S-722

[Guest guest]

I received a political announcement about a new senate bill that could

dramatically expand FDA's powers to pull supplements from the market. As

you know, I do not believe DSHEA will be overturned or changed in any way

that dramatically restricts the sale of most supplements OTC. there is

just too much big money involved. However, were push come to shove, where

would we stand. Personally, I think the best bet would be to take the

tactic that seems to be working for us, which is to seek L.Ac. exemptions

from any such rule, with exemptions likewise for manufacturers whose

products may only be obtained through a licensed healthcare provider.

 

While in theory it might be a libertarian shame if the average joe couldn'

t get his echinacea at 7-11, the fact is that this average Joe is

typically wasting his hard earned money if he buys his supplements in a

health food store. We have nothing to lose and plenty to gain if

regulations forced people to seek the advice of us instead of some high

school working a summer job at the local co-op. Excuse my harshness, but

I was witness yesterday to the debacle of a grocery store intake, where

the 18 year old clerk asked pretty detailed questions to a customer and

then " prescribed " a slew of products. That type of " freedom " doesn't help

anyone, least of all us.

 

So take a look at the letter below , which I have altered from the one

sent to me in order to reflect my quite different position on this matter.

For a detailed consideration of this matter a few years ago, see my

article on the blue poppy website.

 

 

Dear Senator-------------

 

I respectfully urge you to do all in your power to amend S-722 to include

an exemption for licensed acupuncturists and their suppliers. It was

introduced March 26, 2003 by Senator Richard J. Durbin. Its intent is to

overturn the main provisions of the Dietary Supplement Health and

Education Act of 1994. Senators Hatch and Harkin working with Rep. Bill

Richardson won unanimous enactment of DSHEA after years of debate in

Congress. S-722 would give the FDA the potential power to remove thousands

of herbs and other dietary supplements from the marketplace. It would

only take one complaint to trigger FDA's action. S-722 would give FDA

complete discretion to make this determination regardless of whether the

product was used by consumers who completely disregarded dosage, cautions,

or warnings by the manufacturer on the label.

 

While I understand there are reasonable concerns over the current

regulatory framework governing the supplement industry, licensed

acupuncturists are fully trained to prescribe over 300 herbs and other

supplements. Our safety record on this accord is impeccable. We have a

covenant with our patients. In California, we are primary care providers.

Unlike non-professional lay herbalists who cannot be sanctioned by

revocation of licenses and corporations whose sole motivation is profit,

we are professionally constrained in our behavior and there are already

legal mechanisms in place to sanction us. It would serve no public good to

include us in this law. I will support reasonable changes to DSHEA if

Licensed Acupuncturists and other qualified healthcare providers are

exempted.

 

I would urge the the Senate to include language in their proposed law

similar to

that proposed for the regulation of ma huang/ephedrae in California,

adapted as follows:

 

" This rule shall not apply to a licensed health care practitioner who is

practicing within his or her scope of practice and who prescribes, sells or

compounds an herbal mixture in the course of the treatment of a

patient under the direct care of the licensed health care practitioner.

Nor shall it apply to companies whose products are only dispensed from the

offices of or by prescription of licensed healthcare providers "

 

 

Gratefully yours,

 

Name

Address

 

 

 

 

Chinese Herbs

 

 

" Great spirits have always found violent opposition from mediocre

minds " -- Albert Einstein

[Guest guest]

Todd -

Just a thought - that perhaps it should not be the L.Ac. who is

exempted. In many, if not most, states, the L.Ac. has no required

herbal training. This is why in NY we went with exemption for the NCCAOM

herb certification for exemption (and we got it!). In New York

there are many L.Ac's handing out herbs who absolutely should not be and

are not trained to be. While this is not the case in CA, I think it

is important to recognize that this is a federal bill, not a state one

and that we need to use our national certification exams as a standard

rather than a state exam that many people may not take because they do

not graduate from a CA approved school (although they might meet the

standards of CA).

