RE: Ma Qian Zi and FDA - Digest Number 2784

April 11, 2006

Dear Andrew,

It would be great if the FDA simply had a list of herbs that were not

allowed for import, but unfortunately there is no such list. We usually find

out about which herbs are banned by FDA warning letters or enforcement

actions against us or other herb importers. This is because FDA restrictions

are usually based on chemical ingredients, such as ephedrine and

aristolochic acid, not particular herbs. Only Ma Huang, which we now know is

not allowed for import, is explicitly banned:

<http://www.fda.gov/oc/initiatives/ephedra/february2004/>

During inspections, herbs they know or suspect to contain these chemical

ingredients are held by customs, and either the company can produce a

certificate of analysis proving the product doesn't contain any of the

banned substance, or the herbs aren't allowed in the country.

Therefore, Ma Dou Ling cannot be imported, because it contains aristolochic

acid, which shows up on our routine lab testing. Ma Dou Ling was recalled in

2001, and we have not imported any since. You can check this FDA link:

<http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html>

Xi Xin also naturally contains aristolochic acid. Although processing may

reduce the amount of aristolochic acid, unless it is a very minor ingredient

in a formula it will likely be detectible with an aristolochic acid test. As

the FDA tolerance for aristolochic acid is zero (none detected), we have had

to modify our Chuan Xiong Cha Tiao Wan, and we are no longer able to import

any raw herb, raw herb powder or extract powder of Xi Xin.

The problem with Ma Qian Zi is that it contains the poison strychnine, a

substance that is extremely toxic and commonly used as rat poison, among

other uses. If you're interested, you can read more about it at this link:

<http://www.bt.cdc.gov/agent/strychnine/basics/facts.asp> We have also seen

cases where the FDA has sent warning letters to companies that carried Ma

Qian Zi because they made claims about it, which would make it a drug.

Bing Lang/betel nut has been banned as a carcinogen, and has been recalled

from some manufacturers, see bottom of page on this link:

<http://www.fda.gov/bbs/topics/ENFORCE/ENF00119.html> and last paragraph

second page on the link below, which states, " The products Bin Lang, Mu

Xiang Bing Lang Wan, Ji Ming San, and Bin Lang Si Xiao Wan are adulterated

because they contain betel nut or ingredients derived from betel nuts. Betel

nut contains arecoline, an alkaloid that has been demonstrated to cause

cancer in animals... "

<http://www.fda.gov/foi/warning_letters/m4975n.pdf>

Lei Gong Teng/Tripterygium is an herb under hot debate. On the one hand, it

has been used very successfully to treat arthritis, lupus and other

inflammatory diseases, and targets cancer cells. It targets cancers cells

and causes them to self-destruct:

<http://news-service.stanford.edu/news/2002/january16/cancer_herb.html>

An FDA-approved clinical trial is currently exploring the efficacy of T2

(derived from Lei Gong Teng) in the treatment of rheumatoid arthritis:

<http://molpharm.aspetjournals.org/cgi/content/full/57/3/512> On the other

hand it is an extremely toxic herb with a very small margin of safety, and

has resulted in at least one death:

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_u

ids=7628889 & dopt=Abstract> Lei Gong Teng may or may not be banned by the

FDA as further studies on its toxicity are performed, but it should not have

been included in the list of herbs that have already been banned, and that

will be corrected on our site.

I hope this clarifies the online explanation a bit. Please let me know if

you have any further questions.

