Herb regulation

December 2, 2000

Dear Stephen,

thank you for your pointed questions. As an educator of Chinese

herbs, as well as the owner of a Ch. Herb company, I took the time to

try to answer each and every one of your questions. I knew about half of

the toxic herbs by heart. We knew of the aristolocic acid problem by at

least 1995. however you lost me towards the end: what is the " C of A " ?

Cara Frank

December 3, 2000

Cara,

By knowing " about half " of the toxic/sl toxic herbs you definitely win the

door prize. After looking at the list a day earlier I could only remember

about a third. The question probably isn't as relevant as it sounds since

only a few hands full of the toxic or slightly toxic herbs on the list are

commonly used in the US, or even in China for that matter. I am encouraged

that you are interested in the issue of QA/QC since very little response

came from my email, despite the importance of this subject to the future of

Chinese herb use in the US.

A " C of A " , also known as a Certificate of Analysis, is what a lab provides

to tell you a number of important considerations that should be part of

everyone's quality assurance and quality control programs (QA/QC). The

information in a C of A depends on what information you have asked the lab

to provide. The criteria that you decide to use in your quality assurance

(QA) programs would then be part of your quality control (QC) protocols.

Performing a lab analysis on every batch can be expensive, especially if you

order frequently in smaller quantities, which means the cost per kilo for

lab work goes up. So, if you use the same supplier of raw materials, and

that supplier also has a consistent chain of supply for sourcing materials,

then once you have done a C of A on a particular material then periodic spot

checking may suffice, but you should definitely consider it a cost cutting

short cut. If that is the plan, you would probably want to re-certify each

ingredient after the harvest season each year, again, assuming the supply of

the raw material was expected to be consistent, and you felt comfortable

with their storage conditions of the materials. However, source consistency

is often difficult to determine and is not always enough. The larger

companies, many of whom have been lambasted by some on this list for other,

sometimes justifiable reasons, will either insist on a C of A from an

independent lab for every batch, or have their own in house lab that

thoroughly tests every shipment. In fact, on one batch (1500kg) of yin yang

huo extract that we produced last Winter, at two different extraction

facilities using the same exact extraction protocols, with raw materials

that were tested and then provided to the extractors from the same local

herb cultivator cooperative, turned out to have very different levels of

coliforms in every 25kg barrel when it arrived at the US lab! Every 25kg

barrel was tested separately to determine which ones were ok and which ones

were not. Normally the whole batch would have been rejected, even though

there were 1250kg that were ok. But they won't usually test every barrel

expecting to see such a variation. But it happens (!) even under carefully

controlled conditions.

There are three general areas that can be assessed in QC testing. One is

product identity. This is where, for example, aristolochia could be

identified in a batch being sold as stephania. The second is purity. This

category includes many areas, some of which are only occasionally tested,

such as agrochemical adulterants, like quintozene in ginseng. The common

areas of purity on a C of A include:

Particle size, i.e. mesh

Total heavy metals: some also include individual impurities such as:

lead, cadmium, mercury, arsenic,

Moisture: as a percentage

Total ash: as a percentage

Total, although not individual pesticides

Foreign Matter

Standard plate count: bacteria in units per gram

Mold

Yeast

Salmonella

E. Coli

Total Coliforms

Pseudomonas aeruginosa

Staphylococcus

Aflotoxin

The third area of measurement you may chose to undertake would measure the

level, typically in percentage, of certain chemical compounds that are used

as standards to assure consistency. These are referred to as " marker

compounds " or " characterizing compounds " . Some would like to believe that

these compounds are a reflection of active components, and therefore

biological potency. That may be partly the case in some herbs and not the

case in many others. The marker compounds chosen for measurement are

typically a choice reflecting the purified reference materials that are

available to labs for relevant chemicals in that herb.

Cara, What is the name of your herb company and where do you teach? Does

your herb supplier ever provide any of this QC information? I know that

many of these test are done routinely by the Japanese Kampo GMP-standard

manufacturers in Taiwan, such as Sheng Chang.

Stephen Morrissey OMD

CAra Frank [herbbabe]

Saturday, December 02, 2000 4:36 PM

Re: herb regulation

Dear Stephen,

thank you for your pointed questions. As an educator of Chinese

herbs, as well as the owner of a Ch. Herb company, I took the time to

try to answer each and every one of your questions. I knew about half of

the toxic herbs by heart. We knew of the aristolocic acid problem by at

least 1995. however you lost me towards the end: what is the " C of A " ?

Cara Frank

Chinese Herbal Medicine, a voluntary organization of licensed healthcare

practitioners, matriculated students and postgraduate academics specializing

in Chinese Herbal Medicine, provides a variety of professional services,

including board approved online continuing education.

December 4, 2000

well geez, I hope the door prize is a trip to Hawaii!

I do know what a cert. of analysis, I just hadn't heard C of A.

My company is China Herb Co., In philly. I teach on my own, mostly here,

because we have no acup schools in this area. We do have to go to the

expense of testing our products for molds, bacteria, etc, because our

products are water concentrates, with alcohol added later to preserve

them. originally we had less alcohol -16-18%, but the tests came back

high normal, so we felt compelled to increase the alcohol to 20%. this

is lowest amount that we can use and still preserve our product.

we depend on our raw herb suppliers to test for metals, pesticides and

other contaminants. We keep annual files of these certificates.

It's hard to remember all the toxic herbs because some of them are just

plain poisonous and we never use them, like lilu - is that the name? lu

li? lots of the harsh expellants don't really get more than lip service

in an herb class. and some herbs are not terribly worrisome, like ban

xia, which is already processed for us.

What company are you with?

