At 09:01 AM 8/28/98 -0700, you wrote:
>Dear Mr. Hammell,
>    You should really get your facts straight before you accuse companies
like
>Nature's Way of conspiring to take over the supplement industry.  You are
>lucky they did not sue for slander.  Your lack of research and proof of
>conspiracy have made you look like an idiot.  You should be ashamed that you
>have now contributed to the instability of the healthfood industry by
>spreading damaging rumors.  Do your homework and give the company you are
>accusing a chance to explain before you start spouting untrue stories.
>Perhaps you have read Nature's Way's rebuttle to your accusations.  They have
>done their homework and it looks like you stand guilty of your own slander.
><A HREF="http://www.naturesway.com/naturesway/controversy/response.html">John
>Hammell's Accusations Are False</A>
> I and everyone I have ask about this believes Nature's Way and thinks of you
>as a unreliable zealot that blackens the image of the healthfood industry.  I
>do not work for them, I work at a health food store that sells their
>supplements along with all the others in the industry.  They are a good
>company that has only the best intentions.  I wish I we could say the same
for
>you.
>Ann Yearsley

Ann- Theres "TRIAL BY TV" and now it appears that we have "TRIAL BY
WEBSITE". Ann, What things "look like" on the SURFACE and the _TRUTH_ are
often poles apart! As a consumer advocate I TOTALLY lack respect for
growing numbers of so called "dietary supplement" companies, which are
increasingly being proven UNWORTHY of consumer support as pharmaceutical
interests buy their way in to our industry! Do you sell Christopher
Enterprises whole herbal products? You SHOULD, and if you read on, you'll
learn WHY! Its always a pleasure to respond to unfounded criticisms such as
Nature's Way's, and I thank you for this opportunity! Nature's Way has no
basis to sue me for expressing my strong opinions, but you certainly aren't
going to learn the truth from THEIR spin controlled drivel. What is your
fax number, Ann?

Please let me have your fax number, phone number, and your snail mail
address for the sake of your enlightenment.I have an inch and a half thick
stack of documents which are on public file at the FDA having been
submitted by the European American Phytomedicines Coalition to the FDA
since 1992 in an effort to get herbs regulated as... (would you
believe?)... DRUGS(!) There are two fundamental problems here: Nature's Way
is a member of the EAPC, I can fax you proof, and herbs are FOODS, _NOT_
"drugs", which is why we need HR 2868 in order to remove food from the
overly broad statutory definition of "drug". This will allow us to make
therapeutic claims on dietary supplements as long as they're true! THIS is
the bill that we need to put FDA back in their place, ESPECIALLY if they
should ignore our comments to their current Proposed Rule which threatens
to block commercial free speech.

A substance should ONLY be deemed to be a "Drug" based on its toxicity,
carcinogenicity, mutagenicity, and taratogenicity. If a substance has
therapeutic properties, that alone DOES _NOT_ make it a "drug", and under
the first amendment to our Constitution, Congress shall make NO LAW...,
abridging our freedom of speech... Consumers have a RIGHT to learn of the
therapeutic properties of dietary supplements, and I'm talking FULL
THERAPEUTIC claims, not merely so called "structure function claims."

Nature's Way is a member of the EAPC, and I can fax you proof. This is not
conjecture, this is a fact. Nature's Way is a pharmaceutical company as
evidenced by the fast that they are FDA certified to manufacture OTC DRUGS.
They don't want a level playing field, which is WHY they've never been
behind HR 2868, the Consumer Health Free Speech Act, and it is indeed
saddening when myopic health food store owners, who lack the time to do
more than skim the surface of these issues, are unaware of the degree to
which they are being manipulated by pharmaceutical interests, not only in
the USA, but all over the world. HR 2868 has 7 cosponsors, and will be
reintroduced in the next Congress. Any health food store which doesn't
support this bill should be actively boycotted by consumers.

