IAHF LIST: This is my rebuttal to an outrageous letter which was just sent
by an FDA attorney to Congressman Paul's office in an effort to shoot down
our oversight effort. I am faxing this and emailing it in to Congressman
Burton and to other members of Congress in an effort to get an oversight
hearing regarding FDA's illegal Codex comments which threaten to
"harmonize" our laws to ultra restrictive Codex standards.

**Regardless of what country you are in, please read this carefully, as it
explains exactly
what we are up against world wide. This is long, but worth the time to
read, and if you
don't have time to read it now, please print it out and save it in a file-
its a valuable
source of information. Please forward this to more people world wide.
Hopefully we'll get an oversight hearing in the next session of Congress.
 
 

FDA LIES IN LETTER ON CODEX TO RON PAUL AND OTHER MEMBERS OF CONGRESS IAHF
RESPONDS TO FDA's LETTER TO RON PAUL- REQUESTS OVERSIGHT HEARING
 

The Honorable Dan Burton       10/31/98
c/o Milt Copulous
U.S. House of Representatives
Government Reform and Oversight Committee
Fax 202-226-2369

Re: Letter of October 23, 1998 from Melinda K. Plaisier, Deputy Associate
Commissioner of Legislative Affairs, FDA sent to Congressman Ron Paul-
Ongoing Need for an FDA Oversight Hearing
 

Dear Congressman Burton:
 

 Congressman Paul’s office just faxed me the enclosed letter from the FDA
which was in response to the letters which you, Congressmen Paul, Stump, De
Fazio and Cook sent to the FDA (per my urging), which demanded that the FDA
comply with US law by removing the second paragraph from their comments on
vitamins and minerals (agenda item #5), and that they remove the so called
"Risk Assessment" document from the table, because it had not undergone any
sort of comments period or public review, and hadn't even been sent out to
members of the US delegation prior to the meeting, and strong questions
exist as to its scientific accuracy and ability to (in fact) protect
consumer access to high potency vitamins and minerals.

 Upon reading Melinda Plaisier’s response to our concerns, I must inform
you that as usual, the FDA is attempting to finesse you, and upon close
inspection is being less than honest in what they are saying. The Codex
issue can’t be viewed in isolation: it must be viewed in a broad enough
context in terms of how it dovetails with domestic and other international
laws as to clearly see the hidden agenda.

FDA’s ANPR ANNOUNCED THEIR INTENTION TO HARMONIZE TO CODEX

The first thing FDA’s Plaiser doesn’t want you to realize is that with
complete disregard for our Constitution, and for the vast differences
between the FDA’s mission and that of the Codex Alimentarius Commission,
the FDA has announced their intention to “harmonize” their regulations to
emerging Codex standards. The made this announcement in an Advanced Notice
of Proposed Rulemaking in the Federal Register: July 7, 1997 (Volume 62,
Number 129),[Page 36243-36248]
The ANPR can be viewed on the IAHF website at http://iahf.com/codx-fda.txt

THE FDA IS ATTAMPTING TO FINESSE YOU: DON’T BE MISLED!!!

 So called “scientific” Risk Assessment which arrives at a “tolerable safe
upper intake level” of just 35 mg/day of niacin, is not scientific, and a
Congressional oversight hearing should include expert witnesses with years
of clinical experience in using nutrients in the treatment of patients:
Congress must solicit the input of orthomolecular MDs and PhDs such as
Matthias Rath, Abram Hoffer, Bonnie Camo, Majid Ali,  Bill Walsh, and
others. There is no reason to trust the National Academy of Sciences. They
are dominated by mainstream nutritionists whose research grants are paid by
pharmaceutical interests. A conflict of interests clearly exists here, and
Congress must closely investigate the sources of income of ALL of the
scientists involved in drafting the so called  National Academy of
Science“Risk Assessment” document.

 The FDA claims that Codex standards will not effect US consumers, and will
“only” effect American dietary supplement manufacturers seeking to sell
products abroad... but WHAT ABOUT the FDA’s Advance Notice of Proposed
Rulemaking in the Federal Register: July 7, 1997 (Volume 62, Number
129),[Page 36243-36248] ??? (There the FDA states their intention to
harmonize their regulations to emerging Codex standards.) And what about
Mutual Recognition Agreements between the U.S. and E.U. which effect things
like Good Manufacturing Practices???

 Could this force American dietary supplement manufacturers to go to full
pharamceutical GMP’s such as HACCP regs?? This would drive many small
manufacturers out of business, and force consumers to pay much higher
prices as the pharmaceutical companies wade in and take over the market.)
Some SERIOUS questions need to be asked in an Oversight Hearing.

CODEX: A  SCAM EQUIVALENT TO 3 CARD MONTY GAMES
PLAYED ON THE STREET In NEW YORK CITY

 If you go to New York City, street urchins routinely sucker passers by
(usually unstreetwise out of towners visiting the city) using “sleight of
hand” while playing a card game called 3 Card Monty. They do this outside
of subway entrances, using an overturned cardboard box as a table. They are
very adroit in playing their shell game, and routinely burn unwary passers
by luring them into making bets that they cannot win. Many people have been
conned, and this scam is still being run on people.

