herb quality control

[Guest guest]

I agree with some of your conclusions below. Voluntary industry

self-policing is always preferable to government imposed policing, because the

latter is generally more susceptible to corruption and influence by the largest

mega-corporations. As a glaring example of this, the FDA has always been a tool

of the pharmaceutical cartels. Their pretended concern and tears over ephedra is

nothing but hypocrisy, when there are 106,000 deaths/year from " non-error,

adverse effects of medications " - read: correctly prescribed drugs. Check it

out; see:

 

[h1] Starfield, Barbara; " Is US Health Really the Best in the World? " ;

Journal American Medical Association 2000 Jul 26, 284(4):483-5.

Also in webpage at:

http://jama.ama-assn.org/issues/v284n4/ffull/jco00061.html

 

[h2] Castleman, Michael; " The Other Drug War " ; In: webpage at

http://www.motherjones.com/mother_jones/ND98/castleman.html

Mother Jones Magazine, 1998 Nov/Dec.

 

I'm hesitant to endorse standardized granules, however. I've always used whole

dried herbs in preference over pills, powders, or granules, due to the fact that

with whole herbs I have some control over the quality: visual appearance, smell,

texture all give clues as to the species identity and cleanliness of the

product. In powders and granules, one is much more at the mercy of the company's

quality control. I'm sure there are good companies, but there are have been

major documented problems with contamination of vitamins with everything from

solvents to heavy metals and molds. I do not use or recommend vitamin

supplements for that reason, but instead recommend whole foods, organically

grown if possible. High school chemistry texts indoctrinate students into

believing that industrial chemistry is a neat and tidy process where the

reactants are predictable. In reality, the process is considerably messier, even

a simple extraction process will usually leave a certain small percentage of

solvent behind; extraction of oil-soluble vitamins often involves toxic

solvents.

 

Springwind Herbs is one company I believe is taking the best route - checking

for species identity and having standardized chemical assays done on their

batches of whole herb shipments to test for heavy metals, pesticides, and other

known types of contamination for specific herbs. As China industrializes,

increasing caution must be used regarding Chinese herbal products. The advantage

of Springwind's method is that it uses chemical assays to verify indentity and

chemical constitutents, but it also allows the practitioner to double-check

using smell, taste, and visual identification. We do not need to be forced into

a system in which we are totally dependent upon corporations (which have been

knowm to lie) to tell us what is in a batch of greenish-brown powder. I've

noticed that many of my western herbal colleagues are far more sophisticated in

their botanical and phytochemical knowledge, and take species identification

more seriously than most TCM herbalists, who tend to trust what the label says.

With companies other than Springwind, species substitution and mislabeling has

been a persistent problem, and this problem was revealed during the aristolochia

scandal. (I would argue that TCM herbal training programs should consider

including botany and phytochemistry courses, that is, after they have satisfied

their core TCM herbology course requirements, which are also generally

deficient.)

 

This current ephedra scandal, and the aristolochia scandal a few years ago, are

all part of a great chess game, with Macchiavellian rules. It's important that

the players, including ourselves, know what these hidden rules are, or we will

continually be surprised when we lose. The big players always play for the

long-term. Last year I delivered a paper at a UC Berkeley conference on this

topic. You can read all the gory details at:

 

http://www.rmhiherbal.org/review/2003-2.html

Orwellian schemes for maximizing health-care industry profits

- How these endanger the practice of herbal medicine

 

Specifically, you might be interested in the section on herbal standardization,

its advantages and pitfalls, and how this issue is being used by Codex

Alimentarius to impose these standards worldwide:

http://www.rmhiherbal.org/review/2003-2.html#t-bioc

 

Also, there are some important points to keep in mind regarding principles of

Anglo-American law that affect corporations and flesh-and-blood people

differently. If you are operating under a grant of licensure, you are operating

in a quasi-corporate capacity. If you are an herbalist operating as a matter of

common-law right, you are not. See:

 

http://www.rmhiherbal.org/a/f.ahr3.rights.html

The right to practice herbology, legal history and basis

 

http://www.rmhiherbal.org/review/2003-4.html

The Dumbing Down of American Education: Implications for Herbal

Education

(See especially: A summary of Thom Hartmann's findings on corporate

abuse of power)

 

The preceding issues are at the heart of the rights of indigenous people

worldwide to continue traditional herbal practices without interference. Note

that most of the abuses related to ephedra involve deceptive marketing practices

by corporations. Individuals are the downline victims of this. The danger of not

appreciating this distinction is that we will allow the government to crack down

on individuals' rights, when there is a simple corporate-based solution:

Require all corporations who manufacture products with ephedra to

include a simple warning in large print on all of their ephedra products:

" Warning: this product contains ephedra, which may cause or aggravate

high blood pressure, heart palpitations, nervousness, resting perspiration,

etc.... Not recommended for weight loss. "

 

Another aspect that you bring up is comparing the regulatory systems in Japan

and Taiwan - these are much more homogeneous cultures than that of the U.S., and

in which the traditional health professions are better established. In the U.S.,

the general public does not understand much about TCM, plus, via the FDA, the

pharmaceutical cartels have much more power than in almost any other country.

This is one reason drugs are so much more expensive here. The vast majority of

all pharmaceutical profits are made in the U.S. So, according to Macciavellian

rules, you can expect the pharmaceutical interests to sabotage any viable

alternative, which is a major argument for keeping the FDA out of the herbal

business and begin to self-regulate as much as possible.

 

As most of us know deep down, the real agenda of the FDA is not to save lives,

but to use the ephedra and aristolochia issues as excuses to restrict the

availability of herbal health care. So let's start playing the game by the real

rules, instead of the rules by which most people are pretending to play.

 

Roger

 

 

> Thu, 29 Apr 2004 02:18:57 -0000

> " " <

>was do a search/now quality control

>

....

>the logistics are pretty straightforward. it is already done for drugs. I

think we

>should set up our own adverse event reporting infrastructure, but not support

>government imposition. The bush admin supports development of voluntary

controls

>in every other industry, so why not us. Because we have dropped the ball while

we

>rode the gravy train of supplement sales during the past decade. BTW, any

grand

>regulatory overhaul of supplement regulation that creates a category of chinese

>medicinals for rx by licensed healthcare providers only is gonna have some

strings

>attached. We should se this crisis as a great opportunity to settle this

matter once

>and for all.

>

>One issue I have long predicted we would have to face is herb quality control.

It is

>one thing to allow dietary supplements to sold willy-nilly with regard to

dosage.

>Items that have been reserved for professional use must meet a much more

stringent

>standard. No one is going to care how much antioxidants are in your broccoli,

but

>you bettter darn well know how much ephedrine is in your ma huang that you

>prescribe for asthma. Merely saying that has been done safely for thousands of

years

>won't cut it with this crowd. One merely vhas to point to the AA debacle to

identify a

>safety issue that was not known traditionally. While we can claim this issue

is

>overblown, it remains the standard by which other TCM incidents will be judged

for

>some time to come.

>

>There is a reason that Taiwan and Japan's state healthcare systems only

reimburse for

>granules and not raw herbs - standardization. When one goes looking for models

of

>herb regulation worldwide that protect consumers while not restricting licensed

>practitioners, the issue of standardization is always central. Same in

germany, for

>example. We can argue that this has never been necessary in ancient china, but

then

>do we really know how many people needlessly died from using bogus herbs.

People

>have this mystique of the ancient herbalist at one with nature, but I suggest

the

>reality is more likely one of illiterate, undereducated folks trying to get by

in a hostile

>world. Lot of mistakes were probably made. And today's herbalist has even

less

>experience with the actual plants since most people only take pills.

>

>So people can talk all they want about things like sensory evaluation of herbs

based

>upon models from the food industry. No one would even consider applying such a

>model to drugs and this is the comparison that will be made if want to have our

own

>prescriptive category. Think how ludicrous it would sound to go to the FDA and

say

>that we are going to regulate ourselves, but we have decided our standard of

safety

>and potency will be based upon smell and taste of herbs, rather than

biochemical

>analysis. foods may be OK to rate this way, but consider that even substances

that

>are rated by the senses for quality, such as wine, still must be measured for

alcohol

>content using scientific means to be sold legally. the take home message is

that we

>can't have our cake and eat it, too.

>

>If we want to practice medicine and we want our medicinals recognized as

effective

>and physiologically active, we must be willing to submit to standards even

imposed

>upon bioactive foods like alcohol. It does not matter that we do not prescribe

ma

>haung based upon ephedrine content. We better know what consitutes a dangerous

>does of ephedrine and be able to insiure that noone ever receives such a dose.

This

>can never be accomplished satisfactorily with raw herbs or products assessed

purely

>by sensory means. The possibility of human error is much more grave in

medicine

>than in winemaking. So while I would never argue that biochem analysis is

enough to

>determine the best herbs, it is necessary to determine the baseline and upper

safety

>levels in a way that will satisfy the feds. And to be honest, unless you

handle raw

>herbs every day, I don't think it serves the social good to do anything less.

