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This FDA cease letter makes me very angry and I want to PUKE.....I have

uploaded the actual letter from the FDA to Dr Weil, MD and attached

it.....WARNING: if you take blood pressure medication, take it now as your

blood

pressure will go sky high when you read this BS!!!

 

Unfortunately folks, this is only the beginning of what is ahead of

us.....My advice to everyone is STOCK UP and DEMAND your God given RIGHTS, to

make your own healthcare choices....The letter that was sent by the FDA is

attached. I tried to copy and paste the PdF...

 

I always try and take a negative and turn it into a positive.....this act

of ignorance by the FDA should shoot the sales of these products through the

ceiling...

 

Here are just a few things that I personally take as a prevention and keep

a good stock on hand!!!

 

ACS200ppm

ACZnano Zeolite

ZeoGold

VitA (good for lungs)

VitD (a minimum of 5000 units, but I take more, MY CHOICE)

Bio energy C (I'm taking 12 to 16 thousands mgs daily)

Prescript-Assist Probiotics

Quinton Marine Plasma both Isotonic and Hypertonic

Cold & Flu Homeopathic remedy

 

FOR THE RECORD, I DO NOT SELL ANY OF THE PRODUCTS THAT I HAVE CHOSEN

THROUGH MY HEALTHCARE WELLNESS JOURNEY!!

 

Some of this is part of my " lifelong " detox program, so there is much

more, but I DO NOT BELIEVE in vaccines or the toxic flu shots, so I protect my

body daily with the above plus a lot more......I have NEVER and will NEVER

take the toxic and deadly suggestion by the allopathic world. I'm a

survivor of (5) Cancers and two Lyme infections. I didn't chase the white

coats,

but used alternative medicine and modalities through all of the (5)

Cancers and Lyme & Company. I'm alive and well today because of my OWN

HEALTHCARE CHOICES...

 

What grinds my butt is the FDA slams Dr Weil for what he takes, but

approves Aspartame, Splenda, GMO foods and many other very toxic

products....follow the money!!! Stand your ground and fight for your own

personal CHOICE

FOR HEALTH!!

 

TAKE CHARGE OF YOUR OWN HEALTHCARE CHOICES....

 

_Linda's F.I.G.H.T. Blog_ (http://lymebook.com/fight/)

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

 

SupplySide Group News | LinkedIn 10/19/09 9:49 AM

_http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_ (http:

//www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 1 of 5

Inspections, Compliance, Enforcement, and Criminal

Investigations

Weil Lifestyle LLC 10/15/09

UNITED STATES OF AMERICA

FEDERAL TRADE COMMISSION

BUREAU OF CONSUMER PROTECTION

WASHINGTON, D.C. 20580

DEPARTMENT OF HEALTH

AND HUMAN SERVICES

FOOD AND DRUG

ADMINISTRATION

WASHINGTON, D.C. 20740

TO: _ebenjamin_ (ebenjamin)

_www.drweil.com_ (http://www.drweil.com/)

FROM: The Food and Drug Administration and the Federal Trade Commission

RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu

Virus; and

Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure

the H1N1 Virus

DATE: October 15, 2009

WARNING LETTER

This is to advise you that the United States Food and Drug Administration

( " FDA " )

SupplySide Group News | LinkedIn 10/19/09 9:49 AM

_http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

(http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 2 of 5

and the United States Federal Trade Commission ( " FTC " ) reviewed your

website at

the Internet address _www.drweil.com_ (http://www.drweil.com/) on October

13, 2009. The FDA has determined

that your website offers a

product for sale that is intended to diagnose, mitigate, prevent, treat or

cure the

H1N1 Flu Virus in people. This product has not been approved, cleared, or

otherwise

authorized by FDA for use in the diagnosis, mitigation, prevention,

treatment, or cure

of the H1N1 Flu Virus.

This product is your Immune Support Formula. The marketing of this product

violates

the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331,

351, 352.

We request that you immediately cease marketing unapproved, uncleared, or

unauthorized products for the diagnosis, mitigation, prevention,

treatment, or cure of

the H1N1 Flu Virus.

