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What follows is an actual letter sent by the FDA to owners of a health food store in upstate NY. By reading it, you can see how the FDA literally uses words to make it a crime to share actual, scientifically-verified facts about nutritional and botanical supplements. I explain more about this after the letter.
From the FDA:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website..and has determined that the products "Kyolic Original Formula 100" (200 cap), "Nature's Way Sarsaparilla Root" (100 cap), "Nutrition Now PB 8 Pro-Biotic Acidophilus" (60 cap), and "Nature's Way Alfa-Max" (100 cap) are promoted for conditions that cause the products to be drugs under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. (emphasis added) The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your website include:
Kyolic Original Formula 100 (200 cap)
• "Kyolic Formula 100 ... may be beneficial for ... blood pressure, cholesterol levels, heart disease ... arteriosclerosis, arthritis, asthma, cancer ... infections of the eyes, ears, throat, respiratory infections ... flu ... fungal infections, viral infections ...."
Nature's Way Sarsaparilla Root (100 cap)
• "Sarsaparilla [an ingredient in your product] may help in the treatment of congestive heart failure, high blood pressure impotence ... swelling and discomfort from rheumatism and arthritis ... psoriasis ... syphilis ...."
Nutrition Now PB 8 Pro-Biotic Acidophilus (60 cap)
• "Acidophilus [an ingredient in your product] ... has anti-fungal activity ... and play [sic] a role in yeast infections, urinary tract infections, cancer prevention, cholesterol levels ...."
Nature's Way Alfa-Max (100 cap)
• "Alfalfa [an ingredient in your product] ... may be used for allergies, anemia, arthritis, asthma, blood disorders ... high cholesterol and diabetes ...."
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(P)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, your products "Kyolic Original Formula 100" (200 cap), "Nature's Way Sarsaparilla Root" (100 cap), "Nutrition Now PB 8 Pro-Biotic Acidophilus" (60 cap), and "Nature's Way Alfa-Max" (100 cap) are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
My Comments
Note this sentence from the FDA's letter: "The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease." By claiming the definition and usage of the word "drug", the FDA makes it illegal for any nutritional supplement company to share any health benefits related to their supplements without prior permission from the FDA (permission that will not be granted).
Also note that in the majority of examples the FDA cites, the website only said "may" in terms of the potential health benefits that the products might provide. More importantly, science does support the benefits attributed to the product. Kyolic, for instance, is a garlic supplement, and garlic has been shown to be beneficial for the conditions the website cites.
But as soon as someone shares these facts in conjunction with selling supplements, the FDA accuses them of a crime because doing so, they claim, means they are marketing "drugs."
But it's perfectly OK for drug companies to hawk their drugs to anyone without such FDA interference. Despite the fact that drugs, properly prescribed and taken, kill over 100,000 Americans each and every year, hospitalize another 2 million people, and cause additional harm to 20 million more, and these are conservative estimates.
This abominable double standard is just one example of how deeply the FDA is in bed with Big Pharma.
Showing posts with label Ammerican Association for Health Freedom. Show all posts
Showing posts with label Ammerican Association for Health Freedom. Show all posts
Wednesday, February 22, 2012
Wednesday, September 2, 2009
More Proof the FDA Protects Big Pharma and Other Special Interests, Not Your Health
The Food and Drug Administration (FDA) has long been in the pockets of Big Pharma and other special interests opposed to the public’s right to access non-drug-based health care methods of their choice. Sadly, however, most people today believe that the FDA lives up to its mandate to protect them. While there are certainly many dedicated and conscientious scientists and researchers employed by the FDA who are attempting to do just that, their efforts are often thwarted at the FDA’s administration level, due to the cozy and incestuous relationship between FDA higher ups, including many of its commissioners, past and present, and the special interest groups the FDA is charged with regulating.
What follows are two recent examples of the FDA’s abuse of its power at the expense of we the people who fund its operations with our tax dollars. The first was forwarded to me by my friend Dr. Garry Gordon, who wrote: “This is sad. We find out that the Commissioner of FDA was a director of Henry Schein, a major supplier of amalgam to the dentists. She has chosen to protect her stock value and ignore the mercury health risk to children.”
