8.08.2017

A flora of western Norway

"So quickly, without a moment's warning, does the miraculous swerve and point to us, demanding that we be its willing servant."             - Mary Oliver

Top of the waterfall at Kjeasen, end of the Eidfjord

After a combination of driving and hiking, we made it to an improbable cluster of stone dwellings set on a ledge 1,800 feet above sea level. Still a working farm, we found vegetables, grains, animals - and a range of plants common to the places that have long known humans. In the surrounding forests, where glacial runoff feeds an endless stream of water during the warmer months, we also found bogs with more rare, wonderful plants.

Lupinus perennis, common lupine
Impatiens noli-tangere, touch-me-not

In late July, the waters of the fjord - far below us, a dizzying drop - are fully opaque, a light turquoise color. We had been out on the water in small boats before climbing to our vantage point, and had run our hands through it. It was so cold! I cupped some of it and brought it to my lips, expecting the familiar saltiness of the sea (the fjords are, after all, fingers of the Atlantic ocean reaching over 100 miles inland), but the water tasted soft, and sweet.




Rosa rugosa


Artemisia vulgaris, mugwort


Alchemilla vulgaris, lady's mantle


Valeriana officinalis, valerian

A mess of nettle and cleavers (Urtica dioica and Galium aparine)



The milky turquoise whiteness comes from the glaciers. The fresh water runoff - more than six feet of it in the summer - floats, frigid, over the warm, dense salty sea below. The white comes from anorthosite, a bright mineral deposit that's mostly feldspar, found only here in Scandinavia and in parts of Newfoundland (once the same land mass). The glacier, grinding boulders beneath its huge weight, powders it into a fine flowing dust, and the melt waters wash it away.

Geranium robertianum, herb Robert

Rhodiola rosea, rose-root
Corydalis lutea, fumewort

Alchemilla alpina

But the anorthosite deposits may have a deeper, fantastic origin: long ago, when the Earth was very young, a gigantic rock covered almost entirely in this mineral slammed into her, and the moon (who still glows white with anorthosite) was born. Perhaps the rocks that are here are part of a smudge, a scar left over from that early, seminal encounter.


Pinguicula vulgaris, butterwort (purple flower on the left)

Eriophorum angustifolium, swamp cotton-grass

Melampyrum sylvaticum, cow-wheat

Dactylorhiza maculata, bog orchid




But it's not a scar: it's turquoise water and it's sweet and now I'm standing almost two thousand feet above it, at the edge of this waterfall that's pushing moondust past my feet. And it's then I become fully aware of the plants around me. They are suffused with an inner light, like a glow that makes them seem to stand much taller than the eye reports.

Achillea millefolium, yarrow

Hypericum perforatum, St. John's Wort

Angelica archangelica

Galium boreale, bedstraw
And there is yarrow, and angelica, St. John's, clover, bedstraw, daisies and dead-nettle, thistles and the lanky speedwells, rising tall and bright, aware of me as much as I am of them. A quick nod, the gratitude for the time we took to get to know each other, then they return to bending in the wind, and I begin the climb back down.


2.27.2017

Herbalists as cultural stewards

Below is the transcript of my remarks at the 2017 Florida Herbal Conference. The whole event was an amazing experience - from the warm, humid air, to the live oaks, to the old friends and new, each one a shining star. We talked about connection, passion, and our shared experience as plant people.

On this late winter morning, I find myself in Florida. I set out for my morning run just as the sky begins to lighten, the warm air humid and fragrant, birdsong and the last few stars overhead. As I run, I watch tendrils of mist rise up from the lagoons and circle around the treetops. When I return to camp, I am greeted by live oaks hanging thick with moss, music and song, sacred smoke, and cedar on the prayer mound. I am grateful for this gathering of plant people, doing what we do together, the way it's always been done. I am thankful that the trees give us space to be here - but I also like to think they rejoice to see our joy at being together.



Herbal medicine is different from most of what goes on today. Of course we know this intuitively - but I've been so curious as to what this actually means, how to articulate this difference, because I believe this difference holds a secret that can change lives, change communities, and change culture. I know it because, at least in small part, we herbalists all live it. Fundamentally, it's about awareness of interconnection and the will to act on that awareness. But how to convey this message to others?
One of the first and clearest pieces of evidence for me came from my studies of bioflavonoids, a class of botanical polyphenols found in abundance in berries, but present in almost all medicinal plants. While we've talked for a long time about their potential as antioxidants, recent research is finding that this isn't really what they're up to in our physiology. When we consume blueberries, or hawthorn, we aren't engaging in a war with free radicals. On the contrary: we are tapping in to some of our most basic physiologic processes, we are interfacing with the expression of our genes. A complex and beautiful dance, one that rivals misty sunrises, egrets and fish, live oaks and palm trees, is taking place in our every cell as DNA is methodically turned into proteins that become our physical shape on a moment-to-moment basis. By inserting themselves into this dance, bioflavonoids regulate inflammation, increase cellular resilience, and prevent cancer. They ensure that our genes express a smooth, efficient incarnation. They take care of us (or, rather, without them we get lonely and our physical expression becomes sad and less resilient). When I first put this together, I couldn't help thinking that this was real, tangible evidence that plants love us. Which of course they do.
Another example is how bitter-tasting plants work to ensure normal activity in our processes of self-nourishment. It turns out that without bitter plants, we lose the ability to control our consumption of food. Our guts stop being able to digest well. Our livers become more sluggish, less resilient in the face of challenging chemicals. But after a few weeks of bitters, this all gets better. It's amazing!

We have to recognize that this is a fundamentally different way to approach chronic inflammation, obesity, and digestive complaints. First of all, what we're observing here is a living system at work: plants and humans locked in a co-evolutionary dance that is very difficult to disentangle and understand by looking at its isolated components. We have to watch the living system at work to really get what's going on. Secondly, bioflavonoids don't lower your blood pressure (well, they do - but bear with me). Bioflavonoids set the stage in the heart, and in the endothelial lining of our blood vessels, for a physiologic expression that includes no high blood pressure. But there are many other consequences beyond that: our emotional hearts open and we become more flexible, and fall into love more easily. Our circulation opens too, and we feel more warm and comfortable, less cold and withdrawn. Our cells begin to think that cancer isn't necessary, and they settle in to a more loving rhythm of their own. This resonates across our entire being. Modern science is just beginning to discover this level of medicine - and as of today, there are no approved drugs that work this way. Modern science also just discovered, in the last decade, that we have bitter taste receptors on our heart that help coordinate the smooth shifting of blood flow necessary after a meal. Imagine that! Another mechanism for addressing blood pressure hiding in plain sight.





