FDA Letter: astragalus not approved for use for H1N1 flu virus prevention or tx

October 23, 2009

Member's of the AOM Community Alert:

the FDA has posted this letter to Dr. Andrew Weil's instructing him that the

herbal flu formula he recommends for H1N1 flu virus, containing astragalus

must be taken off the website as there are no studies supporting its

effective use for flu tx.

check it out, it's truly frightening:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186837.htm

--

Kath Bartlett, LAc, MS, BA UCLA

Oriental Medicine

Experienced, Dedicated, Effective

Abstain from all that is evil.

Perform all that is good.

Purify your thoughts.

This is the teaching of the Buddhas.

Kath's Blog about , Healthy Living & Spirituality:

http://acukath.blogspot.com/

Flying Dragon Liniment: Effective pain relief for muscles & joints

Formulated by Kath Bartlett, Traditional Chinese Herbalist

Available at Asheville Center for :

www.FlyingDragonLiniment.com

Greenlife Grocery - Asheville, NC

Amazon.com

http://www.amazon.com/Flying-Dragon-Liniment-Eco-Friendly-Wild-Crafted/dp/B001OC\

1AZ2/ref=sr_1_1?ie=UTF8 & s=hpc & qid=1254968032 & sr=8-1

and from the following supply companies:

Kamwo Herbal Pharmacy: NY - Chinatown

https://www.kamwo.com/shop/product.php?productid=17442 & cat=0 & page=1

Golden Needle Acupuncture, Herbal & Medical Supply - Candler, NC

http://www.goldenneedleonline.com/index.php?page=categories & category=14 & vendor= & \

product=5554 & pg=

Asheville Center For

70 Woodfin Place, Suite West Wing Two

Asheville, NC 28801 828.258.2777

kbartlett

www.AcupunctureAsheville.com

October 23, 2009

From

http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-Sto\

ry-OCT2009.html

<http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-St\

ory-OCT2009.html> -

-----

Dr. Weil's Response to Today Show Story, 10/16/2009

For immediate release.

TUCSON, Ariz, Oct. 16, 2009 - I have received several inquiries

regarding a segment on NBC's Today Show that aired Friday, Oct. 16,

2009. The segment was about an FDA/FTC warning that was issued to

numerous websites and other media outlets. The warning stated that the

recipients had made marketing claims that

" unapproved/uncleared/unauthorized " products could " diagnose, mitigate,

prevent, treat or cure " the H1N1 flu virus in human beings. My website,

www.drweil.com, was included in the list.

Many of the outlets on the list promoted products that were unethical

and clearly egregious violations of FDA standards, including counterfeit

versions of pharmaceuticals such as Tamiflu. Weil Lifestyle, LLC, the

company that sells vitamins and herbal supplements under my name, has

never made or marketed a product of that nature.

The content that was called into question in the warning was primarily

educational, including appropriate strategies to avoid getting the flu

this season. It included the official recommendations for H1N1 flu

vaccination

<http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm>

from the Centers for Disease Control. The content also included comments

about ingredients in Weil Lifestyle and other supplements which may help

support a healthy immune system.

Because these products and the flu (which is a medical diagnosis) were

both mentioned in editorial content on the site, and it was suggested

that particular traditional herbal ingredients may provide some

protection against flu, it was the opinion of the FDA/FTC that the

language was in violation of current standards.

All Weil editorial content is reviewed for compliance with FDA /FTC

guidelines. I directed the website team to remove the FDA/FTC-referenced

content for review, and they have done so. I fully support the FDA/FTC

task force in its efforts.

-----

Chinese Medicine , " Kath Bartlett, MS,

LAc " wrote:

>

> Member's of the AOM Community Alert:

>

> the FDA has posted this letter to Dr. Andrew Weil's instructing him

that the

> herbal flu formula he recommends for H1N1 flu virus, containing

astragalus

> must be taken off the website as there are no studies supporting its

> effective use for flu tx.

>

> check it out, it's truly frightening:

>

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186837.htm

>

> --

> Kath Bartlett, LAc, MS, BA UCLA

> Oriental Medicine

> Experienced, Dedicated, Effective

>

> Abstain from all that is evil.

> Perform all that is good.

> Purify your thoughts.

> This is the teaching of the Buddhas.

>

> Kath's Blog about , Healthy Living & Spirituality:

> http://acukath.blogspot.com/

>

> Flying Dragon Liniment: Effective pain relief for muscles & joints

> Formulated by Kath Bartlett, Traditional Chinese Herbalist

> Available at Asheville Center for :

> www.FlyingDragonLiniment.com

>

> Greenlife Grocery - Asheville, NC

>

> Amazon.com

>

http://www.amazon.com/Flying-Dragon-Liniment-Eco-Friendly-Wild-Crafted/d\

p/B001OC1AZ2/ref=sr_1_1?ie=UTF8 & s=hpc & qid=1254968032 & sr=8-1

>

> and from the following supply companies:

> Kamwo Herbal Pharmacy: NY - Chinatown

> https://www.kamwo.com/shop/product.php?productid=17442 & cat=0 & page=1

>

> Golden Needle Acupuncture, Herbal & Medical Supply - Candler, NC

>

http://www.goldenneedleonline.com/index.php?page=categories & category=14 & \

vendor= & product=5554 & pg=

>

> Asheville Center For

> 70 Woodfin Place, Suite West Wing Two

> Asheville, NC 28801 828.258.2777

> kbartlett

> www.AcupunctureAsheville.com

>

October 23, 2009

whatever, no one cares about the fda nor takes them seriously-- they can mouth

off as much as they want, we live in a FREE country and people have the right to

make CHOICES, adults dont need to be spoon fed biased into by the FDA. And the

FDA has met with much resistance every time it tried to regulate supplements and

backed off like the bully it is. No one cares about the FDA or takes it

seriously-- nor should they. They should go back to " regulating " the

pharmaceutical industry to keep them from being perennially sued as they have

been.

