Navigating the sometimes broken components of our system
This is the story of my 10 week journey with navigating the broken system that (thankfully WAS), when I started Enchantment Creek. I had done my due diligence, not only researching and fully understanding the FDA ‘guidelines’ that pertain to herbal supplement companies (I spent nearly 5 years getting these ‘regulations’ dialed into my brain), to then go to start selling my line at the Cody Farmers Market nearly 6 years ago. I had contacted the State Agriculture Department (they see over the regulation of food, our food freedom act, and commercial product offerings coming out of Wyoming). Apparently, by what I was told, they ultimately did not understand what I meant by tinctures, digestive bitters, and topical salves when I initially reached out, when they gave me the green light to go ahead and head over to market…
There were are lot of intense feelings, days of endless phone calls, and meetings with ALL of the officials… this is a paragraph that I am going to leave unedited… and then, let’s get into the details, this truly is, what I hope to be, an inspiring light for anyone out there, wanting to start a business from scratch, and navigate the red tape that surrounds herbal small business and this farmacy garden in Powell, Wyoming… “The light of my Herbal Business has faded to a flicker in the distance. To only then re-emerge in a brilliance that is now so glorious I am drinking it in. It is filling me with an immense gratitude, not only for the past 10 weeks of sludge, but for the 13 years of practice in Herbal Medicine that is behind me. Once again life reaffirms that the darkness is the balance of light. This making one not appreciated without the experience of the other…”
Let’s get back into the juice…
I am choosing not to focus on who the person was that turned me in, or what their reasoning may have been. Nor am I continuing to question why the state does not have certain practices in place, ones that might assist businesses like mine coming to full fruition. It was essential to know that spending precious resources on worrying, and fretting over these details and more would not serve me well. All of this made the next steps clear, that I had to do what I don’t always do best… So, I put on my Business Woman Hat, full of analytics, straight lines, debating skills, and speaking the language of bureaucracy, and Federal ‘guidelines’ (because hey, there is an OBSCENE amount of grey area and interpretation in the FDA Compliance for Dietary Supplements).
It’s an uncomfortable hat to wear for most of us Herbalists, e are nature gods and goddesses after all, and this doesn’t always translate to this material, very physical realm very well at all… The lines we walk are uniquely ours, and these kinds of lines are zig-zagged and don’t fit into the straight box of society. But we walk them with our heads high, knowing all the while that the path we are on is correct for this life, and so I did!
I was at an evening market that week, and had a woman come to my booth and ask immediately, “if I was licensed for what I was doing?” It was a strange way to greet someone, and me being me, thinking, oh another person who questions the legitimacy of herbalism, I went on to explain that Herbalism is a freedom that we all have to practice, and that I simply help people navigate their natural health journey and offer herbal extracts to support that journey.
She then clarified and I was made aware of who she was. A member of the ‘food police”, she was wondering if my space where I manufactured these tinctures was licensed and if I was in compliance with the FDA. This was quite an interaction to have in the middle of speaking with clients, and the buzz of farmer’s market patrons (thankfully I was not nearly as busy as I am these days, and…). She ‘allowed’ me to finish out the market but that, even after I explained to her that I had already contacted a man at the Wyoming Department of Agriculture (WYODA) who had cleared me to sell. She was confused and truly, it was an awkward experience for us both.
Thank goodness for confidence and persistence… for the sake of the farmacy and the gardens at Enchantment Creek…
The initial conversations that I had with the WYODA were rocky, when one hears that they simply do not know what to do with a business like yours, from a regulatory institution that is in place to tell you that you cannot do business, frustration is at the top of the list of responses. I was rocky, they were rocky, and I was not going away, there are SO many instances where I lost my cool and had a bit more of my assertive voice on.
The first few weeks was truly the most intense, I was passed around to at least 5 different people, all who said they could help me and all who, in the end, led me and enchantment creek completely astray. I had found the kitchen in a shed (where I would work for the next 5 years), and purchased it after sharing with the first person I was assigned to, or maybe who was assigned to me, and purchased it, the next person I was passed to, said that the building I had purchased and had sitting in my driveway, would not work. Talk about frustration, and in those moments, I shifted my mindset around the experience thus far and started asking more questions, started applying strategy, and taking more deep breaths.
