This just in... Dr. Ron Paul, health freedom's friend in Congress, introduced two important bills yesterday that, if passed, would rein in the excessive interference in advanced health products by the FDA and FTC.
You can support these bills here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732
Here is the Life Extension Foundation's description of the bills:
HR 3395: The Health Freedom Act. This bill removes FDA’s power of prior restraint over all nutrient-disease relationship claims. Under the bill, the FDA may not prohibit any statement concerning a nutrient affecting a disease (including treatment effects) from being made in the market and may only act against a statement once made if it possesses clear and convincing evidence that the statement is false. Presently the FDA blocks an enormous quantity of truthful information concerning the effects of nutrients and foods on disease from reaching consumers. That barrier is removed by the Health Freedom Act, but the Act preserves the power of the government to prosecute those who communicate falsehood. The essential purpose of the First Amendment is to disarm the federal government of the power to impose a prior restraint on speech. The FDA has imposed a prior restraint for decades to the health detriment of the public. Passage of the Health Freedom Act will restore constitutional governance by reasserting the supremacy of the First Amendment over the Food and Drug Administration.
HR 3394: The Health Information Protection Act. This bill prevents the Federal Trade Commission from taking action against any advertiser that communicates a health benefit for a product unless the FTC first establishes based on clear and convincing evidence that the statement made is false and that its communication causes harm to the public. Presently, the FTC reverses the Fifth Amendment burden of proof on the government when it charges advertisers with deceptive advertising and then demands that they prove their speech true based on contemporaneously held documentation or be deemed to have advertised deceptively. The Fifth Amendment requires that FTC bear the burden of proving advertising deceptive. It may not constitutionally shift the burden to the advertiser to prove its statements not deceptive. The First Amendment requires that FTC not act against speech unless the speech is probably false. It may not constitutionally accuse a party of false advertising yet lack proof that the advertising is false and condemn advertising based on an absence of documentation concerning the truth of the statement rather than the presence of evidence establishing the falsity of the statement.
These bills go to the heart of the issue of valid health claims for nutrient products: how do companies substantiate the claims they are making. Essentially the bills apply Constitutional principles to the making of claims, which are a type of speech, and are therefore protected from excessive bureaurcratic burden.
In this context it is useful to see what then Justice Sandra Day O'Connor wrote for the Supreme Court majority in the leading health claim free speech case, Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357 -
"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort."
"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."
"Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each ...to be labeled with a warning that the [product] had not undergone FDA testing and that its risks were unknown."
The basic rule, announced by the case, to determine constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction) is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If "no" to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is "substantial", (2) the regulation must "directly advance" the governmental interest and (3) the regulation of Commercial Speech cannot be "more extensive than is necessary to serve that interest" (quoting Central Hudson v Public Service, 447 US 557, at 566).
Dr. Paul' s bills make it clear that the government has the burden of proof if it seeks to restrict what marketers say about their health related products. In this way, his bills preserve the Constitutional protections for Commercial Speech.
You can support these bills here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732
And a final thought: “Liberty is to the collective body what health is to every individual body. Without health no pleasure can be tasted by man; without liberty, no happiness can be enjoyed by society.” –Thomas Jefferson
Showing posts with label FDA reform. Show all posts
Showing posts with label FDA reform. Show all posts
Saturday, August 1, 2009
Friday, July 31, 2009
Three Weeks to Save Food and Freedom
The House passed the draconian (sic) "food safety" bill yesterday. Congress is in recess but the Senate takes up the forced industrialization of food production in three weeks.
We have three weeks to save food... and freedom!
Please see: http://www.healthfreedomusa.org/?p=3209
This is an urgent freedom movement alert.
We have three weeks to save food... and freedom!
Please see: http://www.healthfreedomusa.org/?p=3209
This is an urgent freedom movement alert.
Wednesday, January 28, 2009
"Change" - the FDA's Plan to Destroy DSHEA
PYRIDOXAMINE: THE BEGINNING OF THE END FOR DSHEA?
Before discussing the Vitamin B-6 ban, let's quickly review FDA's policies and initiatives that threaten health freedom.
First, in 2007, Congress awards FDA for its failures by increasing its power. This was done through Sen. Kennedy's FDA "enabling act" although the Health Freedom movement did get the "DSHEA product savings clause" 1011 added to the bill.
Second, in 2008 FDA asked for public comments whether the savings clause applies to section 301(11) of the act, that gives FDA authority to ban foods that are being studied for use as "treatment of disease." We of course submitted our comments objecting to this evisceration of DSHEA and thousands of Natural Solutions Foundation's Mouse Warriors did likewise.
Third, a prior "Citizens Petition" from a pharmaceutical company is used by FDA as the excuse to ban a specific form of B6 (Pyridoxamine) to negate the 1994 NNFA Grandfather List of Dietary Ingredients for DSHEA and open all supplements to similar bans is introduced.
Fourth, comments are sought on the idea that FDA can ban any nutritional product it likes from interstate commerce despite specific legislative prohibition preventing the FDA from doing so for products covered under DSHEA - that is, dietary supplements and herbs in use before June, 1994. Such products are "grandfathered" in after inclusion on a list prepared by the NNFA (now NPA) at the request of the FDA when DSHEA was passed. Natural Solutions Foundation and thousands of net roots supporters remind FDA that such actions are illegal under section 311(11) of the 2008 FDA Reorganization act following successful Natural Solutions Foundation efforts to maintain language protecting DSHEA products in the bill when in the Congressional conference committee.
Fifth, in Europe, the EFSD meets to discuss maximum permitted levels (MPLs) of nutrients -- (1) some countries support what the the Codex Vitamin and Mineral Guideline, ratified July 4, 2005, prohibits: MPLs based on a multiple of the biologically unsound, extremely low Recommended Daily Allowance (RDA), (2) the EU wants upper limits based on "Risk Analysis" that would limit levels to below that needed to have any biological effect [even a beneficial one] following the World Health Organization's Guidance to Codex Alimentarius on how to apply the toxicological method of Risk Analysis to nutrients and (3) certain advocacy groups support a limit based on a safety analysis, which could lead to similarly low levels. The fourth position, which Natural Solutions Foundation champions, is based on the principle of biochemical individuality, supported by extensive clinical and scientific data through orthomolecular science, is that there is, and must not be, any upper limits set for foods: nutrient supplements are foods!
Sixth, based on another one of those "citizens petitions" from favored "consumer" groups, EPA has expressed its intention to ban topical nano silver, despite having previously approved it for topical use as a safe, effective sanitizing agent with no negative environmental impact! If forbidden as an "untested pesticide" The equipment used to produce nano silver is also to be banned as an "untested pesticide"! Once topical nano silver is banned, how long will it be before ingested silver supplements will also be banned?
Seventh, FDA seeks to eliminate all nutrients and objects from health use which have had any study about them published of any sort whatsoever - this is the ultimate import of the dangerous section 301(11) of the act.
Eighth, FDA/CODEX seek to eliminate all nutrients which have not had met an artificial "significant scientific agreement" standard that violates DSHEA's commercially reasonable standard of "competent and reliable scientific evidence."
And on it goes...
But back to Pyridoxamine. FDA's "response" as noted above, to the position that DSHEA protects dietary supplements from the unfair tactic of some pharmaceutical company conducting a "study" of the ingredient for medical use and then using that to ban the competing natural substance, was to throw down the gauntlet at the feet of the industry and ban a legal, grandfathered nutritional supplement ingredient. Here is what the Natural Produces Association said about the ban:
FDA responded "to a citizen petition filed on behalf of a pharmaceutical company. FDA has determined that products containing pyridoxamine, a form of vitamin B6 (the letter specifically cites 'pyridoxamine dihydrochloride or any other compound containing pyridoxamine") are not dietary supplements within the meaning as indicated by DSHEA...' and 'may not be marketed as such.' In a confusing twist, the agency goes on to clarify that although pyridoxamine is a dietary ingredient ...FDA has determined by the petition that pyridoxamine is excluded... because: 1. Pyridoxamine is authorized for investigation as a new drug ... and 2. there is no "independent, verifiable evidence" of prior marketing of pyridoxamine as a food or dietary supplement; this includes the Natural Products Association's (developed as NNFA) list of grandfathered ingredients. ...this development presents a number of problems, including the agency's interpretation of §301 (ll) of the FFDC Act"
NPA asked for help proving that Pyridoxamine is in fact "grandfathered" under DSHEA, that is, it was sold to supplement the diet or was part of the food chain in June, 1994. For over 20 years the industry has relied on the NNFA grandfather list, now deemed no longer "evidence" by FDA fiat, without hearing, or court oversight.
Here is the gist of my response back to NPA about this ban of a legal, grandfathered nutritional supplement ingredient:
xx-----xx-----xx
I work with [name of company redacted], one of your NPA members. At our President's request I've been reaching out to some of the "old hands" in the industry [such as Dr. Fleischner] about the Pyridoxamine ban and DSHEA grandfathering. [the President and I are co-trustees of the Institute for Health Research, www.inhere.org - I am also a trustee of Natural Solutions Foundation, www.globalhealthfreedom.org]
Here is what Dr. Albert Fleischner, PhD responded:
"Pyridoxamine has always been regarded as a vitamin and is listed in the early
Remingtons and USP as such."
Dr. Fleischner is a pharmacist and formulator [MS and PHD from Rutgers and formerly an operating officer for pharmaceutical and nutraceutical companies].
Meanwhile, the good folks at [a well known foundation] have also contacted me about this issue and I hope we can all work together to stop this obvious misapplication of 301(11).
Late last year when it became apparent that FDA was seeking to ignore the DSHEA savings language in the 2007 FDA "enabling act" (Section 1011) we reacted by urging opposing comments to be filed with FDA under Docket No. FDA-2008-N-0389
See may blog entry..
http://vitaminlawyerhealthfreedom.blogspot.com/2008/11/emergency-fda-usda-attacking-foods.html
So FDA's response to the comments supporting a broad reading of Section 1011 has been to test how far it can push the industry, by banning Pyridoxamine.