Chinese Medicine

cthmsn

Fri, 23 Oct 2009 19:16:23 +0000

Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

From

http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-Sto\

ry-OCT2009.html

<http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-St\

ory-OCT2009.html> -

-----

Dr. Weil's Response to Today Show Story, 10/16/2009

For immediate release.

TUCSON, Ariz, Oct. 16, 2009 - I have received several inquiries

regarding a segment on NBC's Today Show that aired Friday, Oct. 16,

2009. The segment was about an FDA/FTC warning that was issued to

numerous websites and other media outlets. The warning stated that the

recipients had made marketing claims that

" unapproved/uncleared/unauthorized " products could " diagnose, mitigate,

prevent, treat or cure " the H1N1 flu virus in human beings. My website,

www.drweil.com, was included in the list.

Many of the outlets on the list promoted products that were unethical

and clearly egregious violations of FDA standards, including counterfeit

versions of pharmaceuticals such as Tamiflu. Weil Lifestyle, LLC, the

company that sells vitamins and herbal supplements under my name, has

never made or marketed a product of that nature.

The content that was called into question in the warning was primarily

educational, including appropriate strategies to avoid getting the flu

this season. It included the official recommendations for H1N1 flu

vaccination

<http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm>

from the Centers for Disease Control. The content also included comments

about ingredients in Weil Lifestyle and other supplements which may help

support a healthy immune system.

Because these products and the flu (which is a medical diagnosis) were

both mentioned in editorial content on the site, and it was suggested

that particular traditional herbal ingredients may provide some

protection against flu, it was the opinion of the FDA/FTC that the

language was in violation of current standards.

All Weil editorial content is reviewed for compliance with FDA /FTC

guidelines. I directed the website team to remove the FDA/FTC-referenced

content for review, and they have done so. I fully support the FDA/FTC

task force in its efforts.

-----

Chinese Medicine , " Kath Bartlett, MS,

LAc " wrote:

>

> Member's of the AOM Community Alert:

>

> the FDA has posted this letter to Dr. Andrew Weil's instructing him

that the

> herbal flu formula he recommends for H1N1 flu virus, containing

astragalus

> must be taken off the website as there are no studies supporting its

> effective use for flu tx.

>

> check it out, it's truly frightening:

>

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186837.htm

>

> --

> Kath Bartlett, LAc, MS, BA UCLA

> Oriental Medicine

> Experienced, Dedicated, Effective

>

> Abstain from all that is evil.

> Perform all that is good.

> Purify your thoughts.

> This is the teaching of the Buddhas.

>

> Kath's Blog about , Healthy Living & Spirituality:

> http://acukath.blogspot.com/

>

> Flying Dragon Liniment: Effective pain relief for muscles & joints

> Formulated by Kath Bartlett, Traditional Chinese Herbalist

> Available at Asheville Center for :

> www.FlyingDragonLiniment.com

>

> Greenlife Grocery - Asheville, NC

>

> Amazon.com

>

http://www.amazon.com/Flying-Dragon-Liniment-Eco-Friendly-Wild-Crafted/d\

p/B001OC1AZ2/ref=sr_1_1?ie=UTF8 & s=hpc & qid=1254968032 & sr=8-1

>

> and from the following supply companies:

> Kamwo Herbal Pharmacy: NY - Chinatown

> https://www.kamwo.com/shop/product.php?productid=17442 & cat=0 & page=1

>

> Golden Needle Acupuncture, Herbal & Medical Supply - Candler, NC

>

http://www.goldenneedleonline.com/index.php?page=categories & category=14 & \

vendor= & product=5554 & pg=

>

> Asheville Center For

> 70 Woodfin Place, Suite West Wing Two

> Asheville, NC 28801 828.258.2777

> kbartlett

> www.AcupunctureAsheville.com

>

October 24, 2009

It seems to me that he coward to the mighty FDA. Too bad, I was hoping that he

would make a stand and tell the bullies they are going too far with their desire

to control the information given to the people. Big Pharma and bureaucracy win

again. Maybe all his followers will see that their rights to attain nutrition

and information may one day be in jeopardy.

Jenna

Chinese Medicine , " thmsn " <cthmsn wrote:

>

> From

> http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-Sto\

> ry-OCT2009.html

> <http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-St\

> ory-OCT2009.html> -

>

> -----

> Dr. Weil's Response to Today Show Story, 10/16/2009

> For immediate release.

>

> TUCSON, Ariz, Oct. 16, 2009 - I have received several inquiries

> regarding a segment on NBC's Today Show that aired Friday, Oct. 16,

> 2009. The segment was about an FDA/FTC warning that was issued to

> numerous websites and other media outlets. The warning stated that the

> recipients had made marketing claims that

> " unapproved/uncleared/unauthorized " products could " diagnose, mitigate,

> prevent, treat or cure " the H1N1 flu virus in human beings. My website,

> www.drweil.com, was included in the list.

>

> Many of the outlets on the list promoted products that were unethical

> and clearly egregious violations of FDA standards, including counterfeit

> versions of pharmaceuticals such as Tamiflu. Weil Lifestyle, LLC, the

> company that sells vitamins and herbal supplements under my name, has

> never made or marketed a product of that nature.

