can’t, whatever. How am I going to tell people about my products? Tell them about your products. Just don’t tell them what your products can do. Tell them how you make your products. Tell them the music that you listen to while you make them. Tell them why you got inspired to make them as long as no health issues are involved in there. You can’t say I had rheumatoid arthritis. And that inspired me to make a line of products to help myself. And I hope they help you too. Okay, well you can’t say that, because now you’re saying that those products help with rheumatoid arthritis. But you can say I grew up in a city. And until I was whatever age, I could not identify even a daisy. I just didn’t know anything about plants. And my life was just so stressful and so hectic. And then once I saw that there was a plant walk. And I went out, and I went on that plant walk. And I realized that that’s what my life was missing. And I dedicated the next 10 years of my life to studying plants, and perfecting my products, and immersing myself in nature. And it made such a difference in my health and wellbeing. It made such a difference in my life. And now I present to you these wonderful, beautiful products that I hope will make a difference in your life too.

Katja (35:58):
That’s a fantastic story. And it might not be your story. You may have some totally different story. But it doesn’t say anything about… I mean, I did use the word health once. But there was no health issue that was raised there. It was just it was good for my health and wellbeing. Well sure, being outdoors is good for your health and wellbeing. Nobody can really dispute that. That is not a health claim. So, share a story like that, and you don’t have to talk about what your products do. There’s a whole other half of the herbal community that is doing that job, right? And that side of the community can get frustrated too. Yeah, I’m a teacher, but I also make great products. Why can’t I sell my products to my students? Well, because there’s some scamminess there, right? You can teach. You can say anything that is not practicing medicine without a license. That is an enormous amount of stuff that you can say. You cannot say that self-heal cures Alzheimer’s, even though – yep – there are actually some studies that talk about self-heal being effective as part of Alzheimer’s treatment. There are some amazing studies. As a teacher, as a clinician you could teach about those studies, but you just can’t say outright that it will heal Alzheimer’s. Also, it won’t exactly. It will help improve certain situations around Alzheimer’s. It can be part of this complete health protocol for a person who has Alzheimer’s. But it is not the same as curing Alzheimer’s. And so you’re not allowed to say it, and also it wouldn’t be accurate to say it. So hey, it’s fine either way, right? But you are absolutely allowed to teach the study. You are absolutely allowed to teach your own clinical experience. You know, you just have to stay away from those handful of words that you’re not allowed to say and other than that…

Katja (38:08):
And really stay away from them. You know, like don’t just say well, I’m not allowed to say that this will cure you, but… You know, actually, herbs don’t do the same thing that pharmaceuticals do. We don’t need to pretend that they do. They work holistically. And so we don’t need to make cure claims, because that’s not exactly what herbs are doing. Herbs are like fortifying your body so that your body can do the work of staying healthy. It is not quite the same as what a pharmaceutical does. A pharmaceutical does the work for you. An herb helps your body do what your body does, right? Like it is actually different. So, it isn’t just about cover your butt. It isn’t just about that. It really is that there is a legitimate difference here. And so yes, legally we are not allowed to say some words. But also those words aren’t really our words. Those words are words that belong to a different system. Our system has its own words, and those words are appropriate for us. They’re enough for us honestly. So okay, the telling side of the herbal community is telling a lot. We are out there. And I put myself in that category, because I am a teacher and a clinical herbalist. We are out there teaching people about what herbs can do, and more and more people are learning. Ten years ago this was maybe not the case. But today people know what a calendula salve does. Maybe not every person, some people are new, but a lot of people know what a calendula salve does. A lot of people have enough education to look at the ingredients on your bottle and know that that’s actually what they’re looking for. Yes, it’s true. There are lots of people who are new to herbalism. But so many people are really getting educated and starting to know.

