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Return-Path: jham@iahf.com
Errors-To: <jham@iahf.com>
X-Sender: jham@pop3.concentric.net
Date: Wed, 19 Aug 1998 05:56:32 -0400
To: John Dittrich <joneed@concentric.net>
From: John Hammell <jham@iahf.com>
Subject: New Info on _WHY_ We Must KEEP HAMMERING FDA Til Sept.27!
X-MIME-Autoconverted: from quoted-printable to 8bit by halibut.pnc.com.au id IAA06711

Subject: NEW INFO on _WHY_ We Must KEEP HAMMERING FDA Right Up to
  September 27th!

 
 For those of you who may not yet have heard, we have recently been granted
an additional month to pound the FDA with comments in opposition to their
outrageous proposed rule on dietary supplement structure-function claims
which targets products as "drugs" based on intended use. We now have until
September 27th, but I must caution you NOT TO LET UP!If you don't have time
to read this, please skip to the end, and email the form letter to FDA at
jbutler1@bangate.fda.gov or fax it to them at the number shown.

All of you, newcomers as well as those who have been feverishly working
with me since IAHF first sounded this alarm back in April to get the word
out on this need to keep the following in mind:

*** Pharmanex is _STILL IN COURT_ against the FDA over Cholestin, the rice
yeast product which the FDA has been targetting in an effort to establish a
TEST CASE through which to target ALL dietary supplements as "unapproved
drugs". Yes, the judge _DID_ grant Pharmanex an injunction to force FDA to
lift their ban against the product, but this injunction is only temporary
pending the final outcome of the case, which is still up in the air(!) A
decision could come down in the next 2-3 months, and this case dovetails
with the FDA's comments period. You can bet that the judge will pay
attention to how many comments FDA receives by September 27th, and it could
effect the ruling.

 FDA wants to regard _ANY_ health condition, even _hiccuping_, the
_menopause_, or _flatulence_ to be a "disese"-- even though their arbitary
effort to expand the definition radically and illegally would alter the
statutory definition in the Code of Federal Regulations which existed in
1994 when DSHEA passed Congress.

The statutory definition is quite a bit more limited than the what the FDA
is trying to shove down our throuts via their proposed rule. Here is the
current definition of disease contrasted with what FDA is trying to attack
us with (pay attention- if you KNOW exactly how FDA is trying to burn us,
it will help you to motivate more people to FLOOD EM with COMMENTS!:

The present definition of disease is in 21 CFR Sec.101.14 (a)(6) as follows:

"Disease or health related condition means DAMAGE [emphasis added] to an
organ, part, structure, or system of the body such that it does not
function properly (eg cardiovascular disease), or a state of health leading
to such dysfunctioning (e.g. hypertension); except that diseases resulting
from essential nutrient deficiencies (e.g. scurvy, pellagra) are not
included in this definition (claims pertaining to such diseases are thereby
not subject to Sec.101.14 or 101.70. (Young 1998)

CONTRAST THIS ACCEPTABLE LIMITED DEFINITION OF DISEASE WITH FDA'S
_DANGEROUS_ PROPOSED OVERLY BROAD DEFINITION & CONSIDER THE IMPLICATIONS:

"A disease is any deviation from, impairment of, or interruption of the
normal structure-function of the any part, organ, or system or combination
thereof of the body that is manifested by a characteristic set of one or
more signs or symptoms. For purposes of the definition, signs or symptoms
include laboratory measurements that are characteristics of disease, such
as elevated cholesterol fraction, uric acid, blood sugar, glycosated
hemoglobin, and characteristic signs of disease such as elevated blood
pressure or intraocular pressure."

Under this broadened definition, any minor health condition from minor cuts
and bruises to SNORING could be considered a "disease" and its WRONG,
because it would unfairly restrict the consumer from what he can learn
about the PROPERTIES of dietary supplements at the point of sale, from the
label, in order to help himself and his family through receiving this
useful information.

This flies directly in the face of our first amendment, and illustrates why
we must work diligently to NOT ONLY keep FLOODING FDA with comments right
up til September 27th, but we must ALSO educate our Congressmen and
Senators and their staff to the need to pass HR 2868, the Consumer Health
Free Speech Act in order to stop FDA's madness once and for all by removing
FOOD from the already overly broad statutory definition of "DRUG" thus
allowing us to make therapeutic claims on supplements as long as they're
true. If FDA isn't STOPPED, they will be able to ban claims on ANY product
as an "unaproved drug" without having to prove that a disease claim was
even INTENDED!

