HERBAL PHARMACY: QUALITY CONTROL, REGULATIONS, AND BEST PRACTICES - BY SARAH WELCH, L.AC.

HERBAL
 PHARMACY:
QUALITY CONTROL,
REGULATIONS, AND
 BEST PRACTICES

          BY

   SARAH WELCH, L.AC.

           1

TABLE OF CONTENTS
Wild Harvested or Cultivated                        3
Supply Chain                                        7
EPA + FDA                                           9
USDA Organic                                       11
Organic in China                                   13
Good Agriculture and Collecting Practices (GACP)   14
Daodi                                              16
Organoleptic Assessment                            18
Lab Tests                                          19
How to Read a Certificate of Analysis              24
How to Choose?                                     26
cGMP                                               36
AHPA                                               38
Documentation                                      39
Labeling                                           41
Appendix 1: Certificates of Analysis               44
Bibliography                                       47

                           2

WHERE HERB S COME FROM

              Wild Harvested or Cultivated

    People have been using plants as medicine throughout
the history of our species. The vast majority have been
gathered from the wild (wild harvested), though it is also
likely that early humans intentionally planted and tended to
certain species (cultivation) early on in our evolutionary
history. As we have fully embraced agriculture, we have
brought more and more medicinal plants into cultivation.
Today, more than 150 cultivated species account for over
half of Chinese herbs traded by weight1. Yet still, the
majority of distinct medicinal species are not yet being
cultivated and are still harvested from the wild. Some
herbs on the market may be available in both cultivated
and wild varieties. There are pros and cons and valid
reasons why an herbalist may prefer wild or farmed herbs.
    As for wild plants, they face irregular environmental
conditions – varying availability of water, nutrients, pests,
etc. – they adapt for resiliency. This leads to changing
phytochemistry, and often, better medicine2,3. Many
herbalists and gardeners alike know that wild plants are
stronger and more vigorous. But, as human populations
and demand grows, sustainability is an obvious concern.
Wild populations of many species are increasingly
threatened by over-harvesting and loss of habitat. Some

                             3

herbs have already been declared endangered and
international trade requires special permits under the
CITES treaty (Convention on International Trade in
Endangered Species)3. Another concern for practitioners
and consumers of wild-harvested herbs may be correct
species identification. Wild stands of herbs are likely to
display more phenotypic variation than cultivated crops,
which could lead to misidentification if a person is
unfamiliar with the live plants and/or processed herbs.
    Alternatively, herbs grown on a farm are less likely to be
mis-identified. In general, farmed herbs tend to be more
reliably available on the market, and of consistent quality.
And, in some cases, farming may be the only sustainable
way to meet growing demand for threatened or
endangered wild populations. But, farming too has its
drawbacks. First, farming is more expensive than wild-
harvesting. As long as the market price of a given herb is
low, very few farmers will invest in trying to grow it4, and it
will continue to be gathered from the wild. Of the herbs
that are regularly cultivated, conventional agricultural
practices can produce huge yields by dedicating acres of
land to a single crop (mono-cropping). In this method,
some amount of fertilizer and pesticides are usually
necessary because the practice destroys the biodiversity of
intact ecosystems.
    Wild plants are fed by the metabolic byproducts of
microorganisms in the soil. When the wild microbiome is
destroyed, soil quickly becomes depleted and plants need
added fertilizers to support their nutrition. With the loss of

                               4

habitat, the macro-biome loses its inherent resiliency. Pests
have no competition or predators and they can easily
devastate an entire crop if left unchecked. As for the
medicinal crops themselves, with regular application of
water, fertilizer, and pesticides, the plants don’t face the
stress that makes them stronger, better medicine2. Further,
because of constantly increasing demand or changing
trends in the market, many of the slower, more traditional
growing methods are abandoned. Fruits may be picked
before they are ripe, or roots that should benefit from 3 or
5 years of growth may be picked and sold after only one
year4. For example, as Goji berries gained popularity as a
new “superfood”, market quality sharply declined. Thus,
while the mono-cropping endeavor may produce huge
yields by weight, the medicinal properties of the herbs
often suffer. Further, there is the introduced concern that
the crops have been contaminated with pesticides.
    Some farmers are practicing hybrid solutions in order to
get the higher yields from farming, while maintaining the
quality and vigor found in the wild. “Wild cultivated”,
“forest grown”, or “wild simulated” crops are grown in
diverse polycultures (among other species of plants), and
generally, some environmental stress is allowed with
minimal inputs of fertilizers and pesticides added. This can
mean that crops are planted among an established
ecosystem (“forest grown”) or that a farm or garden is
established to support diversity of species, polyculture
rather than mono-cropping3. While this approach can help
mitigate the drawbacks of both wild-harvesting and of

                              5

conventional farming practices, wild cultivating is not
without its own set of challenges.
    Terms like “wild simulated” are used to describe
cultivation practices, but there is no standard or regulation
to define specifically how the plants are grown. As is
described in an episode of Planet Money, The Problem of
the Root5, Ginseng may be called wild-simulated if a
person just throws a seed in the woods and leaves it there,
or it may also be called wild-simulated if a person digs a
hole in the woods, throws a seed in, and then sprays it with
fungicide. The theory of wild-simulated farming seems like
a viable way to marry the benefits of wild vitality with the
productivity of farming. In practice, though, the term is
vague and creates a lot of “wiggle room” in the market.