FDA’s Sharfstein Covers Up Mercury-Neurological Harm Nexus (6 August 2009)
FDA Deputy Commissioner Joshua Sharfstein has given his seal of approval to major mercury exposure for millions of America’s children and unborn children – and to covering up both the neurological risks and the flawed rulemaking process.
Despite admitting that amalgam causes mercury exposure -- and despite knowing that mercury causes neurological harm to developing brains -- Sharfstein rejects putting on contraindications for amalgam, rejects putting on warnings on amalgam and even rejects a requirement that dentists tell patients that amalgam is mainly mercury.
Sharfstein even withdraws FDA’s website warning that dental mercury can cause permanent neurological harm to children and unborn children. Sharfstein’s rule actually says FDA wants to stop a decline in amalgam sales. At Joshua Sharfstein’s FDA, commerce trumps safety.
When the Republicans ran FDA, to their real credit, they put this warning on the FDA website: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” Upon assuming power, the Democrats withdrew this warning, covering up the fact that mercury from amalgam causes permanent harm to young children and kills unborn babies. Is this the change we Americans voted for?
Washington is famous for the revolving door -- those in the party out of power takes highly paid corporate positions, then returns to government to bail out their benefactors. The new FDA Commissioner, Margaret Hamburg, worked in the Clinton Administration, then went out and became a director at the dental products colossus Henry Schein, earning a quarter million dollars a year for the handful of hours it takes to be a director. Corporations do this because they know the other party will return to power, at which time the corporations will call in their chits.
Upon becoming Commissioner, Dr. Hamburg owned between $250,000 and $500,000 of Henry Schein stock. Certainly the Harvard-educated Hamburg knew the amalgam rule had the potential to affect her stock value. She could have done the right thing -- recuse herself from the rule. Instead, she worked on the rule for a while, then recused herself gradually, first by “deciding not to participate,” then finally “recusing.” Certainly her next-in-command, Deputy Commissioner, Joshua Sharfstein got the message that there was more at stake than good government.
On what date did Hamburg sell her Schein stock? What work did Hamburg do on the rule before she recused herself? What work did she do protecting amalgam from regulators while at Schein? Through her lawyer, Hamburg refuses to answer any of these questions. Ironically, Sharfstein heads a new a FDA “transparency task force.” A perfect first project would be to expose the Hamburg-Henry Schein links.
Joshua Sharfstein had the opportunity to protect children from amalgam, to save unborn babies and nursing babies from mercury exposure, and to warn us all that amalgam exposes us to toxic mercury. He came to Washington as a child advocate, but changed his stripes once he saw the revolving door game in action. Throwing his reputation out the window, Joshua Sharfstein chose to ally with the amalgam industry and cover up the mercury, turning his back on the children of America.
Just as Margaret Hamburg has embarrassed President Obama for bringing back revolving-door government, Joshua Sharfstein has embarrassed the President for deciding not to reduce the use of mercury in oral health care. If ever a President entered office as an inalterable opponent of mercury, it is Barack Obama, who wrote a law banning mercury exports and who is working for a treaty to phase out man-made mercury by a date certain. But at FDA, his appointee Sharfstein is sabotaging the President’s policies by hiding the mercury from Americans and hence keeping amalgam sales going into the indefinite future.
FDA doesn’t even defend its rule on the science. FDA admits it does not know if mercury fillings are safe for children six and under, or for nursing mothers whose mercury goes through the breast milk, or for pregnant women whose dental mercury No, it’s not science -- it’s about commerce. FDA wants Americans to keep buying amalgam.
The children of America have lost. Another generation will be mercury toxic.
Need further evidence on who won? Just yesterday (Aug. 5), Henry Schein’s CEO Stanley Bergman offered this salute to Dr. Hamburg:
“I would like to extend on behalf of the company, our Board and our shareholders our sincere thanks to Dr. Margaret Hamburg, who has served as the Director of Henry Schein Company's Board since 2003. Dr. Hamburg left our Board following her confirmation as Commissioner of the U.S. Food and Drug Administration. We would like to thank Dr. Hamburg for the insight she shared with the Henry Schein Board throughout the years and wish her continued success.”