Of course, as herbalists we also understand that as within, so without: shifts in our internal physiology are coupled with shifts in our external perception, in our homes, gardens, and ecologies. We know this is true because we've learned that we are a living system that is interlocked and nested within larger living systems, and when we affect a part, we affect the whole. Gardening changes our life. Drinking tea changes the way we garden. I am sure everyone here has had an experience like this: when you're brewing tea for someone you love; when you're blending a new tincture formula and a perfect, new flavor synergy emerges; when, deep in winter, you marvel at the bright notes of last summer's lemon balm; when you walk through a grove so familiar it is suffused with a sacred vitality that nourishes and calls you; when you learn the name of a new plant, and a flood of memory and recognition fills your heart. I remember once, on a wild-harvesting walk, I had trapsed over hills, across a bog, and was following the small stream that drained the wetland down into the valley floor. A hemlock tree had fallen across the stream, and I stepped over it to find a bank of reishi mushroom growing out of the opposite side. The mushrooms looked beautiful, I was so happy! I started to pull out my knife, but you know, as herbalists we're trained to take a moment and speak to plant and mycelium, to connect before we harvest. So I stopped, crouched down to get at eye level with the glossy red shelf mushrooms, and just said hello. It felt good. Just a gentle smile, like when someone you love comes home from a weekend trip and you're reconnecting. You feel it in your heart. At that moment, as I felt this flutter in my chest, I had a thought - "turn around!". It was puzzling: was I supposed to go home without these mushrooms? Had I done something wrong? It didn't feel that way, it felt good, like when you're about to give someone a present. I had the thought again - "just turn around!". So, without really thinking about it rationally, I slowly got up and just turned around to face downstream. There, not more than twenty feet away, was a young white-tailed doe that had slowly snuck up on me while I was crouched talking to the reishi. She looked at me for a period of time - I'm not sure how long - and just walked away. Now my heart was really full! Even as I write this, it's filling again. I turned back to the reishi, harvested five beautiful fans, and made my wy back home. Now, every time I suggest reishi to a client in clinic, that moment in the forest comes right back. It's part of the medicine for me. I'm grateful I listened and tapped into that life-moment.

What is it that we're tapping into during these experiences? It's something that all humans instinctively know is possible (I believe we all long for it), and hopefully have experienced at least once. One story that sticks with me was told by Daniel Sarewitz, who is a scientist and researcher focused on public policy, particularly around climate change. He's a professed atheist, straight-ahead science guy, but at the same time is struggling with how to connect with people who, possibly driven by religious belief, reject the scientific interpretation of current events. I so appreciate his compassion in this regard. So he published this beautiful opinion piece in the journal Nature, back in 2012, after he had returned from a visit to the Angkor Wat temples in the jungle of Cambodia. These temples, hidden for centuries under vegetation, reveal an architecture that reflects mathematical patterns resonant across all levels of reality. The buildings are designed to elicit transcendent experiences in those who visit, experiences of fullness and connection, where the boundaries of self and non-self begin to disappear (much like what happened to me with the reishi and the doe). When he visited, that's exactly what happened. It may have been the first time for him, but even if not, it was powerful enough that it led him to write this beautiful article about the temples, the jungle, and the value of art as a way to convey transcendent mystical, emotional experiences in a way science cannot. Perhaps we need both in our culture, he thought. Perhaps these transcendent experiences are an important part of what it means to be human, how we find meaning and truth in our lives, how we are nourished - and if scientists could find a way to speak to this part of our shared humanity, they might be able to connect with those who retreat into religion when science seems inaccessible, who deny humanity's role in climate change, who harden their hearts to the beautiful work he and his colleagues are doing. "Angkor," he concluded, "demonstrates how to achieve an authentic, personal encounter with the unknown." I know we could all use a little more of that! Whatever it is, it holds some serious meaning and power.



But as I came to the end of his article, I saw the comments section. The general tone there was one of anger, with some going as far as to say his article was dangerous and misguided. Others told him he should resign his position as he clearly wasn't a scientist. There were few, if any, comments of support - and these were quickly torn into by the collective, and any chance of conversation immediately squelched. The administrators have since taken down the comments section for that article, and I don't blame them, because is was mean, divisive, and frankly quite rude. What a roller-coaster ride from Dr. Sarewitz's thoughtful, inclusive piece to the reactive, divisive responses.
You probably have seen similar examples of this pattern at work in our culture. We use adjectives like "divided", "polarized", "factional" when talking about our society. We attempt to isolate and separate entire areas of the world because of ideological differences, ethnic differences, language differences. Even our conversations on medicine and healing are filled with words like "inhuman", "quack", and other even less savory monikers. It truly is a pervasive cultural pattern, and it isn't too difficult to see that it is based in large part on fear: fear of the unknown, fear that others will steal from us, hurt us, tear us down, fear that a hidden longing for mystery will never be fulfilled. Our culture wears this fear like a dark cloak, wrapping it tight around us during these modern times when strong winds blow all around us, trying to insulate ourselves from that which would harm us or those we love. This may give us the illusion of security, but as any herbalist (or student of biology) knows, a living system that isolates itself from its surroundings accelerates its path to death. The tighter you squeeze your fist, the more life slips through your fingers. This dark cloak our culture is wearing - it's something herbalists are trained to recognize. Sometimes I think it's my job to dance with darkenss, to find the cloak when it's just coming off the rack and help a person understand that they should put it away, or if it's already been put on, try to loosen it and see if it might fall off.

Disease is a dark cloak - it's often a learned pattern, or a pattern the physiology has been forced into, and part of my job is to know the pattern of that darkness, learn to recognize it, and find a way to untangle it so that a new pattern can take its place. This doesn't mean a return to the same pattern that existed before - rather, it just means trying to establish a new, life-affirming pattern. To do this, you have to seek darkness out and spend a little time with it so you can recognize what it looks like, especially when it's still just getting started, so that you can learn to talk to it in a way it can understand. Of course knowing the light is important too - but this is usually easier and almost always more fun. There are so many examples: unexpressed resentments. Insulin resistance. Depression. Kidney failure. One case I will always remember was of a woman who, in her early 60s, had received a diagnosis of ovarian cancer. The malignancy had spread to her pelvic bones and liver, and while she did a few rounds of chemotherapy, no one expected this to resolve the cancer. This darkness was well-established, and cancer is an awful beast that often comes for no reason at all, invading life and stealing its essence in a way that can be impossible to resist. But in this case, I was more concerned with another pattern I saw emerging in my client: the combination of pelvic pain and despair at her prognosis had made her reach for another cloak to wear, and she was starting to wrap it tight around herself. She had retreated from her husband, closing off communication with him. She had begun to eat less - and when she did, it was often just the same combination of rice and chicken. Normally engaged with friends and active in the community, she stopped going out to events and would just stay home. She took narcotics even though they made it impossible for her to converse effectively. It was at this point we started working together.
It is not hard to understand why, afraid of what her life journey held, she chose to retreat behind the warmth of this new, dark cloak. Some might call it depression. Call it what you want - but it is not a life-affirming pattern. So we worked together using a lot of plants and mushrooms. We were able to reduce and then eliminate her use of narcotics using Cannabis and Corydalis. We established a nervine tea ritual, where linden, green tea, and licorice became welcome companions. She tried small doses of digestive bitters. Slowly at first, she began to walk outside again and after a few months, despite the fact that her cancer hadn't slowed down at all, her eyes began to brighten again and her appetite led her back to a diversity of tasty foods. One afternoon, as we were sharing tea in her sunroom, she asked me what I thought the afterlife held. I said I wasn't sure, but that maybe right before we die, time dilates like it does when we dream, or when we lose consciousness. Maybe, I said, what seems like a second to observers is experienced as many lifetimes. All I can hope, I concluded, is that I enter that final moment feeling happy and loved. She smiled.
Over the course of the next few weeks, she invited her family and close friends into her sunroom to share tea. To each she asked the same question: what did they think the afterlife held? I watched her, over her last few weeks of life, become clear, calm, and loving. To each of her visitors, some of whom were in obvious distress, she extended a warm hand and words of comfort. It was one of the most incredible lessons I've learned from any of my clients (always my best teachers), and when her time came to pass away, I am sure she moved on feeling happy and loved. I am still so grateful she shed that dark cloak when she did.