Sincerely,

Website Project Manager

Mayway Corporation

1338 Mandela Parkway

Oakland, CA 94607

Tel. 510-208-3113

Fax 510-208-3070

www.mayway.com

Digest Number 2784

Message: 4

Tue, 4 Apr 2006 10:34:29 -0600

" Andrew Fisher, L.Ac. " <afisher

Ma Qian Zi and FDA

In doing some more research on the use of Ma Qian Zi in external liniments,

I ran across the following statement in the FAQ section of Mayway's site:

" Ma Qian Zi, Ma Dou Ling, Bing Lang, and Lei Gong Teng are not for sale due

to toxicity or potential for causing cancer. Although toxicity is associated

with a type of use or an amount, as the FDA cannot control how the herbs are

used, it simply banned them. The use or sale of some of these herbs is a

federal offense. "

(http://www.mayway.com/general/faq_chinese_medicine.htm#pro18)

I wonder if anyone can corroborate the fact that these herbs have been

banned by the FDA. I have been able to price Ma Qian Zi with other sources,

so I imagine that I would be able to purchase it from those sources. I also

know of its use in commercially available liniments (Green Willow Liniment

from Blue Poppy, for example). Also, I have never heard of any problems with

Bing Lang (except for its use in Asia with other substances as a kind of

chew), so it seems strange that it would be banned. If anyone has any

insight into this issue, please let me know.

Thanks!

Andrew Fisher, L.Ac.

Inner Balance Center of Health

3549 North University Ave., Suite 200

Provo, UT 84604

801.356.7600

www.innerbalancesolutions.com

--

Version: 7.1.385 / Virus Database: 268.4.1/308 - Release 4/11/2006

April 11, 2006

, " Laura Stropes "

<laurastropes wrote:

> Bing Lang/betel nut has been banned as a carcinogen, and has been

recalled

> from some manufacturers, see bottom of page on this link:

That being said, betel nut remains the 4th most commonly consumed

psychoactive substance in the world, behind only alcohol, nicotine,

and caffeine. Of course, it is clearly linked with oral cancer but it

remains quite popular in a number of places.

Eric

April 11, 2006

, " "

<alonmarcus wrote:

>

> Eric

> Really? what does it do when you cook it? what happens to the

psychoactive property when you cook it?

I'm not sure if it is psychoactive when cooked. Areca nuts (betel

nuts) are chewed fresh in a quid with slaked lime, frequently with the

addition of the Piper betel leaf (which is a leaf of a plant unrelated

to the palm tree that produces the areca nuts). According to some

research that I've seen on Pubmed, there is an interaction between the

active ingredients in the areca nut and the ingredients in the betel

leaf that potentiates the psychoactive effect. The addition of

mineral lime to the quid appears to be an essential component for

psychoactivity; although many users chew areca nuts without the betel

leaf, all users add the lime. I think the lime must help

bioavailability, or perhaps it produces a chemical change in the

arecoline in a way that makes it more active. So in short, a

sufficiently psychoactive betel nut quid doesn't require the betel

leaf addition, but it appears to require the lime (in this way it is

similar to coca leaf as consumed in South America).

In Taiwan, betel nuts are chewed frequently with a number of different

preparations. The preparations used in India are more diverse and

often involve the addition of tobacco and other substances. In

Taiwan, there are two particularly common preparations: One uses a

young, tender areca nut that is split in the center and stuffed with

the inflorescence of a particular flower and a red lime preparation,

while the other uses a slightly more mature areca nut that is left

whole (the calyx is removed in all preparations), and wrapped in a

Piper betel leaf that has a thin coating of a white lime preparation.

Interestingly, in mainland China, betel nut is commonly available

as a processed, packaged import from Hainan island, and the actual

product is da fu pi (areca husk) rather than bing lang (areca nut)

itself. This product is soaked in a sweetened solution with lime and

then dried.

So to answer your question, I am not sure if either da fu pi or bing

lang as used in Chinese medicine are potentially psychoactive drugs.

The lime and the chewing of a quid may be requisites for this effect.