>

> The content that was called into question in the warning was primarily

> educational, including appropriate strategies to avoid getting the flu

> this season. It included the official recommendations for H1N1 flu

> vaccination

> <http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm>

> from the Centers for Disease Control. The content also included comments

> about ingredients in Weil Lifestyle and other supplements which may help

> support a healthy immune system.

>

> Because these products and the flu (which is a medical diagnosis) were

> both mentioned in editorial content on the site, and it was suggested

> that particular traditional herbal ingredients may provide some

> protection against flu, it was the opinion of the FDA/FTC that the

> language was in violation of current standards.

>

> All Weil editorial content is reviewed for compliance with FDA /FTC

> guidelines. I directed the website team to remove the FDA/FTC-referenced

> content for review, and they have done so. I fully support the FDA/FTC

> task force in its efforts.

> -----

>

November 10, 2009

The FDA wasn't bullying Andrew Weil. They were just enforcing a well-known rule

that he didn't follow. It had nothing to do with freedom of expression. It was

all about selling a product that claims to treat H1N1, which violates the

Dietary Supplement and Health Education Act. He would have wasted time and money

if he " took a stand " against the FDA, since they were acting legally in their

action against his company. If he gave out the same information without linking

it to his product, the FDA and FTC would not have bothered him.

- Bill Schoenbart

Chinese Medicine , " hahealing " <hahealing

wrote:

>

> It seems to me that he coward to the mighty FDA. Too bad, I was hoping that he

would make a stand and tell the bullies they are going too far with their desire

to control the information given to the people. Big Pharma and bureaucracy win

again. Maybe all his followers will see that their rights to attain nutrition

and information may one day be in jeopardy.

> Jenna

>

> Chinese Medicine , " thmsn " <cthmsn@> wrote:

> >

> > From

> > http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-Sto\

> > ry-OCT2009.html

> > <http://www.drweil.com/drw/u/ART03081/Dr-Weils-Response-to-Today-Show-St\

> > ory-OCT2009.html> -

> >

> > -----

> > Dr. Weil's Response to Today Show Story, 10/16/2009

> > For immediate release.

> >

> > TUCSON, Ariz, Oct. 16, 2009 - I have received several inquiries

> > regarding a segment on NBC's Today Show that aired Friday, Oct. 16,

> > 2009. The segment was about an FDA/FTC warning that was issued to

> > numerous websites and other media outlets. The warning stated that the

> > recipients had made marketing claims that

> > " unapproved/uncleared/unauthorized " products could " diagnose, mitigate,

> > prevent, treat or cure " the H1N1 flu virus in human beings. My website,

> > www.drweil.com, was included in the list.

> >

> > Many of the outlets on the list promoted products that were unethical

> > and clearly egregious violations of FDA standards, including counterfeit

> > versions of pharmaceuticals such as Tamiflu. Weil Lifestyle, LLC, the

> > company that sells vitamins and herbal supplements under my name, has

> > never made or marketed a product of that nature.

> >

> > The content that was called into question in the warning was primarily

> > educational, including appropriate strategies to avoid getting the flu

> > this season. It included the official recommendations for H1N1 flu

> > vaccination

> > <http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm>

> > from the Centers for Disease Control. The content also included comments

> > about ingredients in Weil Lifestyle and other supplements which may help

> > support a healthy immune system.

> >

> > Because these products and the flu (which is a medical diagnosis) were

> > both mentioned in editorial content on the site, and it was suggested

> > that particular traditional herbal ingredients may provide some

> > protection against flu, it was the opinion of the FDA/FTC that the

> > language was in violation of current standards.

> >

> > All Weil editorial content is reviewed for compliance with FDA /FTC

> > guidelines. I directed the website team to remove the FDA/FTC-referenced

> > content for review, and they have done so. I fully support the FDA/FTC

> > task force in its efforts.

> > -----

> >

>

> >

November 10, 2009

It's not quite so simple. This was not about freedom of speech; it was simply

about the enforcing of labeling laws.

The FDA makes plenty of mistakes, but they also serve a legitimate purpose. For

example, they recently closed down an herb supplier who had a warehouse full of

rodent-infested herbs. That prevented you and your patients from ingesting that

garbage. They have also closed down companies who put pharmaceuticals in " herb

products " , something we all want to be corrected.

- Bill Schoenbart

Chinese Medicine , alex starseeker

<moody1515 wrote:

>

> whatever, no one cares about the fda nor takes them seriously-- they can mouth

off as much as they want, we live in a FREE country and people have the right to

make CHOICES, adults dont need to be spoon fed biased into by the FDA. And the

FDA has met with much resistance every time it tried to regulate supplements and

backed off like the bully it is. No one cares about the FDA or takes it

seriously-- nor should they. They should go back to " regulating " the

pharmaceutical industry to keep them from being perennially sued as they have

been.

>

November 10, 2009

Bill,

At what point is a practitioner able to educate the public, with online info,

and not violate the law? Dr. Weil used info from the CDC's website as was told

to take it down. Something is wrong here.

It used to be that a simple reference that " this statement has not been approved

by the FDA " was good enough. I have to disagree with you as patient education

is a free speech issue and yet this is suggesting that none of us can post

studies or historical usage in support of our therapies and what we do if it

attempts to treat this popular media bug. This is a way to impact the public's

perceptions and limit our influence. Be afraid, be very afraid, as that is what

they want.