                              6

Supply Chain

     The herbs usually make many stops along the way from
farm or forest to practitioner and patient. Very simply,
suppliers are the “middle-men” who coordinate directly
with farmers and pickers, collect all the herbs, and resell
them to manufacturers, importers, or practitioners. There
may be multiple suppliers, or stops along the way, and
“supply chain” is the term used to describe a complex web
of people and steps involved in getting the herb from
where it grew to its final consumer.
     Suppliers keep track of how much of any given herb
their customers want to buy, and they coordinate with
multiple producers to meet the demand. For example, a
large manufacturing company that is producing tablets or
granules may require a whole lot of Dang Gui, more than
any one farm can produce. Thus, the suppliers coordinate
with multiple farms to collect all the Dang Gui and package
it together for shipment to the manufacturer. It is quite
common for batches of herbs from different farms to be
mixed together in this way. This is where “traceability” is
lost. That means, if two batches from different farms get
mixed together, there is no longer any way to definitively
know where the herb came from. If a problem arises with
that lot of herbs, it can no longer be traced back to the
source.
     This mixing of batches is particularly unfortunate and
often a detriment to the overall quality of herbs on the
market. Some farmers are conscientious and spend
                             7

considerable resource and effort to produce high quality,
potent, organic herbs. But as soon as the organic herbs are
mixed with another batch of who-knows-what in a
warehouse somewhere, all of the years of investment and
dedication from that conscientious farmer are squandered.
If the organic herbs are mixed with conventionally grown
herbs, the whole batch may now be contaminated with
pesticide residue, for example. Or, if herbs from one
growing region are mixed with herbs grown in a different
region, the medicinal qualities will vary, and the whole
batch is no longer predictable and uniform. In short, each
time the herb changes hands, is combined with another
batch of herbs, or is moved to a new storage facility, there
is an opportunity for contamination or adulteration, and the
consistency and quality suffers.
     Time is another factor in determining the quality of the
herbs. Since herbs are plants, they do have a “shelf-life”. If
they sit around too long, most of them will eventually go
bad or stale. The more stops the herbs make in the supply
chain, the more time they spend sitting in a warehouse, the
less fresh they will be when they arrive to the final
consumer. As is mirrored by the “farm to table” movement
for fresh food, it is easy to understand why a shorter supply
chain produces reliably higher quality herbs.

                              8

REGULATIONS + CERTIFICATIONS

                       EPA + FDA

                   The Food and Drug Administration (FDA)
                   and the Environmental Protection Agency
                   (EPA) are the primary federal agencies
                   tasked with regulating Chinese herbs in
                   the United States.
    The EPA sets pesticide tolerances, or maximum limits of
how much pesticide residue is allowed on agricultural
products sold in the United States. Every new pesticide on
the market must be registered with the EPA before it can
be sold, and tolerances are set for each pesticide
registered that are crop-specific. For example, asparagus
is allowed to have 0.5ppm of glyphosate residue, while
cotton is allowed to have 210ppm. Safe tolerances are
determined in consideration of how much of a pesticide is
known to be harmful, as well as what mode of exposure
and how much of any particular crop a person is likely to
consume over time6. In the above example, a person is
likely to ingest a lot more asparagus than cotton. Thus, the
allowable level of glyphosate is adjusted accordingly. Of
Chinese herbs, only the most famous (like goji berries and
ginseng, for example) have set pesticide tolerances. The
EPA has not established tolerances for most Chinese herbs.

                             9

The FDA is tasked with enforcing the pesticide
tolerances established by the EPA. When agricultural
products are imported to the United States, the FDA
selectively tests samples for approximately 700 pesticide
residues7. Because most Chinese herbs have no set
tolerances, if an herb sample shows any residue of any
pesticide, it should be refused entry into the US market1.
    On the other hand, of all agricultural products imported
into the US, very few are sampled and tested upon entry.
In 2017 the FDA reports that 4,270 total import samples
were analyzed. Of those, most were fruits and vegetables.
A total of 429 samples were collected from a group called
“other import food products, consisting largely of nuts,
seeds, oils, honey, candy beverages, spices, multi-
ingredient products, and dietary supplements”8. It is not
clear how many of the 429 “other” samples in 2017 were
Chinese herbs. It does seem fair to say that most imported
herbs will not be tested by the FDA at all, and so may arrive
to the US market with some level of pesticide residue.

                             10

USDA Organic

                 USDA Organic is a specifically defined set
                 of regulations about farming and
                 production practices. According to the
                 U.S. Department of Agriculture, “USDA
                 certified organic foods are grown and
                 processed according to federal guidelines
addressing, among many factors, soil quality, animal raising
practices, pest and weed control, and use of additives.
Organic producers rely on natural substances and physical,
mechanical, or biologically based farming methods to the
fullest extent possible”9. Farms outside of the U.S. may
advertise herbs with the USDA Organic certification by
working with organizations in their own country that are
authorized by the USDA to inspect farms and certify that
they meet USDA Organic regulations. Alternatively, the
U.S. has trade partnerships with Canada, the EU, and
Japan, establishing reciprocity between Organic
regulations. For example, if an agricultural product meets
Canada’s organic standards, then it is automatically eligible
to claim USDA Organic standards as well.
    Since the Organic certification standards are specifically
defined, the consumer can have some confidence about
certain aspects of how the plant was cultivated. Generally,
farmers can only use natural fertilizers and pesticides, while
synthetic additives are not allowed10. But, organic
certification does not necessarily indicate that the final
product is of high quality.
                             11

Though we can be sure that the organic farmer did not
spray anything synthetic on their crops, some pesticides
and other pollutants are present in the environment that
can contaminate crops, despite the best intentions of the
farmer. Further, whatever happens after the crops are
harvested and sold is beyond the jurisdiction of organic
certification. Thus, a lovingly grown organic herb can still
potentially be contaminated during preparation, storage,
manufacturing, or transport. Thus, the final quality of an
herbal product relies on more complexity than the Organic
certification can regulate. Even if an herb is certified
organic, it is still prudent to get it lab tested for pesticides
and other contaminants.