>

>Todd

>

 

---Roger Wicke, PhD, TCM Clinical Herbalist

contact: www.rmhiherbal.org/contact/

Rocky Mountain Herbal Institute, Hot Springs, Montana USA

Clinical herbology training programs - www.rmhiherbal.org

[Guest guest]

Springwind Herbs is one company I believe is taking the best route - checking

for species identity and having standardized chemical assays done on their

batches of whole herb shipments to test for heavy metals, pesticides, and other

known types of contamination for specific herbs

>>>I can tell you that Sheng Cheng/Quliherbs also does this on every batch of

raw herbs before they except it from their suppliers, They do all the checks

twice, in Mainland and again at their factory in Taiwan. They not only check for

contamination, but also for levels of active ingredients and finger printing

Alon

 

 

[Guest guest]

Roger,

 

, rw2@r... wrote:

 

> I'm hesitant to endorse standardized granules, however. I've always used

whole dried herbs in preference over pills, powders, or granules, due to the

fact that with whole herbs I have some control over the quality: visual

appearance, smell, texture all give clues as to the species identity and

cleanliness of the product. In powders and granules, one is much more at the

mercy of the company's quality control.

 

Your points are all well taken. However my main interests are pragmatic. I

mainly use raw herbs in my practice, also. I am not sure what your patient

dmographics are, but most patients will not take raw herbs. In addition, pills

are more approriate for long term use, so one's bias towards raw herbs in

certain circumstances cannot mitigiate the fact that sometimes one will use

pills and powders. While I agree that skillful herbalist can make naked sense

judgements, I do not think that is a common skill inour field, nor is there time

to teach this skill at school. Some people clamor for more western science,

others for more chinese classics, others more qi gong. There is no room for

any of these things in the current 3400 hour master's program at PCOM.. I

still maintain the only way to insure quality control is via biochem analysis.

the criticisms you make of the vitamin industry vis a vis contamination are

not inherent processing issues, but, ironically, issues of inadequate

enforcementof existing regs.

 

 

>>> I'm sure there are good companies, but there are have been major

documented problems with contamination of vitamins with everything from

solvents to heavy metals and molds.

 

And I see raw herbs with all these issues sold from every pharmacy in town. I

think you are setting up an ideal scenario to make your case. That the

herbalist would identify the contaminated herbs on sight. And yet every

girlfriend I have ever had has to ask me if the meat or milk is still fresh.

and

most male roommates haven't had a clue how to tell kale from chard. I think

you overestimate people's potential skills in this area.

 

>

>We do not need to be forced into a system in which we are totally dependent

upon corporations (which have been knowm to lie) to tell us what is in a batch

of greenish-brown powder.

 

 

I think you are wrong about this and every worldwide trend in herbal

regulation suggests otherwise to me. Again, I think you paint a rosy scenario

that no legislators would even consider going for. I also think you are

incorrect in your assertion that an herbalist has any legal right to practice

without a medical license of some sort (this is the position of Barbara

Mitchell,JD, LAc, former chair of NCCAOM).. And while I share your concerns

about the codex, it not really a matter of having a codex or not. It is only a

matter of what form it will take. Its coming in some form. If we take the

extreme libertarian position that neither herbs nor herbalists need to be

regulated in any fashion, then the regulations will be crafted by others. Or we

can participate in creating rational regulations that will be a compromise to

some ideals. But if anyone thinks living in a democracy means anything other

than compromise, we live on different planets.

 

Keep in mind that none of this stops the herbalist from using raw herbs. But

one major CA insurance company (calpro) has already pulled the plug on all

malpractice coverage of herbs. Insurance companies and government

regulators will demand standardization. If we want to get paid by insurers,

covered by medicare and have our research accepted, only standardization will

suffice. I don't dispute your ideal as desirable. I just don't see it coming

to

be. And more importantly, I think such a position actually works against our

professional interests.

 

[Guest guest]

, rw2@r... wrote:

 

Roger,

 

You are a prolific and an enjoyable writer. I went to this article as you

suggested and have the following comments:

 

> Specifically, you might be interested in the section on herbal

standardization, its advantages and pitfalls, and how this issue is being used

by Codex Alimentarius to impose these standards worldwide:

> http://www.rmhiherbal.org/review/2003-2.html#t-bioc

 

Tactic: Promote the regulatory standardization of herbal products by requiring

that each batch of product meet or exceed the requirements of a standardized

biochemical profile based on a few presumed " active " ingredients.

