RE: Huh?? CALL TO ACTION on FDA Ephedra Ban

[Guest guest]

What exactly is going on here? You're right, this is getting confusing,

but is this just complicating a simple matter? I get one e-mail one day

from AAOM stating we have an exemption, and the next day says to write a

letter. Huh? I'm lost!

 

> <

> Fwd: CALL TO ACTION on FDA Ephedra Ban

>

> Unfortunately, Acupuncture today's poorly timed and ill-informed

> frontpage article took some steam out of the drive to challenge the

> FDA's ruling on ephedra. that article made it appear that ...

>

> Practitioner Call to Action on Ephedra Ban

>

> The ruling by the FDA, which states " This final rule does not affect

> the use of Ephedra preparations in traditional Asian Medicine. This

> rule applies only to products regulated as dietary supplements.

> Traditional Asian medicine practitioners do not typically use

> products

> marketed as dietary supplements " is very confusing.

 

The FDA is calling what we do 'traditional Asian Medicine' not dietary

supplements. The only confusing thing is the '...products regulated as

dietary supplements' since it is my understanding that our herbs are

labeled as dietary supplements so we stay in the F part of the FDA and

not the D part. I don't see anything in the FDA site stating that the

exemption applies to only 'bulk' traditional asian medicine and is

banning 'patent' traditional asian medicine. 'Traditional Asian Med

practitoners do not typically use products marketed as dietary

supplements' seems pretty straight forward to me. The FDA already

warned herb companies that will fall under this ruling. I know Mayway

has already sent out letters stating they are not affected by this.

Have any TCM herb companies been notified that they have to pull all the

ma huang / ban xia formulas off their shelves? Not that I see:

 

http://www.fda.gov/bbs/topics/NEWS/ephedra/letterslist.html

 

Check it out. All the ephedrine products are sold by nutracutical

companies selling 'stacker' and 'beefcake pills' and 'ripped' and

similar crap sold by 'anabolic source' and 'advanced sports nutrition'

etc. I don't see one TCM company there.

 

I see where there is some confusion, but when you look at the intention

and action, it doesn't seem like the sky is falling. Really - I think

the panic isn't nessesarily a helathy thing to put out there that is

based on the most reasonable interpretation of the ruling. Has anyone

just called and asked about clarifying that statement?

 

I'm very happy to see our national organizations (and my dues) doing the

work to make sure we are getting the exemptions where we may and think

that the seperation of 'dietary supplements' from 'traditonal asian

medicine' is going to be a good one in the long run. We're not selling

'dietary supplements', it is medicine. Not pharmacutical medicine; it's

traditonal asian medicine. Heck - I'm one the the first to say for

every problem there's and equal and opposite government program, but

really - this ruling seems to have been pretty well thought out and

appropriately influenced by our organizations... Just maybe the wording

isn't as clear as everyone would like. If I've missed something, then

please enlighten me. Facts are, as I see it:

 

1. No firms selling 'traditonal asian medicine' have been contacted

about having to stop selling these products - nor does it seem like they

ever will d/t #2:

 

2. Right from the FDA website (they changed asian to chinese - oops -

maybe honso will be in trouble for their AT comments... ;-)

" The scope of the rule does not pertain to traditional Chinese herbal

remedies "

 

Where's the fire? You can 'what if' or 'what about' all day long, but

stick a couple of #30's in Ki1 and look at it for face value, and it

seems very clear that things should be fine rather than a little

confusing wording bringing down our profession.

Geoff

[Guest guest]

Geoff,

 

The FDA's original ruling was confusing, and some people read it the way they

wanted it to be. However, what appears to be the

FDA's interpretation, at the moment the only one that legally counts, is that

the bulk-dispensation of traditional water-based

decoctions is still ok but not the sale of ready-made medicines containing Ma

Huang and Ban Xia. So, if all you do is bulk herbs,

you're golden. If you sell any ready-mades (i.e., " patent medicines " ), these are

" dietary supplements " under DSHEA and illegal as of

Apr. 12. If you would like the legal right to buy, prescribe, and/or sell such

ready-made Chinese medicinals, then I urge you to contact

your representatives in Washignton via one of the on-line letters easily

available. For instance, simply go to: www.bluepoppy.com for a

downloadable letter.

 

Bob

[Guest guest]

Dear Bob and Geoff,

 

 

On Mar 29, 2004, at 11:53 AM, Bob Flaws wrote:

 

> Geoff,

>

> The FDA's original ruling was confusing, and some people read it the

> way they wanted it to be. However, what appears to be the

> FDA's interpretation, at the moment the only one that legally counts,

> is that the bulk-dispensation of traditional water-based

> decoctions is still ok but not the sale of ready-made medicines

> containing Ma Huang and Ban Xia. So, if all you do is bulk herbs,

> you're golden.

