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DEPARTMENT
OF HEALTH&
HUMAN SERVICES
‘
Food and Drug Administration
Washington, DC 20204
OCT-IIW7
B
Ms. Eileen Sheets
Product Manager
Bioforce of America, Ltd.
P.O. Box 507
Kinderhook, New York 12106
Public Health Service
(35!5 7
●
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Dear Ms. Sheets:
This is in response to your letter of August 20, 1997 to the Food and Drug
Administration (FDA) pursuant to section 403(r)(6) of the Federal Food, Drug, and
Cosmetic Act (the act), Your submission states that Bioforce of America, Ltd. is
making the following claims, among others, for “Bio-Strath Original” and “Bio-Strath
Drops:”
“... fewer headaches”
(product insert, section entitled Increased Co ncentration)
“.. patients.. presenting with pre-geriatric disorders were treated” (product insert,
section entitled Pre-Geriatric Study on B1o-Strath.
“Marked improvements were noted in patients from both active treatment groups at the
end of the period in terms of virtually all the characteristics of pre-geriatric illness... ”
(product insert, as above)
“There were significant to highly significant improvements in GEDIS values (GEDIS
= Geriatric Diagnosis Scale for evaluation of age-related concomitant disorders)
(product insert, as above)
Section 403(r)(6) of the act makes clear that a statement included in labeling under the
authority of that section may not claim to diagnose, mitigate, treat, cure, or prevent a
specific disease or class of diseases. The statements that you are making for this
product in the product insert suggest that these products are intended to treat or prevent
disease, namely headaches and chronic diseases of aging. These claims do not meet the
requirements of section 403(r)(6) of the act. These claims suggest that these products
are intended for use as a drug within the meaning of section 201(g)(l)(B) of the act, and
that they are subject to regulation under the drug provisions of the act. If you intend to
make claims of this nature, you should contact FDA’s Center for Drug Evaluation and
Research (CDER), Office of Compliance, HFD-3 10,7520 Standish Place, Rockville,
Maryland 20855.
●
●
Page 2- Ms. Eileen Sheets
@
Please contact us if we may be of further assistance.
Sincerely yours,
James T. Tanner, Ph.D.
Acting Director
Division of Programs and Enforcement Policy
Office of Special Nutritional
Center for Food Safety
and Applied Nutrition
Copies:
FDA, Center for Drug Evaluation and Research, Office of Compliance, HFD-300
FDA, Office of the Associate Commissioner for Regulatory Affairs, OffIce of
Enforcement, HFC-200
FDA, Buffalo District Office, Domestic Operations Branch, HFR-NE350
.,.
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cc:
HFA-224 (w/incoming)
HFA-305 (docket 97S-01 63)
HFS-22 (CCO, KCarson)
HFS-456 (r/f, Moore)
HFS-450 (r/i_)
HFD-310 (BWilliams)
HFD-314 (Aronson)
HFS-600 (Reynolds)
r/d: HFS-456:RMoore:9/23 /97
Init:GCF-1 :PDerfler:9/25/97
f/t: HFS-456:rjm:9/25 /97:54475 &54476 .adv:disc22
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“.
,“
Bioforc~
.
of America, Ltd.
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August 26, 1997
Dr. Victor Fratelli
Office of Special Nutritional
Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 “C” Street, S.W/.(HFS-445)
Washington, DC 20204
Dear Dr. Tanner:
Enclosed please find sample box and insert for a dietary supplement BioStrath Drops. I am also attaching mock ups of the label, as I do not
have any sample labels. The copy without the picture is the final
version, which has the Iatin binominal names. The copy is of poor
quality and I have attached a good copy of the previous version without
the Iatin binomial names.
Sincerely yours,
BIOFORCE OF AMERICA, LTD.
&JLz’
Eileen Sheets
Product Manager
EMS.
tlifib
~Oforce
of America,
P.O. Box 507
KINDERHOOK, NY.
