Guest guest Posted September 9, 2011 Report Share Posted September 9, 2011 To All: I don't post much. I mostly read and try to learn more about staying healthy. This time however I saw the word "FDA." I hope you all read what I've written to the end. It would be appreciated. -- Thanks. Les To Brent Higgins: Congressman G. 's letter to you is a sick joke. In it he says: "The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of possible safety problems." By saying what he did he shows that he supports the FDA and as such supports one of the most corrupt departments of government in the United States of America. The NEXT question one needs to ask is just how much money is he getting from the pharmaceutical industry and/or how deeply associated he is with the pharmaceutical industry. Does he own stock in big Pharma? Does he get campaign contributions from big Pharma? Does he sit on the board of any pharmaceutical company??? Any American with 2 working braincells knows you can't trust the FDA to do the right thing for America or for Americans. Their main game is working WITH the big pharmaceutical and medical supply companies. The FDA is corrupt beyond words and anyone who supports the FDA has to be assumed to also be corrupt or as dumb as a jackass. I know this more than likely wasn't the answer you wanted to see, but everytime I hear the word "FDA" my blood automatically boils. The CDC and World Health Organization (WHO) are other words that make my blood boil by the way. Want to know why? Go here: http://www.zolkor.com/swineflu/swineflu.htm Better yet, just go to Page 19 here: http://www.zolkor.com/swineflu/swf0019.htm In 1976 I chose NOT to take the swine flu vaccine. I made a good choice back then then. Now... fast forward....the U.S. Government starts promoting the Swine Flu Vaccine again at the end of 2008....THIS TIME I want to know why. And that is when I started to dig deep into the FDA, CDC and the World Health Organization connections to the pharmaceutical companies. That was when I started work on this page here: http://www.zolkor.com/swineflu/swineflu.htm I spent the end of 2008 (I actually spent time going back further in time on this vaccine issue and posting that information on this website) on through 2009 and into 2010 and finally PROVED that the whole lot of them - the FDA, the CDC, the World Health Organization - are as corrupt as corrupt gets. It's all about *MONEY* - NOTHING ELSE! These organizations couldn't give a fig about you, your children, your family or the whole population of the United States or this planet! Like I said, just read what's posted on Page 19 if you want a good summation of how "legitimate" those organizations are. Better yet, read starting at Page 1. You'll have your eyes opened up if they aren't open already. And no, this isn't about just vaccines, this is about government, government agencies and the U.N. corruption that'll make you madder than hell. Sorry for the rant, but like I said, when I see the word "FDA" I *REALLY* get angry.....which I feel is more than justified. Les Message from Congressman G. September 9, 2011 Ms. K. Higgins 13657 Norton Avenue Chino, California 91710 Dear Ms. Higgins: Thank you for contacting me to express your concern about the FDA potentially regulating alternative medicine products. I appreciate hearing from you on this issue. As a health and fitness enthusiast, I recognize the value of dietary supplements to overall health and well-being. It may interest you to know, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are exempt from the type of pre-market approval process that drugs, medical devices and food additives must undergo before they are allowed to be sold. This law effectively shifts the burden-of-proof from the manufacturer to the FDA to show that a dietary supplement is unsafe. The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of p ossible safety problems. Dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed. Generally, they are not required to register with the FDA nor get approval before producing or selling dietary supplements. Manufacturers are simply required to ensure that product label information is truthful and not misleading. ; As you may be aware, on July 1, 2011, the FDA published, "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." This document clarifies what a New Dietary Ingredient (NDI) is, when a NDI should be reported to the FDA, and the procedures for submitting an NDI notification to the FDA. The NDI guidelines prov ide direction to supplement manufacturers and distributors, however, the document is not binding at this time. Currently, the FDA is accepting public comments on the new guidelines through October 3, 2011. As the regulatory process moves forward, please be assured I will continue to work in Congress to ensure that supplements are both available and safe for America's consumers. Again, thank you for contacting me. I hope you will remain in touch in the future on other issues of importance to you. & nb sp; Sincerely, GARY