Marnae

At 10:42 PM 7/4/2003 -0700, you wrote:

I received a political

announcement about a new senate bill that could

dramatically expand FDA's powers to pull supplements from the

market. As

you know, I do not believe DSHEA will be overturned or changed in any way

 

that dramatically restricts the sale of most supplements OTC. there is

 

just too much big money involved. However, were push come to shove,

where

would we stand. Personally, I think the best bet would be to take

the

tactic that seems to be working for us, which is to seek L.Ac. exemptions

 

from any such rule, with exemptions likewise for manufacturers whose

 

products may only be obtained through a licensed healthcare

provider.

While in theory it might be a libertarian shame if the average joe

couldn'

t get his echinacea at 7-11, the fact is that this average Joe is

typically wasting his hard earned money if he buys his supplements in a

 

health food store. We have nothing to lose and plenty to gain if

 

regulations forced people to seek the advice of us instead of some high

 

school working a summer job at the local co-op. Excuse my

harshness, but

I was witness yesterday to the debacle of a grocery store intake, where

 

the 18 year old clerk asked pretty detailed questions to a customer and

 

then " prescribed " a slew of products. That type of

" freedom " doesn't help

anyone, least of all us.

So take a look at the letter below , which I have altered from the one

 

sent to me in order to reflect my quite different position on this

matter.

For a detailed consideration of this matter a few years ago,

see my

article on the blue poppy website.

 

Dear Senator-------------

I respectfully urge you to do all in your power to amend S-722 to include

 

an exemption for licensed acupuncturists and their suppliers. It

was

introduced March 26, 2003 by Senator Richard J. Durbin. Its intent

is to

overturn the main provisions of the Dietary Supplement Health and

Education Act of 1994. Senators Hatch and Harkin working with Rep. Bill

 

Richardson won unanimous enactment of DSHEA after years of debate in

 

Congress. S-722 would give the FDA the potential power to remove

thousands

of herbs and other dietary supplements from the marketplace. It

would

only take one complaint to trigger FDA's action. S-722 would give

FDA

complete discretion to make this determination regardless of whether the

 

product was used by consumers who completely disregarded dosage,

cautions,

or warnings by the manufacturer on the label.

While I understand there are reasonable concerns over the current

regulatory framework governing the supplement industry, licensed

acupuncturists are fully trained to prescribe over 300 herbs and other

 

supplements. Our safety record on this accord is impeccable.

We have a

covenant with our patients. In California, we are primary care providers.

 

Unlike non-professional lay herbalists who cannot be sanctioned by

revocation of licenses and corporations whose sole motivation is profit,

 

we are professionally constrained in our behavior and there are already

 

legal mechanisms in place to sanction us. It would serve no public good

to

include us in this law. I will support reasonable changes to DSHEA

if

Licensed Acupuncturists and other qualified healthcare providers are

 

exempted.

I would urge the the Senate to include language in their proposed law

 

similar to

that proposed for the regulation of ma huang/ephedrae in California,

adapted as follows:

" This rule shall not apply to a licensed health care practitioner

who is

practicing within his or her scope of practice and who prescribes, sells

or

compounds an herbal mixture in the course of the treatment of a

patient under the direct care of the licensed health care

practitioner.

Nor shall it apply to companies whose products are only dispensed from

the

offices of or by prescription of licensed healthcare

providers "

 

Gratefully yours,

Name

Address

 

 

Chinese Herbs

 

" Great spirits have always found violent opposition from mediocre

 

minds " -- Albert Einstein

 

 

[Guest guest]

, Marnae Ergil <marnae@p...>

wrote:

-

>

> Just a thought - that perhaps it should not be the L.Ac. who is

> exempted. In many, if not most, states, the L.Ac. has no required herbal

> training. This is why in NY we went with exemption for the NCCAOM herb

> certification for exemption (and we got it!).

