Growing Your Business – Scaling Legally and Strategically
TRANSCRIPT
Christian Maniquis:
Hello and good afternoon everyone. Today is the 30th of April, and we are now on our third and final installment for our IV Hydration Webinar series. The title being, growing Your Business, scaling Legally and Strategically. Our panelist for today and speakers would be Attorney Drew Barnholtz. You guys already know him very well since the very beginning of the series, and I’d like to make an introduction to one of our esteemed attorneys, attorney Fisher James Kinslow. We call him Jim. Jim, you want to take the floor for a bit?
Fisher James Kinslow:
Thanks, Christian. Yes my name’s Jim Kinslow. I’m a California licensed attorney. I’ve been in healthcare practitioner for about 25 years.
My focus has been upon digital health and associated platforms and intellectual property. I’ve been with Cohen Healthcare Law Group for over a year now, and I look forward to meeting you.
Christian Maniquis:
Thank you for that quick and detailed introduction, Jim. Again, this webinar is in collaboration with the founder and CEO of the Drip Success Formula, My Queen Dickens and the Thrive and Hive Community. I see that in the participants, there are some familiar names, some of which has been with us since the beginning of the series, and thank you very much for all being here.
I’d just like to remind everyone that we do have a question and answer box for you to be able to chip in and ask a little bit more specific questions if in case that you have any clarifications or follow up questions regarding the frequently asked questions that we have from the community and the industry.
With that being said let’s start, shall we? All right. First question up, I think, Jim, this is definitely a you question, so let me get started. What are some of common challenges business owners face when scaling and how thoughtful planning ensure growth doesn’t outspace compliance?
Fisher James Kinslow:
That’s a good question.
It’s always a interesting concept to scale your business particularly when you’re looking at either offering new services or expanding on your existing services. If you’re going to offer new services, I think you need to look at the regulatory framework for their services and how it may affect your structure on how you’re offering your services.
If you’re looking at expanding your services into different states or countries, you need to look at the regulatory framework, but also I think you need to look at what are you going to offer and who’s your audience for that offering, because you’re taking a risk, a financial risk, and when you do that, you need to have a good plan as to how do you want to leverage your current service offerings as well as what you want to do with your new service offerings.
And I think it’s very important. That when you plan to scale your business, how does that affect your brand and how does that affect your goodwill with your customers and your future customers? Because that’s important to protect that because that’s your value added proposition to your scaling your business.
Christian Maniquis:
kind of surprised me how big of a deal it isn’t it?
It’s very big. Would be, yeah. Most people would.
Fisher James Kinslow:
Sorry. It’s easy to fall afoul of regulatory issues. And just because you’re offering one service doesn’t mean you can automatically leverage it into another service without being very careful.
Christian Maniquis:
It’s a very common thing that I see as a client support for Cohen Healthcare Law Group.
I think Drew has a couple of encounters with that matter. Yeah, it’s a very good question to start off with. Drew any insights, any additions that you want to add or
Drew Barnholtz:
No. Look I think Jim’s, hit the main things, but, when you’re talking about expansion and then even on the second point of legacy planning, figuring out what your markets that you want to go into figuring out if you want to expand the, those services, I think the biggest thing to think about is how are you going to properly staff that?
And what are those staffing measures and what are the ratios and who do you need and what’s their scope of practice and what supervision is required for those folks that you’re intending to do that ’cause that’s going to make the business successful and thrive.
So that, that’s something very important to think about as you expand not only in your one location, but you expand into multiple locations, even within a state or outside that state.
Christian Maniquis:
Actually that answers a lot. I hear that a lot. And thank you for that addition Drew and Jim for leading the answer to that question.
Okay. Let’s move on to the next.
Alright. Next. How do intellectual property tools like trademarks, copyrights support, brand protection and business growth? Drew, do you mind taking this one?
Drew Barnholtz:
Sure. Yeah. Happy to. There’s definitely and Jim, I’m sure will ring on this one too ’cause he is an IP guy, but there’s, yeah, definitely there are definitely a lot of valuable assets in this kind of business.