The woman I was finally working with ended up being the one who would get me licensed, and we now, are on a hugging basis when she comes once per year, we both know the beginning of our relationship was rocky to say the least, but she began to realize that I was indeed well understood as to what I was attempting to create. She is the only WOYDA Agent who regulates the FDA ‘guidelines’ and we began to work together. I can’t completely explain what happened that day, on my birthday, as I looked over the kitchen in a shed that had just been delivered, on the phone with this woman, but it all started to turn around. Persistence, research and diligence does pay off in the end.
Working together for the sake of the farmacy and herbal medicine
We were finally moving the project forward, and working together to get my business into action, I was released to go back to farmer’s market after nearly 6 weeks of absence to sell my digestive bitters, topical remedies and fresh garden offerings. And working my booty off behind the scenes (this never ends for a small business owner though) after we started to work together, there were finally steps to take on my end and on her’s.
We didn’t agree on all the FDA Guidelines all of the time, but grey area is meant to be navigated, so we did that together, and f1ound common ground, to develop what would be my standard operating procedures, master manufacturing records, and all of the juice that goes into the mountains of paperwork required to be, an FDA Compliant farmacy garden and apothecary.
I did have to go to the county too, and was right behind (by only a few weeks) Sara Wood, of Wyoming Heritage Grains, a comrade that would become a good friend and farming ally in the bason for me. There was more red tape here, in the Planning and Zoning, and I thought it was great that I was creating a Value Added Agriculture Business, something different and that still fit into the framework of Ag in a farming community. So we moved forward, again, more phone calls, more meetings, more paperwork, and drawings, but we were moving forward which is always motivating.
‘Not all who wander are lost…”
J.R.R. Tolkien
My usual way of working in this herbal and healing realm is to meander through the wild spaces, the wild farmacy gardens here at the farm, and feel into each move I make, and those of you who understand bureaucracy and maybe work with more, say, corporatized systems know that these two ways of working, don’t understand one another. So, clear communication was key, which we all did, and in the end, our ‘site’, the kitchen-in-a-shed I purchased, and my business plans reached approval.
The day I stood before the County Commissioners, they applauded me for a unique vision, and bringing something different to the agriculture scene here in the Big Horn Basin, it was an honor, and I still feel that moment in my heart. The vision for Enchantment Creek Apothecary and farmacy gardens is much larger now, than it was then, and the process we went through, my FDA Agent, the county people and now all of you, my friends and clients, was completely worth every bit of the effort and uncomfortable beginning the we faced.
I want to help as I am able to in bringing all of your dreams, visions, and paths to fruition. Maybe you want to make skin care, or tinctures, or grow an herb farm. Are you are harvester of the wild medicines? Where are you facing adversity from these passions? Each of these components of herbalism seem to be ones that are hard to tackle. So, after my experience, I want to start here with a few keys to you starting there…
KNOW YOUR BUSINESS
This may seem easily achieved. But truly it is a place where a lot of start ups struggle. Diversity is key, but precise co-mingling of your aspects of diversity will create a flow of your business that is unstoppable. Questions like the following are the most important to answer if you are starting up a business.
- Who am I selling to? KNOW your people and know how to speak to them, in person, online, and in all ways you communicate with your clients. It sounds simple, but this is a component that I am STILL learning new ways to be more effective every day.
- Is the offering I am selling something I know in and out, is it my passion? I KNOW that if I hadn’t already devoted my entire adult life to this work called herbalism, and farmacy, I would have been EASILY conquered by the immense work load that it takes to bring a business to fruition, let alone keep it going, in year 5 I am STILL learning every day, about business, herbalism, healing modalities, how to hold space for my clients and community. It is no small effort and once you get to one goal, there are years of goals and learning experiences in front of you! Knowing your passion and your business is what you are devoting to, and knowing the ins and outs of it is absolutely vital to your success.