 

good point, but should we use federal law to force the states hands. I am sort

of a states rights advocate to the limit of the law. probably because the west

coast tends to be way ahead of the feds on just about everything that matters

to me. so if a state allows herbal practice w/o a certificate, I support that

right

of the state just to insure that we can still do our own thing out here (since

it

looks like secession won't fly). But I do not feel comfortable using a federal

end run to impose the NCCAOM herbal exam on the states. I do certainly

support high standards for herbal training, but CA standards are way higher

than the feds and ours are still not high enough. However I did hear the

national was much harder this year, so perhaps things are a changin'. If the

national was actually an exam, I might change my mind.

 

[Guest guest]

--- In

, Marnae Ergil

<marnae@p...>

wrote:

-

>

> Just a thought - that perhaps it should not be the L.Ac. who

is

> exempted. In many, if not most, states, the L.Ac. has no

required herbal

> training. This is why in NY we went with exemption for the NCCAOM

herb

> certification for exemption (and

we got it!).

 

At 5:44 AM +0000 7/8/03, wrote:

good point, but should we use federal law to force the states hands.

I am sort

of a states rights advocate to the limit of the law. probably

because the west

coast tends to be way ahead of the feds on just about everything that

matters

to me. so if a state allows herbal practice w/o a certificate, I

support that right

of the state just to insure that we can still do our own thing out

here (since it

looks like secession won't

fly).

--

 

 

The problem with states that don't certify herbal practice is

that it leaves the practitioner in a legal limbo. By not certifying

that we can practice herbal medicine, the state is not really saying

we can do our own thing. The state can very easily come after us for

practicing medicine without a license. So, the states right to not

license herbal medicine (with the emphasis on medicine) is potentially

a greater restriction on the freedom of individual practitioners than

a required license. In a situation where there is an underlying legal

hazard, laissez faire is not really operating even if it pretends to

be, and IMO individual freedom, as well as public safety, is better

protected by specific legislation.

 

I agree with you that it would be preferable if this was done at

the state level, and the federal legislation should defer to states

that have their own license.

 

Rory

--

[Guest guest]

, Marnae Ergil <marnae@p...>

wrote:

 

we need to

> use our national certification exams as a standard rather than a state exam

> that many people may not take because they do not graduate from a CA

> approved school (although they might meet the standards of CA).

 

I think we need to use our states scope of practice laws as the standard. If

the

state allows herbs, then it should be OK by whatever standard they set. Most

states use NCCAOM acu exam as a standard that allows herbal practice. I don't

support this personally, but on the other hand, the safety record in these

states is still excellent. States that minimize government regulation in areas

when no perceived harm is being done have a valid political position. In

Oregon, long before the herbal exam was available, Oregon set requirements

for licensees that included a minimum number of hours of herbology study.

There is alos the CA exam as an other example. There are many ways to skin a

cat and I don't want the federal one imposed upon me unless it is better.

 

In states that do not include herbology in their scope, it is illegal to

practice

herbology. Many people are under the misconception that if it is not banned,

it is legal (Marnae, I know you know all this, but for others...). However all

state medical practice acts ban the practice of ALL forms of medicine unless

one recieves a specific exemption under one's license. So your scope of

practice is your exemption fromthe state medical practice act. If you do any

thing not explicitly stated or implied in your scope, then you are practicing

medicine without a license. This the opinion of Barbabra Mitchell, JD, L.Ac.

former president of NCCAOM and every other legal authority I have spoken

with.

 

If these states want to add herbology to their scopes, they will have to either

accept the NCCAOM herb exam or set up some other mechanism. the easy

route is to just accept the exam. However if a state wants to allow herology in

their scope of practice for acupuncture with no form of testing or

accountability (as some states currently do, I believe), then who am I say what

is right for them.

 

[Guest guest]

At 10:42 PM -0700 7/4/03, wrote:

While in theory it might be a

libertarian shame if the average joe couldn'

t get his echinacea at 7-11, the fact is that this average Joe is

typically wasting his hard earned money if he buys his supplements in

a

health food store. We have nothing to lose and plenty to gain

if

regulations forced people to seek the advice of us instead of some

high

school working a summer job at the local co-op. Excuse my

harshness, but

I was witness yesterday to the debacle of a grocery store intake,

where

the 18 year old clerk asked pretty detailed questions to a customer

and

then " prescribed " a slew of products. That type of

" freedom " doesn't help

anyone, least of all us.

