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Return-Path: jham@iahf.com
Errors-To: <jham@iahf.com>
X-Sender: jham@pop3.concentric.net
Date: Sat, 06 Jun 1998 10:09:02 -0400
To: "Wainwright Churchill" <w@onehandclap.demon.co.uk> (by way of LEF <Lef@lef.org>)
From: John Hammell <jham@iahf.com>
Subject: Understanding "Harmonization" Detailed Analysis of EEC 65/65
  Reply to Wainwright Churchill of UK should be Read by People World Wide
Cc: jham@iahf.com

Distribution List: No matter what country you live in, if you value access
to vitamins & herbs it is very important that you carefully read my reply
to Wainwright Churchill in the UK, because through it the specifics as well
as the process of "harmonization" will become clearer to you, and it will
be easier to see how we must fight back. This might take you 10 minutes to
read, but it will be 10 minutes well spent, I assure you.(Be sure to
forward this widely so more people will understand whats going on. Anyone
can be on the IAHF distribution list by sending email with the word "add"
in the subject line.)

****Americans: The FDA Comments Period on Structure Function Claims ends
August 27, and it is IMPERATIVE that we BURY them with comments! (This
article FULLY explains why and to facilitate the filing of comments, I have
provided a form letter at the end.

What I have outlined here are the SPECIFICS of Council Directive 65/65 from
the European Commission wherein dietary supplements are "ENSLAVED" as
"DRUGS" and we are currently seeing world wide efforts to force
harmonization to this "DIE-WRECKTIVE"

(The US FDA is currently trying to force harmonization with EEC 65/65 via
their current ANPR which attacks structure function claims, and product
names that imply a therapeutic use. FDA is also attacking a product called
"Cholestin" (an extract derived from red rice yeast) which lowers
cholesterol, in an effort to establish a test case through which to once
again attack safe dietary supplements... This case goes to court June 15 in
Salt Lake City. FDA is acting on behalf of MERCK)

We're seeing additional efforts to force "harmonization" in Australia, New
Zealand, Canada, S.Africa, S.America, and all over Europe. Last October in
the US we stopped harmonization (temporarily) by burying Congress with
complaints about the harmonization language in the FDA Reform Bill, and by
getting dietary supplements specifically exempted from the harmonization
language.

EEC 65/65 is being shoved rapid fire down the throuts of people in the EU
via ESCOP, BIOMED, and EMEA (European Agency for the Evaluation of
Medicinal Products.)

The most recent effort to force EU-wide "harmonization" with EEC 65/65 came
through the June 1997 Discussion Paper on Vitamin and Mineral Supplements.
(The so-called "Green Paper") The EU Commission is currently analyzing the
responses of individual countries in an effort to decide if harmonizing
legislation may be achievable.) The best way to monkeywrench these
proceedings is to be VERY vigilant: to educate your elected officials, to
hold demonstrations, and to drive from office any who uphold the
pharmaceutical agenda.

(It also wouldn't be a bad idea to continue the rioting in Geneva which
broke out recently against the various offices of the Globalists there in
order to keep sending the mssg to these bastards that we're mad as hell,
and we're not gonna take it anymore.)

Wainwright:

The situation the UK is in right now is that in 1993, under the Maastricht
Treaty, a single European Market was formed without internal trade
barriers. Numerous directives have been or are in the process of being
adopted for various industry sectors, and member states in the EU (UK is
one) are required to (ahem)...."harmonize" (read "HARM-UH-NIZE") with these
(ahem) "directives" (read "DIE-WRECKIVES")

Although under your UK Food Safety Law of 1990, your country currently has
the most liberal legislation (eg the product must "not be injurious to
health"; responsibility for administration rests with your Ministry of
Agriculture, Fisheries, and Foods (MAFF) which is run by a complete
imbecile named Jeff Rooker (strongly recommended that you "ride him out on
a rail" politically.

