EPHEDRA BAN - Exemption for tradition Chinese herbal remedies

[Guest guest]

This is a quandry in itself, in that we want specificity in order to provide

a sort of security in that we would now know " what is " , while without

specificity that is not known. With government, sometimes a lack of specificity,

which

is what we have had for a few decades now, is an invitation to get our act

together. Specifics can be easily changed and need constant observation by

trained eyes, after one gets the specifics, for a slight nuance can show up

years

later as a legal reinterpretation providing exactly the opposite of what we

intended it to mean. The advantage of vagueness is that it can go both ways.

 

That said, the FDA looks as though they are getting more specific, and also

as if they plan to use the framework for this (the ephedra controversy) process

for other substances over the next few years/ decades. We are lucky now, in

that we do have the ear of the Secretary of HHS and to some extent the FDA, who

work for the HHS secretary, and have gotten included the specific exemptions

we have asked for. Now, we need to build on that by expanding our lines of

communications with HHS and especially the FDA. What do we need? What have we

always needed? A sense of unity, volunteers, money, and a plan.

 

I won't elaborate further because I don't want to have this seem an

advertisement for a professional organization as per the rules of this group,

but to be

truthful, this group may want to discuss how it relates to political activity

and how it relates to academia, medicine and the industry of medicine,

patients, and rights.

 

David Molony

 

In a message dated 1/2/04 5:31:32 PM, pemachophel2001 writes:

 

 

> " 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

>

>

> 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]

At 7:56 PM -0500 1/5/04, acuman1 wrote:

>I won't elaborate further because I don't want to have this seem an

>advertisement for a professional organization as per the rules of

>this group, but to be truthful, this group may want to discuss how

>it relates to political activity and how it relates to academia,

>medicine and the industry of medicine, patients, and rights.

--

 

David,

 

I don't know what rules you are referring to here, but if someone has

been representing the profession with regard to this issue, then I'd

like to know who it is. That isn't advertising, it's professional

communication of important information, IMO. A while back similar

information was reported on this list with regard to the New York ban

on ephedra. I don't think anyone accused us of advertising.

 

Please post an account of your dealings with HHS & FDA, so that we

can know what's going on.

 

Rory

--

 

 

 

[Guest guest]

, Rory Kerr <rory.kerr@w...> wrote:

> At 7:56 PM -0500 1/5/04, acuman1@a... wrote:

> >I won't elaborate further because I don't want to have this seem an

> >advertisement for a professional organization as per the rules of

> >this group, but to be truthful, this group may want to discuss how

> >it relates to political activity and how it relates to academia,

> >medicine and the industry of medicine, patients, and rights.

 

 

David

 

Please speak freely on this matter.

 

[Guest guest]

, Marnae Ergil <marnae@p...> wrote:

>

>

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

>

> >In a message dated 1/2/04 4:41:47 PM, @c... 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.

 

 

I think you are correct and I was actually writing my post a question as to how

such a

rule would be written? But I was just backpedaling due to input from the herb

companies. I still am waiting to see " how " the FDA exempts us.

 

[Guest guest]

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

[Guest guest]

 

I think people are getting lost in the wording. The FDA is not

exempting 'us', it's exempting 'it' (the TCM products containing Ma

Huang). There's a big difference. From the FDA website:

 

---

Are all products containing ephedra 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.

--

 

Geoff

______________________

 

Message: 20

Tue, 06 Jan 2004 16:52:52 -0000

" " <

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

remedies "

 

>

> 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.

 

 

I think you are correct and I was actually writing my post a question as

to how such a

rule would be written? But I was just backpedaling due to input from

the herb

companies. I still am waiting to see " how " the FDA exempts us.

[Guest guest]

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

>

> I think people are getting lost in the wording. The FDA is not

> exempting 'us', it's exempting 'it' (the TCM products containing Ma

> Huang). There's a big difference. From the FDA website:

 

 

I have read that and it was my original point that the FDA does regulate px,but

substances. My question remains what is a " TCM products containing Ma Huang " .

This is not defined and the FDA is unable to provide any more details, though

every

spokesman believes this only applies to teas and not other chinese herb

products,

which are already regulated by DSHEA. So could you tell me how this term is

defined

and how it will be enforced. If I make a product with ma huang tang and lobelia

(a

western herb used for asthma), what is that? Or if I modify a classical

formula, is that

a chinese remedy. we will know in a few weeks.

 

[Guest guest]

Hi All

FYI: activity of your national organization on ephedra.

