Fwd: EPHEDRA BAN - Exemption for tradition Chinese herbal remedies

[Guest guest]

The American herbal products association believes we have a total

exemption for any traditional use of ma huang and ban xia (see below).

 

Again, it will be interesting to see how this is handled. The FDA is

not able to regulate practitioners, only classify substances. Things

are classed as (for example) foods, food additives, dietary

supplements, OTC drugs, rx drugs and banned. State law then decides

who can sell or prescribe any of these things. For example, ND's can

prescribe 1500 pharmaceuticals in OR, but not most other states. We

can prescribe herbs as Lacs in CA, but not in most other states (I

predict this ephedra issue will really bring scope of practice issues

to the forefront in states without herbs in their law and lead to even

further enforcements in those states). chiros can do acupuncture in

some states, but not others. So the FDA is going to ban ephedra with

an exemption for a particular class of products. However as noted in

my lst post, it remains very unclear how this will proceed. Will

exemptions require proof before marketing or will FDA have to chase

everyone down after the fact. I can hardly imagine the latter.

Personally, I have been lax and played down the fears over the FDA this

past 5 years. But lobbyists should assume worst case scenario and have

contingencies in place. Let's just make sure Mr. Mcguffin is right

about this before it too late.

 

 

 

 

> William Egloff <bill

> Fri Jan 2, 2004 12:08:58 PM US/Pacific

> <

> Fwd: EPHEDRA BAN - Exemption for " tradition Chinese herbal

> remedies "

>

> Hi

>

> I hope this further clarifies the FDA statement about the " Rule " which

> will be made available in several weeks.

> Thanks,

> Bill

>>

>> Dear Friends,

>> I am distributing this email to those of you who have attended one or

>> more recent meeting of AHPA's Chinese Herbal Products Committee and

>> to others if I am aware of your interest in product marketed to

>> professionals.

>>

>> I have received a number of questions regarding the status of the use

>> of ephedra (ma huang) and other herbs by TCM practitioners in light

>> of  FDA's imminent ban of dietary supplements containing ephedrine

>> alkaloids. Since we will not see the actual rule for several weeks

>> there is quite a lot of concern about the impact that a ban on use of

>> ma huangin a proper clinical setting for a traditional therapeutic

>> use.

>>

>> Even though the actual rule is not yet available, FDA has made two

>> statements in its communications of December 30th that are relevant

>> to TCM:

>>

>> • They mean ephedrine alkaloids, not justma huang. In identifying

>> what types of products would be subject to the rule, FDA said,

>> " Dietary supplements that contain a source of ephedrine

>> alkaloids,such asephedra, Ma huang, Sida cordifolia, andpinellia[ban

>> xia]. " (emphasis added) [see the 4th to last Q & A

>> athttp://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html].

>> • They will exempt " traditional " use ofma huang(and presumablyban

>> xia). Here's what they said in addressing whether all products

>> containing ephedra would be affected: " Essentially all currently

>> marketed dietary supplements will be affected by the rule.The rule

>> does not pertain to traditional Chinese herbal remedies.It generally

>> doesn't apply to products like herbal teas that are regulated as

>> conventional foods. " (emphasis added) [see the 3rd to last Q & A

>> athttp://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html].

>> As many of you know, AHPA has been active in communication with FDA

>> on the issue of ephedra for many years. We have always attempted to

>> make sure that the needs of each of our members and their customers

>> are addressed, so we made a point in our most recent comments last

>> spring to identify the use of ephedra in clinical practice and to

>> call for protection of such use. I have pasted the relevant text of

>> AHPA's comments below. I also believe that other organizations may

>> have made similar communications and, absent any surprises in the

>> final rule, it appears as if we have been successful in protecting

>> use of ma huang (and again, presumablyban xia and any other

>> ephedrine-containing herb for which there is " traditional " use) by

>> practitioners within their scope of practice.

>>

>> Happy New Year!

>> Michael McGuffin

>>

>> from AHPA's April 7, 2003 Comments on the Proposed Rule for Dietary

>> Supplements Containing Ephedra Alkaloids

>>

>>

>> Use of ephedra by licensed health care providers

>>

>> Ephedra herb, in its raw form and as an ingredient in dietary

>> supplement products, is widely dispensed by licensed health care

>> providers including licensed, certified or registered acupuncturists

>> who are trained in TCM. Licensure, certification, or registration for

>> the practice of acupuncture is established in 40 or more states and

>> the District of Columbia and it is estimated that at least 15,000

>> licensed, certified or registered acupuncturists practice in the U.S.

