VLN... Vitamin Lawyer News...
Actions to
Save Health Freedom
2003/04/05/06/07
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Up to the minute report on the FDA anti-CAM draft guidance!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
Recent Codex Developments
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
http://www.vitaminlawyer.com
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.
Hope and Risks at Codex
Institute of Medicine calls for reversal of DSHEA!
IOM issues report recommending that dietary supplements be subject to much more stringent rules governing safety and effectiveness similar to the way prescription drugs are regulated.
DSHEA, the 1994 Act that allows Dietary Supplement Claims, distinguished such claims from drug claims. IOM recommendation would, in essence, ask Congress to reverse existing law.
See report:
Complementary and Alternative Medicine in the United States (2005)
http://www.nap.edu/books/0309092701/html
What does the public think?
ANH EU Food Supplement Directive
lawsuit was filed 10/16/03.
Details are posted Here.
Updated 02/04
January 25, 2005 Hearing
Thanks to all who donated!
MORE DONATIONS NEEDED!!
December 2003 UPDATES
Australians to Fight Back
Most recent Codex Meeting (11/03)
Report - the threat to Health Freedom!
Overview of Pending Litigation,
Codex and Political Action
Case goes to EU High Court
New Threat from EU
Pharmaceuticals Directive
February2005 Update
Observer Magazine
Reports on EU Suit
National Health Federation Update
On line petitions
Congressperson Ron Paul Introduces
Health Freedom Bill
Legislative Update:
Is S.722 really a threat? Really needed?
NHF's views
Original Message, Here (06/03)
Updated Message, Here
URGENT ACTION! - 09/16/03
Actions Regarding US Senate Bill, S.722 (Here)
Message from IAHF
CODEX Committee Ignores Health Claims
CODEX Acts on Upper Limits
ANH Brief before EU Court
http://www.alliance-natural-health.org/index.cfm?Action=archive&categoryID=7
World Litigation Updates
vitpendlit.htm
2004 November CODEX Meeting
ANH Submission to WHO on
Vitamin Risk Assessment - 12/04
ANH Litigation Reports
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
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
"It is not the function of our Government to keep the citizen from falling into error; it is the function of the citizen to keep the Government from falling into error." U.S. Supreme Court in American Communications Association v. Douds, 339 U.S. 382 at 442.
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. (www.lef.org).
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
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
NATIONAL HEALTH FEDERATION HEALTH-FREEDOM UPDATES - February 2004
http://www.thenhf.org
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
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
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.
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:
From: SCT [mailto:scott@rivieramail.com]
Sent: Monday, September 29, 2003 8:31 PM
To: rs.team@wholefoods.com
Subject: Senate Bill 1538
Dear Whole Foods:
I just read your Statement of Support for US Senate Bill 1538 [so-called Full Implementation of DSHEA Act]. I cannot believe that you are supporting this bill that will just put more bullets in the guns of the FDA to harass and intimidate the health-food industry. I urge you to IMMEDIATELY publicly retract your support of this bill, which certain ill-informed organizations such as the NNFA and Citizens for Health are wrongly touting as an �alternative� to Senate Bill 722.
Senate Bill 722 needs no alternative. It should and can be shot down on its own lack of merits. This so-called �full implementation of DSHEA� bill (S.1538) is nothing more than a Trojan horse that will hurt us all and directly damage your own business. When was the last time that any government agency such as the FDA became better by having more taxpayer dollars pumped into it?? The answer is never.
Please wake up and take action immediately to eliminate your support for this bill. Join with the National Health Federation and many others to oppose increased funding of the FDA monster. You can be sure that the FDA does not oppose this bill !! Think about it, and then act.
If you have any questions regarding this matter, please feel free to contact me directly.
Scott C. Tips
Food-and-Drug Lawyer
General Counsel for the National Health Federation
Legal columnist for Whole Foods Magazine
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.
Ralph Fucetola, JD
http://www.vitaminlawyernews.com
http://www.internetinjunction.com
http://www.lawyer4assetprotection.com
http://www.disclaimersforsale.com
http://www.stupidbusinessmistakes.com
Thanks to John Hammell for the research that went into this open letter, www.iahf.com.
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.
© 2003, 2004, 2005, 2006