TEL: (518) 758-6060
FAX: (51 8) 758-9500
Ltd.
ma
12106
BIOFORCE AG
CH-9325 ROGGWILL TG
TEL.: 41714546161
TELEFAX: 41714546162
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BIO-STRATH@
BIO-STRATHQ
DROPS
DROPS
Ingredients: Flasmolysed
YeastSaccharornycs
If+
and the following herbs
Angelica (mot), Basil (herb), Chamomile
(flowers), Cinnamon (bark), Caraway (fruit), Eider
(flowers), Fennel (fruit), Horseradish (root), HyssoI
(leaves), Lavender (flowers), Lemon Balm (leaves:
Lmrice (root), Parsley (herb), Peppermint 0eave5,
Sage (leaves) and Thyme (herb).
cttrevisiae)
a.
COntainS naturally
OCCUflng
alcoholzs~o
WI
Directions: 3 times daily, 30 drops.
Manufactured by:
BiO-STRATH AG - ZURiCH
SWITZERLAND
I
\
NET 3.4 FL.OZ. (100 ml)
1007. Natural Dietay Supplement
—..-. .. ...
call:
1-800445-8802
NY .—..
12108
. . . . . . . . ..- .._.
_.. - ------------------
Kinderhook,
Use before
-.. —.. ... ...
1
12 mm
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----- .-. .—..-. ..---- ..
I
Facts see outer box or
impotid and distributed by:
BIOFORCE OF AMERICA, LTD.
Enhances concentration and short term
memory in persons of all ages.
This statmsnt
has not bssn waluatsd
by the Food and
Drug Adndnistratlon.
This product is not intendsd to
diagnose, treat, curs or prsvsnt any diseass.
ForSupplement
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BIO-STRATH@
ORIGINAL
and short-term
● Enhances concentration
● Enhances physical endurance
● Helps recover from physical exertion
memoty
in person of all ages
.
BIO-STRATH AND INCREASED
PERFORMANCE
Prof. E Dorling, Hamburg, Germany
“Swiss Pharma J.”, 1981, No. 11.
A marked
success
Published
in
for Bio-Strath:
Of 1,260 possible statements (fatigue, nervousness,
concentration, resistance, physical and mental capacity, vitality), a 10% improvement was reported by the
placebo group and a 64% improvement by the BioStrath group.
Even the results of the interviews alone suggest the
positive action of the Elixir. A comparison of the selfas$essments by the test subjects in the Bio-Strath
group prior to the start of the study and after 12 weeks
clearly illustrates this. The data is reinforced by the
results of the interviews after 2, 4, 6, 8, 10 and 12
weeks and by the results of the objective technical
measurements.
Specific observations made in the Bio-Strath group
were as follows: greater energy and enterprise, less
tiredness, improved sleep, improved digestion, fewer
headaches, less brittle nails, fresher skin.
INCREASED CONCENTRATION
A school trial by M. Neukomm,
Summary
Berne
of the results:
Once agaih, it has been possible to furnish proof that
Bio-Strath helps to improve performance in cases of
school fatigue, weakness in school and poor concentration. The effect is achieved, among other things, by
increasing concentration and endurance and by
reducing restlessness and weakness of memory.
There is a considerable concurrent increase in the
bodv’s resistance to infection and an improvement in
gen&al well-being. This is indicated by the subsidiary
results and demonstrated by medical trials and investigations in this context, these improvements having a
positive effect on performance.
PRE-GERIATRIC
STUDY ON BIO-STRATH
Rainer B. Pelka et. al. Published in notabene medici
Nr. 3: 122-125, Nr. 4196-201,
1990.
Summary: In a controlled study, 184 patients between
men and 66% women) prethe ages of 45 and 75 (34%.
senting with pre-geriatric disorders were treated over
a period of three months with a yeast preparation
manufactured according to a special process, in the
form of a syrup (placebo group nl =60, active treatment group n2=62), and also in tablet form (n3=62). Of
the 218 patients included in the study, treatment was
discontinued in three cases for medically unconfirmed
reasons relating to the therapy, whereas, in the other
cases where treatment was discontinued, the reasons
were unrelated to the therapy.
Marked improvements were noted in patients from
both active treatment groups at the end of the test
period in terms of virtually all the characteristics of pregeriatric illness which had been investigated. These
improvements came out significantly in favor of the
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active treatment groups compared
situation in the placebo group.