So how do we do this? How can we help re-frame destructive patterns in ourselves, our families, our communities, and our culture? Well, by following the lessons that we learn as herbalists. I think the basic principles at work are relatively simple: first, we have to start from a place that respects the living system. Without this foundation, without the belief that life itself has the capacity to affirm and renew itself all on its own, nothing can follow. Second, most living systems thrive when you increase the diversity of inputs: if you provide more options, increase the amount of connections, the system usually becomes more resilient (and, of course, the opposite is true). We can try to open the cloak, just a little bit. Finally, when attempting to intervene to adjust a dark pattern, we can choose to focus on supporting, rather than controlling, the living system. This of course follows naturally if we start from a place of respect. Those are three principles I try to apply when working with clients: start from a place of respect and trust. Increase biodiversity: expose them to a wide range of botanical chemistry. And rather than picking strong, pushy remedies, try to emphasize the ones that support our vital processes: herbs that nourish digestion, soothe and rebuild the nerves, balance the expression of our genes and immune systems. This is tonic herbalism, and it's unique to our art. It is also, in most cases, incredibly safe. Anyone can start. And if you do, you're building resilience and vitality person by person, family by family, community by community.



One of my favorite stories that illustrates these principles (in a sort of magical way) is the story of Airmid, the Irish fairy-goddess who brought the use of plant medicine to the world. Way back when the fairy folk, the Tuatha de Daanan, landed on the shores of Ireland, they encountered a fierce warrior race known as the Fir Bolg who wanted nothing to do with the new arrivals. The Tuatha de Daanan, led by Brighid the fairy queen, decided to engage in battle. Nuada, Brighid's consort and king, led the fray. Dian Cecht was chief healer, and he set up a magical well that would heal any wound, with the one exception that, should a body part be severed, the well could not reattach it. This meant that one of the only ways to kill the Tuatha de Daanan was to sever their heads completely.
One day, Nuada met the leader of the Fir Bolg on the field of battle. Back and forth they went, until Nuada made a misstep and the Fir Bolg leader was able to cut his hand clean off. Nuada ran back to Brighid, who told him that he could no longer be king because he was not whole - a piece of him was missing, and he could not lead the people. Desperate, the former king ran to Dian Cecht who told him that, while he couldn't restore his severed hand, he could craft him a new one out of silver that would work just as well. Nuada's new hand was strong and he was able to weild his sword again - but this was not good enough for Brighid, who reminded him that he was still not whole.
Dian Cecht's son Miach and daughter Airmid had been observing all this from the sidelines. Cautiously, Miach approached Nuada and asked if he could try to restore his hand. Granted permission, he and his sister returned to the battlefield, found Nuada's hand, and together, using deep, now-forgotten magic, they restored Nuada's true hand. This satisfied Brighid, and the fairy folk returned to battle.
Dian Cecht, however, was not pleased. Upstaged by his son, he challenged him to show his true healing skill. Three times he swung his sword at Miach's head, and the first two times, though the cuts were deep, they didn't go clean through and Miach was able to heal himself. But the third time, driven by anger, Dian Cecht completely severed his son's head. It was too late when he realized what he'd done, and he ran off in grief. But Airmid remained, and sat with her brother's body as light rains washed over it. After a few days, plants began to emerge from around Miach's body. Airmid sang to them, and they sang back, telling her their secret healing powers. And even though Dian Cecht returned and scattered all of Airmid's healing herbs, she remembered them and has shared the knowledge with us through a lineage of Irish wise women that continues to this day.

Airmid's deep magic isn't actually lost. While we can't reattach hands, we can provide medicine that restores people, communities and culture back to their whole state - connected to all the parts of life and nature that actually make us human. Of course our culture needs this right now! The reason we treat each other with such anger, and attempt to isolate and divide, is because we feel afraid, alone, disconnected. But look at what happens when herbalists gather to sing, speak to plants, and dance around the fire together! We learn to be inclusive, to stand strong but accept different perspectives, to provide a safe place where everyone can grow, together. This is our culture because the plants shape our culture. It is the plants' culture, too.
Airmid's story goes futher, however. It helps clarify what made my experience with reishi so powerful, what illuminated the last weeks of life for my client. And it puts a point on how we can discriminate, in our daily activity, between what is life-affirming and what is maybe less so. For you see, there is a difference between a mechanical silver hand and one of flesh and blood. Brighid, the mother of life, could tell the difference. But we all have the same gift.
Vandana Shiva, the pre-eminent physicist, activist, and ecological steward, describes this as the difference between the mechanistic mind and the biological mind. The mechanistic mind legislates from above: an intellectual understanding creates a framework into which it attempts to fit reality. The biological mind builds up from the grass roots: evolution, trial and error, and interconnection create a resilient system that emerges from its components, valuing and nourishing each one. The mechanistic mind creates blueprints, while the biological mind self-assembles. If something doesn't fit in to the mechanistic models, it is ignored or pushed aside. In a biological model, nothing can be ignored because it was integral to the development of the model itself. The mechanistic mind sees natural resources as commodities. The biological mind sees natural resources as the beginning and end of all life, the source to which we all return. The mechanistic mind, in pursuit of commodity, is able to spill millions of gallons of oil into the gulf of Mexico and brush the problem aside as a temporary setback, the cost of doing business. And crucially, the mechanistic mind tells us all that we are only as good as our productivity. No wonder we don't feel whole anymore, no wonder we feel afraid. But our response shouldn't be to cloak ourselves with that fear - that only serves to isolate us further, deepening our alienation. It is a dark pattern.

I am in no way saying that systems created by the mechanistic mind are somehow inherently bad - they are not. Look at the information systems we've created, for example. There is incredible potential in these tools. All I am saying is that, especially when we're trying to understand how to heal disease, or heal the rifts in our culture so we can support all beings who live on this planet, it is going to be useful to adopt the biological mind. And it's really an easy exercise: when you're working in clinic, or when you're gardening, or talking to a member of your community, or planning an event, ask yourself: are you using a mechanistic mind or a biological mind? It's not difficult to tell the difference: when we interface with a biological system, we feel it immediately in our hearts. It is full, it is vibrant, it is undeniable. When we interface with a mechanistic system, all the thoughts and emotions associated with that interface just seem a little dull in comparison. I've had plenty of thoughts when out wild-harvesting, or when working in the garden. Sometimes it goes a little bit like this: "well, I know there's not a lot of scullcap here, but I need it for tincture, and it will be ok to harvest it". Or, "well, I'm not sure what's around that bend, but I need to get back to my car if I'm going to be home in time for this appointment". This is our mechanistic mind at work, and it's great, it's practical - but these thoughts originate inside us, and their flavor, their color, is much less vibrant. Compare that to the simple "turn around" I experienced. This was the biological mind speaking, it was me and the reishi and the doe and our shared consciousness resonating at that moment in time. It was a full, vibrant, delicious thought that I felt in my heart as much as in my head. And it rippled into my harvest, my medicine-making, my dispensing. Ground-up, not top-down. When the heart perceives it, it is the living system speaking, it is the biological mind. Love is perhaps the best example.