                               12

Organic in China

                   While USDA Organic regulates farming
                   practices, or how the herb was grown, in
                   China, “organic” refers to an area in which
                   no pesticides are allowed to be used. For
                   example, if an entire mountain is
                   designated as organic, then any plant
from that mountain can be sold as organic. This means that
both cultivated and wild-harvested, as well as wild-
cultivated hybrid practices are all eligible for organic
certification by the Chinese government.11
    Concerns about China organic herbs are similar to
USDA organic herbs. While the certification verifies that no
synthetic chemicals were applied, it cannot verify that the
watershed or soil is not polluted, for example, or that
contamination hasn’t occurred after the herbs were
harvested. Further, since organic herbs can be sold for
higher prices, there is economic incentive for wild-
harvesting in these areas. Counterintuitively, over-
harvesting can lead to the endangerment of certain
species and increased environmental destruction in areas
that are designated as organic.4

                             13

Good Agriculture and Collecting Practices (GACP)

    Good Agriculture and Collecting Practices (GACP) are
guidelines for how medicinal plants should be grown and
harvested. Various organizations and countries have
written versions of GACP standards, including the EU,
China, Japan and other countries. The World Health
Organization (WHO) released guidelines in 2003 that seem
to be the “gold-standard” in the industry to which other
sets of guidelines are compared. Regardless of who wrote
any set of GACP guidelines, all of these recommendations
are voluntary for producers of agricultural products and are
not legally binding. The WHO GACP guidelines cover
topics concerning cultivation or collection, harvesting, and
post-harvest processing, packaging, storage, and shipping.
This includes guidance on correct botanical authentication
of species, ecological and social impacts of production,
site selection, soil, irrigation, personnel requirements,
equipment, documentation, and more12.
    While these guidelines are quite comprehensive, the
WHO acknowledges a gap in implementation. “While
pharmaceutical and other companies are striving to meet
the requirements for the quality control of herbal
medicines, they cannot force farmers, producers, handlers
and processors to follow good agricultural and collection
practices for medicinal plants.”12 Voluntary audit programs
are available for producers who would like to become
                            14

“GACP Certified”, overseen by the USDA and other
independent third party inspectors. For many small
farmers, adherence to these GACP standards may be too
expensive and out of reach.
   One notable concern with increased implementation of
GACP standards is the problem of genetic diversity within
plant species. In an effort to standardize the herbs on the
market, GACP dictates that seeds and propagation
materials be of verified botanical identity and excludes
many varieties and cultivars. The lack of genetic diversity
can be detrimental not only to the medicinal quality of the
plant, but also to the overall health of a plant’s population.
As described above, it is often a wild plant’s adaptation to
harsh environmental conditions that make better medicine.

     Click here to see the full WHO GACP guidelines.

Biologically speaking, we know that genetic diversity is
crucial for the overall health of populations.

                              15

Daodi

                   In ancient times, medicinal herbs were
                   harvested from the wild. It was
                   recognized early on that plants grown in
                   different regions have different
                   medicinal qualities, and regionally
                   specific names have been used to
                   describe where plants came from since
                   at least the time of the Shen Nong Ben
Cao, around 200 CE. For example, the difference between
Zhe Bei Mu and Chuan Bei Mu is whether the plant came
from the province of Zhejiang or Sichuan. Farming of
medicinal herbs became more common during the Ming
dynasty (1368-1644) and knowledge of how to best grow
the herbs was collected and documented. This is when the
term “daodi” begins to show up in classical literature.
   The term ”daodi” is comprised of two Chinese
characters, 道地. The character 地 (di), can be translated as
“earth”, “soil”, or “place." 道 (dao) has many meanings, but
in this case it is something like “the way” or “the method.”
Generally, the term “daodi” can mean something like, “the
method of the place”. In practice, “daodi” refers to an herb
that comes from a specific region known to grow the best
variety of that herb. It encompasses not only location, but
also environmental conditions, genetics, plant and animal

                             16

behaviors that have co-evolved within a specific ecosystem,
as well as specific growing, harvesting, and processing
techniques applied by farmers. Thus, herbs are signified as
“doadi” to indicate that they are of the highest quality13.
    This is not to say that high quality herbs can’t be grown
outside of their traditional daodi regions. Most practically,
the demand for herbs keeps growing and it is not
reasonable to believe we can keep growing enough herbs
in one finite area4. Further, we should remember that the
concept of daodi is based on the writings of the old
doctors, before our modern era of fast global trade and
widespread ecological change. Today, there are no
demonstrable chemical signatures or plant morphology
patterns to indicate that daodi herbs are “best.” As with all
agricultural products, we should expect variation, and we
should adjust our prescriptions accordingly. For example,
if you have a bushel of Granny Smith apples, you might
decide to make a pie, but if it were a bushel of Red
Delicious, you might decide applesauce is the way to go.
Of course, they are all apples, and you could make a pie or
applesauce, or cider, or whatever you want. You might just
need to adjust the amount of sugar according to the flavor
of the apples you have on hand. Medicinal plants work the
same way. They grow all over the world, and come in
endless variety. While “daodi” signifies a specific region
and growing condition known to produce great herbs,
herbalists today are working in a world of changing climate
and global trade conditions that are different from our
ancestors. Today, it is most important to learn to assess the

                             17

plants you have in front of you in order to put them to their
“best” use.

                 ASSESSING QUALITY

                  Organoleptic Assessment

                           Organoleptic (or, macroscopic)
                           assessment concerns all of the aspects
                           that we experience with our sensory
                           organs: taste, smell, appearance, size,
                           texture, color, etc., and is usually the
 John Amos Comenius, Orbis
 Sensualium Pictus, 1695
                           first step in determining herb quality.
                           Most of us use this type of evaluation
every time we pick out produce from the grocery store. For
rapid identification and overall quality assessment, there is
nothing as fast or reliable as the trained human senses. In
general, the lab testing that follows this step is meant to
verify the plant’s identity and verify that there are no
adulterants or contaminants on the herbs.
     Experts in organoleptic assessment have training and
extensive experience assessing herbs. In order to mitigate
variability in people’s taste and subjective experience, each
herb is evaluated using standardized methods and
specifications. For example, is the herb sample the color
that it should be, is it uniform in color or speckled, spotted,
dull, or shiny? Is it hard or soft, rough or smooth, moist or

                                18

dry? Does it smell aromatic, sweet, spicy, foul? Each herb
company may determine their own internal specifications,
so practitioners will find that consistency of bulk herbs will
vary from different suppliers.