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with the initial
There were significant to highly significant improvements in GEDIS values (GEDIS = Geriatric Diagnosis
Scale for evaluation of age-related concomitant disorders), objective and subjective patient condition (more
or less equally in terms of somatic, mental and emotional states), and, finally, mental and physical performance as measured in the psychometric and ergometric tests, The mean test values deviated only slightly
from the standard ranges. Where improvements did
occur, they came out in favor of the active treatment
preparations.
At the start of the treatment, older patients presented
on average with more severe geriatric conditions than
younger patients. At the end of the study, their geriatric symptoms – compared with the initial situation had decreased more markedly than those of the younger patients.
EFFECTS OF SUBCLINICAL NUTRITIONAL
DEFICIENCIES IN HIGH-PERFORMANCE
3p0RTs
By Fritz Hans Schwarzenbach (originally published
in German in “Jugend und Sport,” June 1976
had certain beneficial effects. Apart from a positive
effect on performance in the 12-min endurance run,
there was statistically significant evidence of improved
sleep patterns (based on personal assessment).
The product could also be shown to have a general
stabilizing action, evident from the scores of personal
assessments particularly with regard to “appetite”,
“bowels”, and “concentration” (reduced scatter of
individual values above and below the mean). Furthermore, the sportsmen given Bio-Strath during the first
trial period were definitely better able to stand up to
the stress of the test march than those who had not
been given Bio-Strath beforehand.
For a number of reasons, top-level sportsmen are particularly liable to reach a crisis of exhaustion because
of nutritional deficiency. Nutritional deficiencies in topIevel sportsmen maybe due to increased utilization as
well as to decreased intake of essential nutrients.
It is not possible at present to establish which pafilcuIar constituents of the yeast plasmolysate Bio-Strath
are responsible for the effects observed in the trial.
There was clear evidence, however, that with the basic
diet given, some of the sportsmen suffered from nutritional deficiencies. Those deficiencies were evident
predominantly in the subjective assessments, and
they may be made good, at least in part, by the dietary
supplement (Bio-Strath).
DISCUSSION OF RESULTS
Preface: Excerpts of this interim report summarizes
the results of a broadly based nutritional study on topclass sportsmen in Finland,
BIOFORCE OF AMERICA,
Kinderhook NY 12106
Evaluation of nutritional studies requires the skillful
application of mathematical and statistical techniques
of analysis, so that differences in scatter and mean
values may be clearly demonstrable as due to certain
factors.
In the present trial, it was shown that the yeast plasmolysate Bio-Strath, given as a dietary supplement,
For copies of the complete studies, please call:
1-800-445-8802
Imported and distributed by
LTD
.
LIQUID
100% Natural - Only goodness goes in
●
Enhances concentration
and short-term
●
Memory in persons of all ages
Enhances physical endurance
●
Helps recover from physical exertion
These statements have not been evaluated by
the Food and Drug Administration. This product
is not intended to diagnose, treat, cure or prevent any disease.
In a modern laboratory, overlooking Lake Zurich in
Switzerland, the greatest possible care is taken to ensure that only goodness goes into BIO-STRATH.
In a unique biological Strath Process an especially cul. tivated Good Food Yeast of the type Saccharomyces
cerevisiae is combined with a variety of selected herbs.
This Herbal Yeast is - without heat - liquefied (plasmolysed) by fermentation. The valuable nutritive contents are slowly released from the cell walls by osmosis. In this form the Herbal Yeast is easily digested by
the body. After fermentation natural honey, malt and
the pure juice of oranges are added to the Liquid, not
however to the Tablets or Drops. The finished product
is automatically bottled and packed under the conditions of hygiene and cleanliness demanded in Switzerland.
BIO-STRATH is a special herbal yeast dietary Food
Supplement which is available in over 30 countries in
all 5 continents.