To clarify, there is nothing UNLAWFUL about anything the EAPC or Nature's
Way are doing, but consumers and health food stores should be aware of
_ALL_ pharmaceutical efforts to BUY THEIR WAY IN TO OUR INDUSTRY, as well
as a lot of other things that you're being kept in the dark about through
the professional spin control apparatus of which you have obviously run
afoul. Nature's Way was originally built on John Christoper's whole herbal
formulas. When NW formed their partnership with Madaus AG and Schwabe, they
attempted to improve on God by "standardizing" all their products and at
some point, with great arrogance,STOPPED PAYING COMMISSIONS to Christopher
Enterprizes for the use of his formulas, the ethics of which some people,
including me question. Many people feel that Christopher Enterprises are
currently been raped by this drug company known as Nature's Way.

Personally, I question strongly whether NW's standardized formulas are
better than the Christopher's whole herbal formulas, and I only use
Christopher's original formulas- regarding so called "standardization" to
be a process which alters the natural synergy found in whole herbs. Many
naturopaths and herbalists share my views against standardization,(which we
regard as turning herbs into "drugs" by potentizing the batches) including
Dr.David Christopher, John Christopher's son, who is a master herbalist and
who runs the School of Natural Healing
<www.schoolofnaturalhealing.com/instructors.html> Christopher Enterprises
excellent whole herbal products can be seen at www.drchristopher.com  and
their's is a company truly deserving of consumer loyalty. Dr.Christopher's
daughter, Ruth Bacalla, ably runs Christopher Enterprises today, never
forgetting her father's unselfish crusade for truth in which he was
unjustly imprisoned, accused of "practicing medicine without a license."
Your health food store should carry Dr. Christopher's Whole Herbal formulas
and consumers should support the company because they will NEVER sell out!

The EAPC consists of some American herb companies which in the opinion of
many (not just me) have sold out by forming partnerships with offshore
phytopharmaceutical companies, particularly German companies such as Madaus
AG and Schwabe (which are involved with ESCOP- the European Scientific
Cooperative on Phytotherapy).

ESCOP is developing monographs for standardizing the manufacture of these
products as "drugs." I am leery of ESCOP due to their involvement with the
TRAMED biopiracy program at the University of Capetown in South Africa,
which is stealing the indigenous knowledge of African herbalists in order
to pirate the knowledge and turn herbs into "drugs". I have been exposing
this with a S.African health freedom organization called PHARMAPACT. Please
learn more about PHARMAPACT by visiting their website via
http://iahf.com/africa/98061a.html

I was in S.Africa in May for 10 days and was the keynote speaker at a
Health Freedom Rally. S.Africans are trying hard to keep the Australian
listings system from being imposed upon them, just as Canadians are, and if
you only realized what is really going on, you'd recognize the truth, which
is that the FDA's current proposed rule is an ongoing effort to force
harmonization to EEC 65/65 in the EU, where all dietary supplements are
regulated as "drugs" and where restrictions are outrageous!

I encourage you to learn more about the roll up which has been occurring in
our industry  by downloading an article titled "The European Phytomedicines
Market Figures, Trends, and Analysis by Jorg Grunwald, who is a consultant
to the German phytomedicines industry.

You'll find this article at
http://www.healthy.net/hwlibraryjournals/herbalgram/1995/summer/index.html

To save you the trouble, I have downloaded it and pasted it into this
message (below my coments.)
 