>> At least half of the states in which the practice of acupuncture is

>> regulated include use of herbs in the authorized scope of practice

>> for these health care providers. In addition, ephedra is used by

>> health care providers in other disciplines including, for example,

>> naturopathy and herbalism.

>>

>> Ephedra herb (mahuang) is included in the current English edition of

>> thePharmacopoeia of the People’s Republic of China(PPRC) published in

>> 2000. That document was authorized for publication by China’s State

>> Drug Administration and serves as a national and official standard.

>> Raw material ephedra herb must contain not less than 0.8% total

>> alkaloids to conform to this standard. The usage indication

>> identified in the PPRC for ephedra herb is stated as, “Common cold

>> withwind-coldsyndrome marked by chilliness and mild fever, headache,

>> stuffed and running nose, general aching, but no sweating; edema in

>> acute nephritis; bronchial asthma.” Its action is described as, “To

>> induce perspiration for dispellingcold,to relieve asthma, and to

>> cause diuresis.” Daily dosage for these indications and actions is

>> stated to be 2 to 9 grams when used as a decoction (a tea made by

>> boiling). Separate indications are provided in the PPRC for ephedra

>> herb processed with honey as well as for ephedra root.

>>

>> When used by a TCM practitioner ephedra herb is combined with other

>> botanicals, many of which are considered by practitioners to mollify

>> its action as a stimulant. Generally, ephedra herb is used in TCM for

>> relatively short periods of time rather than for chronic use, unless

>> under the supervision of a qualified TCM practitioner. Examples of

>> TCM formulas are set forth on Attachment 1, as are a number of

>> contemporary English language references where additional formulas

>> may be recorded.

>>

>> Ephedra herb is of significant importance to licensed health care

>> providers who use herbs in their scope of practice. In some cases and

>> in some practices, the herb in its raw form is utilized for

>> preparation of tea for use by a patient. Other practitioners prefer

>> prepared products, including ephedrine-containing supplements, and a

>> number of AHPA members manufacture products specifically to meet the

>> needs of this community.

>>

>> It is AHPA’s position that, in addition to protecting consumers

>> access to appropriately labeled and marketed ephedrine-containing

>> supplements generally, use of ephedra herb and ephedrine-containing

>> supplements by licensed health care providers who use herbs in their

>> scope of practice must be protected.

>>

>>

 

Chinese Herbs

 

FAX:

 

 

 

[Guest guest]

, wrote:

> The American herbal products association believes we have a total

> exemption for any traditional use of ma huang and ban xia (see below).

>

 

 

I am trying to figure out how the FDA would word a ruling that somehow exempted

acupunctutists across the board whether they sold patents or teas. How about:

 

" except when dispensed from the office of a licensed healthcare practitioner who

is

legally allowed to prescribe substances containing ephedrine alkaloids in their

state

of practice "

 

I am assured by sources in the herb industry that my concerns are overblown.

They

clearly have a lot to lose, so let's hope they are right.

 

[Guest guest]

" I am assured by sources in the herb industry that my concerns are overblown.

They

> clearly have a lot to lose, so let's hope they are right. "

 

 

 

Amen. All the respondents to my phone calls and e-mails today have sought to

allay my fears. However, as of this writing, it is still

not clear to me that ready-made Chinese medicinal products such as pills,

tablets, capsules, and powders, as opposed to " teas, " i.e.,

decoctions, will be exempt. I sure as hell hope so, but I won't be happy until I

see a much more specific and categorically complete

ruling from the FDA.

 

Bob

[Guest guest]

At 9:39 PM +0000 1/2/04, wrote:

> " except when dispensed from the office of a licensed healthcare

>practitioner who is legally allowed to prescribe substances

>containing ephedrine alkaloids in their state of practice "

--

 

I would name the herbs that are banned by the ruling, rather than say

anything about alkaline alkaloids. State regulations that mention

herbs don't talk about molecules, afaik.

 

Rory

--

 

 

 

[Guest guest]

In a message dated 1/2/04 4:41:47 PM, writes:

 

 

> " except when dispensed from the office of a licensed healthcare

> practitioner who is

> legally allowed to prescribe substances containing ephedrine alkaloids in

> their state

> of practice "

>

This does not take into account those states who do not have prescription

rights for OM folks, the majority of states. It may be time to define what an

education is or a certification is.

David Molony

 

 

 

[Guest guest]

At 08:03 PM 1/5/2004 -0500, you wrote:

 

>In a message dated 1/2/04 4:41:47 PM, writes:

>

>

> > " except when dispensed from the office of a licensed healthcare

> > practitioner who is

> > legally allowed to prescribe substances containing ephedrine alkaloids in

> > their state

> > of practice "

> >

>This does not take into account those states who do not have prescription

>rights for OM folks, the majority of states. It may be time to define what an

>education is or a certification is.