If we seek the input of the biological mind in clinic, we will gravitate more towards nurturing and supporting rather than to strong, powerful herbs. This is not to say we shouldn't use heroic herbs in an appropriate context - it's just to say the input of the biological mind needs to be brought to bear. The same applies to our families and our communities. But we herbalists, we who understand these things, also have a responsibility to bring the biological mind to the halls of power locally, nationally, internationally - because Western culture is showing the signs of disease similar to those you would see in wounded animals, in cancer patients, in depression. As herbalists, our joy and our bright, shining light grows from the heart experiences that come from engaging with living, biological systems - our kitchens, our gardens, our forests and our fields. It is precisely the support that Western culture needs today.
I am here to say that it's not enough to just rejoice in this. We need to shine this light into the larger community. It will take effort, but it is certainly not impossible! Just as the old alchemists wrapped their remedies in layers of extraction, digestion, maceration and language that invoked concepts from the Christian trinity, we today need to wrap our joy and light in layers that reflect society's preference for the mechanistic mind. We need to make an effort to speak the language of science and to understand the laws that govern our land, not to become compliant and appease, but to inject ourselves, virally, like green tendrils, into the concrete wall built up by five centuries of unfettered mechanistic dominance. We can enter the cities, the courtrooms, the government and show a clear and different way of doing business, one that values and respects life, increases biodiversity wherever and whenever possible, and relentlessly strives to support rather than to control. It is the next turn of human evolution, and we need the plants beside us as we move forward. Herbalists are the perfect agents of cultural renewal, because we deeply understand these principles, and we are united in our common love for plants and the resonant experiences of renewal they provide.



When I travel to East Africa, I always make it a point to connect with my friend Sangau. He is a local traditional Maasai healer and herbalist, and taught me a lot of what I know about the plants there. We speak (sort of) through an interpreter, share tea, talk about the hospital where I work. He listens because I speak the language of plants, and I am an American. Many people say Sangau is a witch doctor. The Christian community says that he speaks with Satan. But when I ask him about this, he tells me that he sits under trees in the forest and speaks to their spirits. This misunderstanding is the root of the schism between the mechanistic mind and the biological mind, and it won't be easy to heal. But where I work in East Africa, we've trained hospital staff to use usnea and honey for wound care, and simple ginger compresses for swelling and pain. They listen to us, because we speak the language of science and come from America - we speak the language of the mechanistic mind. Hospital staff start asking more questions about other plants, and what they might be used for. So we create a decent guide to over 40 local medicinal species, along with all their names (in 3 languages) and uses. Slowly, folks start to say that maybe what Sangau is recommending is not so bad. And in the end, it's all to the patients' benefit.

I will leave you with one last story, it is a very old fable, probably one you've heard before, but it's a good one. The sun and the wind, always having to share the sky, would get into a lot of arguments about who was the strongest. The sun would say, I light up the whole sky. The wind would reply, I wear down mountains and reshape the land. The sun would reply, I raise water up into the air and create clouds. The wind would retort, I whip the waters and clouds into powerful storms - no one can stand in my path. One day, tired of arguing, the sun and the wind decided to test their skills. "Do you see that traveler on the road down there?" the wind asked the sun. "Yes, I see him," the sun replied. It was a cool day, and the traveler was wearing a heavy, dark cloak. "Will you agree," the wind asked, self-assuredly, "that whoever can remove his cloak is the strongest?" The sun agreed. The wind went first, blowing gently, then harder and harder until the traveler was barely able to walk forward, the gale was so strong. But every time the wind blew harder, the traveler just pulled his coat tighter and tighter around his body. Finally, exhausted, the wind turned to the sun. "Your turn," he gasped. Then the sun shone his light, beaming down on the traveler, filling the air with warmth. After a few minutes, the traveler, amazed at the beautiful weather, took off his cloak.

5.19.2016

Integrated technologies: building capacity and resilience

A case study at the Wasso district hospital, rural Tanzania

This year the work at a rural hospital on the edge of the Serengeti was with a team comprised of two other herbalists, my wife Anne (gynecologist and surgeon) and two medical students from the University of Vermont. Herbalists Molly Hagan, Annie SewDev and myself worked on the inpatient wards, gathering daily case details and tracking patients’ improvement; we cared for wounds and trauma in the minor surgical theater (using only honey and botanical treatments, along with occasional iodine, lidocaine, and lots of gauze, tape and bandages); we harvested and processed many plants, notably Usnea, Lippia, Lantana, Eucalyptus, Zingiber, Opuntia, Ocimum, Galium, Acacia and Aloe; and collected samples of many more with the help of knowledgeable local folks. After a few days there, people started to seek us out where we were processing medicine: the guesthouse common space, where we had access to a blender, hotpot, and storage space for herbs. They were curious to see what the herbalists were doing, to share their thoughts on plant medicine, and to seek out our help for a range of complaints.

Wild-harvesting adventures: Annie climbing through a tangle of vines while Molly watches

One day my friend Joseph came over. He is a cheery man, always ready to engage in the long greeting ritual and exchange of news. We find a way to understand each other by making the best of our limited language skills – I get to practice my Swahili, he pulls out a little English. The answer to the standard “Habari?” (what news?) is always “nzuri” (good), and we began this way. But today, Joseph started to complain that he hadn’t been sleeping very well for some time: he was restless, waking up a lot, and not feeling refreshed. He works physically all day long, helping to tend the hospital grounds, and his workload had been particularly heavy as of late. I noticed an unexpected weakness in his pulse, and so we decided to walk him over to the stand of wild ashwagandha (Withania, called ol’asaiyet by the Maasai). He dug up a huge, gnarled, very fragrant root and we instructed him to peel it and simmer some of the root bark in milk every evening (hot boiled milk, rich and super-creamy, is somewhat of a staple – and perfect for ashwagandha extraction).

Withania somnifera root

 A few days later, I ran in to Joseph as he was cutting grass. He was using a sort of long, hooked metal blade – not quite a scythe, more of a blunt machete with a short 90 degree bend at the bottom. He would swing at the grass with this tool, chopping and flinging off big clumps of the tall weeds that grew between the hospital ward buildings and lawns. No wonder he was wiped out! This is tough work – but all the grass is cut this way, week after week, all around the hospital and the access road. Nevertheless, when I asked how he was doing, he said his sleep was much improved, he loved the ashwagandha, and felt like he had plenty of energy for his work. He smiled, gave me the thumbs up, and kept swinging at the grass.

I was surprised, the next morning, to hear the loud, choppy sound of a small engine as I walked to our morning meeting. There was Joseph, somewhat awkwardly pushing a gas-powered lawnmower through the tall grass left unfinished from the day before. We smiled broadly at each other, and I thought to myself how this machine was really going to make my friend’s work easier. Granted, it was a little surreal to see the lawns, where the Maasai women sit every morning in the sun airing their red, black, and purple checkered cloaks, mowed in visible lines more characteristic of an American suburb. But still, I thought, maybe this is progress.