Katja (40:10):
And the bottom line is that a well-educated populace makes better customers, right? They know what they’re looking for. They don’t have to depend on you to tell them what they want or to tell them that something will do whatever it will do. And honestly, what are you going to tell them that ginger will do? If you tell them that it will lower cholesterol, will it do that for all people across the board? Not necessarily. If you tell them that it is warming, that’s enough. A person who already runs really hot is maybe not going to get the benefits from ginger that a person who runs really cold is going to get. Warming is actually enough for a person to make a choice about whether that’s the right product for them. Because if they look at that label and say warming. And they’re like I don’t need to be warmer. I am warm enough already, thanks. Then they can say oh, what I really need is your elderflower product, because elderflower is cooling. Great. All right. That’s the one I want. Both of them can be relaxing. But one of them does it with warmth, one of them does it with cool, great. If we stick to our own words that don’t have anything to do with diagnoses, don’t have anything to do with the medical system, it actually is enough for people to make the kinds of choices that they need to make. That, especially combined with people are getting more and more educated.

How to Collaborate

Katja (41:40):
So, all right, you’re out there, you’ve got these products. You’ve got a social media account. And you’re thinking, well how do I help my customers get more educated? Why not collaborate with an educator that you like? And say hey, I’ve got these great products. And because I spend all my time making these great products, I’m not a teacher. But you know who’s an awesome teacher? My friend Joe, my friend Danica, my friend whoever. They’re a fantastic herb teacher, and I just wanted to let you know about them. I love them, and maybe you’ll love them too. Done. You didn’t say anything you’re not allowed to say. That person is not related to you. They’re not part of your business. They’re a totally different entity, and now you’re helping each other. Maybe you have teamed up with Joe or Danica or whoever it is, right? And they also say I spend all my time teaching, and I don’t have a lot of time to make products. But you know, whose stuff I love? Sally’s. And done. Okay. You are two literally separate businesses. Now the FTC and the FDA don’t like it if you are not two different businesses. And to be also clear, they’re not going to like it if you make a post that says here’s my beautiful elderberry syrup. And check out Danica’s webpage for information about what elderberry can do to help you. Technically, very technically that’s following the rules. But it’s one of those letter of the law, spirit of the law. That would be kind of on the borderline. I’m not really sure how they would come down on that. It might even just depend on the particular person who happened to be inspecting that day.

Katja (43:33):
So, you just don’t do that. Don’t be quite that specific. Just say if you are looking for education, check out Danica’s stuff. If you’re looking for products, here I am. I’ve got great stuff for you. If you keep it super general like that, fine. But a lot of people think I’m going to have two businesses. And one is going to be me as a product maker, and one is going to be me as a teacher. And I’ll just make two businesses, and then I’ll refer to them. No, you can’t do that. You could have two businesses, but they must never refer to each other at all in any way. There must be no connection between them, no links, no reference, no check out this whatever. Totally separate as if they did not know each other existed, even though you’re the person who owns both of them. And if you’re going to do it, it’s pretty important that in your product business you have an SOP that outlines all the ways that you keep your two businesses separate. You’re not required to have SOP – that’s standard operating procedure. You’re not required to have those kinds of forms for your educational businesses, but you are required to have them for your product business. And so you better have one that says this is how these two businesses are kept separate. There is a brick wall between them. They will never meet. Because that way if you get inspected, they might not like it, but they will at least see that you attempted to follow all of the rules. And they may still tell you that you have to sell off one of your businesses or whatever, that you’re not allowed to have the telling and the selling.