In figure 6 on p.8, he clearly illustrates the problem of "roll up" which
has been occurring as pharmaceutical giants keep buying their way into our
industry. From the article you will also learn a few things about the
economics which is driving the pharmaceutical takeover. American Home
Products has acquired Dr.Much (Germany). (Incidentally, they have also
acquired Solgar, quite recently.) Boerhinger Ingleheim has acquired
Pharmaton (Switzerland) and Quest (the largest vitamin company in Canada),
Boots has acquired Kanold (Germany), Bausch and Lomb has acquired Dr. Mann
(Germany), Degussa has acquired Asta Medica (Germany), Fujisawa has
acquired Klinge (Germany), Johnson and Johnson/Merck has acquired Woelm
Pharma (Germany), Pfizer has acquired Mack (Germany), Rhone Poulenc Roherer
has acquired Natterman (Germany), Sanofi has acquired Plantorgan (Germany),
Searle has acquired Heumann (Germany), SmithKline Beecham has acquired Fink
(Germany), Solvay has acquired Kali Chemie, Sandoz expressed an interest in
acquiring Madaus, and was rejected, however Madaus and Schwabe are the two
largest of the German phytopharmaceutical companies probably have a steep
price.

Far from being the "unreliable zealot" that you characterize me as, in
reality, I am a person who has working professionally as a consultant to
the health food industry for the past 10 years, and I've done far more than
most to truly defend the cause of health freedom, and am not afraid of
making controversial statements in defense of what, in my opinion, is true.

Due largely to my efforts to sound an international alarm, we drove the
German vitamin proposal backwards from Step 5 to step 3 at the Codex
meeting last June in Geneva, and at the end of this mssg you'll find my
latest form letter which reflects the extended FDA comments period which
still needs addressing right on through September 27th, as well as the need
to flood the FDA with comments in light of the upcoming Codex meetin in
Berlin, Sept. 21-25th. I will be on the US delegation in Berlin, monitoring
Dr.Yetley of the FDA as well as the other harlot bastions of officialdom
from other countries. If you wish to contribute to my airfare to Berlin,
your assistance would be most welcome as I make little money doing this work.

I recovered from a life threatening illness 20 years ago via a suppressed
alternative treatment mode involving the use of dietary supplements
(orthomolecular medicine), and all I want is for other people to have the
same chance I've had in order to heal.

It is important for you to know that elements within our industry exercise
considerable political control within NNFA, UNPA, AHPA and so called
"Citizens for Health" and that the pharamceutical industry has their
tentacles deep into these organizations through the roll up process
described in the article below. This is why NNFA has opposed HR 1951 in the
past (which would have plugged the gaping holes in DSHEA which currently
allow the FDA to come at us with their proposed rule to limit
structure/function claims), and most recently, HR 2868, the bill which
would stop FDA dead in their tracks by removing food from the current,
overly broad statutory definition of "drug", thus allowing us to make
therapeutic claims on dietary supplements, as should be allowed under the
first amendment- but which FDA blocks, as evidenced by their legal attack
on Cholestin, which still hasn't been resolved, the Judges injunction not
withstanding.

If the Courts rule Cholestin to be an "unapproved new drug" there will be a
dire need for this industry to get behind HR 2868, but you'll never see
Nature's Way lead that charge, because its not in their best interests to
have a level playing field. They are licensed by the FDA as an OTC drug
manufacturing facility, and they would much prefer that the FDA regulate
herbs as drugs, in my opinion. This would certainly help them and their
German partners to expand their N.American market.

It saddens me greatly that Susan Haeger of Citizens for Health takes her
marching orders from Loren Israelson, who is counsel to the EAPC as well as
to Nature's Way, rather than from her own legislative director, Jim Turner,
who sees the need to get behind HR 2868. Members of Citizens for Health
should strongly question why Haeger doesn't even listen to her legislative
director and get behind HR 2868, and why she listens to Israelson, who is
unequivocally a representative of pharmaceutical interests- outward
appearances to the contrary notwithstanding. I suspect strongly that this
may boil down to who provides CFH with funding (Israelson appears to have
more clout with Haeger because he is counsel to Nature's Way which provides
funds to CFH, which I suspect Jim Turner may not be able to match.) Turner
is also a health freedom attorney and a good one. He is the author of a
good book that I recommend called "The Chemical Feast" which is about
corruption within the pharmaceutical/chemical industries and the FDA.

