Dietary Supplement
Structure/Function Claims
|
Submitted to FDA
under the Dietary Supplement Health & Education
Act and compiled by F-D-C Reports, Inc. from
information recently made available by the
agency.
|
Company
|
Product/Ingredient
|
Date
|
FoodScience
of Vermont
|
Best
Digest
|
9/17/02
|
"Supports
healthy functioning of the digestive and urinary
systems."
|
FoodScience
of Vermont
|
Simple
Steps Carb Down
|
9/17/02
|
"Inhibits
carbohydrate absorption."
|
Gaia
Herbs
|
Astragalus
|
9/13/02
|
"Supports
healthy immune function."
|
Gaia
Herbs
|
Bilberry
|
9/13/02
|
"Supports
healthy eye function and circulation."
|
Gaia
Herbs
|
Black
Cohosh Root
|
9/13/02
|
"Supports
balanced change of life."
|
Gaia
Herbs
|
Echinacea
Supreme
|
9/13/02
|
"Ultimate
support for healthy immune function."
|
Gaia
Herbs
|
Feverfew
|
9/13/02
|
"Ultimate
support during stress and tension."
|
Gaia
Herbs
|
Ginkgo
Leaf
|
9/13/02
|
"Promotes
memory and circulation."
|
Gaia
Herbs
|
Hawthorn
Flower & Berry Supreme
|
9/13/02
|
"Ultimate
support of healthy cardiovascular function."
|
Gaia
Herbs
|
Kava
Kava
|
9/13/02
|
"Ultimate
support for relaxation."
|
Gaia
Herbs
|
Melissa
Supreme
|
9/13/02
|
"Supports
healthy attention levels."
|
Gaia
Herbs
|
Milk
Thistle Seed
|
9/13/02
|
"Ultimate
support for healthy liver function."
|
Gaia
Herbs
|
Valerian
Root
|
9/13/02
|
"For
ultimate support of restful sleep."
|
Global
Chinese Herbs Depot
|
Heart
Health Treasure (multi-ingredient)
|
9/04/02
|
"Helps
maintain healthy blood circulation."
|
Global
Chinese Herbs Depot
|
Puller
Herbal Extract Liquid (multi-ingredient)
|
8/28/02
|
"A natural
herb extract to help maintain healthy lung function
and support the immune system."
|
Global
Chinese Herbs Depot
|
Zhi Chang
Kang
|
8/28/02
|
"A natural
herbal extract to help maintain and support human
immune system."
|
Herbsforever
|
Blood
Cleaner (multi-ingredient)
|
9/16/02
|
"Helps to
maintain skin lustrous smooth and silky with natural
glow"; "Supports skin natural health and beauty";
"Maintains healthy blood circulation"; "Skin support
system from inside out": "Blood purification
support"; "Overall body health"; "A unique, balanced
natural herbal formula"; "Helps to keep a clean colon
and supports healthy liver and kidney functions";
"Recommended safe to be used along with any of our
other products as a body purifier to enhance their
fast effective results."
|
Herbsforever
|
Cholesterol
Health (commiphora mukul, terminalia arjuna, pearl
powder, inula racemosa)
|
9/16/02
|
"For
smokers, high fat diet consumers, overweight and
those having a highly stressful life"; "Guggul
(commiphora mukul) and terminalia arjuna along with
other herbs have been used safely for centuries in
Ayurveda (Indian herbal system) as a natural support
for healthy circulatory and cardiac function";
"Recent scientific studies confirm this."
|
Herbsforever
|
Digestive
Care (multi-ingredient)
|
9/16/02
|
"Helps
promote healthy digestive system and gastrointestinal
tract"; "Supports stomach function and food
absorption"; "A safe unique, balanced natural formula
that helps to alleviate occasional gas, minor heart
burn and minor acidity due to excessive/heavy food
intake and supports ingested food to the final
product"; "Considered a household product formulation
of herbs and spices, which have been sued safely for
centuries in South Asia as a home recipe"; "This
product is a natural support for healthy digestive
feeling in daily life."
|
Herbsforever
|
Female
Health (multi-ingredient)
|
9/16/02
|
"Supports
female body fitness"; "Provides energy, stamina,
vigor and vitality"; "Helps to reshape and revitalize
the body"; "A herbal tonic provides overall female
health"; "A unique, balanced natural support for the
nourishment and replenishment of the delicate female
body from regular wear and tear"; "This product has
herbs, which supports normal menstruation cycle,
firmness of skin tissues and are astringent in
action."
|
Herbsforever
|
Female-30
Plus (trifolium alexandrianum [arial plant], plant
estrogens-isoflavones extract)
|
9/16/02
|
"Nutritional support for females beyond 30";
"Promotes emotional well-being"; "Promotes bone
health and revitalizes the body"; "Trifolium
alexandrianum is rich in proteins, clacium, iron,
isoflavone and plant estrogens in natural form";
"Plant estrogens are close to human estrogens and the
body accepts them as such"; "Supplements the body's
own decreasing estrogen supply associated with
mid-life"; "Dietary supplement for women interested
in replenishing and maintaining healthy estrogen
consumption to a level similar to those of
traditional Latin and Asian diets, as Western diet
contains less plant estrogens."
|
Herbsforever
|
Gluco
Health (multi-ingredient)
|
9/16/02
|
"Stops
sugar craving"; "Natural herbal balanced sugar
regulator formula"; "Revitalizes body, optimizes many
body functions"; "A unique natural support as a
pancreatic tonic"; "The main herb gymnema sylvestre,
sanskrit name gurmar, blended with other herbs have
been used safely for centuries as part of daily diet
to help maintain healthy blood sugar level that is
already within the normal limits"; "Recent scientific
studies confirm this."
|
Herbsforever
|
Heart
Health (multi-ingredient)
|
9/16/02
|
"Supports
circulatory system"; "Helps to maintain healthy blood
pressure that is already within normal limits";
"Helps to support calmness and relaxation";
"Guggullipid (commiphora mukul) and terminalia arjuna
along with other herbs have been used safely for
centuries in Ayurveda (Indian herbal system) as a
natural support for healthy circulatory and cardiac
function"; "Recent scientific studies confirm
this."
|
Herbsforever
|
Joint
Health (multi-ingredient)
|
9/16/02
|
"Helps
maintain joint health and flexibility, supports
cartilage and joint function"; "Revitalizes body and
optimizes many body functions"; "Boswellia serrata
balanced with other effective herbs has been used for
centuries in Ayurvedic medicine (Indian plant
medicine)"; "A safe balanced herbal support for
healthy joints' function"; "Recent scientific studies
confirm this."
|
Herbsforever
|
LaxaComfort
(ginger powder, senna, licorice, Indian
laburnum)
|
9/16/02
|
"Alleviates
occasional constipation and helps to maintain
regularity"; "This products generally produces bowel
movement in 6 to 12 hours."
|
Herbsforever
|
Male-40
Plus (multi-ingredient)
|
9/16/02
|
"Natural
support of testosterone"; "Helps provide
concentration, bone and joint health"; "Supports
memory and daily life activity"; "Helps to provide
energy, stamina, vigor and vitality"; "Supports
healthy immune system"; "Has a particular method of
preparation according to traditional Tibetan theory,
which has been safely used for many centuries as part
of daily diet."
|
Herbsforever
|
Menopause
Health (multi-ingredient)
|
9/16/02
|
"Herbal
support for a normal, healthy attitude during and
post menopause"; "Natural support for mood swings and
hot flashes associated with menopause"; "A unique
herbal body tonic"; "This unique, balanced herbal
formula contains herbs that have a safe history of
usage for physical and emotional well being during
and post menopausal period."
|
Herbsforever
|
Reslim
(multi-ingredient)
|
9/16/02
|
"Supports
weight loss and body fitness"; "Helps decrease hunger
and desire for sugar"; "Provides energy and stamina";
"Keeps skin tight and healthy"; "Helps to lose weight
progressively the same way the body gains weight";
"It helps to keep skin tight while losing weight with
maximum health and ho side effects"; "A safe and
balanced formulation of garcinia cambogia (regulates
deposition of fatty acids) gymnema (neutralizes the
craving for sweets) gugglelipid (for normal
cholesterol) shilajit-mineral pitch (for healthy
R.B.C) ashwagandha (body tonic provides energy and
stamina)."
|
Herbsforever
|
Triphala
(emblica offcinalis, terminalia belerica, terminalia
chebula)
|
9/16/02
|
"A natural
detoxifying and rejuvenating formula"; "Helps to
rejuvenate the membrane lining of the digestive tract
and contributes to colon cleansing"; "Cooling in
nature"; "As per Ayurvedic theory helps to
reestablish the harmony of tridosa vatta (air) pitta
(fire) kapha (water) of human body in balanced
natural state"; "Recommended safe to be used before
or along with any herbal supplement as a body
purifier to enhance their effectivness."
|
Herbsforever
|
URI-Flush
(multi-ingredient)
|
9/16/02
|
"Helps
promote healthy urinary tract"; "Supports clear and
clean urinary tract"; "Supports healthy kidney
function"; "Revitalizes and optimizes many body
functions"; "A unique, balanced, natural herbal
formula, which contains many herbs that have been
used for centuries in Ayurveda (Indian herbal system)
as safe, natural support for urinary tract healthy
and kidney function."
|
Herbsforever
|
Vigor Forte
(multi-ingredient)
|
9/16/02
|
"Powerful
rejuvenator"; "Promotes sexual vigor and vitality";
"Supports erection and satisfactory libido"; "A
unique herbal body tonic that contains herbs sanskrit
name ashwagandha (means horse vitality)"; "Mineral
pitch sanskrit name shilajit (means rock warrior)
obtained from the Himalayan region"; "A natural
source of 84 minerals required by our body."
|
Herb
Pharm
|
St. John's
Wort
|
9/11/2002
|
"Promotes
positive mood and healthy emotional balance."
|
Indiana
Botanic Gardens
|
Memory
Complex Formula (under Botanic Choice brand
name)
|
8/21/2002
|
"Supplies
DHEA that decreases with age because it contains
DHEA-hormone"; "Helps mental clarity and alertness
because it contains L-Glutamine"; "Improves
circulation, oxygen and blood flow because it
contains ginkgo biloba"; "Supports physical endurance
because it contains eleuthero"; "Helps stimulate the
body because it contains peppermint"; "Energizes
cells because it contains gotu kola, lecithin and
choline."
|
Indiana
Botanic Gardens
|
Royal Jelly
Capsules (under Botanic Choice brand name)
|
8/21/02
|
"Helps
boost vitality"; "Protects the immune system";
"Promotes alertness, energy, and that get up and go
feeling"; "Plays a role in helping to maintain firm
youthful looking skin by protecting skin cells and
preserving collagen."
|
Indium For
Life
|
Indium-APW
(indium sulfate)
|
8/19/02
|
"Seems to
enhance the absorption of the minerals and improve
their utilization by the body"; "Seems to have a
positive effect on hormonal balance"; "Increases
levels of energy, speeds up metabolism, reduces
visible signs of aging, and enhances sense of
well-being."
|
Leiner
|
Menopause
Formula
|
7/29/02
|
"Daytime
relief: lack of energy, hot flashes, irritability,
mood swings"; "Nighttime relief: occasional
sleeplessness, night sweats, hot flashes"; "24-hour
relief of menopause symptoms"; "AM/PM menopause
formula is the only natural formula to relieve the
common menopause symptoms you may experience during
the day and at night"; "AM formula features
standardized ginseng and green tea to give you
daytime energy"; "PM formula offers theanine and
valerian to help you sleep better"; "Both include
time-tested black cohosh for relief of hot flashes,
night sweats, and irritability."
|
Leiner
|
YourLife
Concentrated Garlic
|
3/27/02
|
"Helps
regulate already healthy cholesterol"; "Research
indicates that consumption of garlic helps retain
normal, healthy cholesterol and blood pressure
levels. Scientific studies suggest that the frequent
inclusion of garlic in the diet may offer another
means to help maintain good health."
|
Michael's
Naturopathic Programs
|
Michael's
Naturopathic Programs Green Tea Extract
|
9/10/02
|
"Ephedra-free thermogenesis"; "Has a
controlled dosage of polyphenols enhanced with 50 mg
of quercetin, an important bioflavanoid, further
enhancing the formula's thermogenic effects. One
great benefit of this standardized 90 mg of catechin
in this green tea extract is its ability to stimulate
thermogenesis without the associated increase in
heart rate. Green tea extract is known as an
all-natural fat burner, meaning it can increase fat
oxidation while sparing lean muscle mass in all body
types. Additionally, the polyphenol epigallocatechin
gallate (EGCG), which is found in green tea, is
recognized as a powerful antioxidant, among other
health benefits."
|
Michael's
Naturopathic Programs
|
Michael's
Naturopathic Programs Probiotic Factors
|
9/10/02
|
"FOS are
natural carbohydrates that enhance replication of
beneficial bacteria"; "Six species promote healthy
intestinal flora balance."
|
Michael's
Naturopathic Programs
|
Michael's
Naturopathic Programs Reishi Extract
|
9/10/02
|
"Our
exclusive hot water process removes all of the
naturally occurring indigestible materials found in
mushrooms and mushroom mycelium bio-mass, leaving you
with a potent 100% of the pure active compounds";
"Made exclusively from the fruit body, the only part
of Reishi that contains those compounds traditionally
used for their tonic properties."
|
Michael's
Naturopathic Programs
|
Michael's
Naturopathic Programs Cordyceps Extract
|
9/10/02
|
"Our
exclusive hot water process removes all of the
naturally occurring indigestible materials found in
mushrooms and mushroom mycelium bio-mass, leaving you
with a potent 100% of the pure active compounds";
"Used to increase energy and endurance, cordyceps is
also used for supporting respiratory and immune
health and as a male sexual tonic."
|
MTI
BioTech
|
Re-Vigor
(multi-ingredient)
|
8/13/02
|
"Clinically
proven to maintain muscle and strength"; "The first
nutritional supplement proven to reverse
age-associated muscle loss and function without the
rigors of exercise. The patented Re-Vigor formula is
safe and works by targeting the underlying cause of
muscle loss and reversing it."
|
Natural
Organics
|
Ultra
Cranberry Chewable (cranberry)
|
8/5/02
|
"Nutritional support for healthy urinary
tract and overall well-being."
|
Natural
Organics
|
Ultra
Source of Life (lutein, vitamins and minerals)
|
8/5/02
|
"Nutritional support for natural energy
production, healthy eye function and overall
well-being."
|
Natural
Organics
|
Ultra
Lutein (lutein, zeaxanthin)
|
8/5/02
|
"Nutritional support for healthy eye
function."
|
Natural
Organics
|
Lemon/Lime
Chewable Vitamin C (vitamin C)
|
8/5/02
|
"Nutritional Support for free radical
defense and overall well-being."
|
Nature's
Way
|
EFA Blend
for Children (fish oil, evening primrose oil)
|
9/13/02
|
"Eye and
brain function formula. DHA and related omega-3
polyunstaruated fatty acids are major elements of
both brain and eye tissue"; "Combines the researched
levels of these key essential fatty acids to support
eye and brain function."
|
New Vision
International
|
Liquid
Essentials for Women
|
9/6/02
|
"Specifically designed to meet the
nutritional needs of women throughout their
reproductive cycle and through the transition of
menopause, this formula features black cohosh, an
herb used traditionally by Native Americans and over
the last half century in Europe for natural relief of
PMS and menopause symptoms"; "Relieves symptoms
commonly associated with PMS and menopause, including
hot flashes, irritability, night sweats and related
sleeplessness"; "Includes soy isoflavones and
important vitamins B-6, B-12 and folic acid commonly
used for symptom relief and nutritional support";
"Nutritional support for relief of PMS and menopause
symptoms"; "Provides relief for hot flashes,
irritability, night sweats and related
sleeplessness"; "Experience natural relief of the
uncomfortable symptoms often associated with PMS and
menopause today!"; "Designed to meet the needs of
women of all ages, especially those looking for
relief of symptoms commonly associated with PMS and
menopause"; "Vitamin B-12 - Along with folic acid,
provides some of the necessary nutrients for DNA
synthesis, nerve cell function and provides heart
health benefits"; "Vitamin B-6 - This nutrient is
needed by the body to make seratonin, melatonin, and
dopamine that are essential for the regulation of
mental processes."
|
New York
Healthy Herbs
|
Health Plus
for Women (multi-ingredient)
|
9/15/02
|
"Helps
women to revitalize her body's feminine activities
and energy."
|
NOW
Foods
|
Black
Walnut 500 mg
|
8/7/02
|
"Black
walnut hulls come from the immature fruit of the
black walnut tree (Juglans nigra). References
to the use of black walnut hulls dates back to the
ancient Greeks and Romans, and they have been used by
many cultures throughout history as an herbal tonic.
The black walnut tree is indigenous to the Middle
East, but is currently grown in the U.S., Canada, and
Europe as well."
|
NOW
Foods
|
Coral
Calcium 1000 mg
|
8/7/02
|
"Now coral
calcium contains an alkaline form of calcium that can
help to support a healthy serum pH. In addition,
coral calcium contains a number of trace minerals
that are important for bone health, as well as for
optimal enzymatic activity. Now coral calcium is not
harvested from living coral reefs or even from the
ocean environment, but from above-ground sources in
an ecologically friendly manner."
|
NOW
Foods
|
Elder
Flower and Berry Extract
|
7/27/02
|
"Elder
(Sambucus nigra) is a small tree indigenous to
Europe and to Western and Central Asia and the use of
its berry and flower dates back to ancient Rome. More
recently, elderberry has been recognized for its high
nutritive value. Elderberry provides both vitamins A
and C, as well as anthocyanins, which are potent free
radical scavengers."
|
NOW
Foods
|
Fennel Seed
Caps, 500 mg
|
7/27/02
|
"Fennel
(Foeniculum vulgare) is an herb that is native
to the Mediterranean region, but is currently
cultivated in most temperate areas where cooks
appreciate it for its culinary uses. The constituent
oils of fennel seed have been shown to possess
considerable antioxidant activity."
|
NOW
Foods
|
Feverfew
|
7/27/02
|
"Feverfew
(Tanacetum parthenium) is an herb native to
southwest Europe and its use dates back to ancient
Greece. Recent studies have validated the efficacy of
Feverfew for the relief of occasional headaches. In
addition, significant scientific evidence inidcates
that Feverfew may help to support healthy
cardiovascular and immune function. NOW Feverfew
contains 4% parthenolides, which are considered to be
the bioactive constituents of the herb."
|
NOW
Foods
|
Organic
Alfalfa Leaf, 400 mg Caps
|
7/27/02
|
"Alfalfa
(Medicago sativa) is a perennial herb that is
indigenous to the Middle East. Because of its deep
root system, Alfalfa is better able to absorb
minerals from the soil than other plants. Therefore,
Alfalfa is a rich source of vitamins and minerals, as
well as chlorophyll. NOW Alfalfa Leaf Caps contain
only organic Alfalfa, so it contains no pesticide or
herbicide residues."
|
NOW
Foods
|
Parsley,
450 mg Caps
|
7/27/02
|
"Parsley
(Petroselinum crispum) is an herb native to
the Mediterrancean region, but is not cultivated in
most temperate regions of the world. Parsley was
known as early as the first century and was used by
the ancient Greeks and Romans as both a flavoring and
garnish. Parsley provides potassium, vitamin A, and
folate and is high in chlorophyll. The aromatic oils
of Parsley make it an ideal breath freshener."
|
Nutra
Therapeutics
|
FloraZyme
|
8/28/02
|
"Contains a
full spectrum digestive enzyme formula in combination
with two proven probiotic agents, which provide
nourishment and foster the growth and replication of
health-promoting friendly bacteria within the large
intestine"; "The digestive enzymes in FloraZyme help
support the processes of digestion and assimilation
by helping the body breakdown food matter into its
most basic and absorbable form. Probiotics have been
shown to support the proliferation of friendly gut
bacteria, which in turn have been shown to modulate
digestion, immune function, and important metabolic
processes within the large bowel."
|
Nutra
Therapeutics
|
Glucosamine
Joint Formula
|
8/28/02
|
"Provides a
pure and stabilized grade of glucosamine sulfate,
MSM, and other natural agents that work
synergistically to support the structure and
integrity of joint cartilage as well as joint
mobility. As our bodies age, and as a consequence of
certain joint injuries, the ability to produce some
of the nutrients necessary for normal joint function
and cartilage building may decline. This can lead to
degenerative changes within the joint cartilage,
which are known to disturb normal joint function and
produce varying degree of discomfort"; "Our unique
blend provides proven, natural agents that nourish
joint cartilage and help support joint health, with
particular application for joints that have undergone
degenerative changes to the cartilage
structure."
|
Nutra
Therapeutics
|
Nature's
Relief
|
8/28/02
|
"A unique
formula that contains the correct dosage and
standardized grade of four powerful herbal agents
that have been shown to suppress the production of
pro-inflammatory prostaglandins. A major contributing
cause of joint and muscle inflammation and discomfort
stems from the synthesis of chemical hormones of the
prostaglandin-2 series. These and other
pro-inflammatory chemicals are produced in the body
and affect the structure and function of muscles,
tendons, bursa and other musculoskeletal
structures."
|
Nutrilogix
|
Prostate
2.0
|
9/10/02
|
"A
nutritional supplement scientifically created to
support healthy prostate tissue"; "The formulation
was created by a panel of board-certified urologists,
and is based on recent studies which establish a link
between nutrition and the maintenance of normal
prostate tissue."
|
Perrigo
|
Garlic
(under GoodSense brand)
|
8/16/02
|
"Helps
maintain a healthy circulatory system."
|
PhytoPharmica
|
Cellular
Forte MAX (multi-ingredient)
|
8/27/02
|
"Delivers
exceptional support for the most critical combination
of cells in the immune system"; "We have added cat's
claw and maitake mushroom extracts to help enhance
natural killer cell activity and critical B- and
T-cell effectiveness, as well as support of the most
important elements of the immune system."
|
PhytoPharmica
|
Concentration Formula
(multi-ingredient)
|
9/11/02
|
"Taurine
supports overall health in the central nervous
system"; "NAC supports neurological health and
enhances detoxification processes in the body";
"L-theanine is an amino acid that help promote a
relaxed state without diminishing daytime alertness";
"DMAE is clinically studied in children to support
focus, concentration, and healthy brain function";
"Phosphatidylserine supports brain health at a
cellular level"; "Sea Friends Concentration Formula
is a delicious, chewable formula with five
ingredients that help support healthy focus and
concentration in children"; "Chewable formula to
support focus and attentiveness."
|
PhytoPharmica
|
End Fatigue
Daily Energy B Complex (multi-ingredient)
|
8/26/02
|
"Dr.
Teitelbaum has done groundbreaking research that
identifies the precise nutritional requirements
needed to help your patients forget fatigue and feel
fantastic!" "The End Fatigue Energy Revitalization
system was designed with Jacob Teitelbaum, M.D., for
people who lack daytime energy, often followed by
restless sleep."
|