                          Lab Tests

                    HPLC Identification

                 High Performance Liquid Chromatography
                 (HPLC) tests an herb’s chemical signature to
                 verify its botanical identity. Very simply,
HPLC works by measuring how much time it takes for a
given set of chemicals to percolate down through a filter-
like column. For example, if you put a liquid extract of what
you think is gan cao through the HPLC column, the various
chemical components in the plant will filter through the
column at different rates. The computer will make a graph
that shows which specific chemicals came through after
one minute, two minutes, five minutes, eight minutes, etc.
By comparing this graph to a control graph of gan cao, you
can verify whether or not your sample is indeed gan cao.
    Typically, by the time an herb sample has made it to the
lab, it has already been assessed for organoleptic,
macroscopic and/or microscopic characteristics. This
means that a person has looked at the sample, tasted it,
smelled it, etc. to verify its identity. A person with
knowledge, experience, and a trained palate is the first
                              19

step to determine a plant’s identity. HPLC is then used to
confirm.
                         Pesticides

    Pesticides are abundant in our ecosystem; pesticide
contamination of herbs can be the direct result of
application on the plants themselves, or can be due to
environmental drift, or cross-contamination during
processing and storage. As discussed above, many herbs
will not be tested for pesticides upon import into the
United States. Thus, many importing companies routinely
commission their own pesticide testing. Labs can easily
test for pesticide residues, but each unique chemical
requires its own specific test. With hundreds, if not
thousands of unique chemicals registered with the EPA, it is
important to ask which specific pesticides have been
tested for and what the acceptable limits are (how much of
any given pesticide is tolerated). Each herb company sets
their own standards for this; some will reject shipments if
any pesticides are detected at all, while others have
determined that low levels of some pesticides are
acceptable. It is also important to know which herbs were
tested; some companies test samples from every lot they
receive, while others just test random samplings.
    The Certificate of Analysis (CoA) shows the results of the
tests and may list each chemical tested for separately, or
they may list only broad categories: organophosphates,
organonitrogens, organochlorines, and N-methyl
carbamates.

                             20

Heavy Metals

                    Heavy metals accumulate in the soil
                    either naturally or due to human made
                    pollution. Plants that grow in
                    contaminated areas will absorb the
                    metals and thus, they may end up in our
medicinal herbs. The preparation method is the key that
determines how much heavy metal could potentially be
consumed in the final medicine. Since most heavy metals
are not water soluble, if contaminated bulk herbs are
decocted in water, most of the metals will not make it into
the final decoction. On the other hand, if the herb is
powdered and taken raw, then 100% of the metals would
be consumed. Therefore, when considering heavy metals,
a test of the final product (pill, tincture, granular formula,
etc.) will be more relevant than a test of the single bulk
herbs before they are prepared.
    The issue with heavy metals was realized in the 1990’s
by many of the granule manufacturers. At the time, most
granules were made with powdered bits of the herb itself
as the “seed” for the granule. Today, almost all
manufacturers have switched to potato or corn starch in
order to avoid the problem of heavy metals11.
    Labs can test for heavy metals. Most reports will have
either a “Total Heavy Metal Test”, or will list arsenic,
cadmium, mercury, and/or lead separately. The United
                              21

States has not set tolerances for heavy metals, so each
company will set their own standards.
                            Sulfur

                Sulfur is among the most common elements
                in the universe; it is not particularly toxic.
                Sulfur dioxide (the smoke of burning sulfur) is
                sometimes applied to herbs in order to
               prevent pests and molds, and to keep the
herbs looking fresh. Some farmers rely on sulfur so that
they don’t risk losing their crop. Sulfur smells bad, but
when applied to crops as sulfur dioxide, it is probably
relatively innocuous.
    This is not to be confused with an allergic reaction that
some asthmatics have to sulfites. A food additive, and also
found naturally in some foods and animals, sulfites are
common in dried fruits and wines, and have been sprayed
onto salad bars and used in restaurants to keep the
vegetables looking fresh. The FDA outlawed this use in
1986, after severe allergic reactions led to multiple
deaths14. There are no sulfites being sprayed onto Chinese
herbs, and there are no reported accounts of sulfite
induced allergic reaction due to Chinese herbs11.
    Labs can test for both sulfur dioxide and for sulfites, but
they are not the same test. In order to test for sulfur
dioxide, an electronic “nose” must test the air inside the
bag that the herb has been packaged in. In order to test
for sulfites that have been sprayed on directly, an extraction
of the bulk herb itself must be tested. If an herb claims to

                              22

be “sulfur free”, you must ask which form of sulfur was
tested for15.
              Microbiological Contaminants

                  Microbial contamination can be from any
                  biological pathogen, from E. Coli, yeast,
                  mold, staphylococcus, salmonella, and
                  more. This sort of contamination is
commonly seen in food-born outbreaks. In 2019, romaine
lettuce was recalled after multiple people got sick with E.
coli, for example16. Microbial contamination can happen at
any point during production, harvest, processing, packing,
shipping, or storage. These tests are almost always
included.

   Ultimately, there is no uniform standard when a
company says their herbs are “lab tested”, so you need to
ask for the details.

                             23

How to Read a Certificate of Analysis

    Upon testing an herb sample, labs create a report
called a Certificate of Analysis (CoA). They typically list
what has been tested for, what test methods were used, the
specifications (or, how much of any given contaminant is
acceptable), and the results.
    You will find that each company’s CoA is a bit different.
Each company decides what to test for, and they each set
their own acceptable limits (if there is no legal mandate).
These determinations are informed by issues specific to
each herb or product. Certain pesticides may be more
common on the more delicate herbs than the hardy roots,
or, a particular type of crop may require a particular type of
pesticide that isn’t widely used on all crops in general. For
example, in 2009, Spring Wind Herbs discovered that Gou
Qi Zi was frequently contaminated with two pesticides that
were not included in their regular battery of tests and isn’t
found on the other herbs. Now Spring Wind includes
these two extra tests on Gou Qi Zi specifically15.
    Some tests are more appropriate for certain types of
products than others. When comparing the CoA samples
included in Appendix 1, you will find SpringWind and
NuHerbs have tested bulk Wu Wei Zi, Evergreen has tested
Xiao Yao San granules, and KanHerbs has tested Zhi Bai Di
Huang Wan tablets. The CoA reports vary accordingly. For
example, the CoA for tablets lists test of hardness,
                             24

disintegration, appearance, color, and odor, but these
factors wouldn’t be relevant to a bulk dried herb. The
granulated formula report does not list tests for pesticides,
but does include TLC images to verify the botanical identity
of each individual herb. You might assume that each of the
bulk single herbs were tested for pesticides before they
were processed together into a granular formula; the only
way to know for sure is to ask the company you are buying
from.
    In summary, most reputable herb companies
incorporate lab testing into their quality assurance
protocol. But, “lab tested” is not standardized, and each
company does it a bit differently. If you want to know more
specific information about the products you are buying,
you should ask to see the CoA. Look to see what tests have
been run, and what the acceptable limits are.