 The World Trade Organization combined with the FDA and their international
counterparts are currently operating a similar shell game, on a global
scale, through the UN’s Codex Commission. The intent is to make an “end
run” around any country’s domestic legislation which grants access to the
full range of dietary supplements, including high potency vitamins, found
in American health food stores.

 Hopefully after carefully reviewing what I have to say, you will agree
that a need remains to probe this situation via an Oversight Hearing.We
must stop the FDA’s ongoing efforts to ignore the constitutional contraints
which bind them as they continue violating current US law by doing things
which threaten to harmonize our laws pertaining to the regulation of
dietary suppements with emerging Codex standards. Unless we get
Congressional Oversight, and can bring in the testimony of expert witnesses
to question the scientific accuracy of the "Risk Assessment" document,
nothing will stop the FDA from pursuing this illegal, unconstitutional
agenda.

 The risk assessment document is calling for unduly restrictive maximum
upper potency levels, such as 35 mg for niacin. The FDA would have us
believe that “scientific” risk assessment (as defined by the National
Academy of Sciences academics, with little or no clinical experience to
draw on, operating in University research settings, being paid by
pharmaceutical research grants) is preferable to establishing upper safe
limits of vitamins and minerals on arbitrary limits of the Recommended
Daily Allowance (RDAs) or similar nutrient intake reference values.

 Actually, although the “Risk Assessment” method may be preferable to
basing limits on RDA’s, and is the lesser of two evils, it still represents
a move in the direction towards harmonization with EEC 65/65, the grossly
restrictive EC directive under which they’re threatening to ban access to
high potency vitamins and minerals across the EU. The key sentence in the
National Academy of Sciences “Risk Assessment” document seems to be:  “The
UL is not meant to apply to individuals who are treated with the nutrient
or food component under medical supervision.” (In other words, the goal of
setting tolerable upper safe limits is to establish a standard slightly
higher than the RDA, “justify” it on a basis of a number of allegedly
scientific criteria, in order to set strict LIMITS on the allowable
potencies consumers would be allowed to take unless under medical
supervision(!!)

While the FDA claims these deliberations would never effect American
consumers, and would only effect what American vitamin companies would be
allowed to sell abroad, what about the FDA's ANPR (discussed in detail
below), in which the FDA announces their intention to harmonize their
regulations to emerging Codex standards, and what effect would U.S.-E.U.
mutual recognition agreements on GMPs have, when dietary supplements are
regulated as "drugs" in the EU? Could these Mutual Recognition Agreements
force American dietary supplement manufacturers to full pharmaceutical
HACCP regulations? If so, that would drive many small companies out of
business, and force consumers to pay higher prices- assuming the products
they wanted were even still available.)

The EC hopes to complete draft legislation on harmonizing standards for
vitamin and mineral supplements by June of 1999. An EC Advisory Body, the
Scientific Committee for Food is looking at upper safe levels for vitamins
and minerals and expects to develop recommendations within 2 years. Most
European countries use RDA’s to distinguish between foods and medicines,
and consider anything containing over 3 times the FDA to be a medicine.

While a number of EU members states support an RDA valuation approach to
regulating supplements, industry representatives, including CRN, oppose
such an approach since RDA’s generally are not related to safety and are
invalid as markers.

The real question though is how accurate are the Tolerable Upper Intake
Level (UL) in assessing upper safe levels? (There aren’t any valid
statistics to justify the need for ANY sort of upper safe limits- one look
at the American Association of Poison Control Centers report (202-362-7217)
should be enough to convince anyone of this. Deaths and injury simply
aren’t being caused by vitamins, they’re being caused by prescription and
OTC drugs, but NOT by vitamins!! I know from personal experience that they
didn’t base their decision to set the UL on niacin at 35 mg/day on any sort
of scientific basis. 35 mg might cause some people to experience flushing,
as blood rushes to the surface of the skin, but theres nothing DANGEROUS
about the niacin flush! Its a minor annoyance to people, but thats ALL, and
certainly isn’t DANGEROUS. Having taken megadoses of niacin for 20 years, I
don’t want to have to go to a doctor for a PRESCRIPTION for high potency
niacin!

DR. RATH HOLDS BERLIN TRIBUNAL - DEMONSTRATES IN FRONT OF CODEX MEETING

In his website at http://www.rath.nl/GB/WEBGB.pdf  Matthias Rath, MD
published a statement about The Berlin Tribunal held on the eve of the
Codex Alimentarius meeting for the purpose of condemning the Pharma-Cartel,
Helmut Kohl and other accomplices of this Cartel for planning, committing,
and assisting mass murder and crimes against humanity. Dr.Matthias Rath,
MD, who led the breakthrough in the control of cardiovascular disease by
vitamins, convened this Public Tribunal. The House Oversight Committee
should carefully review Dr.Rath's website at www.rath.nl in order to view
the full text of his complaint which will be submitted to the International
Court of Justice and other courts around the world.

Rath led a demonstration of over 1000 people in front of the gate of the
compound that housed the German Ministry of Health building where the Codex
meeting took place.
Berlin police in full riot gear barred them from entering the compound.
Rath was accompanied to the demonstration by two huge armed bodyguards, and
had billboards up all over Berlin to protest the Codex meeting. The
billboards dramatized the greed and evil of what is going on by depicting
blood dripping claws of the drug cartel coming out of the sky to squeeze
the life blood out of the planet, while the benevolent looking hands of
consumers seek to protect access to vitamins and minerals.

