FDA cGMP compliance open source project

Our strength as herbalists is that we come together. We share processing tips and secret harvest spots (sometimes - depending on who's asking), discuss difficult cases, and generally help each other learn. This has been evident to me all the way from herbalist pot-lucks to the biggest herb conferences. Now I believe it is time for us to come together on another critical issue: the modern regulatory environment, enforced by the FDA, in which we find ourselves.
At Urban Moonshine (we make bitters and other tinctures and blends), I can't say we've come to a complete understanding with FDA. The issue of how to identify a liquid formula made from multiple herbs remains. But we have been through every step along the way, and have discovered successful strategies that FDA agrees are valid, and that rely on traditional methods for evaluating and identifying plants - the way herbalists have always done it. These strategies have been tested through multiple inspections. And now it's time for us to share them, share templates of the paperwork, share the research that justifies the specifications we've developed, and help explain what the regulations are, what FDA wants, and how to get there. Not because we've got all the answers, but because we want to open the conversation and create a forum where small-scale producers can get actual news they can use - not just copies of the rules, but actual examples in action. If we can have an ongoing conversation and herbalists across the country can share their collective wisdom, I know we'll have the tools to support anyone who wants to make tinctures for sale in their local communities or across the country.
I won't lie - this is a complicated task, and there are a lot of moving pieces. It's not something you can understand over a weekend and implement with a few days' work. This complexity may have deterred a lot of you, and in the future, may make it impossible for some to keep their heart-centered, small-scale herbal products on the market. FDA welcomes consolidation in the industry - hoping that herbal medicine will become concentrated in the hands of a few, and thus easier to control, easier to oversee.

**NOTE: all the information presented under the "FDA cGMP compliance open source project" is not intended to be legal advice, nor is it in any way guaranteed that my interpretation of the statute and system for compliance is going to satisfy any individual FDA inspector or compliance officer. These pages are a synthesis of my own understanding of the regulations and how to achieve compliance.

We reject the idea that our medicines can only be made by large-scale manufacturers. Despite the pressures today, there is a safe way forward for the community herbalist to make medicine, to  keep this vital and direct link between plant and health alive.

First, we must show that we herbalists – not physicians, not research scientists, not machines, but herbalists – understand the plants we use, and know the intimate details of their growth, their smell, their taste, their essence. We must show how herbalists have a clear, practical and safe way of successfully matching plants with people. Second, we must support a model that relies on customized, individualized medicine making for the local community: a practitioner-based, rather than product-based, economic relationship that focuses on plants, not pills; that encourages client self-care and self-resilience, rather than product-based dependence. And  third, we must reach out to our partners in all fields, to weave green tendrils into places where they’ve all too long been absent: in the halls of medicine, in the offices of urban planning, in the minds of FDA compliance officers, in the backyards of clients everywhere. 

So starting today, we are committing to unfold an ongoing open-source project to achieve FDA compliance for small-scale producers. Every Wednesday I will post information here, including some audio recordings, starting with an overview of the regulations in layperson's terms and a clarification of what FDA is after, then progressing through the moving pieces from documentation to batch records, all the while providing specific examples of documents that have worked for us and helping to tailor them to your needs. This is starting today, and will continue for as long as it takes. I urge you to take part in the conversation: post comments, questions, concerns, and examples. Ask for more detail, ask why, not just how. We will do our best to answer. But ultimately, we are doing this because everyone involved will get stronger as a result. Our collective experience, once open-sourced, will home in on amazing solutions with the ruthless efficiency of nature. This will help Urban Moonshine as much as it will help everyone else.

Posted below find an outline of the curriculum you can expect. Check back here in a week for our first installment and an overview of the compliance landscape. Contact us if you want to help. But before you go further, I ask you to please consider the idea that this could be done more efficiently than blog posts, uploaded documents, and audio recordings. We are trying to build a fully-interactive online classroom for just this type of conversation - where you can be present, ask questions and get answers in real time, and ensure this open-source process is a two-way street. In fact, we need you here contributing: how do you make medicine? How can we make FDA compliance work for you? It's going to be a lot less effective for this to just be an exposition of information - we all need to know what your experience looks like so we can build a truly resilient and adaptable compliance model for actual herbalists. 

