Immune Formula

Healthcare Professional Product Guide

This is an educational publication provided to
help licensed healthcare practitioners understand
the science upon which Immune Formula is
based and the mechanism of action by which
Immune Formula works.This pamphlet should
not be used to sell Immune Formula, and it
should be distributed only to licensed healthcare practitioners.
The only claims that can be made for
Immune Formula are those that have been
approved by the Company.

A Scientific Product Review

Comprehensive blend of immune-enhancing ingredients*

Official Sponsor of the 20002004 U.S. Olympic Team

36 USC 220506

*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.

Immune Formula

Immune Boost*
Summary
Immune Formula is a dietary supplement developed
and marketed by Pharmanex, LLC to support the bodys
natural immune function.* Immune Formula contains
a proprietary blend of vitamin C, echinacea, goldenseal,
and two unique immune-stimulating ingredients
arabinogalactan and beta-sitosterol. Each of these ingredients has been shown individually to boost immune
function during the cold and wet weather season and
support the bodys natural immune function.* Immune
Formula provides beneficial levels of active ingredients
correctly standardized for optimal results.

Background
The immune system is an intricate system with a
variety of functions vital to health.When functioning
properly, the immune system performs the following
important functions:

Maintains the integrity of the body,

Protects against invasion by pathogens,
Removes damaged or aged cells,
Seeks out and destroy altered cells damaged by
oxidative stress.

Cells, tissues, organs, and products of the immune

system are found throughout the body.Among the organs
that are involved with the immune system are the bones,
thymus and spleen. Components of the immune system
include T cells (including T helper and T cytotoxic cells),
B cells, natural killer (NK) cells, macrophages, monocytes,
neutrophils, and a host of other cell types.
The immune system also has the capacity to overreact
or, in contrast, lose its ability to respond appropriately.1
Oxidative stress can cause several types of immune
dysfunction. Examples of these include rheumatoid
arthritis, the decline of immune function associated with
the aging process, and the effects of environmental factors,
such as cigarette smoking. Decreased immune function
is a widespread and serious problem among the elderly,
resulting in highly increased morbidity and mortality
under a variety of circumstances. A number of studies
with vitamin supplements show significant benefits for
immune function in the elderly. Other reviews have also
documented the benefit of essential nutrients, including
antioxidants, for proper immune function.2, 3

Primary Active Constituents

Immune Formula contains a proprietary blend of
vitamin C, echinacea, goldenseal, and two unique immunestimulating ingredientsarabinogalactan and beta-sitosterol.
Each of these ingredients has been shown individually
to support the bodys natural immune function.*
Echinacea species contain a variety of chemical
compounds that contribute to their activity.These chemical
classes include caffeic acid derivatives, flavonoids, essential
oil, polyacetylenes, alkylamides, alkaloids, polysaccharides,
and other constituents.413 Immune Formula is standardized to provide a 6:1 extract of Echinacea (Echinacea
purpurea) Root.
The primary active constituents of goldenseal are the
isoquinoline alkaloids hydrastine and berberine. Goldenseal
contains lesser amounts of canadine (tetrahydroberberine),
berberastine, hydrastidine, isohydrastidine, (s)-corypalmine,
(s)-isocorypalmine, and 1-alpha hydrastine.14 Immune
Formula is standardized to provide a 4:1 extract of
Goldenseal (Hydrastis candensis).
Arabinogalactan is a highly branched polysaccharide
consisting of a galactan, galactose and arabinose sugars, with
a galactose/arabinose ratio of 9:1.1517 The arabinogalactan
extract found in Immune Formula is derived from the
Larch tree, and is standardized to 98% arabinogalactan.15, 18
Beta-sitosterol is one of several plant sterols found in
almost all plants. High levels are found in rice bran, wheat
germ, corn oils, and soybeans. Immune Formula provides
a purified source of beta-sitosterol from soybean and
vegetable oils.

Mechanisms of Action
Immune Formula has multiple mechanisms of action
to support the bodys natural immune function.* These
mechanisms include the involvement of vitamin C,
echinacea, and arabinogalactan in cell-mediated immune
function.4, 7, 15, 1933 Secondly, beta-sitosterol appears to
modulate immune function and the inflammatory response
through its effects on the production of inflammatory
cytokines.34, 35 Lastly, arabinogalactan may support the
bodys natural protective mechanisms; it has been shown
to block bacteria and viruses from attaching and binding
to cell membranes in the liver and other organs.16, 18, 29
Arabinogalactan may also improve gastrointestinal health
by influencing two primary gut microflora, lactobacilli
and bifidobacteria.16, 29

Health Benefits
Immune Formula supports the bodys natural
immune function and may boost immune function

*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.

during the cold and wet weather season.* This product

is indicated for individuals who want to support the bodys
natural immune function.*

Clinical Evidence of Efficacy

Vitamin CClinical Studies
Vitamin C has been shown in clinical studies to help
prevent overt and marginal nutritional deficiencies, decrease
incidence and duration of acute infections, and increase
immune cell proliferation.The studies have evaluated the
effects of supplemental vitamin C in various age groups,
including young adults and the elderly, who often experience an age-associated decline in immune function;
the studies have also involved healthy adults, smokers, and
patients with acute infections.
Dietary intake data analyzed from NHANES II
identified that vitamin C status may correlate with
respiratory symptoms. NHANES II was conducted on a
sample representative of the civilian, non-institutionalized
U.S. population, which included 9,074 white and
black adults aged 30 years and over.When multiple nutrients and total caloric intake were considered for each
respiratory outcome, bronchitis and wheezing were
negatively associated with serum vitamin C.36
A review of four clinical trials with British schoolchildren stated that there was a highly significant average
reduction in common cold incidence of 30%.37 In several
trials, vitamin C supplementation (200 mg/day) also
significantly reduced the incidence of acute respiratory
infections, including pneumonia and influenza A
infections.38 In a trial involving elderly patients, this
relatively modest oral dose led to a significant increase
in plasma and white cell vitamin C concentration even
in the presence of acute respiratory infection.39
Aging is associated with a greater susceptibility to
progressive senescence of the immune system.Vitamin C
supplementation (200 mg/day) produced a more significant
effect on immune cell proliferation in older adults compared
to young adults. At baseline, leukocyte count, absolute
neutrophil and lymphocyte numbers, and leucocyte
ascorbic acid concentration were significantly lower in
older adults. Supplementation with vitamin C enhanced
immunocompetent cells and the ascorbic acid concentration in leucocytes, and suppressed leucocyte migration
in older individuals.27 Cigarette smoking greatly increases
the free radical burden.The micronutrient most affected
by cigarette smoking is vitamin C; however, data suggests
that about 250 mg vitamin C is required to maintain the
same blood levels for smokers as for nonsmokers consuming
the RDA of 60 mg.1

Echinacea purpureaClinical Studies

Placebo-controlled clinical trials have shown that
supplementation with Echinacea (Echinacea purpurea) can
increase phagocytosis and speed up recovery time in subjects
with acute infections. Additional studies have found that
echinacea produces a general immune-stimulating effect
on various components of the immune system including
T lymphocytes, neutrophils, NK cells, tumor necrosis
factor alpha, granulocytes, macrophages, interleukins,
monocytes, antibodies, and phagocytic activity.4, 7, 1921, 33
In a double-blind trial with oral Echinacea purpurea
root, granulocytic phagocytosis increased by 120%
compared to 30% for the placebo group.40 In a placebocontrolled study with adults who had the first signs of
common cold symptoms, the median amount of time for
patient improvement was zero days for the Echinacea
group and 5 days for the placebo group.41 In another
clinical trial, patients on a high dose standardized Echinacea
extract showed significant reductions of flu-like symptoms
in 3 4 days; no significant changes were seen in the
placebo group.42

GoldensealClinical Studies
Goldenseal has been shown to speed up recovery
time in subjects with diarrhea, and decrease diarrhea
volume in clinical studies.43 In one study, 400 mg of
goldenseal (berberine sulfate) produced a significantly
higher rate of recovery from E. coli-induced diarrhea
within 24 hours of treatment and significantly lower
stool volume in subjects with cholera-induced diarrhea.
Other research has also indicated that goldenseal may
be beneficial for some forms of diarrhea.44, 45

ArabinogalactanClinical Studies
Clinical studies with arabinogalactan (ImmunEnhancer
AG), have demonstrated increased immune cell proliferation, increased levels of gut microflora, and improved
quality of life in patients with acute infections.46 In a
double-blind, placebo-controlled, randomized trial in
healthy adult females, assessment by quality of life
measurements showed significant improvement in overall
physical health, vitality and emotional health, including
symptoms associated with digestive function, bowel
habits, sleep and mood in the treated group compared to
placebo.46 Studies at the University of Minnesota and the
Southwest College of Naturopathic Medicine have shown
increases in total white blood cells, absolute monocyte
counts, and neutrophil counts. Consumption of arabinogalactan also produced a 47% increase in Lactobacillus
and Bifidobacterium levels in the gut. In another study,

*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.

these friendly bacteria increased almost 3-fold in human

subjects with consumption of arabinogalactan.4749
The arabinogalactan extract used in Immune Formula
has been shown to be even more effective in human
blood tests than Echinacea at stimulating macrophages and
other components of the immune system (see graph 1).30, 31
While the effectiveness of Echinacea decreased as dosages
increased, no decline in performance was seen with the
arabinogalactan preparation.30

Graph 1
ImmunEnhancer AG vs. Echinacea
120

Echinacea
ImmunEnhancer AG

Immune cell
count

100
80

Side Effects

60

There are no known side effects at the recommended

dosage.Allergic responses to the herbs are very infrequent,
and are limited to a few case reports.51, 52

40
20

Safety and Toxicity

0
25

100

250

750

Beta SitosterolClinical Studies

In vivo and in vitro studies have found that beta
sitosterol and its glucoside can increase proliferation of
T cells, increase concentration of lymphocytes and
eosinophils, and improve general immune response in
human subjects. An in vivo study demonstrated that
proliferation of T-cells was significantly enhanced in
healthy adult subjects after four weeks ingestion of beta
sitosterol, when compared with baseline values.31, 50 A
blinded, randomized, placebo-controlled clinical study
evaluated the adjuvant effect of beta sitosterol in the
treatment of pulmonary tuberculosis patients. Change
in lymphocyte counts from baseline was significantly
higher in the sitosterol group as was the increase in
eosinophil counts.34

Proprietary Processing
The combination of quality ingredients, qualified
manufacturers, certified independent laboratory verification,
and a continuous drive to supply leading edge products,
ensure our representatives and consumers the highest quality
products available in the industry. Immune Formula is
standardized to provide a 6:1 extract of Echinacea
(Echinacea purpurea) Root and a 4:1 extract of Goldenseal
(Hydrastis candensis).The aribinogalactan extract found

in Immune Formula is derived from the Larch tree, and

is standardized to 98% arabinogalactan.15, 18 Immune
Formula also provides a purified source of beta-sitosterol
from soybean and vegetable oils.
The vitamins and minerals used in Pharmanex
products meet the requirements and guidelines established by the United States Pharmacopoeia (USP) and/or
Food Chemicals Codex (FCC), where applicable. All
ingredients are tested for purity, and where applicable,
ingredients are certified pure by microbial testing, such as
tests for Salmonella, E. coli, other coliforms, Staphylococcus
aureus, total plate counts, yeasts, molds and pesticide
residues. Our manufacturers go through a detailed selection
and certification process to assure their compliance with
Good Manufacturing Practice (GMP) standards set by the
Food and Drug Administration (FDA).

Immune Formula is safe and well-tolerated at the

recommended dosage.4 Chronic administration of freshpressed juice from the aerial parts of Echinacea purpurea
to rats at many times the human therapeutic dose resulted
in no evidence of toxic effects.Tests for mutagenicity and
carcinogenicity registered negative.53, 54
It has been reported that Goldenseal is well tolerated
at the therapeutic dose of 500 mg.55
The Tolerable Upper Intake Level (UL) for adults with
vitamin C is set at 2 g/day; the adverse effects upon which
the UL is based are osmotic diarrhea and gastrointestinal
disturbances.56 Considerable evidence from clinical trials
has revealed no pattern of adverse effects with intakes up
to 10 grams/day over several months. The evidence of
adverse effects of vitamin C is so nebulous that no Lower
Observed Adverse Effects Level (LOAEL) can be established.The No Observed Adverse Effects Level (NOAEL)
has been set at more than 1000 mg.57
Arabinogalactan is Generally Recognized As Safe
(GRAS).17 Clinical feedback suggests an occasional reaction
of bloating and flatulence in less than three percent of
individuals. This side effect might be secondary to the
effect arabinogalactan has on the gut microflora.15, 31
Sitosterols are among the most abundant sterols found
in plants.34, 58 Also known as phytosterols, plant sterols,
abundant in fat-soluble fractions of plants, are consumed
at levels of 200 400 mg/day in Western diets.59

*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.

Contraindications and Drug Interactions

According to the German Commission E monograph, the use of echinacea is not recommended in
cases of progressive systemic diseases such as AIDS,
tuberculosis or diabetes or autoimmune-related diseases
such as multiple sclerosis, leukemia, lupus erythematosus,
collagenosis and other connective tissue diseases, or
tendency to allergies.60, 61, 62 There are no known drug
interactions with Echinacea. Although goldenseal is
generally nontoxic at recommended dosages, at high
dosages goldenseal may interfere with vitamin B metabolism.63 It has been stated that people with high blood
pressure should avoid goldenseal.63 If you are pregnant
or nursing, or taking a prescription medication, consult
a physician before using this product.

5.

6.

7.
8.

9.

Directions for Use

10.

Immune Formula is a dietary supplement for individuals who want to support the bodys natural immune
function.Take one (1) capsule one to three (3) times daily.
Use as needed for up to two (2) weeks, followed by a
resting period of at least one week.

11.
12.

How Supplied
Immune Formula is supplied in a 30-day supply of
60 capsules. Each natural gelatin capsule contains 200 mg
of vitamin C (as calcium ascorbate), 225 mg of Echinacea
(Echinacea purpurea) Root extract, 125 mg of Goldenseal
(Hydrastis canensis) Root, 100 mg of Arabinogalacatan,
and 30 mg of Beta-Sitosterol.

13.

14.

15.

Storage
Store in a cool, dry place. Avoid excessive heat.
Protect from light.

16.

Shelf-Life

17.

Expiration date and lot code numbers are stamped

on the side of the bottle.

18.

Warnings

19.

Keep out of reach of children. If you are pregnant

or nursing, or taking a prescription medication, consult
a physician before using this product.

20.

References

21.

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Bauer R, Wagner H. Echinacea Species as potential immunostimulatory drugs. In: Farnsworth NR,Wagner H, eds. Phytomed-

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*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.

25. Kaneda Y. In vitro effects of Berberine Sulphate on the growth

and structure of Entamoeba histolytica, Giardia lamblia and
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28. Penn ND, Purkins L, Kelleher J, Heatley RV, Mascie-Taylor BH,
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*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.

The Pharmanex 6S Quality Process

The Pharmanex 6S Quality Process is central to the Pharmanex
mission of transforming time-honored, traditional preparations into
health promoting botanical products with known content and consistent activity.

Selection

Exhaustive scientific review of research and databases is conducted.

Authenticity, usefulness, and safety standards are determined.

Sourcing

Teams of experts investigate potential sources and evaluate quality.

Comprehensive botanical and chemical evaluations are completed.

Structure

Structural analyses of natural compounds are determined.

Active ingredients are isolated and studied.

Standardization Strict standardization to at least one relevant marker molecule is required.

Proprietary processing methods to increase consistency and ensure measured dose
effectiveness are developed.
Safety

Safety is assessed from available research.

Microbial test, chemical, toxin, and heavy metal analyses are conducted.

Substantiation

Documented pre-clinical and clinical studies are reviewed.

Pharmanex sponsored studies are initiated when appropriate.

For More Information:

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Customer Service 1-800-487-1000 or FAX us at 1-800 -800 - 0259.
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