G. MILLER Member of Congress Higgins www.becomingaspecialneedsadvocate@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 9, 2011 Report Share Posted September 9, 2011 I got the same sort of letter from my senator. Carol Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 10, 2011 Report Share Posted September 10, 2011 Brilliant site. the lady typist echoes a war poster?So did you intend to suggest there isa war going on?I agree with all you have written butit's much worse than you represent.Two references may be of interest1. Pfizers the biggest drug companyin the world were called serial liarsby the judge in a whistleblower trialwhere they were fined $2.3 billion.it was the 4th time in 10 years theyhad been been before the courtfor similar offences.Obviously they don't give a hootabout the fines. This suggests thatthe Justice Dept are letting them offwith a slap on the wrist see taf.orgfor details of fines given out bythe Justice Dept.2. Glaxo Kline Knowingly manufacturing and distributingtablets which were worthless, fined $750 million for fraud,in a whistlebloweraction. one of the drugs was Avandiathe biggest selling diabetes drugwhich was banned by the EU butbecause the FDA has so many on thepanel who are in Pharmas pocket it isstill available in the US.If an individual were to act as these companiesdo they would be executed for murder.And the doctors all know whats going on. "Last year, Pfizer paid about $2.3 billion to settle charges related to its painkiller drug Bextra, which is now withdrawn.The settlement was far larger than Eli Lilly's $1.4 billion settlement related to its antipsychotic drug Zyprexa which was marketed to unapproved segments of children and .the elderly."Glaxo to Pay $750 Million for Sale of Bad Productsgoogle this headline and see NYT article.http://www.independent.co.uk/news/science/glaxo-chief-our-drugs-do-not-work-on-most-patients-575942.html Glaxo chief: Our dugs don't work on most people!!!From: Les Lemke <leslemke@...>iodine Sent: Saturday, 10 September 2011, 3:59Subject: Re: Fwd: Message from Congressman G. To All: I don't post much. I mostly read and try to learn more about staying healthy. This time however I saw the word "FDA." I hope you all read what I've written to the end. It would be appreciated. -- Thanks. Les To Brent Higgins: Congressman G. 's letter to you is a sick joke. In it he says: "The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of possible safety problems." By saying what he did he shows that he supports the FDA and as such supports one of the most corrupt departments of government in the United States of America. The NEXT question one needs to ask is just how much money is he getting from the pharmaceutical industry and/or how deeply associated he is with the pharmaceutical industry. Does he own stock in big Pharma? Does he get campaign contributions from big Pharma? Does he sit on the board of any pharmaceutical company??? Any American with 2 working braincells knows you can't trust the FDA to do the right thing for America or for Americans. Their main game is working WITH the big pharmaceutical and medical supply companies. The FDA is corrupt beyond words and anyone who supports the FDA has to be assumed to also be corrupt or as dumb as a jackass. I know this more than likely wasn't the answer you wanted to see, but everytime I hear the word "FDA" my blood automatically boils. The CDC and World Health Organization (WHO) are other words that make my blood boil by the way. Want to know why? Go here: http://www.zolkor.com/swineflu/swineflu.htm Better yet, just go to Page 19 here: http://www.zolkor.com/swineflu/swf0019.htm In 1976 I chose NOT to take the swine flu vaccine. I made a good choice back then then. Now... fast forward....the U.S. Government starts promoting the Swine Flu Vaccine again at the end of 2008....THIS TIME I want to know why. And that is when I started to dig deep into the FDA, CDC and the World Health Organization connections to the pharmaceutical companies. That was when I started work on this page here: http://www.zolkor.com/swineflu/swineflu.htm I spent the end of 2008 (I actually spent time going back further in time on this vaccine issue and posting that information on this website) on through 2009 and into 2010 and finally PROVED that the whole lot of them - the FDA, the CDC, the World Health Organization - are as corrupt as corrupt gets. It's all about *MONEY* - NOTHING ELSE! These organizations couldn't give a fig about you, your children, your family or the whole population of the United States or this planet! Like I said, just read what's posted on Page 19 if you want a good summation of how "legitimate" those organizations are. Better yet, read starting at Page 1. You'll have your eyes opened up if they aren't open already. And no, this isn't about just vaccines, this is about government, government agencies and the U.N. corruption that'll make you madder than hell. Sorry for the rant, but like I said, when I see the word "FDA" I *REALLY* get angry.....which