The media on this bug have gotten out of control in trying to make this an

epidemic, when it clearly is not. Similarly, this is a repeat of 30 years ago

as well. Some things go full circle if you remain here long enough.

Michael W. Bowser, DC, LAc

Chinese Medicine

plantmed2

Tue, 10 Nov 2009 05:19:35 +0000

Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

It's not quite so simple. This was not about freedom of speech; it was

simply about the enforcing of labeling laws.

The FDA makes plenty of mistakes, but they also serve a legitimate purpose. For

example, they recently closed down an herb supplier who had a warehouse full of

rodent-infested herbs. That prevented you and your patients from ingesting that

garbage. They have also closed down companies who put pharmaceuticals in " herb

products " , something we all want to be corrected.

- Bill Schoenbart

Chinese Medicine , alex starseeker

<moody1515 wrote:

>

> whatever, no one cares about the fda nor takes them seriously-- they can mouth

off as much as they want, we live in a FREE country and people have the right to

make CHOICES, adults dont need to be spoon fed biased into by the FDA. And the

FDA has met with much resistance every time it tried to regulate supplements and

backed off like the bully it is. No one cares about the FDA or takes it

seriously-- nor should they. They should go back to " regulating " the

pharmaceutical industry to keep them from being perennially sued as they have

been.

>

_______________

Hotmail: Trusted email with Microsoft's powerful SPAM protection.

http://clk.atdmt.com/GBL/go/177141664/direct/01/

November 10, 2009

Mike,

Patient education was not the issue here. Weil provided a link to one of his

products in the middle of his article on swine flu. The link suggested that his

product could prevent someone from catching H1N1. That was what got him in

trouble. He could have said the exact same thing about the exact same herbs,

without providing a link to his product, and the FDA / FTC would not have

bothered him. As soon as he provided the link to his product, the entire article

became product labeling.

The disclaimer " this statement has not been approved by the FDA " applies to

legal structure function claims for products. As soon as a product mentions a

disease, it is an illegal disease or drug claim. The disclaimer doesn't help in

that case.

FDA and FTC were making a statement, but it wasn't meant to make the public

afraid. They wanted to show companies that it is unprofitable to make illegal

claims about treating H1N1. They warned in advance that they would do this,

after the rash of products that illegally claimed that they could treat SARS. It

was no surprise that they followed through on their warning.

- Bill

Chinese Medicine , mike Bowser

<naturaldoc1 wrote:

>

> Bill,

> At what point is a practitioner able to educate the public, with online info,

and not violate the law? Dr. Weil used info from the CDC's website as was told

to take it down. Something is wrong here.

> It used to be that a simple reference that " this statement has not been

approved by the FDA " was good enough. I have to disagree with you as patient

education is a free speech issue and yet this is suggesting that none of us can

post studies or historical usage in support of our therapies and what we do if

it attempts to treat this popular media bug. This is a way to impact the

public's perceptions and limit our influence. Be afraid, be very afraid, as

that is what they want.

> The media on this bug have gotten out of control in trying to make this an

epidemic, when it clearly is not. Similarly, this is a repeat of 30 years ago

as well. Some things go full circle if you remain here long enough.

>

> Michael W. Bowser, DC, LAc

>

November 11, 2009

So, it's a question of making " illegal claims, " not false claims. Gotchya.

-

" bill_schoenbart " <plantmed2

Tuesday, November 10, 2009 1:07 PM

Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

> Mike,

>

> Patient education was not the issue here. Weil provided a link to one of

> his products in the middle of his article on swine flu. The link suggested

> that his product could prevent someone from catching H1N1. That was what

> got him in trouble. He could have said the exact same thing about the

> exact same herbs, without providing a link to his product, and the FDA /

> FTC would not have bothered him. As soon as he provided the link to his

> product, the entire article became product labeling.

>

> The disclaimer " this statement has not been approved by the FDA " applies

> to legal structure function claims for products. As soon as a product

> mentions a disease, it is an illegal disease or drug claim. The disclaimer

> doesn't help in that case.

>

> FDA and FTC were making a statement, but it wasn't meant to make the

> public afraid. They wanted to show companies that it is unprofitable to

> make illegal claims about treating H1N1. They warned in advance that they

> would do this, after the rash of products that illegally claimed that they

> could treat SARS. It was no surprise that they followed through on their

> warning.

>

> - Bill

>

> Chinese Medicine , mike Bowser

> <naturaldoc1 wrote:

>>

>> Bill,

>> At what point is a practitioner able to educate the public, with online

>> info, and not violate the law? Dr. Weil used info from the CDC's website

>> as was told to take it down. Something is wrong here.

>> It used to be that a simple reference that " this statement has not been

>> approved by the FDA " was good enough. I have to disagree with you as

>> patient education is a free speech issue and yet this is suggesting that

>> none of us can post studies or historical usage in support of our

>> therapies and what we do if it attempts to treat this popular media bug.

>> This is a way to impact the public's perceptions and limit our influence.

>> Be afraid, be very afraid, as that is what they want.

>> The media on this bug have gotten out of control in trying to make this

>> an epidemic, when it clearly is not. Similarly, this is a repeat of 30

>> years ago as well. Some things go full circle if you remain here long

>> enough.

>>

>> Michael W. Bowser, DC, LAc

>>

>

> ---

>

> Subscribe to the free online journal for TCM at Times

> http://www.chinesemedicinetimes.com

>

> Help build the world's largest online encyclopedia for Chinese medicine

> and acupuncture, click, http://www.chinesemedicinetimes.com/wiki/CMTpedia

>

> and adjust

> accordingly.

