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.
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Company
|
Product/Ingredient
|
Date
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SmartScience
Labs
|
FireFighter
(orange [Citrus sinensis] peel extract,
standardized to contain a minimum of 98.5%
d-limonene)
|
2/21/03
|
"For the
prevention of meal induced heartburn"; "For effective
relief of discrete, episodic, occasional symptoms of
heartburn"; "To relieve heartburn symptoms and for
relief of acid indigestion and sour stomach"; "For
relief of occasional heartburn, acid indigestion and
upset stomach"; "Provides relief from occasional
heartburn and acid indigestion"; "For relief of
occasional heartburn and acid indigestion"; "Orange oil
is non-acidic, safe and is well tolerated when taken
orally"; "All natural alternative to conventional
occasional heartburn remedies"; "All natural,
patent-pending ingredient provides lasting relief from
occasional heartburn"; "Dietary supplement to relieve
occasional heartburn, acid indigestion and upset
stomach"; "In a laboratory study, researchers found
that orange peel extract exerts a spasmo-genic activity
and the spasmogenic activity was associated with the
levels of d-limonene in the extract"; "Will not reduce
mineral absorption or inhibit protein digestion"; "Does
not neutralize stomach acids or stop their production";
"Its all natural, patented ingredient provides lasting
relief, plus it does not adversely affect your normal
digestive process"; "Provides effective relief from
occasional heartburn while allowing your body to digest
food normally and absorb the nutrients nature
intended"; "Provides relief from occasional heartburn
while not interfering with normal digestion"; "Provides
sustained relief from occasional heartburn and acid
indigestion for up to six months"; "Ten pills, 20 days
for effective relief of occasional heartburn and relief
that lasts for up to six months"; "Provides effective
relief of occasional heartburn and acid indigestion and
relief lasts up to six months"; "Provides lasting
relief from occasional heartburn and acid indigestion
for up to six months"; "Provides lasting relief"; "Does
not interfere with normal digestion"; "Does not
interfere with protein digestion or mineral
absorption"; "Reduces the surface tension of the liquid
contents in the stomach, decreasing the potential for
the highly acidic stomach fluid to splash up into the
esophagus"; "Supports healthy peristalsis, moving food
through the stomach effectively and efficiently"; "Does
not disrupt stomach acids allowing proper digestion";
"Does not shut down acid production nor adversely
affect acid-producing cells"; "Maximum relief of
occasional heartburn is obtained by taking one softgel
capsule every other day for 20 days until all 10
capsules are taken"; "Effectiveness improves over
time"; "Prevents the onset of occasional heartburn for
up to six months"; "Relief lasts up to six
months."
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Solstice
Medicine
|
Kwai Look
Yuen Dietary Supplement
|
3/19/03
|
"Helps in
maintaining the strength of the body, as well as to
calm and relax"; "Also supports the health of the
blood, circulatory system, respiratory system, throat,
and lumbar region."
|
Solstice
Medicine
|
Li Chung Yuen
Dietary Supplement
|
3/19/03
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"Supports
normal energy levels, and aids the health of the
throat, bronchi, spleen, and the gastrointestinal and
urinary systems."
|
Solstice
Medicine
|
Po Lung Yuen
Dietary Supplement
|
3/19/03
|
"Helps to
calm and relax adults as well as babies and children";
"Helps improve absentmindedness"; "Helps to maintain
healthy immune, gastrointestinal, circulatory and
respiratory systems"; "Supports general health and
well-being."