                             25

How to Choose?

       There are a lot of variables involved when trying to
decide which herbal products to buy for your clinic. As
practitioners, we want the best for our patients and we
want the medicine to work. Ultimately, the choice of which
products are “best” is a decision that each practitioner will
need to make for themselves, considering their own needs
and priorities. Some factors that you may consider:

                    Clinical Preference

    Which form of herbal products will be best for your
practice? What is most effective and/or convenient for
your patients?
    Bulk herbs, granules, and some tinctures allow you to
customize formulas for your patients, to varying degrees,
which can potentially make the medicine more effective.
Patent or pre-manufactured pills, tinctures, and topical
products are very convenient, but can not be customized
for the patient. Because they are pre-manufactured, they
circumvent legal responsibilities surrounding pharmacy
manufacturing practices (as described below). There seem
to be almost endless options for herbalists. It is good to
experiment with a few and determine what is best for you
and your practice.

                             26

Cost

    Obviously a concern for any small business. Some
higher quality herbs and products cost more money.
Often, patients expect high quality and they are easily
willing to pay extra. You will need to determine which
quality standards are worth paying for, and match that with
your budget.

                    Supplier Practices

    Does the supplier maintain clean and safe facilities? Do
they maintain records of their processes? Are they
transparent and responsive to your questions? Can you
get a hold of them if you need support?
    It is important to know that the facilities manufacturing
your herb products are clean and safe. But also, if they are
maintaining good records of their supply chain and
manufacturing processes, they will be in a better position
to help you if you need support with your own
documentation. For example, if you are doing your work to
track lot numbers, the supplier should be able to help
continue that paper trail in case of a recall or adverse
event. If you ask for support, or contact them with
questions, they should respond in a timely manner.

                             27

Pesticides

    Pesticides are a concern for most practitioners; some
pesticides have been shown to cause ill effects on human
health. Some have been removed from market after we
learned how damaging they are, but there are still many
thousands of pesticide products available on the market
today. This guide does not discuss the regulation and
safety testing of pesticides, but it is reasonable to
understand why many people have concerns.
    Unfortunately, pesticides are abundant in ecosystems
around the world. Remember that the EPA has determined
safe tolerances of pesticides on our produce crops, and it
is assumed that we all consume a low level of pesticides
regularly. Even the most diligent organic shopper is likely
exposed when they eat at a restaurant or enjoy the
landscaping at a public park. In general, annual food crops
tend to be delicate, highly refined cultivars that are
selected for size, color, fragrance, etc, but not necessarily
for resilience to pests. They are grown in a way that is most
convenient for the farmer and they tend to need a lot of
care and chemical inputs. By comparison, medicinal herbs
require less pesticide input than annual food crops
because they are hardier plants with built in pest
resistance. Herb farms tend to be smaller and more closely
resemble the crops’ native ecosystem than large scale food
operations.
    While only buying pesticide-free herbs seems ideal on
the face of it, expense and availability may lead a

                             28

practitioner to tolerate some low levels of pesticides. It is
expensive for an herb supplier to test for every pesticide
on every herb, and that expense will be passed along to
the consumer. In order to decide if the higher price is
worth it, a practitioner may consider their patient’s
exposure – is it an herb to be taken short term for an acute
situation or is it to be taken daily for months? In some
cases a practitioner may find that there is no pesticide-free
version available of a certain herb. Then the decision
becomes whether to use the herb that you want, tolerating
“safe” levels of pesticides, or if you will make some
substitutions. At times, a strict adherence to pesticide-free
herbs may exclude a large portion of high-quality products.
To illustrate, if you only buy wine from your trusted local
organic certified vineyard, you may be able to avoid
pesticide residues in that bottle, but you will be missing out
on the vast majority of excellent wines that are available
throughout the world1
    Having said that, a very good and often overlooked
reason to avoid products with pesticides is to influence
global markets in a certain direction, to push the industry
to use less pesticides overall. As harmful as pesticide
residues may be for an individual who consumes them, the
bulk of the damage from pesticides is done to the local
ecosystems where they are applied. Local wildlife and
biodiversity is damaged, soil and water contaminated, the
natural resiliency of an in-tact ecosystem is lost. The
farmers who apply the pesticides, the children who live and
play near the fields, pregnant women who are exposed to

                             29

the drift as chemicals are sprayed, these are the people
who suffer the most toxic effects, as they are exposed to
levels far beyond what the EPA has determined is safe. As
the land becomes reliant on chemical inputs and loses its
natural fertility, the farm becomes less financially lucrative
and it becomes more difficult to make a good living as a
farmer. More and more young people are moving to cities
around the world in search of better pay, leaving rural and
small village economies broken. As consumers of these
agricultural products, we should not forget that we can use
our purchasing power to move markets. This may be worth
the added expense.

                           Sulfur

    While sulfur is relatively harmless, it does smell bad.
Understandably, farmers have used sulfur because it is a
relatively safe way to prevent pest and mold infestation
during storage and shipping. Farmers operate on tight
margins and they can’t risk the loss of an entire crop.
Further, sulfur tends to make some herbs look more white
or “clean”. This has been an aesthetic preference among
many consumers, but now the trend is changing.
Consumers are starting to expect and tolerate more
variance and “blemishes” – evidence that the plant was
once alive and growing in the dirt. The current push for
sulfur-free herbs is a great example of how market demand
can influence production practices. Buyers in the west

                              30

began to demand sulfur-free herbs and more producers
changed their practices. Noticing the trend, buyers
throughout Asia have followed suit. Today it is getting
increasingly easier to find sulfur-free options11.

