Errors-To: <>
Date: Thu, 03 Sep 1998 02:19:36 -0400
From: John Hammell <>
Subject: CNN Wants U.S.Herbs Regulated as "Drugs" Like in
  Germany-Quotes Schwabe-

CNN ran an alarming story on Sept. 1 (see complete article below) which
promotes the interest of German Phytopharmaceutical firm Schwabe
International (and although not directly stated, Schwabe's US partners
Nature's Way). These companies would like for herbs to be regulated as
"drugs" in the USA, and CNN is clearly on their side, pushing for tougher
regulation for herbs and other supplements. Active Grassroots action is
badly needed to offset this push!

With CNN now actively promoting the interests of the proGermans who want to
turn herbs into drugs in the USA and to bring in the same kind of mindless,
pro pharmaceutical regulation here, we must redouble our efforts to flood
the form letter (at the end) in to the FDA and Congress. Additionally, if
you wish for me to go to Berlin to monitor the Codex meeting Sept 21-25, I
need your donations NOW in order to get there to monitor the Codex shell
game so we don't get BURNED.

The CNN story (belwo) is from  CNN extolls the (alleged)
virtures of the way dietary supplements and herbs are regulated in Germany,
as opposed to the USA. I find it disturbing that CNN quoted Schwabe
International, a large German Phytopharmaceutical Company which is
partnered with Nature's Way in the USA (which contributes heavily to so
called "Citizens for Health"-- which I regard to be "controlled opposition"
which PURPORTS to be defending health freedom, while in actuality, they are
slyly maneuvering us in the wrong direction.

If CFH were behind HR 2868, I might not believe this... but unfortunately,
there are too many indicators that they are far more on the side of
Nature's Way and their German partners, Schwabe, and Madaus AG than they
are on the side of American consumers... Consumers need to help their local
health food store owners to SEE PAST THE SPIN put out by NNFA, their own
trade association- which echos the views of CFH/Nature's Way. The
proGermans don't want HR 2868 because they don't want a level playing
field. Their "excuse" is that they don't want to "open up DSHEA", but this
is ludicrous!

(Two years ago the same people opposed HR 1951 which would have plugged the
gaping holes in DSHEA which are allowing FDA to attack us _NOW_ via their
Proposed Rule, and CFH said the same thing THEN about "not wanting to open
up DSHEA"! (I BELIEVE they don't want to "open it up" but seriously
question their MOTIVES.) The unlevel playing field being pushed by the
proGermans threatens to drive small companies out of business, to limit
your access to supplements, and to force you to pay much higher prices.
Nature's Way is certified by the FDA as an OTC drug manufacturing facility.
How many OTHER US dietary supplement companies are? (Very few). Do the
smaller companies which can't afford the costs invovled with HACCP GMPs
deserve to be driven out of business, and should consumers be forced to pay
higher costs for these products? CNN sure thinks so! It is imperative that
you distribute this alert to more people and that you send in the form
letter at the end to the FDA and to Congress-- even if you already have.
Heres the CNN article:

Study: More doctors learning
alternative medicine, but safety
still questioned

                  September 1, 1998
                  Web posted at: 6:08 p.m. EDT (2208 GMT)

                  From Medical Correspondent Al

                  BERLIN (CNN) -- Although
                  so-called "natural medicines" are the
                  routine remedy for an estimated
                  one-third of the U.S. population, few
                  doctors routinely prescribe them.

                  However, according to a new study in the Journal of the
American Medical
                  Association, more doctors may soon be prescribing zinc
for the common cold
                  or St. John's wort for depression.

                  The study shows more than half of medical schools in the
United States now
                  offer at least some courses in "alternative" therapies.

                  If more doctors are aware of treatments such as
acupuncture and herbal
                  remedies, it may be easier for them to discuss it with
their patients.

                  "Roughly three-fourths of those who use alternative
therapies never mention
                  this to their doctors," said Dr. David Eisenberg of Beth
Israel Deaconess
                  Medical Center in Boston. "So it's my sense that the
current status quo, which
                  could easily be described as 'don't ask, don't tell,' is
obsolete and needs to be

                  But many doctors say they wonder if they can trust
alternative therapies.
                  They want the U.S. Food and Drug Administration to
require the same level
                  of scientific proof of natural medicines the FDA requires
of prescription drugs.

                  But unless Congress changes federal law, the FDA is very
limited in its
                  authority to regulate botanical or herbal treatments.

                  In Germany, where the herb St. John's wort, not Prozac,
is the
                  most-prescribed anti-depressant, the alternative medicine
industry is regulated
                  by the government.

                  "Something like a sixth of all the products on the market
are natural products,
                  and many of the leading prescribed products are indeed
natural products," said
                  Melvin Eaves of herbal drug company Schwabe International.

                  Germany's Commission E requires natural medicine
manufacturers to prove
                  their products are safe and effective in much the same
way the FDA controls
                  prescription drugs in the United States.

                  Schwabe International's variety of natural medicines are
shipped around the
                  world. But on U.S. shelves, their pills are up against
competitors that don't
                  need to meet the same standards for potency and quality.

                  "This is a great problem in your country," said Dr.
Dieter Loew of Commission
                  E. "You have a lot of ginkgo biloba, a lot of hypericum
(St. John's wort), but
                  the quality of one is not the same as the other."

                  The commission does more than ensure consistency for
botanicals -- it also
                  sponsors extensive scientific research.

                  "Most of the clinical research that's conducted on the
leading herbal medicines
                  in the United States comes from Germany," said Mark
Blumenthal, chairman
                  of the American Botanical Council.

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! 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. It is imperative that we bury the FDA with
complaints about CSPI’s comments, and that we insist that the FDA demand
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, email us at, for more info call 800-333-2553.  (Get in to FDA by Sept.
19, if possible, Sept. 27th at latest.)
----------------------------cut here-----------------------------------cut
Submit comments to: Dockets Management Branch (HFA 305) FDA, 200 C. St. SW,
Washington, DC 20204 (email 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

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.



City:________________________________State: __________ Zip:_______________


Am On the US Codex Delegation, But the Gov.
Doesn't Pay Our Way for NGO Observers
If YOU Want the Shell Game Monitored-
Kindly Help Met To Defend YOUR Access to
Send Check or MO in US $ to:
John C. Hammell, legislative advocate
IAHF 2411 Monroe St.
Hollywood, Florida 33020 USA
800-333-2553, 954-929-2905 outside USA, fax 954-929-0507