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Source
Naturals
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AHCC (Active
Hexose Correlated Compound)
|
3/14/03
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"AHCC is a
proprietary compound produced by cultivation and
enzymatic modification of several species of mushroom
mycelia, including shiitake, grown in rice bran
extract"; "Considered a superfood supplement in Japan,
AHCC has been researched extensively for its immune
enhancement properties"; "According to human and animal
research, AHCC may significant increase natural killer
(NK) cell activity"; "AHCC may also increase macrophage
activity, enhance cytokine production, and support the
healthy functioning of the liver as well as act as an
antioxidant."
|
Source
Naturals
|
Ester-C
Chewable
|
4/4/03
|
"Ester-C
contains ascorbates that are fully reacted with
minerals making Ester-C non-acidic and 'stomach
friendly'"; "Vitamin C metabolites are the key
difference between Ester-C and other vitamin C
products."
|
Source
Naturals
|
Gaba
Powder
|
3/27/03`
|
"GABA
(gamma-aminobutyric acid) is an amino acid derivative
and a key inhibitory neurotransmitter";
"Neurotransmitters are chemical messengers that carry
information between nerve cells or from nerve cells to
other target cells"; "GABA is synthesized directly from
glutamic acid. It has an inhibitory effect on the
firing of neurons and supports a calm mood."
|
Source
Naturals
|
Metafolin
|
4/4/03
|
"Metafolin is
a new, coenzymated form of folic acid"; "Upon
absorption, folate is converted into L-methylfolate,
which is the predominant form of folate in circulation
and is the only type of folate that can cross the
blood-brain barrier"; "Metafolin does not require
enzymatic conversion that folic acid does which is
difficult for some people"; "Preliminary research
suggests that it is more bioavailable than folic
acid."
|
Source
Naturals
|
R-Lipoic
Acid
|
3/27/03
|
"R-Lipoic
Acid (R-LA) is 10 times more effective than other forms
of lipoic acid in mitochondrial ATP production.
Commercially available alpha-lipoic acid is a 50%
mixture of natural R-LA and synthetic S-lipoic acid
(S-LA)"; "R-LA is a form of lipoic acid that your body
synthesizes and can safely metabolize"; "Alpha-lipoic
acid is a combination of natural and synthetic lipoic
acid where as R-LA is a natural form found in the
body"; "In vitro testing showed 40% better
absorption than S-LA, as measured by plasma
concentration levels"; "When racemic mixtures
(alpha-lipoic acid) of lipoic acid are used, S-LA
competes with and may block the functions of R-Liopic
Acid (R-LA). Animal research has shown they each
compete for binding sites and the less active S-LA
prevents binding of the more active R-LA"; "R-LA has
been shown in animal studies to increase mitochondrial
activity for preventing mitochondrial decay, which may
help weaken the reported increase in oxidative stress";
"Animal research has shown that R-LA can increase or
maintain levels of other antioxidants include CoQ10,
vitamin C, vitamin E and glutathione."
|
Standard
Process
|
Allerplex
(multi-ingredient)
|
3/31/03
|
"Allerplex is
a special combination product formulated to support the
body's immune system response to seasonal,
environmental, and dietary stresses"; "Allerplex
contains vitamin A and C complexes which have been
shown to be important supporters of the immune system";
"It has also been formulated to maintain healthy liver
function - the body's natural cleansing system."
|
Standard
Process
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Antronex
(bovine liver fat extract [Yakriton], calcium lactate,
calcium stearate, Arabic gum, mixed tocopherols)
|
3/31/03
|
"Antronex
contains Yakriton, a bovine liver fat extract that has
been shown to help maintain healthy liver function via
its blood filtering and affect on histamine."
|
Standard
Process
|
Cal-Amo
(multi-ingredient)
|
3/31/03
|
"Cal-Amo is a
calcium product and an acidifying compound providing
chlorides, which are useful in the support of proper
acid/alkaline balance"; "Cal-Amo helps maintain a
healthy pH balance at the cellular level to help
support and maintain respiratory and connective tissues
and skeletal structures and support the immune system";
"In addition, calcium is a major nutrient building
block for the body."
|
Standard
Process
|
Drenamin
(multi-ingredient)
|
3/31/03
|
"Cortisol
helps feed and maintain the body's inflammation
response mechanisms."
|
Standard
Process
|
Fen-Gre
(multi-ingredient)
|
3/31/03
|
"Fen-Gre
supports healthy lung and lymph function"; "Fen-Gre
contains Fenugreek seed, which is a mucus
solvent."