- Is my business set up properly in my State and Federally? THIS could be a week long, hey maybe a month long course. ESPECIALLY when it comes to herbal businesses, farmacy gardens making medicines, truly any dietary supplement operation. It is many binders deep in my apothecary. I do at least 3 reems of paperwork each season for the tinctures that come out of Enchantment Creek. It is real, and there are literally, NO blueprints for it, you get to make it up on your own, as you go. One component of the success of our licensing process was that I curated a training program with the WYODA to help them train other businesses coming up behind me. It has been sweet to get the licensing portal in Wyoming streamlined and being a part of it was truly cool.
- Do I have a Marketing Plan? HOW are you going to test your products before they launch? Where is your first year or two of sales going to come from? How much cash flow do you need to get going? All of these are key questions as a startup business, and again, marketing will change quarterly, even monthly throughout your time in business. I started with making medicines for family and friends and people gave me feedback, and I went with stuff that they loved. I also started in Farmers Markets… this was a HUGE success for Enchantment Creek, community, other business people, direct feedback from strangers. It was and IS awesome! Know your starting place and run with it! There will always be failures and do not expect (unless you have a sweet nest egg) to start out your marketing plan with a big, big boom, slow and steady truly does win the race.
- What are my top 5 goals for my business over the next year, 2 years, and 5 years. I cannot stress enough to WRITE these out. I am on my 15 year plan and it is a beautiful blueprint, it makes me cry when I read it, and I can break down the yearly goals into quarterly action steps. It is a vital tool and EVERY single entrepreneur you listen to (if they are worth anything) will tell you to do this, get it out of your head onto paper, trust me.
It is always easier said than done. Going through these questions, writing them down and getting to the root of your goals will take you to a successful business model. It is not as easy to just look at something. Say you want to do it, and bam! You’re successful! Any business takes time, and immense dedication. Even when you are not turning a profit, which you most likely won’t in the beginning. You need to be able to keep moving forward. Knowing that you are moving along with your goals each month and year to keep your momentum going.
KNOW the Federal & State Regulations For Herbalists
The plain truth about our line of work is that we aren’t regulated by the Feds or the State. But at the same time we are HEAVILY regulated by them. True that we don’t have Federal or State Licensing for Herbalists. True that there are MANY laws and regulations at a Federal and State Level. False that your State enforcement agency always knows the correct path to your business being in compliance.
The moral of this story is to know the Federal Regulations, and Current Good Manufacturing Processes, AND how your individual state enforces these laws. Be prepared that your State Representative may not know that they don’t know the laws either. It is OUR job to know these laws backwards and forwards to protect ourselves. It is their job to make sure that you know and are in compliance.
If dedication to achieving the first few questions was a struggle… this will be a big one. There are over 500 pages of Federal Regulations, and many more for your State. Some states require a Liquor License to operate a tincture manufacturing business, and ALL will require a Commercial Kitchen to stay in compliance.
I recommend reaching out to your Consumer Health Services department in your state. Dietary Supplements, and Cosmetics are generally under the cGMP regulations and MOST states operate as this as their guidelines. Be friendly, and obliging. Explain more than you think you need to so that they are sure to understand what information you are seeking. Question them and stand up for your-self. In other words… KNOW YOUR RIGHTS.
Remember… Success is NEVER an accident
This is the ultimate truth of your process as a business owner, entrepreneur and navigator of the new ideas, you are forging a path, but you don’t need to reinvent the wheel. There are people who have come before you and who will follow your lead. No matter where you are in the process of launching your business. What matters is your perseverance, dedication and ultimate LOVE of what you do.
There will be scary times. Eng-raging conversations with people you have to keep your cool with. Sleepless nights due to worry, AND excitement! Business life is a roller-coaster ride that truly, never stops, but you learn to roll with the flow, and the rewards are SO worth it. What it takes to get there, is to keep on going.
As you go through this journey, remember your meditation practice. Read and listen to people who inspire you. Stay balanced, and when you feel like you need a break, TAKE one. Nourish your body, and when all else fails, a little crying session never hurt any one. If you are COMPLETELY devoted and saturated with the business path you are going towards now. I urge you to take the risk! Run with the fear that holds you back. The end result will be more than worth it. I promise.
If you want to schedule a consultation, I would be happy to work with you.
Head to my contact page and fill out the form! We can get a session on the books.