Swallowing the juice when chewing a betel quid produces nausea, which

does not seem to be a common complaint when used areca products in

Chinese medicine. Furthermore, the coloration of the transverse

slices of bing lang in its dried form in the Chinese pharmacy are

characteristically different than the cross section produced by

slicing a Taiwanese betel nut. Whether the two products are different

cultivars of the same species or whether they are harvested at

different stages of maturity, I am not sure. I do know that betel

nuts in Taiwan are picked when they are fairly young and tender, and

I've heard that betel nuts (for chewing) in mainland China are often

very large. The habit is not prominent in the PRC outside of Hainan

island, as far as I am aware. In Taiwan, it is prevalent in the south

and among minority groups; it is also prevalent among taxi drivers,

bus drivers, and manual laborers. Infrequent recreational use is

common among the general population, but it is considered to be a

disgusting habit by many because of the spitting, the redness of the

mouth, and the damage to the oral cavity seen in chronic users.

People often chew betel quids to stay alert on long drives and it is

widely acknowledged in folk medicine as a useful medicinal substance

for the beginning stage of common colds (should be specifically for

cold patterns- many average people don't know much about

distinguishing cold and heat in common colds, but all Taiwanese people

know that betel nut is considered to be a hot substance).

Eric

April 12, 2006

Eric, are you a Taiwaness??? you explained that better

than me..

The weather in Taiwan is humid & hot, easy to got the

wind-damp-heat syndromes, so, that is the best way to

expel the wind-damp from the body¡K, and we believed

that it is cooler after breaking out the sweat.

Just a side note for your wonderful explanation about

¡§Taiwan¡¦s chewing gum- bing lang¡¨

Christine

--- Eric Brand <smilinglotus wrote:

> , " Alon

> Marcus DOM "

> <alonmarcus wrote:

> >

> > Eric

> > Really? what does it do when you cook it? what

> happens to the

> psychoactive property when you cook it?

>

> I'm not sure if it is psychoactive when cooked.

> Areca nuts (betel

> nuts) are chewed fresh in a quid with slaked lime,

> frequently with the

> addition of the Piper betel leaf (which is a leaf of

> a plant unrelated

> to the palm tree that produces the areca nuts).

> According to some

> research that I've seen on Pubmed, there is an

> interaction between the

> active ingredients in the areca nut and the

> ingredients in the betel

> leaf that potentiates the psychoactive effect. The

> addition of

> mineral lime to the quid appears to be an essential

> component for

> psychoactivity; although many users chew areca nuts

> without the betel

> leaf, all users add the lime. I think the lime must

> help

> bioavailability, or perhaps it produces a chemical

> change in the

> arecoline in a way that makes it more active. So in

> short, a

> sufficiently psychoactive betel nut quid doesn't

> require the betel

> leaf addition, but it appears to require the lime

> (in this way it is

> similar to coca leaf as consumed in South America).

>

> In Taiwan, betel nuts are chewed frequently with a

> number of different

> preparations. The preparations used in India are

> more diverse and

> often involve the addition of tobacco and other

> substances. In

> Taiwan, there are two particularly common

> preparations: One uses a

> young, tender areca nut that is split in the center

> and stuffed with

> the inflorescence of a particular flower and a red

> lime preparation,

> while the other uses a slightly more mature areca

> nut that is left

> whole (the calyx is removed in all preparations),

> and wrapped in a

> Piper betel leaf that has a thin coating of a white

> lime preparation.

> Interestingly, in mainland China, betel nut is

> commonly available

> as a processed, packaged import from Hainan island,

> and the actual

> product is da fu pi (areca husk) rather than bing

> lang (areca nut)

> itself. This product is soaked in a sweetened

> solution with lime and

> then dried.

>

> So to answer your question, I am not sure if either

> da fu pi or bing

> lang as used in Chinese medicine are potentially

> psychoactive drugs.

> The lime and the chewing of a quid may be requisites

> for this effect.