The biggest one is going to be your name, right? And you might want to consider trademarking that asset. But there’s also taglines and things like I’m Loving it, right? That’s McDonald’s, that stuff. Oh yeah. That’s trademarked, t he logo itself, the arches is the arch trademarked.
Christian Maniquis:
Yeah.
Drew Barnholtz:
And the name itself, McDonald’s is is more than likely than trademarked, but as you scale, you want to make sure that people can’t, poach your trademarks, right? They can’t poach those. And so really the thing to do is to have those file with the United States Patent and Trademark Office. But the other thing I think to think about with brand protection is that you’re if you’ve got materials that you’re putting up on your website or you’ve got materials that you’re handing out, you can put just like a little circle with a little c in it.
You’ve probably seen that is give you some copyright protection on any materials that truly are s omething that you put together that you want to make sure that no one else can just, make copies of and hand out and use as their own. It’s tough in today’s world, everything’s online, so it’s tough to do that.
But and then, as far as patents if you really have a process that’s openly and obviously different from somebody else’s whether it’s or a device, that you develop. We can certainly talk to you about that and the FDA’s process about that and some patent protection on that.
But that’s really something different. And as you grow your business, you just look into the value of that portfolio and the value of your brand. And it’s someone, we’ve had clients where they open up something and it’s called. Maximum IV therapy and then somebody else opens up something and it’s called Maximum Enhancing IV therapy, and it’s in the same city.
So what kind of protection do you have that, in a Google search that someone doesn’t think that maximum enhancing IV therapy aren’t one in the same? And how can we help you to make sure that your business is protected?
Christian Maniquis:
All right, so Jim, being an IP guy, definitely I know you have something to add to this, and I see you smiling right there.
Fisher James Kinslow:
Yeah. In my experience your brand really is your business. It’s your goodwill, as it were. It’s what your customers recognize and what they associate with your brand is how you want to communicate the value of your business. And so it’s very important to not only use it for promotional purposes, but also to protect it as Drew says.
There are tools that you use to protect your brand. You use on your promotional literature, you’ve got your copyright the name of your practice or your business is, can be trademarked depending upon what level you want to take it to. Trademark applications are very simple to take forward, as well as copyright applications.
If you have something that you think should be patented, I would caution you to think it’s an expensive process and you need to take it to the United States Patented Trademark Office, which will investigate it, and it is, can or can be expensive. So that is something to take into consideration.
But I think the main thing is that when you want to leverage your business or you want to expand it. You want to protect your brand and you want to promote it. So the most important thing is to ensure that your brand stands for what you stand for and that you protect it as you go forward.
Christian Maniquis:
And we’ve been with clients for like years and this is something that is inevitable, I think, I believe.
Fisher James Kinslow:
I always advise, Christian, I always advise clients that when they start their business, it’s important that you understand how you want to be perceived by your customer base.
And part of that is what your brand says about you. So I think it’s very important that when you open, say, an IV hydration or some other type of healthcare service business that you be careful about how you properly brand your business so that it resonates with your customers as you gain customers, but also as you gain the value of your business.
Because if you ever wanted to exit your business and sell it, your brand and your associated intellectual property is going be you, probably your most valuable asset.
Christian Maniquis:
I think yeah, especially when it comes to protecting the name of the brand. You built it from the bottom. Now it’s now you did the work.
Now you took care of it, you scaled it. You get into a point where you’re now doing really good business, now’s the time that you really want to protect it. All right. Okay. This is getting a little bit more, interesting and interesting. Okay. The next one I think is going to be you as well, Jim. So let’s move on to the fourth question. What are factors entrepreneurs should explore when deciding whether their business is ready for franchising? I think this is very much related to the previous questions. So go on and Jim.
Fisher James Kinslow:
The good thing about franchising and looking at franchising is your business is being successful.
And that success is resonating into demand from potential customers either within your state or country or outside your state or country. And your franchise, again, goes back to your brand and your customers and your potential franchisees are relying upon the quality of your brand, your service offerings, and also how you promote your brand and your business in order for your franchisees to become successful.