Dr.s Rath and Pauling are the authors of perhaps the most suppressed
medical research paper in history, “Solution to the Puzzle of Human
Cardiovascular Disease: Its Primary Cause is Ascorbate Deficiency Leading
to the Deposition of Lipoprotein(a) and Fibrinogen/Fibrin in the Vascular
Wall”

The article was submitted by Linus Pauling to the Proceedings of the
National Academy of Sciences on April 23, and accepted for publication on
June 11, 1991. Under questionable circumstances this decision was later
revoked by the editor. Pauling and Rath stated “We are aware that this pull
back was not the decision of an individual. It happened in the interest of
those who are personally or economically dependent on the present dogma of
human cardiovascular disease. We are confident that the scientific
historians will make the proper judgement on this interesting development.
We are indebted to the Journal of Orthomolecular Medicine for the
publication of this article without delay and we know that this decision
willl not be to the disadvantage of the Journal. Above all, we are
convinced that the uncompromised publication of this article lies in the
best interest of millions of patients and perhaps every human being.”

It should be conspicuously noted that the SAME so called “National Academy
of Sciences” which decided NOT to publish Rath’s and Pauling’s incredibly
important article is the group which has generated this so called
“Scientific” “Risk Assessment” document in an effort to LIMIT our access to
the high potency vitamins and minerals which Rath and Pauling identify as
being necessary to prevent heart disease, the world’s number 1 killer. It
should be noted that the largest sector of the pharmaceutical market lies
in the sale of heart drugs. It should be obvious to the House Oversight
Committee that the NAS does not want to prevent heart disease (or anything
else for that matter)- they seek to protect the profits of the drug
companies- and their “Risk Assessment” document must be viewed accordingly.
The Oversight Committee should invite Dr.Rath to come over from Holland
(along with other orthomolecular practitioners) in order to testify to its
fraudulence.

 NAS Says This about Adverse Effects in the Risk Assessment Document:

“The term “adverse effect” is defined as any significant alteration in the
structure or function of the human organism, or any impairment of a
physiologically important function, in accordance with the definition set
by the joint World Health Organization, Food and Agriculture Organization
of the United Nations, and International Atomic Energy Agency Expert
Consultation in Trace Elements in Human Nutrition and Health. In the case
of nutrients, it is exceedingly important to consider the possibility that
the intake of one nutrient may alter in detrimental ways the health
benefits conferred by another nutrient. Any such alteration (referred to as
an adverse nutrient-nutrient interaction) is considered an adverse health
effect. When evidence for such adverse interactions is available, it is
considered in establishing a nutrient's UL. Tolerable Upper Safety Levels
are defined as: “the highest level of daily nutrient intake that is likely
to pose no risks of adverse health effects to almost all individuals in the
general population”.

 Steps in the (so called) “Risk Assessment Process”

    The organization of risk assessment is based on a model proposed by the
NRC; that model is widely used in public health and regulatory decision
making. The steps of risk assessment as applied to nutrients are as follows:

      Step 1. Hazard identification involves the collection, organization,
and evaluation of all information pertaining to the adverse effects of a
given nutrient. It concludes with a summary of the evidence concerning the
capacity of the nutrient to cause one or more types of toxicity in humans.

      Step 2. Dose-response assessment determines the relationship between
nutrient intake (dose) and adverse effect (in terms of incidence and
severity). This step concludes with an estimate of the ULC it identifies
the highest level of daily nutrient intake that is likely to pose no risks
of adverse health effects to almost all individuals in the general
population. Different ULs may be developed for various life-stage groups.

       Step 3. Intake assessment evaluates the distribution of usual total
daily nutrient intakes among members of the general population.

      Step 4. Risk characterization summarizes the conclusions from Steps 1
through 3 and evaluates the risk. Generally, the risk is expressed as the
fraction of the exposed population, if any, having nutrient intakes (Step
3) in excess of the estimated UL (Steps 1 and 2). If possible,
characterization also covers the magnitude of any such excesses. Scientific
uncertainties associated with both the UL and the intake estimates are
described so that risk managers understand the degree of scientific
confidence they can place in the risk assessment.

    The risk assessment contains no discussion of recommendations for
reducing risk; these are the focus of risk management

So called “scientific” Risk Assessment which arrives at a “tolerable safe
upper intake level” of just 35 mg/day of niacin, is not scientific, and a
Congressional oversight hearing should include expert witnesses with years
of clinical experience in using nutrients in the treatment of patients,
people such as orthomolecular MDs such as Abram Hoffer, Bonnie Camo, Majid
Ali, and others. Vitamins and minerals are safe. There is no need to
establish ANY sort of “tolerable safe upper intake level.”