Jeff Rooker has clearly been given his marching orders by his Globalist
Masters, and its evident to me that the fate of access to high potency
supplements in England depends on whether or not you are able to derail
Rooker's mindless effort to force the arbitrary restriction on vitamin B-6
to just 10 mg, because if he gets away with that, this would indicate to
the Pharmaceutical Stooges in Brussels that England is no longer standing
in the way of the forced harmonization to EEC 65/65 under which dietary
supplements are restricted to the "nth" degree...(see below for complete
details)

The beast which is currently upon you is known as EEC 65/65 Relating to
Medical Products.

Directive 65/65 provides two separate definitions of the term "medicinal
product", one relating to presentation, the other to function.

A)TWO DEFINITONS OF MEDICINAL PRODUCT
 
A product is medicinal if it is:

a) any substance or combination of substances "presented for" treating or
preventing disease in human beings or animals, or

b) any substance or combination of substances which may be administered to
human beings or animals "with a view towards" making a diagnosis or to
restoring, correcting, or modifying physiological function

B) "Presented for Treating or Preventing Disease" Test

1) Product "presented for treating or preventing" disease not only when it
is expressly "indicated" or "recommended" by means of labels, leaflets or
oral representation but also whenever any averagely well informed consumer
gains the impression that the product may meet the definition of a
medicinal product.

2) Some factors: form of the product (eg, is it a pill or tablet or other
traditional pharmaceutical form?); form of the pacakaging; trade dress;
express or implied representations; intent of person placing the product on
the market; target customers (especially those at high risk); whether any
similar products authorized as medicinal products

3) testimonials of physicians or reference in the labelling to
pharmaceutical research or methods is also evidence product is presented as
medicinal product.

4) European Court of Justice (ECJ) decision in Ter Voort (1991 Dutch
proceedings relating to the sale of herbal teas) confirmed that a product
is a medicinal product under the first definition of Directive 65/65 if it
is recommended or described as having therapeutic properties, even if it is
generally recognized as a foodstuff and has no therapeutic effect. The
alleged therapeutic benefit need not be on the labelling of the product
itself, but can be supplied by the manufacturer or its agent after the sale
(such as by sending a brochure to consumers upon request.)

5) In the UK, claims to manage "stress, anxiety, or nervous tension" are
treated as medicinal claims. If product marketed to vulnerable section of
the population it might be treated as medicinal if it claims to restore a
specific bodily function or organ to a normal healthy state. In general,
words like "restores, repairs, eliminates, controls, alleviates, heals,
cures, treats, protects, or prevents" may all be viewed as implying a
medicinal claim.

a) other specific claims that are generally regarded in the UK as
indicating a medicinal claim, pareticularly if used in connection with a
disease or specific adverse condition include:

--traditionally used for________________

-- is said to benefit those who suffer from __________________

--can lower cholesterol

--stengthens the immune system

--fights gum disease

--burns fat

--stops craving for _____________

--stimulates immune system

--helps body adjust after crossing time zones

b) claims that are not likely to be considered medicinal, provided not used
in connection with a specific disease or adverse condition, include:

-helps to maintain health or healthy lifestyle
-revitalizing
-relaxing (except for products containing sedatives)
-refreshing
-invigorating
-uplifting
-soothing

c) "Function" Test

1. many herbs and other substances have well recognized pharmacological
properties, and their presence in a product may trigger regulation as a
medicinal product

2. function test is extremely broad and may sweep in:

a) products endowed with medicinal properties or capable of having an
effect on physiological function but not presented as such.

b) products such as contraceptives or hair loss remedies which alter
physiological functions in the absense of disease

c. products which affect physiological functions but do not have the
advertised effect (for consumer protection reasons)

d. BUT NOT certain substances with a de minimis effect on physiological
functions (eg cosmetics).

