**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!!!