FDA Draft Guidance on CAM Products

[Guest guest]

Some of you may be aware that the FDA on Feb 27 issued a Draft

Guidance on CAM Products. The comment period closes April 30, 2007.

I've prepared a one-page analysis of the document, as a pdf file. It

is posted at http://www.convergentmedical.com (Click on News Desk

when you go there).

 

There's been a bit of a flap about this document in CAM

circles,largely through lack of understanding over what it says and

means. Yes, it is indeed important to learn about it. No, you probably

needn't rush to comment to the FDA on it.

 

The FDA reiterates a number of important working definitions, points

out that context of use defines regulatory category, and reminds CAM

entities that they are subject to the same regulatory standards as

everyone else. Hence be very very careful about claims for products.

 

Greetings!

 

David Kailin, Ph.D., M.P.H., L.Ac.

[Guest guest]

Hi everyone,

 

Check out...

 

www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

 

particularly pg.8 par. 3

 

To illustrate how these definitions might apply, consider an herbal

product that is

intended to treat arthritis in humans. The herbal product, which would

be a " biologically

based practice " insofar as CAM domains are concerned, would be a

" drug " under section

201 (g)(l)(B) of the Act because it is intended for use in the

diagnosis, cure, mitigation,

treatment, or prevention of disease (arthritis) in man. The same

herbal product would

also be a " new drug " under section 201 (p)(l) of the Act unless it is

generally recognized,

among experts qualified by scientific training and experience to

evaluate the safety and

effectiveness of drugs, as safe and effective for use under the

conditions prescribed,

recommended, or suggested in the labeling. " New drug " status triggers the Act's

requirements for premarket review and approval by FDA.'~

 

 

My question...

 

How are we to " not treat " treat, for instance, arthritis?

 

" Here, Bob, I'm " not prescribing " prescribing this herb formula for

your " not arthritis " general well being. This formula is in no way

intended to treat, mitigate or cure your arthritis.

 

This, of course, is absurd. Yet, it seems to me that this is what the

above paragraph dictates.

 

This is what the FDA is currently considering and will accept public

input only until April 30th.

 

Read the whole document and see if my interpretation is correct or

not... maybe I'm wrong. I think it is pretty clear.

 

I disagree with Dr. Kailin. I think it is VERY important!!

Do not assume that all will be well. This is how we lost Ma Huang.

The FDA assured herb suppliers that the ban would not apply to Chinese

Medicine, but here we are...no Ma Huang. There was an interview in

Acupuncture Today with the president of, I believe, Lotus some time

ago. If anyone has back issues of A.T. and can find that interview, I

would appreciate you posting it as an example of how the FDA is not

exactly forthcoming with it's agenda.

 

 

Sincerely,

dr.w

[Guest guest]

This is basically the situation we have now and have had for a long time. It

basically says

that this or that therapy can make no (unproved) claim about treating a disease.

It may

seem unfair but that is why if one wants to move at the Western Medical level we

need to

have these (very expensive) trials. Read further down in the document you cited

about the

cranberry juice. One can give juice for urinary discomfort but not UTI's. As I

understand it,

I can give my herbs to " treat " abdomen discomfort and nausea conditions but not

the

" disease " of hepatitis.

On the surface, again it may seem unfair, especially with our history, but

without it some

sort of structure, every formula from Si Ni San to Zuo Gui Yin would treat

cancer. And if

Zuo Gui Yin would not then be classified as a Drug, there will be ten thousand

hucksters

who will hock it to the consumer in just that way.

So of course, I would like to be able to " treat " more but I don't see an easy

way out of the

dilemma. It's going to take a real creative effort to changes things out of the

current

regulations and I don't see it happening without massive changes to the way our

profession is licensed and regulated. For that reason, I'm not that dissatisfied

with the

current situation.

doug

 

 

 

, " Dr. W. W. Waldrope DOM AP "

<dr.w.w.waldrope wrote:

>

> Hi everyone,

>

> Check out...

>

> www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

>

> particularly pg.8 par. 3

>

> To illustrate how these definitions might apply, consider an herbal

> product that is

> intended to treat arthritis in humans. The herbal product, which would

> be a " biologically

> based practice " insofar as CAM domains are concerned, would be a

> " drug " under section

> 201 (g)(l)(B) of the Act because it is intended for use in the

> diagnosis, cure, mitigation,

> treatment, or prevention of disease (arthritis) in man. The same

> herbal product would

> also be a " new drug " under section 201 (p)(l) of the Act unless it is

> generally recognized,

> among experts qualified by scientific training and experience to

> evaluate the safety and

> effectiveness of drugs, as safe and effective for use under the

> conditions prescribed,

> recommended, or suggested in the labeling. " New drug " status triggers the

Act's

> requirements for premarket review and approval by FDA.'~

>

>

> My question...