|
Standard
Process
|
Ligaplex I
and Ligaplex II
|
3/31/03
|
"Ligaplex I
supports connective tissue and the natural healing
process in joints"; "Ligaplex I and Ligaplex II contain
vitamins, minerals, and Protomorphogen and Cytosol
brand extracts to provide support to connective tissue
and joints especially during times of increased
demand"; "The ingredients in each product work
synergistically to bring essential nutrients to their
cellular destinations and support chemical and
physiological processes within tissues and joints";
"The whole food ingredients found in Ligaplex I and
Ligaplex II are formulated specifically to support
healthy skeletal connective tissue by: providing organ
tissue and tissue extracts that support connective
tissue at the cellular level, supplying vitamins and
minerals that support connective tissue and joints in
meeting the demands of everyday activity, and supplying
specific nutrients in a ratio that maximizes support
and maintenance of connective tissue and joints during
increased activity and repetitive movement"; "The whole
food ingredients in the Ligaplex supplements provide
the following supportive benefits: antioxidant
protection; the Ligaplex supplements contain vitamins
A, C and E - strong antioxidants that are recognized
for providing cellular protection especially when
combined synergistically"; "Restorative properties;
Ligaplex I and Ligaplex II contain bovine adrenal
Cytosol brand extracts that promote the natural repair
process at the cellular level of the joints"; "Vitamins
and minerals essential for connective tissue health;
the vitamins in the Ligaplex supplements are required
for tissue growth and repair"; "Vitamin E promotes
healthy circulation, enhances athletic performance, and
helps ease muscle cramping"; "Both Ligaplex supplements
contain vitamin B12 important in cellular formation and
longevity"; "Calcium is required for strong bones and
proper muscular growth and contraction - an important
consideration during exercise"; "Manganese is an
important mineral for bone growth and the formation of
cartilage and synovial fluid in joints"; "Bovine and
ovine glandulars, plus veal bone Protomorphogen
extract; specific organ tissues and extracts provide
unique raw materials to like cells to help them
restore, repair and regenerate"; "The patented process
by which Protomorphogen brand extracts are extracted
from animal tissues yields concentrated cellular
components to promote healthy cellular function"; "The
Ligaplex supplements offer primary nutritional
components, as well as synergistic cofactors, to
provide natural nutritional support to the physiologic
structures and biochemical processes of the entire
skeletal system"; "The benefits of many of the
ingredients overlap in some areas, yet their
combination with compounds from different whole food
sources offers a unique blend of substances, providing
optimal nutritional activity."
|
Standard
Process
|
OPC
Synergy
|
3/31/03
|
"Helps
maintain a healthy cardiovascular system"; "Reinforces
vascular walls and makes them more pliable"; "Helps
support healthy brain tissue"; "Can help maintain brain
tissue exposed to free radicals"; "Can also help
maintain the integrity of blood vessels in the brain";
"Encourages healthy brain function by improving
vascular efficiency and by supporting the cells from
challenge by cellular oxidation"; "Decreases capillary
leakage by making capillary walls stronger"; "Helps
restore collagen integrity"; "Interferes with collagen
destruction in a number of ways: regulates the amount
of collagen links in connective tissue, fortifies
collagen proteins, increases the ability of collagen to
maintain itself, supports elastin, and improves overall
tissue nutrition by strengthening capillary walls";
"The following is a short list of how OPC can help your
body: support cells in every part of the body from
oxidation and free radicals"; "Supports the ability of
collagen to rebuild itself; helps maintain collagen as
we age"; "Increases pliability and integrity of all
types of blood vessel walls"; "Inhibits histamine
release."