In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et

seq., requires

that claims that a dietary supplement can prevent, treat, or cure human

infection

with the H1N1 virus, must be supported by well-controlled human clinical

studies at

the time the claims are made. More generally, it is against the law to

make or

exaggerate health claims, whether directly or indirectly, through the use

of a product

name, website name, metatags, or other means, without rigorous scientific

evidence

sufficient to substantiate the claims. Violations of the FTC Act may

result in legal

action in the form of a Federal District Court injunction or Administrative

Order. An order also may require that you pay back money to consumers.

Some examples of the claims on your website include:

On a webpage entitled, " The Swine Flu - H1N1 , " with the subtitle " Swine

Flu

and You " :

" [D]uring the flu season, I suggest taking a daily antioxidant,

multivitamin-mineral

supplement, as well as astragalus, a well-known immune-boosting herb that

can help

ward off colds and flu. You might also consider. .. the Weil Immune Support

Formula[,] which contains both astragalus and immune-supportive polypore

mushrooms .... "

On a product webpage describing the Immune Support Formula:

SupplySide Group News | LinkedIn 10/19/09 9:49 AM

_http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

(http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 3 of 5

" The Immune Support Formula contains astragalus. . . . Astragalus ... is

used

traditionally to ward off colds and flu and has been well studied for its

antiviral and

immunity-enhancing properties. "

" Th[e] synergistic combination of immune modulators [found in the Immune

Support

Formula] is especially useful for those who tend to get every bug that

goes around

during the winter. "

On the same webpage, under " Supplement Facts, " describing the Astragalus

supplement (which is one element of the Immune Support Formula):

" Astragalus ... is ... used traditionally to ward off colds and flu, and

has

demonstrated both antiviral and immune-boosting effects in scientific

investigation. "

On the website's home page, DrWeil.com:

" Worried About Flu? Dr. Weil's Immune Support Formula can help maintain a

strong

defense against the flu. It contains astragalus, a traditional herb that

boosts

immunity. Buy it now in one click, and start protecting your immune system

against

flu this season. "

On the Dr. Weil Vitamins - Daily Vitamin Packs webpage:

" [L]earn more about Dr. Weil's Immune Support Formula, which contains

astragalus -

an herb Dr. Weil recommends to help ward off colds and flu. "

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

SupplySide Group News | LinkedIn 10/19/09 9:49 AM

_http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

(http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 4 of 5

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.

You should take immediate action to ensure that your firm is .not

marketing, and

does not market in the future, products intended to diagnose, mitigate,

prevent,

treat or cure the H1N1 Flu Virus that have not been approved, cleared, or

authorized

by the FDA. The above is not meant to be an all-inclusive list of

violations. It is your

responsibility to ensure that the products you market are in compliance

with the

FFDC Act and FDA's implementing regulations. We advise you to review your

websites, product labels, and other labeling and promotional materials to

ensure that

the claims you make for your products do not adulterate or misbrand the

products in

violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours,

please

send an email to _FDAFLUTASKFORCECFSAN_

(FDAFLUTASKFORCECFSAN) , describing the

actions that you have taken or plan to take to address your firm's

violations.

If your firm fails to take corrective action immediately, FDA may take

enforcement

action, such as seizure or injunction for violations of the FFDC Act

without further

notice. Firms that fail to take corrective action may also be referred to

FDA's Office

of Criminal Investigations for possible criminal prosecution for

violations of the FFDC

Act and other federal laws.

FDA is advising consumers not to purchase or use H1N1 Flu Virus-related

products

offered for sale that have not been approved, cleared, or authorized by

FDA. Your

firm will be added to a published list on FDA's website of firms and

websites that

have received warning letters from FDA concerning marketing unapproved,

uncleared

and unauthorized H1N1 Flu Virus-related products in violation of the FFDC

Act. This

list can be found at _www.accessdata.fda.gov/scripts/h1n1flu_

(http://www.accessdata.fda.gov/scripts/h1n1flu) . Once the violative

claims and/or products have been removed from your website, and these

corrective

actions have been confirmed by the FDA, the published list will be'

updated to

indicate that your firm has taken appropriate corrective action.