>

> How are we to " not treat " treat, for instance, arthritis?

>

> " Here, Bob, I'm " not prescribing " prescribing this herb formula for

> your " not arthritis " general well being. This formula is in no way

> intended to treat, mitigate or cure your arthritis.

>

> This, of course, is absurd. Yet, it seems to me that this is what the

> above paragraph dictates.

>

> This is what the FDA is currently considering and will accept public

> input only until April 30th.

>

> Read the whole document and see if my interpretation is correct or

> not... maybe I'm wrong. I think it is pretty clear.

>

> I disagree with Dr. Kailin. I think it is VERY important!!

> Do not assume that all will be well. This is how we lost Ma Huang.

> The FDA assured herb suppliers that the ban would not apply to Chinese

> Medicine, but here we are...no Ma Huang. There was an interview in

> Acupuncture Today with the president of, I believe, Lotus some time

> ago. If anyone has back issues of A.T. and can find that interview, I

> would appreciate you posting it as an example of how the FDA is not

> exactly forthcoming with it's agenda.

>

>

> Sincerely,

> dr.w

>

[Guest guest]

On 4/26/07, Dr. W. W. Waldrope DOM AP <dr.w.w.waldrope wrote:

>

> " New drug " status triggers the Act's

> requirements for premarket review and approval by FDA.'~

>

> My question...

>

> How are we to " not treat " treat, for instance, arthritis?

>

 

 

 

 

 

 

 

 

I believe that this issue comes down to making " claims " . What a formula does

is between me and my patients, but that is a verbal statement made in the

practice of our medicine. However when I state what a formula does such as

treat arthritis in a medium in which there is an adjacent purchase

opportunity, it becomes a claim.

 

The Dietary Supplement and Health Education Act of 1994 (DSHEA) never

actually mentions how these statements would be interpreted in a clinical

setting. I can say however that in terms of enforcement, they seem much more

focused on stuff that is mass marketed than how a particular practitioner is

presenting their herbs to a patient. If we had no economic interest in the

sale of the herbs, that might provide an additional layer of protection from

the intent of DSHEA.

 

So, Bu Fei Tang given to your patient treats, addresses, and improves asthma

due to Lung qi deficiency. However Bu Fei Tang on a website or some other

context in which there is a purchase opportunity can only " support healthy

lung functions " or something along those lines.

 

If you have a website in which you describe herb formulas and there is no

opportunity to purchase them on your website, if the website is just

educational, you can state that Bu Fei Tang treats asthma. If however it is

a statement made to induce a sale, it becomes a " claim " , which is what the

FDA cares about.

 

Here's more:

http://gancao.net/DSHEA/

 

> This is what the FDA is currently considering and will accept public

> input only until April 30th.

>

 

 

 

 

What you quoted really looks identical to the existing DSHEA stuff, but I'll

spend more time with it.

 

--

 

Pain is inevitable, suffering is optional.

 

 

 

[Guest guest]

Here are AHPA's extensive comments to FDA:

 

http://www.ahpa.org/Portals/0/pdfs/07_0427_AHPAComments_FDA_CAM_Guidance.pdf

 

Here are CSOMA's brief comments:

 

http://www.csomaonline.org/i4a/pages/index.cfm?pageid=3388

 

- Bill

...........................

Bill Schoenbart

P.O. Box 8099

Santa Cruz, CA 95061

 

office: 831-335-3165

email: plantmed

 

 

 

[Guest guest]

Let me take a moment to respond to several posts.

First, the APHA comments to FDA are excellent.

APHA makes the following major points (among others):

1. FDA has not made clear whether its guidance is for manufacturers,

importers, Internet marketers or clinicians.

2. The term CAM Products is not only too vague, but also infers that

such products are necessarily medical.

3. The draft guidance does not clarify the limits of FDA jurisdiction

over the practice of medicine, which is governed by State law.

4. The 90 day comment period should end May 29, not April 30, 2007.

 

Hats off and a cheer for APHA's response to FDA!

 

But note that APHA explicitly confirms the validity of context of use

as defining regulatory category. (They do add that a clinician's use

cannot and should not reflect on the product category garnered by the

label printed by the manufacturer.)