There are a few things I think that you really need to consider before franchising is, and I think one of the most important things is how are you going to control your franchisees? Because your franchisees are basically promoting and living off your brand. So are you going to be hands-on with regards to their business decisions, with regards to who they hire?
Or are you going to say you’re your own independent business? You’re going to pay me a franchise fee for the use of my brand? And probably, maybe a percentage of your profits if you’re successful. So it all depends on how you want to protect your brand and how you want to monetize your brand when you start to franchise.
There’s a few other things with regards to franchising, but I think the most thing, most important thing also is to protect yourself from anything that happens with a franchise so that it doesn’t come back and result in a legal liability on you personally or your business. So it’s important that you have a really good franchise agreement and get good legal advice as to how to structure a franchise and also how to police the franchisee to make sure you protect your business.
Christian Maniquis:
That’s very interesting. Franchising. I think the next question is best off handled by you, Jim, as well. And it’s actually in contrast to the franchising, right? The spectrum would be is, you’re going to be still growing your business, but this is the other side of growing business.
If you don’t have anything to add, Drew I think we should move on to the next.
Drew Barnholtz:
Sure.
Christian Maniquis:
All right. Okay, next question. And Jim I hope that you could still take this on. What are some of the reasons a growing healthcare business might explore M&A and what should founders understand about the process?
Fisher James Kinslow:
Is this one for me?
Drew Barnholtz:
I think this one was for me. So I think from a business standpoint, growing a healthcare business and M&A the, probably the hardest thing is finding the deals, right? So if you can find the deal, it fits in your buy box, right? In terms of how much you want to pay for the deal what we call EBITDA, earnings before income taxes, deductions, amortization and you can work the deal out. Then, we can, do everything for you from draft a letter of intent through due diligence to purchase agreement and closing and post-closing.
But the activities are really figuring out. What do you want? How do you want to grow, right? Do you want to grow by adding, in this case more, more IV clinics, so do you want to buy out people that have small shops and add them for getting into other, geographies or just literally having more locations?
Do you want to add more? That, so they would call that a tuck in, right? If you have one, like a private equity. So if you had one shop, one IV therapy clinic and you bought more IV therapy clinics, you’re literally tucking them in to the other one. If you bought something that they call a bolt on, that means you have IV therapy and let’s say you wanted to add like some med spa services, you would literally take that Med Spa service and you would buy existing med spa and you would bolt it on, literally bolted on, essentially to your IV therapy. And, the way that you do that, from a business standpoint, you got to figure out that it makes sense, right?
You could even look at, primary care and nurse practitioners and different kinds of things that, concierge care. And, but from a legal standpoint, we can always help you through that. We can look at any regulatory issues, but you got to look at fair market value and know that you’re paying what makes sense and and then post merger, that the culture and the branding and the team align and all that good stuff. But that’s really from an M&A perspective it’s knowing where you want to take your business and how you want to grow it. The types of services and locations and the types of types of things that you want to offer to your clientele and the types of clientele that you want to go after.
Christian Maniquis:
I think Jim may have mentioned something about this one, so I think there’s some implications on the intellectual property side on this one. Jim, what do you think, you know when you’re, yeah, there are working on something like
Fisher James Kinslow:
We go back to how successful is your brand, and your brand is your goodwill and your goodwill results in your bottom line. It’s important again to ensure that your brand is protected. Also during a M&A phase, there’ll be due diligence and there’ll be a lot of discussion about, what do you own? And is your brand protected?
Is it, do you have copyright on the things you’ve written? Do you have trademark protection on your brand? If you have patents, what are those patents for? Can you license them? So it’s important again, to understand that part of an M&A is going to value your assets and your brand will probably one of your be most important assets that you can offer.
Christian Maniquis:
Okay. I think the next one would be very much relevant to that one. Because it could lead to setbacks, right?
Drew, Jim?
Drew Barnholtz:
Yep. Yeah, no, for sure. So I think you were going to have me take this on and then have Jim, ring in on it. But look if you, the next question is as your business expands, how can you stay aligned with legal best practices and avoid setbacks down the road?