I have evidence on both sides of the US, Canadian border that Nature's Way
has not been working in the best interests of consumers, and if you wish to
verify what I'm saying, please contact Debbie Anderson, of Citizens Voice
for Health Rights, in British Columbia, Canada, at 604-793-9087, or Marilyn
Nelson, Freedom of Choice in Health Care at 416-282-6496. They have been
working with Grant Hill's office (Hill is a member of the Canadian
Parliament) in an effort to get the Foods are Not Drugs amendment passed to
protect Health Freedom in Canada, but Nature's Way has not supported this
effort north of the border. Nature's Way is involved with a coalition which
many Canadians regard to be "fake grass roots" called the "Canadian
Coalition for Health Freedom" which has been politically pushing in the
direction of harmonization with the Australian listings system, which is
very similar to the system which has so  repressed health freedom in Norway.

For your perusal, Grunwald's article follows:
 

The European Phytomedicines Market
Figures, Trends, Analyses

by Jörg Grünwald, Ph.D.
Director, Medical-Scientific Department, Lichtwer Pharma GmbH
Berlin, Germany
 

European roots of phytotherapy

In many cultures prehistoric people used plants to treat physical
complaints. Besides China, Central Europe produced the most solid
documentation of early plant use as medicines. Most importantly, Greek and
Roman medical practices, as preserved in the documents of Hippocrates and
Galen, provided the patterns for later western medicine. The first European
document on the properties and uses of medicinal plants was compiled by the
Greek physician Dioscorides in the first century A D. This compendium
described the use of more than 500 plants and remained the major reference
up to the 17th century.

In later periods special treatment forms developed like the system of
homeopathic medicine, which was founded in the 19th century by Samuel
Hahnemann or the water cure from the German physician Sebastian Kneipp.

In our recent time the use of herbal medicines in Europe is rather
diversified. In some countries like Germany, France or Italy the treatment
with phytomedicines is well established and regulated by the health
authorities. Many phytomedicines are even reimbursed by the health
insurance system. In other countries, like in Great Britain and the
Netherlands, most phytomedicines are regarded as food supplements without
any medicinal claims. Due to the European Union (EU) harmonisation there
will be dramatic changes in the European phytomedicine market in the near
future.

The purpose of this article is to summarize the present situation of
phytomedicines on the European market, to interpret actual changes and to
analyze the importance of
these facts for the United States.

Definition of phytomedicines

The terms phytotherapy and phytomedicines were first introduced by the
French physician Henri Leclerc (1870-1955). By definition phytomedicines
are therapeutics
based only on plant material either from the complete plant or extracts
used for treatment purposes. Approximately 500 plants are therapeutically
used as starting
material for the production of medicines. For example the German medicines
list (Rote Liste) contains 40 percent of drugs based on plant material. [1]
In the United
States 23 percent of all prescriptions contained plant substances, at least
in 1976. [2]

Table 1. Herbal Medical Sales by Selected Regions
Country
Million US $ RSP
EU 6,000
Rest of Europe 500
Asia 2,300
Japan 2,100
North America 1,500

Total 12.4 billion US $
RSP=Retail Sales Prices
Source: IMS 1994 and The Herbal Medical Database 1993
 
 

The world market of herbal remedies

Only very few data exist regarding the world market of phytomedicines or
herbal medical sales. Table 1 summarizes the data obtained from IMS in 1994
[3] and The Herbal Medical Data Base in 1993 [4] indicating the largest
sales with 6 billion US $ retail sales price (RSP) in Europe compared to
2.1 billion in Japan, 2.3 billion in the rest of Asia and approximately 1.5
billion in North America. The annual growth rates in all regions are
impressive, as indicated in table 2. Since Europe has the strongest market
position, growth rates are smaller compared to Asia or the U. S.

One important reason for the strong market position of phytomedicines in
Europe is their historic acceptance and high share in the reimbursement
system for drugs. While in Germany and France approximately 40 percent of
all herbal remedies are reimbursed, the situation is much less for the
United Kingdom (UK), the US or Canada, where only plant laxatives are
partially reimbursed.
 