 

And also note that APHA does not claim that FDA is creating new and

binding regulations with the draft guidance.

 

Now, on to questions posed by Dr. Waldrope:

There are actually two regulatory boundary issues you should be aware

of: product claims under FDA, and scope of practice under State

licensing law.

 

Under FDA regulations, biomedical therapeutic claims for an herb

create the context of use for classification of the herb as a drug.

 

Under State scope of practice laws, performing biomedical diagnoses

may be beyond the scope permitted to acupuncturists (though this

varies by State).

 

There is a simple way to handle both limitations:

diagnose, treat, and chart TCM conditions.

 

" Here, Bob, I'm prescribing these herbs

for what in TCM is called a Jing Deficiency. "

 

If the patient has a diagnosis of arthritis

from a biomedical source, you certainly may include that fact in your

chart notes. It is best to obtain a copy of the biomedical report

to support the patient's statement.

 

The Draft Guidance document is indeed important to TCM.

But it does not alter any regulatory stipulations currently in force.

 

There are FDA regulations that apply to the labelling of products,

and FDA regulations that apply more broadly to claims made for

products. They are related but not identical. Both labels and verbal

statements may assert claims for a product. Both may contribute to

context of use, which then defines regulatory status (drug, dietary

supplement, etc.).

 

You'll find a deeper discussion of FDA regs, charting, scope of

practice, and legal duties in Quality In Complementary & Alternative

Medicine (D. Kailin, 2006, CMS Press, http://www.qualityincam.com)

 

Best Regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

[Guest guest]

Thanks for the comprehensive response. CHA Members should also follow

the link for David's website. Just in the samples provided, I see he

is an excellent writer and I look forward to reading his book about

Quality CAM.

 

doug

 

 

 

, " convergentmedical "

<kailin wrote:

>

 

>

-------------------------

> You'll find a deeper discussion of FDA regs, charting, scope of

> practice, and legal duties in Quality In Complementary & Alternative

> Medicine (D. Kailin, 2006, CMS Press, http://www.qualityincam.com)

>

> Best Regards,

>

> David Kailin, Ph.D., M.P.H., L.Ac.

>

[Guest guest]

On 4/27/07, convergentmedical <kailin wrote:

 

> Hats off and a cheer for APHA's response to FDA!

>

 

 

 

I presume that you're referring to the AHPA (American Herbal Products

Association) and not the APHA (American Public Health Association).

 

This org has really been our advocates at the level of national policy (USA)

and should be supported as best we are able. Their membership cost favors

those one level in the supply chain above private practitioners. In other

words, those companies from which we buy our herbs tend to join the APHA.

Still, they're always open to new memberships and you can find out more

here:

http://ahpa.org.

 

> There are actually two regulatory boundary issues you should be aware

> of: product claims under FDA, and scope of practice under State

> licensing law.

>

 

 

 

 

 

This has long been my blind spot. Not sure how this works especially given

the fact that in the California practice act it describes our ability to

dispense " dietary supplements " which places it into a context similar to the

DSHEA (FDA) definition. Had they said " Chinese Herbs " or something more

specific to TCM diagnosis, I'd feel more confident in my belief that between

the practitioner and patient, whatever happens is sacred and not subject to

FDA regulations.

 

Under FDA regulations, biomedical therapeutic claims for an herb

> create the context of use for classification of the herb as a drug.

>

 

 

 

 

Non-compliant disease claims don't have to be stated as a biomedical term. I

agree that there are conflicting statements made by the FDA on this

particular issue, but I've found enough evidence to suggest otherwise to

believe that we need to be careful even with terms such as " deficiency " as

it suggests something wrong that needs to be fixed. That's a disease claim

which we must avoid.

 

> There is a simple way to handle both limitations:

> diagnose, treat, and chart TCM conditions.

>

> " Here, Bob, I'm prescribing these herbs

> for what in TCM is called a Jing Deficiency. "

>

 

 

 

 

 

 

 

One would think that if we hide behind our TCM diagnosis that the FDA would

be unable to define such as a disease, and since only drugs (and a few

highly researched vitamins and minerals such as calcium for osteoporosis or

vitamin C for scurvy) can treat disease.