The Acupuncture and Oriental Medicine Alliance sent a letter to the

FDA comments on ephedra on April 4, 2003 describing the history of

ephedra (ma huang)coming to this country from China, the national

certification and state licensure of acupuncturists, the safe history

of use of ephedra by these trained acupuncturists, and requesting an

exemption from the ban based on this safe history. This letter is on

file for public view at the FDA website. We took our letter to several

organizations as a template to encourage more letter writing.

We also sent out a press release at that time entitled " Ephedra Safe

in Small Doses " which quoted those very words from FDA director Mark

McClellan, MD, and underscored his words with interviews with two

acupuncturists. This was sent out to newswriters identified as having

previously written on ephedra or health issues. These contacts need to

be developed into stronger relationships. As noted in Acupuncture

Today October 2003 issue, in general, the media ignored the

perspective of the trained acupuncturist on the safety of ephedra.

During March 2003 we distributed an email entitled " Ephedra Issue May

Have a Silver Lining " to acupuncturists with a template letter

encouraging participation in the comments period on ephedra. This note

held the hope that FDA recognition of our safe herbal practice would

actually be of benefit to our profession. It is hard to know how many

people act when they receive a message of this sort, or feel

comfortable passing it on. How many acupuncturists does it take to

write a letter to the FDA? In May at the national meeting in Florida

we discussed the need to strengthen our distribution of urgent emails.

This communication technology is free, and fast once it is set up. It

is however, my experience that many acupuncture organizations struggle

with finding the time and skills to create effective mailing lists etc.

After the ephedra flurry in spring came another flurry on the GMP

issue. Back to ephedra in the fall I began a review of the Rand

Report(on adverse events related to ephedra)data with a goal of

describing numerically how safe ephedra use by acupuncturists is,

according to the FDA's own source. If any of you have had a chance to

read the report you will know that some parts are vague. After several

attempts to sift this into something definite, my best offer is the

letter which I posted (#23840), much to my chagrin, it seems, after

the horses had bolted. Who knew the FDA would make an announcement on

December 30?

The AOMAlliance works with other organizations and herb companies on

these issues. I am curious to see what effect we have had. As states

regulate health care, improving scope of practice laws to include

herbal medicine is/will be an area of focus for many state organizations.

Clearly herbal issues need our political vigilance. As all of you who

read this are active in professional discussions I will assume that

you already belong to your choice of state and national organizations.

May I suggest a Year of the Monkey Resolution: to bring someone else,

a new or lapsed acupuncturist, or other contributor to membership in

the organizations that help to move our profession forward?

My work is, of course, as a volunteer.

Thank you for the opportunity to share this information.

Mercy Yule, L.Ac.

Chair, Herb Committee

AOMAlliance

 

, " "

wrote:

> , Rory Kerr

<rory.kerr@w...> wrote:

> > At 7:56 PM -0500 1/5/04, acuman1@a... wrote:

> > >I won't elaborate further because I don't want to have this seem an

> > >advertisement for a professional organization as per the rules of

> > >this group, but to be truthful, this group may want to discuss how

> > >it relates to political activity and how it relates to academia,

> > >medicine and the industry of medicine, patients, and rights.

>

>

> David

>

> Please speak freely on this matter.

>

 

[Guest guest]

In a message dated 1/6/04 8:34:42 AM, rory.kerr writes:

 

 

> David,

>

> I don't know what rules you are referring to here, but if someone has

> been representing the profession with regard to this issue, then I'd

> like to know who it is. That isn't advertising, it's professional

> communication of important information, IMO. A while back similar

> information was reported on this list with regard to the New York ban

> on ephedra. I don't think anyone accused us of advertising.

>

> Please post an account of your dealings with HHS & FDA, so that we

> can know what's going on.

>

> Rory

> Rory;

In the rules for this group, it says not to use the group for commercial or

political purposes, which I try not to do. If the following is to much of

either for anyone, I will be happy to step back,

 

Earlier in the Ephedra deal, about a year ago, we sent a letter through

Secretary Thompson regarding our views on Ephedra, and it was sent from the

Secretary's office to the FDA, which is under HHS. It is our opinion that the

number

of letters the FDA got from OM folks (which I think we all supplied), combined

with a letter from a professional organization (AAOM) that came down from

above showing that they were being watched to make sure that folks who had been

using the substance safely continue to have access to it, was what stimulated

the proposed exemption. We have yet to see the wording to that exemption, and

are asking to have input into it, but we are hopeful it will be somethig we can

live with, plus, and this is a big plus, we will start a track record for

working with the FDA on herbal issues from a professional front instead of a

consumer front.

We are hopeful and we have been working a long time on this, even before

Tommy Thompson was made Secretary of HHS, and it is hopeful it will continue

long

after he leaves, which will be next December.

David Molony