The reason for the strong market growth of phytomedicines in the last
decades is most probably due to several changes in the health environment.
Due to an increasing age of the population the amount of chronic diseases
is growing and the results of the conventional treatments in these cases
are often unsatisfactory. Many patients refuse to swallow more and more
"chemical" drugs with long lists of side-effects and ask their physician
for "natural" biological alternatives. If the physician is not willing to
provide other forms of complementary medicine, they will look for ways to
experience more patient-orientated therapeutic approaches.

The typical consumers of complementary medicine tend to have less faith in
conventional medicine. They believe that one can build up resistance to
disease and want to have control over their own health and disease. Most of
them are better educated and have more than a medium income. [5]

Regional differences and trends

Phytomedicines can be regarded as bridging the gap between traditional
based complementary medicine and the highly scientific conventional medicine.

As shown in figure 1 this link is best established in the European medical
community. For example, in Germany more than 80 percent of all physicians
regularly use plant medications. Even in Europe the trend of complementary
medicine is still increasing, especially the scientifically well-documented
phytomedicines which are more and more accepted and appreciated not only by
the patients but also by most of the physicians.

In Asia both therapeutic forms--complementary and conventional
medicine--are practiced in parallel, but none of the two is regarded as the
only therapy being the truth for human health.

The situation in the U.S. seems to be different from the two above
mentioned regions. Complementary medicine and conventional medicine are far
apart and regarded from both sides as "strange enemies." The basis for this
discrepancy has certainly historic reasons but also based on a lack of
information from many physicians in the US. While every student of medicine
in Germany has to learn about complementary medicine and especially
phytomedicine, the education for US students neglects these treatment
forms. On the other hand, the community supporting complementary medicines
does not see a need for clinical proof of effectiveness for these treatment
forms, being proposed by some.

Additionally, most of the scientific papers regarding phytomedicines are
published in European journals, often not in English, since their market is
Germany, France or Italy.

This situation might change quickly when the American health authorities
realize the demand of the population for well proven alternatives in
medical treatment. Whenever public funding for phytomedicine research
becomes available in greater amounts, the scientific community will find
out about the European data in this area and try to catch up quickly.
 
 

The actual situation in Europe

The market situation in Europe is very diversified regarding the sales of
herbal drugs. The leading market is in Germany with annual sales of $3
billion US RSP. Germany covers 50 percent of the EU market with spendings
of $37 annually per inhabitant. The second place with $1.6 billion US and
26.5 percent of the EU market is France, followed by Italy, the UK, Spain,
the Netherlands and Belgium.

This gives an overall annual sales amount of $6 billion US spent for herbal
drugs in the EU. Every member of the European community spends a mean of
17.4 US $ per year on phytomedicines (Table 3).

Phytomedicines cover a broad range of different indications. The categories
are indicated in figure 2, showing that the largest proportion is spent for
herbal drugsinfluencing the cardiovascular system followed by the
respiratory system for cough and cold, the gastrointestinal system for
digestive improvements, tonics, hypnotics and
sedatives, as well as topicals. [6]

The leading European products are indicated in Table 4. The most successful
single plant in Europe is Ginkgo biloba for the improvement of brain
circulation, high in
prescriptions in Germany and France. The leading product Teboninreg. rom
the company Schwabe sells for approximately $200 million US manufacturer
sales price
(MSP).

Following is Ginsanareg., the leading Ginseng product from
Pharmaton/Boehringer Ingelheim, accounting for approximately $50 million
US. Subsequently the leading
garlic product Kwaireg. from Lichtwer Pharma with approximately $40 million
US. [4]

Table 2. Annual Growths by Region (%)

Region     Growth 1985-1991  Growth 1991-1992  Forecast  1993-1998
North America  10     12     12
EU    10      5      8
Rest of Europe  12      8     12
Japan   18     15     15
SE Asia   15     12     12
India and Pakistan 12     15     15

Source: The Herbal Medical Database 1993
 
 

Registration status of phytomedicines in Europe

In the past the situation in Europe differed a lot regarding the
registration status of phytomedicines. In Germany for example a special
commission (Kommission E) of the
Bundesgesundheitsamt (the German Federal Health Agency) was responsible for
developing plant monographs. Based on safety and efficacy data, more than
230 positive monographs were published in the Bundesanzeiger (equivalent to
the Federal Register).