Katja (45:23):
Right now I think you would get away with that if there truly was just a chasm between the two businesses with no connection whatsoever. But even if they come in and they say this is sketchy. But then they see that you actually have thought this through, and that you have an SOP form for the separation of the two businesses. That is going to say to them oh, this person is trying to be really compliant. And it might change their opinion about your situation. I can’t guarantee that it will. But it is a good idea if you’re going to try that two-business route to have documented your attempt to follow the rules to separate them. But listen, here’s where we get to the Pollyanna silver lining part of all of this. You can’t actually have two businesses. You’re one person. You just can’t do that much. Burnout is a huge factor in herbal businesses because herbal businesses get really busy really fast. And so if you are a product maker, first off, it takes way more time than you think it’s going to take when you start getting into production. Even if you’re small scale. Even if you’re just going to a handful of farmer’s markets, and you’ve got a little website, it gets so busy so fast. And if you are teaching or if you are seeing clients that gets so busy so fast. Even as a clinician… I don’t do this anymore, but when I saw clients in person, I did custom blend products for them. And that is permitted. It is not permitted to have a product line that you sell to clients, but it is permitted to have something, you know, an apothecary. I’m kind of waving my hands at the jars behind me here, but if you’re listening you can’t see that.

Katja (47:26):
It is permitted to have all of the ingredients and then to custom blend for a client in the context of a clinical consultation. That is allowed. And I used to do that. I don’t anymore, because now I see clients online pretty much exclusively. And I don’t have time to blend up stuff, and take it to the post office, and mail it to people. But even when I did that, I always taught people how to make it themselves. Because I didn’t really have time to make refills. And you might be thinking it doesn’t really take that long to make a refill. How do you mean you didn’t have time? I really didn’t have time. I really didn’t have time. There are so many people who want to see a clinical herbalist. And in the beginning, in the first few months, sure. It wasn’t a big deal to just blend up some extra stuff. But really quickly that became a task that I had to fit in somewhere. And often it would be the end of the day. And I was like ah, I didn’t do that yet. Okay, first thing tomorrow. And then the next day would get so busy, and it would fall to the day after that. And I realized I couldn’t keep up with refills. And so when I tell you that herbal business gets really busy really fast, I really mean it. And in the beginning, you think, how am I ever going to find clients? And where am I going to sell my products? And you think that it’s always going to be slow. But man, really fast stuff ramps up. And you’re starting to think holy cow, how can I keep up with all these clients? Or how can I keep up with all these orders?

You Can’t Do It All Anyway

Katja (49:03):
So, you know, before you really get started or before you really take off, you might be thinking no, I can do all of it. And in fact, it’s a good idea for me to do all of it, because that way I’ve got revenue diversity, you know? And yes, diversifying your revenue is a great idea. But a products business is a full-time job. A teaching business is a full-time job. A clinical practice is a full-time job. You just can’t do all of them. You will burn yourself right out. And so what it comes down to for me is yeah, the FTC guidelines and the FDA guidelines do mean that for a product maker you have to be a little bit more careful about what you say about your products and a little more careful about your hashtags and stuff like that. But beyond that, I really don’t find them constraining. Because after the first few months of whichever kind of business you want to start, it becomes really apparent that you can’t actually maintain two different businesses at the same time. There’s just not enough time in the day. So, you know, yeah, there is some feeling of constraint in these rules. And it never feels good to have somebody telling you what you can and can’t do. Like okay, that doesn’t feel awesome. But at the end of the day for me, I feel like those rules kind of become a little bit irrelevant or a little bit kind of redundant, because the reality is you can’t actually tell and sell. There’s just not enough time to do it.

Katja (50:50):
So, if you want to make products, yes, you do have to be a little bit careful about your marketing, a little bit careful about your online presence, and stuff like that. But it gets easy. It takes a month or two to kind of get used to what words you want to say to present yourself, and to present your product, and to get used to what words you just simply don’t say. But very quickly that just becomes your habit of speech. And even though in the very first bit of time it feels maybe a little stilted. Or maybe you’re thinking what am I going to say? But very quickly it just becomes very natural. And it also allows you to focus on you and allows you to focus on the quality of your product, the quality of the ingredients, where you are purchasing those ingredients, or growing them if you grow them yourself. And the stories about the weather that impacted the quality of this particular chamomile or whatever else. It just allows you to focus on the things that separate you from everyone else. There are so many herbal product makers. And people kind of think well, how am I going to make a name for myself? It’s by telling about yourself. Because people aren’t just buying the product. They could get the product so many places. They’re buying the product from you. They want to know who you are. And there’s no FDA rules about what you can say about yourself. Well, with the exception of I have rheumatoid arthritis. And these products work to help me feel great. Okay, well, you’ve got to be really careful about that kind of thing. But other than that, you can say all kinds of stuff about yourself. And that I think is honestly the best kind of niche to get your marketing into. And then if you are a person in a telling profession, whether that’s clinical herbalism, or teaching, or a little of both, no problem.