If you are not located in the United States, please note that unapproved,

uncleared,

or unauthorized products intended to diagnose, mitigate, prevent, treat,

or cure the

H1N1 Flu Virus offered for importation into the United States are subject

to detention

and refusal of admission. We will advise the appropriate regulatory or law

enforcement officials in the country from which you operate that FDA

considers your

product listed above to be an unapproved, uncleared, or unauthorized

product that

cannot be legally sold to consumers in the United States.

Please direct any inquiries to FDA at _FDAFLUTASKFORCECFSAN_

(FDAFLUTASKFORCECFSAN) or by

contacting Kathleen Lewis at 301-436-2148.

SupplySide Group News | LinkedIn 10/19/09 9:49 AM

_http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

(http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

%2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 5 of 5

It is also your responsibility to ensure that the products you market are

in

compliance with the FTC Act. FTC staff strongly urge you to review all

claims for

your products and ensure that those claims are supported by competent and

reliable scientific evidence. The FTC also asks that you notify it via

electronic

mail at _flu_ (flu) within 48 hours of the specific

actions you have taken to

address the agency's concerns. If you have any questions regarding

compliance

with the FTC Act, please contact Karen Jagielski at 202-326-2509.

Very truly yours,

/S/

Mary K. Engle

Associate Director

Division of Advertising Practices

Federal Trade Commission

/S/

Roberta F. Wagner

Office of Compliance

Center for Food Safety and Applied Nutrition

Food and Drug Administration

 

 

 

 

 

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i am not surprised, they will be arresting us 4 taking vitamins next. I have

been taking Herbalife products since 1982, after being diagnosed with severe

ulsers by Houson Dr. @ prescribed tylenol with codine. Fight back this is my

country,I will not allow pharmacy giants 2 control my life.VOTE the S.O.B " s out

that will not fight 4 us.Do not take vaccines that kill @ mame.Take

resposibility 4 you @ your family.I am 49 @ in perfect health, we are the fatest

we have ever been, unhealthiest we have ever been.Time 2 march to Washington

again? The power is in the hands of the people.I am mad as hell, and I am not

going to take it anymore.

 

, Angls4Hope wrote:

>

>

>

> This FDA cease letter makes me very angry and I want to PUKE.....I have

> uploaded the actual letter from the FDA to Dr Weil, MD and attached

> it.....WARNING: if you take blood pressure medication, take it now as your

blood

> pressure will go sky high when you read this BS!!!

>

> Unfortunately folks, this is only the beginning of what is ahead of

> us.....My advice to everyone is STOCK UP and DEMAND your God given RIGHTS, to

> make your own healthcare choices....The letter that was sent by the FDA is

> attached. I tried to copy and paste the PdF...

>

> I always try and take a negative and turn it into a positive.....this act

> of ignorance by the FDA should shoot the sales of these products through the

> ceiling...

>

> Here are just a few things that I personally take as a prevention and keep

> a good stock on hand!!!

>

> ACS200ppm

> ACZnano Zeolite

> ZeoGold

> VitA (good for lungs)

> VitD (a minimum of 5000 units, but I take more, MY CHOICE)

> Bio energy C (I'm taking 12 to 16 thousands mgs daily)

> Prescript-Assist Probiotics

> Quinton Marine Plasma both Isotonic and Hypertonic

> Cold & Flu Homeopathic remedy

>

> FOR THE RECORD, I DO NOT SELL ANY OF THE PRODUCTS THAT I HAVE CHOSEN

> THROUGH MY HEALTHCARE WELLNESS JOURNEY!!