INGREDIENTS
Plasmolysed Yeast (Saccharomyces cerevisiae), Malt,
Honey, Orange juice and the following herbs: Angelica
(Angelica Archangelica) (root), Basil (Ocimum BasiIicum) (herb), Chamomile (Matricaria Chamomilla)
(flowers), Cinnamon (Cinnamomum) (bark), Caraway
(Carum carvi) (fruit), Elder (Sambucus nigra) (flowers),
Fennel (Foeniculum
vulgare) (fruit), Horseradish
(Cochlearia armoracia) (root), HYSSOP(HYssoPus officinalis) (leaves), Lavender (Lavandula officinalis) (flowers), Lemon Balm (Melissa ollcinalis) (leaves), Licorice (Glycyrrhiza glabra) (root), Parsley (Petroselinum
sativum) (herb), Peppermint (Mentha piperita) (leaves),
Sage (Salvia officinalis) (leaves) and Thyme (Thymus
vulgaris) (herb).
Naturally occurring alcohol from yeast fermentation
2.5 Y. Wlw.
DIRECTIONS
Three times daily, 1 teaspoonful.
BIO-STRATH is suitable for the whole family, professional people and athletes.
STORAGE
Do not expose the liquid product to direct sun or heat.
It contains yeast and may expand under extreme heat
which could cause the bottle to rupture.
CONTENTS
3.4 FI.OZ. (100 ml)
8.4 FI.OZ. (250 ml)
Supplement
Facts
Serving
Size1teaspoonful
BIO-STRATH is free from all artificial colorings, flavorings, preservatives and synthetic chemicals.
60800C6
US APATRT 696
Servinm
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container
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DROPS
TABLETS
4
INGREDIENTS
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INGREDIENTS
Plasmolysed Yeast (Saccharomyces cerevisiae) and
the following herbs: Angelica (Angelica Archangelica)
(root), Basil (Ocimum Basilicum) (herb), Chamomile
(Matricaria Chamomilla) (flowers), Cinnamon (Cinnamomum) (bark), Caraway (Carum carvi) (fruit), Elder
(Sambucus nigra) (flowers), Fennel (Foeniculum VUL
gare) (fruit), Horseradish (Cochlearia armoracia) (root),
Hyssop (Hyssopus officinalis) (leaves), Lavender
(Lavandula officinalis) (flowers), Lemon Balm (Melissa
officinalis) (leaves), Licorice (Glycyrrhiza glabra) (root),
Parsley (Petroselinum sativum) (herb), Peppermint
(Mentha piperita) (leaves), Sage (Salvia officinalis) (leaves) and Thyme (Thymus vulgaris) (herb).
Contains alcohol 25~0 w/w.
Yeast (Saccharomyces cerevisiae), Cellulose, Pectin
(from apples) and the following herbs: Angelica (AngeIica Archangelica) (root), Basil (Ocimum Basilicum)
(herb), Chamomile (Matricaria Chamomilla) (flowers),
Cinnamon (Cinnamomum) (bark), Caraway (Carum
carvi) (fruit), Elder (Sambucus nigra) (flowers), Fennel
(Foeniculum vulgare) (fruit), Horseradish (Cochlearia
armoracia) (root), Hyssop (Hyssopus officinalis) (leaves), Lavender (Lavandula officinalis) (flowers), Lemon
Balm (Melissa officinalis) (leaves), Licorice (Glycyrrhiza
glabra) (root), Parsley (Petroselinum sativum) (herb),
Peppermint (Mentha piperita) (leaves), Sage (Salvia
officinalis) (leaves) and Thyme (Thymus vulgaris)
(herb).
on
DIRECTIONS
Three times daily, 30 drops
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DIRECTIONS
Three times daily, 2 tablets.
BIO-STRATH is suitable for the whole family, professional people and athletes.
CONTENTS
3.4 FI.OZ. (100 ml)
BIO-STRATH is suitable for the whole family, professional people and athletes.
CONTENTS
100 Tablets/7.7 grains each
j Supplement
Serving Size 2 Tablets
Serwngs per container
Facts]
50
Am.,,.,. . . . . ...”.
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Calories
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Total Carbohydrates
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Manufactured and packaged in Switzerland
BIO-STRATH AG, Zurich/Switzerland
Imported and distributed
1-800-445-8802
by
by BIOFORCE OF AMERICA,
LTD, Kinderhook,
NY 12106
>,,
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Bioforck
i
of America, Ltd.