And the concept of winging it right as you grow and look, I’m not a fan, I’m sure I know Jim isn’t Christian is of Hey, we’re going to load, a whole bunch of legal requirements on you and try to, just overwhelm you with that stuff. That’s nuts. We don’t do that.
That’s not our firm’s sort of way of doing things or try to scare the daylights out of you, with all the requirements. But I think, what could happen is that you could have a stop start mechanism, right? Where you. You get out of the gates, but you didn’t, make sure you know that you had the right malpractice coverage in place and you didn’t have, I don’t know, consent forms and patient responsibility forms and financial responsibility forms and things like that.
And just, HIPAA notices and some sort of basic clinical protocols and if you are doing this where there’s going to be a physician involved, the medical director agreement, and if there’s a physician involved and you are not one, and we’re talking about California for instance, then, we’re setting up something called a management services organization that you just got that agreement in place and we’ve looked at, the fee structure and the services being provided.
And, but the like nuggets to take away is, set it up the right way before you get in. Not just the legal, but the accounting, the ops, the operations. Everything. And then, once a year we’ll do a little legal checkup for you. We’ll take a look at your website, we’ll take a look at your policies and procedures.
We’ll just take a look at, how you’re doing things. I’m doing that right now for a client. They’re a tattoo removal, similar general industry. Get us in there so we can take a look and build policies and contracts that like, make sense, independent contractors, employees policies, clinical policies and standard policies that you can pick it up, read it, someone can read it and they’re like, okay, I know what I need to do.
That’ll really set you on the right path. And honestly, it makes it a lot easier. And if I would say there’s big boulders, it’s anything around employees, privacy and security of data, advertising and claims and things that you’re saying. IP protection, which we’ve talked about. And then that relationship from a client’s perspective.
Understanding, that if you’ve got a physician involved and then you’ve got a business person involved, the difference between that manager and that clinic.
Christian Maniquis:
They work hand in hand, so to speak. And yeah. Actually, what you mentioned, and Jim, please feel free to chime in.
We normally encounter clients that sometimes they get overwhelmed. Because the more they know, the more they realize that they have to work on things. But in reality, since we deal with a lot of startups, y ou have to cross the bridge when it’s there and you could always circle back when you’re ready for that phase that the essence is if in case that you need that support, you know where to go to.
Or you could just simply deal with what is the bare minimum, if that makes sense. Drew, I’m not trying to play attorney, but basically on my experience, what would be the bare minimum to get you going? Just be still in compliance. Then when you’re ready for the next phase, that’s about the time that you revisit the engagement.
You follow through up until such time that you know what’s been being discussed by Jim and Drew is you’re eventually going to grow your business and you’re going to come to a point whether you’re going to trademark it, you’re going to expand it, or you’re going to merge it. You have those bolt on things.
Those are very exciting. But it doesn’t come, as something that would happen at the very beginning. So even if it requires work, it doesn’t mean that you’re supposed to be overwhelmed with the amount of work that is there because you’re not there yet. You’re still at the beginning.
All right. Okay, so this would be last but not the least of the questions. I think we have a couple of minutes left for the Q&A and I see a couple there. Maybe we could choose later. So last up would be, what is succession planning and why is it an important part of long-term sustainability in the IV hydration and med spa industry?
I think it, this thing doesn’t really just apply in IV Hydration and Med Spa. It applies to all practices. And yeah. I’ll leave the floor to you, Drew and Jim, let’s start with Drew.
Drew Barnholtz:
Yep. Look, succession planning, I’m doing this right now actually. It’s a father and a son. The father’s actually a physician.
The son is actually a business person. The dad wants to ride off into the sun, literally Florida, t he Sun State and the son wants to, no pun intended, the son, SON wants to take over the business and bring in, a different doc at some point after a transition and own the business, and we’re setting it up, right? There’ll be a management services organization so that he can have it’ll, it’s not ownership in the clinic itself, but it’ll allow him to to make, fees, l egally fair market value, commercial reasonable fees. Sorry, I put all that junk in there, those adages.