>

> Some of this is part of my " lifelong " detox program, so there is much

> more, but I DO NOT BELIEVE in vaccines or the toxic flu shots, so I protect

my

> body daily with the above plus a lot more......I have NEVER and will NEVER

> take the toxic and deadly suggestion by the allopathic world. I'm a

> survivor of (5) Cancers and two Lyme infections. I didn't chase the white

coats,

> but used alternative medicine and modalities through all of the (5)

> Cancers and Lyme & Company. I'm alive and well today because of my OWN

> HEALTHCARE CHOICES...

>

> What grinds my butt is the FDA slams Dr Weil for what he takes, but

> approves Aspartame, Splenda, GMO foods and many other very toxic

> products....follow the money!!! Stand your ground and fight for your own

personal CHOICE

> FOR HEALTH!!

>

> TAKE CHARGE OF YOUR OWN HEALTHCARE CHOICES....

>

> _Linda's F.I.G.H.T. Blog_ (http://lymebook.com/fight/)

> ===========================================

>

> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_ (http:

> //www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 1 of

5

> Inspections, Compliance, Enforcement, and Criminal

> Investigations

> Weil Lifestyle LLC 10/15/09

> UNITED STATES OF AMERICA

> FEDERAL TRADE COMMISSION

> BUREAU OF CONSUMER PROTECTION

> WASHINGTON, D.C. 20580

> DEPARTMENT OF HEALTH

> AND HUMAN SERVICES

> FOOD AND DRUG

> ADMINISTRATION

> WASHINGTON, D.C. 20740

> TO: _ebenjamin_ (ebenjamin)

> _www.drweil.com_ (http://www.drweil.com/)

> FROM: The Food and Drug Administration and the Federal Trade Commission

> RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu

> Virus; and

> Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure

> the H1N1 Virus

> DATE: October 15, 2009

> WARNING LETTER

> This is to advise you that the United States Food and Drug Administration

> ( " FDA " )

> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 2 of

5

> and the United States Federal Trade Commission ( " FTC " ) reviewed your

> website at

> the Internet address _www.drweil.com_ (http://www.drweil.com/) on October

> 13, 2009. The FDA has determined

> that your website offers a

> product for sale that is intended to diagnose, mitigate, prevent, treat or

> cure the

> H1N1 Flu Virus in people. This product has not been approved, cleared, or

> otherwise

> authorized by FDA for use in the diagnosis, mitigation, prevention,

> treatment, or cure

> of the H1N1 Flu Virus.

> This product is your Immune Support Formula. The marketing of this product

> violates

> the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331,

> 351, 352.

> We request that you immediately cease marketing unapproved, uncleared, or

> unauthorized products for the diagnosis, mitigation, prevention,

> treatment, or cure of

> the H1N1 Flu Virus.

> In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et

> seq., requires

> that claims that a dietary supplement can prevent, treat, or cure human

> infection

> with the H1N1 virus, must be supported by well-controlled human clinical

> studies at

> the time the claims are made. More generally, it is against the law to

> make or

> exaggerate health claims, whether directly or indirectly, through the use

> of a product

> name, website name, metatags, or other means, without rigorous scientific

> evidence

> sufficient to substantiate the claims. Violations of the FTC Act may

> result in legal

> action in the form of a Federal District Court injunction or Administrative

> Order. An order also may require that you pay back money to consumers.

> Some examples of the claims on your website include:

> On a webpage entitled, " The Swine Flu - H1N1 , " with the subtitle " Swine

> Flu

> and You " :

> " [D]uring the flu season, I suggest taking a daily antioxidant,

> multivitamin-mineral

> supplement, as well as astragalus, a well-known immune-boosting herb that

> can help

> ward off colds and flu. You might also consider. .. the Weil Immune Support

> Formula[,] which contains both astragalus and immune-supportive polypore

> mushrooms .... "

> On a product webpage describing the Immune Support Formula:

> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 3 of

5

> " The Immune Support Formula contains astragalus. . . . Astragalus ... is

> used

> traditionally to ward off colds and flu and has been well studied for its

> antiviral and

> immunity-enhancing properties. "

> " Th[e] synergistic combination of immune modulators [found in the Immune

> Support

> Formula] is especially useful for those who tend to get every bug that

> goes around

> during the winter. "