I feel is more than justified. Les Message from Congressman G. September 9, 2011 Ms. K. Higgins 13657 Norton Avenue Chino, California 91710 Dear Ms. Higgins: Thank you for contacting me to express your concern about the FDA potentially regulating alternative medicine products. I appreciate hearing from you on this issue. As a health and fitness enthusiast, I recognize the value of dietary supplements to overall health and well-being. It may interest you to know, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are exempt from the type of pre-market approval process that drugs, medical devices and food additives must undergo before they are allowed to be sold. This law effectively shifts the burden-of-proof from the manufacturer to the FDA to show that a dietary supplement is unsafe. The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of p ossible safety problems. Dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed. Generally, they are not required to register with the FDA nor get approval before producing or selling dietary supplements. Manufacturers are simply required to ensure that product label information is truthful and not misleading. ; As you may be aware, on July 1, 2011, the FDA published, "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." This document clarifies what a New Dietary Ingredient (NDI) is, when a NDI should be reported to the FDA, and the procedures for submitting an NDI notification to the FDA. The NDI guidelines prov ide direction to supplement manufacturers and distributors, however, the document is not binding at this time. Currently, the FDA is accepting public comments on the new guidelines through October 3, 2011. As the regulatory process moves forward, please be assured I will continue to work in Congress to ensure that supplements are both available and safe for America's consumers. Again, thank you for contacting me. I hope you will remain in touch in the future on other issues of importance to you. & nb sp; Sincerely, GARY G. MILLER Member of Congress Higgins www.becomingaspecialneedsadvocate@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 10, 2011 Report Share Posted September 10, 2011 Hi , You might mention that you are not only aware of DSHEA, but that you are also aware of the history of how it came into being in the first place. Perhaps some statistics about the number of drugs that were actually allowed by the FDA, only to be pulled off the market because of all the deaths and adverse reactions they caused might make an impression as to the reason for your lack of confidence in the ability of the FDA to successfully regulate anything. As for Mr. 's statement that the guidelines are not binding at this time, any salesman worth his or her salt can tell you that before you can sell anything, first you have to get your foot in the door. So, the concern is that once this does get passed it will be used as a way to circumvent DSHEA. And believe me, it will Finally, you might subtly imply that his job might be on the line. So, get as many of your friends to contact Mr. as well. Who knows? If he likes his job and wants to keep it, it might adjust his viewpoint. Regards, BastidaFrom: Brent Higgins <Luff2sail@...>Subject: Fwd: Message from Congressman G. iodine Date: Friday, September 9, 2011, 4:00 PM This is the message I received from my congressman in response to sending him an e-mail about current legislation regarding supplements. Does anyone have a good response to this? I believe he is misinformed but I know so little and want to educate him further so that he wont be swayed to vote for something that could hurt all of us who are trying to take more responsibility for our health. I am also betting that there are others out there who will receive similar messages when you try to advocate to members of the House or Senate. Higgins Begin forwarded message:From: "Congressman G. " <gary.miller@...>Date: September 9, 2011 1:26:15 PM PDT<luff2sail@...>Subject: Message from Congressman G. September 9, 2011 Ms. K. Higgins13657 Norton AvenueChino, California 91710 Dear Ms. Higgins: Thank you for contacting me to express your concern about the FDA potentially regulating alternative medicine products. I appreciate hearing from you on this issue. As a health and fitness enthusiast, I recognize the value of dietary supplements to overall health and well-being. It may interest you to know, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are exempt from the type of pre-market approval process that drugs, medical devices and food additives must undergo before they are allowed to be sold. This law effectively shifts the burden-of-proof from the manufacturer to the FDA to show that a dietary supplement is unsafe. The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of possible safety problems. Dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed. Generally, they are not required to register with the FDA nor get approval before producing or selling dietary supplements. Manufacturers are simply required