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alternative-health, big-pharm

Herbal Formulas in Common Use

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Liu wei di huang wan
Liu wei di huang wan is a traditional formula made from raw herbs or from many manufacturers (Photo credit: SuperFantastic)

‘In Chinese medicine there are hundreds of traditional formulas that belong to the commons. If you buy Liu wei di huang wan (Rhemannia 6) or Bu zhong yi qi tang (Tonify the Middle and Augment the Qi Decoction) you will find essentially the same formula made by a wide variety of manufacturers under the same name. They may have minor variations but are essentially the same in function and content.Many of the recipes and their names derive from famous doctors like Zhang Zhongjing who wrote the Shan Han Lun or Sun Si Miao. The names of the formulas neither are nor can be trademarked by a single company.  The Bensky formulas book contains over 500 traditional formulas.

There exist in Chinese medicine private, patent-protected formulas like the famous Yunnan Bai Yao stop bleeding formula.     The difference is that Yunnan Bai Yao is relatively modern, developed by  Dr. Qu Huan Zhang in 1902, was always private (but now controlled by the Chinese government) whereas other traditional formulas are and have been public for centuries. So no one can trademark “Liu wei di huang wan”, although one can create other similar formulas for yin deficiency. There certainly are other formulas to stop bleeding and many of them use san qi (notoginseng root) which is believed to be the basis of Yunnan Bai Yao’s secret formula but they cannot use the non-traditional trademarked name.

Yunnan Baiyao
Yunnan Baiyao a protected Chinese herbal formula

There are also many modern “hospital formulas” whose exact content remains sketchy in Medscape abstracts and these are being protected for profit.  In addition many companies make patent-protected variants of traditional formulas under other names, but the vast majority of herbal formulas are traditional. In Japan these formulas with regulated recipes are part of the the National Health Insurance drug registry.

We have traditional recipes in Western herbal medicine too although far fewer of them.  Mithridaticum was a shotgun anti-poison remedy from the first century BCE,.  The Romans enlarged and adapted it as “Theriacum”, described in pharmacopoeias for centuries up through the European Renaissance.  The Middle Ages brought Thieves’ vinegar, allegedly composed by the midwife mother of one of a gang of 4 thieves who managed to steal from houses where the Black Death had stricken without themselves contracting the plague. During many centuries great herbalists from Hildegard of Bingam to Gerard to Maimonides to  Culpepper used formulas, but few were standardized.  Most  Western herbals classified single herbs both by properties and energetics even if they might be used in combined formula. And assaults against using herbal medicine, from early Christian faith-healing through the witch trials up to the early 20th century Carnegie Commission broke the continuity of traditional herbal formulas in a way that the documented Chinese herbal tradition did not have to contend with.

There were a number of well-known formulas in the 19th and 20th century  Samuel Thompson came up with his famous Composition Formula which treated diarrhea and dysentery along with a variety of formulas featuring cayenne and lobelia. Roberts Formula is traditional for ulcers.  Neutralizing cordial was developed by the Eclectics for fermenting and irritating conditions of the stomach and intestine.  Mother’s cordial was an Eclectic formula promoted by Feltzer and Lloyd to prepare the uterus for labor at the end of pregnancy.  Antispasmodic Tincture made from lobelia seed, crushed skullcap, skunk cabbage root, gum myrrh, black cohosh and cayenne  was developed by Thompson and refined by both Dr. Christopher and Jethro Kloss for spasms of all kinds and lung conditions. Kloss, D. Schulz, Tommie Bass, Hannah Kroeger, Dr. Shook and Dr. Christopher popularized a variety of  formulas for the public good including Blood Stream Formula for clearing “bad blood”, Bone Flesh and Cartilage (BF&C), Anti- Gas Formula and many others. These were freely adapted and many companies produce versions of the formulas.  Other herbalists who drew on common formulas include Harry Hoxsey whose named formula drew heavily on the Park Davis Trifolium (red clover) Formula.  Black salves and drawing salves for cancer also percolated through the herbal commons, as did versions of Essiac.

