Guest guest Posted October 21, 2009 Report Share Posted October 21, 2009 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 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 21, 2009 Report Share Posted October 21, 2009 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 > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 22, 2009 Report Share Posted October 22, 2009 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 >> >> >> >> >> Quote Link to comment Share on other sites More sharing options...
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