to ensure that product label information is truthful and not misleading. As you may be aware, on July 1, 2011, the FDA published, "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." This document clarifies what a New Dietary Ingredient (NDI) is, when a NDI should be reported to the FDA, and the procedures for submitting an NDI notification to the FDA. The NDI guidelines provide direction to supplement manufacturers and distributors, however, the document is not binding at this time. Currently, the FDA is accepting public comments on the new guidelines through October 3, 2011. As the regulatory process moves forward, please be assured I will continue to work in Congress to ensure that supplements are both available and safe for America's consumers. Again, thank you for contacting me. I hope you will remain in touch in the future on other issues of importance to you. Sincerely, GARY G. MILLER Member of Congress Higginswww.becomingaspecialneedsadvocate@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 11, 2011 Report Share Posted September 11, 2011 The Friggin Doping Agency is indeed a corrupt and useless bureaucracy that needs to be dissolved. I am sure that most Americans have no clue, because before I had cancer, I really thought they were there to protect us. Now I know better. For those of you wishing to do something about the FDA, consider joining the Canary Party. This group of non partisian citizens is working to get back our health freedom by organizing action against the overreach of government in our health. Memmesheimer preventcanswers.org > > To All: > I don't post much. I mostly read and try to learn more about staying healthy. This time however I saw the word " FDA. " > I hope you all read what I've written to the end. It would be appreciated. -- Thanks. Les > > -------------------------------------------------------------------------------- > > > To Brent Higgins: > > Congressman G. 's letter to you is a sick joke. > > In it he says: > > " The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of possible safety problems. " > > By saying what he did he shows that he supports the FDA and as such supports one of the most corrupt departments of government in the United States of America. > > The NEXT question one needs to ask is just how much money is he getting from the pharmaceutical industry and/or how deeply associated he is with the pharmaceutical industry. Does he own stock in big Pharma? Does he get campaign contributions from big Pharma? Does he sit on the board of any pharmaceutical company??? > > Any American with 2 working braincells knows you can't trust the FDA to do the right thing for America or for Americans. Their main game is working WITH the big pharmaceutical and medical supply companies. > > The FDA is corrupt beyond words and anyone who supports the FDA has to be assumed to also be corrupt or as dumb as a jackass. > > I know this more than likely wasn't the answer you wanted to see, but everytime I hear the word " FDA " my blood automatically boils. The CDC and World Health Organization (WHO) are other words that make my blood boil by the way. > > Want to know why? Go here: http://www.zolkor.com/swineflu/swineflu.htm > > Better yet, just go to Page 19 here: http://www.zolkor.com/swineflu/swf0019.htm > > In 1976 I chose NOT to take the swine flu vaccine. I made a good choice back then then. > > Now... fast forward....the U.S. Government starts promoting the Swine Flu Vaccine again at the end of 2008....THIS TIME I want to know why. And that is when I started to dig deep into the FDA, CDC and the World Health Organization connections to the pharmaceutical companies. > > That was when I started work on this page here: http://www.zolkor.com/swineflu/swineflu.htm > > I spent the end of 2008 (I actually spent time going back further in time on this vaccine issue and posting that information on this website) on through 2009 and into 2010 and finally PROVED that the whole lot of them - the FDA, the CDC, the World Health Organization - are as corrupt as corrupt gets. It's all about *MONEY* - NOTHING ELSE! > > These organizations couldn't give a fig about you, your children, your family or the whole population of the United States or this planet! > > Like I said, just read what's posted on Page 19 if you want a good summation of how " legitimate " those organizations are. Better yet, read starting at Page 1. You'll have your eyes opened up if they aren't open already. > > And no, this isn't about just vaccines, this is about government, government agencies and the U.N. corruption that'll make you madder than hell. > > Sorry for the rant, but like I said, when I see the word " FDA " I *REALLY* get angry.....which I feel is more than justified. > > Les > > > Message from Congressman G. > > > > > > > > > > > > > > > > September 9, 2011 > > > > > Ms. K. Higgins > 13657 Norton Avenue > Chino, California 91710 > > > Dear Ms. Higgins: > > > Thank you for contacting me to express your concern about the FDA potentially regulating