But look, he’ll make money out of the business and he’ll bring his business acumen, his knowledge about how to build a business to that business that his dad built with blood, sweat, and tears as a doc. And , that’s big. So I think when you think about succession planning is are you going to sell to one of your employees, and are you going to finance that at all? Are you going to sell to private equity? And what does that deal look like for you? And when do you want that to happen? Are you going to sell to a strategic partner, meaning like another IV hydration or med spa that you know who would be your ideal buyer?
Do you want to be involved? Do you want to do a small transition period? Do you want to just get out? Do you want to stay involved? Do you want to be, the operator they bring, you made it successful, they buy you. But then often a PE company might make you the operator and leave you in because you made it successful.
They want you to run it up again. You keep a little piece of equity and you’re running up again. And I, so I think you look at these things and you figure out, what’s. And how does that look like if you have a partner? Do you have a buy sell agreement, an operating agreement in place that, that allows the transfer of those rights and and it probably figures into, some, maybe some key person insurance, right? So they, God forbid, or disability insurance is some, one of those things. God forbid happens, but also, in Jim’s area of expertise, the IP assignment and licensing and making sure that all of that is looked over.
So you want continuity of care for your patients. You want brand reputation and to be protected. You want to make sure you get value for the sale of your business and that you’re attracting investors or strategic partners that make sense for you. While, addressing any risks that might, come to you when you transfer that ownership.
So that’s, but we do it all the time and would have, there’s lots of opportunity.
Fisher James Kinslow:
I agree with Drew. I, one of the things I think is important. As the nod towards Drew is that, when you are setting up the structure of your business, that’s a great opportunity to plan for succession, and you can do that by, depending upon your structure, if you have an operating agreement with an LLC or a shareholder’s agreement with a s corp.
It’s a good opportunity to say who’s going to own the shares and what happens if they leave the business or they predeceased the other owners? Where do those shares go? How, who has control after that? Because in a lot of these IV hydration and med spa businesses, you maybe have one or two key players.
And as Drew says, if one of them leaves, then the business is going to struggle and it’s good to have a roadmap in place. And plan for that upfront as part of your corporate structure.
Christian Maniquis:
I believe Jim we had a client like that, right? The physician, and eventually God bless and rest his soul, it departed us untimely, right?
It’s a struggle and the scenario is there’s nothing set in place. It becomes a very difficult and meticulous process and a costly one too.
Fisher James Kinslow:
It does. And if there is a death obviously you then may maybe have a will or probate or other things that could tie up the business, which means you have to make some hard decisions.
Are you going to take the business forward in agreement with the other stakeholders or are you going to start up your own? And then who owns the brand, who gets the copyright. So it becomes very involved and expensive.
Christian Maniquis:
Yeah. And actually I’ve seen a couple of Drew that, did the preparation ahead of time, which made the transition much easier.
So we, we see both sides of the scenario here. Someone who anticipated and someone that was not able to foresee and, it’s just a reality, right? Sometimes things happen and time and time again, much like what Drew said, you could always circle back. You don’t have to do everything all at once, as the business grows.
That’s how we help startups. As the business grows, we can check in, you can check in, can figure out if it’s even really the time to do stuff, have to assess the situation and see what will be the best course of action. And definitely what we encounter with groups like, for example, My Queen and the Drip success Formula.
With the help of the mentors they have the support that they need on those things that we don’t necessarily do. The business stuff, the nursing stuff, the medical side of things, because we’re a law firm and we’re there to help you on the legal side. It’s also good to get the support on the other things that you would need on the business side.
On the actual medical side, you have your mentors. Drew mentioned that if the finance side, the accounting side, Jim mentioned earlier as well. Trademark, trademarking attorney. Get help on that to protect your business, especially if it’s growing and you want to, or you intend to keep it in the long run or have rights to it. So yeah, having the right support is always crucial, both the beginning and up until the very end.
Alright. Yeah, actually I don’t see questions on the Q&A. We do have at least maybe five more minutes. I’d like to encourage the participants to throw in some follow up questions.