3. in Van Bennekom (1983 Dutch criminal proceedings related to the supply
of vitamins and multi-vitamin tablets, pills, and capsules), ECJ said
vitamins sold for consumption in small quantities as an essential part of
the daily diet indispensable for the proper functioning of the body were
NOT medicinal products, whereas vitamins sold in LARGE DOSES FOR
THERAPEUTIC PURPOSES in combating certain diseases other than for which the
cause is vitamin deficiency WERE medicinal products.

The court also stated, however, that mere concentration level alone is not
always sufficient to determine whether a vitamin is a medicinal product and
that it is impossible to specify a concentration above which a vitamin
would always be deemed a medicinal product.

D) Herbal Medicinal Products

1. herbal medicinal products are covered by Directive 65/65

2. the European Scientific Cooperative on Phytotherapy (ESCOP) formed in
1989, has prepared monographs ("summaries of product characteristics") for
several herbal remedies with the goal that compliance with the monographs
will allow for registration and marketing as a medicinal product. As of
1995, 15 monographs issued.

3. European Agency for the Evaluation of Medicinal Products (EMEA)
established in 1997 the Ad Hoc Working Group on Herbal Medicinal Products

a) discussing role or ESCOP and WHO organization monographs for approving
medicinal products for marketing, and role of long history of safe use in
approval process in establishing efficacy of such substances, particularly
reliance on bibliographic (non clinical) data.

b. proposed good manufacturing practice (GMP) requirements focusing on
ensuring quality of inputs (rather than measuring quality of outputs.)
--------

CURRENT SITUATION with Vitamin and Mineral Supplements:

A) General

1. growing demand in the EU combined with wide variations in regulations of
Member States due to cultural differences has resulted in numerous trade
complaints that Member states are using their local regulations to erect
barriers to the free circulation of vitamins and minerals throughout the EU.

2. lack of harmonization means that Member States are free to regulate
supplements as they wish- typically as foods or medicines. Currently there
is a wide range of national regulations, ranging from prior authorization
required for marketing to vitually no regulations provided the supplement
must be "safe to consume". Some Member States focus on first establishing a
nutritional need for increased consumption of a particular vitamin or
mineral beyond normal diet, while others focus only on safety (ie no
marketing unless established need vs marketing unless established harm)

To get a clearer view of how the Drug Trust is attempting to "boil the frog
slowly" and to force their dictates on the people of the world, it is very
important that you visit so called "PHYTONET" at
www.exeter.ac.uk/phytonet/welcome.html  and follow the links there to
ESCOP, BIOMED, and EAPM. It says right there that ESCOPs mission is to
force the "harmonization" of laws pertaining to the manufacture and sale of
herbal products throughout the EU and throughout the world. They want to
force us all to full pharmacuetical GMPs in order to drive all the small
companies out of the market, upon getting control of the market, a lot of
products will disappear and those that remain will cost 10 or more times
what they do right now, just as with l-tryptophan which cost about
$15./bottle back in 1989 when FDA banned it, and now as a "drug" it sells
for between $90.- and $120. per bottle.

Americans: PLEASE sign, and send the following form letter to the FDA and
to your Senators and Congressman. Print it out, and use it to educate the
owner and manager of your local health food store. INSIST that they BAG
STUFF this form letter. STRONGLY URGE them to READ the article above. They
aren't learning of ANY of this through NNFA, UNPA, AHPA, or CRN (trade
associations) due to the long tentacles of the pharmaceutical industry
reaching deep into these trade associations excercising control over their
Boards.