                   Organoleptic Quality

    For practitioners, organoleptic evaluation is our primary
way of determining the quality of products we are selling
to our patients. Though lab testing can ensure that our
products are authentic and free of certain contaminants,
our own senses remain our best way to determine overall
quality. As is the case when picking produce from the
grocery store, personal taste, preference, and intended use
will play a large part. There is no “right” answer for which
apple is the “best”; likewise, herbalists may have varying
opinions of which variety of Dan Shen best suits their
needs. On the other hand, that is not to say that herbal
quality is anyone’s guess.
     Throughout history herbalists have always been
intimately familiar with organoleptic qualities of the plants
they used, and that body of collective knowledge has
traditionally been passed along from teacher to student
through generations. By comparison, the practice of
Chinese herbalism in the United States today has lost that
hands-on, generational thread of knowledge. Our “herbs”
come pre-processed and packaged in plastic,
unrecognizable from the live plants they once were.

                             31

Woefully few practitioners are familiar with the
organoleptic qualities of the plants we use, and a vital
dimension of understanding plant medicine has been
overlooked. The more that practitioners pay attention to
the organoleptic qualities of plants, the more we can
rebuild the collective body of knowledge and create
standards amongst our profession to serve as a baseline of
comparison.
     Characteristics of bulk herbs to consider are the
appearance of an herb: color, texture, shape, and size.
Smell: is it fruity, aromatic, strong or mild, does it smell like
mold, plastic, sulfur, is it just bland? When cooked into a
decoction, what does it taste like: is it bitter, acrid, sweet; is
it a thick strong flavor, or light and thin; does it disperse
quickly or linger? Consider the mouthfeel: is it astringent,
drying, oily, pungent, sticky, etc. Compare the herb that
you have on hand to the descriptions in your reference
materials. If you can, get multiple samples of the same
herb to compare side by side. The more herbs you sample,
the better you will develop your organoleptic senses.
Then, talk to other herbalists and compare your findings.
     When assessing granules you should consider the
texture: coarse granules or fine powder. How well do they
dissolve in water? Fine powders will tend to dissolve easily,
which also leaves them prone to clumping. A higher
percentage of starch (or “binder”) is needed in fine
powders to prevent clumps, compared to coarse granules.
Granules can be more concentrated without clumping
together; they require less starch binders. Sediment that

                               32

settles to the bottom after a few minutes is likely the starch
binder.18
    Next, when assessing granules you should consider the
flavor and aroma. Because most organoleptic
characteristics are lost due to processing - the appearance,
size, color, and texture of the original plant - the flavor and
aroma become the primary means for a practitioner to
assess quality. Notice the smell, both as the bottle is first
opened and after it is mixed with hot water. A stronger
smell indicates that more volatile oils have been preserved.
When you drink the mixture, can you taste distinct flavors
(sweet, bitter, acrid, sour, salty)? Of course, each herb has
its own unique flavor and aroma, but in general, the
powder/granules should be rich and fragrant, not stale or
bland.18

 For more specific guidance on organoleptic assessment:

   Organoleptic Analysis of Herbal Ingredients by Steven
                     Dentali, Ph.D.24

   Materia Medica by Bensky and Gamble includes very
   brief descriptions of quality criteria for each herb.21

 Chinese Medicinal Identification: An Illustrated Approach
                 by Zhongzhen Zhao22

  Chinese Medicinal Plants, Herbal Drugs and Substitutes:
       An Identification Guide by Christine Leon.23

                              33

Ecological and Social Responsibility

        Herbalists are working for the best interest of our
patients and our practice; many of us are also concerned
about our impacts on a wider scale. Most variables in the
world of herbal medicine will remain beyond our control,
but as described previously, we can make choices about
where we spend our money and what kind of market we
would like to support. As with everything in life, there is no
universally “good” choice, and sometimes even our own
priorities will conflict with each other.
        For herbalists, the tools of our trade depend upon
healthy ecosystems. In fact, our health and the health of
our patients does as well. But, it’s not clear what practices
are “best” as we continue to increase our demand for
natural resources. The only hard line here is that no
herbalist should ever be using endangered species.
Beyond that, some questions to ask yourself: wildcrafted
versus cultivated herbs, imported or domestically
produced, whether or not you will use animal products (or
which ones), whether some level of pesticides will be
tolerated, do you prefer organic or GACP certifications,
how long is the supply chain, who is getting most of the
profit from your purchases, etc. You will need to rely on
your suppliers for much of this information, which is why it
is important that they are transparent and communicative.
There are no right answers, and as is described in previous
sections, each of these decisions comes with its own pros
and cons.

                              34

At times, your priorities may be at odds with each other.
For example, the desire for consistent, uniform, high quality
herbs can be at odds with the ideal that wild-harvested
plants make better medicine4. Ultimately, the global
landscape of herbal medicine is shifting; making “good”
choices is a constantly moving target. The most important
thing is to keep yourself informed and occasionally take
time to reflect and reassess your practices.

          For more information on threatened and
                   endangered species:

                       www.cites.org

                www.unitedplantsavers.org

        Mending the Web of Life by Elizabeth Call.

       For more information on domestic production
                         of herbs:

           www.chinesemedicinalherbfarm.com

                www.highfallsgardens.com

                             35

BEST PRACTICES IN THE PHARMACY

    This section pertains to pharmacies that compound
granules or bulk herbs. Since these herbal products will be
opened, combined, and repackaged, the FDA considers
this to be “manufacturing”. The following sections describe
the responsibilities of “manufacturers”. If you are selling
pills or tinctures that are pre-manufactured, these
guidelines do not apply.