HARRIS COMMENTS ON ANPR QUESTION THEIR LEGALITY

Regarding: Advanced Notice of Proposed Rulemaking in the Federal Register:
July 7, 1997 (Volume 62, Number 129),[Page 36243-36248] The ANPR can be
viewed on the IAHF website at
http://iahf.com/codx-fda.txt

In comments submitted to the FDA before the deadline on October 6, 1997,
Suzanne Harris, JD, of the Law Loft, acting on behalf of the Life Extension
Foundation and the National Health Federation, stated:
 
“Nowhere in its advance notice of proposed rulemaking does the FDA, in a
straightforward fashion, address the DIFFERENCES inherent in the
determination [as to] whether a Codex standard, guideline or regulation
falls under the Sanitary Phytosanitary Agreement (SPS) or the Technical
Barriers on Trade (TBT) agreement of the GATT.  Yet there are very
substantial differences between the two.”
 "The Sanitary Phytosanitary Agreement acts as an exception to the general
parameters of the Technical Barriers to Trade Agreement.  If a Codex
standard, guideline or regulation falls under the SPS, certain
very specific and highly detailed rules of interpretation, with few
exceptions or escape clauses, apply.  In its essence, the SPS makes Codex
standards, guidelines and recommendations [regarding] the
international standards for food safety." --excerpted from Harris comments
to FDA
 
By not making any distinction between the TBT and SPS agreements, FDA is
doing nothing to protect the American consumer, and they are setting us up
for so called “harmonization” with the EU.  We set them back by getting
dietary supplements specifically exempted from the harmonization
language in the FDA Reform Bill; however, due to our successful efforts at
the international level in getting the German Codex proposal knocked back
to step 3, when they tried to move it to Step 5, the
multi-nationals have REDOUBLED their takeover campaign at the national
level all over the world.
 
To illustrate this:
 
* In the US, the Commission on Dietary Supplements is seeking to facilitate
the making of OTC drug claims on herbs by strongly advising Congress that
the FDA should create a special panel for this purpose.  Although,
technically, this is not creating a “new OTC category,” in reality, this
move is still encouraging a shift from FOOD to “DRUG”, and they are trying
to make it seem INNOCUOUS.
 
* In S.Africa, legisation has just been fast tracked, without a hearing, to
impose full HACCP GMP standards, (full pharmaceutical standards), a
definition of “compementary medicine” which includes any substance, or
device, which has any physiological effect whatsoever on the human body,
allowing even air and water to be regulated. (The same thing is happening
in Chile, and many other countries.) The number on the proposed rule which
preceeded this bill was IDENTICAL to the number on a nearly identical
proposed rule in the United States two years ago regarding GMPs. This is no
coincidence. It is obvious that regulatory bodies world wide are being
scripted in their legislative moves by the WHO. Pharmapact was denied the
constitutional right to deliver critical presentation to Parliamentary
Portfolio Committee for Health to stop the Listing System enabling SAMMDRA
Bill, they were thrown out of Parliament for no reason, and are appealing
to the Public Protector for Oversight. Pharmapact has appealed to IAHF to
get consumers world wide to protest this gross injustice by sending a form
letter to S.African embassies world wide in an effort to lobby the Public
Protector's office by showing him that the eyes of the world are upon
S.Africa, wanting to know if it is a dictatorship or if there is any
fairness and oversight. Small manufacturers and consumers were
disenfranchised from the decision making process which led to this tyranny,
and this is well documented in the PHARMAPACT website at
http://www.angelfire.com/biz/pharmapact/MAIN.html

* In the UK, MAFF attempted to restrict B-6 to just 10 mg, without
prescription, and they might have succeeded with this criminal action if
enough consumers hadn’t fought back.  Although the UK is currently with us
in opposition to the German Codex proposal, MAFF's action could have
resulted in the German proposal being foisted off on the people of the UK
in this indirect way, because if MAFF could get away with imposing
arbitrary restrictions on B-6 this way there wouldn't be anything to stop
them from imposing similarly arbitrary restrictions on any OTHER nutrient.
I think the decision to have the NAS generate the so called "Risk
Assessment" document may have stemmed from our successful grass roots
campaign to stop the reguation of B-6 in England. (See UK section of IAHF
website, iahf.com)
 
* In Australia, the Competition Tribunal is attempting to create a new
advertising code that would become a part of the Therapeutic Goods Act,
which is similar to the American Food, Drug, and Cosmetic Act.  The problem
is that drug companies will exercise MAJOR CONTROL over how the
Act is administered by having over HALF the votes in the "Code Council".
Joshua Shaw, who is on my e-mail distribution list, sells a device called a
"Negative Ioniser" which threatens pharmaceutical
profits just like vitamins do, and he is planning to file a lawsuit in
February, because this is racketeering.
(See Australian section of IAHF website, iahf.com)

There are different variations on the same theme unfolding worldwide, as
the multi-national pharmaceutical industry tightens its control by
continuously eroding national sovereignty.  In her comments to the
aforementioned ANPR, Suzanne Harris asked the FDA why they intend to toss
the Constitution out the window as they seem so eager to do.  She told them
that rather than harmonize their regs. with Codex standards, they should
petition the appropriate Federal District Court to ask for declaratory
relief: to ask for the interpretation of the Codex standards based on our
Constitution.
 
The FDA did not do this, and the Oversight Committee should inquire as to
WHY they didn’t do it, and must now take measures to undo the FDA’s illegal
actions and must take steps to cut their funding so that they can’t keep
abusing their power in this way.