> On the same webpage, under " Supplement Facts, " describing the Astragalus

> supplement (which is one element of the Immune Support Formula):

> " Astragalus ... is ... used traditionally to ward off colds and flu, and

> has

> demonstrated both antiviral and immune-boosting effects in scientific

> investigation. "

> On the website's home page, DrWeil.com:

> " Worried About Flu? Dr. Weil's Immune Support Formula can help maintain a

> strong

> defense against the flu. It contains astragalus, a traditional herb that

> boosts

> immunity. Buy it now in one click, and start protecting your immune system

> against

> flu this season. "

> On the Dr. Weil Vitamins - Daily Vitamin Packs webpage:

> " [L]earn more about Dr. Weil's Immune Support Formula, which contains

> astragalus -

> an herb Dr. Weil recommends to help ward off colds and flu. "

> 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

> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 4 of

5

> 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.

> You should take immediate action to ensure that your firm is .not

> marketing, and

> does not market in the future, products intended to diagnose, mitigate,

> prevent,

> treat or cure the H1N1 Flu Virus that have not been approved, cleared, or

> authorized

> by the FDA. The above is not meant to be an all-inclusive list of

> violations. It is your

> responsibility to ensure that the products you market are in compliance

> with the

> FFDC Act and FDA's implementing regulations. We advise you to review your

> websites, product labels, and other labeling and promotional materials to

> ensure that

> the claims you make for your products do not adulterate or misbrand the

> products in

> violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours,

> please

> send an email to _FDAFLUTASKFORCECFSAN_

> (FDAFLUTASKFORCECFSAN) , describing the

> actions that you have taken or plan to take to address your firm's

> violations.

> If your firm fails to take corrective action immediately, FDA may take

> enforcement

> action, such as seizure or injunction for violations of the FFDC Act

> without further

> notice. Firms that fail to take corrective action may also be referred to

> FDA's Office

> of Criminal Investigations for possible criminal prosecution for

> violations of the FFDC

> Act and other federal laws.

> FDA is advising consumers not to purchase or use H1N1 Flu Virus-related

> products

> offered for sale that have not been approved, cleared, or authorized by

> FDA. Your

> firm will be added to a published list on FDA's website of firms and

> websites that

> have received warning letters from FDA concerning marketing unapproved,

> uncleared

> and unauthorized H1N1 Flu Virus-related products in violation of the FFDC

> Act. This

> list can be found at _www.accessdata.fda.gov/scripts/h1n1flu_

> (http://www.accessdata.fda.gov/scripts/h1n1flu) . Once the violative

> claims and/or products have been removed from your website, and these

> corrective

> actions have been confirmed by the FDA, the published list will be'

> updated to

> indicate that your firm has taken appropriate corrective action.

> If you are not located in the United States, please note that unapproved,

> uncleared,

> or unauthorized products intended to diagnose, mitigate, prevent, treat,

> or cure the

> H1N1 Flu Virus offered for importation into the United States are subject

> to detention

> and refusal of admission. We will advise the appropriate regulatory or law

> enforcement officials in the country from which you operate that FDA

> considers your

> product listed above to be an unapproved, uncleared, or unauthorized

> product that

> cannot be legally sold to consumers in the United States.

> Please direct any inquiries to FDA at _FDAFLUTASKFORCECFSAN_

> (FDAFLUTASKFORCECFSAN) or by

> contacting Kathleen Lewis at 301-436-2148.

> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 5 of

5

> It is also your responsibility to ensure that the products you market are

> in

> compliance with the FTC Act. FTC staff strongly urge you to review all

> claims for

> your products and ensure that those claims are supported by competent and

> reliable scientific evidence. The FTC also asks that you notify it via

> electronic

> mail at _flu_ (flu) within 48 hours of the specific

> actions you have taken to

> address the agency's concerns. If you have any questions regarding

> compliance

> with the FTC Act, please contact Karen Jagielski at 202-326-2509.