                           cGMP

    Current Good Manufacturing Practice (cGMP)
regulations are the laws that apply to all dietary
supplements on the market in the USA, and describe
requirements of production methods, facilities,
manufacturing, processing, and packaging of dietary
supplements. The FDA has been given the authority to
issue and enforce cGMP regulations under the Dietary
Supplement Health and Education Act (DSHEA) of 1994.
Manufacturers are responsible for meeting the standards
and ensuring the safety of their own products, and the FDA
is charged with monitoring manufacturers’ compliance to
cGMP regulations.17
    Because cGMP regulates everything from personnel,
facilities, and processes, to record keeping and traceability
standards, true cGMP compliance can be expensive and

                             36

unrealistic for many small businesses. Recognizing this, the
FDA has stated its intent to practice “discretionary
enforcement” for licensed practitioners of Chinese herbal
medicine compounding herbs for individual patients who
have had a one-on-one consultation. Most Chinese herb
pharmacies in the United States today are operating under
this discretionary enforcement18. This discretion does not
apply if a practitioner is making larger batches without a
specific patient in mind. For example, if you want to make
a large batch of your proprietary allergy tincture because it
is ragweed season and you know that a lot of patients will
need it, that does not fall under discretionary enforcement.
In that case, your pharmacy facilities, processes, records,
etc. are expected to meet all cGMP standards.
    It is important to recognize that the FDA’s discretion is
tenuous. As with any cGMP compliant facility, the burden
of safety lies on the manufacturer of the product, and the
FDA is charged with oversight. The FDA typically does not
check in on every manufacturer, but rather, responds to
complaints after they have been registered. Thus, the
Chinese medicine practitioner should remember that the
FDA has the authority to revoke discretionary enforcement,
and they would be likely to do so if safety problems arise
with Chinese herbs.

              Federal Code, Title 21 Part 111,
           outlines cGMP regulations for dietary
           supplements, and can be found here.

                             37

AHPA

    The American Herbal Products Association (AHPA) is a
trade association that advocates for safe regulation of
herbal products in the United States. Together with the
National Certification Commission for Acupuncture and
Oriental Medicine (NCCAOM) they have created a guide
for Chinese medicine practitioners that outlines best
practices in herbal compounding to ensure the safety and
quality of the medicine being dispensed. The guide is
based on FDA cGMP regulations and, as such, is intended
to reduce the risk of potential adverse events and increase
public safety19.
    Topics covered in the guide include personnel, facilities,
equipment, general practices, herbal compounding
practices, packaging and labeling, records, and complaints
and recalls. The suggestions made are within the financial
reach of most individual or group practices and are
designed to be attainable for most Chinese herbal
pharmacies. This document is not legally binding, and is
only a suggestion. The intention is that, as a profession, we
can maintain the safety and efficacy of herbal medicine and
prevent adverse events.

              Good Herbal Compounding and
                  Dispensing Practices

                             38

Documentation

     While some of the cGMP regulations can be expensive
to attain (like facilities: sinks, countertops, storage,
bathrooms, etc.), meeting the documentation requirements
is within reach for most practitioners. In the unlikely event
of an FDA audit, compliant documentation can go a long
way to show that you are operating responsibly, especially
if you are relying on “discretionary enforcement”.
     Start with a written SOP, or standard operating
procedures. This document describes the details of how
the pharmacy operates from day to day. It is useful not
only for demonstrating that you have safe procedures in
place, but also for training your employees how you would
like things to be done. It should include details of tasks -
everything from filling and restocking herbs to cleaning the
bathrooms - and describe who does the tasks, when, and
how. It should also establish procedures for quality control,
fixing mistakes, and how your pharmacy will respond to
complaints, adverse reactions, or recalls.
     After you have an SOP established, there should be a
system in place for keeping records of all the herbs that
come in and out of the pharmacy. Each shipment of bulk
herbs or granules will have its own unique lot number. You
will keep records of lot numbers as well as every
prescription that you compound and dispense. The goal is
that, in case an issue arises with a patient’s prescription,
you should be able to determine exactly which herbs were
in it, and which supplier they came from. If you find that a
                             39

particular lot of a single herb is contaminated, for example,
your records should also show which of your patients have
received the contaminated herb so that you can quickly
recall it or otherwise address the situation. As problems
and complaints do arise, you should also keep records of
the issue, and how it was resolved.
    You can find guides and templates to help you get
started writing an SOP, and there are various systems to
keep track of inventory and lot numbers that you can adapt
to suit your needs. It may be helpful to refer to documents
from other businesses as an example. The American
Herbal Products Association (AHPA) has many resources to
help pharmacies with documentation, though some
require a paid membership for access.

     The American Herbal Products Association (AHPA)
       has many resources to help pharmacies with
       documentation, though some require a paid
                membership for access.

                             40

Labeling

    The FDA oversees labeling regulations for dietary
supplements. The label must have two key panels: the
principal display panel (front label), and the information
panel (immediately to the right of the principal display
panel). The principal display panel will contain the name of
the product and the net quantity. The information panel
will contain the “Supplement Facts” (nutrition labeling), the
ingredients list, and the name and place of business20.

   • Statement of identity: The name of the product
   should be the most prominent part of the label, in a
   bold font that is appropriately sized in relation to the
   rest of the label. It must include the words “Dietary
   Supplement”, or “Herbal Supplement”, or any word to
   describe which type of supplement it is.
   • Net quantity: The amount in the bottle should be
   expressed by weight, measure, or numerical count in
   both metric and U.S. customary terms. It must be
   prominent and easy to read, in the lower third of the
   principal display panel.
   • Nutrition labeling: This is the “Supplement Facts”
   panel. It must be enclosed in its own box, and the
   words “Supplement Facts” must be in bold and larger
   than all of the other text in the box. The box must
   include the serving size, and how many servings per
   container. The name and quantity of each ingredient
   (including what part of the plant) should be listed
                             41

according to its “common” or “usual” name, no smaller
   than 8 point font. Quantity per serving of each
   ingredient should be listed by weight. For Chinese
   herbs, the “% Daily Value” column should have an
   asterisk to a footnote that states “Daily Value not
   established”.
   • Ingredients list: If all of the ingredients have already
   been listed in the “Supplement Facts” panel (above),
   there is no need to list them again. If there are carriers
   or fillers (alcohol, glycerine, honey, starch, etc.) they
   must be listed as “Other Ingredients” immediately
   below or to the right of the “Supplement Facts” box.
   • Name and place of business: Including the name of
   the business, city, state, and zip code.

   In addition to the pieces required by the FDA, the AHPA
recommends that each label contain:
   • The Patient’s name
   • Dosage form and strength
   • Preparation date
   • Dispensing date
   • Control number
   • Expiration date, if relevant

   Additionally, if not on the label, the prescription should
be accompanied with a declaration of alcohol if present,
any relevant allergy warnings, recommendations for use/
dosage, possible side-effects if applicable, and contact

                             42

information of the herbal compounder, if different from the
practitioner.
    The FDA has outlined protocols for exceptions,
particularly for small labels that can’t fit all of this
information, or for ingredients that are not Chinese herbs.