Lydia Pinkham's Herb Medicine (circa 1875) rem...
Lydia Pinkham’s Herb Medicine (circa 1875) a proprietary herbal patent medicine still under trademark

There were also trademarked names and patented products.  Swedish Bitters is a trademarked version of digestive bitters There are licensed and trademarked Edgar Cayce formulas.  Lydia Pinkham tonic is trademarked.  Airborne is a modern trademarked and patented product derived from the traditional Yin Qiao San with additional nutrients and echinacea. The difference between a trademark and a patent is that a trademark restricts the name of the formula but not the content while the patent restricts both.

Rosemary Gladstar was one of the early pioneers of the current wave of American herbalists and started teaching in the 1970s.  In the tradition of the earlier herbalists she did not trademark her formulas and a wide variety of products have been inspired from her teachings, often using the same names.  Fire Cider is a term invented by Rosemary Gladstar over 35 years ago, and has been shared by her freely since then to tens of thousands of people. She has it in her published and copyrighted books and teaching handouts from the 90‘s and pamphlets from the 1970’s. The formula is much older than her – indeed Mrs. Grieve has a similar formula under another name and countless middle European grandmothers have made horseradish and onion-based therapeutic vinegars.  Various people have used both the name and basic formula for decades.  Monica Rude of Desert Woman Botanicals has sold Fire Cider since the 1990s, for instance and taught the recipe under that name.

Fire Cider by UberHerbal
Fire Cider by UberHerbal

We have an herbal incident occasioned by a firm named Shire City who decided to trademark the term “Fire Cider” based on inaccurate information provided to the US Patent and Trademark Office.  One of the principals of the firm apparently studied herbalism at the school where Monica Rude was teaching about Fire Cider and experimented with making fire cider at that time. The Shire City  Trademark application summarized here claimed that the  the first use of the term was 12/4/2010 and that date was its first use in commerce.

A simple time delimited Google search would have uncovered Fire Cider for sale listings before 2010 like this one .

  • Susun Weed had a Fire Cider forum topic on Fire Cider in 2003.
  • Amanda McQuade made a video on it in 2009.
  • Food.com listed the recipe in 2005.
  • The current Desert Woman Botanicals sales page is dated March 15, 2005 and Rootwork Herbals sold it in 2008.
  • A 2005 article on the Desert Woman Botanicals web site discusses selling Fire Cider in Massachusetts, Utah, Texas and Arizona as well as New Mexico.
  • A 2002 Etsy page listed several Fire Cider variations by different sellers. (All dates according to Google.)
  • GreenMedInfo discussed it in a Joe Cross interview on February 1, 2001.
  • Rosemary  Gladstar of course has it in her copyrighted books and teaching materials at least since the early 1980s and perhaps earlier. And on Rosemary’s Fire Cider YouTube video.
  • Rosemary is credited with inventing the term and bringing the basic recipe to the herbal community in her books, The Home Medicine Chest (Storey Publications, 1999) and Rosemary Gladstar’s Family Herbal (Storey Publications, 2001)  and has expressed her desire that the term remain in the herbal commons.

We do not know whether the erroneous information in the trademark application is accidental, due to the ineptitude of their attorney (who apparently didn’t do a Google search) or was deliberate, done with the specter of future work defending the trademark, or was done with the cooperation of Shire City.  What we do know is that someone from the company or their counsel contacted Etsy and Amazon and that a number of small herbalists were shut down . They insisted on their right to trademark the name, describing its use as unknown before they publicized it. Given the patently untrue assertions, the high regard Rosemary Gladstar is held in and the history of fire ciders, the herbal community erupted with petitions that picked up thousands of signatures in a few hours, calls for boycotts and the Shire City Fire Cider Facebook page was flooded with critical comments.

fire cider fixins
Fire Cider Fixins’ from http://www.fareisle.com/blog/2014/2/2/world-fire-cider-day for World Fire Cider Da

After requesting a few weeks to consider what to do they doubled down and essentially claimed that the only thing to be done is to sue them, “The only thing that will make the name ‘fire cider’ a generic term is a ruling from the USTPO. Challenging a trademark through the USTPO is a commonplace occurrence with clear rules and requirements, and we welcome anyone who would like to avail themselves of this path. This is legal, fair, and something to be expected as a part of doing business.” Now it isn’t their only option and they may be trading on the idea that the herbal community is unable to mount a legal challenge.  The trademark can be withdrawn or abandoned , as was “Soap Loaf”  or “Lotion Bar.”   It could be transferred to Rosemary Gladstar who would allow free use or it could be amended to exclude “Fire Cider” as “Cider” was also excluded but to protect a name like “Dana’s Fire Cider” or “Shire Fire Cider.