How far can it push the industry? It's been our opinion at Natural Solutions Foundation that the industry has failed to see the "writing on the wall" and has failed to rally to protect its fundamental interests. Is it finally ready
now?
The November 2007 Congressional study of FDA showed that it is a failed agency; its efforts to "regulate" nutritional products and natural remedies through the 2006 infamous anti-CAM draft guidance was called "an abuse of FDA authority" by Dr. Ron Paul.
It's our opinion that what we - industry and the consumers of the United States, need to protect their access to high potency supplements is a concerted campaign to Divest the FDA of Food Authority. Congress has, at least three times before, divested FDA of authority it was misusing, when DEA, EPA and CPA were created.
Can the industry survive more FDA mis-regulation?
xx-----xx-----xx
How much more FDA mis-regulation can the industry survive? How much more FDA-mis-regulation will consumers tolerate? Are we ready to act? Click here () to indicate your interest in attending a joint industry-consumer webinar (date TBA) on ending this reign of terror for food supplements. And visit www.HealthFreedomUSA.org to join the distribution list of the safe, secure and highly informative Health Freedom Action eAlert.
So there we have it: either the FDA is divested of food authority or we will, bit by bit, lose our access to high potency, advanced nutrition.
For more on Divesting the FDA see: http://www.healthfreedomusa.org/?p=1601
Here is the version of this posting used for the January 31, 2008 Health Freedom Action eAlert: http://www.healthfreedomusa.org/?p=1969
[My thanks to Dr. Laibow and Gen. Stubblebine for helping with this blog entry.]
Before discussing the Vitamin B-6 ban, let's quickly review FDA's policies and initiatives that threaten health freedom.
First, in 2007, Congress awards FDA for its failures by increasing its power. This was done through Sen. Kennedy's FDA "enabling act" although the Health Freedom movement did get the "DSHEA product savings clause" 1011 added to the bill.
Second, in 2008 FDA asked for public comments whether the savings clause applies to section 301(11) of the act, that gives FDA authority to ban foods that are being studied for use as "treatment of disease." We of course submitted our comments objecting to this evisceration of DSHEA and thousands of Natural Solutions Foundation's Mouse Warriors did likewise.
Third, a prior "Citizens Petition" from a pharmaceutical company is used by FDA as the excuse to ban a specific form of B6 (Pyridoxamine) to negate the 1994 NNFA Grandfather List of Dietary Ingredients for DSHEA and open all supplements to similar bans is introduced.
Fourth, comments are sought on the idea that FDA can ban any nutritional product it likes from interstate commerce despite specific legislative prohibition preventing the FDA from doing so for products covered under DSHEA - that is, dietary supplements and herbs in use before June, 1994. Such products are "grandfathered" in after inclusion on a list prepared by the NNFA (now NPA) at the request of the FDA when DSHEA was passed. Natural Solutions Foundation and thousands of net roots supporters remind FDA that such actions are illegal under section 311(11) of the 2008 FDA Reorganization act following successful Natural Solutions Foundation efforts to maintain language protecting DSHEA products in the bill when in the Congressional conference committee.
Fifth, in Europe, the EFSD meets to discuss maximum permitted levels (MPLs) of nutrients -- (1) some countries support what the the Codex Vitamin and Mineral Guideline, ratified July 4, 2005, prohibits: MPLs based on a multiple of the biologically unsound, extremely low Recommended Daily Allowance (RDA), (2) the EU wants upper limits based on "Risk Analysis" that would limit levels to below that needed to have any biological effect [even a beneficial one] following the World Health Organization's Guidance to Codex Alimentarius on how to apply the toxicological method of Risk Analysis to nutrients and (3) certain advocacy groups support a limit based on a safety analysis, which could lead to similarly low levels. The fourth position, which Natural Solutions Foundation champions, is based on the principle of biochemical individuality, supported by extensive clinical and scientific data through orthomolecular science, is that there is, and must not be, any upper limits set for foods: nutrient supplements are foods!
Sixth, based on another one of those "citizens petitions" from favored "consumer" groups, EPA has expressed its intention to ban topical nano silver, despite having previously approved it for topical use as a safe, effective sanitizing agent with no negative environmental impact! If forbidden as an "untested pesticide" The equipment used to produce nano silver is also to be banned as an "untested pesticide"! Once topical nano silver is banned, how long will it be before ingested silver supplements will also be banned?
Seventh, FDA seeks to eliminate all nutrients and objects from health use which have had any study about them published of any sort whatsoever - this is the ultimate import of the dangerous section 301(11) of the act.
Eighth, FDA/CODEX seek to eliminate all nutrients which have not had met an artificial "significant scientific agreement" standard that violates DSHEA's commercially reasonable standard of "competent and reliable scientific evidence."
And on it goes...
But back to Pyridoxamine. FDA's "response" as noted above, to the position that DSHEA protects dietary supplements from the unfair tactic of some pharmaceutical company conducting a "study" of the ingredient for medical use and then using that to ban the competing natural substance, was to throw down the gauntlet at the feet of the industry and ban a legal, grandfathered nutritional supplement ingredient. Here is what the Natural Produces Association said about the ban:
FDA responded "to a citizen petition filed on behalf of a pharmaceutical company. FDA has determined that products containing pyridoxamine, a form of vitamin B6 (the letter specifically cites 'pyridoxamine dihydrochloride or any other compound containing pyridoxamine") are not dietary supplements within the meaning as indicated by DSHEA...' and 'may not be marketed as such.' In a confusing twist, the agency goes on to clarify that although pyridoxamine is a dietary ingredient ...FDA has determined by the petition that pyridoxamine is excluded... because: 1. Pyridoxamine is authorized for investigation as a new drug ... and 2. there is no "independent, verifiable evidence" of prior marketing of pyridoxamine as a food or dietary supplement; this includes the Natural Products Association's (developed as NNFA) list of grandfathered ingredients. ...this development presents a number of problems, including the agency's interpretation of §301 (ll) of the FFDC Act"
NPA asked for help proving that Pyridoxamine is in fact "grandfathered" under DSHEA, that is, it was sold to supplement the diet or was part of the food chain in June, 1994. For over 20 years the industry has relied on the NNFA grandfather list, now deemed no longer "evidence" by FDA fiat, without hearing, or court oversight.
Here is the gist of my response back to NPA about this ban of a legal, grandfathered nutritional supplement ingredient:
xx-----xx-----xx
I work with [name of company redacted], one of your NPA members. At our President's request I've been reaching out to some of the "old hands" in the industry [such as Dr. Fleischner] about the Pyridoxamine ban and DSHEA grandfathering. [the President and I are co-trustees of the Institute for Health Research, www.inhere.org - I am also a trustee of Natural Solutions Foundation, www.globalhealthfreedom.org]
Here is what Dr. Albert Fleischner, PhD responded:
"Pyridoxamine has always been regarded as a vitamin and is listed in the early
Remingtons and USP as such."
Dr. Fleischner is a pharmacist and formulator [MS and PHD from Rutgers and formerly an operating officer for pharmaceutical and nutraceutical companies].
Meanwhile, the good folks at [a well known foundation] have also contacted me about this issue and I hope we can all work together to stop this obvious misapplication of 301(11).
Late last year when it became apparent that FDA was seeking to ignore the DSHEA savings language in the 2007 FDA "enabling act" (Section 1011) we reacted by urging opposing comments to be filed with FDA under Docket No. FDA-2008-N-0389
See may blog entry..
http://vitaminlawyerhealthfreedom.blogspot.com/2008/11/emergency-fda-usda-attacking-foods.html
So FDA's response to the comments supporting a broad reading of Section 1011 has been to test how far it can push the industry, by banning Pyridoxamine.
How far can it push the industry? It's been our opinion at Natural Solutions Foundation that the industry has failed to see the "writing on the wall" and has failed to rally to protect its fundamental interests. Is it finally ready
now?
The November 2007 Congressional study of FDA showed that it is a failed agency; its efforts to "regulate" nutritional products and natural remedies through the 2006 infamous anti-CAM draft guidance was called "an abuse of FDA authority" by Dr. Ron Paul.
It's our opinion that what we - industry and the consumers of the United States, need to protect their access to high potency supplements is a concerted campaign to Divest the FDA of Food Authority. Congress has, at least three times before, divested FDA of authority it was misusing, when DEA, EPA and CPA were created.
Can the industry survive more FDA mis-regulation?
xx-----xx-----xx
How much more FDA mis-regulation can the industry survive? How much more FDA-mis-regulation will consumers tolerate? Are we ready to act? Click here () to indicate your interest in attending a joint industry-consumer webinar (date TBA) on ending this reign of terror for food supplements. And visit www.HealthFreedomUSA.org to join the distribution list of the safe, secure and highly informative Health Freedom Action eAlert.
So there we have it: either the FDA is divested of food authority or we will, bit by bit, lose our access to high potency, advanced nutrition.
For more on Divesting the FDA see: http://www.healthfreedomusa.org/?p=1601
Here is the version of this posting used for the January 31, 2008 Health Freedom Action eAlert: http://www.healthfreedomusa.org/?p=1969
[My thanks to Dr. Laibow and Gen. Stubblebine for helping with this blog entry.]
Wednesday, November 26, 2008
Divesting the FDA of Food Authority
It's been a year since an official government study of the FDA said:
1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
4) FDA does not have the capacity to ensure the safety of food for the nation.
5) The development of medical products based on “new science” cannot be adequately regulated by the FDA.
6) There is insufficient capacity in modeling risk assessment and analysis.
7) The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
8) The FDA has substantial recruitment and retention challenges.
9) The FDA has an inadequate and ineffective program for scientist performance.
10) The FDA has not taken sufficient advantage of external and internal collaborations.
11) The FDA lacks the information science capability and information infrastructure to fulfill is regulatory mandate.
12) The FDA cannot provide the information infrastructure support to regulate products based on new science.
From: the November 2007 Report of the Subcommittee on Science and Technology, "FDA Science and Mission at Risk."