      You can refer to the FDA in order to ensure that
       your label is in compliance with regulations.

This sample label was retrieved from Crane Herb
Company’s online custom pharmacy, available to licensed
practitioners.

                            43

Appendix 1: Certificates of Analysis

nuherbs Co.
14722 Wicks Blvd, San Leandro, CA 94577

                                        CERTIFICATE OF ANALYSIS
 Latin Name:                     Organic Fructus Schisandrae Chinensis
 Botanical Source:               Schisandra chinensis (Turcz.) Barll.                     Pinyin Name:         You Ji Wu Wei Zi
 Plant Part Used:                Dry Fruit                                                Batch No.:           160101BH086
 MFTD Date:                      Feb. 27, 2016                                            Batch Quantity:      1000kg
 Retest Date:                    Feb. 27, 2021                                            Issue Date:          Mar. 04, 2016
                                 Quality Standard of Organic Fructus Schisandrae
 Testing Reference:                                                                       Origin:              China
                                 Chinensis
                                                                 Test
 Analysis                        Specification                Results          Test Methods                      Detection Limits

                                 Macroscopical Complies       Complies         Visual & Organoleptic, CP2010     /
 Identity
                                 Microscopical Complies       Complies         CP2010                            /

 Impurity

Evergreen Herbs and Medical Supplies, LLC
 17431 East Gale Ave. City of Industry, CA 91748
Website: www.evherb.com; E-mail: sales@evherb.com
     Tel: (626) 810-5530; Fax: (626) 810-5534

                                                    45

This is the first page of an 11 page report from SpringWind Herb
Co. Each analyte is listed specifically.

                                  46

Bibliography

    1. Brand E. Pesticides and Chinese Herbs: Understanding the
Issues. https://www.acupuncturetoday.com/mpacms/at/article.php?
id=32895. Published 2014.
    2. Schafer P, Max M. Cultivating the Wild: Growing Chinese Herbs
in the West, Qi079. 2019.
    3. Schafer P. The Chinese Medicinal Herb Farm. White River
Junction, VT: Chelsea Green Publishing Company; 2011.
    4. Zhao-Seiler N. Sustainability of Chinese medicinal herbs: A
discussion. J Chinese Med. 2013;101(52).
    5. Dewitt J, Chang A. The Problem of the Root. 2018.
    6. US EPA O. About Pesticide Tolerances.
    7. Pesticides | FDA. https://www.fda.gov/food/chemicals-metals-
pesticides-food/pesticides. Accessed February 19, 2020.
    8. 2017 Pesticide Monitoring Report | Enhanced Reader. moz-
extension://6c9f2cac-733a-3b4c-b13b-caae435b4923/enhanced-
reader.html?
openApp&pdf=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F130291
%2Fdownload. Accessed February 19, 2020.
    9. McEvoy M. Organic 101: What the USDA Organic Label Means.
    10. McEvoy M. Organic101: Allowed and Prohibited Substances.
    11. Max M. Qiological: A man out standing in the field of Chinese
herbs: a conversation with Andy Ellis. 2018:Qi013. http://
traffic.libsyn.com/qiological/
A_man_outstanding_in_the_field_of_Chinese_herbs__a_conversation_
with_Andy_Ellis_Qi013.mp3.
    12. WHO guidelines on good agricultural and collection practices
(GACP) for medicinal plants | Enhanced Reader. moz-extension://
6c9f2cac-733a-3b4c-b13b-caae435b4923/enhanced-reader.html?
openApp&pdf=https%3A%2F%2Fapps.who.int%2Firis%2Fbitstream%2
Fhandle%2F10665%2F42783%2F9241546271.pdf%3Bjsessionid%3D

                                  47

B7B41504D4B85A15BBE242EC77F1B645%3Fsequence%3D1.
Accessed February 13, 2020.
    13. Garran TA. Chinese Herb Cultivation: Daodi Practices for
Growing and Processing Chinese Herbs. (Ochs S, ed.). Passiflora Press;
2019.
    14. U.S. ISSUES BAN ON SULFITES’ USE IN CERTAIN FOODS - The
New York Times. https://www.nytimes.com/1986/07/09/us/us-issues-
ban-on-sulfites-use-in-certain-foods.html. Accessed February 16, 2020.
    15. Ellis A. A Discussion of Pesticides and Sulfur in Chinese Herbs.
2009.
    16. Four people in Texas now ill after eating lettuce linked to E. coli
outbreak | KXAN.com. https://www.kxan.com/news/simplehealth/four-
people-in-texas-now-ill-after-eating-lettuce-linked-to-e-coli-outbreak/.
Accessed February 16, 2020.
    17. Current Good Manufacturing Practice (CGMP) Regulations |
FDA. https://www.fda.gov/drugs/pharmaceutical-quality-resources/
current-good-manufacturing-practice-cgmp-regulations. Accessed
February 10, 2020.
    18. Brand E. A Clinician’s Guide to Using Granule Extracts. First.
Boulder, CO: Blue Poppy Press; 2010.
    19. AHPA. Guidance: Best TCHM Compounding and Dispensing
Practices. Silver Spring, MD; 2017.
    20. Dietary Supplement Labeling Guide | FDA. https://
www.fda.gov/food/dietary-supplements-guidance-documents-
regulatory-information/dietary-supplement-labeling-guide. Accessed
February 12, 2020.
    21. Bensky D, Gamble A. Chinese Herbal Medicine: Materia
Medica. Revised. Eastland Press; 1993.
    22. Zhao Z, Chen H. Chinese Medicinal Identification: An Illustrated
Approach. Paradigm Publications; 2014.
    23. Leon C, Yu-Lin L. Chinese Medicinal Plants, Herbal Drugs and
Substitutes: An Identification Guide. Royal Botanic Gardens, Kew; 2017.

                                      48

24. Dentali S, Ph D, Editor M. Organoleptic Analysis of Herbal
Ingredients. 2013;(March).

                                 49