Two days later, Joseph was back at it with the machete. I gave him a puzzled look, made a lawnmower-pushing motion with my arms, and asked “wapi?” (where?). He looked at me with a half-grin and said, simply, “kaput” (a pretty universal word for “broken”). I later learned that the belt had snapped, and that they had tried to repair it, to no avail. Perhaps a replacement could be found in Arusha, over 9 hours away, but one would have to coordinate purchase and delivery somehow. This was hard enough for medical supplies; I was skeptical that a new, functional belt would be arriving anytime soon. And so the lawnmower sat in the garage, like a fish out of water, its potential untapped because it was disconnected from the supply chain it needed for survival.

It is important to contextualize any technology. Our tools, like everything else, do not exist outside of their environments, of the cultural and environmental niches they occupy. One cannot simply say “a lawnmower is great at cutting grass, let’s get one” and use it regardless of where the grass is growing. Joseph’s circumstances and environment are as important to the function of the lawnmower as is the gasoline it uses. Technology’s impacts and effectiveness cannot be measured in absolute terms: like anything else, the relationship and connections that technology has in any given situation have as much to do with how well it will work as the nuts and bolts of the technology itself. Sometimes tech is so powerful that it changes its environment: witness the widespread adoption of cell phones around the globe. Commerce has changed as a result. Maasai bomas (dwelling communities) install small solar panels for the sole purpose of charging their phones, so they can send funds back and forth and connect with friends and family. Still, the way the cell phone works in rural Tanzania is very different than how it works in America: even if a technology is powerful enough to alter its new environment, its expression is still bound to its context. Technology must be effectively integrated into its cultural and environmental context to be successful, sustainable, and non-damaging.

Nowhere else is this more evident than in global development work. If our goal is to increase capacity, resilience, and sustainability in the developing world (or anywhere, really), we must consider context when discussing the application of technology. Consider the example of water: in East Africa, year-round water supply is essential. In the 1980s, when the country was still stable, my father (a geologist and soil engineer) worked in Somalia digging wells in desert areas, so local communities could have water security. I remember him (and my mother) being gone during all of Summer vacation. When he returned, he told stories of the fancy wells the Italian government had dug, only to have them break and be left, abandoned, after a few months’ use. He worked with local engineers to develop a pump system that relied on donkeys walking in circles, strapped to a central, rotating piston. Primitive? Perhaps. But much more effective and resilient in the context of East Africa. Here we had a merging of the modern and the ancient: sophisticated geological surveys found the water, drilling rigs accessed it, and donkeys kept the water flowing. This is integrated technology.

While working on wound care and support at the Wasso district hospital, the team of herbalists was confronted with this reality every day. There are old, broken pieces of Western medical tech littered throughout the hospital: rusted, broken leg braces; dysfunctional surgical lights with no lightbulbs; ventilator bags with tape over the cracking plastic. So when there is an issue, we must find a solution not by bringing our technology (be it essential oils and tinctures, or laparoscopic surgery equipment), but by developing integrated technologies. Perhaps the best example of this was the improvised traction splint we made for a woman whose femur had been completely broken when she was hit by a car. Hospital staff had applied a makeshift cast on the leg, but it didn’t even come up to the femur fracture. And now, because there are no orthopedic surgeons in Wasso, they were suggesting she get into a Land Rover and travel 9 hours to Arusha, the nearest facility that could properly set her bone. Now, the femur is the longest bone in the human body. It keeps the powerful quadriceps muscles stretched out, ready to help us walk, run and jump. But when it’s broken, the quads contract back, pulling the jagged edges of the fracture until they overlap and dig into muscle tissue, ripping vessels. Patients can lose huge amounts of blood inside their leg, risking compartment syndrome and even death. I’ve been on the road to Arusha – “bumpy” is a gross understatement. What this woman needed was traction: something to pull her ankle and pelvis apart with enough strength to counterbalance the quad’s contraction, so the two pieces of the femur would remain in line and separated, preventing them from destroying tissue.

When we made this suggestion, staff laughed. “You cannot hold traction for the entire ride to Arusha,” they exclaimed. And they were right: the force needed to pull back against the quad requires two people, one at the ankle and the other at the armpits, pulling with all their might. What she needed was a traction splint: something to hold the tension and stabilize the femur at the same time. Of course, no such device exists at Wasso hospital. So, remembering my wilderness first responder training, we decided to make one. Molly, her Maasai sime (long machete) in hand, went out to hack off yellow-bark acacia limbs: one for the outside of the leg, up past the pelvis, and a shorter piece for the inside of the leg. She also fashioned a cross-member for the bottom of the splint and a smaller, “twisting stick” to increase and secure traction. I started tearing up a bedsheet into long strips to lash the splint together. Annie stayed with the patient and helped explain our plan to the hospital staff, who were now gathering around, very interested.

Getting ready to apply traction. Molly at the shoulders, Annie and I get the splint ready.

We lashed the outer and inner sticks to the cross-member (which was about 6 inches under the patient’s heel), padded the tip of the inner stick so it could rest comfortably in the crotch, and loosely tied a strip of bedsheet around her ankle. This strip was also secured to the cross-member, and the “twisting stick” slid between the loop just under the heel. Then, giving it all we had, Molly and I applied traction, pulling the femur bone apart so that the heel almost touched the cross-member while Annie turned the twisting stick to make sure there was no slack between the heel and the cross-member of the splint. Annie finished by tying the two sticks together, under the knee, above and below the fracture, and then placing a final belt around the outer stick and across the woman’s pelvis. Molly and I released traction – and the leg didn’t move. Success.

Splint ready for traction
We remarked to ourselves that we would probably never make another improvised traction splint. But never say never: just two days later, a seven-year-old boy came in to minor theater, having been trampled by an elephant. He was moving in and out of consciousness, and showed abrasions on his head, chest, and arms. But his pupils reacted, and when he was conscious, he could respond to commands well. So what concerned us most was the right leg, which was floppy and bleeding at mid-thigh from a compound femur fracture. We moved quickly, repeating our work (but this time on a smaller scale). After getting everything ready, we applied traction. Dr. Anne remarked that she heard a slight “pop” as the leg extended and the femur moved back into position. We secured the splint, and the boy was moved to the intensive care ward to await transfer to Arusha.




After applying traction and securing: heel is closer to cross-member
In America, you can buy fancy traction splints. They are amazing, quick and super-effective. Our work was probably not as effective, but it did the job (especially considering the long car ride ahead for both patients). And it was simple enough to replicate: hospital staff can make similar splints now, and improve outcomes for those who come through Wasso. Similarly, hospital staff now uses honey and herbal treatment for wound care, and after extensive research this time around, we look forward to continuing to enhance the hospital’s portfolio of low-cost, effective herbal interventions that come from the local environment. These are sustainable, improve the hospital’s capacity to help others, and build independent capacity rather than dependence on Western intervention. These are integrated technologies.

Yet another example of success building hospital capacity with integrated technology came from our partners, Dr. Anne Dougherty and medical students Sabrina Bedell and Melanie Ma. They followed pregnant women in the hospital, screened for gynecologic complaints, and performed surgery when necessary (using old-school, open laparotomy). They traveled to outreach clinic to perform prenatal checks and vaccinate babies against polio and other diseases. Beyond all this (including middle-of-the-night work on complicated deliveries), they worked a whole week of 16+ hour days screening women for breast cancer, HIV, and cervical cancer. In so doing, they also helped establish and cement a cervical cancer screening and treatment program at the hospital where none existed before.