Phytomedicines could be marketed according to the indications, mentioned in
the monographs. If those indications are generally reimbursed by the health
insurance system, there is no difference in reimbursement for chemical or
plant based products.

In France is a list of over 200 plants with 37 indications of their
traditional use. As well as in Germany many phytomedicines are reimbursed
in France. In the UK most phytomedicines are in the General Sales List
category and sold as food supplements without any reimbursement possibility.

This divestification within Europe led to the situation that a single
product, for example Ginkgo biloba, was reimbursed in Germany and France
and sold as food supplement in the UK and in the Netherlands. Another
example: Garlic is available in Germany as semiethical (ciara - Explain)
reimbursed product for cholesterol lowering besides being and OTC drug. In
France garlic had a traditional claim without reimbursement and in the
Netherlands it is sold as food supplement. The situation for Hypericum (St.
John's Wort) is similar: reimbursed semiethical as well as OTC in Germany,
only available as an OTC drug in France and food supplement in the
Netherlands.
 

The European situation will change dramatically in the near future since
all member states have to adapt to EU laws. According to EU directive 65/65
phytomedicines are treated as drugs and registrations based on quality,
safety and efficacy will be required. [7]

The European Scientific Cooperative for Phytomedicines ciara - therapy?
(ESCOP) prepares European monographs or summaries of products
characteristics (SPC's), which should be used as the basis for European
registrations of phytomedicines. Besides national registrations in every
member state there exists the decentralized registration procedure starting
January 1, 1995.

If a drug is registered in one EU member state, the registration holder can
apply for mutual recognition in other member states. The other countries
have to answer within 90 days. If no agreement can be reached, the central
EU agency (Committee for Proprietary Medicinal Products, CPMP) has to find
an EU-wide decision, which is binding for all member states. In addition,
there will be national regulations regarding traditionally used medicines
with lower levels of indications.

The growth rate of phytomedicines in Europe

European phytomedicines are still growing at a higher percentage than the
overall pharmaceutical market. According to Nicolas Hall Company [6] the
growth rates in 1993 for selected countries were the following: Spain 35
percent, Germany 15 percent, Italy 11 percent, UK 10 percent.

The high increase in Spain is explainable by a small phytomedicine market
and the recent growth of which is higher from a percentage point of view,
although it is much smaller from a dollar perspective, compared to the
other markets.

In the UK the overall growth by 10 percent was highlighted by several
products growing extremely well, like garlic with a 16 percent increase in
1993.

Table 3. OTC Herbal Drug Sales in European Union
Member  Annual Retail Sales (US$)
State  Total in Millions  Percent  Per Capita
Germany  $3000    50%   $37.0
France  $1,600    26.5    28.0
Italy  600     10.0        10.5
United Kingdom 300     5.0     5.0
Spain  230     4.0     6.0
Netherlands 100     1.5     6.5
Belgium  40     1.0     4.0
Rest   130     2.0     4.5
Total  $6,000    100.0%  $17.4
Source: IMS, 1994
 
 

Phytomedicines in Germany

As indicated earlier, Germany has the largest market share of
phytomedicines in Europe. Figure 3 illustrates the situation of the
nonrescription drug market in German
pharmacies from the year 1993. [8] Almost 1/3 of all non
""prescription-only" drugs were phytomedicines (27 percent). This category
is divided in two parts: 12 percent
are prescribed and reimbursed semiethical phytomedicines accounting for a
volume of cents0.9 billion US and 15 percent are pure OTC phytomedicines,
accounting for
$1.1 billion US in retail sales prices.
 