Hamburg claims she broke her ties with Schein three months ago. But Schein’s CEO issues his thank-you the day after the FDA rule was published in the Federal Register. Margaret Hamburg may not be in the hip pocket of Henry Schein Inc, but Schein’s CEO sure thinks she is. And he has the evidence to show it: a rule that allows Schein to sell amalgam to anyone, a rule that covers up the mercury, a rule that contains propaganda to be used by Schein to defend against the upcoming class action suits.
FDA bans mercury in all veterinary products. The new FDA, under Margaret Hamburg and her Sancho Panza, Joshua Sharfstein, have decided that children don’t merit the protection FDA gives horses and dogs.
The Washington bigshots have direct access to Joshua Sharfstein. So should you: his e-address is JMSharf1@fda.hhs.gov Why not write him yourself? Talking points follow:
Questions to consider asking Deputy Commissioner Sharfstein
(1) Dr Sharfstein, why, under your rule, are children less important than horses and dogs when it comes to mercury exposure?
(2) Why did you Democrats withdraw FDA’s website warning that dental mercury can cause neurological harm to children and unborn children, which the Republican Commissioner agreed to last year?
(3) Will your new “transparency task force” disclose the details of your boss’s ties with Henry Schein, or will she be allowed to cover it up like you cover up the risks of ental mercury?
(4) Does President Obama know that you approved a rule that will keep Americans from learning that amalgam is mainly mercury, and does the President know about Commissioner Hamburg’s conflict of interest with Henry Schein?
Charles G. Brown, National Counsel
Consumers for Dental Choice
www.toxicteeth.org
This next item was sent to me by Deborah A. Ray, MT of the American Association for Health Freedom, an organization I strongly support. (To find out more about AAHF, visit www.healthfreedom.net.)
FDA Attacks Natural Thyroid Millions Depend On
We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.
According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder. Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.
Armour and other "whole" natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing "T4" "T3" "T2" and "T1" in the same proportions made by the human thyroid.
The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain "T2" or "T1". It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.
As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be its thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”
We will report further as soon as we confirm more of the facts, and as always, we’ll let you know how you can get involved.
What follows are two recent examples of the FDA’s abuse of its power at the expense of we the people who fund its operations with our tax dollars. The first was forwarded to me by my friend Dr. Garry Gordon, who wrote: “This is sad. We find out that the Commissioner of FDA was a director of Henry Schein, a major supplier of amalgam to the dentists. She has chosen to protect her stock value and ignore the mercury health risk to children.”
FDA’s Sharfstein Covers Up Mercury-Neurological Harm Nexus (6 August 2009)
FDA Deputy Commissioner Joshua Sharfstein has given his seal of approval to major mercury exposure for millions of America’s children and unborn children – and to covering up both the neurological risks and the flawed rulemaking process.
Despite admitting that amalgam causes mercury exposure -- and despite knowing that mercury causes neurological harm to developing brains -- Sharfstein rejects putting on contraindications for amalgam, rejects putting on warnings on amalgam and even rejects a requirement that dentists tell patients that amalgam is mainly mercury.
Sharfstein even withdraws FDA’s website warning that dental mercury can cause permanent neurological harm to children and unborn children. Sharfstein’s rule actually says FDA wants to stop a decline in amalgam sales. At Joshua Sharfstein’s FDA, commerce trumps safety.
When the Republicans ran FDA, to their real credit, they put this warning on the FDA website: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” Upon assuming power, the Democrats withdrew this warning, covering up the fact that mercury from amalgam causes permanent harm to young children and kills unborn babies. Is this the change we Americans voted for?
Washington is famous for the revolving door -- those in the party out of power takes highly paid corporate positions, then returns to government to bail out their benefactors. The new FDA Commissioner, Margaret Hamburg, worked in the Clinton Administration, then went out and became a director at the dental products colossus Henry Schein, earning a quarter million dollars a year for the handful of hours it takes to be a director. Corporations do this because they know the other party will return to power, at which time the corporations will call in their chits.
Upon becoming Commissioner, Dr. Hamburg owned between $250,000 and $500,000 of Henry Schein stock. Certainly the Harvard-educated Hamburg knew the amalgam rule had the potential to affect her stock value. She could have done the right thing -- recuse herself from the rule. Instead, she worked on the rule for a while, then recused herself gradually, first by “deciding not to participate,” then finally “recusing.” Certainly her next-in-command, Deputy Commissioner, Joshua Sharfstein got the message that there was more at stake than good government.