The FDA is a failed agency that, in Dr. Ron Paul's words, engages in "abuse of power."
Even the FDA's own scientists are complaining about the corruption that pervades the agency: http://www.naturalnews.com/z024910.html -- and this is not the first time conscientious scientists have raised these issues.
I believe that due to its focus on the drug industry (80% of its funding comes from Big Pharma "user fees") and its failure to protect the safety of the food supply, while engaging in international "HARMonization" that degrades organic standards and allows ever-increasing levels of toxins (including antibiotic residues) in the food supply, the FDA is incapable of administering food regulations.
The FDA's prejudice against nutrient supplementation and traditional, natural remedies means these advanced healthcare alternative competitors to pharmaceuticals are denigrated, marginalized and regulated against.
See also the Natural Solutions Foundations recent comments to the FDA condemning the agency's latest moves against nutrients: http://www.healthfreedomusa.org/index.php?p=1449
What is the answer? It is to, in the immortal words of John Galt, "Get out of the way." We need to engage market forces to stimulate advanced alternatives to a medical system that is now the major source of death in our society. We need to divest the FDA of any authority over foods. Maybe then it can focus on the dangers of pharmaceuticals, including the uninsurable risks of mandatory vaccination.
We need to free Foods (including nutrients and natural remedies) from the deadly hands of the FDA.
Natural Solutions Action Item on Divesting the FDA:
http://www.healthfreedomusa.org/?p=1601
1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
4) FDA does not have the capacity to ensure the safety of food for the nation.
5) The development of medical products based on “new science” cannot be adequately regulated by the FDA.
6) There is insufficient capacity in modeling risk assessment and analysis.
7) The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
8) The FDA has substantial recruitment and retention challenges.
9) The FDA has an inadequate and ineffective program for scientist performance.
10) The FDA has not taken sufficient advantage of external and internal collaborations.
11) The FDA lacks the information science capability and information infrastructure to fulfill is regulatory mandate.
12) The FDA cannot provide the information infrastructure support to regulate products based on new science.
From: the November 2007 Report of the Subcommittee on Science and Technology, "FDA Science and Mission at Risk."
The FDA is a failed agency that, in Dr. Ron Paul's words, engages in "abuse of power."
Even the FDA's own scientists are complaining about the corruption that pervades the agency: http://www.naturalnews.com/z024910.html -- and this is not the first time conscientious scientists have raised these issues.
I believe that due to its focus on the drug industry (80% of its funding comes from Big Pharma "user fees") and its failure to protect the safety of the food supply, while engaging in international "HARMonization" that degrades organic standards and allows ever-increasing levels of toxins (including antibiotic residues) in the food supply, the FDA is incapable of administering food regulations.
The FDA's prejudice against nutrient supplementation and traditional, natural remedies means these advanced healthcare alternative competitors to pharmaceuticals are denigrated, marginalized and regulated against.
See also the Natural Solutions Foundations recent comments to the FDA condemning the agency's latest moves against nutrients: http://www.healthfreedomusa.org/index.php?p=1449
What is the answer? It is to, in the immortal words of John Galt, "Get out of the way." We need to engage market forces to stimulate advanced alternatives to a medical system that is now the major source of death in our society. We need to divest the FDA of any authority over foods. Maybe then it can focus on the dangers of pharmaceuticals, including the uninsurable risks of mandatory vaccination.
We need to free Foods (including nutrients and natural remedies) from the deadly hands of the FDA.
Natural Solutions Action Item on Divesting the FDA:
http://www.healthfreedomusa.org/?p=1601
Wednesday, November 5, 2008
President-elect Obama: Change for Healthcare Freedom of Choice?
It is truly an historic moment, with the election of a candidate for president of the United States who identifies himself as a member of a minority ethnic group. One therefore hopes that president-elect Obama will be open to hearing dissenting and alternative opinions about issues such as healthcare freedom of choice. Surely, an administration built on the idea of "change" should be willing to listen to advocates of change.
We are, however, concerned that candidate Obama offered very little about issues that are of concern to health freedom advocates. The campaign chose not to respond to the Health Freedom Presidential Candidate Questionnaire -- although several of the Principled Third Party candidates did so; you can see their generally pro-health freedom responses at: http://www.healthfreedomusa.org/index.php?p=1303
We could not find any major media mention of vaccine mandates directly by the winning candidate, but in September, when Sen. Obama and the New Jersey governor passed a demonstration of pro-health freedom parents, some of whom were attending a fund raiser in an upscale community with the politicians, there was a report from the fundraiser,
"I'm afraid Barack Obama was asked by someone at the fundraiser if he supported the parent's right to choose to vaccinate, and he said he did not!"
The governor, however acknowledged,
"We get more e-mails and letters on this than any other issue other than tolls."
http://www.ageofautism.com/2008/09/obama-and-corzi.html
On another touchstone issue for health freedom advocates, Genetically Modified products foisted on the public without truthful labeling, the new President may not take an entirely pro-industry position. In a pre-election report we learn,
"[Obama b]elieves GM plants are beneficial with tests for environmental and health effects and regulatory oversight."
The requirement for testing, while falling short of truthful labeling, would be a change from current policy which "deems" GM products safe without third party testing.
On issues such as international harmonization, the "new world order" advisers surrounding the president-elect suggest that it may be difficult to focus any attention by the new administration on this important issue. We can expect the US Codex delegation to continue to have a free hand in supporting the international agenda of the "bigs" - Big Finance, Big Agra, Big Pharma, et al. Codex Alimentarius (the world food code) must continue to be a focus of the movement.
And finally, last year, when we were in Washington several times to help educate Congress about health freedom, we were not able to discuss with Sen. Obama's staff the important issue of divesting the FDA of its food authority, so that food (including dietary supplement) regulation would not remain the neglected step-child of the FDA's focus on supporting Big Pharma. However, discussions with other left/liberal legislative aids at that time, including people who will be allies of the president-elect in Congress, suggests a basis for pursuing the divestment issue.
Divesting the FDA may therefore be one health freedom issue that will have some "play" in the new Congress. What will be necessary, of course, will be for several Democratic members of Congress to be willing to co-sponsor a divestment bill. And for hundreds of thousands of Health Freedom Mouse Warriors to demand an end to FDA abuse of power.
The prospects for healthcare freedom of choice are mixed in the coming period.
Advocates of health freedom will need to redouble their efforts, especially to protect our children from vaccine mandates and to prevent ever more HARMonization of our health freedoms with international restrictions.
Divesting the FDA of its misused food authority appears to be a policy for which we may have some hope for real change...
We are, however, concerned that candidate Obama offered very little about issues that are of concern to health freedom advocates. The campaign chose not to respond to the Health Freedom Presidential Candidate Questionnaire -- although several of the Principled Third Party candidates did so; you can see their generally pro-health freedom responses at: http://www.healthfreedomusa.org/index.php?p=1303
We could not find any major media mention of vaccine mandates directly by the winning candidate, but in September, when Sen. Obama and the New Jersey governor passed a demonstration of pro-health freedom parents, some of whom were attending a fund raiser in an upscale community with the politicians, there was a report from the fundraiser,
"I'm afraid Barack Obama was asked by someone at the fundraiser if he supported the parent's right to choose to vaccinate, and he said he did not!"
The governor, however acknowledged,
"We get more e-mails and letters on this than any other issue other than tolls."
http://www.ageofautism.com/2008/09/obama-and-corzi.html
On another touchstone issue for health freedom advocates, Genetically Modified products foisted on the public without truthful labeling, the new President may not take an entirely pro-industry position. In a pre-election report we learn,
"[Obama b]elieves GM plants are beneficial with tests for environmental and health effects and regulatory oversight."
The requirement for testing, while falling short of truthful labeling, would be a change from current policy which "deems" GM products safe without third party testing.
On issues such as international harmonization, the "new world order" advisers surrounding the president-elect suggest that it may be difficult to focus any attention by the new administration on this important issue. We can expect the US Codex delegation to continue to have a free hand in supporting the international agenda of the "bigs" - Big Finance, Big Agra, Big Pharma, et al. Codex Alimentarius (the world food code) must continue to be a focus of the movement.
And finally, last year, when we were in Washington several times to help educate Congress about health freedom, we were not able to discuss with Sen. Obama's staff the important issue of divesting the FDA of its food authority, so that food (including dietary supplement) regulation would not remain the neglected step-child of the FDA's focus on supporting Big Pharma. However, discussions with other left/liberal legislative aids at that time, including people who will be allies of the president-elect in Congress, suggests a basis for pursuing the divestment issue.
Divesting the FDA may therefore be one health freedom issue that will have some "play" in the new Congress. What will be necessary, of course, will be for several Democratic members of Congress to be willing to co-sponsor a divestment bill. And for hundreds of thousands of Health Freedom Mouse Warriors to demand an end to FDA abuse of power.
The prospects for healthcare freedom of choice are mixed in the coming period.
Advocates of health freedom will need to redouble their efforts, especially to protect our children from vaccine mandates and to prevent ever more HARMonization of our health freedoms with international restrictions.
Divesting the FDA of its misused food authority appears to be a policy for which we may have some hope for real change...
Monday, October 1, 2007
Health Freedom Threat Alert: DHEA may be outlawed!
DHEA threatened again -- instead of promoting freedom of choice in healthcare; instead of defending our right as adults to use whatever natural food products we choose to manage our own health, instead of reforming the out-of-control FDA, Congress is at it again... treating us like subjects to be controlled instead of free citizens of a free society.
Truly "When Congress is in session no person's life and liberty are safe..."
------ Original Message ------
From: news@naturesbotanicals.com
Subject: Action Alert--Stop Congress from Restricting Access to DHEA Action Alert--Stop Congress from Restricting Access to DHEA
Your access to DHEA is in jeopardy! The Senate is considering a bill, S.762, to classify DHEA as an anabolic steroid, adding it to the list ofcontrolled substances and removing it from the market. H.R. 1249 is thecompanion bill in the U.S. House of Representatives. Your immediate help is needed to keep this safe and effective dietary supplement legal and accessible. DHEA is not an anabolic steroid. It is a naturally occurring hormone that hasa wide range of benefits, including maintaining muscle strength and strongbones, boosting immunity, and improving mood and sleep patterns. Furtherstudies suggest that DHEA may be helpful for such conditions as obesity,cancer and Alzheimers disease.
DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family; for more information. - http://www.capwiz.com/nnfa/issues/bills/?bill=9492216
We need your help to keep DHEA legal. Send a message to Congress asking yourSenators and Representative to oppose S. 762 and H.R. 1249 and any amendmentto restrict access to DHEA to minors. Congress should not restrict access toa dietary supplement that has given health to millions of Americans. Take action now! "
If you want some background see my article on how I kept DHEA legal in 1995.
http://www.lifespirit.org/dhealegal.html
Truly "When Congress is in session no person's life and liberty are safe..."
------ Original Message ------
From: news@naturesbotanicals.com
Subject: Action Alert--Stop Congress from Restricting Access to DHEA Action Alert--Stop Congress from Restricting Access to DHEA
Your access to DHEA is in jeopardy! The Senate is considering a bill, S.762, to classify DHEA as an anabolic steroid, adding it to the list ofcontrolled substances and removing it from the market. H.R. 1249 is thecompanion bill in the U.S. House of Representatives. Your immediate help is needed to keep this safe and effective dietary supplement legal and accessible. DHEA is not an anabolic steroid. It is a naturally occurring hormone that hasa wide range of benefits, including maintaining muscle strength and strongbones, boosting immunity, and improving mood and sleep patterns. Furtherstudies suggest that DHEA may be helpful for such conditions as obesity,cancer and Alzheimers disease.
DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family; for more information. - http://www.capwiz.com/nnfa/issues/bills/?bill=9492216
We need your help to keep DHEA legal. Send a message to Congress asking yourSenators and Representative to oppose S. 762 and H.R. 1249 and any amendmentto restrict access to DHEA to minors. Congress should not restrict access toa dietary supplement that has given health to millions of Americans. Take action now! "
If you want some background see my article on how I kept DHEA legal in 1995.
http://www.lifespirit.org/dhealegal.html
Wednesday, August 29, 2007
Educating Congressional Staffers
While the rest of us are enjoying the hazy days of late summer, my intrepid co-trustees at Natural Solutions Foundation, Gen. Bert Stubblebine and Dr. Rima Laibow are in Washington DC, educating congressional staffers who are already back in town about pressing health freedom and FDA reform issues -- as Congress gets ready to reconvene.
Here is the message they are delivering this week:
------------------------------------
Natural Solutions Foundation Media Releasewww.GlobalHealthFreedom.org
Protecting Health Freedom for Consumer and Entrepreneur
1. While manufacturers and retailers seek to meet consumer demand for high potency, high quality Dietary Supplements and advanced Natural Therapies, abusive FDA regulatory initiatives restrict continued access to them. FDA enforcement includes unwarranted raids against “mom-and-pop” shops, including a current invasion diabetes therapy providers. FDA enthusiastically endorses this “aggressive enforcement policy” (http://www.fda.gov/oc/whitepapers/enforce.html)
2. Access to wholesome nutrition is threatened by regulatory initiatives:
* FDA CAM (“Complimentary and Alternative Medicine) Guidance) – final – would criminalize natural health services not provided by licensed physicians, create new regulatory category of “Complementary and Alternative Products” which would be regulated as unlicensed drugs and devices if used with an intent to bring about a beneficial health result. Ex: FDA threatened to turn cherries into an untested (forbidden) drug when Michigan Cherry Growers Ass’n mounted 6 independent scientific papers on benefits of cherry juice for arthritis on its website.
* FDA Health Claims Guidance – draft – would prevent disclosure of food-related health benefits to consumers by requiring impossible significant scientific agreement instead of more reasonable common law standard – “more than a scintilla of evidence”. This policy is consistent with Codex prohibition on “advertising” which reveal health benefits that would change consumer’s food beliefs, behaviors or purchases.
* FDA Dietary Supplement GMPs (Good Manufacturing Practices) – final – would, by FDA’s own admission, close down significant numbers of small businesses.
FDA Economic Impact: “significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... very small [less than 20 employees] and … small dietary supplement manufacturers [less than500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry…”
Supplements, because they are treated as food, are generally regarded as safe under the Dietary Supplements Health and Education Act (DSHEA, 1994).
* AER (Adverse Event Reporting) Regulations for dietary supplements, despite little to no history of dangers associated with supplements, are about to be issued. These could easily lead to questionable reporting and misuse of data, further threatening dietary supplements with additional draconian and unnecessary regulation
3. “Harmonization” with Codex Alimentarius is the basis for the regulatory initiatives. FDA has announced preference for International Standards (i.e., Codex) in preference to U.S. regulation and law. (Fed. Reg., October 11, 1995). Consistent with the definition of advertising adopted by the Codex Committee on Food Labeling (2007) with FDA leadership, these regulations will create a stranglehold on truth and choice. FDA head of Office of Dietary Supplements, who also acts as the US Codex Delegate, is pushing to eliminate health claims and information re: health benefits for foods both domestically and through Codex.
4. The FDA Revitalization Act, pending congressional conference committee, is a bad law which rewards FDA abuse of power with more power to abuse and more money to do it with. Sect 608 of the Senate version would protect DSHEA (the 1994 Dietary Supplement Health Education Act) products from additional regulation and should remain in the law.
5. Conflicts of interest in favor of drugs and against foods (a major economic competitor to drugs) currently leads FDA to preside over the active degradation of the food supply, including the subclass of food known as "Dietary Supplements”, at the same time the FDA fails to protect the public from dangerous drugs. Properly used drugs are a leading cause of death in the developing world. Supplements do not pose a significant morbidity/mortality threat.
Solution:
1. Reverse the decision Congress made in 1938 to put drug and food regulation under the auspices of the same organization. Experience since that time has shown this to be a serious administrative and regulatory error. To protect the integrity of the food supply and the health of Americans, it is essential to separate food regulatory authority from the same regulatory agency which regulates drugs.
2. Support HR 2117, The Health Freedom Protection Act, which protects Health Claims for Dietary Supplements from FDA restrictions unless the claim cannot be made truthful by revision.
The Natural Solutions Foundation is a 501 ( c )3 nonprofit with 230,000 members, founded in 2004, with the goal of protecting the majority of humans in their preference for healthy, natural therapies, goods and services, from threatening overregulation by national and international Government Entities. Its Medical Directed is Rima Laibow, MD. For more information or to sign up for our e Newsletter, please check out our website, http://www.globalhealthfreedom.org/.
-----------------------------------------
The reports I am receiving indicate that Congress may be ready to listen to the call for real reform of the FDA and for the adoption of Dr. Ron Paul's health freedom bill.
My thanks, as always, to Charlie Frohman, our equally intrepid DC consultant, for sheparding Rima and Bert through the House and Senate office buildings maze! http://www.cfrohman.com/ As always, the messanger and the message...
Here is the message they are delivering this week:
------------------------------------
Natural Solutions Foundation Media Releasewww.GlobalHealthFreedom.org
Protecting Health Freedom for Consumer and Entrepreneur
1. While manufacturers and retailers seek to meet consumer demand for high potency, high quality Dietary Supplements and advanced Natural Therapies, abusive FDA regulatory initiatives restrict continued access to them. FDA enforcement includes unwarranted raids against “mom-and-pop” shops, including a current invasion diabetes therapy providers. FDA enthusiastically endorses this “aggressive enforcement policy” (http://www.fda.gov/oc/whitepapers/enforce.html)
2. Access to wholesome nutrition is threatened by regulatory initiatives:
* FDA CAM (“Complimentary and Alternative Medicine) Guidance) – final – would criminalize natural health services not provided by licensed physicians, create new regulatory category of “Complementary and Alternative Products” which would be regulated as unlicensed drugs and devices if used with an intent to bring about a beneficial health result. Ex: FDA threatened to turn cherries into an untested (forbidden) drug when Michigan Cherry Growers Ass’n mounted 6 independent scientific papers on benefits of cherry juice for arthritis on its website.
* FDA Health Claims Guidance – draft – would prevent disclosure of food-related health benefits to consumers by requiring impossible significant scientific agreement instead of more reasonable common law standard – “more than a scintilla of evidence”. This policy is consistent with Codex prohibition on “advertising” which reveal health benefits that would change consumer’s food beliefs, behaviors or purchases.
* FDA Dietary Supplement GMPs (Good Manufacturing Practices) – final – would, by FDA’s own admission, close down significant numbers of small businesses.
FDA Economic Impact: “significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... very small [less than 20 employees] and … small dietary supplement manufacturers [less than500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry…”
Supplements, because they are treated as food, are generally regarded as safe under the Dietary Supplements Health and Education Act (DSHEA, 1994).
* AER (Adverse Event Reporting) Regulations for dietary supplements, despite little to no history of dangers associated with supplements, are about to be issued. These could easily lead to questionable reporting and misuse of data, further threatening dietary supplements with additional draconian and unnecessary regulation
3. “Harmonization” with Codex Alimentarius is the basis for the regulatory initiatives. FDA has announced preference for International Standards (i.e., Codex) in preference to U.S. regulation and law. (Fed. Reg., October 11, 1995). Consistent with the definition of advertising adopted by the Codex Committee on Food Labeling (2007) with FDA leadership, these regulations will create a stranglehold on truth and choice. FDA head of Office of Dietary Supplements, who also acts as the US Codex Delegate, is pushing to eliminate health claims and information re: health benefits for foods both domestically and through Codex.
4. The FDA Revitalization Act, pending congressional conference committee, is a bad law which rewards FDA abuse of power with more power to abuse and more money to do it with. Sect 608 of the Senate version would protect DSHEA (the 1994 Dietary Supplement Health Education Act) products from additional regulation and should remain in the law.
5. Conflicts of interest in favor of drugs and against foods (a major economic competitor to drugs) currently leads FDA to preside over the active degradation of the food supply, including the subclass of food known as "Dietary Supplements”, at the same time the FDA fails to protect the public from dangerous drugs. Properly used drugs are a leading cause of death in the developing world. Supplements do not pose a significant morbidity/mortality threat.
Solution:
1. Reverse the decision Congress made in 1938 to put drug and food regulation under the auspices of the same organization. Experience since that time has shown this to be a serious administrative and regulatory error. To protect the integrity of the food supply and the health of Americans, it is essential to separate food regulatory authority from the same regulatory agency which regulates drugs.
2. Support HR 2117, The Health Freedom Protection Act, which protects Health Claims for Dietary Supplements from FDA restrictions unless the claim cannot be made truthful by revision.
The Natural Solutions Foundation is a 501 ( c )3 nonprofit with 230,000 members, founded in 2004, with the goal of protecting the majority of humans in their preference for healthy, natural therapies, goods and services, from threatening overregulation by national and international Government Entities. Its Medical Directed is Rima Laibow, MD. For more information or to sign up for our e Newsletter, please check out our website, http://www.globalhealthfreedom.org/.
-----------------------------------------
The reports I am receiving indicate that Congress may be ready to listen to the call for real reform of the FDA and for the adoption of Dr. Ron Paul's health freedom bill.
My thanks, as always, to Charlie Frohman, our equally intrepid DC consultant, for sheparding Rima and Bert through the House and Senate office buildings maze! http://www.cfrohman.com/ As always, the messanger and the message...
Thursday, August 2, 2007
FDA enabling act delayed... hope for Health Freedom Protection Act?
This report in late yesterday:
http://blogs.wsj.com/washwire/2007/07/31/no-action-likely-on-fda-bill-until-the-fall/
"No Action Likely on FDA Bill Until the Fall
Anna Wilde Mathews reports on the FDA.
"The House and Senate don't appear likely to reconcile their divergentversions of a major Food and Drug Administration bill before their August recess, according to congressional staffers and lobbyists.
"The bill is unusually time-sensitive because it renews the FDA'sability to collect fees from drug makers and device manufacturers that are needed to keep important agency operations running. The fee authority runs out at the end of the government's fiscal year, Sept.30.
"Lawmakers didn't want to play it too close and force the agency tosend out warnings to employees about possible layoffs. Staffers from the House and Senate have been negotiating for the last few weeks, trying to work out the outlines of a deal lawmakers could quickly complete and pass before heading out for their break. But the full meeting adjourned last night and now might not pick up again for the rest of the week. Staffers generally believe that a bill can't pass before the recess begins this weekend. The movement toward a fast agreement seems to have stalled over a variety of issues..."
From the perpective of supporters of Dr. Ron Pauls' Health Freedom Protection Act - HR 2117 - this is a good development and indicates that our efforts to educate Congress may be having an effect. How can the FDA be "revitalized" if Health Freedom protection is not in the picture? We specifically told the major players in Washington this past Monday,
"...the "FDA Revitalization Act" is not going to satisfy the American public. Congress must use the opportunity presented by HR 2117 to protect the health of the American people and that is our message to Congress today. The final adoption of the FDA Revitalization Act should be delayed; hearings should be held and careful consideration should be given to HR 2117, The Health Freedom Protection Act and other measures to protect the health freedom of Americans."
(From Gen. Stubblebine's 07/30/07 Congressional Briefing Document: "Congressional Choice: Health Freedom or Health Tyranny" - see previous posting for text.)
During the past three months over a half million citizen messages have been generated through the Natural Solutions Foundation - http://www.healthfreedomusa.org/ - to Congress, FDA, USDA educating DC decision makers that Health Freedom is an issue of great concern to the public. Will Congress listen?
http://blogs.wsj.com/washwire/2007/07/31/no-action-likely-on-fda-bill-until-the-fall/
"No Action Likely on FDA Bill Until the Fall
Anna Wilde Mathews reports on the FDA.
"The House and Senate don't appear likely to reconcile their divergentversions of a major Food and Drug Administration bill before their August recess, according to congressional staffers and lobbyists.
"The bill is unusually time-sensitive because it renews the FDA'sability to collect fees from drug makers and device manufacturers that are needed to keep important agency operations running. The fee authority runs out at the end of the government's fiscal year, Sept.30.
"Lawmakers didn't want to play it too close and force the agency tosend out warnings to employees about possible layoffs. Staffers from the House and Senate have been negotiating for the last few weeks, trying to work out the outlines of a deal lawmakers could quickly complete and pass before heading out for their break. But the full meeting adjourned last night and now might not pick up again for the rest of the week. Staffers generally believe that a bill can't pass before the recess begins this weekend. The movement toward a fast agreement seems to have stalled over a variety of issues..."
From the perpective of supporters of Dr. Ron Pauls' Health Freedom Protection Act - HR 2117 - this is a good development and indicates that our efforts to educate Congress may be having an effect. How can the FDA be "revitalized" if Health Freedom protection is not in the picture? We specifically told the major players in Washington this past Monday,
"...the "FDA Revitalization Act" is not going to satisfy the American public. Congress must use the opportunity presented by HR 2117 to protect the health of the American people and that is our message to Congress today. The final adoption of the FDA Revitalization Act should be delayed; hearings should be held and careful consideration should be given to HR 2117, The Health Freedom Protection Act and other measures to protect the health freedom of Americans."
(From Gen. Stubblebine's 07/30/07 Congressional Briefing Document: "Congressional Choice: Health Freedom or Health Tyranny" - see previous posting for text.)
During the past three months over a half million citizen messages have been generated through the Natural Solutions Foundation - http://www.healthfreedomusa.org/ - to Congress, FDA, USDA educating DC decision makers that Health Freedom is an issue of great concern to the public. Will Congress listen?
Tuesday, July 31, 2007
Trip to DC: Congress, Liberty Coalition, FDA bill...
I caught the 6:36 AM train from Metropark to DC Monday, for a day of meetings with congressional aides. Training passed New Brunswick I remembered many other train trips there in the '60s, returning to Rutgers from weekends... and I remembered Henry Adams' autobiography where he was taking the same trip to DC, expecting to influence post-Civil War policy. He expected to be embraced; after all, both his father and grandfather had been presidents. He learned that Washington is a hard town to take by storm...
As I walked through the refurbished Union Station I was remembering other trips to DC in the '70s mostly to protest the fiasco in VietNam... Later for NTU and libertarian events... And again in '93 to lobby for the passage of DSHEA (Kathy and I brought our then 5 year old son)... An amazing city: magnificent monuments; awesome buildings; beautiful parks... the might of empire displayed. Surely, not even ancient Rome or Babylon could rival it. Would this place become like them... All I could think of were Shelly's lines:
"'My name is Ozymandias, king of kings:
Look on my works, ye Mighty, and despair!'
Nothing beside remains.
Round the decay
Of that colossal wreck, boundless and bare
The lone and level sands stretch far away."
Such musings ended as I met Charles Frohman, Natural Solutions Foundation's DC agent. He took me to a congressional staff meeting with about 100 conservative and libertarian congresspeople represented and then around to a half dozen congressional offices involved in the so-called FDA Revitalization Act (S.1082 - HR.2900), including Senator Harkin's office, where we were assured that Congress had heard us and the DSHEA protective language, Section 608, will remain in the final bill.
What they heard was a strong protest mounted by NSF and the Liberty Coalition a non-partisan right/left coalition of pro-freedom groups. The letter hand-delivered to the appropriate committee charis, signed by dozens of groups and individuals, reads:
-----------------
Dear Messrs. Chairman,
The purpose of this letter is to alert Congress to the opportunity it has to protect the health of the American people by protecting a certain section in the "Food and Drug Administration (FDA) Revitalization Act" (S. 1082 and HR 2900), and overriding recent FDA Guidance threatening consumer access to natural therapies.
While the sponsors of the FDA Revitalization Act spoke on the Senate floor that the bill holds harmless natural supplements, Senator Durbin’s Food Title (VI) does include an explicit Section (608), “Rules of Construction,” authored by Senators Hatch and Harkin, protecting nutrients and natural supplements already regulated by the 1994 Dietary Supplement Health and Education Act (DSHEA). If Title VI is retained in the Conference Report for the underlying FDA bill, we respectfully request that Section 608 remain in the final bill. This is necessary as the FDA consistently interprets enactments contrary to clear Congressional intent that supplements are to be regulated like foods, not drugs.
This, however, is not the only problem facing consumers of Dietary Supplements. Recently FDA issued two draft Guidance’s: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category - without Congressional approval while the second places a heavy burden on proof of health claims. The FDA Guidance’s could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy, which lowers morbidity, mortality and health costs. The undersigned organizations, representing in the aggregate millions of voters, are deeply concerned about the important health freedom assaults facing the people. We urge Congress to take immediate action to reverse these dangerous and potentially lethal regulations. One immediate step would be to adopt the Health Freedom Protection Act, HR 2117, mandating FDA approval of Health Claims that have scientific substantiation.
Signed, Natural Solutions Foundation et. al.
(to see 3 page list of co-signers, please go to
http://www.libertycoalition.net/)
-----------------
We also brought along a Natural Solutions Foundation Congressional Briefing Document to the staff meeting and offices, giving out 100 of them. The Briefing reads:
-----------------
From the Desk of Major General StubblebinePresident, Natural Solutions Foundation
Re: Congressional Choice: Health Freedom or Health Tyranny
To the Members of the 110th Congress and National Decision Makers:
During the past three months supporters of the Natural Solutions Foundation – http://www.healthfreedomusa.org/ - have sent over a half million messages to Congress, the USDA and the FDA about health freedom issues. Of these, 197,000 individual messages went to the FDA regarding its recent "Guidance" about complementary and alternative healthcare modalities (docket 2006D-0480). Hundreds of thousands of health freedom supporters have signed onto the Natural Solutions Foundation's Health Freedom Alert and are ready to make their voices heard to agencies and to their congressional representatives "at the drop of a mouse..."
The House and Senate are currently conferencing the so-called "FDA Revitalization Act" - HR 2900 and S 1082. This legislation is not likely to solve the problems of the Food and Drug Administration; throwing more money and more bureaucracy at the problems caused by bureaucracy hardly ever does, but this new law is likely to further erode Americans’ access to wholesome nutrition and natural remedies.
Because hundreds of thousands of citizens made their views known to their Senators, the Senate, without dissent, added language to S 1082 protecting products already regulated under the Dietary Supplement Health and Education Act (DSHEA) from certain provisions of the act. The House did not adopt similar language. We strongly support the retention of Section 608, the DSHEA protection language, whether or not Section 6, on food safety, remains in the final bill. Better yet would be the adoption of the Health Freedom Protection Act, HR 2117, which would assure Americans that we could receive truthful health claims information from nutrient purveyors, despite FDA efforts to prevent that exercise of free speech.
Natural Solutions Foundation's supporters have further concerns. Today the Liberty Coalition is delivering a letter to the chairmen of the health committees of both houses of Congress, signed by organizations representing millions of citizens. That letter supporting the retention of Section 608 states, in part.
"Recently FDA issued two draft Guidances: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category - without Congressional approval, while the second places a heavy burden on proof of health claims. These FDA Guidances could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy which lowers morbidity, mortality and health costs."
The Natural Solutions Foundation, seeking to educate Washington decision makers, has criticized both of these guidances. We agree with Dr. Ron Paul who called the CAM guidance "...an abuse of FDA power..." and call for further protections for nutrients and natural remedies. HR 2117 would make the Health Claims guidance moot and enhance consumer access.
Just as Congress did unanimously in 1994, when DSHEA was adopted, Congress needs to intervene and really reform the FDA. The bills that passed this session, assuming they survive conference, will not accomplish meaningful reform, especially in the area of foods. It is time to re-evaluate the entire structure of the FDA. It may very well be that a mistake was made in 1938 when the FDA was empowered, combining oversight of foods with that of drugs in a single agency. The combination led to a confused and confusing bureaucracy which under values the role of food in health and is far too supine to the interests of the hugely powerful pharmaceutical industry.
A good first step to real reform would be the adoption of HR 2117, supporting free speech in health claims. In the leading case of Thompson vs. Western States, 2002, Justice Sandra Day O'Connor stated: "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort ... We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."
The FDA is conducting the world's largest experiment on the American people, without either their knowledge or consent. In the absence of any safety testing or review, it permits genetically modified (GM or "Frankenfood") in America's food supply and explicitly refuses to allow it to be labeled as such since it says that the truth would "mislead" consumers who would not eat GM food if they had a choice about it. GM food safety has been questioned scientifically; however, be that as it may, by withholding truthful information on what is, and what is not genetically modified, the FDA is simultaneously adulterating America's food supply and taking away the right of Americans to choose whether they want to be part of an experiment for which they have not signed up and which may, in the long run, cost them their lives, the right to have children, give them cancer and poison the environment for all future generations - we just don't know yet. The same reasoning applies to the FDA position on irradiation of foods without notice to the consumer; or to the USDA's recent decision to permitting 38 non-organic ingredients while still allowing purveyors to label the products (sic) "organic." Not only are these agency biotech-friendly decisions dangerous, they are also illegal since withholding this information is against the law in this country. These are yet more abuses of FDA power and the power of the other national and international agencies involved.
Americans understand that government agencies increasingly invade personal decisions, taking custody of children away from parents who do not want to vaccinate or medicate them and forcing drugs on the elderly and other vulnerable populations. They resent secret government access to their medical records under HIPPA and homeland security provisions which allow the government to invade their lab results and other records, checking up on diabetic's blood sugar levels, for example and identifying doctors who do not prescribe potentially dangerous drugs as "practicing substandard care" while paying them less money for their supposedly "substandard" treatment.
Americans are angry that the FDA and EPA have canceled their right of informed consent about human experimentation for certain powerless populations (e.g., prisoners, children in foster care) and whole populations (as long as there is secret notification of local police forces 30 days before exposing Americans to radiological, biological, frequency chemical or other experimental hazards).
Health Freedom is an issue that is supported by a majority of Americans; they want a new pro-freedom policy at the FDA, USDA, EPA and other government agencies which are currently threatening both the health and the freedom of Americans. Protection by Congressional enactment would mean that Americans would no longer be forced into compliance with international agencies, such as the Codex Alimentarius (World Food Code) serving corporate agendas, and denigrating organic standards, allowing increased levels of toxins in the international food supply in the process. We would, by adopting HR 2117 and similar laws, declare our independence from Codex and similar international mandates and, once again, lead the world toward greater personal choice in health care by the example of the freedoms our people will enjoy.
This process is what the Natural Solutions Foundation calls "The Codex Two Step." Codex Alimentarius - the World Food Code - is a UN agency under WHO and FAO. It sets international food standards and guidelines regarding food safety and food trade. The guidelines are, under the Codex Statute, advisory only. Many health conscious countries want to support standards that are stricter than Codex might allow; others want to defend traditional foods and remedies; some countries may want to allow their citizens more freedom of choice in what they eat and how they care for their own health.
However, Codex rules are enforced through the World Trade Organization (WTO) which says Codex rules are "presumptive" evidence of the standards for decisions. Nonetheless, the WTO has refused to make Codex the sole rule of decision. In the event of a WTO dispute, if a country has not designated another standard, Codex applies. So, what is the Codex Two Step? It is the legal strategy Natural Solutions Foundation has devised to protect health friendly nations’ traditional foods and remedies and American's freedom of choice.
How does the Two Step work? A country adopts its own food and health guidelines that may vary from Codex. That country then adopts science-based law enforcing its own guideline (somewhat like the US has done with DSHEA... but for a little snag we will discuss later...) - Natural Solutions Foundation has prepared model guidelines and laws for countries to use. What happens, then, if there is a dispute in the WTO involving foods and health? Since one of the countries has adopted its own guidelines and law, the WTO presumption regarding Codex standards and guidelines does not apply. Instead, the WTO judges by the science behind the dispute and each country will be judged based upon its own science-based law - a country cannot be penalized if its science is as good as the complainant's science.
The snag in US regulation is that the FDA declared, in a October 11, 1995 Federal Register announcement (60 FR 53078) that it would "harmonize" US law and regulation with international standards... and Congress and the people be d-----d! So, except for a very limited extent through 19 U.S.C. 3512 (the Uruguay Round anti-harmonization act) we are not protected from forced harmonization and only Congress can act to close the loophole in US health sovereignty.
And that is why the "FDA Revitalization Act" is not going to satisfy the American public. Congress must use the opportunity presented by HR 2117 to protect the health of the American people and that is our message to Congress today. The final adoption of the FDA Revitalization Act should be delayed; hearings should be held and careful consideration should be given to HR 2117, The Health Freedom Protection Act and other measures to protect the health freedom of Americans.
July 30, 2007
Maj. Gen. Albert N Stubblebine III (US Army, Ret.)
President, Natural Solutions Foundation
By: Ralph Fucetola JD, Foundation Counsel & Trustee
http://www.healthfreedomusa.org/
http://www.globalhealthfreedom.org/
© 2007
-----------------
I left the city that evening with the sense that I'd be back soon.
As I walked through the refurbished Union Station I was remembering other trips to DC in the '70s mostly to protest the fiasco in VietNam... Later for NTU and libertarian events... And again in '93 to lobby for the passage of DSHEA (Kathy and I brought our then 5 year old son)... An amazing city: magnificent monuments; awesome buildings; beautiful parks... the might of empire displayed. Surely, not even ancient Rome or Babylon could rival it. Would this place become like them... All I could think of were Shelly's lines:
"'My name is Ozymandias, king of kings:
Look on my works, ye Mighty, and despair!'
Nothing beside remains.
Round the decay
Of that colossal wreck, boundless and bare
The lone and level sands stretch far away."
Such musings ended as I met Charles Frohman, Natural Solutions Foundation's DC agent. He took me to a congressional staff meeting with about 100 conservative and libertarian congresspeople represented and then around to a half dozen congressional offices involved in the so-called FDA Revitalization Act (S.1082 - HR.2900), including Senator Harkin's office, where we were assured that Congress had heard us and the DSHEA protective language, Section 608, will remain in the final bill.
What they heard was a strong protest mounted by NSF and the Liberty Coalition a non-partisan right/left coalition of pro-freedom groups. The letter hand-delivered to the appropriate committee charis, signed by dozens of groups and individuals, reads:
-----------------
Dear Messrs. Chairman,
The purpose of this letter is to alert Congress to the opportunity it has to protect the health of the American people by protecting a certain section in the "Food and Drug Administration (FDA) Revitalization Act" (S. 1082 and HR 2900), and overriding recent FDA Guidance threatening consumer access to natural therapies.
While the sponsors of the FDA Revitalization Act spoke on the Senate floor that the bill holds harmless natural supplements, Senator Durbin’s Food Title (VI) does include an explicit Section (608), “Rules of Construction,” authored by Senators Hatch and Harkin, protecting nutrients and natural supplements already regulated by the 1994 Dietary Supplement Health and Education Act (DSHEA). If Title VI is retained in the Conference Report for the underlying FDA bill, we respectfully request that Section 608 remain in the final bill. This is necessary as the FDA consistently interprets enactments contrary to clear Congressional intent that supplements are to be regulated like foods, not drugs.
This, however, is not the only problem facing consumers of Dietary Supplements. Recently FDA issued two draft Guidance’s: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category - without Congressional approval while the second places a heavy burden on proof of health claims. The FDA Guidance’s could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy, which lowers morbidity, mortality and health costs. The undersigned organizations, representing in the aggregate millions of voters, are deeply concerned about the important health freedom assaults facing the people. We urge Congress to take immediate action to reverse these dangerous and potentially lethal regulations. One immediate step would be to adopt the Health Freedom Protection Act, HR 2117, mandating FDA approval of Health Claims that have scientific substantiation.
Signed, Natural Solutions Foundation et. al.
(to see 3 page list of co-signers, please go to
http://www.libertycoalition.net/)
-----------------
We also brought along a Natural Solutions Foundation Congressional Briefing Document to the staff meeting and offices, giving out 100 of them. The Briefing reads:
-----------------
From the Desk of Major General StubblebinePresident, Natural Solutions Foundation
Re: Congressional Choice: Health Freedom or Health Tyranny
To the Members of the 110th Congress and National Decision Makers:
During the past three months supporters of the Natural Solutions Foundation – http://www.healthfreedomusa.org/ - have sent over a half million messages to Congress, the USDA and the FDA about health freedom issues. Of these, 197,000 individual messages went to the FDA regarding its recent "Guidance" about complementary and alternative healthcare modalities (docket 2006D-0480). Hundreds of thousands of health freedom supporters have signed onto the Natural Solutions Foundation's Health Freedom Alert and are ready to make their voices heard to agencies and to their congressional representatives "at the drop of a mouse..."
The House and Senate are currently conferencing the so-called "FDA Revitalization Act" - HR 2900 and S 1082. This legislation is not likely to solve the problems of the Food and Drug Administration; throwing more money and more bureaucracy at the problems caused by bureaucracy hardly ever does, but this new law is likely to further erode Americans’ access to wholesome nutrition and natural remedies.
Because hundreds of thousands of citizens made their views known to their Senators, the Senate, without dissent, added language to S 1082 protecting products already regulated under the Dietary Supplement Health and Education Act (DSHEA) from certain provisions of the act. The House did not adopt similar language. We strongly support the retention of Section 608, the DSHEA protection language, whether or not Section 6, on food safety, remains in the final bill. Better yet would be the adoption of the Health Freedom Protection Act, HR 2117, which would assure Americans that we could receive truthful health claims information from nutrient purveyors, despite FDA efforts to prevent that exercise of free speech.
Natural Solutions Foundation's supporters have further concerns. Today the Liberty Coalition is delivering a letter to the chairmen of the health committees of both houses of Congress, signed by organizations representing millions of citizens. That letter supporting the retention of Section 608 states, in part.
"Recently FDA issued two draft Guidances: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category - without Congressional approval, while the second places a heavy burden on proof of health claims. These FDA Guidances could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy which lowers morbidity, mortality and health costs."
The Natural Solutions Foundation, seeking to educate Washington decision makers, has criticized both of these guidances. We agree with Dr. Ron Paul who called the CAM guidance "...an abuse of FDA power..." and call for further protections for nutrients and natural remedies. HR 2117 would make the Health Claims guidance moot and enhance consumer access.
Just as Congress did unanimously in 1994, when DSHEA was adopted, Congress needs to intervene and really reform the FDA. The bills that passed this session, assuming they survive conference, will not accomplish meaningful reform, especially in the area of foods. It is time to re-evaluate the entire structure of the FDA. It may very well be that a mistake was made in 1938 when the FDA was empowered, combining oversight of foods with that of drugs in a single agency. The combination led to a confused and confusing bureaucracy which under values the role of food in health and is far too supine to the interests of the hugely powerful pharmaceutical industry.
A good first step to real reform would be the adoption of HR 2117, supporting free speech in health claims. In the leading case of Thompson vs. Western States, 2002, Justice Sandra Day O'Connor stated: "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort ... We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."
The FDA is conducting the world's largest experiment on the American people, without either their knowledge or consent. In the absence of any safety testing or review, it permits genetically modified (GM or "Frankenfood") in America's food supply and explicitly refuses to allow it to be labeled as such since it says that the truth would "mislead" consumers who would not eat GM food if they had a choice about it. GM food safety has been questioned scientifically; however, be that as it may, by withholding truthful information on what is, and what is not genetically modified, the FDA is simultaneously adulterating America's food supply and taking away the right of Americans to choose whether they want to be part of an experiment for which they have not signed up and which may, in the long run, cost them their lives, the right to have children, give them cancer and poison the environment for all future generations - we just don't know yet. The same reasoning applies to the FDA position on irradiation of foods without notice to the consumer; or to the USDA's recent decision to permitting 38 non-organic ingredients while still allowing purveyors to label the products (sic) "organic." Not only are these agency biotech-friendly decisions dangerous, they are also illegal since withholding this information is against the law in this country. These are yet more abuses of FDA power and the power of the other national and international agencies involved.
Americans understand that government agencies increasingly invade personal decisions, taking custody of children away from parents who do not want to vaccinate or medicate them and forcing drugs on the elderly and other vulnerable populations. They resent secret government access to their medical records under HIPPA and homeland security provisions which allow the government to invade their lab results and other records, checking up on diabetic's blood sugar levels, for example and identifying doctors who do not prescribe potentially dangerous drugs as "practicing substandard care" while paying them less money for their supposedly "substandard" treatment.
Americans are angry that the FDA and EPA have canceled their right of informed consent about human experimentation for certain powerless populations (e.g., prisoners, children in foster care) and whole populations (as long as there is secret notification of local police forces 30 days before exposing Americans to radiological, biological, frequency chemical or other experimental hazards).
Health Freedom is an issue that is supported by a majority of Americans; they want a new pro-freedom policy at the FDA, USDA, EPA and other government agencies which are currently threatening both the health and the freedom of Americans. Protection by Congressional enactment would mean that Americans would no longer be forced into compliance with international agencies, such as the Codex Alimentarius (World Food Code) serving corporate agendas, and denigrating organic standards, allowing increased levels of toxins in the international food supply in the process. We would, by adopting HR 2117 and similar laws, declare our independence from Codex and similar international mandates and, once again, lead the world toward greater personal choice in health care by the example of the freedoms our people will enjoy.
This process is what the Natural Solutions Foundation calls "The Codex Two Step." Codex Alimentarius - the World Food Code - is a UN agency under WHO and FAO. It sets international food standards and guidelines regarding food safety and food trade. The guidelines are, under the Codex Statute, advisory only. Many health conscious countries want to support standards that are stricter than Codex might allow; others want to defend traditional foods and remedies; some countries may want to allow their citizens more freedom of choice in what they eat and how they care for their own health.
However, Codex rules are enforced through the World Trade Organization (WTO) which says Codex rules are "presumptive" evidence of the standards for decisions. Nonetheless, the WTO has refused to make Codex the sole rule of decision. In the event of a WTO dispute, if a country has not designated another standard, Codex applies. So, what is the Codex Two Step? It is the legal strategy Natural Solutions Foundation has devised to protect health friendly nations’ traditional foods and remedies and American's freedom of choice.
How does the Two Step work? A country adopts its own food and health guidelines that may vary from Codex. That country then adopts science-based law enforcing its own guideline (somewhat like the US has done with DSHEA... but for a little snag we will discuss later...) - Natural Solutions Foundation has prepared model guidelines and laws for countries to use. What happens, then, if there is a dispute in the WTO involving foods and health? Since one of the countries has adopted its own guidelines and law, the WTO presumption regarding Codex standards and guidelines does not apply. Instead, the WTO judges by the science behind the dispute and each country will be judged based upon its own science-based law - a country cannot be penalized if its science is as good as the complainant's science.
The snag in US regulation is that the FDA declared, in a October 11, 1995 Federal Register announcement (60 FR 53078) that it would "harmonize" US law and regulation with international standards... and Congress and the people be d-----d! So, except for a very limited extent through 19 U.S.C. 3512 (the Uruguay Round anti-harmonization act) we are not protected from forced harmonization and only Congress can act to close the loophole in US health sovereignty.
And that is why the "FDA Revitalization Act" is not going to satisfy the American public. Congress must use the opportunity presented by HR 2117 to protect the health of the American people and that is our message to Congress today. The final adoption of the FDA Revitalization Act should be delayed; hearings should be held and careful consideration should be given to HR 2117, The Health Freedom Protection Act and other measures to protect the health freedom of Americans.
July 30, 2007
Maj. Gen. Albert N Stubblebine III (US Army, Ret.)
President, Natural Solutions Foundation
By: Ralph Fucetola JD, Foundation Counsel & Trustee
http://www.healthfreedomusa.org/
http://www.globalhealthfreedom.org/
© 2007
-----------------
I left the city that evening with the sense that I'd be back soon.
Friday, July 20, 2007
Current Health Freedom issues
Since the last days of 2006 there have been a series of challenges to Health Freedom
* Adverse Event Reporting Act [signed late December 2006]
* FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]
* USDA & Codex: Organic Standards Diminished
* Codex: Raising Toxic Levels, Mandating Irradiation
* Codex: GM (Genetically Modified) Labeling Failures
* FDA GMPs (Good Manufacturing Practices for Dietary Supplements) [Late June 2007]
* Senate & House adoption of FDA enabling bills [S.1082 & HR.2900] [Only S.1082 contains DSHEA protection language]
* Failure of US House to consider Health Freedom Protection Act – HR.2117 [Although over 100,000 messages to Congress demanded such protection]
Now the FDA has directly challenged HR.2117 with a new draft guidance, “Evidence-Based Review System for the Scientific Evaluation of Health Claims” [07/02/07]
Citation: http://www.cfsan.fda.gov/~dms/hclmgui5.html
This draft guidance document represents the agency's current thinking on
1) the process for evaluating the scientific evidence for a health claim,
2) the meaning of the significant scientific agreement (SSA) standard
3) credible scientific evidence to support a qualified health claim. …
Ron Paul’s Health Freedom Protection Act (HR.2117) -
Citation: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
Health Claims must be allowed unless the FDA determines that –
(i) there is no scientific evidence that supports the claim;
(ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer
The distinction between the Constitutional system of Freedom of Speech -proposed by its champion, Dr. Paul, and the FDA's bureaucratic illegal desire to impose "prior restraint" could not be clearer.
The opportunity should be clear: support HR.2117 - the Health Freedom Protection Act. While we need further protectio with language addressing each of the pending challenges noted above, this is a good start.
“It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07
* Adverse Event Reporting Act [signed late December 2006]
* FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]
* USDA & Codex: Organic Standards Diminished
* Codex: Raising Toxic Levels, Mandating Irradiation
* Codex: GM (Genetically Modified) Labeling Failures
* FDA GMPs (Good Manufacturing Practices for Dietary Supplements) [Late June 2007]
* Senate & House adoption of FDA enabling bills [S.1082 & HR.2900] [Only S.1082 contains DSHEA protection language]
* Failure of US House to consider Health Freedom Protection Act – HR.2117 [Although over 100,000 messages to Congress demanded such protection]
Now the FDA has directly challenged HR.2117 with a new draft guidance, “Evidence-Based Review System for the Scientific Evaluation of Health Claims” [07/02/07]
Citation: http://www.cfsan.fda.gov/~dms/hclmgui5.html
This draft guidance document represents the agency's current thinking on
1) the process for evaluating the scientific evidence for a health claim,
2) the meaning of the significant scientific agreement (SSA) standard
3) credible scientific evidence to support a qualified health claim. …
Ron Paul’s Health Freedom Protection Act (HR.2117) -
Citation: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
Health Claims must be allowed unless the FDA determines that –
(i) there is no scientific evidence that supports the claim;
(ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer
The distinction between the Constitutional system of Freedom of Speech -proposed by its champion, Dr. Paul, and the FDA's bureaucratic illegal desire to impose "prior restraint" could not be clearer.
The opportunity should be clear: support HR.2117 - the Health Freedom Protection Act. While we need further protectio with language addressing each of the pending challenges noted above, this is a good start.
“It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07
Tuesday, July 17, 2007
New FDA Draft Guidance: “Evidence-Based Review System for the ScientificEvaluation of Health Claims”
New FDA Draft Guidance: “Evidence-Based Review System for the Scientific Evaluation of Health Claims” - http://www.cfsan.fda.gov/~dms/hclmgui5.html
Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August. Says the introduction:
“This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act …and 3) credible scientific evidence to support a qualified health claim. …
"This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners …
"The specific topics addressed in this guidance document are: (1) identify ingstudies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”
This guidance attempts to impose a high standard on Health Claims.
Dr. Ron Paul’s pending bill, the Health Freedom Protection Act - HR.2117 - addresses this further FDA power grab by imposing the standard commercial substantiation requirement instead.
Essentially Dr. Paul's bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer."
Thus, even "a scintilla" of scientific evidence would allow the making of nonfraudulant claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.''
The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
This latest FDA Guidance needs further analysis and comments will need be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency. If not, Congress needs to act fast to protect our alternatives!
Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August. Says the introduction:
“This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act …and 3) credible scientific evidence to support a qualified health claim. …
"This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners …
"The specific topics addressed in this guidance document are: (1) identify ingstudies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”
This guidance attempts to impose a high standard on Health Claims.
Dr. Ron Paul’s pending bill, the Health Freedom Protection Act - HR.2117 - addresses this further FDA power grab by imposing the standard commercial substantiation requirement instead.
Essentially Dr. Paul's bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer."
Thus, even "a scintilla" of scientific evidence would allow the making of nonfraudulant claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.''
The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
This latest FDA Guidance needs further analysis and comments will need be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency. If not, Congress needs to act fast to protect our alternatives!
Monday, July 9, 2007
A message to the House Leadership on FDA reform
The following emails made today's rounds...
SPECIAL ALERT
To: Natural Solutions Foundation eList
Hello! This message is from Ralph Fucetola, JD., one of the trustees of the Natural Solutions Foundation. Dr. Laibow and Gen. Stubblebine are boarding a plane in Europe just about now and they asked me to convey this message to you.
This morning I received an urgent email message from Congressman Ron Paul'sWashington, DC office. The bottom line: a newly introduced bill, HR.2900 should now be a focus of health freedom activities.
We need your help in getting a message through to the House leadership. Please reference HR.2900 and ask that HR.2900 be "brought up under a regular order" to be considered by the House WITH amendments.
The bill is expected to be moved on Tuesday, so this is an URGENT matter.
Speaker Pelosi's office in DC is: (202) 225-4965
Email her at: AmericanVoices@mail.house.gov
Email the following message:
---------------------------
"I urge the House leadership to allow HR.2900 to be brought up under a regular order so it can be fully debated and amended. I support Ron Paul's Health Freedom Protection Act, HR.2117."
---------------------------
Currently the bill is scheduled for 40 minutes of debate and NO amendments, which means Ron Paul's important Health Freedom Protection Act, HR.2117 or other amendments, such as that proposed by attorney Jonathan Emord, would not be allowed to become amendments to this bill. HR.2900 is the House companion bill to S.1082, the FDA "revitalization" bill that breezed through the Senate last month. That Senate bill was amended to protect Dietary Supplements and we want to make sure the House bill will also be amended to protect supplements and natural remedies.
To do that, HR.2900 must be "brought up under a regular order" so it can befully debated and amended. Please forward this widely.
Ralph Fucetola JD
www.globalhealthfreedom.org
www.healthfreedomusa.org
PS - and remember to support Natural Solutions by shopping thoughwww.organics4u.org
------ Original Message ------
Received: Mon, 09 Jul 2007 08:34:21 AM EDT
From: "Singleton, Norman" <Norman.Singleton@mail.house.gov>
To: "'Ralph Fucetola JD'" <ralph.fucetola@usa.net>
Subject: RE: Now 82,918+ messages supporting Ron Paul
HR 2900 (FDA Reform) is on the SUSPENSION calendar tomorrow. It might be helpful if people called Pelosi, Hoyer, Bonner, and Blunt to see if it can be pulled and brought up under a regular order.
Norman Kirk Singleton
Legislative Director
Congressman Ron Paul
203 Cannon
Washington, DC 20515
202-225-2831
Liberty "...will win eventually because it and only it is compatible with thenature of man and of the world. Only liberty can achieve man's prosperity, fulfillment, and happiness....libertarians now propose to fulfill the American dream and the world dream of liberty and prosperity for all mankind." - MurrayRothbard
-----Original Message-----
From: Ralph Fucetola JD [mailto:ralph.fucetola@usa.net]
Sent: Tuesday, June 26, 2007 9:30 PM
To: Singleton, Norman; McAdams, DanielCc: Bailey, Jennifer; releyes@gmail.com
Subject: Now 82,918+ messages supporting Ron Paul
Natural Solutions Foundation's supporters have now generated 82,918 messages to the House supporting Ron Paul's HR.2117 or opposing HR.1561 and urging that HR.2117 be added to it by way of amendment. Which Committee and Subcommittee should we direct our supporters to contact to move HR.2117?
Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved . . .
SPECIAL ALERT
To: Natural Solutions Foundation eList
Hello! This message is from Ralph Fucetola, JD., one of the trustees of the Natural Solutions Foundation. Dr. Laibow and Gen. Stubblebine are boarding a plane in Europe just about now and they asked me to convey this message to you.
This morning I received an urgent email message from Congressman Ron Paul'sWashington, DC office. The bottom line: a newly introduced bill, HR.2900 should now be a focus of health freedom activities.
We need your help in getting a message through to the House leadership. Please reference HR.2900 and ask that HR.2900 be "brought up under a regular order" to be considered by the House WITH amendments.
The bill is expected to be moved on Tuesday, so this is an URGENT matter.
Speaker Pelosi's office in DC is: (202) 225-4965
Email her at: AmericanVoices@mail.house.gov
Email the following message:
---------------------------
"I urge the House leadership to allow HR.2900 to be brought up under a regular order so it can be fully debated and amended. I support Ron Paul's Health Freedom Protection Act, HR.2117."
---------------------------
Currently the bill is scheduled for 40 minutes of debate and NO amendments, which means Ron Paul's important Health Freedom Protection Act, HR.2117 or other amendments, such as that proposed by attorney Jonathan Emord, would not be allowed to become amendments to this bill. HR.2900 is the House companion bill to S.1082, the FDA "revitalization" bill that breezed through the Senate last month. That Senate bill was amended to protect Dietary Supplements and we want to make sure the House bill will also be amended to protect supplements and natural remedies.
To do that, HR.2900 must be "brought up under a regular order" so it can befully debated and amended. Please forward this widely.
Ralph Fucetola JD
www.globalhealthfreedom.org
www.healthfreedomusa.org
PS - and remember to support Natural Solutions by shopping thoughwww.organics4u.org
------ Original Message ------
Received: Mon, 09 Jul 2007 08:34:21 AM EDT
From: "Singleton, Norman" <Norman.Singleton@mail.house.gov>
To: "'Ralph Fucetola JD'" <ralph.fucetola@usa.net>
Subject: RE: Now 82,918+ messages supporting Ron Paul
HR 2900 (FDA Reform) is on the SUSPENSION calendar tomorrow. It might be helpful if people called Pelosi, Hoyer, Bonner, and Blunt to see if it can be pulled and brought up under a regular order.
Norman Kirk Singleton
Legislative Director
Congressman Ron Paul
203 Cannon
Washington, DC 20515
202-225-2831
Liberty "...will win eventually because it and only it is compatible with thenature of man and of the world. Only liberty can achieve man's prosperity, fulfillment, and happiness....libertarians now propose to fulfill the American dream and the world dream of liberty and prosperity for all mankind." - MurrayRothbard
-----Original Message-----
From: Ralph Fucetola JD [mailto:ralph.fucetola@usa.net]
Sent: Tuesday, June 26, 2007 9:30 PM
To: Singleton, Norman; McAdams, DanielCc: Bailey, Jennifer; releyes@gmail.com
Subject: Now 82,918+ messages supporting Ron Paul
Natural Solutions Foundation's supporters have now generated 82,918 messages to the House supporting Ron Paul's HR.2117 or opposing HR.1561 and urging that HR.2117 be added to it by way of amendment. Which Committee and Subcommittee should we direct our supporters to contact to move HR.2117?
Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved . . .
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