FIRST AMENDMENT ALERT! COMMENTS DUE AT FDA
BY AUGUST 27,1998 [Docket No. 98N-0044] RIN 0910-AA59
Regulations on Statements Made for Dietary Supplements Concerning the
Effect of the Product on the Structure or Function of the Body; Proposed
Rule and Dietary Supplements: Comments on Report of the Commission on
Dietary Supplement Labels; Notice

Submit written comments to: Dockets Management Branch (HFA-305) FDA 200 C.
St. SW, Washington DC 20204, 202-205-4697 or send them to LEF Box 229120,
Hollywood, FL 33022 Dept IAHF

To Whom it May Concern at FDA:
A Supreme Court  decision on June 28, 1993 renders your proposed rule to
limit manufacturers ability to properly inform the American public on the
health benefits of dietary supplements utterly and completely illegal. (It
puts Section 403 (r)(6) of the Food, Drug, and Cosmetic Act pertaining to
structure-function claims in question, and it means that the so called
Commission on Dietary Supplement Labels (whose advice you were following
when you drafted your proposed rule) has utterly and completely ignored the
Supreme Court Decision of Daubert v. Merrill Dow. (We hereby put you on
notice that the Supreme Court is the highest court in America, and the
Commission on Dietary Supplement Labels (CDSL), Congress, and the FDA are
required by law to not only be aware of their decisions, but to abide by
them when proposing new regulations such as this.)

Under Daubert, the "General Acceptance Test" (an equivalent phrase to
significant scientific agreement) was replaced by the Federal Rules of
Evidence for admitting scientific testimony at a Federal Trial. As a
Federal Agency FDA ought to formulate its proposed rules in accordance with
this decision, but has failed to.

Given the Daubert decision, rather than find in favor of the so called
"significant scientific agreement" standard, what CDSL should have done as
to define what kinds and combinations of studies validate claims based on
significant scientific evidence. Rather than recommend arbitrary and
capricious limits on health information provided at the point of sale
through labels and labeling of dietary supplements, CDSL should have
recommended the adoption of the "gradation of claims" proposal recommended
in comments to the CDSL by Durk Pearson and Sandy Shaw, Jonathan Emord and
Associates, International Advocates for Health Freedom, and many others.
This proposal allowed for a gradation of claims, depending on the amount of
evidence supporting them, and the consumer can then be in a position to
make their own decisions- but you have no legal right to withhold truthful
information, and your proposal severely BLOCKS our access to information
that we need in order to make better health choices for ourselves and our
families.

In your proposed rule you say that it would be illegal to suggest anything
but drugs to reduce nausea associated with chemotherapy. This is arbitrary
and capricious. What about ginger to reduce nausea? What about co-enzyme
Q-10 and vitamin E to reduce chemotherapy-induced heart muscle damage;
melatonin to reduce chemotherapy-induced immune system damage; and
n-acetyl-cysteine to reduce chemotherapy induced liver damage??
Since you are ruling it "illegal" to use the words "protects against
cancer", you will also consider it "illegal" to use the words "protects
against heart attacks." This means folic acid can be promoted to "lower
homocysteine levels" but it would be "Illegal" to say that folic acid
"protects against heart attacks" even though The New England Journal of
Medicine (April 9, 1998) recommends the use of folic acid to lower heart
attack risk (!!!) Since when did the FDA become the sole repository of truth?

In light of the fact that your proposed rule is of questionable legality in
view of  the Daubert decision, I hereby call for its immediate withdrawal,
and demand that my Congressman address this outrage by cosponsoring HR 2868
The Consumer Health Free Speech Act, which removes food from the current,
overly broad statutory definition of drug. This will allow us to make
therapeutic claims on dietary supplements, something which you have no
legal right to block with this proposed rule. Now that I have appraised you
of the Daubert decision, please let me know precisely how you  intend to
artfully dodge the law by utterly ignoring it?
(cc to my Senators and Congressman)
Signed:________________________________________  Date: _______________
 
Address:______________________________________________________________

 
City:___________________________________ State:____________ Zip:___________
 
Provided by International Advocates for Health Freedom www.iahf.com,
jham@iahf.com,
fax 954-929-0507, 800-333-2553
 
 
 
 
 
 
 
 
 
 

******************************************
Donations Needed- Need Help to Keep Helper On
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
jham@iahf.com    http://www.iahf.com
HERBS ARE _NOT_ DRUGS! HELP PASS HR 2868
THE CONSUMER HEALTH FREE SPEECH ACT!!!