|
Standard
Process
|
Palmettoplex
(multi-ingredient)
|
3/31/03
|
"Palmettoplex
is made up of three different botanicals that are
well-known for supporting the prostate gland"; "These
botanicals, combined with other whole food sources,
join forces with prostate PMG extract to provide strong
and natural male genitourinary system support"; "The
whole food and herbal ingredients in Palmettoplex
provide the following nutritional and tertiary
functional benefits: saw palmetto berry extract and
powder contains nine different fatty acids, diterpenes,
triterpenes, sesquiterpene, and alcohols to help
support healthy androgenic activity"; "Prostate PMG
extract provides cells with the specific raw materials
to support their natural restoration, repair and
regeneration function"; "Stinging nettle root contains
polysaccharides, one lectin, multiple phenolic
compounds, linear hydroxyl acids, dimeric compounds,
and sterols to help support urinary health and is
obtained by a methanol extract which has been shown to
be more effective in delivering the compounds found in
stinging nettle root to the body"; "Pygeum contributes
phytosterols, pieces of long-chain fatty acids,
triterpenes and linear alcohols and their esters to
support a healthy genitourinary tract"; "Zinc liver
chelate contains zinc that is chelated to bovine liver
to maintain healthy zinc levels in prostate tissue";
"Tomato powder (lycopene) stimulates and strengthens
immune function and helps protect cells from oxidative
damage"; "Three amino acids - alanine, glutamine and
glycine helps support proper urinary tract function and
prostate health and these amino acids are found in
prostate fluid"; "Each ingredients offers its nutrients
and synergistic cofactors to provide efficacious
nutritional support to the male genitourinary
physiologic structures"; "The whole food and herbal
ingredients in Palmettoplex provide a natural
alternative for helping the prostate gland and urinary
tract function properly and stay healthy"; "The
botanical and whole food ingredients found in
Palmettoplex offer a natural formula created
specifically to support a healthy prostate gland by:
providing prostate cell determinants to help support
and maintain healthy tissue, encouraging healthy cell
cycling, decreasing cellular oxidative damage, and
improving bladder elasticity."
|
Standard
Process
|
Wormwood
Complex (multi-ingredient)
|
3/31/03
|
"Together
these herbs and their constituents can help support
healthy bowel function, cleanse the gastrointestinal
tract, stimulate digestion and encourage a healthy
intestinal environment to help maintain proper
gastrointestinal flora."
|
Synergy
Worldwide
|
Body
Guard
|
3/5/03
|
"Body Guard
is formulated from the finest deep sea shark liver oil
to provide maximum protection against oxidative stress,
boost the immune system, and promote cardiovascular
health."
|
Synergy
Worldwide
|
Breakdown
|
3/5/03
|
"Breakdown
fat complexer uses the pH chemistry of the digestive
system to break down fats"; "Breakdown will complex 34
times its weight in fat"; "It also allows for better
absorption of fat-soluble vitamins, allowing for a
better balanced diet."
|
Synergy
Worldwide
|
Calcium
Plus
|
3/5/03
|
"Calcium Plus
is a synergistic blend of vitamins, chelated calcium,
trace minerals, and other potent ingredients which help
maintain proper bone structure and function"; "It
combines the optimal blend of nutrients that years of
research have shown to be most important for bone
health."
|
Synergy
Worldwide
|
CarboSmart
|
3/5/03
|
"Thermogenic
diet formula"; "CarboSmart naturally and safely
prevents the digestion of carbohydrates and reduces the
available calories your body may otherwise convert to
fat"; "CarboSmart is 100% stimulant free."
|
Synergy
Worldwide
|
CyberPlex
|
3/5/03
|
"CyberPlex
Strength Enhancer provides the nutrients athletes need
in order to build strength while at the same time
supplying essential elements necessary for lean muscle
gain."
|
Synergy
Worldwide
|
Detox
Plus
|
3/5/03
|
"Clean out
your body naturally and the easy way with this
all-herbal formula that 'hauls out trash and leaves
everything internally looking spotless.'"
|
Synergy
Worldwide
|
MetaPlex
|
3/5/03
|
"MetaPlex
provides the nutrients that allow for increased
muscular size and strength"; "It is rich in a host of
nutrients that interact with the major metabolic
pathways, cycles, systems and functions of the body to
enhance the formation of lean muscle."