On what date did Hamburg sell her Schein stock? What work did Hamburg do on the rule before she recused herself? What work did she do protecting amalgam from regulators while at Schein? Through her lawyer, Hamburg refuses to answer any of these questions. Ironically, Sharfstein heads a new a FDA “transparency task force.” A perfect first project would be to expose the Hamburg-Henry Schein links.
Joshua Sharfstein had the opportunity to protect children from amalgam, to save unborn babies and nursing babies from mercury exposure, and to warn us all that amalgam exposes us to toxic mercury. He came to Washington as a child advocate, but changed his stripes once he saw the revolving door game in action. Throwing his reputation out the window, Joshua Sharfstein chose to ally with the amalgam industry and cover up the mercury, turning his back on the children of America.
Just as Margaret Hamburg has embarrassed President Obama for bringing back revolving-door government, Joshua Sharfstein has embarrassed the President for deciding not to reduce the use of mercury in oral health care. If ever a President entered office as an inalterable opponent of mercury, it is Barack Obama, who wrote a law banning mercury exports and who is working for a treaty to phase out man-made mercury by a date certain. But at FDA, his appointee Sharfstein is sabotaging the President’s policies by hiding the mercury from Americans and hence keeping amalgam sales going into the indefinite future.
FDA doesn’t even defend its rule on the science. FDA admits it does not know if mercury fillings are safe for children six and under, or for nursing mothers whose mercury goes through the breast milk, or for pregnant women whose dental mercury No, it’s not science -- it’s about commerce. FDA wants Americans to keep buying amalgam.
The children of America have lost. Another generation will be mercury toxic.
Need further evidence on who won? Just yesterday (Aug. 5), Henry Schein’s CEO Stanley Bergman offered this salute to Dr. Hamburg:
“I would like to extend on behalf of the company, our Board and our shareholders our sincere thanks to Dr. Margaret Hamburg, who has served as the Director of Henry Schein Company's Board since 2003. Dr. Hamburg left our Board following her confirmation as Commissioner of the U.S. Food and Drug Administration. We would like to thank Dr. Hamburg for the insight she shared with the Henry Schein Board throughout the years and wish her continued success.”
Hamburg claims she broke her ties with Schein three months ago. But Schein’s CEO issues his thank-you the day after the FDA rule was published in the Federal Register. Margaret Hamburg may not be in the hip pocket of Henry Schein Inc, but Schein’s CEO sure thinks she is. And he has the evidence to show it: a rule that allows Schein to sell amalgam to anyone, a rule that covers up the mercury, a rule that contains propaganda to be used by Schein to defend against the upcoming class action suits.
FDA bans mercury in all veterinary products. The new FDA, under Margaret Hamburg and her Sancho Panza, Joshua Sharfstein, have decided that children don’t merit the protection FDA gives horses and dogs.
The Washington bigshots have direct access to Joshua Sharfstein. So should you: his e-address is JMSharf1@fda.hhs.gov Why not write him yourself? Talking points follow:
Questions to consider asking Deputy Commissioner Sharfstein
(1) Dr Sharfstein, why, under your rule, are children less important than horses and dogs when it comes to mercury exposure?
(2) Why did you Democrats withdraw FDA’s website warning that dental mercury can cause neurological harm to children and unborn children, which the Republican Commissioner agreed to last year?
(3) Will your new “transparency task force” disclose the details of your boss’s ties with Henry Schein, or will she be allowed to cover it up like you cover up the risks of ental mercury?
(4) Does President Obama know that you approved a rule that will keep Americans from learning that amalgam is mainly mercury, and does the President know about Commissioner Hamburg’s conflict of interest with Henry Schein?
Charles G. Brown, National Counsel
Consumers for Dental Choice
www.toxicteeth.org
This next item was sent to me by Deborah A. Ray, MT of the American Association for Health Freedom, an organization I strongly support. (To find out more about AAHF, visit www.healthfreedom.net.)
FDA Attacks Natural Thyroid Millions Depend On
We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.
According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder. Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.
Armour and other "whole" natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing "T4" "T3" "T2" and "T1" in the same proportions made by the human thyroid.
The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain "T2" or "T1". It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.
As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be its thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”
We will report further as soon as we confirm more of the facts, and as always, we’ll let you know how you can get involved.
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