> Very truly yours,

> /S/

> Mary K. Engle

> Associate Director

> Division of Advertising Practices

> Federal Trade Commission

> /S/

> Roberta F. Wagner

> Director

> Office of Compliance

> Center for Food Safety and Applied Nutrition

> Food and Drug Administration

>

>

>

>

>

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Share on other sites

I have a grandson who loves Cheerios. The FDA says they are going to

classify it as a drug if they don't stop making claims.

Margi

 

IleneD wrote:

> i am not surprised, they will be arresting us 4 taking vitamins next. I have

been taking Herbalife products since 1982, after being diagnosed with severe

ulsers by Houson Dr. @ prescribed tylenol with codine. Fight back this is my

country,I will not allow pharmacy giants 2 control my life.VOTE the S.O.B " s out

that will not fight 4 us.Do not take vaccines that kill @ mame.Take

resposibility 4 you @ your family.I am 49 @ in perfect health, we are the fatest

we have ever been, unhealthiest we have ever been.Time 2 march to Washington

again? The power is in the hands of the people.I am mad as hell, and I am not

going to take it anymore.

>

> , Angls4Hope wrote:

>

>>

>>

>> This FDA cease letter makes me very angry and I want to PUKE.....I have

>> uploaded the actual letter from the FDA to Dr Weil, MD and attached

>> it.....WARNING: if you take blood pressure medication, take it now as your

blood

>> pressure will go sky high when you read this BS!!!

>>

>> Unfortunately folks, this is only the beginning of what is ahead of

>> us.....My advice to everyone is STOCK UP and DEMAND your God given RIGHTS,

to

>> make your own healthcare choices....The letter that was sent by the FDA is

>> attached. I tried to copy and paste the PdF...

>>

>> I always try and take a negative and turn it into a positive.....this act

>> of ignorance by the FDA should shoot the sales of these products through the

>> ceiling...

>>

>> Here are just a few things that I personally take as a prevention and keep

>> a good stock on hand!!!

>>

>> ACS200ppm

>> ACZnano Zeolite

>> ZeoGold

>> VitA (good for lungs)

>> VitD (a minimum of 5000 units, but I take more, MY CHOICE)

>> Bio energy C (I'm taking 12 to 16 thousands mgs daily)

>> Prescript-Assist Probiotics

>> Quinton Marine Plasma both Isotonic and Hypertonic

>> Cold & Flu Homeopathic remedy

>>

>> FOR THE RECORD, I DO NOT SELL ANY OF THE PRODUCTS THAT I HAVE CHOSEN

>> THROUGH MY HEALTHCARE WELLNESS JOURNEY!!

>>

>> Some of this is part of my " lifelong " detox program, so there is much

>> more, but I DO NOT BELIEVE in vaccines or the toxic flu shots, so I protect

my

>> body daily with the above plus a lot more......I have NEVER and will NEVER

>> take the toxic and deadly suggestion by the allopathic world. I'm a

>> survivor of (5) Cancers and two Lyme infections. I didn't chase the white

coats,

>> but used alternative medicine and modalities through all of the (5)

>> Cancers and Lyme & Company. I'm alive and well today because of my OWN

>> HEALTHCARE CHOICES...

>>

>> What grinds my butt is the FDA slams Dr Weil for what he takes, but

>> approves Aspartame, Splenda, GMO foods and many other very toxic

>> products....follow the money!!! Stand your ground and fight for your own

personal CHOICE

>> FOR HEALTH!!

>>

>> TAKE CHARGE OF YOUR OWN HEALTHCARE CHOICES....