>

> Messages are the property of the author. Any duplication outside the group

> requires prior permission from the author.

>

> Please consider the environment and only print this message if absolutely

> necessary.

November 11, 2009

So why was he forced to remove links to the CDC website that spoke about the

H1N1 virus? And why was this considered a matter of national security (also

posted at the bottom of the letter)?

Michael W. Bowser, DC, LAc

Chinese Medicine

magisterium_magnum

Tue, 10 Nov 2009 20:18:20 -0600

Re: Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

So, it's a question of making " illegal claims, " not false claims.

Gotchya.

-

" bill_schoenbart " <plantmed2

Tuesday, November 10, 2009 1:07 PM

Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

> Mike,

>

> Patient education was not the issue here. Weil provided a link to one of

> his products in the middle of his article on swine flu. The link suggested

> that his product could prevent someone from catching H1N1. That was what

> got him in trouble. He could have said the exact same thing about the

> exact same herbs, without providing a link to his product, and the FDA /

> FTC would not have bothered him. As soon as he provided the link to his

> product, the entire article became product labeling.

>

> The disclaimer " this statement has not been approved by the FDA " applies

> to legal structure function claims for products. As soon as a product

> mentions a disease, it is an illegal disease or drug claim. The disclaimer

> doesn't help in that case.

>

> FDA and FTC were making a statement, but it wasn't meant to make the

> public afraid. They wanted to show companies that it is unprofitable to

> make illegal claims about treating H1N1. They warned in advance that they

> would do this, after the rash of products that illegally claimed that they

> could treat SARS. It was no surprise that they followed through on their

> warning.

>

> - Bill

>

> Chinese Medicine , mike Bowser

> <naturaldoc1 wrote:

>>

>> Bill,

>> At what point is a practitioner able to educate the public, with online

>> info, and not violate the law? Dr. Weil used info from the CDC's website

>> as was told to take it down. Something is wrong here.

>> It used to be that a simple reference that " this statement has not been

>> approved by the FDA " was good enough. I have to disagree with you as

>> patient education is a free speech issue and yet this is suggesting that

>> none of us can post studies or historical usage in support of our

>> therapies and what we do if it attempts to treat this popular media bug.

>> This is a way to impact the public's perceptions and limit our influence.

>> Be afraid, be very afraid, as that is what they want.

>> The media on this bug have gotten out of control in trying to make this

>> an epidemic, when it clearly is not. Similarly, this is a repeat of 30

>> years ago as well. Some things go full circle if you remain here long

>> enough.

>>

>> Michael W. Bowser, DC, LAc

>>

>

> ---

>

> Subscribe to the free online journal for TCM at Times

> http://www.chinesemedicinetimes.com

>

> Help build the world's largest online encyclopedia for Chinese medicine

> and acupuncture, click, http://www.chinesemedicinetimes.com/wiki/CMTpedia

>

> and adjust

> accordingly.

>

> Messages are the property of the author. Any duplication outside the group

> requires prior permission from the author.

>

> Please consider the environment and only print this message if absolutely

> necessary.

November 12, 2009

As soon as a company has been warned about illegal claims, they must remove all

references to any disease states from their commercial web pages. Since he

provided a link to his immune product and recommended it for preventing H1N1, he

would not be allowed to provide that sort of link as part of his compliance with

the order. If he stopped marketing products on his web site, he could talk about

diseases all he wants.

I haven't seen any references to national security, but here is FDA's mindset:

1. No claims are allowed for any products that mention a disease name.

2. If the named disease is potentially fatal (cancer, diabetes, H1N1, etc.), FDA

will come down especially hard on that company.

3. Once FDA, and especially FTC, take action against a company for illegal

claims, they are watched VERY closely to be sure that they are in compliance.

Future screwups are met with a vicious fine.

- Bill

Chinese Medicine , mike Bowser

<naturaldoc1 wrote:

>

> So why was he forced to remove links to the CDC website that spoke about the

H1N1 virus? And why was this considered a matter of national security (also

posted at the bottom of the letter)?

>

> Michael W. Bowser, DC, LAc

>

> Chinese Medicine

> magisterium_magnum

> Tue, 10 Nov 2009 20:18:20 -0600

> Re: Re: FDA Letter: astragalus not approved for use for H1N1

flu virus prevention or tx

>

So, it's a question of making " illegal claims, " not false claims.

Gotchya.

>

> -

>

> " bill_schoenbart " <plantmed2

>

> <Chinese Medicine >

>

> Tuesday, November 10, 2009 1:07 PM

>

> Re: FDA Letter: astragalus not approved for use for H1N1 flu

>

> virus prevention or tx

>

> > Mike,

>

> >

>

> > Patient education was not the issue here. Weil provided a link to one of

>

> > his products in the middle of his article on swine flu. The link suggested

>

> > that his product could prevent someone from catching H1N1. That was what

>

> > got him in trouble. He could have said the exact same thing about the

>

> > exact same herbs, without providing a link to his product, and the FDA /

>

> > FTC would not have bothered him. As soon as he provided the link to his

>

> > product, the entire article became product labeling.

>

> >

>

> > The disclaimer " this statement has not been approved by the FDA " applies

>

> > to legal structure function claims for products. As soon as a product

>

> > mentions a disease, it is an illegal disease or drug claim. The disclaimer

>

> > doesn't help in that case.