This endeavor needs a lot of infrastructure, and we can't afford to do it alone. From fit-up costs for the space, to AV and telepresence equipment, we are relying on your help to make this a rich, interactive process. There will be a lot of other good stuff along the way, too - but what excites me most is the opportunity to create an open-source compliance conversation that happens every week, with intensive on-site experiences as required, and is available free of charge to anyone who wants to join up. But as you know, nothing is actually free. So please consider supporting Railyard - our herb center project. Hiring consultants for FDA compliance can cost thousands of dollars - even a weekend workshop can cost hundreds. If everyone from a group of engaged herbalists who want to maintain control over their own medicine-making contributed even half that much to the project, we can make Railyard happen. Think about it, and I hope to see you next week.

https://www.kickstarter.com/projects/2032475629/railyard-herbal-apothecary-classroom-clinic

Tentative curriculum (we can customize it together):

Intro to federal regulations

A detailed breakdown of the federal regulations under CFR 21 part 111 (good manufacturing practices), part 101 (labeling requirements), and parts 174-186 (food contact surfaces and packaging requirements) will give the us the tools to critically evaluate a sound master manufacturing record, compliant dietary supplement label, and scientifically valid testing regime.


Herbal Product Manufacturing

The details involved in making a range of herbal products: research, formulation, safety considerations, process control steps required for compliance (FDA cGMPs), extraction, dosage forms, considerations of large-scale operations, packaging supplies.


Facilities and Equipment

We will become familiar both with the basic tools needed for manufacturing and larger-scale equipment such as floor scales, macerating vessels, presses. Maintenance and calibration requirements and tracking.


Records and Paperwork

We will cover the recordkeeping methodology for maintaining a cGMP compliant manufacturing operation, based on requirements from CFR 21.111, and grounded in specific examples currently in use. We will become familiar with creating: master manufacturing records and their associated batch production records; specification sheets for raw, in-process, and finished products as well as eccipients, solvents, and packaging materials; and valid testing methods and documentation.


Marketing, Sales, and DSHEA-compliant language

We will cover design and marketing concepts and suggestions, as well as thoroughly review what constitutes compliant language under DSHEA (regarding promotional material, labels, social media and websites, video, and product trainings).


Quality Control Laboratory

We will become thoroughly familiar with the requirements for identity testing under CFR 21.111, be able to access and compile relevant resources to aid in identity testing (voucher specimens, e.g.), and understand how to contract with third-party laboratories for identity, microbiological, heavy metal, pesticide and herbicide contamination testing.


Orientation to Industry

We will familiarize ourselves with the resources and connections in national professional organizations for the herbal products industry, such as AHPA, as well as legal and consultant resources that might prove useful. Additionally, we will talk about the requirements and practicalities of launching an herbal product: from interfacing with large retailers such as Whole Foods Market, to making barcodes for products, and more.

Our dream is real

This is a transcript / copy of my presentation at the recent Urban Moonshine herbal conference up here in Vermont, on the shores of Lake Champlain, at beautiful Shelburne Farms. It was a great event, I was honored to be able to address the whole group and talk about how to leverage the strengths of herbal medicine to address some emergent threats to medicine as a whole.

Herbalists are all anarchists to a certain degree. In the sense that we want weeds, diversity, and decentralization. Of course we're also dreamers... Sometimes we dream for a really long time! Did you hear a couple of years back about this seed researchers found in Siberia, buried by some squirrel almost 32,000 years ago? They coaxed it into germinating, and it grew and flowered into this beautiful white flower, a plant the world hasn't seen for thousands of years, and that seed held its essence for so long, perfectly encapsulated. That's amazing to me. When I was in Ireland, I was speaking to a botanist who told me how, during the last glaciation, the tops of some hills were left uncovered by the ice sheets, like islands in a slow, white river, and pre-glaciation plants survived up on those hilltops, kept the memory of those old times and re-populated the island after the glaciers retreated. Dreaming of warmer times. Holding the essence. Herbalists are kind of like that too, in a way.

But I'm not here this morning to talk about herbalists. I'm here to talk about medicine.