 

For today, bulk herbs are " golden " , and/but we have the Proposed FDA

GMP's coming up later in the year which will hopefully define " do bulk

herbs have to be tested (bio-assays, pesticide, heavy metals, species

ID, etc) by the importer or will testing just be mandated for finished

product " . The Canadian Natural Product Regulations seem like a

reasonable first step for product licensing, but we further need to

disassociate the practitioner from the OTC model. Note : why shouldn't

sinephrine from Zhi Shi, Qing Pi, etc. be a New Drug?

 

Personally, for the practitioner market, the costs of testing will be

well worth the marketing " advantage " it gives the practitioners and

patients.

 

Bill Egloff

 

 

 

> If you sell any ready-mades (i.e., " patent medicines " ), these are

> " dietary supplements " under DSHEA and illegal as of

> Apr. 12. If you would like the legal right to buy, prescribe, and/or

> sell such ready-made Chinese medicinals, then I urge you to contact

> your representatives in Washignton via one of the on-line letters

> easily available. For instance, simply go to: www.bluepoppy.com for a

> downloadable letter.

>

> Bob

>

>

>

>

[Guest guest]

, " Bob Flaws "

<pemachophel2001> wrote:

 

the bulk-dispensation of traditional water-based

> decoctions is still ok but not the sale of ready-made medicines containing Ma

Huang and Ban Xia.

 

what about powders?

 

[Guest guest]

, " Bob Flaws "

<pemachophel2001> wrote:

 

So, if all you do is bulk herbs,

> you're golden.

 

Are you sure. Earlier emails from AHPA and John Chen implied that raw ban xia

and

ma huang may also be banned. I have not heard anything to counteract their

position

since that time. Have you or someone else gotten comment fromthe FDA on this

matter?

 

[Guest guest]

, " Geoffrey Hudson " <list@a...>

wrote:

 

Traditional Asian Med

> practitoners do not typically use products marketed as dietary

> supplements' seems pretty straight forward to me.

 

except that it is incorrect when applied to patent medicines which are all

regulated as dietary supplements. maybe they only intended to exempt teas.

 

The FDA already

> warned herb companies that will fall under this ruling. I know Mayway

> has already sent out letters stating they are not affected by this.

> Have any TCM herb companies been notified that they have to pull all the

> ma huang / ban xia formulas off their shelves?

 

 

good questions.

 

 

Facts are, as I see it:

>

> 1. No firms selling 'traditonal asian medicine' have been contacted

> about having to stop selling these products - nor does it seem like they

> ever will d/t #2:

>

> 2. Right from the FDA website

> " The scope of the rule does not pertain to traditional Chinese herbal

> remedies "

 

 

Except that number 2 is not part of the rule, but only part of the preamble. I

still think number 1 is a very good point, but here is the actual rule:

 

PART 119 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR

UNREASONABLE RISK

119.1 Dietary supplements containing ephedrine alkaloids.

Dietary supplements containing ephedrine alkaloids present an unreasonable

risk of illness or injury under conditions of use recommended or suggested in

the labeling, or if no conditions of use are recommended or suggested in the

labeling, under ordinary conditions of use. Therefore, dietary supplements

containing ephedrine alkaloids are adulterated under section 402ffl(1)(A) of

the Federal Food, Drug, and Cosmetic Act.

 

If it was the intent of the FDA to exempt TCM remedies,it should be written

into the rule. The rule as it stands does not exempt any type of dietary

supplement. People are free to make their own interpretation of this rule,

but for those who are wondering which of the legalese arguemnts is correct,

lets consider the sources. Bill Egloff, president of crane herbs and Bob Flaws

of Blue Poppy and John Scott of Golden flower and John Chen of CSOMA and

Michael Mcguffin of AHPA and Jake Fratkin, noted expert on patent medicines,

all agree that:

 

1. patents are legally regulated as dietary supplements.

 

2. ALL dietary supplements " containing ephedrine alkaloids " are banned by the

above rule.

 

3. Thus all patent meds containing ephedrine alkaloids are banned.

 

There is no other way to read the actual rule, whatever the intent of the FDa

was/is. If the intent was to exempt TCM remedies, this needs to be codified.

By stating it in the preamble, but not the rule itself, the FDA may be stating

its intent to not enforce this rule against makers of TCM remedies, but this

is not satisfactory. A change of heart or administration could lead to

increased enforcement. The rule as it stands does allow enforcement against

chinese patents. Whether that will actually happen is an open question and

the absence of any letters from the FDA as of yet is telling.

 

However Bob is right, whatever stance one might take against this rule is

somewhat mitigated by the fact that both product liability and malpractice

insurers will just not cover the use of these products at all even if

manufacturers are willing to sell them and practitioners prescribe them. And

companies and practitioners who perform dangerous practices or sell

dangerous products may may just find themselves too big a risk to insure at

all. That raises the ethics of prescribing products to patients who may have

no recourse to sue the manufacturer if they become ill from said product (not

due to the presence of ephedrines, but from some truly dangerous

contamination like mold or bacteria). If you prescribe a non covered item, it

does not matter why it made the patient sick. You are not covered, as I

understand it.