>David Molony

 

I agree that the above is not the way to state this " rule " at this time -

and in fact, as I understand it the FDA cannot exempt individuals anyway.

 

But haven't we already defined what an education/certification is? We have

an education as defined by ACAOM that is nationally accepted (except in CA

- although many ACAOM schools meet/exceed CA standards). We have a

national exam that leads to certification in Herbs and are headed toward an

integrated certification for individuals who have taken multiple

exams. So, is it not more of a political issue on the state level to get

these standards accepted? We may not all agree that these are the best or

the highest standards, but they are the standards that have been accepted

by a national governing bodies and it is my belief that we therefore need

to work with them as minimum standards. A minimum standard can always be

exceeded. To me the issue seems to be more about state associations that

have not been willing to take on the fight to get herbal medicine included

in the practice. Many of the state organization were founded as

professional acupuncture associations and are led by individuals who

unfortunately have little interest in the practice of herbs. As a result,

the issue is often sidelined until something reaches a crisis point. Our

state organizations, with leadership from the national organizations, need

to step up to the plate and start addressing the issue. Now, obviously the

response is well - why aren't you involved. I am - to an extent. I have

experienced a great deal of frustration in my own state regarding the state

association and the issue of herbs. I have been on the board and I was

unable to get it addressed. I have tried from the outside and not been

very successful. So, what's next? Appeal to the national

organizations? I don't know.

 

Marnae

 

 

>

[Guest guest]

Thanks Bob -

 

I've thought about it but I'm not quite ready to take

that step. I'm hoping that the precedents that have

been set in other states will make it possible to

avoid having to put myself through that (selfish?

Perhaps!) The remnants of my political idealism

believe that there are other pathways to getting

things done - working from the grassroots as we did

here in NY with the Suffolk County Legislature set a

precedent that NY City, NY State and CA have followed

- and perhaps the FDA even took it into account - so,

maybe, such a thing would work again. Clearly if it is

going to happen someone has to moblilize the troops.

I have been trying to save up the qi to do it (I am

definitely not a MHT type person!) and I am having

daydreams about the ways to approach it, so maybe I'm

getting there - anyone else in NY who wants to take a

stab at it?

 

Marnae

 

 

--- Bob Flaws <pemachophel2001 wrote:

> Marnae,

>

> One way to " force the issue, " if you are really

> serious, is to purposefully get yourself busted.

> With your credentials, being a woman, a

> recent mother, a law-abiding, responsible member of

> your community, and a bread-winner, you have great

> PR potential. How would it

> look to John Q. Public if little ol' sweet you were

> prevented from feeding your family due to some

> " unfair restraint of trade? " I believe

> Cissy ajebe did purposefully get herself busted in

> NC in order to get acupuncture initially legalized.

> It was also Miriam Lee's getting

> busted in CA that got the law passed there. So there

> is precedent. But don't expect the Democrats to help

> you. They are the party

> that supports the AMA and the general notion of in

> loco parentis. Ironically, it'll be the Republicans

> that'll actually come to your aid in

> the legislative process.

>

> While I did not seek getting busted here in

> Colorado, this what it took for us to get herbs

> added to our legal scope of practice. Like

> many states, we could not have gotten herbs in our

> scope when we were first legalized. It was a

> no-start proposition. However, once a

> well credentialled member of the community was being

> prosecuted and facing inability to continue

> supporting his family, this

> catalyzed the necessary awareness and support. It

> was a helluva 18 months personally, but it did get

> the job done. BTW, get yourself

> back on the Board of Directors of ASNY if you plan

> on taking this route. It's just one more credential

> supporting the fact that you're not

> just a local, individual anomaly. I went out and

> immediately giot elected Prez of the AAC and

> chairperson of the Legislative

> Committee. So now it was the Prez of the AAC who was

> being unfairly harassed and persecuted by the

> medical monopoly and their

> minions, the BME. Had to buy a suit, had to wear a

> tie, had to attend many meetings at the capitol, had

> to deal with a number of AAC

> members who were not on the same page, had to bear

> being libeled and defamed in public, but was it

> worth it all? You bet it was.

>

> Just some personal reflections and experiences.

>

> Bob

>

>

> Chinese Herbal Medicine offers various professional

> services, including board approved continuing

> education classes, an annual conference and a free

> discussion forum in Chinese Herbal Medicine.