 

However, the definition of disease is any description recognizable to

conventional health providers as disease or a disease process. In other

words, we can get away with jing deficiency until someone asks for the signs

and symptoms of such. When the answer comes back, low bone density, mental

retardation, hearing loss, premature graying, etc. then we're back in a

disease category. Some of these issues that are the result of aging are not

considered diseases, and that's where we could get away with treating some

symptoms of jing deficiency, but if you return to Lung qi deficiency asthma,

even if you leave off the " asthma " word, you're still left with shortness of

breath, frequent colds and flues, spontaneous perspiration, fatigue, etc.

These are looking like signs and symptoms of a diseased state.

 

If its broken then its a disease.

 

If its problematic, but part of one's normal growth maturation process,

there are exceptions for these from the disease definition such as

menopausal syndrome, adolescent acne, and memory loss due to aging. This

last point would not include something more severe such as Alzheimer's, but

more what my mother would call " a senior moment " .

 

--

 

Pain is inevitable, suffering is optional.

 

 

 

[Guest guest]

First a correction: Bill Schoenbart and Al Stone have brought to my

attention that I mixed up the letters of the AHPA acronym.

AHPA = American Herbal Products Association.

My apologies to all for making this error!!

 

Second, Al Stone has raised some fine points about limitations on

diagnosis that may be imposed, primarily under State scope of practice

regulations. If one sticks to reporting and treating signs and

symptoms, and not biomedical diseases, then one has chosen a

conservative (and generally safe) route. Reporting and treating TCM

conditions is typically within scope under acupuncture laws and regs.

To understand the limits, you must refer to the law and regulations in

the State in which you practice. The FDA concern isn't scope of

practice, but product claims,legality of marketing the product,

product safety, etc.

 

Best Regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

[Guest guest]

Hi folks,

 

Al, you have made a very good point. The fact that we even have this

gray area is my concern. For one thing, Federal law supersedes state

law. If the FDA eventually rules that Chinese herbs are considered to

be drugs or new drugs then that's it. Game, set, match.

 

The disparity in scope of practice from state to state additionally

makes us vulnerable. Every state and national TCM organization should

be working towards educating the powers that be that TCM is it's own

medical paradigm and ENTITLED to access to our traditional

pharmacoepia. According to Dr. Kailin's info, the FDA recognises this

but it does not seem to guarantee that they respect our

methodologies... (one being that millenia of clinical observation have

shown that Chinese herbs, when prescribed by a qualified practitioner,

are safe and effective.)

 

I refer again to the Ma Huang issue. I think all would agree that any

Joe should probably not be able to walk into a convenience store and

purchase ephedra for " energy " or " weight loss " . Herbal suppliers were

" assured " by the FDA that the ephedra ban would not apply to our use

of Ma Huang. Yet it has. What about Ban Xia? Can anyone imagine

practicing herbal medicine without it??? The FDA has considered

looking at it. It might be " toxic " !!! By not having equal scope of

practice in every state, we lose cohesiveness and credibility as a

profession.

 

There is no doubt in my mind that we are the target of Big Pharma.

These corporations only make $$$ if people are sick. TCM is based on

preserving wellness. If people are well, they don't need Rx.

 

I'm sure that virtually every TCM practitioner in the country thinks

of themselves as doctors that treat diseases. The fact that, in many

states, we have the appellation LAC (kind of like licensed

cosmetologist) and not Dr. should tell us that the government (state,

local, federal, whatever) considers our profession to be a joke. I am

lucky to be practicing in Florida. We are primary care providers and

are licensed as Acupuncture Physicians and allowed to use the

appellation " Dr. " This, of course will do us little good if we lose

access to herbs.

 

I believe that a STRONG, concerted effort on our part is necessary to

assure the continued existence of TCM as we know it. We are doctors

and we should say so. Our pharmacoepia is comprised of herbal

medicines that treat disease and we should say so. We should not have

to hide behind TCM diagnosis jargon in order to avoid notice.

 

TCM would not exist in any legal form in the U.S. if it weren't for

patient demand. While we as practitioners are relatively few in

number, our patient base is considerable. Why have our state and

national organizations not coordinated a movement to make our case? I

believe it is fear. We have tried to " keep our heads down " in order to

stay off the radar and avoid stepping on toes. The very fact that our

medicine is so effective puts us on the radar. Hence our current

dilemma. What is to be done? If we do not take a pro-active stance, we

may find ourselves fighting a rear guard battle. Better to push the

issue now rather than trust that Big Pharma and the FDA will do " the

right thing " .

 

I don't enjoy being so strident, but I feel it is necessary. Given the

political tone by the current Federal administration for the past few

years and the fact that U.S. citizens are in danger of losing a number

of rights guaranteed by the constitution, it is, perhaps no surprise

that TCM doctors find ourselves in this situation.

