URGENT FIRST AMENDMENT & CODEX ALERT
FDA COMMENTS PERIOD EXTENDED- - BUT....
CSPI ASKS FDA TO BACK GERMAN CODEX PROPOSAL
BURY FDA WITH COMMENTS & PROTESTS PRIOR TO CODEX MEETING--
by Sept. 19 (Sept 27 at latest)

Dear Dietary Supplement Consumer:

 We have flooded the FDA with so many comments against their proposed rule
to block your access to truthful health information on the labels of
dietary supplements, that they have extended their comments period an extra
month until September 27th, 1998. It is of critical importance that we keep
the pressure on, right up until the deadline! The form letter below fully
explains this situation, as well as another which we must also protest
simultaneously!

 The German Codex proposal which threatens to internationally limit
consumers to untherapeutic potencies of vitamins and minerals, as well as
to regulate any dietary supplement not having an RDA as a “drug” threatens
to advance, once again, at the upcoming Codex meeting in Berlin from
September 21-25th. Beth Yetley, Ph.D. and Robert Moore, Ph.D, of the FDA
will represent America at this meeting. An inside the beltway pressure
group called “Center for Science in the Public Interest” has submitted
comments to the FDA in an effort to pressure them to stop opposing the
German Codex proposal, alleging falsely that dietary supplements are
“dangerous” to consumers.

 CSPI is urging the FDA to exploit several loopholes existing in DSHEA,
claiming that they allow FDA to back the German Codex proposal. These
loopholes require us to ask Congress to pass HR 2868, so cc the form letter
to your Congressman. In light of CSPI's CODEX Comments, it is imperative
that we bury the FDA with demands for the complete withdrawal of the German
Codex proposal which diametrically opposes our domestic policy regarding
access to dietary supplements. For more information on how you can help
carry this warning to consumers all over the world, please visit the IAHF
website at iahf.com, email us at jham@iahf.com, for more info call
800-333-2553.  (Get in to FDA by Sept. 19, if possible, (Before the CODEX
Mtg) Sept. 27th at latest.)

-------cut here----------cut her--------------cut here-----------cut
here---------------
Submit comments to: Dockets Management Branch (HFA 305) FDA, 200 C. St. SW,
Washington, DC 20204 (email FDADockets@bangate.fda.gov or fax 301/827-6870)
Re: (Docket # 98 N-044) RIN 0910-AA59 Regulations on Statements Made for
Dietary Supplements Concerning the Effect of the Product on the Structure
or Function of the Body/   email to Dr.Yetley EAY@cfsan.fda.gov (Re CODEX MTG)

To: FDA Dockets Management Branch & Beth Yetley, Ph.D., Robert Moore,
Ph.D., US Codex Delegates:

Your Proposed Rule on dietary supplement labeling will have an adverse
effect on public health by placing arbitrary and capricious limits on the
allowable health information that can be presented to consumers at the
point of sale on dietary supplements, in compliance with the First
Amendment. Your definition of disease is overly broad, and you are clearly
over reaching. In your zeal to “insure that dietary supplements don’t act
as a disincentive to new drug development” (Gary Dykstra, FDA), you would
even disallow structure-function claims relative to aging: i.e.: “hot
flashes” (since when are aging or menopause “disease states”?)

In the US District Court in Utah, Judge Dale Kimball just issued an
injunction against the FDA forcing you to lift your ban on cholestin, which
he declared was a dietary supplement under DSHEA. You tried to ban this
safe Chinese red rice yeast extract which helps lower cholesterol because
its sale angers pharmaceutical giant Merck. 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 on this issue as recently as October, 1997. Prior to that,
in 1994, Congress received more mail on this issue than on anything since
the Vietnam war. For the sake of the public health, we strongly urge you to
change the proposed rule and stop blurring the distinction between disease
and a health condition. ADDITIONALLY: I request that you forward this
message to Dr.s Yetley and Moore at FDA Office of Special Nutritionals
(CFSAN) to inform them that at the CODEX meeting in Berlin (September
21-25), I INSIST that they demand the complete withdrawal of the German
Codex Proposal which diametrically opposes US law, and which threatens the
public health world wide.

cc to my Congressman in support of HR 2868, Consumer Health Free Speech
Act- removes food from the overly broad statutory definition of a drug-
allowing for therapeutic claims, as long as they are true.

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