ADDITIONAL ANALYSIS of ILLEGAL FDA HARMONIZATION MANEUVERS

An in depth analysis of the ongoing problem of the FDA’s ongoing efforts to
“harmonize” their regulations with other those of Europe and other
countries can be found on the IAHF website in Suzanne Harris' comments on
behalf of the Life Extension Foundation and the National Health Federation
to the Commission on Dietary Supplement Labels at
http://iahf.com/cdsl-su2.html  Following is an excerpt from Harris’
analysis, which should be read in full:

“In fact the United States has taken an active role in recognition of the
equivalence of other nation's drug regulations. At the Denver Group of 8
Conference in June, the United States announced the signing of a MRA,
Mutual Recognition Agreement with the European Union that contains a
sectoral annex on Pharmaceutical Good Manufacturing Practices. This annex
sets up a phase-in protocol for use of other foreign drug regulatory
inspectors to assure conformity with US standards for good manufacturing
practices for drugs and vice versa and openly states that the end goal is
harmonization and merger of EU and US standards for good manufacturing
practices for pharmaceuticals.”

“It is quite clear here that ultimately across the board international
harmonization of both food and drug standards is what is being sought.”

“We need look no further than the currently pending FDA Modernization and
Accountability Act of 1997 (S.830) to see that this is true:

     (1) the Secretary of Health and Human Services, in consultation with
the Secretary of Commerce should move toward the acceptance of mutual
recognition agreements relating to the regulation of drugs, biological
products, devices, foods, food additives, and color additives, and the
regulation of good manufacturing practices, reached between the European
Union and the United States.

     (2) The Secretary of Health and Human Services should regularly
participate in meetings with representatives of other foreign governments
to discuss and reach agreement on methods and approaches to harmonize
regulatory requirements and

     (3) the Office of International Relations of the Department of Health
and Human Services should have the responsibility of ensuring that the
process of harmonizing international requirements is continuous.

It is clear that nothing less than a shift in emphasis in the work of the
FDA is contemplated here. Whereas hithertofore it could be argued that
FDA's primary emphasis was on safety and efficacy of products manufactured
or sold in the United States, nowadays the emphasis has shifted to
increasing market access and market share for American products by
facilitating the flow of products by eliminating conflicts in regulations
wherever possible.

Can we stop our analysis here? No, we must look further down the road in
order to appreciate that international standards will come into play more
and more as the US carries out its stated objective of market expansion
through expansion of regional trading blocks.”
 
 

CONGRESS HAS ALREADY SPOKEN AND TOLD THE FDA NOT TO
HARMONIZE DIETARY SUPPLEMENT LAWS WITH EUROPE OR WITH ANY COUNTRY: MASSIVE
GRASS ROOTS PRESSURE
AMENDS FDA REFORM BILL - DIETARY SUPPLEMENTS
SPECIFICALLY EXCLUDED FROM HARMONIZATION LANGUAGE
 

In October of 1997, I led a grass roots rebellion against the so called
“harmonization” of our dietary supplement laws with those of Europe by
heavily lobbying the Senate Labor Committee, especially Congressman
Jeffords, to amend the harmonization language of the FDA Reform Bill to
specifically EXCLUDE dietary supplements. The full story is available at
http://iahf.com/s830vict.html

Senator Jeffords drafted the harmonization section of the bill, and was the
only one who could amend the language at that stage of the process, with
the bill about to go into a conference committee. I almost hadn’t noticed
the threat, and was in a desperate position of being forced to put in very
long hours, on short notice, to muster the necessary grass roots opposition
to the language to be able to get it amended. Following a tremendous amount
of work, I was able to generate a sufficient number of faxes to the Senate
Labor Committee that I made their fax machines run out of paper and ink,
which resulted in the top Committee staff calling me to establish a dialogue.

I then flew to Washington, and easily walked for miles all over Capital
Hill during 3 weeks of intense lobbying, meeting with as many Congressional
staff and Congressmen as possible relative to my concerns, while also doing
radio shows and urging people via the internet to call Senator Jeffords,
the Labor Committee, and their own Senators and Congressmen.

Congressman Ron Paul was of invaluable assistance in this effort when he
enabled me to get my foot in the door by drafting a “Dear Colleague”
letter, which explained the threat to the rest of Congress.

IAHF OPPOSED BY ASTROTURF- CONTROLLED OPPOSITION GROUP

While I was on Capital Hill doing this work, my efforts were diametrically
opposed by a fake grass roots so called “health freedom organization”
(Citizens for Health), which sent faxes to Congress which
diametrically opposed my message about the harmonization language posing a
threat. They did this because Nature’s Way, one of their biggest
supporters, is part of the EAPC and would have benefitted if I had failed
in my efforts.