alternative medicine products. I appreciate hearing from you on this issue. As a health and fitness enthusiast, I recognize the value of dietary supplements to overall health and well-being. > > > It may interest you to know, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are exempt from the type of pre-market approval process that drugs, medical devices and food additives must undergo before they are allowed to be sold. This law effectively shifts the burden-of-proof from the manufacturer to the FDA to show that a dietary supplement is unsafe. The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of p ossible safety problems. > > > Dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed. Generally, they are not required to register with the FDA nor get approval before producing or selling dietary supplements. Manufacturers are simply required to ensure that product label information is truthful and not misleading. ; > > > As you may be aware, on July 1, 2011, the FDA published, " Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. " This document clarifies what a New Dietary Ingredient (NDI) is, when a NDI should be reported to the FDA, and the procedures for submitting an NDI notification to the FDA. The NDI guidelines prov ide direction to supplement manufacturers and distributors, however, the document is not binding at this time. Currently, the FDA is accepting public comments on the new guidelines through October 3, 2011. As the regulatory process moves forward, please be assured I will continue to work in Congress to ensure that supplements are both available and safe for America's consumers. > > > Again, thank you for contacting me. I hope you will remain in touch in the future on other issues of importance to you. > > & nb sp; Sincerely, > > GARY G. MILLER > Member of Congress > > > Higgins > www.becomingaspecialneedsadvocate@... > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 11, 2011 Report Share Posted September 11, 2011 Thank you so much for this; as my usual wit has failed me, in coming up with an alternative for " FDA " . " Friggin Doping Agency " ; (or *ssholes), I love it! I will look into the Canary organisation. One thing to remember is the Gov't can only take our freedoms with our passive consent!Keep up the good work! Jim > > > > To All: > > I don't post much. I mostly read and try to learn more about staying healthy. This time however I saw the word " FDA. " > > I hope you all read what I've written to the end. It would be appreciated. -- Thanks. Les > > > > -------------------------------------------------------------------------------- > > > > > > To Brent Higgins: > > > > Congressman G. 's letter to you is a sick joke. > > > > In it he says: > > > > " The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of possible safety problems. " > > > > By saying what he did he shows that he supports the FDA and as such supports one of the most corrupt departments of government in the United States of America. > > > > The NEXT question one needs to ask is just how much money is he getting from the pharmaceutical industry and/or how deeply associated he is with the pharmaceutical industry. Does he own stock in big Pharma? Does he get campaign contributions from big Pharma? Does he sit on the board of any pharmaceutical company??? > > > > Any American with 2 working braincells knows you can't trust the FDA to do the right thing for America or for Americans. Their main game is working WITH the big pharmaceutical and medical supply companies. > > > > The FDA is corrupt beyond words and anyone who supports the FDA has to be assumed to also be corrupt or as dumb as a jackass. > > > > I know this more than likely wasn't the answer you wanted to see, but everytime I hear the word " FDA " my blood automatically boils. The CDC and World Health Organization (WHO) are other words that make my blood boil by the way. > > > > Want to know why? Go here: http://www.zolkor.com/swineflu/swineflu.htm > > > > Better yet, just go to Page 19 here: http://www.zolkor.com/swineflu/swf0019.htm > > > > In 1976 I chose NOT to take the swine flu vaccine. I made a good choice back then then. > > > > Now... fast forward....the U.S. Government starts promoting the Swine Flu Vaccine again at the end of 2008....THIS TIME I want to know why. And that is when I started to dig deep into the FDA, CDC and the World Health Organization connections to the pharmaceutical companies. > > > > That was when I started work on this page here: http://www.zolkor.com/swineflu/swineflu.htm > > > > I spent the end of 2008 (I actually spent time going back further in time on this vaccine issue and posting that information on this website) on through 2009 and into 2010 and finally PROVED that the whole lot of them - the FDA, the CDC, the World Health Organization - are as corrupt as corrupt gets. It's all about *MONEY* - NOTHING ELSE! > > > > These organizations couldn't give a fig about you, your children, your family or the whole population of the United States or this planet! > > > > Like