>

> >

>

> > FDA and FTC were making a statement, but it wasn't meant to make the

>

> > public afraid. They wanted to show companies that it is unprofitable to

>

> > make illegal claims about treating H1N1. They warned in advance that they

>

> > would do this, after the rash of products that illegally claimed that they

>

> > could treat SARS. It was no surprise that they followed through on their

>

> > warning.

>

> >

>

> > - Bill

>

> >

>

> >

>

> >

>

> > Chinese Medicine , mike Bowser

>

> > <naturaldoc1@> wrote:

>

> >>

>

> >>

>

> >> Bill,

>

> >> At what point is a practitioner able to educate the public, with online

>

> >> info, and not violate the law? Dr. Weil used info from the CDC's website

>

> >> as was told to take it down. Something is wrong here.

>

> >> It used to be that a simple reference that " this statement has not been

>

> >> approved by the FDA " was good enough. I have to disagree with you as

>

> >> patient education is a free speech issue and yet this is suggesting that

>

> >> none of us can post studies or historical usage in support of our

>

> >> therapies and what we do if it attempts to treat this popular media bug.

>

> >> This is a way to impact the public's perceptions and limit our influence.

>

> >> Be afraid, be very afraid, as that is what they want.

>

> >> The media on this bug have gotten out of control in trying to make this

>

> >> an epidemic, when it clearly is not. Similarly, this is a repeat of 30

>

> >> years ago as well. Some things go full circle if you remain here long

>

> >> enough.

>

> >>

>

> >> Michael W. Bowser, DC, LAc

>

> >>

>

> >>

>

> >

>

> >

>

> >

>

> > ---

>

> >

>

> > Subscribe to the free online journal for TCM at Times

>

> > http://www.chinesemedicinetimes.com

>

> >

>

> > Help build the world's largest online encyclopedia for Chinese medicine

>

> > and acupuncture, click, http://www.chinesemedicinetimes.com/wiki/CMTpedia

>

> >

>

> >

>

> > and adjust

>

> > accordingly.

>

> >

>

> > Messages are the property of the author. Any duplication outside the group

>

> > requires prior permission from the author.

>

> >

>

> > Please consider the environment and only print this message if absolutely

>

> > necessary.

November 12, 2009

So what about all the other illnesses such as the normal flu, which claims many

more lives, as well as auto and other immune issues? At some point, we must

admit that there is more to this then simply following their duties. Yes Dr.

Weil did make some errors but then some of their demands could be considered

excessive, such as we have previously mentioned. Making reference to a link to

the CDC can hardly be considered hype nor is it justified by their removal

request. They may not like how the CDC has changed its tune about this illness

to a lesser one then the media hype has been making it.

I have quoted some test from the letter. Please also note that in the letter

there was mention of removal of a reference to huang qi boosting the immune

system. Since we share this similar herb, in this case, and the fact that they

are stating that unless a substance has the FDA approval they are recommending

that the public not buy it. As I read this, I can only think that this also

means the public is being warned not buy our herbal formulations if they treat

any condition, especially the H1N1 virus.

" The Secretary of Health and Human Services, under section 319 of the Public

Health Service Act, 42 U.S.C. § 247d, has determined that a public health

emergency exists nationwide involving the H1N1 Flu Virus that affects or has the

significant potential to affect national

security. Following this determination and in response to requests from the U.S.

Centers for Disease Control and Prevention, FDA issued letters authorizing the

emergency use of certain unapproved and uncleared products or unapproved or

uncleared uses of approved or cleared products, provided certain criteria are

met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or

uncleared H1N1 Flu Virus-related products that are not authorized by and used in

accordance with the conditions of an Emergency Use Authorization, is a

potentially significant threat to the public health. Therefore, FDA is taking

urgent measures to protect consumers from products that, without approval or

authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1

Flu Virus in people. "

Michael W. Bowser, DC, LAc

Chinese Medicine

plantmed2

Thu, 12 Nov 2009 00:02:05 +0000

Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

As soon as a company has been warned about illegal claims, they must

remove all references to any disease states from their commercial web pages.

Since he provided a link to his immune product and recommended it for preventing

H1N1, he would not be allowed to provide that sort of link as part of his

compliance with the order. If he stopped marketing products on his web site, he

could talk about diseases all he wants.

I haven't seen any references to national security, but here is FDA's mindset:

1. No claims are allowed for any products that mention a disease name.

2. If the named disease is potentially fatal (cancer, diabetes, H1N1, etc.), FDA

will come down especially hard on that company.

3. Once FDA, and especially FTC, take action against a company for illegal

claims, they are watched VERY closely to be sure that they are in compliance.

Future screwups are met with a vicious fine.

- Bill

Chinese Medicine , mike Bowser

<naturaldoc1 wrote:

>

> So why was he forced to remove links to the CDC website that spoke about the

H1N1 virus? And why was this considered a matter of national security (also

posted at the bottom of the letter)?

>

> Michael W. Bowser, DC, LAc

>

> Chinese Medicine

> magisterium_magnum

> Tue, 10 Nov 2009 20:18:20 -0600

> Re: Re: FDA Letter: astragalus not approved for use for H1N1

flu virus prevention or tx

>

> So, it's a question of making " illegal claims, " not false claims.

Gotchya.

>

> -

>

> " bill_schoenbart " <plantmed2

>

> <Chinese Medicine >

>

> Tuesday, November 10, 2009 1:07 PM

>

> Re: FDA Letter: astragalus not approved for use for H1N1 flu

>

> virus prevention or tx

>

> > Mike,

>

> >

>

> > Patient education was not the issue here. Weil provided a link to one of

>

> > his products in the middle of his article on swine flu. The link suggested

>

> > that his product could prevent someone from catching H1N1. That was what

>

> > got him in trouble. He could have said the exact same thing about the

>

> > exact same herbs, without providing a link to his product, and the FDA /

>

> > FTC would not have bothered him. As soon as he provided the link to his

>

> > product, the entire article became product labeling.