August 20, 1997
Dr. Victor Fratelli
Office of Special Nutritional
Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 “C” Streetr S.W. (HFS-455)
Washington, DC 20204
Dear
Dr. Tanner
Attached is a sample label, box and insert for a dietary supplement - BioStrath
Original (8.4 OZ) entered into commerce recently. At the next printingthe Latin
binomial nameswillbe included.
Sincerely yours,
BIOFORCE OF AMERICA, LTD.
&JdEileen Sheets
Product Manager
Encs
+
,$
Bioforce of America,
PO. Box 507
KrNDERHOOK,
N.Y. 12106
TEL
(5 I 8) 758-6o6o
FAX. (51S) 758-9500
Ltd.
BIOFORCE AG
CH-9325 ROGGWILL
TEL.: 41714546161
TG
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The Original
Formula
Swiss Herbal Yeast
Whatever our age, there are timeswhen
life demands that little bit extra, particularly when we are under pressure, feeling
tired and rundown
or recovering
from
illness. Fati ue and tiredness can affect
our daily 7wes and that’s when BIO-
STRATHOriginal can help!
Butyou don’t have to feel rundown be
fore taking Bic-Strath. Many athletes,
sportsmenand womentake it regularlyas
part of their fitnessregimento help when
they need that little bit extra.
Only Goodness Goes In
In a modern laboratory, overlooking !-ake
Zurich in Switzerland,
the greatest possible care is taken to ensure that only
goodness goes into Bi&trath.
This sp~
cial herbal yeast Dietary Supplement is
available in over 40 countrieson all 5
continents.
Manufactured
BIO-STRATH AG
SWITZERLAND
by
ZURICH
Imported and distributed by
BIOFORCE OF AMERICA,
Kinderhook, NY 12106
1-800445-8802
lTD
$!l
. ——_—.
—...--—
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Use before:
.:7?
—
mmi
m’mrm
from physica
exertion
Enhances physical enduranc
Nutrition Facts
Helps recover
Serving Size 1 teaspoonful
Servincss t3er container 50
I
] Amount Per Serving
Calaries 20
-
Enhances concentration and
short term memory in perso
of all ages.
% Doily
Vol”e’
@!E!&&!
“ PercentDaily
Values are bed
Studies have shown that 6imStrath
been helpfulfor enhanced physical p
formanceand recoveryafter exhaust
In addition, studies have demonstr
that Bia-Strath im roves Short te
memoryabilitiesancfhelpsenhancec
centration.Far more information, see
on a 2.0s0 calorie diet.
lngredents
Plasmolysed Yeast [Saccharomyces
cerevisiae), Malt, Honey, Orange Juice and
the following
herbs: An elica
root,
~asil
[~erb],
lemon
Balm
(leaves),
Chamomile
(flowers , Cinnamon
(bark),
Caraway
(fruit , Elc1er (flowers), Fennel
(fruit], Horsera i ish [root], Hyssop (leaves],
Lavender (flowers), Licorice (root], Parsley
(herb], Peppermint [leaves], Sage [leaves)
and Thyme (herb). Contains
naturally
occuring alcohol 2.5% w/w,
No Artificial Colors
No Artificial Sweeteners
No Preservatives
Only Goodness &ses In
Directions:
One or more teaspoonfuls doily as required.
Slerage
Do not expose this product to direct sun or
extreme heat. BicAtrath contains active
yeast and may expand under extreme heat
which could cause the bottle to break.
enclosed
insert, ar call
us,
These statements have not bee
evaluoted by the Food and Dru
Administration. This product is n
intended to dia nose, treatt cu
or prevent any 3 mease.
Specially
cultured food yeasts [Sacch
rom ces cerevisiae]
are nourished in
broi i of 16 helpful herbs, The Herb
Yeast is then liquefied (plasmolyzed)
fermentation withaut heat. The valuabl
nutritive contents are slowly released an
are then easily digested. Persons susce
tible to candida infections can take B
Strath without worry. The Yeast in B
Strath is the Good Food Yeast, and
unrelated to the candida yeast.
; —.-,
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