Katja (52:58):
And you are even allowed to provide items to your clients, just not products. Not something that is a product line that you have pre-made, that you’re also selling at Whole Foods, or that you’re selling at the farmer’s market, or whatever else. It has to be something custom blended for the client in the context of the consultation. But as long as it is that you’re good to go. So, really to me, what this all comes down to is this is just one more opportunity for us as herbalists to recognize that we are a community together. That we support one another, and that we are stronger because there are a lot of us. We are stronger because we are able to focus on what we do best. Listen, clinical herbalism is not easy. Teaching is not easy. Product making is not easy. And trying to do all of it really well, it’s just not possible. So, do the thing that you do best. Do the thing that you are so good at that is like really your talent. And then expand into the whole community. Support product makers, support teachers, support clinicians. And don’t feel like you have to be everything to everyone. Just be who you are. Do your part, and let this whole community fill all the other things that need to be done.

Katja (54:37):
In this country we really have kind of a go it alone sort of a legendary myth or whatever. But you can’t do anything alone actually. We all need to be in community. Whether we are getting through a wildfire, or educating children, or taking care of elders, or just taking care of our own family, or providing food, or any of those other things. And the herbal community is no different. We can lean on each other. We can lift each other up. And all of us will benefit from that. Plus, the whole rest of the world will benefit from it too. Because literally every community needs a lot of herbalists. There is so much work to do. There are so many people who need care and support. And so many people who don’t have time to make their own products, who don’t have time to learn all the different intricacies of clinical herbalism, who don’t have time to or maybe don’t feel comfortable teaching all that kind of stuff. And so we need a lot of herbalists everywhere. You don’t have to feel like you have to do it all. You don’t have to feel like you’ll lose your competitive edge if you don’t cover all the bases. It isn’t like that. This is a community, right? We don’t have to compete with one another. All of us do things a little bit differently. And that’s fantastic. Because there are so many people out there, and they all want things a little bit differently. So, we can just lift each other up, lean on each other. If you make products, then support a bunch of teachers. And if you’re a teacher or a clinician, support a bunch of product makers. And that’s how we get through all of this. Not only how we all adhere to the guidelines that might feel a little frustrating and constraining, but also how we grow as a community and how we model community support for the whole rest of the world.

Katja (56:40):
Okay. So yes. I am a silver lining kind of girl, but I also believe it. I really think that it’s just not as big of a deal. It’s just not as frustrating as it feels when you first hear it. And if you can settle into this kind of idea of like oh, I don’t actually have to do everything. I’m not allowed to do everything, but also doing everything was going to break me anyway. And I don’t have to because I have a whole community to lean on. I only have to do the part that I like the best. I only have to do the part that I’m really good at. All the rest of it I can leave to all the other herbalists, and we can all just be in this together. So, there you go. That’s my overview on all the FDA and FTC stuff. There’s so much more specific information in the Herbal Business program. There are chapters on every part of GMP. There are chapters on staying legal in your clinical practice. There’s just all the different parts of information that you need, whether you are selling or telling. So, check that out at online.commonwealthherbs.com and scroll on down to the Herbal Business Program. That’s it for me today. We will see you next time with more Holistic Herbalism podcast. Until then, take care of yourself. Have fun with your business dreams. Try not to get too frustrated. Drink some tea and support your whole herbal community.


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