Dr. Anne in outreach clinic, showing a mom her baby using portable ultrasound

Cervical cancer is a huge problem in Tanzania. While in the US every year there are 7.5 cases out of 100,000 women, in Tanzania there are 54. Out of the 7,300 cases diagnosed in Tanzania in 2012, over 4,200 died. It is the leading cause of cancer-related deaths in Tanzania for women aged 15-44.  One of the biggest reasons for the differences between the US and Tanzania is essentially an issue of integrated technology: in the US, frequent screenings and the pap smear have made early detection and treatment easy and effective. An abnormal pap brings a call from your physician, and you can decide on a range of treatment options, from herbal and nutritional strategies to LEEP procedures and beyond (depending on the nature of the problem), and come back for re-testing. But this technology just doesn’t work in East Africa: first of all, you need a pathology lab to analyze pap smears (there is one, but it’s nine hours away in Arusha). Secondly, after getting results, you need to find a way to inform the women, and get them to come back to the hospital (often hours, if not days, away) for treatment. This is difficult. As a result, if women are screened at all, they are often lost to follow-up and worrisome screening results are left untreated – until they return to the hospital with persistent vaginal bleeding and weight loss from advanced, invasive cancer. Our Western technology fails in this case, because the context in East Africa is so vastly different from the context in the US.

The medical team relied on a simple, yet surprisingly effective combination of screening and treatment to circumvent these issues. First, the cervix is swabbed with a solution of simple white vinegar (available everywhere). After one minute, the cervix is examined. Any white lesions indicate a potential issue with cervical cells, most likely from dysplasia or early cancerous changes. If such lesions are found, staff performs cryotherapy: using compressed carbon dioxide gas, a metal tip is super-cooled and used to freeze off the top layer of cervical cells. The tip is relatively inexpensive, and can be re-used forever; the compressed CO2 can be flown in from Arusha and allows for between 25 and 30 cryotherapy treatments. This see-and-treat model completely bypasses the followup problem. And in the end, it saves lives (to read more, see this WHO report). Dr. Anne and her team screened over 300 women, treated almost 30 for pre-cancerous lesions, identified 6 others who needed more advanced treatment in Arusha, and discovered one case of invasive cancer. This last case was sad to hear about – but now, this screening program is established in Wasso, and such cases will hopefully be prevented in the future. This see-and-treat model may not be the gold standard in the US, but it is much more effective in East Africa. It builds sustainable capacity. It is a well-integrated technology.

In all these examples, we see a few common threads. There is an awareness of the context in which the technologies are being applied: what’s the nature of the problem? Where does it live? What are the social, cultural, and environmental factors at play? There is also a focus on empowering the system, rather than building dependence. When Western resources are used, they are often just catalytic – the technology is meant to stand on its own. Finally, the solutions are built with resilience in mind: in the parlance of systems theory, all the examples described increase the system’s capacity for “disturbance rejection”. Integrated technologies are like herbal adaptogens: nutritive, gentle, familiar ways to enhance adaptability and build sustainable energy.

I would argue that herbal medicine is a quintessential example of an integrated technology. It shows awareness of context, strives for empowerment rather than dependence, and increases resiliency (not only of the person taking the herbs, but also of the community that embraces herbal medicine). And to push a little further, let me suggest that context, in the case of medicine, means more than culture and environment: it means the ecosystem of diseases with which we struggle. Modern tech medicine sometimes loses awareness of this facet of context: cardiovascular disease, for example, is as different from acute infection as the Western woman is from the Maasai bibi. How can we develop truly integrated technologies for handling the chronic diseases of our culture? Part of the answer lies in letting go of labels like “advanced” and “primitive”. Let us think more about effectiveness, rather than pursuing new technology for its own sake. We may find that the plants that have evolved side-by-side with us for hundreds of thousands of years can help create a more sustainable, effective, and resilient system for medical care. In so many ways, and on so many levels, consuming plants is an exquisitely fine-tuned integrated technology. I am grateful to the people of Wasso, and the Wasso phytotherapy project, for reminding me of this with such simple clarity.

Our team for 2016 (L>R): Guido, Molly, Anne, Uli, Annie, Melanie, Sabrina and Niclous Rotiken, cultural liaison

12.23.2015

FDA cGMP compliance project update

This week saw an excellent development in the quest to provide open-source resources to the herbal community in our efforts to achieve compliance with FDA cGMP regulations: AHPA (the American Herbal Products Association) has posted hundreds of document templates, including manufacturing record templates, testing method templates and specifications, policy templates for almost anything you could imagine (and more) that might be involved in making an herbal dietary supplement. This is a great resource (thank you Ellen Kahmi, http://www.naturalnurse.com for bringing this to my attention the day it was released). Find it here:

http://ahpa.org/Resources/cGMPSOPTemplates.aspx

As you can see, the list of available documents is quite extensive. It is available for members of AHPA (base-level membership for a small-scale manufacturer is $1,000 per year. AHPA is a fantastic organization. $1,000 is a lot of money).

Another development is that I will no longer be posting updates and documents at this site, but rather at a new dedicated site where you can find all previous information and also future updates. Find it here:

https://sites.google.com/site/gmpopensource/home

Hopefully this will be a more practical way for us to communicate about this. Over the next few weeks, I will be reaching out to folks who have expressed interest in helping, to make them contributors to the site and allow them to edit and add material as they see fit. There are a few items I might suggest putting on our agenda and to-do list for this project:
- live online forum discussion to help us meet, define the work, and agree on goals
- working through explaining the pieces of cGMP compliance (more documents and voice-overs of why they are structured the way they are, and how to customize them for your own business)
- the problem of testing, and its cost: even a testing program that takes random annual samples (which requires some baseline level of confidence in raw materials and in-house manufacturing, and data to support it) still can run hundreds or thousands of dollars, depending on how many products you make
- the lingering uncertainty around defining identity and strength specifications, and testing for those specs, for a multi-botanical herbal dietary supplement.

I'm taking next week off. Stay tuned at https://sites.google.com/site/gmpopensource/home for further updates in the new year.

12.17.2015

FDA cGMP project - raw material identity specifications and testing


**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.

When manufacturing any dietary supplement (herbal or otherwise), the guidelines on current good manufacturing practices (cGMPs) require that specifications be established for everything that goes into what you're making. This essentially means that you have to define a few things and set a standard that you find acceptable, and then test the relevant material and record the results of that test. The regulations under 21CFR111 tell us what specifications we need - sort of. Let's take a look.

A great outline of all of 21CFR111 is here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=111
and, for the details on specifications, see section 111.70:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=111.70

The key pieces are identity (what is it?), purity (for a raw herb, is it all the herb in question? Is there dirt and/or foreign non-herbal matter?), strength and composition (for a raw herb, this is full-strength 100% raw herb), and contamination.
The identity, purity, strength and composition for whole or cut-and-sifted (NOT powders, which require a microscope) can be assessed through organoleptic testing (using sight, smell, feel, and taste) if conducted by a qualified herbalist. The contamination, unfortunately, requires help. This is even if you get a certificate from your vendor telling you that there is an acceptably low level of contamination, if any. This is one of the big pieces that we still have to solve as herbalists: the cost for contamination testing of each batch of raw material can get steep. Is there a way to consolidate results on lots of herbs so all can benefit and/or spread the costs?