The most prescribed herbal mono-preparations in Germany are listed in Table
5. [9] The leading product again is Ginkgo biloba with total sales of $280
million US RSP,
followed by horse-chestnut with $103 million US.

Under the non-prescription phytomedicines garlic tablets are the leading
product category. According to actual surveys 7 million Germans take garlic
supplements
regularly, which accounts for about 8 percent of the German population. The
leading garlic product Kwaireg. holds about 50 percent of the pharmacy
market share with
an annual sales volume of $50 million US.

Changes in the phytomedicine industry

The majority of leading companies, specialized in phytomedicines, are
located in Germany, France, Italy and Switzerland. Some of them are over
100 years old and many are still privately owned.

***In the last decade a tendency of multinational pharmaceutical companies,
to buy smaller phytomedicine oriented companies in Europe, can be observed.
Table 6 summarizes such acquisitions, where also several American companies
like American Home Products, Bausch and Lomb, Johnson & Johnson, Pfizer and
Searle can be found. Other developments in this regard are joint ventures
between European phytomedicine companies and American partners. Nature's
Way was founded in 1969 and later became Murdock Health Care. In 1988
Madaus Murdock was founded as a joint venture between the German Madaus and
Murdock Healthcare in the US. In 1993, Madaus and the German firm Schwabe
formed a new entity, Murdock-Madaus-Schwabe (MMS). The new corporate entity
which markets the Nature's Way and Naturalife brands in the U. S.

A further group of multinational pharmaceutical companies market
phytomedicines in several countries, which are produced by smaller
companies, specialized in phytomedicines. Such collaborations exist, e. g.,
between the Ciba Geigy daughter Zyma, which sells a special phytomedicines
line called "Valverde," produced by the phytomedicines company Zeller AG in
Switzerland.

Also the BASF daughter Knoll in Germany sells products from Zeller AG. In
selected regions companies like Boehringer Ingelheim (Sweden), Lederle
(Australia) and Schering (Belgium and Hungary) sell phytomedicines, in
these cases the garlic product Kwaireg. from the German company Lichtwer
Pharma.

The overall development makes clear that the historic situation of European
companies, specialized in phytomedicines, has began to change.
Multinational companies are interested in this strongly developing market
segment. The future will probably lead to more concentration.

Table 4. Leading European Products
 
Product  Manufacturer  Million US $     Plant
      (manufacturer's selling price)
Tebonin  Schwabe     $195     Ginkgo biloba
Ginsana  Pharmaton/Boehringer Ing. 50     Ginseng
Kwai   Lichtwer     40     Garlic
Efamol  Scotia Pharm.    30     Evening Primrose
Echinacin  Madaus     30     Echinacea

Source: The Herbal Medical Database 1993
 
 

Current obstacles and opportunities

The European market situation of phytomedicines indicates which
developmentmight be possible in the U. S. There is strong growth
internationally of complementary medicine and an increasing trend of
phytomedicineuse. The longest experience in these products regarding
quality, safety, and efficacy comes from Europe and European companies are
interested in bringing their high quality products to the U.S. One approach
is the European American Phytomedicine Coalition (EAPC), which
leading European phytomedicine companies have joined to undertake a common
approach to the US market. Difficulties have occurred with the U.S. FDA
since the OTC regulations restrict information from outside the U.S. This
situation is hopefully changing since a meeting of the NIH-Office of
Alternative Medicine in cooperation with the Food and Drug Administration
seemed to offer a more open-minded approach and possible changes in the
registration laws for phytomedicines in the future.