One thing I noticed in East Africa, where I had the privilege of working for a bit this Spring, was that the system of traditional medicine is being forgotten. Old timers took me around, stripped bark off trees, pointed out how to prepare it in different ways for different conditions. They know this stuff! But the younger folks know it a lot less. They understand that this knowledge exists, they are very curious about it, but it felt very strange when it was me telling them about the medicinal uses of plants that grow all around them, and not the other way around. This is happening all over the world, I fear - it's happening in Italy and the rest of Europe, in Central and South America, and native plant knowledge is endangered in the United States too (see Carlos Ramirez, 2007). Maybe the exporting of Western culture is displacing these older, native systems of medicine - the young Maasai could show me pictures from their Facebook feeds on their cell phones, but couldn't tell me much about the different Acacia species growing by the river. Who's going to keep the roots of medicine alive?

Another thing I noticed, and this was mostly in conversation with the physicians at this rural hospital, was that antibiotics don't really work very well anymore. Pathogen resistance is a very real problem down there. Part of the issue is that folks can buy amoxicillin over the counter, and they do, and take it for every minor respiratory complaint. They take it for three or four days, feel better, then stop. We know it's not the antibiotic making them feel better, it's just a self-limiting viral infection, but the trend continues. So amoxicillin doesn't work at all anymore. Other antibiotics are failing, too - because specific testing is difficult, docs will just prescribe strong, broad-spectrum agents and pathogens are developing resistance to these, too. One physician told me of an untreatable urinary tract infection in an 8-month-old child. She had tried a series of antibiotics. None had worked. She developed a fever - and of course here we're getting concerned about her kidneys, but no antibiotics were working, not penicillin, not sulfa drugs, not cipro. She had multi-drug-resistant E. coli. The physician needed this stuff vancomycin, a ridiculously strong intravenous antibiotic, but unfortunately it was a 9-hour drive away. Eventually it happened, probably not timely enough, and the child improved but having to use vancomycin for a UTI is crazy, because it's the end of the line in terms of antibiotic treatment: if it doesn't work, that's it.

The WHO is recognizing this, and just this month put out a strongly-worded position paper advising physicians to drastically cut back on antibiotic prescriptions, especially in the developing world where they are so often overused. And you know bacteria are savvy, and very well connected: if they're learning these skills in Africa, they'll soon have them the world over. It's kind of like carbon emissions.

We know more and more that the "war on germs" is misguided, for many different reasons. Minnesota just passed a law banning Triclosan - you know about this stuff? It's the agent in antibacterial soaps and cleansers. Promotes bacterial resistance, is a known endocrine disruptor, and is no better than regular soap and water to slow the spread of infectious germs. So great, good job Minnesota, thank you WHO, we're thinking about these issues now - but who's going to help the little girl with the multi-drug-resistant UTI? She has a fever today.

Another thing I noticed is that there aren't enough people in medicine. The hospital I worked at is understaffed - especially in terms of those who can provide basic wound care, nutrition advice, nursing care. Those who practice medicine one-on-one, intimately, are hard to come by. This is hardly a problem limited to the developing world! Primary care providers are scarce here in the US. One in five graduates go into primary care after training. Why? Because all the docs choose to specialize - they go into cardiology, they go into oncology, they fill these specialties because that's where all the patients are, that's where all the money is. Everyone has heart disease. Everyone has cancer. I may be wrong, but it seems to me that if we had more health care providers working one-on-one, intimately, with patients, we might make headway in the prevention of heart disease and cancer. The way to meet these diseases isn't years after they develop, with high-priced and specialized interventions. Why are healthcare costs going up? I wonder. Who is going to work intimately with patients to help prevent the top causes of mortality in our culture?

So medicine is facing huge challenges. They move through the landscape of modern healthcare like giant, unseen beasts we can't seem to control. Everyone is looking for a way to stop them. No one knows what to do, how to track the problem, what the problem even is. Is it economic? Do we need better drugs? Where's the enemy? And at the same time here we are, in our meadows, in our gardens, in our clinics, kitchens, production labs. Where we experience deep, blissful connections with plants and place. Where we watch body, mind and spirit heal and grow. In a dream where there is no separation between us and ecology, between spirit and form. In our dream of flowers.