 

I suggest:

 

1. Urge our state and national organizations to recognise and

coordinate the need for action regarding scope of practice

disparities, access to the pharmacoepia, and outreach to the public in

general. (NOTE: a few decades ago, Chiropractors found themselves in a

similar situation. They organized and, most importantly, created PSA

type T.V. commercials. This changed the mindset of the public about

Chiropractic Medicine and helped to secure their position in the

health care world.)

 

2. Enlist our patient base in this effort. They are, after all, what

got us this far.

 

3. Raise our education standards. DAOM programs as a standard could help a lot.

 

I apologize beforehand if my views disturb anyone, but I just felt it

necessary to say my piece. I would like to believe that all of this

discussion is unnecessary... but I don't.

If anyone can assure me that my concerns are without foundation...please do so.

 

I realize that by taking a pro-active approach may open the " can of

worms " . It's preferable to death by a thousand cuts... which is what

we seem to have now.

 

sincerely,

dr.w

[Guest guest]

I think we've managed to deal with the FDA Draft Guidance Document

pretty thoroughly at this point, and it's probably time to close the

thread and start a new one.

 

Some summary thoughts: First, a word of thanks to those of you who

have read or contributed to the thread, even though it is much more

engaging to discuss herbs and their uses. However, we do work within

regulatory contexts, and we must therefore come to grips with those

contexts, in addition to our therapeutic contexts.

 

Second, we made some clarifications with respect to State scope of

practice regs and FDA regs. They do overlap in the area of devices and

products.

 

Third, we can conclude that the sky isn't falling with respect to the

impacts of the FDA draft guidance document.

 

I wish I could say the same about the FDA proposed rule for Current

Good Manufacturing Practice for Dietary Supplements. This rule, if

enacted as proposed, will effectively end in-office herbal compounding.

 

But that is the topic of a new thread, which I'll compose tomorrow. If

you'd like to get a head start on it, I've posted an article on the

topic at http://www.convergentmedical.com , under News Desk.

 

Best Regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

[Guest guest]

David,

Thanks for your efforts.

It is surprising that we, as a profession, do not have better

informational processes. Please do start this discussion here. Also,

would you share your overview with Acupuncture Today and other

journals? I'm sure more practitioners and students would be exposed to

this info there than here on Chinese Herbal Medicine.

 

Thanks again,

dr.w

[Guest guest]

I agree with most of the points you are making, except for the

statement " we should not have to hide behind TCM diagnosis jargon " .

The language of Chinese medicine contains the essence of the subject,

and your statement implies that only 'biomedical jargon' is real.

Yes we treat disease, largely through pattern differentiation, but

medical Chinese language and principles is what we base our practice

on primarily. We shouldn't discount it in any way.

 

 

On Apr 29, 2007, at 4:12 PM, Dr. W. W. Waldrope DOM AP wrote:

 

>

> I believe that a STRONG, concerted effort on our part is necessary to

> assure the continued existence of TCM as we know it. We are doctors

> and we should say so. Our pharmacoepia is comprised of herbal

> medicines that treat disease and we should say so. We should not have

> to hide behind TCM diagnosis jargon in order to avoid notice.

 

 

 

 

[Guest guest]

But this is where the crux of the issue with the FDA lies. If we indeed say we

treat diseases

then we need the proof that we do. Forget about us for a minute, if this wasn't

required

then everybody could make claims on treating diseases. It would be snake-oil

redux. I

would glad enough just to say we can treat in our own TCM medical vocabulary.

 

doug

 

 

, " " <zrosenbe

wrote:

>

> I agree with most of the points you are making, except for the

> statement " we should not have to hide behind TCM diagnosis jargon " .

> The language of Chinese medicine contains the essence of the subject,

> and your statement implies that only 'biomedical jargon' is real.

> Yes we treat disease, largely through pattern differentiation, but

> medical Chinese language and principles is what we base our practice

> on primarily. We shouldn't discount it in any way.

>

>

> On Apr 29, 2007, at 4:12 PM, Dr. W. W. Waldrope DOM AP wrote:

>

> >

> > I believe that a STRONG, concerted effort on our part is necessary to

> > assure the continued existence of TCM as we know it. We are doctors

> > and we should say so. Our pharmacoepia is comprised of herbal

> > medicines that treat disease and we should say so. We should not have

> > to hide behind TCM diagnosis jargon in order to avoid notice.

>

>

>

>