If you have, we do have a box at the very bottom. It says Q&A. You could just type in your questions and if Jim and Drew would have the time to answer them within the availability that we have, we’ll make sure to accommodate them. Let’s give it like a few minutes.
Other than that, I would like to sincerely thank the participants, especially those that I see that have been with this webinar series from the very beginning. This is the final installment of this webinar series, but it doesn’t mean that this is the end of the webinars. We will try to continue and support the community and you’re more than welcome to reach out to us if you have any questions.
Again, I’d like to thank the Drip Success Formula and the Thrive and Hive community for initiating and making this happen. And thank you, Jim and Drew for, for gracing us with your presence and your answers. Oh, now I see two questions. Let’s see here. If you have any questions that you want to answer, Jim and Drew, yeah, they’re in the Q&A box.
Fisher James Kinslow:
I guess the question is there any recommendations for doing corporate wellness events with companies?
My recommendation is to make sure that you document what you are going to do, because I think corporate guidelines are going to require you to adhere to certain guidelines and guardrails, and you want to be sure you understand what those are so that you can accommodate what you’re trying to do within the guidelines of the company.
Also whether you’re going to be remunerated and how much that is going to be. And there might be other issues regarding transportation. So I would suggest that you be represented by an attorney and take a look at the documentation and how that’s going to affect whether you can comply, how you’re going to comply and how you’re going to basically take forward any wellness recommendations in part as part of your services.
Christian Maniquis:
So this is kinda like a large scale thing, right? When Yeah. Yeah. A company wants to I think I remember some client of ours from New York that did that, right? She did that for a hotel. It’s very similar to how Jim described it. The rules may be different. When you’re doing it for a company or you’re providing the service for a company, I think this happens with I say it’s occupational therapist as well, or chiropractors, I think.
What do you think? Yeah,
Drew Barnholtz:
I think it just need to be clear on what you’re providing. What services is it? Is it screenings, wellness coaching? Is it chair massage? Is it the IV hydration itself? Vitamin injections? Is it what are you going to provide and make sure that you avoid practicing medicine unless there’s medical oversight there, right?
So you’ve got licensure and scope of practice. Then I would, I, to Jim’s point and to your point, Christian, I would have a contract in place that just says, Hey, here are the services we’re providing. Here are fees. And let, unless you’re, comping and here are fees, who pays the employer, the employees, how does that work?
Have some sort of informed consent for anybody that participates, and hopefully a little bit of a liability waiver in there, as much as we can protect you with that. And then, just make sure your liability insurance covers you to do such an event. So you could check with your, your agent or your broker, whatever it may be.
And then, just when you market it and then, be careful with people’s information. Have it, have them put it in either directly into your EMR, or into something that’s secure. And then make sure you’re properly staffed, right? And when you do the marketing, make sure that you’re just careful about what you say.
What claims you’re, you’re saying right? You could say, just, what you can and can’t, provide them and things like that. So I think, you can definitely do them. And I think there are great ways of marketing your services and getting more folks in and.
But I think you just need to know what you’re going to do and and how you’re going to go about doing it.
Christian Maniquis:
Yeah. It’s actually that’s everybody’s dream. I think, you get a corporate account with you, yeah. You get events. Yeah. I see a lot of this in the Ivy space really, sporting events. Some of them, they go on hotels, weddings, the potential is limitless because I see it growing.
People come up with stuff, you know what I’m saying? When it comes to, elective type of services for treatments. Okay. Oh, Jim, I saw that the other question you want to answer it as well? We still have a few minutes.
Fisher James Kinslow:
Thoughts on the weight loss, recent changes and how to navigate through that?
That’s a really good question and I think it’s a developing field and my main concern, and I’m no expert on this, but I think you’re looking at risk. Particularly with regards to how the FDA is treating these weight loss drugs. And I, my recommendation was, and is that you take a good look at what you want to do and how you want to do it with regards to weight loss drugs and if you want to market them or make them as part of your offering then to seek legal advice on how you can do that through the FDA guidelines. Drew, do you have any more information on that?