But there's another problem, too. It's very obvious in this country, but it has occurred, at different times and in different ways, all over the world. We have been wounded - wounded with weapons like the Flexner report, which basically outlawed herbal medicine in the US at the beginning of the 20th century. Wounded by witch hunts, wounded by imperialistic culture and colonialism, wounded by a creeping poison that would seek to co-opt and dilute our diverse, anarchical traditions. Wounded by organizations that would seek to outlaw, trademark, or patent our tradition for profit. Wounded by harsh skepticism (which sometimes borders on racism) aimed at ideas such as qi, vital force, viriditas, the healing power of nature - aimed at our dream.

So that's where we closed the last century, and where we begin this new one. In a dream of flowers, but wounded, wary, unsure if our dream can help to solve the challenges that medicine is facing all over the world, unsure if we even want to wake up and help to fix medicine.

I'd like to tell you a story about the Maasai lands. I was drawn to it because it's ostensibly the story of a young warrior, the best endurance runner of his tribe, and those of you who know me know I like to run, I had a great time running in the savannah and exploring. But really, like all good stories, it's about more than that.

When young Maasai men begin puberty, they stop cutting their hair and leave their villages to gather in "warrior camps", where they train in survival, tracking, endurance, fighting and hunting. Usually this training continues until age 30, and during this time warriors help keep everyone in the surrounding areas secure. Sankei was one such warrior. He wasn't the strongest, nor the bravest, and certainly not best with the spear, but there was one thing he could do well: run for a long, long time without getting tired. This served his companions well on hunting expeditions, where he was often the scout.

One night while they were sitting around the fire, Sankei and his companions heard a rumble which began to grow stronger and stronger, until they could feel the ground shaking beneath them. It was like thunder deep underground, under a clear starry sky. After a minute or so, the sound retreated and faded into the distance. Everyone went out to see if they could discover its source, to no avail. The next night the sound returned, and it was stronger than before, to the point where the warriors were a bit scared to go out into the night to investigate. When, on the third night, the sound came so close they feared their camp would be overrun, the warriors decided that they must track down its source during the day, lest it trample them completely when night returned. Looking at each other, they were all reluctant to accept the mission. Finally it was decided that Sankei would set off the next morning, and that if he wasn't back by early afternoon, his companions would come find him.

It took Sankei little time to find the first tracks. They were enormous, bigger than an elephant's, and led off into the dry savannah. He followed them at a good pace, mindful of his water supply which he carried in a hollow calabash gourd secured with a beaded leather strap. Eventually he reached a dry riverbed, and the tracks stopped completely. No trace on either side, nor upstream or down. Sankei looked up at the noon sun straight overhead, and took another sip of water. The supply was getting low. Time for a rest, he thought.

Perhaps it was the heat of the day, or the exhaustion of the run, or the frustration at having lost the tracks of the giant beast, but Sankei didn't stop to think before lifting a large stone to use as a seat under a shady acacia nearby. As soon as he picked it up, a scorpion hidden underneath climbed onto his foot and stung him with his sharp tail, injecting him with venom. If you know scorpions, you know that while they may not always be lethal, their sting can cause serious distress. Sankei knew he was in trouble. His foot was sore already. Soon it would be throbbing in pain. Forget about running - he would be lucky if he could walk using his stick for support.

In a strange way, this made his resolve all the more adamant. He walked back to the tracks and now, somehow, saw that they clearly crossed the river and headed towards distant hills. Hobbling on his wounded foot, he started to follow them. The sun began its journey down from the top of the sky. He took his last drink from the calabash.

Soon, Sankei felt like he was in a new country. Could I have wandered so far to have lost my bearings, he thought to himself. The trees were unfamiliar. The boulders unrecognized. But still the tracks continued, and still he followed them, with a severely swollen foot and a piercing pain spreading up his leg. He was beginning to feel light-headed, and knew he needed water. That was when he saw the silhouette of a giant baobab tree, halfway up a short hill, not too far away. There he knew he could find shelter, food, and water. He could rest there, and his companions would find him. With his last bit of energy, he dragged his bad leg behind him in a quest to reach the baobab.