Simultaneous to my efforts, due to the need to APPEAR to take action, CFH
had consumers call Senators Hatch and Harkin, en masse, BECAUSE they
couldn’t change the bill’s harmonization language (only Jeffords could and
they knew it.) At the same time, they participated in creating a website
for the express purpose of trying to discredit me, hoping to push my
buttons while I was on the Hill in order to render me ineffective.
Then, when they failed to stop me from getting the language amended, they
attempted to take credit for my victory(!!)   It has become painfully
obvious to me over the course of several years of observation that
“Citizens for Health” represents “Controlled Opposition” and that they
aren’t truly representing the needs of the American consumer, but instead
are being very heavily influenced by the European-American Phytomedicines
Coalition, (EAPC) via Loren Israelson, Alex Schauss, and Ken Murdock. The
EAPC has been lobbying the FDA since 1992 in an effort to turn herbs into
“drugs”. I have a stack of documents measuring 2" thick which the EAPC has
submitted to the FDA for this purpose, and they clearly indicate
Israelson’s affiliation with EAPC. Prior to his law license being suspended
for 3 years, Israelson was legal counsel to the EAPC along with Robert
Pinco, and he was also legal counsel to Nature’s Way, a member of the EAPC
along with their German partners, Madaus AG and Schwabe- the two largest
German phytopharmaceutical companies. (See
http://iahf.com/world/eapc.html#exposed)

If the EAPC could succeed in bringing about the harmonization of our laws
with those of Europe, it would enable them to dominate the N. American
market by creating an unlevel playing field whereby the companies which are
certified by the FDA as OTC drug manufacturing facilities, and which have
the money and manpower to comply with full pharmaceutical GMP standards,
would take marketshare away from the numerous smaller companies which
comprise the heart and soul of the American dietary supplement industry.
The ability to make claims, and get insurance reimbursement for the sale of
products, would enable the EAPC to quickly develop a monopoly within the
N.American market, while economically driving a pharmaceutical takeover of
the natural products industry.

ECONOMICS OF THE PHARMACEUTICAL TAKEOVER WELL DOCUMENTED
BY A CONSULTANT TO THE GERMAN PHYTOPHARMACEUTICAL INDUSTRY

The economics driving the pharmaceutical takeover of the natural products
industry are well documented in an article by Jorg Grunwald titled “Germany
Moves to the Forefront of the European Herbal Medicines Industry” which can
be viewed at
http://www.healthy.net/hwlibraryjournals/herbalgram/1995/summer/features/phy
tomed.htm

Grunwald, a consultant to the German phytopharmaceutical industry, includes
Table 6  which indicates that German phytopharmaceutical companies are
increasingly becoming targets for acquisition by the multinational
pharmaceutical giants, who want to take over this industry.

A letter from the German Embassy to the FDA, urging the FDA to act on the
EAPC’s petition requesting that herbs be regulated as “drugs” can be viewed
at http://iahf.com/world/980830.html

Along with Grunwald’s article, this clearly indicates an effort on behalf
of foreign interests, which have some American partners, to invade and
dominate the N.American market- something which would not be good for
consumers- either in the USA or in Canada.

DSHEA IS RIDDLED WITH GAPING HOLES

The Dietary Supplement Health and Education Act of 1994 was not in fact the
great and glorious victory for consumers that some people think. It was
riddled with gaping holes, in no small measure due to compromises made as a
result of the EAPC’s lobbying campaign, as Loren Israelson, Alex Schauss,
Ken Murdock, and others seeking to dominate the market negotiated with the
FDA while DSHEA was moving through Congress. This is discussed in detail at
http://iahf.com/world/eapc.html#exposed    and at the “Rebuttal to Nature’s
Way” section of the IAHF website at http://iahf.com/usa/980828.html and at
http://iahf.com/nway.html

DSHEA contains 3 major Trojan Horses, which the FDA clearly is hoping to
exploit in an effort to reverse things. Those Trojan Horses are: 1) GMPS:
The FDA was handed a HUGE weapon by the FDA when they were given the right
to draft new Good Manufacturing Practice Regulations for the dietary
supplement industry. A global push is afoot to force manufacturers world
wide to go to full pharmaceutical (HACCP) regulations. This is driving
small manufacturers out of business by creating a ton of unecessary red
tape and unwarranted expenses which small companies can't afford.
Consumers, who need to be able to access these products at affordable
prices, are being forced to pay much higher prices (when they can find the
products they seek AT ALL as this process is making many products
unavailable as small companie continue to be driven out of business.

2. SSA: “Significant Scientific Agreement” DSHEA imposed this arbitrary and
capricious so called “standard” which means anything the FDA wants it to
mean as they use it to block the making of true health claims for dietary
supplements. Given that one of the main purposes of DSHEA was to help us
move past the roadblock posed by the NLEA (Nutrition Labeling and Education
Act of 1990) so that consumers health can benefit by being able to learn of
the healing properties of dietary supplements, at the point of sale, from
reading product labels, so called SSA enabled the FDA to once again erect a
roadblock.

3. The third "Trojan Horse" contained in DSHEA was the so called
“Presidentially Appointed Commission on Dietary Supplement Labels”

For a good analysis of how this commission failed to adhere to their
congressional mandate, see the commentary of  IAHF at
http://iahf.com/cdsl-sub.html  and also of the Law Loft at
http://iahf.com/cdsl-su2.html

Emord and Associates has filed comments with the President's Commission on
Dietary Supplement
Labels, faulting the Commission for failing to propose alternatives to the
FDA's prior
 restraint on health claims (as mandated by Congress in the Dietary
Supplement Health
and Education Act). These comments can be viewed at
http://www.emord.com/dietary.htm

The FDA’s position was well represented on the CDSL by Margaret Gilhooley,
formerly an FDA attorney, who now teaches law at Seton Hall University. It
was also well represented by Ken Fisher, the chairman of the CDSL. Fisher,
formerly of Federation of American Societies of Experimental Biology
(FASEB) was lured out of retirement to chair the CDSL. FASEB, which is
located inside the Beltway, does so much subcontracting for the FDA that
they might as well be part of the Agency, so Fisher was right in sync with
the FDA, which is why he was selected to be the Chairman. CDSL had no one
on it representing consumers.