Drew Barnholtz:
Yep. There’s there’s some guidance in 2024 around what kind of pharmacy you want to use. So if you’re going to get those compounded peptides, you can still offer them. And if you’re going to buy ’em in bulk, you’re fine.
If there’s a certain kind of pharmacy, it’s a 503(a) pharmacy, so it’s state license, it’s FDA, registered. I have some connections. I’m sure Jim does too. But those compound pharmacies make sure they’re using legitimate semaglutide, not salt versions.
They’re using they’re filling prescriptions for identified patients. You’ve got that established provider patient relationship. I’ve used them myself and lost a whole bunch of weight. So did my wife. Thank God. I think they’re remarkable. And really helpful.
I think it’s a great space to be in. From a business standpoint, honestly, you could probably buy them for 300, 300 bucks and sell ’em for 600 or 700. It all makes sense. You do have to be licensed in the state in which you are prescribing, so it’s not like you can be licensed in just, California and then just, do telehealth visits and send ’em all across the country.
That doesn’t work. But from a, the biggest thing is that if you’re going to buy in bulk, you got to have prescriptions and you get a buy from a pharmacy that’s licensed and FDA registered.
Christian Maniquis:
I think that’s a very good topic to revisit in the future if we’re going to, follow through with the webinar series. Because FDA is like everywhere I see. Oh yeah. You don’t escape it regardless of the practice. It’s there.
Drew Barnholtz:
Especially if a lot of people are using them and depending on them and want access to them.
And then there’s been an explosion with semaglutide and tirzepatide weight loss drugs, and then a difficulty accessing them supply. ’cause Eli Lilly and Novo Nordisk, they can only make so many of them. And so then there was an explosion of compounds. Sure have all the same ingredients.
It’s like buying, I don’t know. It is like buying, the Walgreens version of Robitussin. There’s Robitussin and then there’s Robitussin.
Christian Maniquis:
Like when you do like supplements, right? I have here two, two different brands, but they’re identical.
Drew Barnholtz:
Same active ingredients, and there’s no, Jim’s corner of the world, there’s no IP issues generally there. It’s, there’s generics, there’s all this stuff, but the point is that you just have to make sure that those things are regulated and that you’re not buying junk.
It’s true. And there’s been some of that. So if you’re going to a reputable pharmacy that’s really what the FDA’s concern was, right? You go to a reputable pharmacy. A reputable compound pharmacy. That’s it.
Christian Maniquis:
Very well, thank God for that question.
Drew Barnholtz:
Yeah.
Christian Maniquis:
Okay. So I think we have time for just one last question.
Drew Barnholtz:
Unfortunately, we’re a little bit short. We need to wrap it up. But yeah, you could always reach out to us. Yeah. Jim, Drew, if you want to choose just one more question. I think we have a few minutes left. Yeah.
I think the questions about cease and desist letters. Yeah I’m aware of this. I think that a lot of them are coming, when people are using these meds that are meds, what you call it. Some of them are labeled for research use only, and I’m not sure if that’s to the person that is, kindly sent in the question. I hope I am talking your language for lack of a better word, but I have looked at this question.
There are these peptides that basically say for research use only on them. And then, people are using them for non-research purposes. And you have to reconstitute them with with basically adding, liquid to them and things like that. And I think that that has led to to the FDA sending letters.
The other purposes I think are about misleading saying it’s compounded Ozempic, right? So it’s a protected trade name. So you’re infringing. So you might be violating a patent or something like that and if you’re selling, non FDA approved drugs or you’re, doing those kinds of things.
So I think it’s really just making sure that you look at, you review your contract with those compounding pharmacies. You confirm that their APIs they’re using and the meds are not. semaglutide sodium or salts, which the FDA’s says are unapproved. We can take a look at your website or you take a look at your website, audit it, your social media take off, unverified claims, those brand names, take that off.