FDA's efforts to arbitrarily block our commercial free speech are clearly
unconstitutional as measured by the Daubert v Merrill Dow Supreme Court
Decision-- but since they ignore the supreme court-- they must be FLOODED,
for the simple reason that Congress is watching to see how many comments
FDA receives from us, and if we FAIL to REALLY POUND THEM, if the judge
moves against Cholestin to give the FDA the Test Case from HELL that they
hope to wield against us, we will be in dire need of help from Congress to
pass HR 2868 which will have to be reintroduced regardless of what happens
here in the next Congress. Moreover, the FDA is attempting to appease their
pharmaceutical task masters and to "harmonize" their regs to what the
pharmaceutical industry hopes will be some very restrictive emerging CODEX
guidelines for vitamins and minerals. (Next Codex meeting of CCFSDU is at
the end of September in Berlin, and with your help I hope to be able to
attend in order to monitor it once again.)

(Please bear in mind that ANYTHING can happen in the Codex Shell Game,
those stupifyingly boring meetings held by the UN in the hope of lulling
you to sleep while they boil the frog slowly.)

(Last June in Geneva due to the international alarm sounded by IAHF, we
knocked the German Codex proposal back to step 3 from step 5, but we SHOULD
have been able to flood governments world wide with sufficient pressure to
GET THE GERMAN CODEX PROPOSAL WITHDRAWN ENTIRELY!)

Although most of you have already emailed or faxed the enclosed form letter
in to the FDA Dockets Managements Branch, you must do it AGAIN AND AGAIN
and get your FRIENDS and health food stores to DO THE SAME from now RIGHT
ON THRU September 27th! If we show ANY lack of resolve on this, FDA will
just go into schoolyard bully mode once more and start banning things just
like they did before DSHEA passed. DSHEA only provides a thin VENEER of
protection which is why we are in this mess, and why we must keep pushing
to pass HR 2868. Monkeywrenching ongoing Codex "harmonization" maneuvers by
the FDA requires PERSEVERANCE. By reaching deep inside yourself for a
SECOND WIND at this time, you can assist me in once again alerting the
health food stores, all your friends, relatives and neighbors to get
involved with this. This alert will be posted in the breaking news section
of the IAHF website along with the following form letter:

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,
 fax(301) 827-6870, email jbutler1@bangate.fda.gov

To Whom it May Concern at FDA:
Your proposed rule will have an adverse effect on public health by placing
arbitrary and capricious limits on the allowable health information to be
presented to consumers at the point of sale on dietary supplements, in
complete violation of the first amendment. Your definition of disease is
overly broad. Under proposed §101.93(g)(1) a "disease" is any deviation
from, impairment of, or interruption of the normal structure or function of
any part, organ, or system (or combination thereof) of the body that is
manifested by a characteristic set of one or more signs or symptoms.) Thus,
in your zeal to "insure that dietary supplements don't act as a
disincentive to new drug development" (the now "immortal" words of FDA's
Gary Dykstra), you would even disallow structure/function claims relative
to aging: ie "hot flashes". (Since when are"aging" or the menopause
"disease states"?) You are clearly over-reaching here.

Norman Farnsworth, PhD was on the Commission on Dietary Supplement Labels
and is a Research Professor in Pharmacognosy and Senior University Scholar
at University of Illinois. In a letter dated December 15, 1997, he stated
to Michael Friedman of FDA that your final rules "were not helpful to
industry as to how to craft truthful non misleading health claims." For
this reason, the CDSL stated on p.37 of their Report "...it is possible to
craft a statement of nutritional support and not a health claim or drug
claim." Farnsworth went on to say "it seems to me that having a mild to
moderately elevated cholesterol level being lowered is a clear structure
function claim as opposed to a statement that lowering cholesterol may
prevent atherosclerosis."

Your recent ban on the dietary supplement "cholestin" (derived from red
rice yeast) in order to protect the profits of Merck, and their
prescription drug "Mevacor" clearly illustrate your intention to try to
force the "harm-onization" of American food and drug laws to EEC 65/65.
(Through this "directive" all dietary supplements are regulated as "drugs"
in the European Union.)

Red rice yeast extract (Cholestin) is not a "drug". It has been used as a
dietary supplement for years in both China and the United States.
Dr.Farnsworth considers it to be a dietary supplement, and I agree with his
expert opinion. Foods are NOT drugs, and neither is WATER!
 
In your zeal to force "harmonization" to the EU's EEC 65/65,  you are
utterly ignoring the will of the American people who sent more letters to
Congress over DSHEA than have been received on a single issue since the
Vietnam war. We remind you that dietary supplements were specifically
exempted from the "harmonization" language in the FDA Reform Bill, and that
Congress was flooded with faxes, email, and outraged calls over this issue
in October, 1997.

(cc to my Senators and Congressman in support of HR 2868 which removes food
from the definition of "drug")
 
Signed:_________________________________ Date:_____________
 
Address:___________________________________________________
 
City:____________________________ State:___________ Zip:____________
 
Provided by International Advocates for Health Freedom www.iahf.com,
jham@iahf.com,fax 954-929-0507
******************************************
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
y2kbug threatens your LIFE:access to food,water,
vitamins- Donations to IAHF Keep Updates Coming
FDA Comments Period Ends September 27 on Structure-
Function Claims- Be Sure to Download Form
Letter and Send In! (Breaking News www.iahf.com)