--

 

 

Your anecdote addresses the issue of whether store clerks should

be permitted to advise customers about health care matters, rather

than the issue of whether supplements should be available. I thought

that what you describe was illegal. If so, and the current laws were

enforced, surely stores would not allow their employees to do what you

describe, yet a customer would be free to buy products whether by

prescription or as a personal choice. The individual freedom would

therefore be preserved.

 

Rory

--

[Guest guest]

At 10:42 PM -0700 7/4/03, wrote:

Dear

Senator-------------

 

I respectfully urge you to do all in your power to amend S-722 to

include

an exemption for licensed acupuncturists and their suppliers. It

was

introduced March 26, 2003 by Senator Richard J. Durbin. Its

intent is to

overturn the main provisions of the Dietary Supplement Health and

Education Act of 1994. Senators Hatch and Harkin working with Rep.

Bill

Richardson won unanimous enactment of DSHEA after years of debate

in

Congress. S-722 would give the FDA the potential power to remove

thousands

of herbs and other dietary supplements from the marketplace. It

would

only take one complaint to trigger FDA's action. S-722 would

give FDA

complete discretion to make this determination regardless of whether

the

product was used by

consumers who completely disregarded dosage,

cautions,

or warnings by

the manufacturer on the label.

 

While I understand

there are reasonable concerns over the

current

regulatory framework

governing the supplement industry, licensed

acupuncturists are fully trained to prescribe over 300 herbs and

other

supplements. Our safety record on this accord is impeccable.

We have a

covenant with our patients. In California, we are primary care

providers.

Unlike non-professional lay herbalists who cannot be sanctioned by

revocation of licenses and corporations whose sole motivation is

profit,

we are professionally constrained in our behavior and there are

already

legal mechanisms in place to sanction us. It would serve no public

good to

include us in this law. I will support reasonable changes to

DSHEA if

Licensed Acupuncturists and other qualified healthcare providers

are

exempted.

 

I would urge the the Senate to include language in their proposed

law

similar to

that proposed for the regulation of ma huang/ephedrae in

California,

adapted as follows:

 

" This rule shall not apply to a licensed health care practitioner

who is

practicing within his or her scope of practice and who prescribes,

sells or

compounds an herbal mixture in the course of the treatment of a

patient under the direct care of the licensed health care

practitioner.

Nor shall it apply to companies whose products are only dispensed from

the

offices of or by prescription of licensed healthcare

providers "

 

Gratefully

yours,

===================

 

 

I like your letter but, like Marnae, I have problems with the

second paragraph, first sentence. Here is an alternative to knock

around:

 

" While I understand there are reasonable concerns over the

current regulatory framework governing the supplement industry, it is

not reasonable to apply the same regulations, for that industry, to

the professional scope of licensed practitioners of Chinese medicine.

The national standard for training in our profession is a master's

degree including thorough theoretical and clinical training, so that

licensees are fully qualified to prescribe Chinese medicinals safely.

Our safety record is impeccable... "

 

You could also include mention of New York to add weight.

 

Rory

 

Rory

--

[Guest guest]

, Rory Kerr <rorykerr@w...>

wrote:

 

>

>

> I like your letter but, like Marnae, I have problems with the second

> paragraph, first sentence. Here is an alternative to knock around:

 

I appreciate all the comments and they are being incoporated, nothing has

been mailed yet.

 

[Guest guest]

 

May I have your permission to copy the following on to emails for the

board of the Acupuncture Association of Washington(of which I

currently serve as Secretary)? We are currently working on this

very issue and are gathering as much information as possible.

Thank you,

Jill Likkel

wrote

> In states that do not include herbology in their scope, it is

illegal to practice

> herbology. Many people are under the misconception that if it is

not banned,

> it is legal (Marnae, I know you know all this, but for others...).