>

> >

>

> > The disclaimer " this statement has not been approved by the FDA " applies

>

> > to legal structure function claims for products. As soon as a product

>

> > mentions a disease, it is an illegal disease or drug claim. The disclaimer

>

> > doesn't help in that case.

>

> >

>

> > FDA and FTC were making a statement, but it wasn't meant to make the

>

> > public afraid. They wanted to show companies that it is unprofitable to

>

> > make illegal claims about treating H1N1. They warned in advance that they

>

> > would do this, after the rash of products that illegally claimed that they

>

> > could treat SARS. It was no surprise that they followed through on their

>

> > warning.

>

> >

>

> > - Bill

>

> >

>

> >

>

> >

>

> > Chinese Medicine , mike Bowser

>

> > <naturaldoc1@> wrote:

>

> >>

>

> >>

>

> >> Bill,

>

> >> At what point is a practitioner able to educate the public, with online

>

> >> info, and not violate the law? Dr. Weil used info from the CDC's website

>

> >> as was told to take it down. Something is wrong here.

>

> >> It used to be that a simple reference that " this statement has not been

>

> >> approved by the FDA " was good enough. I have to disagree with you as

>

> >> patient education is a free speech issue and yet this is suggesting that

>

> >> none of us can post studies or historical usage in support of our

>

> >> therapies and what we do if it attempts to treat this popular media bug.

>

> >> This is a way to impact the public's perceptions and limit our influence.

>

> >> Be afraid, be very afraid, as that is what they want.

>

> >> The media on this bug have gotten out of control in trying to make this

>

> >> an epidemic, when it clearly is not. Similarly, this is a repeat of 30

>

> >> years ago as well. Some things go full circle if you remain here long

>

> >> enough.

>

> >>

>

> >> Michael W. Bowser, DC, LAc

>

> >>

>

> >>

>

> >

>

> >

>

> >

>

> > ---

>

> >

>

> > Subscribe to the free online journal for TCM at Times

>

> > http://www.chinesemedicinetimes.com

>

> >

>

> > Help build the world's largest online encyclopedia for Chinese medicine

>

> > and acupuncture, click, http://www.chinesemedicinetimes.com/wiki/CMTpedia

>

> >

>

> >

>

> > and adjust

>

> > accordingly.

>

> >

>

> > Messages are the property of the author. Any duplication outside the group

>

> > requires prior permission from the author.

>

> >

>

> > Please consider the environment and only print this message if absolutely

>

> > necessary.

November 12, 2009

Mentioning ANY disease on a label is illegal. FDA just comes down harder when

the disease has a potential for harm or when the company is very large. Airborne

paid millions of dollars for mentioning colds and flu on their labels and in

their advertising. There is nothing new here with the action against Weil.

- Bill

Chinese Medicine , mike Bowser

<naturaldoc1 wrote:

>

> So what about all the other illnesses such as the normal flu, which claims

many more lives, as well as auto and other immune issues? At some point, we

must admit that there is more to this then simply following their duties. Yes

Dr. Weil did make some errors but then some of their demands could be considered

excessive, such as we have previously mentioned. Making reference to a link to

the CDC can hardly be considered hype nor is it justified by their removal

request. They may not like how the CDC has changed its tune about this illness

to a lesser one then the media hype has been making it.

> I have quoted some test from the letter. Please also note that in the letter

there was mention of removal of a reference to huang qi boosting the immune

system. Since we share this similar herb, in this case, and the fact that they

are stating that unless a substance has the FDA approval they are recommending

that the public not buy it. As I read this, I can only think that this also

means the public is being warned not buy our herbal formulations if they treat

any condition, especially the H1N1 virus.

> " The Secretary of Health and Human Services, under section 319 of the Public

Health Service Act, 42 U.S.C. ï¿½ 247d, has determined that a public health

emergency exists nationwide involving the H1N1 Flu Virus that affects or has the

significant potential to affect national

> security. Following this determination and in response to requests from the

U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing

the emergency use of certain unapproved and uncleared products or unapproved or

uncleared uses of approved or cleared products, provided certain criteria are

met, under 21 U.S.C. ï¿½ 360bbb-3. The marketing and sale of unapproved or

uncleared H1N1 Flu Virus-related products that are not authorized by and used in

accordance with the conditions of an Emergency Use Authorization, is a

potentially significant threat to the public health. Therefore, FDA is taking

urgent measures to protect consumers from products that, without approval or

authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1

Flu Virus in people. "

>

> Michael W. Bowser, DC, LAc

>

> Chinese Medicine

> plantmed2

> Thu, 12 Nov 2009 00:02:05 +0000

> Re: FDA Letter: astragalus not approved for use for H1N1 flu

virus prevention or tx

>

As soon as a company has been warned about illegal claims, they must

remove all references to any disease states from their commercial web pages.

Since he provided a link to his immune product and recommended it for preventing

H1N1, he would not be allowed to provide that sort of link as part of his

compliance with the order. If he stopped marketing products on his web site, he

could talk about diseases all he wants.

>

> I haven't seen any references to national security, but here is FDA's mindset:

>

> 1. No claims are allowed for any products that mention a disease name.

>

> 2. If the named disease is potentially fatal (cancer, diabetes, H1N1, etc.),

FDA will come down especially hard on that company.

