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Return-Path: jham@iahf.com
Errors-To: <jham@iahf.com>
X-Sender: jham@pop3.concentric.net (Unverified)
Date: Wed, 05 Aug 1998 06:53:46 -0400
To: jham@iahf.com
From: John Hammell <jham@iahf.com>
Subject: FDA BLOCKS EMAILED COMMENTS ON PROPOSED RULE- PLEASE FAX OR
  MAIL BY AUGUST 27!
X-MIME-Autoconverted: from quoted-printable to 8bit by halibut.pnc.com.au id JAA04607
 

ALERT! Previously I sent the enclosed alert with an email address so you
could flood the FDA with comments to stop them from dismantling DSHEA, BUT
the FDA is attempting to BLOCK us from emailing comments (they stopped
using the email address). So INSTEAD, please FAX or mail the form letter at
the end of this mssg to them.
 

U.S. FDA AXE FALLS AUGUST 27- UNLESS WE BOMB 'EM NOW TIL THEN!
WE HAVE 22 DAYS- (AND NOT A SECOND TO WASTE!!!) UNLESS FDA RECEIVES A FEW
HUNDRED THOUSAND of the enclosed Form letter, we won't have any leverage
with Congress to appeal for legislative HELP!

WHAT YOU MUST DO IMMEDIATELY:

1.  Read this action alert which explains FDA's agenda regarding their
    proposed rule to ban commercial free speech:  they want to ban
    structure function claims.  In other words, no claim can be made that
    a food supplement improves any structure or function of the human
    body!

 Aging, pregnancy and menopause will be defined as DISEASES- and
 manufacturers of dietary supplements won't be able to tell you how their
 products can help you or what new scientific research has been linked to
 supplements that address the "natural" states.

 FDA will also start attacking products based on intended use, (eg: if a
product is  intended to reduce cholesterol levels, (such as Cholestin,
which FDA is currently attacking  in court) they'd BAN it an unapproved
"drug", (even if no direct mention is made for this  use  on the label.)
(None of this is what Congress intended when DSHEA was passed. Through
rulemaking, FDA is trying to circumvent the will of Congress.)

2.  You must sign the enclosed form (scroll to the end) (or your own
    letter) and mail it to the FDA Dockets Management Branch at the
    address given.  Cc to your legislator (so that they'll cosponsor HR
2868 which would stop FDA  from what they're trying to do here. Go to
www.iahf.com for more on HR 2868)
 

3.  Download the enclosed form letter to your word processor, print it out,
make copies and urge
    your local health food store to bag stuff it so that all their
    customers will send it in! Fax and or mail it REPEATEDLY to the FDA,
and get friends to also!

4.  If you are in a multilevel vitamin company - pump it out to your
    downline and encourage your company to put it in their website!
    Don't wait for your company to act at the top--they might not move
    fast enough.  Take action now, and pump this out thru your downline!

5.  Put this in your website and encourage more people to take action.

(If you don't have time to read the following lengthy explanation, please
just skip to the end to the form letter which explains the problem more
succinctly, and mail or fax it in.)
 

FDA'S SLEAZY AGENDA TO BURN US ON AUGUST 27:

The FDA's current proposed rule (Docket No. 98-N-0044) bears the same
identical number as an even more restrictive proposed rule currently
pending in South Africa! (When I called Dr. Robert Moore at FDA to
inquire about this "coincidence" he as "smirking" on the phone, and
"rubbing his hands together in gleeful anticipation.

The International Pharmaceutical Industry's concerted effort to
undermine and take over the dietary supplement industry began in earnest
on June 18, 1989 with the first meeting of ESCOP, the European
Scientific Cooperative on Phytotherapy, in Cologne, Germany. I don't
think it's any coincidence that this meeting was held in Cologne, which
is where Madaus AG is located. Madaus AG and Schwabe are the two largest
German phytopharmaceutical companies, and they are part of a sleazy
coalition called the EAPC, (European American Phytomedicines Coalition)
which is comprised of American herb companies which have sold out, and
European (mostly German) phytopharmaceutical companies.

These companies have been petitioning the FDA since 1992 in an effort to
turn herbs into "drugs". I don't think it's any coincidence that Norway
began "harmonizing" their food and drug laws to really restrictive WHO
guidelines right after that first ESCOP meeting. Today, you can't buy
vitamins and minerals within the therapeutic range in Norway, and
anything that doesn't have an RDA, as well as all vitamins more than
2.5x the RDA are regulated as "drugs" and are heavily restricted and
grossly overpriced--  when you can get them at all!   (If you want that
here, do nothing, and I guarantee, it will happen.)

This "listings" system that was first developed in Norway to regulate
vitamins as "drugs" then spread throughout Europe, with the exception of
England and Holland. It also spread to Australia, it has been partially
shoved down the throats of Canadians, and they're trying to shove it
down the throats of South Africans, and New Zealanders right now
in a very blatant manner!