I said, just read what's posted on Page 19 if you want a good summation of how " legitimate " those organizations are. Better yet, read starting at Page 1. You'll have your eyes opened up if they aren't open already. > > > > And no, this isn't about just vaccines, this is about government, government agencies and the U.N. corruption that'll make you madder than hell. > > > > Sorry for the rant, but like I said, when I see the word " FDA " I *REALLY* get angry.....which I feel is more than justified. > > > > Les > > > > > > Message from Congressman G. > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > September 9, 2011 > > > > > > > > > > Ms. K. Higgins > > 13657 Norton Avenue > > Chino, California 91710 > > > > > > Dear Ms. Higgins: > > > > > > Thank you for contacting me to express your concern about the FDA potentially regulating alternative medicine products. I appreciate hearing from you on this issue. As a health and fitness enthusiast, I recognize the value of dietary supplements to overall health and well-being. > > > > > > It may interest you to know, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are exempt from the type of pre-market approval process that drugs, medical devices and food additives must undergo before they are allowed to be sold. This law effectively shifts the burden-of-proof from the manufacturer to the FDA to show that a dietary supplement is unsafe. The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of p ossible safety problems. > > > > > > Dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed. Generally, they are not required to register with the FDA nor get approval before producing or selling dietary supplements. Manufacturers are simply required to ensure that product label information is truthful and not misleading. ; > > > > > > As you may be aware, on July 1, 2011, the FDA published, " Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. " This document clarifies what a New Dietary Ingredient (NDI) is, when a NDI should be reported to the FDA, and the procedures for submitting an NDI notification to the FDA. The NDI guidelines prov ide direction to supplement manufacturers and distributors, however, the document is not binding at this time. Currently, the FDA is accepting public comments on the new guidelines through October 3, 2011. As the regulatory process moves forward, please be assured I will continue to work in Congress to ensure that supplements are both available and safe for America's consumers. > > > > > > Again, thank you for contacting me. I hope you will remain in touch in the future on other issues of importance to you. > > > > & nb sp; Sincerely, > > > > GARY G. MILLER > > Member of Congress > > > > > > Higgins > > www.becomingaspecialneedsadvocate@ > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 11, 2011 Report Share Posted September 11, 2011 Consider another frame for what Pharma and their agents are up to murder plain and simple. The "settlements" by the Justice Dept are a way of doing two things 1.it appears that Pharma are being punished and 2. Most important of all the settlement avoids their dirty dealings coming out in multiple full blown trials in every state where they committed fraud. Consequently the public don't get the whole story. That way Pharma can continue with their dirty dealings untroubled by the consequences. The question to your congressman should be how do the Justice Dept arrive at their settlements and why aren't fines set at such a level that Pharma makes no money from their dealings? Finally how many people are harmed by their actions ie made sicker and even killed and what steps have the Justice Dept taken to find that out instead of believing Pharma. From: dutchdivco <jdutchmanjim@...>iodine Sent: Sunday, 11 September 2011, 17:35Subject: Re: Fwd: Message from Congressman G. Thank you so much for this; as my usual wit has failed me, in coming up with an alternative for "FDA"."Friggin Doping Agency"; (or *ssholes), I love it! I will look into the Canary organisation. One thing to remember is the Gov't can only take our freedoms with our passive consent!Keep up the good work! Jim> >> > To All: > > I don't post much. I mostly read and try to learn more about staying healthy. This time however I saw the word "FDA."> > I hope you all read what I've written to the end. It would be appreciated. -- Thanks. Les> > > > ----------------------------------------------------------> > > > > > To Brent Higgins:> > > > Congressman G. 's letter to you is a sick joke.> > > > In it he says:> > > > "The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of possible safety problems." > > > > By saying what he did he shows that he supports the FDA and as such supports one of the most corrupt departments of government in the United States of America. > > > > The NEXT question one needs to ask is just how much money is he getting from the pharmaceutical industry and/or how deeply associated he is with the pharmaceutical industry. Does he own stock in big Pharma? Does he get campaign contributions from big Pharma? Does he sit on the board of any pharmaceutical company???