***The CDSL set the stage for the FDA to come at us with their current
proposed rule which threatens to impose arbitary and capricious limits on
allowable label claims. This is another example of FDA’s onoing efforts to
illegally harmonize our laws to Europe’s. It goes directly against the
Supreme Court Decision of 44 Liquormart v. Rhode Island, a decision which
upholds first amendment rights with regards to commercial free speech.
See http://iahf.com/usa/fda.html#form letter and
http://iahf.com/usa/980731a.html

The FDA has been pummelled with a huge number of comments in opposition to
their proposed rule which would limit allowable structure function claims,
and has yet to publish their final rule. Hopefully an oversight hearing
will occurr BEFORE they do publish their final rule, and a goal of the
hearing could be to make sure the FDA comes out with a rule that is
consistent with 44 Liquormart in
upholding the first amendment, and the consumers right to access
information via labelling.
 

FDA ATTACK ON PHARMANEX ILLUSTRATES THE WHOLE PROBLEM

Their intent with the proposed rule and their ongoing effort to harmonize
our laws with Europe’s is clearly evident in their court case against
Pharmanex, manufacturers of Cholestin. Cholestin is a product derived from
red rice yeast extract which angers Merck, makers of a drug called Mevocor.
Merck alleges that Cholestin isn't a dietary supplement, (they feel that it
is an unapproved new drug) and that Pharmanex is making an illegal
therapeutic claim in labeling when they state that it lowers cholesterol.
In deference to Merck’s wishes, the FDA blocked Pharmanex from being able
to import the product from China, but the court has issued an injunction to
stop the FDA from doing this, and has ruled that pending the final outcome
of the case, Pharmanex can keep selling Cholestin as a dietary supplement.
This is discussed at
http://iahf.com/usa/fda.html#FDA Ban On Cholestin
http://iahf.com/usa/980622d.html
http://iahf.com/usa/980622e.html
http://iahf.com/usa/980622f.html

DIRE NEED FOR OVERSIGHT OF FDA’S ILLEGAL EFFORTS
TO “HARMONIZE” OUR LAWS WITH THE EU & CODEX

>From these examples, it is plainly evident that the FDA is doing everything
humanly possible to attack the dietary supplement industry on behalf of
companies such as Merck. It is plainly evident that the FDA is doing
everything humanly possible to harmonize our laws pertaining to dietary
supplements with those of Europe and other countries DESPITE the will of
Congress as expressed in the Proxmire Act of 1976, DSHEA of 1994, and most
recently, in October of 1997 when the FDA Reform Bill was specifically
amended to exclude dietary supplements from the harmonization language.

The FDA failed to send copies of the Risk Assessment document to members of
the US Codex delegation to the meeting of the Committee on Nutrition and
Foods for Special Dietary Use prior to the meeting. I only got one because
I learned of it at the last minute after seeing the US draft comments and I
specifically requested it, but didn’t receive it until just a few days
before the meeting, without sufficient time to read it thoroughly and no
time to find an expert to review it. I was told by Dr.Moore at the FDA that
it was available in abridged form for download, but he wasn't sure if the
unabridged version was available.

At the pre-meeting of the US delegation, when confronted with the letters
from Congressman Burton, Paul, Stump, De Fazio, and Cook demanding that the
second paragraph be removed from the US Codex comments on agenda item #5,
and that the Risk Assessment document be withdrawn from the table, I caught
Dr.Beth Yetley of the FDA on videotape refusing to amend the US comments
and to withdraw the document even though she acknowledged receiving the
letter from the Congressmen.

Additionally, at this pre-meeting, I have Dr. Christine Lewis of the FDA
stating on video that the entire Risk Assessment document had been uploaded
to the FDA website on Friday (when the meeting began on monday, just 3 days
later.) This turned out to be a bold faced LIE!!!

Upon returning to Florida after the meeting ended, I went to the FDA
website and did a search for the Risk Assessment Document.

I got the following message from the search engine on the FDA website on
October 5, 1998:

“Your Query: “A Risk Assessment Model for Establishing Upper Intake Levels
for Vitamins” matched 0 documents out of 31942. 0 documents displayed.”

We are obviously being lied to, and a massive cover up is obviously being
perpetrated via this so called “Risk Assessment” document. As a person who
requires dietary supplements to address genetic biochemical imbalances, it
is not acceptable to me that the FDA do ANYTHING which would harmonize our
laws to other nations, yet this is EXACTLY what the FDA is busy doing at
Codex.

In an effort to move beyond the impasse generated by millions of angry
consumers from around the world who would like for the draft guidelines for
vitamins and minerals to be entirely withdrawn from the program, the FDA
has agreed to participate in the development of a discussion paper
“providing an objective presentation of the issues and controversies”
surrounding the establishment of the draft guidelines for vitamins and
minerals.