However all

> state medical practice acts ban the practice of ALL forms of

medicine unless

> one recieves a specific exemption under one's license. So your

scope of

> practice is your exemption fromthe state medical practice act. If

you do any

> thing not explicitly stated or implied in your scope, then you are

practicing

> medicine without a license. This the opinion of Barbabra Mitchell,

JD, L.Ac.

> former president of NCCAOM and every other legal authority I have

spoken

> with.

>

> If these states want to add herbology to their scopes, they will

have to either

> accept the NCCAOM herb exam or set up some other mechanism. the

easy

> route is to just accept the exam. However if a state wants to

allow herology in

> their scope of practice for acupuncture with no form of testing or

> accountability (as some states currently do, I believe), then who

am I say what

> is right for them.

>

 

[Guest guest]

what you say if the store clerk was a licensed acupuncturist , or an

acupuncture student?

many good health food stores do employ/ solicit acupuncturist as clerks (hey

its a paycheck!)

Many HFS's advertise the benefit of their store staffed with

herbalist/acupuncturists

And they do field questions regarding herbal supplements.

 

Would there also be a question of ethics as well as legality?

Should the acupuncturist-clerk maintain records, be HIPPA complaint, is

there a clinet-practionor relationship established. Should the clerk simply

point to the Big Book (Proclaiming the miracle of this special standardized

herb) right next to the special standardized herb on Sale Today

 

I do side with the FDA (here, only) when they express their concerns for the

overly and often outrageous claims made by these phyto-pharmauceticals (as

well as their well paid authors)

 

The drug-cartel is doing the same thing to their doctors. They create a

mass-media hype of the advantages of their drug with free offers and a not

so veiled promise of their wonder drug. Most doctors are hard pressed not to

prescribe the drug.

 

OR like we used to say in Chicago " forget 'bout it "

 

 

Ed Kasper LAc Santa Cruz, CA

 

 

Message: 1

Tue, 08 Jul 2003 12:09:31 -0400

Rory Kerr <rorykerr

Re: S-722

 

At 10:42 PM -0700 7/4/03, wrote:

>While in theory it might be a libertarian shame if the average joe couldn'

>t get his echinacea at 7-11, the fact is that this average Joe is

>typically wasting his hard earned money if he buys his supplements in a

>health food store. We have nothing to lose and plenty to gain if

>regulations forced people to seek the advice of us instead of some high

>school working a summer job at the local co-op. Excuse my harshness, but

>I was witness yesterday to the debacle of a grocery store intake, where

>the 18 year old clerk asked pretty detailed questions to a customer and

>then " prescribed " a slew of products. That type of " freedom " doesn't help

>anyone, least of all us.

--

 

 

Your anecdote addresses the issue of whether store clerks should be

permitted to advise customers about health care matters, rather than

the issue of whether supplements should be available. I thought that

what you describe was illegal. If so, and the current laws were

enforced, surely stores would not allow their employees to do what

you describe, yet a customer would be free to buy products whether by

prescription or as a personal choice. The individual freedom would

therefore be preserved.

 

Rory

 

---

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Checked by AVG anti-virus system (http://www.grisoft.com).

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[Guest guest]

In a message dated 7/8/03 9:12:23 AM, rorykerr writes:

 

 

The problem with states that don't certify herbal practice is that it leaves the practitioner in a legal limbo. By not certifying that we can practice herbal medicine, the state is not really saying we can do our own thing. The state can very easily come after us for practicing medicine without a license. So, the states right to not license herbal medicine (with the emphasis on medicine) is potentially a greater restriction on the freedom of individual practitioners than a required license. In a situation where there is an underlying legal hazard, laissez faire is not really operating even if it pretends to be, and IMO individual freedom, as well as public safety, is better protected by specific legislation.

 

 

This is not to say that if herbs is not in your scope in your state, your malpractice will most likely not cover it, the weasels.

DAVe