>

>

>

>

>

[Guest guest]

In a message dated 1/6/04 10:09:04 AM, marnae writes:

 

 

> Our

> state organizations, with leadership from the national organizations, need

> to step up to the plate and start addressing the issue.  Now, obviously the

> response is well - why aren't you involved.  I am - to an extent.  I have

> experienced a great deal of frustration in my own state regarding the state

> association and the issue of herbs.

>

 

This is true. OM folks need to get more involved to get the state laws to be

inclusive so that we get our practice rights. Right now it isnt' so difficult

to make these changes, but it will get more difficult every year.

David Molony

 

 

 

[Guest guest]

Actually, by adding simple language into the practice act legislatively, we

can do it.

 

Supplemental techniques.--The practice of acupuncture

shall also encompass, as regulated by the board, the use of

traditional and modern oriental therapeutics, heat therapy,

moxibustion, electrical and low-level laser stimulation,

acupressure and other forms of massage, herbal therapy and

counseling that shall include the therapeutic use of foods and

supplements and lifestyle modifications and any other techniques

approved by the board. These supplemental techniques may be for

use within the public domain or for use by any other licensed or

registered health professionals, according to State law and

regulation.

 

Any of these things are generally considered in the public domain (health

food sotres, etc) at this time, so if someone doesn't want you to have it in

your

legislation, ask why we can't regulate our own profession via our board by

responsibly using these things. This is what a board should do. We are not

making it so anyone cannot do these things, but making sure our profession does

them to a credible standard. If other health profession want to meet our

standards, they cn do so to, so it them makes it so physicians who meet our

standards

meet community standard s of care, so they can then not have problems brought

on by lack of education via malpractice suits, etc. It is a win/win paragraph

for any law.

 

David Molony

 

 

Thanks Bob -

 

I've thought about it but I'm not quite ready to take

that step.  I'm hoping that the precedents that have

been set in other states will make it possible to

avoid having to put myself through that (selfish?

Perhaps!) The remnants of my political idealism

believe that there are other pathways to getting

things done - working from the grassroots as we did

here in NY with the Suffolk County Legislature set a

precedent that NY City, NY State and CA have followed

- and perhaps the FDA even took it into account - so,

maybe, such a thing would work again. Clearly if it is

going to happen someone has to moblilize the troops.

I have been trying to save up the qi to do it (I am

definitely not a MHT type person!) and I am having

daydreams about the ways to approach it, so maybe I'm

getting there - anyone else in NY who wants to take a

stab at it?

 

Marnae

 

 

--- Bob Flaws <pemachophel2001 wrote:

> Marnae,

>

> One way to " force the issue, " if you are really

> serious, is to purposefully get yourself busted.

> With your credentials, being a woman, a

> recent mother, a law-abiding, responsible member of

> your community, and a bread-winner, you have great

> PR potential. How would it

> look to John Q. Public if little ol' sweet you were

> prevented from feeding your family due to some

> " unfair restraint of trade? " I believe

> Cissy ajebe did purposefully get herself busted in

> NC in order to get acupuncture initially legalized.

> It was also Miriam Lee's getting

> busted in CA that got the law passed there. So there

> is precedent. But don't expect the Democrats to help

> you. They are the party

> that supports the AMA and the general notion of in

> loco parentis. Ironically, it'll be the Republicans

> that'll actually come to your aid in

> the legislative process.

>

> While I did not seek getting busted here in

> Colorado, this what it took for us to get herbs

> added to our legal scope of practice. Like

> many states, we could not have gotten herbs in our

> scope when we were first legalized. It was a

> no-start proposition. However, once a

> well credentialled member of the community was being

> prosecuted and facing inability to continue

> supporting his family, this

> catalyzed the necessary awareness and support. It

> was a helluva 18 months personally, but it did get

> the job done. BTW, get yourself

> back on the Board of Directors of ASNY if you plan

> on taking this route. It's just one more credential

> supporting the fact that you're not

> just a local, individual anomaly. I went out and

> immediately giot elected Prez of the AAC and

> chairperson of the Legislative

> Committee. So now it was the Prez of the AAC who was

> being unfairly harassed and persecuted by the

> medical monopoly and their

> minions, the BME. Had to buy a suit, had to wear a

> tie, had to attend many meetings at the capitol, had

> to deal with a number of AAC

> members who were not on the same page, had to bear

> being libeled and defamed in public, but was it

> worth it all? You bet it was.

>

> Just some personal reflections and experiences.

>

> Bob

>

>

> Chinese Herbal Medicine offers various professional

> services, including board approved continuing

> education classes, an annual conference and a free

> discussion forum in Chinese Herbal Medicine.

>

>

>

>

>