 

The ramifications here are potentially immense and if anyone is dawdling

about writing letters, I can't see the rationale. If the concern is overstated,

writing a letter won't hurt. On the other hand, failing to write a letter could

really hurt if the concern is stated correctly. there are 850 members on this

list and this is the only forum I know of where an ongoing discussion of this

matter has taken place since the first notice of this rule 3 months ago. If

everyone makes sure they inform 10 others (and they each tell a few others,

too) of this matter and impress the importance of writing a letter even if the

case is overstated, we can get most of the L.Ac. and TCM students in the US

on board.

 

 

[Guest guest]

Bob,

I've searched through the register for the FDA ruling and the Q & A

section. Where did you find the wording that this ruling only applies

to patents and not bulk herbs? I did not find any such wording on the

entire site. Additionally, none of the TCM herb companies have been

contacted. The wording on the FDA website clearly states, and correctly

so, that what TCM practitioners do is 'traditional Chinese medicine',

not dietary supplements - regardless of what we print on the labels or

bulk vs. patent (I'll wager a bet that the words on our herb labels

don't fool anybody at the FDA into thinking patent or bulk herbs are

'dietary supplements', but they do tolerate us as long as we keep our

nose clean). I'll make a wild assumption and assume that patents

massively out-sell bulk herbs and therefore it would be reasonably

assumed that patents and bulk easily fit under the umbrella 'TCM'. I

agree, it's not a clear as could possibly be. If there was wording that

said bulk herbs were exempt, then I would be up in arms. I'm not trying

to be argumentative; I just think that a phone call could clear this up

rather than panic.

 

Geoff

 

> __________

>

> Message: 6

> Mon, 29 Mar 2004 16:53:10 -0000

> " Bob Flaws " <pemachophel2001

> Re: Huh?? CALL TO ACTION on FDA Ephedra Ban

>

> Geoff,

>

> The FDA's original ruling was confusing, and some people read

> it the way they wanted it to be. However, what appears to be the

> FDA's interpretation, at the moment the only one that legally

> counts, is that the bulk-dispensation of traditional water-based

> decoctions is still ok but not the sale of ready-made

> medicines containing Ma Huang and Ban Xia. So, if all you do

> is bulk herbs,

> you're golden. If you sell any ready-mades (i.e., " patent

> medicines " ), these are " dietary supplements " under DSHEA and

> illegal as of

> Apr. 12. If you would like the legal right to buy, prescribe,

> and/or sell such ready-made Chinese medicinals, then I urge

> you to contact

> your representatives in Washignton via one of the on-line

> letters easily available. For instance, simply go to:

> www.bluepoppy.com for a

> downloadable letter.

>

> Bob

[Guest guest]

 

Good points - but I think your later post that had the response from the

FDA on ban xia and ma huang just clarified that WYSIWYG. I would love

to see the wording 'officalized' but could see that we're being closely

watched and they are going to keep TCM in the 'gray' area - therefore

ambiguity is the axe they're holding over us.

 

Geoff

 

PS - is anyone getting a copy of these 'exemptions' off of the FDA

website? Get it printed out before they're gone! It will help build a

good defence if ever needed.

 

 

> __________

>

> " " <

> Re: Huh?? CALL TO ACTION on FDA Ephedra Ban

>

> except that it is incorrect when applied to patent medicines

> which are all

> regulated as dietary supplements. maybe they only intended

> to exempt teas.

>

> The FDA already

> > warned herb companies that will fall under this ruling. I

> know Mayway

> > has already sent out letters stating they are not affected by this.

> > Have any TCM herb companies been notified that they have to

> pull all the

> > ma huang / ban xia formulas off their shelves?

[Guest guest]

> I've searched through the register for the FDA ruling and the Q & A

> section. Where did you find the wording that this ruling only applies

> to patents and not bulk herbs?

 

This further clarification has come through communication with the FDA to AHPA,

the American Herbal Products Assoc., the trade

association that represents most of the CM ready-made companies in the U.S. It

is also the interpretation of the ruling by more than

one lawyer. It is the working interpretation of K'an, Blue Poppy, Golden Flower,

Mayway, Nuherbs, KPC. Sunten/Brion, Evergreen,

Health Concerns, Pacific Biologic, Crane Herbs, etc., etc. The ruling only has

to do with DSHEA. Our ready-made products are legally

sold in the U.S. under DSHEA. As dietary supplements, any product containing Ma

Huang and Ban Xia is banned from sale in the

U.S. as of Apr. 12, 2004.

 

Bob