Identity specifications are established in an herb monograph, and there should also be a voucher sample of the herb in question, as well as a sample of the cut-and-sifted material if that's how you purchase it. Additionally, details should be included about potential adulterants, if an herb is known to be adulterated (goldenseal and yellowroot for instance). Rejection criteria - meaning, if you find this you mail the herb back to sender - should also be included.
AHPA has begun to collect excellent information on botanical identity, including microscopic identity. You should visit:
http://www.botanicalauthentication.org/index.php/Main_Page
Purity specifications can include details on adulterants, but also a way to assess (and reject if necessary) how much filth and foreign matter is present in a sample.
Contamination specifications include:
- microbiological testing. What's an acceptable total bacteria count? What about yeast and mold? Note that in many cases, bacteria, yeast and mold are a normal part of, say, a fresh berry. Without them there would be no wine. But sometimes there's too much. And certain specific bacteria, like E. coli and salmonella, should never be present.
- heavy metal testing. How much arsenic, mercury, lead, cadmium are in the sample? It's tricky to determine what an acceptable level could be for a raw herb. Additionally, there is good evidence that tincturing actually removes heavy metals from the final product (because most, if there are any, remain in the discarded marc).
- pesticide testing. Our argument so far has been that using certified organic herbs shifts the burden of responsibility to USDA, and that we are not required to test for pesticides. We do use only certified organic herbs. This may or may not be enough - the jury is still out. I'd be curious to hear of other's experience here, especially if there has been pushback from FDA even for those who use certified organic raw material.

AHPA has put out great guidance documents to help define these specifications. For an overview, see:
http://www.ahpa.org/Portals/0/2009/10_0120_Guidance_Policies.pdf
And, for much more details on heavy metals specifically:
http://www.naturalhealthresearch.org/wp-content/uploads/2013/02/09_1214_AHPA_Heavy-Metals-White-Paper-Revised.pdf

The above is good, but the heavy metals specifications refer to daily total maximum intakes, not how much can be in an herb you're planning to use. This is a complex question that has to do with the weigh-to-volume ratio of your tincture(s), the dose, and how much heavy metal is left in the tincture from the original raw herbs. Working backwards from the daily limits, you can make a case for how much should be present in a raw herb. Here is an example of how to make such a case, and includes the final heavy metal limits:
Heavy metals contamination rationale.

Again, the problem isn't necessarily defining the specification, but testing for it. These tests can get quite expensive. There are ways to reduce the amount of testing you do, especially once you have some data to go on - but getting there can be an overwhelming financial burden. We need to find a way to collaborate on these types of tests - to spread the financial burden and somehow, effectively, share results if we want to support small-scale manufacturers.

What follow are a couple of examples: the first is a raw material monograph (the specifications) for Echinacea purpurea root. The second is a specification sheet, where the results of testing are recorded to ensure they comply with the specifications. A voice walk-through is below as well.

Full document .pdf file




Full document .pdf file



One note: these are "controlled" documents. They must be signed, dated and approved by whomever is in charge of quality control; revision numbers must be advanced if any changes are made; and they should be "secure" (i.e. not easily tampered with or alterable). Filled-out spec sheets must be in hard copy, filled out in ink, and stored. Until this documentation exists, and is signed off at the bottom, you cannot use the herbs for manufacturing and they should be stored in a designated "quarantine" area (blocked off by fencing, walls/doors, or even tape on the floor to distinguish the area from one of active use).

Finally, one cannot necessarily rely on organoleptic testing unless the person conducting the test(s) is qualified to do so. While you don't have to convince me that you know what dry, cut-and-sifted Echinacea purpurea root looks, smells, and tastes like, you will have to convince FDA. Plus, herbalist qualification does raise some interesting questions: could you tell the difference between E. purpurea and E. angustifolia? Perhaps. What about Actaea racemosa and Actaea pachypoda dry, cut-and-sifted rhizome? It's not always so straightforward. Again, AHPA is doing a great job putting together a lot of the specifications and images necessary for herbalists to conduct these tests (see, for instance, the detailed Actaea racemosa monograph), but unless you are a botanist or pharmacognosist with a degree, you will have to prove to FDA that you can competently identify herbs. Essentially, you have to find a way to "test the tester", or qualify the analyst, who is ensuring that the organoleptic specifications are being met. Here are two document that give an example of how one might do this:
Analyst testing method (how we test our testers)
Analyst testing record (where we record the test results)
Ideally, you will build a testing record that shows you can competently identify all the herbs you use. Now, the question remains: how do you know that the sample you're using as a way to certify the herbalist's skill is actually what you think it is? This requires either the purchase of a validated sample, the assistance of a qualified botanist or pharmacognosist, or validation through an external lab test. This can add extra cost. Is there a way for us to centralize this somehow? Could analyst certification be offered at herb conferences?
Any additional training seminars, certificate programs, or herb schools that you can attend (and collect certificates!) serve to bolster your case that you are, indeed, qualified to conduct these tests. Build a strong case, and identity of raw (non-powdered) herbs can be tested using our senses and good reference materials.


So, specifications need to be developed for everything - including packaging and labels - and you have to maintain a record that you checked everything that comes in against those specifications before using material to make any kind of product that will go to the public. This is a big undertaking. In the coming weeks/months we'd like to share as much of what we have as possible. Hopefully these documents can be edited, improved, and custom-tailored to adapt to different individual situations. But the scope of the project has already outgrown this blog: we need a platform that allows for collaborative sharing, posting, and discussion. So next week, I will provide links to a separate website that will hopefully be more interactive and allow us to leverage the excellent experience and advice, as well as offers for help and contributions, that have been coming our way. Thank you for supporting the FDA cGMP open source project and stay tuned!

12.09.2015

FDA cGMP project - labels and language

Though not technically part of the regulations that govern good manufacturing practices, product labels, websites, and social media pages and the language they contain are also regulated by FDA and are, unfortunately, a ripe potential target for government agents who enjoy browsing the internet at their desks. Lately, warning letters have been issued just for unapproved website claims (for example, here). Regardless, it makes good sense to start by having compliant packaging and marketing materials: anything else invites scrutiny.


**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'll look at the label itself in a bit. First, what about claims on labels? There are two types: ingredient claims (this much Vitamin C, for instance, or these many calories), and structure/function claims ("supports healthy immunity" and other such language). It's rare that herbalists will need to make nutrient claims - but I've included a label for a product that contains some honey, so you can see how to articulate the carbohydrate count on a label. But structure/function claims are a source of perpetual befuddlement. What can be said? What cannot? Are there code phrases or tricks?

I will start by saying that there really aren't tricks. You can't get away with saying "this statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease" and then making any claim you want. You can't say "traditionally used" in front of any claim you want, and think this exempts the language. You can't get tricky and say things like "useful during the cold and flu season", because colds and flus are diseases, and herbs can't be useful during disease season because "useful" can only mean "medically useful" in this context. You can make a claim that a supplement supports the normal, healthy function of an organ, system, process or function of the physiology, provided those processes and functions are part of the normal, healthy course of life. You can also use language that FDA doesn't understand, or considers meaningless - like "enhancing yin" or "unblocking stagnant liver qi".