>

> 3. Once FDA, and especially FTC, take action against a company for illegal

claims, they are watched VERY closely to be sure that they are in compliance.

Future screwups are met with a vicious fine.

>

> - Bill

>

> Chinese Medicine , mike Bowser

<naturaldoc1@> wrote:

>

> >

>

> >

>

> > So why was he forced to remove links to the CDC website that spoke about the

H1N1 virus? And why was this considered a matter of national security (also

posted at the bottom of the letter)?

>

> >

>

> > Michael W. Bowser, DC, LAc

>

> >

>

> > Chinese Medicine

>

> > magisterium_magnum@

>

> > Tue, 10 Nov 2009 20:18:20 -0600

>

> > Re: Re: FDA Letter: astragalus not approved for use for H1N1

flu virus prevention or tx

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> >

>

> > So, it's a question of making " illegal claims, " not false claims.

Gotchya.

>

> >

>

> >

>

> >

>

> > -

>

> >

>

> > " bill_schoenbart " <plantmed2@>

>

> >

>

> > <Chinese Medicine >

>

> >

>

> > Tuesday, November 10, 2009 1:07 PM

>

> >

>

> > Re: FDA Letter: astragalus not approved for use for H1N1 flu

>

> >

>

> > virus prevention or tx

>

> >

>

> >

>

> >

>

> > > Mike,

>

> >

>

> > >

>

> >

>

> > > Patient education was not the issue here. Weil provided a link to one of

>

> >

>

> > > his products in the middle of his article on swine flu. The link suggested

>

> >

>

> > > that his product could prevent someone from catching H1N1. That was what

>

> >

>

> > > got him in trouble. He could have said the exact same thing about the

>

> >

>

> > > exact same herbs, without providing a link to his product, and the FDA /

>

> >

>

> > > FTC would not have bothered him. As soon as he provided the link to his

>

> >

>

> > > product, the entire article became product labeling.

>

> >

>

> > >

>

> >

>

> > > The disclaimer " this statement has not been approved by the FDA " applies

>

> >

>

> > > to legal structure function claims for products. As soon as a product

>

> >

>

> > > mentions a disease, it is an illegal disease or drug claim. The disclaimer

>

> >

>

> > > doesn't help in that case.

>

> >

>

> > >

>

> >

>

> > > FDA and FTC were making a statement, but it wasn't meant to make the

>

> >

>

> > > public afraid. They wanted to show companies that it is unprofitable to

>

> >

>

> > > make illegal claims about treating H1N1. They warned in advance that they

>

> >

>

> > > would do this, after the rash of products that illegally claimed that they

>

> >

>

> > > could treat SARS. It was no surprise that they followed through on their

>

> >

>

> > > warning.

>

> >

>

> > >

>

> >

>

> > > - Bill

>

> >

>

> > >

>

> >

>

> > >

>

> >

>

> > >

>

> >

>

> > > Chinese Medicine , mike Bowser

>

> >

>

> > > <naturaldoc1@> wrote:

>

> >

>

> > >>

>

> >

>

> > >>

>

> >

>

> > >> Bill,

>

> >

>

> > >> At what point is a practitioner able to educate the public, with online

>

> >

>

> > >> info, and not violate the law? Dr. Weil used info from the CDC's website

>

> >

>

> > >> as was told to take it down. Something is wrong here.

>

> >

>

> > >> It used to be that a simple reference that " this statement has not been

>

> >

>

> > >> approved by the FDA " was good enough. I have to disagree with you as

>

> >

>

> > >> patient education is a free speech issue and yet this is suggesting that

>

> >

>

> > >> none of us can post studies or historical usage in support of our

>

> >

>

> > >> therapies and what we do if it attempts to treat this popular media bug.

>

> >

>

> > >> This is a way to impact the public's perceptions and limit our influence.

>

> >

>

> > >> Be afraid, be very afraid, as that is what they want.

>

> >

>

> > >> The media on this bug have gotten out of control in trying to make this

>

> >

>

> > >> an epidemic, when it clearly is not. Similarly, this is a repeat of 30

>

> >

>

> > >> years ago as well. Some things go full circle if you remain here long

>

> >

>

> > >> enough.

>

> >

>

> > >>

>

> >

>

> > >> Michael W. Bowser, DC, LAc

>

> >

>

> > >>

>

> >

>

> > >>

>

> >

>

> > >

>

> >

>

> > >

>

> >

>

> > >

>

> >

>

> > > ---

>

> >

>

> > >

>

> >

>

> > > Subscribe to the free online journal for TCM at Times

>

> >

>

> > > http://www.chinesemedicinetimes.com

>

> >

>

> > >

>

> >

>

> > > Help build the world's largest online encyclopedia for Chinese medicine

>

> >

>

> > > and acupuncture, click, http://www.chinesemedicinetimes.com/wiki/CMTpedia

>

> >

>

> > >

>

> >

>

> > >

>

> >

>

> > > and adjust

>

> >

>

> > > accordingly.

>

> >

>

> > >

>

> >

>

> > > Messages are the property of the author. Any duplication outside the group

>

> >

>

> > > requires prior permission from the author.

>

> >

>

> > >

>

> >

>

> > > Please consider the environment and only print this message if absolutely

>

> >

>

> > > necessary.

FDA Letter: astragalus not approved for use for H1N1 flu virus prevention or tx

Recommended Posts

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Guest guest

Link to comment

Share on other sites

Join the conversation

Support the Ashram

Join Groups

Top Downloads