They know they can't move as aggressively here in the USA to push this
pharmaceutical agenda, so they are currently trying to *take a huge bite*
out of the Dietary Supplement Health and Education Act of 1994 (DSHEA)
in an effort to begin a process of "harmonizing" us to EEC 65/65, the
European Commission Directive through which dietary supplements are
regulated as "drugs" in Europe.

(We told the FDA we didn't WANT this so called "harmonization" last fall
when we succeeded in getting dietary supplements specifically exempted
from the harmonization language in the FDA Reform Bill, but they are
relentlessly trying through *rule making* to get past what we have blocked
them from doing legislatively!   When we were doing our work on Capital
Hill last fall to get the FDA Reform Bill amended, relentless efforts by
companies within the EAPC were made to stop us, because these "sold out"
companies want herbs to be regulated as "drugs"!   (So we can't trust
the supplement industry to defend us, WE MUST DO IT OURSELVES, because
the vitamin trade associations are increasingly being controlled by herb
companies which have _sold out_.

For this reason, if you do not help me pump the following form letter in
to the FDA in very high volume, like any schoolyard bully the FDA will
then question our resolve.  They'll take any sign of weakness from us
as a sign that they can do whatever they want!  (And if we give them
an inch, they'll try to take two hundred miles, because that's the way
they always do things.)

I've been fighting them professionally for 10 years, and believe me, I
know how they do things. I know these guys! I've had _meetings_ with
them, and know the way they think. I once had a meeting with Gary Dykstra,
Deputy Associate Commissioner of Regulatory Affairs. It was supposed to
be a one on one meeting. I knew he'd bring 15 of his cronies to the
meeting so they could all gang up on me, and sure enough, he did! But
I foiled him by bringing Clinton Ray Miller with me, so I wasn't alone.

Clint is the most experienced health freedom lobbyist in America. We
turned a tape recorder on, stuck it in Dykstra's face, and informed him
that he was a public servant and that we were going to tape the
proceedings. The year was 1990, one year after ESCOP held their first
meeting in Germany. Dykstra had a really draconian proposed rule on the
table, which was _identical_ to the German Codex proposal.

The proposed rule went with the passage of the Nutrition Labeling and
Education Act of 1990, a terrible bill that the FDA was able to fast
track through Congress because we weren't paying attention!  Dykstra
proposed banning vitamins and minerals more than 2.5 x the RDA,
and anything without an RDA would have been regulated as a "drug." (His
proposal was identical to the German Codex Proposal.)  We wanted an
extension on the comments period, because this was before the web was
used to disseminate documents, and the only way anyone could get a copy
of FDA's proposed rule was through the US gummint printing office, and
they only printed 200 copies!

If we hadn't gotten DSHEA through Congress, Dykstra's proposed rule
would have been shoved down our throats at high speed.   But we
*embarrassed* the FDA and their drug cartel masters when we got DSHEA
through Congress.

****The FDA has already announced their intention to "harmonize" their
regulations to emerging CODEX standards. They made this unconstitutional
announcement on July 7, 1997 in the 1997 Federal Register, Vol. 62, #129
pp.36243-36248. I filed comments opposing this, asking them why they
intended to give more power to the Codex Commission than was warranted
under even the broadest interpretation of our obligations under
international law.  I demanded to know why they didn't petition the
appropriate Federal District Court in order to find out what their
constitutional obligations were in this situation.

PLEASE! HELP _STOP_ FDA'S DESPICABLE SHELL GAME!

Go to your health food store and show this to the owners and
managers and INSIST that they help out!  They MUST bagstuff copies of the
letter, and You must help me, because I can't win this battle for you
without your help!

please TAKE IMMEDIATE ACTION- comments period ends August 27.
-------------------------------------------------------------
Form letter follows:

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 letter to::

Dockets Management Branch (HFA-305) FDA
200 C. St. SW,
Washington DC 20204, Fax: 301/827-6870
 

Re: Support of: HR 2868

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 nonmisleading 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."

 In the US District Court in Utah, Judge Dale Kimball just issued
an injunction against FDA to force you to lift your aribtarily imposed
ban on cholestin, and I am ALSO telling you to BACK OFF!

  I remind you that the drive to pass DSHEA generated more mail to
Congress than any issue in history, including the Vietnam War!  Where do
you get off trying to circumvent the will of Congress? Is it your belief
that the law is "in your mouth?" 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 trying to push dietary supplements across a line from food to "drug",
as has been done in the EU. 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.Sincerely,

Cc: to my Senators and Congressman in support of HR 2868 which removes
food from the definition of "drug")

Date:___________

Signed:___________________________________

Address:___________________________________________________

City:______________________________________________________

State:_________________ Zip:____________

******************************************
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 August 27 on Structure-
Function Claims- Be Sure to Download Form
Letter and Send In! (Breaking News www.iahf.com)