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X-Sender: jham@pop3.concentric.net (Unverified)
Date: Sun, 14 Jun 1998 11:53:23 -0400
To: jham@iahf.com
From: John Hammell <jham@iahf.com>
Subject: MERCK & FDA TO ATTACK CHOLESTIN IN COURT TOMORROW, 6/15, SEE
  ENCLOSED FORM PROTEST

**Distribution list: Please carefully read the newest form letter for the
Comments Period on the FDA's latest proposed rule (their latest proposal to
screw us). Upon the urging of Merck, the FDA will once again prove tomorrow
in court that they are in fact nothing more than a trade association for
the multinational pharmaceutical giants.

In the past 10 years of lobbying for health freedom, I've seen the FDA
attack black currant seed oil,tryptophan and a host of other safe dietary
supplements. They banned tryptophan in order to protect Eli Lilly and their
drug, Prozac. Similarly, they are now attacking cholestin, a red rice yeast
extract because Merck feels that it competes with their drug, Mevacor. In
reality, Cholestin isn't used by people who need Mevacor, it is used by
people with mildly elevated cholesterol as a preventive measure. The sick
thing about what Merck/FDA are trying to do here is that if they succeed,
more people will get atherosclerosis, and will need to be put on Mevacor,
whereas the condition might be prevented in some people by using Cholestin.
Dr. Norman Farnsworth, Research Pharmacognosist at U.Illinois was on the
Commission on Dietary Supplement Labels, which took 2 years to discuss what
sort of statements of nutritional support could be made for structure
function claims. He clearly feels that the FDA is way off base in attacking
Cholestin, yet the law is in the FDA's mouth, and they have no problem
ignoring a Presidentially appointed Commission.

It is up to EACH of us to hold their feet to the fire! I spent several
hours handing the enclosed form letter out yesterday at a local health food
store here in S.Florida. I can't win this battle on my own, I need you to
chip in and do your share. Please take the following form letter to Kinkos,
and make as many copies as you can afford. Go through the yellow pages and
make a list of all the health food stores within a 50 mile radius of your
home, and call them all to get their fax numbers. Fax this in, then make an
appointment to go see their owners and managers. Let me have the numbers of
the stores that help us, as well as the ones which refuse to bother. Ask
them to reimburse you for making copies for them to bagstuff. When the
going gets TOUGH, the TOUGH get GOING! If you are in a multilevel, you MUST
urge your downline to ACT on this, and your company should put this in
their website (let me have names of companies that will and won't help out.)
We either recognize FDA's attack on Cholestin for the shot across the bow
that it is, or we can kiss our health freedom goodbye, because this is an
effort by FDA to harmonize with EEC 65/65 in the EU where dietary
supplements are heavily restricted as "drugs".

***COPY THE FOLLOWING _NEW_ FORM LETTER, GET IT TO FRIENDS, FAMILY,
PATIENTS, HEALTH FOOD STORES, VITAMIN COMPANIES, & ONTO AS MANY WEBSITES &
DISTRIBUTION LISTS AS POSSIBLE! GO ON RADIO, PUT ME ON RADIO, WRITE LETTERS
TO THE EDITOR, CALL YOUR CONGRESSMAN, SEND THIS TO THE FDA AND TO CONGRESS!
URGE YOUR FRIENDS TO GET ON THE IAHF DISTRIBUTION LIST- SEND IAHF BADLY
NEEDED DONATIONS: WE'RE HERE TO SERVE _YOU_! YOUR DONATIONS WILL HELP US
COMPLETE THE INTERNATIONAL HEALTH FREEDOM VIDEO!!
 

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 This info provided courtesy John
C. Hammell, legislative advocate, IAHF, 800-333-2553, www.iafh.com,
jham@iahf.com

To Whom it May Concern at FDA:
Your proposed rule to limit manufacturers ability to properly inform the
American public on the health benefits of dietary supplements flies in the
face of sound public health policy, and constitutes nothing more than a
crass and despicable effort to protect the interests of multinational
pharmaceutical giants whose profits you protect at the expense of the
American public.

Your bias against the use of dietary supplements is glaringly apparent in
the case of FDA v Pharmanex, manufacturers of a product called Cholestin,
an extract of red rice yeast, which you (and Merck) falsely maintain
contains the prescription drug "lovastatin" which is sold by Merck under
the trade name "Mevacor".

Norman Farnsworth, Ph.D. is a Research Professor in Pharmacognosy and
Senior University Scholar at University of Illinois. He is a former member
of the Presidentially Appointed Commission on Dietary Supplement Labels. On
December 15, 1997 he sent a letter to Michael A. Friedman, MD, Lead Deputy
Commissioner of the FDA to inform you thusly: "Cholestin does not contain a
prescription or regulated drug. It contains mevolin, which is chemically
distinct from Lovastatin (Mevacor), the latter being a prescription drug.
This fact, in combination with a knowledge that the fermented red rice
product has been used as a food or dietary supplement both in China and the
United States for many years, in my opinion makes the product a "dietary
supplement" as defined in DSHEA. Further, DSHEA was enacted by Congress
"....following public debate concerning the importance of dietary
supplements in leading a healthier life, the need for consumers to have
current and accurate information about supplements and controversy over the
FDA's regulatory approach to dietary supplements...." (CDSL Report p.v)
Farnsworth goes on to state: "The FDA Final Rules on labeling statements,
in my opinion, were not helpful to industry as to how to craft truthful and
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."

CDSL took two years to study this matter, yet it is painfully evident that
in your zeal to "harmonize" American food and drug laws to EEC 65/65 (An EU
directive which turns all dietary supplements into "drugs") that you choose
to utterly IGNORE this Presidentially Appointed Commission, and further
waste our tax dollars attacking Pharmanex due to the revolving door between
the FDA and such pharmaceutical giants as Merck. The American people have
spoken, FDA. We told you to keep your hands off our supplements, and we
MEAN it! I am ccing this to my congressman to request that he cosponsor HR
2868 The Consumer Health Free Speech Act, which removes "food" from the
current, overly broad statutory definition of "drug" because FOODS are NOT
DRUGS!!!!

We are ON to your little shell game, FDA! We have TAKEN NOTICE of the
despicable efforts of the EU funded ESCOP at University of Exeter in the UK
to attempt to force the global harmonization of laws governing the
manufacture and sale of herbal products, just as we are ALSO enraged by the
German Codex Proposal to restrict our access to only RDA levels of vitamins
& minerals! IAHF has exposed the whole scam at www.iahf.com, especially the
ANPR in the July 7, 1997 Federal Register (Vol. 62, #129, pp. 36243-36248)
in which you vow to "harm-onize" your regs to emerging Codex (and ESCOP)
full ISO pharmaceutical standards! BACK OFF, FDA, OBEY THE LAW, & LISTEN TO
FARNSWORTH!
(cc to my Senators & Congressman)
Name ________________________________________________
Date_____________________

Address_____________________________________________________________________
___

City
__________________________________________________State___________Zip_______
_____
******************************************
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!!!