 

My thought: I would never want to restrict the whole plant. The japanese and

the taiwanese have access to both type of herbs and both professionaland lay

care. My interest in creating a scheme for standardization is to make

research and insurance coverage possible. This so as many as pssoible may

have access to the least invasive, most effective therapies. Nonstandard

methods with no evidence behind them will be be relegated to only those who

can afford them (pretty much as it is now). Unfortunately, I see the trend in

medicine as being towards reform of managed care. we are not going back to

fee for service. National healthcare is just another form of MCO. In order to

reach the greatest number of people over the next 50 years, we must make a

version of TCM palatable to the mainstream. I know you disagree. but once

inside, our mere presence will disrupt things in unfathomable ways that will

ripple for decades. I see us shrinking into oblivion if we remain completely on

the outside. However I definitely salute you for planting the flag that you

have. At the very least, it will be a banner under which we can retreat when

you are finally proved right. :-)

 

 

Roger: Such a requirement may seem on its face to prevent cheap or ersatz

raw material substitutions, but it also conveniently ignores the complexity of

many plant products (i.e., ginseng) and dramatically increases the expense of

production, effectively shutting down many small herbal wildcrafters and

herbalists.

 

Me: You detail many of the good reasons to standardize in your last post, but

seem to remain concerned that any type of standardization would result in an

aberration from natural complexity. As I have stated many times, thisis

possible, but not necessary. for example, if the process is merely one of

simple alcohol extraction and concentration, I hardly see how manipulating

the concentration of the final product alters the natural proportions of

constituents.

 

1. I take 25 grams of ma huang

 

2. I add 16 oz. vodka

 

3. After two weeks, I measure the ephedrine content. Hypothetically it

measures at 25 mg/oz.

 

4. Since I want to standardize at 35 mg/oz., I distill off about 30% of the

liquid. I now have a standardized product.

 

If the next batch tests at 40 mg/oz., I will have to ADD solvent to standardize

it. The standardization only guarantees consistency of dosage. It does not

mean that ma huang is limited in its action to ephedrine content. But if

ephedrine is proportional to the volatile oils in the plant, that ratio stays

the

same whether you add or remove solvent. Sure, you can indeed manipulate

products to pass spec. But this only means one should buy from smaller or

reputable companies. It does raise the question of whether some japanese

products are whole extracts or just pass biochem spec.

 

Roger: Moreover, this scheme creates new opportunities for profit by

synthesizing counterfeits of the " herb " that meet the biochemical profile

regulatory standards but are significantly cheaper to produce. Only the larger

companies, of course, have the resources to take advantage of this exciting

opportunity.

 

Me: interesting. we must be ever vigilant.

 

Roger: If the certification process remains voluntary, and if consumers could

still freely purchase the raw unprocessed herbal product, the added

competition might help to improve overall industry standards and quality.

However, all these advantages may be overwhelmed by the following risks if

such standardization becomes mandatory and results in the removal of non-

standardized products from the marketplace [i5]:

* Mandatory certification of biochemical profiles would transform the herbal

industry into a high-tech operation for which large corporations would have

the distinct advantage of finances and resources.

* Mandatory certification would likely increase the costs of herbal products.

 

Me: I agree. we should oppose any mandatory certification.

 

Roger: * Once a company obtained FDA approval for a standardized version of

an herbal product, the company would have a clear financial self-interest in

lobbying for regulations and legislation to make such product available only in

standardized form and only with a physician's prescription, regardless of

public denials of such intent.

 

Me: all the more reason to engage in the legislative process. we must prevent

this and would have broad support from the supplement industry on this one.

 

[Guest guest]

The question to ask about these tests are always the limits. Yes, Sheng

Chang checks, but the limit is most of the time 100ppm for the sum of the

heavy metals. This means, they do not differentiate them. The limit for

mercury lies in most countries at around 0.1ppm. Thus 100ppm (or even 20ppm,

which sometimes is done) simply does not cut it. Even for lead, a sensible

limit is 10ppm. Hence, 20ppm or 100ppm is completely useless in my opinion.

>>>>>Simon, do you know how many companies do these when they sell raw herbs

Alon

 

 

[Guest guest]

Also, most granule companies do testing but, like I said in my last mail,

with non-relevant limits.

>>>>>Simon what have you found when testing granules. i would really like to

know. I hate to think that I am giving herbs high in lead etc.

Alon