He was almost under the tree's branches when he heard the sound, except now it was impossibly close, shaking everything around him, appearing out of nowhere with a deafening roar. His only reaction was to spin around, and in so doing he lost his balance, falling backward just as a colossal rhinoceros charged past him, missing him by inches. The rhino kept charging, straight towards the baobab tree, and when he reached it, head down, plunged his horn deep into the trunk. Sankei watched, stunned, as the rhino bellowed and heaved trying to get loose - to no avail. Finally, with all the muscles of his powerful neck and shoulders rippling with strength, the rhino gave a final twist, and the horn splintered and cracked right off his head. Howling in pain he ran off, defeated.

Slowly Sankei crawled to the tree. From where the horn was embedded in the tree trickled a stream of fresh water. He washed his face, and drank deeply. His wound still throbbing, he propped himself up against the trunk, and fell asleep as the sun went down.

Now what you may not know about baobab trees is that they only flower once a year, at night. The sweet flowers are pollinated by bats, then drop from the tree before sunrise. It happened that, as Sankei slept that night, the baobab bloomed, and was covered with a mass of delicate white flowers. And as the night wore on, before the first rays of the sun, Sankei was covered with them too as each one floated gently to the ground.

The first thing to wake him was the sound of his companion's voice. His friends were crowded around him, shaking him, trying to get him up. He opened his eyes and smiled, telling the story of the huge rhinoceros, the thundering beast he'd tracked, how it had been defeated by the baobab tree. He tried to get up to point out the tree to the other warriors, and show them the massive horn - but his foot, red and throbbing, could not hold him.

His friends looked puzzled at his story. As they stepped aside, Sankei saw a different landscape: acacia trees, a dry riverbed, a large stone. This was where he'd been stung by the scorpion! What was going on? Finally one warrior spoke, saying that they'd found him here, passed out, his foot obviously wounded by a venomous creature. "Your story, Sankei," they told him, "must have been a dream".

As they made their way back to warrior camp, Sankei began to believe that, in fact, he had only been dreaming. The story did seem remarkable, both because of his endurance and because of his sheer luck. Still, he had a strong feeling that the rhino or whatever it was wouldn't return. After the ol'oiboni treated his foot, he left the group to go rest. Sitting there, alone, inside a small mud hut, he began to remove his cloaks in preparation for some good, well-deserved sleep. When he took off his last layer, a delicate, white baobab flower fell to the ground at his feet.

My friends, our dream of flowers isn't a dream. We were all at that baobab tree, we all know it can stop the unseen beast in its tracks. We all drank of its life-giving water. That's why we are all here now. Knowing our dream is real is exciting, it's inspiring, but it should be sobering too. It's up to us to move forward, to track down the challenges of modern medicine until they run smack into the deep, rooted plant wisdom we all have tasted. We have to move forward in spite of our wounds, in spite of how comfortable our dream may feel, in spite of the bullying, derision, co-opting and outright murder that may have wounded us. What does moving forward mean? Think about it today. As you talk about new, accessible models of clinical practice. About using our bodies to relate to and understand a new kind of medicine. About building spirit-bridges to heal people and place. About growing medicine, and applying it to new and intractable diseases - or learning how to treat old problems in new ways. About how to do all this with respect for tradition and a powerful sense of honor. Think about it as you walk by the lake and through the forest and meadows. Our ancestors are counting on us. Twenty-first century medicine is counting on us.

In moving forward, one thing that seems clear to me is that there can be no "us" and "them". Maintaining these  distinctions only keeps the wounds open. In truth, we are all just warriors training together: companions on the journey of medicine, be we herbalists, nurses, physicians, or pharmacists. Companions who work in hospitals, in offices, on tilled soil, in wild valleys, over a massage table, in laboratories. It just so happens that we are all struggling with scary, unseen threats right now, and our companions need help. It just so happens that our companions think we're in a some sort of dream when we tell them about the baobab tree, about the medicine we've found in a weedy, flowering, abandoned lot. Friends, I am here to tell you that the medicine is real. I am here to tell you that the dream is real.