> Swallowing the juice when chewing a betel quid

> produces nausea, which

> does not seem to be a common complaint when used

> areca products in

> Chinese medicine. Furthermore, the coloration of

> the transverse

> slices of bing lang in its dried form in the Chinese

> pharmacy are

> characteristically different than the cross section

> produced by

> slicing a Taiwanese betel nut. Whether the two

> products are different

> cultivars of the same species or whether they are

> harvested at

> different stages of maturity, I am not sure. I do

> know that betel

> nuts in Taiwan are picked when they are fairly young

> and tender, and

> I've heard that betel nuts (for chewing) in mainland

> China are often

> very large. The habit is not prominent in the PRC

> outside of Hainan

> island, as far as I am aware. In Taiwan, it is

> prevalent in the south

> and among minority groups; it is also prevalent

> among taxi drivers,

> bus drivers, and manual laborers. Infrequent

> recreational use is

> common among the general population, but it is

> considered to be a

> disgusting habit by many because of the spitting,

> the redness of the

> mouth, and the damage to the oral cavity seen in

> chronic users.

>

> People often chew betel quids to stay alert on long

> drives and it is

> widely acknowledged in folk medicine as a useful

> medicinal substance

> for the beginning stage of common colds (should be

> specifically for

> cold patterns- many average people don't know much

> about

> distinguishing cold and heat in common colds, but

> all Taiwanese people

> know that betel nut is considered to be a hot

> substance).

>

> Eric

>

Christine Wei Chang, LAc, MTOM

BOD & Herbal Medicine Committee

American Association of Oriental Medicine (AAOM)

310-951-8698 (cel)

panasiaintl

" I think, therefore I am. "

April 12, 2006

, Christine Chang

<panasiaintl wrote:

>

> Eric, are you a Taiwaness??? you explained that better

> than me..

Of course not, I'm a gringo, a lao wai. But bing lang is a phenomena

in Taiwanese culture, so naturally it is an interesting thing to pay

attention to and learn about.

> The weather in Taiwan is humid & hot, easy to got the

> wind-damp-heat syndromes, so, that is the best way to

> expel the wind-damp from the body¡K, and we believed

> that it is cooler after breaking out the sweat.

I'm not really sure about this. You would know more than me on this

topic. The only people I've ever really talked to about betel nut

chewing and common colds were not educated in medicine, and the

generic word for common cold could refer to summerheat, wind-heat,

wind-cold, etc. I always assumed that betel nut was best for

wind-cold because it is warm in nature (by the textbook), and it often

seems to be regarded by locals as a hot substance because it causes

one to feel flushed with warmth and induces sweating. But as you have

mentioned, sweating does help to cool off the body, which is probably

why hot chili peppers are so popular in tropical countries.

Furthermore, bing lang is clinically used to treat malaria when it is

combined with herbs like chang shan and cao guo; malaria is often

related to damp-heat, so maybe bing lang has a wide range of

appropriate use for both damp-heat and cold conditions? Is betel nut

use considered to be better in the summertime or the wintertime?

Eric

April 12, 2006

I used to chew betel nut as pan when I lived in India many years ago.

When I was back this winter, I noticed that pan is now packaged in

single-serving foil packets sold at corner tea and tobacco stands. Of

course, I had to try some. Definitely gave me a buzz, but not

particularly pleasant. The bhang was better.

Bob

, " Eric Brand "

<smilinglotus wrote:

>

> , " Laura Stropes "

> <laurastropes@> wrote:

>

> > Bing Lang/betel nut has been banned as a carcinogen, and has been

> recalled

> > from some manufacturers, see bottom of page on this link:

>

> That being said, betel nut remains the 4th most commonly consumed

> psychoactive substance in the world, behind only alcohol, nicotine,

> and caffeine. Of course, it is clearly linked with oral cancer but it

> remains quite popular in a number of places.

>

> Eric

>

April 12, 2006

Eric's observation is very close to what I experienced....

When I was in service as an ROTC officer back in Taiwan, I had the opportunity

to observe the betel nut chewing habbit closely. Upon my troop's requests, I

often buy these nuts for them. (Remember, these privates came from all walks of

life.) In the winter, or cold nights, they said it warms them up. In the summer,

they said it excites them. Out of curiosity, I did try a few times of different

flavors. They were just too strong for me. Compared to the raw betel nuts, the

processed Bing Lang we have for CM seems to be tastless.

Mike L.

Eric Brand <smilinglotus wrote: