04/27/07 -
Don't be
Duped: Multiple Attacks on Health Freedom
Up to the minute report on the FDA anti-CAM draft guidance!
The most important action needed to save health freedom:
SUPPORT THE ALTERNATIVE CODEX VITAMIN AND MINERAL GUIDELINE
On October 18, 2005, at a Public Hearing at FDA Headquarters, an alternative to the recently adopted Codex Vitamin & Mineral Guideline was offered to the FDA, to preserve access to high potency nutrients while supporting UN Food & Agriculture Organization adopted international standards for the use of nutrition to promote health.
Message from Dr. Laibow: "please visit www.HealthFreedomUSA.org to sign to new Citizen's Petition which contains the Revised Vitamin and Mineral Guideline which can make the US Codex Compliant and preserve your rights to optimal health through nutrition. If you have signed it before, you can sign it again since the original Citizen's Petition has been revised."
Revised VMG at: http://www.healthfreedomusa.org/action/step3/Revised_VMG_Markup.pdf
What
Does Codex Really Require? - 05/21/06
Codex CCFL Meeting in Ottawa -- 05/03/06
Bulletin:
COALITION FOR HEALTH FREEDOM
Meeting of Health Freedom Activists to
Defend DSHEA, Defeat Codex - 04/23/05 - story [Here].
Index: Update,
ANH Donations
CODEX Threat,
Monthly Updates
Pending Litigation Updates
Links to Health Freedom Sites
Vitamin Wars Battles Intensify!
July 2005 - The Vitamin Wars – the battle intensifies . . . URGENT Update to the Vitamin Lawyer contact list. July 2005 produced several international regulatory challenges that will heavily impact the nutrient industry and alternative healing. As one observer’s blog put it, “Pro-Illness forces are pushing hard to consolidate their gains at CODEX last week when the Vitamin and Mineral Guideline (VMG) was passed without any dissenting voices.” The battle has just begun. Read more below about how you can help and the Nutrient Access Initiative. More up to date info on Codex and related health freedom issues can be found at http://www.healthfreedomusa.org and http://www.thenhf.com. I was on two web radio shows on this issue during July – http://www.rense.com and http://www.thebyteshow.com. My take on this all is that both the threat to freedom of choice and the opportunity to turn around the international agencies are at the highest levels they've been in years. A new anti-vitamin bill has been introduced in the House, HR 3156, but several pro-freedom congresspeople are also getting involved. Contact your congress people to oppose HR 3156. Use this link: http://www.demaction.org/dia/organizations/healthfreedomusa/campaign.jsp?campaign_KEY=678 Congressman, and doctor, Ron Paul has introduced a bill to protect the rights Congress unanimously enacted in 1994 (the Dietary Supplement Health and Education Act - DSHEA). His bill is H.R.2352 "To amend the Federal Food, Drug, and Cosmetic Act to ensure that health claims for foods and dietary supplements include accurate statements of the curative, mitigation, treatment, and prevention effects of nutrients on disease or health-related conditions, and for other purposes." In recent weeks the EU high court upheld the very restrictive (treats dietary supplements like toxins!) Food Supplement Directive (EU regulation) BUT, according to the Alliance for Natural Health attorneys, limited its application to synthetic supplements, not natural dietary substances, thereby alleviating some of the concern about those rules. Also, the Codex committee adopted similarly restrictive guidelines (the VMG – Vitamin and Mineral Guidelines), but, the "upper limits" are still in dispute and Codex's parent orgs, WHO and FAO have told Codex to "review its mandate" and consider how nutrition and supplements can help health - something it has tried to avoid so far. The central issue here seems to be the clash between international bureaucracies regarding what “science based” approach to take regarding dietary supplements. We know the choice that was made in the US, when Congress unanimously adopted DSHEA (Dietary Supplement Health and Education Act) in 1994: Dietary Supplements are FOODS and are not subject to toxic material (drug) controls. This also needs to be the choice made at the international level. Currently, Codex (the international Food Code) treats Dietary Supplements as though they were toxic substances, seeking to use the science of toxicology to determine upper limits. This is just junk science and will result in upper limits so low as to be ineffective as nutrition. The proper science to use to determine possible adverse effects is the science of Nutrition. What are the practical results of this distinction? Under the Codex toxicology model, for example, Vitamin C upper limits are set so low as to merely prevent the deficiency disease, scurvy (about 60 mg daily). However, the metabolic role of Vitamin C is much, much more important than just preventing scurvy. The amount of C that a healthy person needs, according to Nutritional Science, for optimal health, is several grams a day (2 to 3,000 mg a day). Thus we are fighting for continued access to effective levels of nutrients. Many people believe we are fighting for our lives. I was not sure about this, so I decided to try an experiment. After 30 years of faithful daily high dose vitamin taking, I stopped, about June 21st. By July 10th I was feeling so ill, with numbness in my fingertips, out of breathe, unable to concentrate, and uncomfortable heart palpitations, that I ended the one month experiment early and started taking my supplements again. Within about 48 hours I was feeling normal. Now I know what I’m fighting for. If I’m ever deprived of the nutrients I’ve been taking for decades, it is the same as a death sentence. I know what I’m fighting for. Do you? The challenge is this: the large nutrient companies are either owned by pharma interests, or soon will be. They will not support freedom of choice efforts. Only the small and struggling nutrient companies – like those to which this email is being sent – have the true incentive to support the various groups I’ve discussed in this email. I’ve intentionally limited my law practice over the past year or so to just advising nutrient companies and alternative practitioners and institutions. I am willing to devote myself full time to defending the nutritional world. What I need to do is generate funding for these efforts. I am working with a number of nonprofits and we are putting together Industry Support Program to get the industry to support greater efforts by the Vitamin Lawyer in conjunction with pro-freedom forces. More about ISP in a later email. This is war! When we ask for YOUR help, will you be ready to give it? The detailed proposal we will be making will be for regular monthly support for the efforts to Defend DSHEA. Consider it part of your public relations budget. The companies will get up-to-the-minute information about market developments and a strong voice advocating their interests, which are the interests of their customers: ready access to high quality, high dose, nutrients. Ralph Fucetola JD October 2005
Update: Alternative Vitamin & Mineral Guideline offered to FDA: |
Parts of the EU Food Directive Held
Invalid - 04/05/05
Details here:
http://www.alliance-natural-health.org/index.cfm?action=news&ID=151
EU Advocate General held: "The Food Supplements Directive infringes the principle of proportionality because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not properly been taken into account."
The European Court may only partially uphold this determination in June, thereby preserving some access to Dietary Supplements. The Codex threat (see below) remains real, but this is a great victory that will allow the Health Freedom Movement to go from defense to offense: we want our rights under DSHEA (the 1994 law that allows health claims for vitamins) to be strengthened and we want the rest of the world's food supplement rules harmonized to our freedoms! Congratulations to the Alliance and all its supporters!
04/14/05 EPHEDRA UNBANNED!- The most important part of Judge Campbell's Ephedra decision
today, as far as health freedom goes, is that among the important explanations
of the DSHEA statute offered by the Court, was the following, citing the Senate
Report on DSHEA: “..the legislative history of the DSHEA indicates that Congress
generally intended to harmonize the treatment of dietary supplements with that
of foods when it added the dietary supplement subsection…”
The court held that FDA’s attempt to apply a drug standard “risk –
benefit” analysis was contrary to law. Vitamins are foods, not drugs! They are
presumed to be safe.
This means any FDA attempt to “harmonize” US law with drug-like
international standards will now have even less chance of being upheld by the US
courts. If food supplement laws are to be harmonized, DSHEA (as correctly
understood by jurists like Judge Campbell!) is the model.
Court decision here:
http://www.nutraceutical.com/courtruling.pdf
THE CODEX THREAT
- MY OPINION 02/12/05 - Recently an industry organization spokesperson told a Health Freedom activist that “9 out of 10” lawyers involved with Dietary Supplement issues do not think Codex Alimentarius and the WTO are a threat to American health choice freedoms. I am one of those "1 of 10" lawyers without-pharma-cartel-clients who takes the CODEX issue very seriously. Frankly, with the EU "positive list," the US IOM calling for scrapping DHSEA, and our "public servants" in FDA working to "harmonize" our laws to Europe's restrictions, any lawyer, or vitamin industry association, failing to see the threat is either deluded or a shill for the cartel. Lawyer Nancy Lord wrote a good article on the threat at her lawloft.com web site. When I was on the Gary Null show a while ago, I said: "Don't subject our dietary supplement rights to WTO - CODEX controls, instead, Harmonize the rest of the world to American freedoms protected under DSHEA." - this political position remains valid and needs to be raised as often and loudly as possible. Last night, I was at an organizing meeting for NJ Natural Health Professionals group - njnatural@aol.com. Fifty MDs, acupuncturists, homeopaths, complementary therapists, nutrient purveyors and a couple consumers all came together specifically to oppose CODEX and related threats. This is happening all over the country. The Grass Roots are waking up. The people there knew about S3, they knew about CODEX, they knew about the efforts of Alliance for Natural Health in Europe and they were not at all surprised that some industry associations and "experts" are objectively "controlled opposition" doing the cartel's bidding. No one is being fooled anymore. The "Vitamin War" is entering a decisive crisis. Once ANH wins in the EU, the restrictive European regulatory model will not be an option for CODEX. Our current American regulatory model, where people are free to innovate and make broad claims for the benefits of nutrients, enshrined in DSHEA, must become the world model. Isn't that the new American Mission - to bring freedom to the whole world? We can all help by donating to the Alliance for Natural Health – to make sure their fight to overturn the EU’s restrictive Food Supplement Directive is successful (they’ve hired the only European law firm to have ever overturned an EU directive and have already gotten over a couple of the legal hurdles toward that goal). http://www.alliance-natural-health.org We can also help by going to important web sites like the International Advocates, www.iahf.com and www.bolenreport.com. Also, www.saveoursupplements.org, www.lef.org, www.HealthFreedomUSA.org or www.vitaminlawyernews.com. |
MONTHLY UPDATES
Index
January 2005 What does the public think? |
ANH EU Food Supplement Directive
LATEST UPDATE Thanks to all who donated! |
December 2003 UPDATES
Most recent Codex Meeting
(11/03)
Overview of Pending Litigation,
Case goes to EU High Court February2005 Update
Observer
Magazine National Health Federation
Update Congressperson Ron Paul Introduces |
Legislative Update: Original Message, Here (06/03) May 2004 Update Message from IAHF July 2004 Update August 2004 Update ANH Brief before EU
Court
World Litigation
Updates 2004 November CODEX Meeting
ANH Submission to WHO on
ANH Litigation Reports |
Index
Back to
www.vitaminlawyernews.com
Back to www.vitaminlawyer.com
Here are some links to pro-health freedom sites:
Life Extension -
www.lef.org
International Advocates - www.iahf.com
Natural Solutions Foundation - www.HealthFreedomUSA.org
American Holistic Health Association -
http://ahha.org
Alliance for Natural Health -
http://www.alliance-natural-health.org
The Bolen Report,
www.bolenreport.com
National Health Federation - www.thenhf.com
"Don't
subject our dietary supplement rights to WTO - CODEX controls,
instead, harmonize the rest of the world to
American freedoms protected under DSHEA."
Ralph Fucetola JD on the
Gary Null Show, 06/11/02.
RIGHT NOW THE MOST IMPORTANT STEP ANYONE INTERESTED IN HEALTH FREEDOM CAN TAKE IS TO DONATE TO THE EUROPEAN HEALTH FREEDOM MOVEMENT TO SUPPORT THEIR LAWSUIT AGAINST THE E.U. FOOD SUPPLEMENT DIRECTIVE! http://www.alliance-natural-health.org
See Dr. Corsella's Red Alerts web page
http://www.corsello.com/politics/politics_red_alerts.htm
Monthly Updates
Pending Litigation Updates
Support for European Union Lawsuit, DONATE HERE
http://www.alliance-natural-health.org.
Background on the issue: Here.
Update: Pending Litigation
on the World Stage - 08/28/03
More Information, see
www.iahf.com
Back to Top
Congressperson Ron Paul
introduces Health Freedom Bill - H.R. 4004
http://www.house.gov/paul/index.shtml
Dr.
Paul introduced a bill to allow access to
truthful and understandable dietary supplement claims. HR 4004 -
Health Information Independence Act -
prevents the Federal Government from restricting the distribution of a dietary
supplement or other nutritional food because the manufacturer makes health
claims unapproved by the Food and Drug Administration (FDA) if: (1) the product
has a label clearly stating that its health claims are not FDA-approved; (2) the
FDA lacks evidence establishing probable cause that the claims contain
misleading information posing a threat to the safety and well-being of those who
use the product. Requires an independent review of a determination by the FDA
that there is such probable cause.
Message from International Advocates for
Health Freedom
[The views expressed by IAHF are not necessarily those of The Vitamin
Lawyer]
IAHF Webmaster: Breaking News, Whats New, Codex, EU
FSD, All Countries
Monday, May 17, 2004
IAHF List: Last week the Codex Committee on Food
Labelling held a meeting in Montreal, Canada. The work of this committee
overlaps with the work of the Codex Committee on Nutrition and Foods for Special
Dietary Use.
Vitamin consumers world wide owe a debt of gratitude to the South African
Codex Delegation which was represented at this meeting in Montreal by Antoinette
Booyzen and Anthony Rees.
Going in to the meeting, Booyzen and Rees had hoped to trigger an African
backlash against Codex, identifying the agenda clearly as a global genocide
initiative, but after being lied to by all these countries who promised during
the lunch breaks to support South Africa, when the time of recknoning came- all
of these countries (along with the rest of the world including the... US,
Canadian, Australian, English and New Zealand governments) turned their back on
the South African proposal which you can read here:
ftp://ftp.fao.org/codex/ccfl32/fl04_11e.pdf
As you can see- South Africa proposed a revision to the Codex General Guidelines
on Claims (which currently prohibits any mention of foods serving to treat and
cure diseases) based entirely on existing scientific evidence from peer reviewed
scientific journals which attest to the healing properties of dietary
supplements in treating a variety of diseases including:
Asthma, Arthritis, Adrenoleukodistrophy and other metabolic disorders including
maple syrup urine disease, phenylketonuria, etc; hypertension, osteoperosis,
migraine, osteoporosis, migraine, artherosclerosis, cholesterol reduction,
constipation, bacterial infections, cardiac arrythmias, acne, allergies,
alzheimers disease, anxiety and stress, attention deficit hyperactivity
disorder, multiple sclerosis, epilepsy, breast cancer, thyroid deficiency,
parkinson's disease, HIV/AIDSs, Glacoma, influenza virus, diabetes mellitus,
depression, all the classical nutrient deficiency diseases: scurvy,
berri berri, rickets, kwasiorkor, etc
As you can see, South Africa proposed that CODEX bring its work into sync
with current scientific findings, and that the Committee on Nutrition make
changes to its preamble reflecting these current scientific findings to allow
for health claims to be made for foods and nutrients.
As you can see, South Africa noted that foods and nutrients are MORE EFFECTIVE
than pharmaceutical drugs, which they correctly noted only address SYMPTOMS
without addressing their root CAUSES.
During the coffee breaks and lunch breaks of this week long meeting whenever
Booyzen and Rees met with the representatives of the 7 other African countries
present at the meeting to try to secure their backing, they were PROMISED
support, but last Wednesday, when they made their historic proposal, they were
torpedoed even by their fellow Africans because these corrupt people did the
bidding of their former colonial masters from Europe.
Prior to this meeting, the South African delegation had hoped to not only secure
support from the other 7 African countries, but to then secure proxies from all
the rest of Africa to bring with them to the next Codex meeting of the Committee
on Nutrition and Foods For Special Dietary Uses in Bonn in November (South
Africa leads the African Union), and in so doing, they had hoped to counter the
effort of the European Union to ram a draconian finalized Codex vitamin standard
through to completion.
They had hoped to have economists draft a white paper attesting to the economic
wisdom of basing national health care systems on nutrition and prevention as
vastly preferable to the existing allopathic medical model, and they'd hoped to
get the rest of Africa behind these efforts.
It remains to be seen what will happen now. I hope South Africa goes ahead and
PRODUCES this white paper, and I hope President Mbeki sends a letter to the
United Nations CONDEMNING the Codex "process" as unscientific, undemocratic, and
GENOCIDAL because thats EXACTLY what it is.
I've said it before, and I'll say it again: We can't win at CODEX, we can ONLY
win INDIRECTLY by things we do OUTSIDE of Codex which IMPACT Codex.
Right now, the ONLY thing I can see that will have even a CHANCE of stopping
this global genocide agenda that threatens to destroy consumer access to dietary
supplements is the Alliance for Natural Health's lawsuit to overturn the EU Food
Supplement Directive in the European Court of Justice in Luxemborg.
ANH CAN WIN this lawsuit. The bureaucrats who crafted the EU FSD had a poor
working knowledge of EU law and they put themselves on very thin ice. ANH has
the best lawfirm in Europe in their corner, the first firm to ever succeed at
overturning an EU Directive, but the Alliance needs donations to be able to PAY
this firm.
Donations can be made at
http://www.alliance-natural-health.org
If you still need help connecting the dots on this issue, please read these two
articles:
http://www.thehealthcrusader.com/pgs/article-0104-ban.shtml (Cover story
interview of me in the Dec/Jan Health Crusader Magazine done by Greg Ciola)
http://www.lef.org/magazine/mag2003/2003_preprint_eu_01.htm Article of mine
re the ANH lawsuit in July issue of Life Extension Magazine
Some of you heard Robin Falkov discuss this issue on Coast to Coast AM with
George Noory. I appreciate Robin's solid effort as a member of the IAHF
Speaker's Bureau. I'd like to go on the George Noory show myself, and have
emailed Noory's producer to that effect. I've been on the front lines addressing
this issue since 1996 when I was the first person to call it to global
attention, and could easily do a two hour program on it via which I could
thoroughly help people to grasp what is going on and why they must act.
If you'd like to help me get on the George Noory show, please contact Noory's
producer at
CoastProducer@aol.com and fill him in on what I'm telling you in this email.
South Africa's experience in Montreal deserves widespread attention because they
have totally exposed the whole crooked agenda.
Please forward this to as many people as you can and urge them to sign onto the
IAHF email distribution list at
http://www.iahf.com Tnanks for your assistance - this is a TRUE grass roots
effort.
For Health Freedom,
John C. Hammell, President
International Advocates for Health Freedom
556 Boundary Bay Road
Point Roberts, WA 98281-8702 USA
http://www.iahf.com
jham@iahf.com
800-333-2553 N.America
360-945-0352 World
Index
NATIONAL HEALTH FEDERATION HEALTH-FREEDOM UPDATES
Two
bills are in Congress that require your attention - S.1538
& HR.3377. Both of these bills are dangerous to your health freedom and need
action on your part.
S.1538
DSHEA Full Implementation & Enforcement Act (Petition)
This
bill would give FDA $105 million over a multi-year period to �implement� the
FDA�s anti-supplement view of DSHEA, which we all know is not our view of DSHEA.
You can be sure that this money will not promote health-freedom. The FDA needs
to be on a fiscal diet, not fed more money by naïve do-gooders who think that by
bribing the FDA, the FDA will somehow become benevolent and start treating the
dietary-supplement industry and consumers better than before. Throwing money at
an anti-freedom government agency has never been a good idea and it still
isn't. Appeasement did not prevent World War II and it will not prevent DSHEA
from being assaulted by a richer FDA either.
Scott
Tips (NHF legal counsel), has provided an excellent article exposing the true
nature of this harmful bill and alerting the reader
to take action against it. Unfortunately, many other trade-association and
health-freedom groups have been fooled into thinking it will be something
positive for DSHEA if the FDA gets even more money than it already has. Don't
be deceived. See
http://www.thenhf.com/government_affairs_10.htm.
H.R.3377
Dietary Supplement Access and Awareness Act (Petition)
This
"Son of Durbin" legislation is very dangerous as it will alter the original
intent of the 1994 DSHEA law. All supplements would be subject to prescription
drug like FDA approval, post-market surveillance and adverse event reporting
requirements. This will decimate the dietary supplement industry and consumers
rights. Only vitamin/mineral supplements would be covered by DSHEA.
Please
go to our website
http://www.thenhf.com/government_affairs_federal.html to get the full story
and to review & sign our petition.
Since
NHF members are known on Capitol Hill for their strong outpouring of letters and
petitions in defense of their health-freedom, we ask you to take the time and
show your support by printing out and mailing in both petitions. Let your
Senators and Congressional representatives know that you oppose S.1538 and
H.R.3377.
Petition
links S.1538
http://www.thenhf.com/TargetLetterfors1538.pdf
H.R.3377
http://www.thenhf.com/NHFWaxmanLtr.pdf
Back to Top
STED Program - MORE "Harmonization" on the way
- 09/15/03
"Summary Technical Documentation for Demonstrating Conformity to the
Essential Principles of Safety and Performance of Medical Devices"
Says FDA - "The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) is pleased to announce a pilot program to assess the feasibility of using an internationally harmonized format in review of submissions for device safety and performance *** for the benefits that will accrue to the medical device community." - http://www.fda.gov/cdrh/International/sted.html
S.722 - Bill may reverse recent pro-health freedom court cases.
Update: Is S.722 really a threat? Is S.1538 really needed? - See NHF update.
www.altmedicine.com
From: Frank Grazian, Editor and Publisher
Alternative Health News Online
Date: 07/16/2003
Sen. Richard Durbin (D-Ill.) has introduced a bill (S.722) - "Dietary
Supplement Safety Act of 2003" - that would amend the Federal Food Drug and
Cosmetic Act (FDCA) and possibly shake the foundation of the Dietary Supplement
Health and Education Act (DSHEA).
The bill would require reporting adverse events to the government, and also pre-market approval for dietary supplements carrying stimulants. As written, the bill would also categorize products promoting muscle growth as anabolic steroids rather than dietary supplements.
"According to critics, this bill would subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is both unwarranted and unnecessary. Products that have been used safely for hundreds -- and in some cases thousands -- of years would be subject to clinical evaluation using standards that are the discretion of the FDA. Under this new legislation, the FDA has complete discretion to make this determination, regardless of whether the product was used under conditions cautioned against by the manufacturer on the label."
The Vitamin Lawyer comments -
"While this bill does not have much support at present, it could reverse the Supreme Court majority's recent moves to protect consumer access to truthful information. Let's oppose it without losing sight of what may be the even more direct dangers to Health Freedom from WTO's CODEX and the European Union's Food Supplement Directive."
For a review of the Court's decisions protecting consumer access, see: The Right of the Public to Know.
Express your opinion to your Senators http://capwiz.com/nnfa/S722.html
The most urgent action to take for Health Freedom is Here.
Back to Top
Is S.722 really a threat to health
freedom? Is S.1538 needed?
Here is Attorney Scott Tip's view in a letter to Whole Foods:
Threats to Health Freedom
Throughout the World
Message from Ralph Fucetola JD - 06/04/03 -
www. Vitamin Lawyer News. com
We have a limited time to save Health Freedom globally, by
urging American dietary supplement companies and users to send donations to the
Alliance for Natural Health
http://www.alliance-natural-health.org in the UK, enabling them to file suit
to overturn the European Union Food Supplement Directive.
Legal Analysis & Commentary:
How Events in the European Union Tie in
With Harmonization of Dietary Supplement Laws World Wide
To: Supplement Purveyors and Health Freedom Activists -
The European Union Food Supplement Directive (FSD) passed into European Law in June 2002, and EU member nations have a
deadline of this July to harmonize their national laws to it, unless the
European Alliance for Natural Health (ANH) mounts
a legal challenge. See article at
http://www.iahf.com/anh_lawsuit.html.
The EU is going to expand by 10 new nations in 2004, all of which will
politically fall in line behind Germany and France which politically dominate
the EU. None will seek to oppose whatever the German government wants for any of
the EU Directives (be it in the FSD, the Traditional Herbal Medicines Directive, or
the Pharmaceuticals Directive - which is the most dangerous of the three to our
industry.)
Given this, it is not hard to see the writing on the wall. As goes the EU, so
will go the Codex Alimentarius (the WTO Food Code, or Codex for short) - unless we actively step in and get Europe to harmonize to
our Dietary Supplement Law, DSHEA.
This would serve the interests of all supplement users.
With the Australian regulators just having pulled over 1300 dietary supplements
from the shelves under false pretenses and without testing for contamination
[see Ron Law's article which was recently published in The Independent, New
Zealand's largest business newspaper
http://www.iahf.com/asia/20030520.html] there is massive pressure on NZ to
harmonize their liberal, food based regs to Australia's grossly onerous,
pharmaceuticalized regs- and all of this is happening just at the precise moment
that Canada is on the verge of harmonizing their law to Australia's via a
scheduled June 18th gazetting of new regulations on our northern flank- and the
FDA is planning on coming out with Current Good Manufacturing Practice
regulations (CGMPs) that appear designed to achieve
the same result here.
I filed comments with FDA on behalf of small vitamin purveyors objecting to what
are essentially "drug" based GMPs, not the food based regs mandated by Congress,
see:
http://www.lifespirit.org/vitfdacgmpreport.htm.
I have also written about the new climate in Commercial Speech protection,
pioneered by the pro-Speech majority on the US Supreme Court, see,
www.lifespirit.org/rightruth.html.
If the industry does not act now, clearly, we are being destroyed from within -
via a group culture in the supplement industry whose motto seems to be "go
along/get along/don't make waves." That's not how DSHEA was achieved in 1994,
even with its limited protections.
Leading Health Freedom attorney, J. Emord will be seeking injunctions to stop
the FDA from being able to enforce their planned GMP regs, which clearly go very
far beyond what is allowed under DSHEA. The FDA made no effort to conduct HONEST
impact studies on how their regs would impact small businesses -- I hope to join
him in this effort.
See my article on the proposed CGMPs accessible through
http://www.lifespirit.org/vitfdacgmpreport.htm.
Although we must oppose Rep. Durbin's S.722 (bill that gives the bureaucracy
even more unbridled power), for which Rep. Waxman might be introducing a House
companion bill, it is STILL ESSENTIAL that we implore the American industry to
assist ANH with donations for their planned suit to overturn the EU FSD, here is
why:
The Congressional Research Service confirmed to Congressmen De Fazio (D-OR) and
Paul (R-TX) that if the UN Codex Alimentarius Commission's Committee on
Nutrition and Foods For Dietary Use does finalize a standard for vitamins and
minerals, that the USA CAN be legally compelled to harmonize its dietary
supplement laws to an international standard by "virtue" of our membership in
the WTO.
Prior to a Congressional Oversight hearing held on March 20, 2001 by Dan Burton,
De Fazio and Paul sent this letter -
http://www.iahf.com/index2.html - to Rep. Burton urging him to use his
investigative powers to stop the FDA from violating an amendment to the FDA
Modernization Act of 1997 which expressly forbids the Agency from engaging in
actions at Codex meetings intended to set us up for the harmonization of our
dietary supplement laws to an international standard.
Current international activities of FDA indicates that FDA may very well violate
the will of the American people, and the will of Congress as expressed through
the words of Senator Orin Hatch in the Federal Register (following the
Conference Committee on FDA Modernization Act) through an artful interpretation
of an amendment which John Hammell (International Advocates for Health Freedom - www.iahf.com)
was only able to get during the Conference Committee on the FDA Modernization
Act of 1997 by generating a sufficient number of phone calls to the Senate Labor
Committee to make their phones ring off the hooks for several days. Hammell won
APMA's President's award in '97 for this lobbying campaign in which he was
assisted by Suzanne Harris, JD.
Unfortunately for our industry, the subsequent Congressional oversight hearing
on March 20, 2001 was pretty much a "whitewash" as far as the Codex vitamin
issue is concerned. The issue was ignored.
The only legal basis by which the USA can avoid harmonizing its dietary
supplement laws to a finalized Codex vitamin standard is on a basis of SAFETY. (SPS
Agreement) It would be no problem for us to do this if the matter were
adjudicated in an American court using our rules of evidence, because in our
courts we would be able to bring forth any and all evidence necessary for the
court to see the truth - much as Counsel Emord has been able to do in his first
amendment suits.
The difficulty lies in the fact that a World Trade Organization (WTO) Trade Dispute over the matter would
not be heard in our courts - rather, it would be heard by a new international
court that does not follow our rules of evidence: the WTO's Dispute Settlement
Body (DSB) - which is rigged to uphold the interests of multinational corporations, and
before which no private citizen has standing to present testimony unless
mutually agreed to by both parties engaged in the dispute. Generally, only
national reps of WTO member nations have standing to appear before it – in our
case, FDA agents who may not be vigorous supporters of Health Freedom.
The decisions made thus far by the WTO's DSB has gone against the environment,
against the public health, against human rights, labor rights, and most of the
other intangibles that go into the shaping of any nation's laws. Practically the
sole determining factor in their decision-making has been the "bottom line" of
the multinational corporations whose lobbying pressure got us into the WTO in
the first place.
Hammell recommends that you read Whose Trade Organization? Corporate
Globalization and the Erosion of Democracy -
http://www.citizen.org/publications/release.cfm?ID=7081 by Lori Wallach, JD,
Director of Public Citizens' Global Trade Watch Division. Also read The
Harmonization Handbook - Accountable Governance in the Era of Globalization:
the WTO, NAFTA and International Harmonization of Standards -
http://www.citizen.org/publications/release.cfm?ID=5193.
HOW HEALTH FREEDOM IS BEING THREATENED:
Prior to the '98 Codex meeting in Berlin, the FDA commissioned the National
Academy of Sciences to generate an unscientific, pharmaceutically funded paper
titled, "A Risk Assessment Model for Establishing Upper Intake Levels for
Nutrients" -
http://www.iahf.com/nas/nutrisk.html - Richard Malter, PhD
http://www.malterinstitute.com had
a solidly written rebuttal to this biased paper published in the Journal of
Orthomolecular Medicine
http://www.iahf.com/nas/index.html.
Also see The Perils and Pitfalls of Harmonized Food Supplements, by Bill Sardi
at
http://www.iahf.com/nas/20001128.html.
Also see The ABC's of Confusion as a Weapon by the late Brian Leibovitz, PhD,
former editor of the Journal of Applied Nutrition (and the man who formulated
most of Twin Labs products) at
http://www.iahf.com/leibovitz/jon.html#CONFUSE.
Dr. Malter should have been allowed to testify in the March 20, 2001 oversight
hearing on Codex, but was not allowed. Suzanne Harris, JD and Hammell should
also have been allowed to testify, instead, pharma industry connected figures
told Congress that there was no danger from Codex harmonization.
Just 10 days after, one of the speakers chaired a meeting in Capetown South
Africa titled "Toward a Global Regulatory Model". A South African ally of IAHF
provided Hammell with complete info from this meeting - all meeting materials,
and notes. If the industry people were, in fact, attempting to get the EU (and
rest of the world) to harmonize to the very liberal food based regulations
exemplified by New Zealand's regs, and our US Uniform Food GMPs, this might not
be a problem, but all evidence clearly points to the exact OPPOSITE.....
http://iadsa-exposed.tripod.com.
Those who see no danger in Codex did NOTHING to try to stop the EU Food
Supplement Directive, nor have they made ANY EFFORT to positively amend either
the Traditional Herbal Medicines Directive or the Pharmaceuticals Directive----
all of which are threatening to drive a very restrictive Codex vitamin standard
through to completion at the EXACT TIME that the FDA is attempting to attack us
with GMPs that are even more stringent than pharmaceutical GMPs, in direct
violation of DSHEA, which Rep. Durbin is trying to bring down via S.722.