If you’re saying that it’s FDA approved you got to be careful there, right? And, just educate your staff about saying that it’s ozempic or wegovy, but it’s not, ’cause it’s a compounded peptide. So that’s probably what’s, I think what we’re talking about. ’cause I’ve had them sent to me to take a look at and generally , we can get you out of it.
Christian Maniquis:
So I think, yeah, Drew you pointed out a couple of things about, maybe it’s. IP is protected. That’s very much related to how Jim presented it earlier. So some companies that are there maybe ahead or maybe doing it at the same pace as you may…
Drew Barnholtz:
It’s Novo Nordisk and Eli Lilly. Man, you want to mess with, that’s Ozempic, Wegovy, Mounjaro, Zepbound. You want to play with the big boys? Just don’t. Ask Jim. They will crush you like a bug.
Fisher James Kinslow:
I don’t need to. I endorse that opinion. ’cause they will.
Drew Barnholtz:
You don’t need to. There’s plenty of compounds from reputable compounding pharmacies and if you’re, if you market them the right way and don’t put crazy claims in there and don’t hold them out as being the same as the those four brands, you’re good.
It’s not, I’m, neither of these lawyers or Christian are all about overly complicating this. There’s ways to avoid these problems.
Christian Maniquis:
Yeah. I’m not going to sit on the big kids’ table. I’m going to sit there. Okay. I’m going to do it my way silently.
Drew Barnholtz:
We can keep you out of these problems. We got you.
And if you get one of these letters, flip it over, we’ll take a look at it. We can respond to it. It’s not, it, this is not the end. It’s not the end of the world. What they’re wanting you to do is remediate whatever issue they think you’re causing. And so you basically, you fix it.
And we’ll help you fix it. And it shouldn’t be a big fix. It might cost you more to buy the drug. You might not like it because the marketing efforts might be reduced because you can’t call it, a thing that it’s not, but people still want access to these meds. Even if they’re not, you can’t call it, the name brand drug.
It’s supply and demand supply. Basic business.
Christian Maniquis:
Yeah. It’s a $10 billion industry and it’s ever-growing. And weight loss is, yeah, the weight loss, medical weight loss is catching up as well. Lots of opportunity.
Drew Barnholtz:
Apparently the little town that Eli Lilly manufactures this in has literally become, has exploded.
It’s it, it’s like money fell from the sky. It just it just solved a lot of, it solved the obesity. It, in theory has solved a lot of the obesity problem. It’s a massive problem. And so that’s a great thing. But then when you can’t get access to it, or your insurance company says, screw you, we’re not going to pay for it.
You want it in a secondary market and that’s compounds. And so you just got to do that the right way. And there’s just a couple things that Jim and I can help you through and we’re happy to help.
Christian Maniquis:
I think. Jim, if you have anything to add, I think that about concludes our question and answer portion.
Fisher James Kinslow:
No, I don’t have anything to add except if you get a cease and desist letter. Please reach out to us because basically whoever issued it wants your attention and they already have legal advice.
Christian Maniquis:
Yeah, but much like what you said, it’s not the end of the world.
Fisher James Kinslow:
It’s not the end of the world, but it’s the beginning of a journey.
Christian Maniquis:
It’s a very gentle shoulder tap, if I’m going to describe it. I assist clients. I’m not the attorney, but whenever I hear those concerns, it’s like a gentle shoulder tap to the client, in most cases.
Drew Barnholtz:
It’s just a wake up call that, someone’s looking and, but it’s not the end of the world. These things are like, you got to be a bad actor. Like you got to be doing something bad generally to get shut down, right? If you do something even innocently, as long as it’s not, really bad and you didn’t hurt a bunch of people, generally we can fix it up for you.
Christian Maniquis:
All right. So it’s very interesting conclusion to our. Third webinar installment. Again, thank you everyone from the Drip Success Formula and Thrive and Hive community. Those that have missed the previous webinars please reach out to us at www.cohenhealthcarelaw .com and we’ll be more than happy to assist you.
If you have any inquiries you are in capable hands. With My Queen and the Drip success formula, and we look forward to seeing you on to the next. Again, thank you so much everyone, for being part of this journey with us.
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