Table 5. Most Prescribed Herbal Monopreparations in Germany
Herbal DRUG  Therapeutic Class   Retail Sales US $ (mil.)
Ginkgo Biloba  Circulatory Agent   $280
Horse Chestnut  Venous Agent    103
Yeast   Antidiarrheal Agent   48
Crataegus   Cardiac Agent    27
Urtica   Urologic Agent    33
Hypericum   Antidepressant    26
Echinacea   Immunstimulant    9
Valerian   Sedative     5

Source: Arzneimittelverordnungsreport 1994
 

Table 6. Acquisitions of Phytomedicine Companies by Multinational
Pharmaceutical Companies
Multinational Pharmaceutical Firm  Phytomedicine Company
American Home Products    Dr. Much (Germany)
Boehringer Ingelheim    Pharmaton (Switzerland) Quest(Canada)
Boots       Kanold (Germany)
Bausch and Lomb     Dr. Mann (Germany)

Degussa       Asta Medica (Germany)
Fujisawa       Klinge (Germany)
Johnson & Johnson/Merck    Woelm Pharma (Germany)
Pfizer       Mack (Germany)
Rhone Poulenc Rohrer    Natterman (Germany)
Sanofi       Plantorgan (Germany)
Searle       Heumann (Germany)
SmithKline Beecham     Fink (Germany)
Solvay       Kali Chemie (C)
Discussed/Rejected:
Sandoz       Madaus (Germany)
 
 

On the other hand, there are several obstacles attached to phytomedicines.
Usually they are not protected by patents and, therefore, can be copied
very easily. Also, until recently no medical claims were allowed in the
U.S. and even the Dietary Supplement Health and Education Act of 1994 only
allows limited "structure and function" claims for herbs as dietary
supplements. Therapeutic or drug claims are still not allowed.

The DSHEA opens better possibilities for dietary supplements. No medical
claims can be used, but changes in the structure and function of the human
body by phytomedicines can be mentioned in advertisements and product labels.

Product quality is an other critical issue. In contrast to chemical
substances plants vary in their composition and, therefore, quality has to
be controlled carefully. The know-how of the active ingredients and their
quantification is costly in terms of time and money and for medical claims
multi million dollar clinical trials are expected by the FDA.

Furthermore the medical community in the U.S. is still skeptical towards
phytomedicines, but hopefully government funding will attract their
interest in this exciting, very
old but, for the U.S., rather new group of medicines.--Jörg Grünwald, Ph.D.

[Author's addresses - 1 - Lichtwer Pharma GmbH, Wallenroder Straße 8 - 10,
D - 13435 Berlin, Germany. 2 - W. Schwabe (full name and address to come)]

Literature
1. Haas , H. (1991) Arzneipflanzenkunde. BI-Wiss-Verlag, Mannheim: 1- 196.

2. Farnsworth, N. R., Morris, R. W. (1976) Higher plants the sleeping giant
of drug development. Am J Pharmacy 148: 46 - 52.

3. Institute of Medical Statistics (1994) In: Eaves M: The European
Experience. Symposium "Botanicals: A Role in US Health Care?" Washington,
Dec. 1994.

4. The Herbal Medical Data Base (1993) Who's Who in the World Herbal
Medical Industry. Mc Alpine, Thorpe and Warrier Limited, London.

5. De Smet PAGM (1993) An introduction to herbal pharmacoepidemiology. J
Ethnopharmacology 39: 197 - 208.

6. Nicholas Hall Report (1994) Natural Remedies, International Overview.
Nicholas Hall Company, Southend-on-Sea.

7. Keller K (1994) Phytotherapy at a European level. European
Phytotelegram, ESCOP August 1994: 40 - 45.

8. Bundesverband der Arzneimittel-Hersteller BAH (1994) Das freie
Medikament, 6/94.

9. Schwab U, Paffrath D (1994) Arzneiverordnungs-Report '94. Gustav Fischer
Verlag, Stuttgart.
 

©1995 HerbalGram

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

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 iahf.com, email us at
jham@iahf.com, for more info call 800-333-2553.  (Get in to FDA by Sept.
19, if possible, Sept. 27th at latest.)
----------------------------cut here-----------------------------------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

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)