Cara

December 5, 2000

If it is, Cara, I'll be glad to show you local medicines.

> well geez, I hope the door prize is a trip to Hawaii!

David

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January 12, 2004

Hi All, & Hi

wrote

> My extensive thoughts on herb regulation can be found at:

> bluepoppy.com/press/download/articles/chin_herb_reg_oct.cfm

that was a fine article.

I agree that " if we can't beat them, join them! " The herbal

professions should join forces with the Drug Registration agencies

and push for the highest standards of GMP and QC (certification of

active ingredients, contaminants, etc; adequate labelling, adequate

data-sheets, with dosages, indications, contraindications, etc).

Below is a summary of some key points in Todd's article and his

selected abstracts:

As used by trained practitioners, Chinese herbalism appears to be

safe, w rare adverse reactions documented worldwide. Most CHMs

are safe if used on professional advice. One UK eczema cluster is

thought to be related to allergic hypersensitivity, not general

toxicity.

AVOID CHM/use w caution in pregnancy & infants; may increase

risk of neonatal jaundice. Chuenlin & Yinchen can increase risk of

hyperbilirubinaemia. AVOID these in neonates.

AVOID unnecessary (non-medical) long-term use of Mahuang,

Eucommia, & Renshen.

AVOID unnecessary use of Hbs/Formulas w cinnabar (red mercuric

sulfide), [like Bao Chi San, Xiao Er Zhi Bon Ding & Xiao Er Bai

Shou Dan], calomel (mercurous chloride), / other Hg-containing

agents. They can cause Hg poisoning.

AVOID use of CHMs except on professional advise. Most serious

poisoning with CHMs are due to a few preparations containing AA,

aconitine, podophyllin or anticholinergics,/proprietary preparations

containing toxic Western drugs or heavy metals. Wintergreen oil

(methyl salicylate) can be very TOXIC if ingested.

Chinese herb nephropathy (CHN): Samples used by affected

people had aristolochic acid (AA), a known nephrotoxin. incidents

did not involve traditional use of herbs. In no case was formula

prescribed by a fully trained & licensed practitioner of TCM. amount

of AA in formulas used in Belgian outbreaks was exceedingly low

(maximum 3-6mg per day). This is much lower than would be

expected to exert nephrotoxic effects & also much lower than

amounts typically present in Chinese formulas which contain this

Aristolochia species. AA-containing herbs have apparently been

used safely in Asian medicine for hundreds of years. TCM prohibits

long-term use of Aristolochia fangchi (Guangfangji); this may have

protected people in past.

Chuanwu (Rx Aconiti carmichaeli) & Caowu (Rx Aconiti kusnezoffii)

have very toxic C19 diterpenoid alkaloids, esp aconitine,

mesaconitine & hypaconitine. Excessive amounts are TOXIC

(nausea & emesis, paraesthesia, numbness in mouth &

extremities, hypotension & ventricular extrasystole) & may kill.

Death may occur from ventricular arrhythmia, usually within first 24

h. antiinflammatory, analgesic & cardiotonic effects;

musculoskeletal disorders.

Interferon (IFN) Tx may cause acute interstitial pneumonitis as a

side effect, & Xiao Chaihu Tang (Sho-saiko-to, TJ-9) may worsen

this side effect. IFN causes neutrophils to accumulate in LU. TJ-9

alone may not injure LU but it increases IFN effects. When

stimulated by some antigen, TJ-9 may overstimulate neutrophils.

Granulocytes elastase & oxygen radicals released from activated

neutrophils may damage LU. Fibroblasts that repair damaged

tissue may increase risk of LU fibrosis. In patients w chronic active

hepatitis, the pneumonitis was due to allergic-immunological

mechanisms. S & Ss incl: fever, dry cough, dyspnoea, hypoxaemia,

diffuse infiltrates both on chest radiography & chest CAT, restrictive

pulmonary functional impairment, & alveolitis on examination of

lung biopsy, lymphocytosis was observed in association w

dominant CD8+ T-cell subset in bronchoalveolar lavage fluid. TJ-9 is

used in type B chronic hepatitis; can modulate both cellular &

humoral immune responses specific for HBV. It is an IFN-

alpha/beta inducer capable of repeated peroral administration.

Jin Bu Huan (Lycopodium, serratum) has potent neuroactive levo-

tetrahydropalmatine. Jin Bu Huan Anodyne Tablets have caused

severe toxic effects after acute ingestion in children & long-term

use in adults. A single, acute ingestion in children rapidly produced

life-threatening neurologic & cardiovascular S & Ss (rapid onset

bradycardia & CNS & respiratory depression). Long-term use in

adults was associated w hepatitis, fever, fatigue, nausea, pruritus,

& abdominal pain & w signs of jaundice & hepatomegaly.

Podophyllum emodi & Datura metel are TOXIC.

Some countries have banned Stephania & Magnolia, even though

they were not implicated in CHN. Stephania tetrandra (Hanfangji)

had been substituted by Guangfangji. Magnolia officinalis (Houpo)

is not known to have any toxic potential.

FDA will require certificates of analysis for AA & contaminants for

import of certain herbs, esp Hanfangji, Muxiang, Mutong & Xixin.

Some people have suggested finding substitutes for herbs such as

Mutong, Xixin, & Muxiang. However, it is impossible to practice

" ancient prescription (gu fang) " herbalism without using Mutong &

Xixin. One should use only herbs w certificate of analysis.

Best regards,

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January 13, 2004

Hi All,

See the article by on herb regulation at:

http://bluepoppy.com/press/download/articles/chin_herb_reg_oct.cf

m

I agree with Todd that " if we can't beat them, join them! " The herbal