To summarize, Fire Cider has been part of public domain for decades, not a brand name and not even one that was trademarked by its inventor.  It is traditional like Bu zhong yi qi tang rather than proprietary like Yunnan Baiyao.  Analogously one could legitimately trademark “Shire Fire Cider” which is not a common name. But it was improper to trademark “Fire Cider” because that term was generic in the trade, just as the traditional Chinese herbal formulas like Lu wei di huang wan are.

There is currently a boycott of Shire City’s Fire Cider and it looks like there may have to be a lawsuit.  People are asking local health food stores and other venues not to carry the product until the trademark is resolved.  So speak to your local health food, food store or co-op and :

Rosemary Gladstar by : Jason Houston
Rosemary Gladstar by : Jason Houston

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alternative-health

Are Herbal Supplements Safe?

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The New York Times had an article this week, Herbal Supplements Are Often Not What They Seem, that suggested that herbal capsules may not contain what they say, often containing different species in the family or fillers.  The study cited is found here.

The study has major problems and the American Botanical Association has called upon the BMC medicine journal to retract the paper:

In our view, and in the opinion of expert reviewers of this critique, and with all due respect to the authors and BMC Medicine, the journal should retract this paper, and require that the authors address various errors, ambiguities, and areas of confusion by appropriately rewriting, correcting, and resubmiting it to the journal. The editors of the journal should then submit the corrected revision to an appropriate peer-review process that employs numerous expert reviewers (not just the two who presumably reviewed the initial paper) who are knowledgeable not only in the fields of DNA testing, but also in botanical analytics and related disciplines. Only then, if the paper passes such appropriately expanded peer review, should the paper be republished. Until then, despite the good intentions of its authors, this paper creates confusion, promotes false conclusions, and, unfortunately, may constitute a disservice to scientific researchers and other responsible members of the botanical products community.

Herbalism
Herbalism (Photo credit: Nomadic Lass)

The DNA barcode study looked at extracts as if they were herbs.  Herbal extracts do not contain complete DNA from the plants, but instead concentrate constituents from the plants.  You need fewer capsules of extract than of powdered herb which is why most capsules contain  extracts or extracts spray dried onto carriers.  The extracts usually require a solid base which can range from the herbal marc, to rice to alfalfa, or they will clump and not break down well in the body.  But in the study the extracts were seen as missing herbs and the excipients and fillers were seen as adulterants.

While it was not possible to tell the difference between slight contamination- a few dandelion leaves in a hectare of herbs or wholesale substitution of amaryllis family for cinnamon, we know there is some adulteration  in the herbs supply, just not most of it as the study implies. In an era where most herbal products are subject to intense Good Manufacturing Practice (GMO) and third party verification there is less adulteration than one might think.

Still, I almost never suggest using encapsulated herbs, for reasons of identification and freshness, as well as because taste is an important signal to the body that the herbs are coming and to start secreting digestive juices to use them.  Besides, herbs you taste can get into the lymphatic system in your tongue and throat, instead of waiting in your stomach for the gel cap to dissolve.  But I had several reactions to the article:

  • We have adulterated olive oil, e-coli in meat, melamine in pet food, banned pesticides in our fruit,  counterfeit or badly studied pharmaceuticals and bottled tap water sold as “fresh from the spring”.  In all cases, including herbs, the regulations are strong but the FDA is pitiful at enforcing them.  Frankly I prefer that they focus on hamburger and chicken since it causes more health problems.  Misidentified herbs, which I abhor, have not killed anyone. But we have nowhere enough inspections for an internationally sourced food and medicine supply.
  • The herbs you purchase from your acupuncturist, herbalist or naturopath are not likely to be a problem.  I prefer to use fresh herbs which I was trained to inspect, purchased directly from growers I have met in the US or firms which use liquid chromatography and a variety of other means to test for species, heavy metal contamination or other problems. I use five exceptional tincture companies or make tinctures myself.  Serious herbalists, many of whom I know started companies to help heal people. The granules I use are from Taiwanese firms with pharmaceutical-grade manufacturing, certified GMP (good manufacturing practice compliant) and have third party inspection certificates.  When I do use teapills or capsules I purchase from firms that I know to be careful, from a Chinese medicine pharmacy that inspects sources or from high quality US firms.
  • Be careful where you get your herbs if you buy them yourself.  I don’t purchase herbs from my local CVS or even GMC. We have a high quality independent health store where the proprietor is careful to select brands with good quality standards.  You can grow your own herbs for teas or tinctures. There are quality mail-order herbs.  Ask questions. Join Consumerlab and purchase the supplements that have passed their tests for species, potency and heavy metals. Ask for GMC compliance and third party verification.
  • It appears that the test in the article was to promote a new DNA bar code scanning technology to be a standard, although it can identify herbs, but  not when they are processed or in formulas and which can neither account for potency or heavy metal contamination.  (See the Consumerlab founder’s letter at the bottom of the NY Times article.)  While this does not excuse the mislabeled herbs, the actual percentage is likely under the  amount identified in their study.

    Herbal supplements
    Herbal supplements (Photo credit: Ano Lobb. @healthyrx)

  • Some species are similar to others and have similar properties, others not.  In Chinese medicine a pharmaceutical name like niu xi may refer to several functionally similar species although they really ought to be identified. by Latin binomial species name.  The black cohosh (Actea racemosa) cited in another study had Actea asiatica substituted, but that plant is used in Chinese medicine and really is not a serious risk for toxicity at normal doses.  It is used differently though.  Echinacea species usually have similar properties.
  • Most capsules are made with herbal extracts where constituents from plants are extracted but the DNA is not present.  This would show up with the barcoding as missing the herb when in fact it is the basis of the extract.
  • Keep it in perspective.  Hundreds of thousands of people each year die from properly-identified pharmaceuticals while you need to go back several years to find any deaths from herbs, properly identified or not.

The study does not name manufacturers by name,  which would have been helpful.  Here are some herb companies I deal with which I consider safe and accurate:   Herbalist & Alchemist, HerbPharm, Cedar Bear Naturals, Mountain Rose Herbs, Zach Woods Herb Farm, Healing Spirit Herb Farm, Blessed Maine Herbs , Wise Women Herbals, Mushroom Harvest, Plum Flower, Lotus Herbs, Gaia, Spring Wind Herbs, KAN, KPC, Kamwo Herbs, New Chapter, Starwest, Frontier, Pacific, and there are many, many more.

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Addenda:  The American Botanical Council has called for a recall of the study because of its serious failures.  Here are a few extracts from its critique:

” The approach taken by the authors was to create a number of homemade definitions and then evaluate materials against those definitions using DNA fingerprinting. …There are internationally recognized definitions for identity, authenticity, contamination, and substitution. Invention of new definitions for these terms by the authors in order to demonstrate the novelty of their approach and their technical virtuosity is self-referential and, unfortunately, very possibly self-serving. Their apparent lack of adequate knowledge in this field has allowed them to create a virtual problem and then, figuratively, ride to the rescue and solve it.”

Despite the authors’ contention to the contrary, there is no evidence that DNA can be obtained from botanical extracts, and DNA from relatively highly processed materials such as finished supplements in tablets and capsules is of poor quality. As a result, the DNA that is detected in these cases is typically either accidental environmental contamination, cross-contamination among samples in the lab, and/or the DNA from the product’s carrier or filler (soy, potato, or rice).

… In the same PCR reaction mix, a shorter fragment (e.g., from the adulterant) is preferably amplified over a larger fragment, which also could be misinterpreted to mean that the sample has more adulterant material than authentic material…We thus are at a loss to know whether or not non-target DNA found in a product is present at levels that would constitute a significant amount of extraneous material or perhaps a few dandelion (Taraxacum officinale, Asteraceae) leaves commingled with a hectare’s worth of harvested crop.

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