>>

>> _Linda's F.I.G.H.T. Blog_ (http://lymebook.com/fight/)

>> ===========================================

>>

>> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

>> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_ (http:

>> //www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 1

of 5

>> Inspections, Compliance, Enforcement, and Criminal

>> Investigations

>> Weil Lifestyle LLC 10/15/09

>> UNITED STATES OF AMERICA

>> FEDERAL TRADE COMMISSION

>> BUREAU OF CONSUMER PROTECTION

>> WASHINGTON, D.C. 20580

>> DEPARTMENT OF HEALTH

>> AND HUMAN SERVICES

>> FOOD AND DRUG

>> ADMINISTRATION

>> WASHINGTON, D.C. 20740

>> TO: _ebenjamin_ (ebenjamin)

>> _www.drweil.com_ (http://www.drweil.com/)

>> FROM: The Food and Drug Administration and the Federal Trade Commission

>> RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu

>> Virus; and

>> Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure

>> the H1N1 Virus

>> DATE: October 15, 2009

>> WARNING LETTER

>> This is to advise you that the United States Food and Drug Administration

>> ( " FDA " )

>> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

>> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

>> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 2

of 5

>> and the United States Federal Trade Commission ( " FTC " ) reviewed your

>> website at

>> the Internet address _www.drweil.com_ (http://www.drweil.com/) on October

>> 13, 2009. The FDA has determined

>> that your website offers a

>> product for sale that is intended to diagnose, mitigate, prevent, treat or

>> cure the

>> H1N1 Flu Virus in people. This product has not been approved, cleared, or

>> otherwise

>> authorized by FDA for use in the diagnosis, mitigation, prevention,

>> treatment, or cure

>> of the H1N1 Flu Virus.

>> This product is your Immune Support Formula. The marketing of this product

>> violates

>> the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331,

>> 351, 352.

>> We request that you immediately cease marketing unapproved, uncleared, or

>> unauthorized products for the diagnosis, mitigation, prevention,

>> treatment, or cure of

>> the H1N1 Flu Virus.

>> In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et

>> seq., requires

>> that claims that a dietary supplement can prevent, treat, or cure human

>> infection

>> with the H1N1 virus, must be supported by well-controlled human clinical

>> studies at

>> the time the claims are made. More generally, it is against the law to

>> make or

>> exaggerate health claims, whether directly or indirectly, through the use

>> of a product

>> name, website name, metatags, or other means, without rigorous scientific

>> evidence

>> sufficient to substantiate the claims. Violations of the FTC Act may

>> result in legal

>> action in the form of a Federal District Court injunction or Administrative

>> Order. An order also may require that you pay back money to consumers.

>> Some examples of the claims on your website include:

>> On a webpage entitled, " The Swine Flu - H1N1 , " with the subtitle " Swine

>> Flu

>> and You " :

>> " [D]uring the flu season, I suggest taking a daily antioxidant,

>> multivitamin-mineral

>> supplement, as well as astragalus, a well-known immune-boosting herb that

>> can help

>> ward off colds and flu. You might also consider. .. the Weil Immune Support

>> Formula[,] which contains both astragalus and immune-supportive polypore

>> mushrooms .... "

>> On a product webpage describing the Immune Support Formula:

>> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

>> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

>> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 3

of 5

>> " The Immune Support Formula contains astragalus. . . . Astragalus ... is

>> used

>> traditionally to ward off colds and flu and has been well studied for its

>> antiviral and

>> immunity-enhancing properties. "

>> " Th[e] synergistic combination of immune modulators [found in the Immune

>> Support

>> Formula] is especially useful for those who tend to get every bug that

>> goes around

>> during the winter. "

>> On the same webpage, under " Supplement Facts, " describing the Astragalus

>> supplement (which is one element of the Immune Support Formula):

>> " Astragalus ... is ... used traditionally to ward off colds and flu, and

>> has

>> demonstrated both antiviral and immune-boosting effects in scientific

>> investigation. "

>> On the website's home page, DrWeil.com:

>> " Worried About Flu? Dr. Weil's Immune Support Formula can help maintain a

>> strong

>> defense against the flu. It contains astragalus, a traditional herb that

>> boosts

>> immunity. Buy it now in one click, and start protecting your immune system

>> against

>> flu this season. "

>> On the Dr. Weil Vitamins - Daily Vitamin Packs webpage:

>> " [L]earn more about Dr. Weil's Immune Support Formula, which contains

>> astragalus -

>> an herb Dr. Weil recommends to help ward off colds and flu. "

>> 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

>> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

>> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

>> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 4

of 5

>> 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.