This is the tricky part. It really is up to FDA to decide what a normal, healthy course of life looks like and I have to say that, based on my experience, it appears FDA (and/or their medical consultant squad) spends a little too much time sitting at desks on the computer, eating a questionable diet, feeling stressed and not sleeping too well. This is in part because anxiety, tension and stress, occasional heartburn, gas, upset stomach, PMS and insomnia are all considered part of a normal, healthy course of life. But I digress.
Blood-based parameters - like blood sugar, cholesterol, pressure etc... - are fair game as long as it is clear that the herbal product "supports healthy blood sugar levels that are already in a normal range" (emphasis mine, and is required). Anything else would imply disrupted blood levels, which means disease. Certainly can't mention diabetes.
I have found the following document very helpful:
http://www.fda.gov/ohrms/dockets/98fr/010600a.txt
It gives a good background on how we got here (namely, the Dietary Supplement Health and Education Act, or DSHEA), which is interesting to read if you like context. But you can also search the document right in your web browser. Try typing in "heartburn". Or "blood pressure". Or "insomnia". Then, try "potency" (improving sexual potency is not an acceptable claim, but improving sexual performance is - poor performance is apparently part of a normal, healthy course of life).
These searches give you ways to approach herbal actions from an acceptable structure-function perspective, and more importantly, if you spend a little time reading, you can get a good sense of what will be acceptable, and what might get you into trouble. There are some tricks - "occasional" heartburn and sleeplessness are fine, but without that qualifier, they are diseases (though of course this wouldn't work for "occasional" migraines). Best of all, FDA explicitly says "this is acceptable" after a good many statements, and you can use these statements as you see fit. Beyond this, you have to prove that a claim refers to supporting something that happens anyway as part of being a healthy human if you want to use it.
All claims - even mentioning the word "immune" in a product name - must have an asterisk next to them. This asterisk must point to the FDA disclaimer somewhere on your label, which must be enclosed in a hairline box: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

These regulations around claims apply to print and internet material, too. Brochures, business cards, shelf talkers and sales sheets, catalogs, websites, and social media pages - even, perhaps, audio and video - must all comply (and must include the FDA disclaimer). You can't control what others post on your sites - but don't "like" or acknowledge them. Testimonials, if not properly worded, aren't acceptable either. Personally, this is a big loss: I remember back in the day herb companies often had some of the best information on herbs, their pharmacology and applications, in their print and web media. Now, you can't even post a study that references one of the herbs you use because it's seen as implying that the herb can actually do what it does in the study.
One way around this is to set up, or ally yourself with, a few personal social media pages and weblogs. You can link to these from your product pages, even if these external sites say outlandish unacceptable things like how herbs prevent heart attacks. Some warn that such sites must be "two links" away from your herbal company's website - I haven't seen this distinction in action yet.

Once you have defined what acceptable claims you want to use (and I do recommend connecting with ahpa.org to find a lawyer to review these, if you have the financial means), you are required to submit them to FDA, just to let them know that you're saying herbs do things, within 30 days of beginning sales of the product. Here's an example of what such a letter might look like, including the address to send it to:

Herb Pharm Liquid Herbal Extract Vein Health Letter.

Furthermore, you are required to have files that substantiate the claims you're making: if, for example, your elderberry syrup says it supports the immune system, you should have a file that references actual research and dosing, and/or traditional sources (such as 19th century texts), pointing to elderberry's effectiveness (you just can't ever share any of that information with the public on your website).

How to build such claim substantiation files? In the near future, I'd love to start sharing some of what we've put together and would welcome anyone else's support in this. Perhaps a shared online repository? To a certain extent, some of the files are customized for a particular formula or extraction - but there is still the possibility for substantial overlap. For now, start at Health Canada (in many ways more enlightened on this particular regulatory topic), where monographs on many plants are included with references that back up a range of claims. Note, however, that most of these claims are unacceptable to FDA - such as Ashwagandha's effect as a sleep aid - but you can rephrase it as "helps with occasional sleeplessness" and use the Health Canada reference as part of your claim substantiation.

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=eng&monotype=single


Now, we can look at the specifics of label regulations themselves. There are rules for how a food label generally, and a dietary supplement label specifically, must be structured. There are also variations in requirements depending on the label size. And there is a specific exemption: if there are no nutrient claims or structure/function claims on the label, and there are no wholesale sales, and total annual sales are less than $500,000 or there are less than 100,000 units of a product sold, then having a supplement facts label is not required. If you want to sell your products through a store or distributor, this exemption is not an option. It really only applies to herb shops, farmer's markets, and direct-to-consumer sales.
General rules on food labeling, including the details on exemptions (found in subsection (j)) are in the Code of Federal Regulations (CFR), Title 21, Part 101, subpart 9 (abbreviated as 21CFR101.9). Find the whole thing here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.9
Specific rules on dietary supplement labeling are in 21CFR101.36, which is available here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.36
I'll go over these regulations while looking at some specific label examples, which makes it much more clear. But a few pieces to note:
- less that 12 square inches on a label allows you to use 4.5 point font. Anything bigger than 40 square inches requires 6 point at a minimum for text, and 8 point at a minimum for the serving size text in the supplements facts box.
- note the requirements for hairlines, lines, and columns in the supplements facts box. There are some good examples included in 21CFR101.36
- list plants by common name and include the part (root, rhizome, leaf, seed, flower, etc...)
- many herb supplements only need a proprietary blend listed, along with a symbol pointing to a footnote that says "% Daily Value not established". If you add honey or other sweeteners, you may need to list the carbohydrates/sugars, and perhaps the calories, per serving (if the amount per serving exceeds 1g of carbohydrates, and/or if it exceeds 5 calories). The website nutritiondata.com gives good carb/sugars counts for various foods (and a whole lot of other stuff, here's an example for honey: http://nutritiondata.self.com/facts/sweets/5568/2). Just remember, if your serving is 2ml, and there's less than 1g of carbohydrates in there, you don't have to list them on the supplements facts panel.

So, with a little of the background information available, let's take a look at some example labels for two different sizes of a dietary supplement that also contains a little honey. Because writing it all out would take too long, here is a voice walk-through identifying all the important pieces of a (in this case liquid) herbal dietary supplement:






And here are the labels: first, a larger size with a complete supplements facts panel.


Next, a small size with a "linear" supplement facts declaration (only for labels smaller than 12 square inches, though you could make a case to use this way if it's under 40 square inches and there's no room for a big panel).





Next week we'll start to talk about the ingredients and packaging that go into making dietary supplements: from herbs and other ingredients, to your labels, bottles, closures and seals. We'll look at specifications and hopefully get to some ideas on testing. Another piece to cover (if we can get to it) is getting to know your vendors and "qualifying" them to help streamline future work. As always, questions and comments are welcome and I will do my best to include your experience in the conversation. Anyone who has had labels vetted by FDA inspection or legal counsel is really encouraged to send examples to guido at urbanmoonshine dot com. Thank you!