> > > > Any American with 2 working braincells knows you can't trust the FDA to do the right thing for America or for Americans. Their main game is working WITH the big pharmaceutical and medical supply companies. > > > > The FDA is corrupt beyond words and anyone who supports the FDA has to be assumed to also be corrupt or as dumb as a jackass. > > > > I know this more than likely wasn't the answer you wanted to see, but everytime I hear the word "FDA" my blood automatically boils. The CDC and World Health Organization (WHO) are other words that make my blood boil by the way. > > > > Want to know why? Go here: http://www.zolkor.com/swineflu/swineflu.htm> > > > Better yet, just go to Page 19 here: http://www.zolkor.com/swineflu/swf0019.htm> > > > In 1976 I chose NOT to take the swine flu vaccine. I made a good choice back then then. > > > > Now... fast forward....the U.S. Government starts promoting the Swine Flu Vaccine again at the end of 2008....THIS TIME I want to know why. And that is when I started to dig deep into the FDA, CDC and the World Health Organization connections to the pharmaceutical companies. > > > > That was when I started work on this page here: http://www.zolkor.com/swineflu/swineflu.htm> > > > I spent the end of 2008 (I actually spent time going back further in time on this vaccine issue and posting that information on this website) on through 2009 and into 2010 and finally PROVED that the whole lot of them - the FDA, the CDC, the World Health Organization - are as corrupt as corrupt gets. It's all about *MONEY* - NOTHING ELSE! > > > > These organizations couldn't give a fig about you, your children, your family or the whole population of the United States or this planet!> > > > Like I said, just read what's posted on Page 19 if you want a good summation of how "legitimate" those organizations are. Better yet, read starting at Page 1. You'll have your eyes opened up if they aren't open already.> > > > And no, this isn't about just vaccines, this is about government, government agencies and the U.N. corruption that'll make you madder than hell.> > > > Sorry for the rant, but like I said, when I see the word "FDA" I *REALLY* get angry.....which I feel is more than justified.> > > > Les > > > > > > Message from Congressman G. > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > September 9, 2011> > > > > > > > > > Ms. K. Higgins> > 13657 Norton Avenue> > Chino, California 91710> > > > > > Dear Ms. Higgins:> > > > > > Thank you for contacting me to express your concern about the FDA potentially regulating alternative medicine products. I appreciate hearing from you on this issue. As a health and fitness enthusiast, I recognize the value of dietary supplements to overall health and well-being.> > > > > > It may interest you to know, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are exempt from the type of pre-market approval process that drugs, medical devices and food additives must undergo before they are allowed to be sold. This law effectively shifts the burden-of-proof from the manufacturer to the FDA to show that a dietary supplement is unsafe. The FDA's post-marketing responsibilities include monitoring safety, through reports of adverse events by consumers, and ensuring that product information, such as labeling, claims, package inserts, and accompanying literature, are truthful. Since DSHEA's passage, the FDA has issued alerts on several supplements to warn consumers of p ossible safety problems. > > > > > > Dietary supplement manufacturers are responsible for ensuring that their products are safe before they are marketed. Generally, they are not required to register with the FDA nor get approval before producing or selling dietary supplements. Manufacturers are simply required to ensure that product label information is truthful and not misleading. ;> > > > > > As you may be aware, on July 1, 2011, the FDA published, "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." This document clarifies what a New Dietary Ingredient (NDI) is, when a NDI should be reported to the FDA, and the procedures for submitting an NDI notification to the FDA. The NDI guidelines prov ide direction to supplement manufacturers and distributors, however, the document is not binding at this time. Currently, the FDA is accepting public comments on the new guidelines through October 3, 2011. As the regulatory process moves forward, please be assured I will continue to work in Congress to ensure that supplements are both available and safe for America's consumers.> > > > > > Again, thank you for contacting me. I hope you will remain in touch in the future on other issues of importance to you.> > > > & nb sp; Sincerely,> > > > GARY G. MILLER> > Member of Congress > > > > > > Higgins> > www.becomingaspecialneedsadvocate@> >> Quote Link to comment Share on other sites More sharing options...
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