>> You should take immediate action to ensure that your firm is .not

>> marketing, and

>> does not market in the future, products intended to diagnose, mitigate,

>> prevent,

>> treat or cure the H1N1 Flu Virus that have not been approved, cleared, or

>> authorized

>> by the FDA. The above is not meant to be an all-inclusive list of

>> violations. It is your

>> responsibility to ensure that the products you market are in compliance

>> with the

>> FFDC Act and FDA's implementing regulations. We advise you to review your

>> websites, product labels, and other labeling and promotional materials to

>> ensure that

>> the claims you make for your products do not adulterate or misbrand the

>> products in

>> violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours,

>> please

>> send an email to _FDAFLUTASKFORCECFSAN_

>> (FDAFLUTASKFORCECFSAN) , describing the

>> actions that you have taken or plan to take to address your firm's

>> violations.

>> If your firm fails to take corrective action immediately, FDA may take

>> enforcement

>> action, such as seizure or injunction for violations of the FFDC Act

>> without further

>> notice. Firms that fail to take corrective action may also be referred to

>> FDA's Office

>> of Criminal Investigations for possible criminal prosecution for

>> violations of the FFDC

>> Act and other federal laws.

>> FDA is advising consumers not to purchase or use H1N1 Flu Virus-related

>> products

>> offered for sale that have not been approved, cleared, or authorized by

>> FDA. Your

>> firm will be added to a published list on FDA's website of firms and

>> websites that

>> have received warning letters from FDA concerning marketing unapproved,

>> uncleared

>> and unauthorized H1N1 Flu Virus-related products in violation of the FFDC

>> Act. This

>> list can be found at _www.accessdata.fda.gov/scripts/h1n1flu_

>> (http://www.accessdata.fda.gov/scripts/h1n1flu) . Once the violative

>> claims and/or products have been removed from your website, and these

>> corrective

>> actions have been confirmed by the FDA, the published list will be'

>> updated to

>> indicate that your firm has taken appropriate corrective action.

>> If you are not located in the United States, please note that unapproved,

>> uncleared,

>> or unauthorized products intended to diagnose, mitigate, prevent, treat,

>> or cure the

>> H1N1 Flu Virus offered for importation into the United States are subject

>> to detention

>> and refusal of admission. We will advise the appropriate regulatory or law

>> enforcement officials in the country from which you operate that FDA

>> considers your

>> product listed above to be an unapproved, uncleared, or unauthorized

>> product that

>> cannot be legally sold to consumers in the United States.

>> Please direct any inquiries to FDA at _FDAFLUTASKFORCECFSAN_

>> (FDAFLUTASKFORCECFSAN) or by

>> contacting Kathleen Lewis at 301-436-2148.

>> SupplySide Group News | LinkedIn 10/19/09 9:49 AM

>> _http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss_

>> (http://www.linkedin.com/news?viewArticle= & articleID=78116076 & gid=…

>> %2FWarningLetters%2Fucm186837%2Ehtm & urlhash=TNIr & trk=news_discuss) Page 5

of 5

>> It is also your responsibility to ensure that the products you market are

>> in

>> compliance with the FTC Act. FTC staff strongly urge you to review all

>> claims for

>> your products and ensure that those claims are supported by competent and

>> reliable scientific evidence. The FTC also asks that you notify it via

>> electronic

>> mail at _flu_ (flu) within 48 hours of the specific

>> actions you have taken to

>> address the agency's concerns. If you have any questions regarding

>> compliance

>> with the FTC Act, please contact Karen Jagielski at 202-326-2509.

>> Very truly yours,

>> /S/

>> Mary K. Engle

>> Associate Director

>> Division of Advertising Practices

>> Federal Trade Commission

>> /S/

>> Roberta F. Wagner

>> Director

>> Office of Compliance

>> Center for Food Safety and Applied Nutrition

>> Food and Drug Administration

>>

>>

>>

>>

>>

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