We are up against an intentionally incremental internationalist agenda. It is
long and drawn out by design to lull us to sleep so that we won't pay any
attention to what is going on. The pharma cartel is counting on their spin
apparatus to cause people to wrongly ignore fighters such as Hammell who have
been bird-dogging these international matters from the beginning, monitoring
them very closely.
Hammell is currently on our northern flank, in Canada, working closely with Tony
Stephan of Truehope, Inc. who has just filed a lawsuit against Health Canada,
and with Trueman Tuck of Friends of Freedom
http://www.friendsoffreedom.org
who is on the verge of filing a lawsuit against Health Canada to stop them from
harmonizing Canada to Australia. Tuck was able to get gazetting postponed from
June 4th ‘til June 18th.
Only a handful of Canadian companies are attempting to defend our northern flank
- while most are being steered to the cliff by the same interests that are
manipulating our industry. Hammell was on a Vancouver radio show Monday,
generating donations for Stephan's lawsuit.
The most effective thing American industry can do right now to monkey-wrench the
pharma cartel's sneak attack is to provide ANH in the UK with a massive infusion
of capital necessary to enable them to bring Simkins and Associates into the
picture to overturn the EU Food Supplements Directive in the European Court of
Justice. Simkins is one of the very few firms that have ever succeeded in
overturning an EU Directive, and they say this is doable- we have the science
behind us - we just have to roll up our sleeves, and harmonize the EU to DSHEA -
http://www.alliance-natural-health.org. THIS BATTLE CAN TURN THE TIDE
AGAINST THE CARTEL!
Demonstrations against the EU FSD will occur on June 15th simultaneously in both
the UK and France. We can't turn our backs on our allies in New Zealand, Canada,
or the UK. If we do, and they fall, we're next to surrender Health Freedom via
global harmonization.
We have one month. Lets work together and throw this into high
gear.
Help ANH -
http://www.alliance-natural-health.org.
Life Extension Magazine – www.lef.org - has an
article coming out this month about this situation, and the World Natural Health
Organization is calling attention to it. We need to get all of the pro Health
Freedom groups, such as the National Health Federation, American Association for
Health Freedom, Citizens for Health and American Holistic Health Association
working on this too. Let them know you want them in on this fight!
All of this is doable, but we can't let ANY grass grow under our feet.
We have a couple months to save Health Freedom.
For Health Freedom,
Ralph Fucetola, JD
http://www.vitaminlawyernews.com
http://www.vitaminlawyer.com
http://www.internetinjunction.com
http://www.lawyer4assetprotection.com
http://www.disclaimersforsale.com
http://www.stupidbusinessmistakes.com
All Rights Reserved.
Thanks to John Hammell for the research that went into this open letter,
www.iahf.com.
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RALLY IN WASHINGTON FOR
HEALTH FREEDOM: OCTOBER 21, 2003
WASHINGTON--A broad coalition of dietary supplement industry associations and consumer groups are calling on members and supporters to gather in Washington, D.C., on Oct. 21 to meet with members of Congress and their staffs in defense of the Dietary Supplement Health and Education Act (DSHEA).
The "Rally on Capitol Hill" is sponsored by Virgo Publishing and endorsed by the American Herbal Products Association (AHPA), Citizens For Health, National Nutritional Foods Association (NNFA) and the Utah Natural Products Alliance.
The event is open to all companies and individuals, and there is no registration fee to participate. Appointments with members of Congress and their staffs will be arranged for participants.
"The threat to DSHEA and the entire industry is real and it is now," said Jon Benninger, director of business development for Phoenix-based Virgo Publishing. "We need as many people as possible to come to Washington to defend this industry. The situation is critical in Congress, which is why we've arranged to have this event on such short notice."
The event includes a morning "how-to" session on lobbying Congress, which will be held adjacent to Capitol Hill. Participants will learn message points and information on current legislation and receive materials to leave behind with their legislators. The afternoon will be devoted to pre-arranged appointments with legislators and their staffs, and an evening mixer will be held to recount the day's events.
The focus of the rally will be to oppose legislation introduced by Sen. Richard Durbin (D-Ill.) (S.722, the "Dietary Supplement Safety Act of 2003") and to support a bill introduced by Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) (S.1538, the "DSHEA Full Implementation and Enforcement Act of 2003"). The Durbin bill would change key parts of DSHEA and place access to many dietary supplements at risk, while the Hatch/Harkin bill would provide funds to the Food and Drug Administration (FDA) to fully implement DSHEA.
To register for the "Rally on Capitol Hill," individuals can contact any of the supporting organizations or visit www.dietarysupplementday.com.
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