>From the Final Report from the Codex meeting, it becomes very clear that
Dr.Yetley violated US law by agreeing to participate in the drafting of
this discussion paper. The Final Report states:

46. The Chairman proposed that in order to facilitate consensus, efforts
should be made to combine the different approaches as it should be possible
to integrate both safety and nutrition concerns on the following basis: the
establishment of a science based risk assessment model to develop upper
safe limits, taking into account al sources of nutrients and adequate
safety factors to make recommendations for vitamin and mineral daily intake
for vitamin and mineral supplements. The committee could not come to a
conclusion at this stage, but ageed to continue its discussion at the next
session in light of the above proposal and the issues raised during the
debate.

47. The Secretariat drew the attention of the Committee to the Joint
FAO/WHO Expert Consultation on Human Vitamin and Mineral Requirements,
currently being held in Bangkok (21-30 September 1998). the intention of
the Consultation was to review the full scope of food-based vitamin and
mineral requirements, including their role in normal human physiology and
metabolism and in deficiency disease conditions and it might provide the
basis for the solution to the issue.
48. The Observer from the EC indicated that the question of dietary
supplements was currently under consideration in the EC, where no
legislation existed as yet, and informed the Committee that a paper on this
matter had been prepared by the EC services. This paper provided a neutral
and objective presentation on the issues that shoud be considered on the
subject an aimed to understand the rationale behind the different
approaches. The Observer pointed out that this paper currently discussed
had been developed in the EU context but that it would be useful to study
in depth the principles justifying each position in order to find a common
ground for discussion. the Committee agreed that, before proceeding further
in the elaboration of the Guidelines a discussion paper, taken as a basis
the above mentioned paper, should be jointly prepared by Canada, USA, and
EC on the issues raised above.

Question: Under current US law, isn’t it ILLEGAL for the US Codex delegate
to do ANYTHING which would HARMONIZE our laws to Canada’s , to any EU
country, or to ANY other country?

Question: Given that it IS illegal, and that Yetley was put on NOTICE by 5
members of Congress, including the Chair of the Oversight Committee to
remove the 2nd paragraph from the US comments on vitamins and minerals, and
to remove the risk assessment document from the table, and given the fact
that Cheney broke the law by not doing as she was told by Congress, and
that she agreed to participate in the drafting of a discussion paper which
is described as an effort to build consensus towards accepting the draft
guidelines on vitamins and minerals, shouldn't Dr.Yetley be fired from her
job?

Shouldn’t the United States formally WITHDRAW the Risk Assessment document
from the table, and shouldn’t it be replaced by a document drawn up by
people such as Dr.Rath, and by Dr. Majid Ali, author of the book “Rats,
Drugs, and
Assumptions- (which explodes the fallacy of the RDA- and the way groups
such as the National Academy of Sciences deliberately lie in order to
protect the profits of the pharmaceutical industry??

The FDA will attempt to argue that they “HAD” to take the position that
they did (“the lesser of two evils”) in order to defend American
interests..... but is THIS what is REALLY happening in the Codex shell
game? IADSA, a newly formed lobby group called “International Assn. of
Dietary Supplement Trade Associations” is embracing the Risk Assessment
document, and apparently either doesn’t grasp what is going on, or doesn’t
think anything can be done about it so appear to be willing to embrace the
lesser of two evils, because they fear what could happen to their
businesses if they don’t take this position. It is obvious that IADSA, as
an international lobby of vitamin trade associations, is not in sync with
IAHF- which strictly represents consumers, and which is unwilling to sell
out, for any reason. Consumers world wide had better wake up because we’re
being SCREWED!

The FDA MUST REFUSE to participate in the Codex meetings, and taxpayers
money should not be used to send people like Yetley to Europe for any reason.

The USA should immediately withdraw from the UN, the WHO, and especially
from the Codex Alimentarius Commission, and Congress should fire Dr.sYetley
and Lewis from their jobs to send a message to the FDA and Codex on this
issue.

I was stopped from videotaping the Codex proceedings, but my footage, along
with my footage of Yetley at the pre-Codex meeting of the US delegation are
being uploaded to the iahf website at iahf.com, along with this report in
order to protest the gross lack of transparency and honesty. I demand an
immediate end to genocide.
 
            Sincerely,
cc: Congressmen Paul, Stump, De Fazio, Cook
Drs. Rath, Hoffer, Camo, Ali, Kunin, and others
on the Board of the Journal of Orthomolecular    John C. Hammell
Medicine,LEF, NHF, APMA, PHARMAPACT,
CVHR, FCHC, NZCCMP, CAFMR, and other
allied groups world wide

******************************************
International Advocates for Health Freedom
2411 Monroe St. #3 Hollywood, FL 33020 USA
800-333-2553, overseas 954-929-2905
fax 954-929-0507, www.iahf.com,
jham@iahf.com
Donations Needed For Trips to DC
To Get FDA Oversight Hearing
Due to Illegal FDA Codex Comments
& for Trips to Europe to Assist
Dr.Rath in Getting Hearing at
International Court of Justice
Against the Pharmaceutical Cartel
*********************************