|
Synergy
Worldwide
|
Paradise Noni
Guava
|
3/5/03
|
"A
traditional tonic drink from the South Pacific that
enhances energy and invigorates the body."
|
Synergy
Worldwide
|
Perfect
Shape
|
3/5/03
|
"The best of
science and nature in a complete and easy-to-use weight
management supplement."
|
Synergy
Worldwide
|
TheraPlex
|
3/5/03
|
"TheraPlex
Recovery Enhancer provides nutrients necessary for the
synthesis of connective tissues, bones, muscle,
ligaments and tendons"; "It enhances recovery from
workouts."
|
Synergy
Worldwide
|
Young
Again
|
3/5/03
|
"Young Again
features the latest in anti-aging hormone technology,
including an exclusive blend of powerful human growth
hormone releasers, DHEA, pregnenolone and natural
progesterone"; "These hormones are some of the most
powerful anti-aging compounds known to man."
|
Trader
Joe's
|
Trader
Darwin's Calcium Digestion Support
(multi-ingredient)
|
11/19/02
|
"For
occasional acid indigestion."
|
Traditional
Medicinals
|
Breathe Easy
(multi-ingredient)
|
3/31/03
|
"Promotes
respiratory health"; "A traditional formula for the
nasal passages"; "Beneficial for upper respiratory
tract health."
|
Twin
Laboratories
|
Twinlab
Carp-L Care Tabs (astaxanthin, boswellia serrata,
turmeric)
|
3/15/02
|
"Promotes
joint function."
|
Twin
Laboratories
|
Twinlab Diet
Fuel Weight Loss Drink (caffeine, chromium picolinate,
garcinia cambogia fruit extract, green tea leaf
extract)
|
4/4/03
|
"Lose weight
and gain energy"; "Will help you cut the fat"; "Get
maximum weight loss results when combined with other
Diet Fuel products."
|
Twin
Laboratories
|
Twinlab
Ripped Fuel Extreme Ephedra Free (caffeine, citrus
aurantium fruit extract, cocoa seed extract, green tea
leaf extract, guarana seed extract)
|
3/26/03
|
"Encourages
the body to naturally promote fat metabolism"; "Fight
fat and promote lean body mass."
|
Weeks &
Leo
|
Acidophilus
with Pectin Capsules (calcium, citrus pectin,
lactobacillus acidophilus)
|
2/24/03
|
"Helps
reinforce intestinal flora."
|
Weeks &
Leo
|
Echinacea
Capsules 450 mg
|
2/24/03
|
"Helps
enhance the immune system"; "Echinacea herb may help
enhance the body's immune system."
|
Weeks &
Leo
|
Ester C
Caplets 500 mg with Bioflavonoids (bioflavonoid,
calcium, hesperidin, rutin, vitamin C)
|
2/24/03
|
"Helps
support the immune system."
|
Weeks &
Leo
|
Evening
Primrose Oil Softgels 500 mg
|
2/24/03
|
"Helps
support women's health."
|
Weeks &
Leo
|
Folic Acid
Tablets 400 mcg (calcium, folate)
|
2/24/03
|
"Helps
support the cardiovascular system."
|
Weeks &
Leo
|
Gelatin
Capsules 10 GR (650 mg)
|
2/24/03
|
"Helps
support bones and joints."
|
Weeks &
Leo
|
Ginkgo Biloba
Leaf Extract Capsules 30 mg
|
2/24/03
|
"Helps to
improve circulation and concentration"; "May be helpful
in improving circulation to the arms, legs and brain,
as well as promoting mental function and
concentration."
|
Weeks &
Leo
|
Glucosamine
Sulfate Capsules 750 mg
|
2/24/03
|
"For healthy
tissues"; "Helps support joints"; "Helps support joints
and promotes healthy tissues."
|
Weeks &
Leo
|
Lecithin
Softgels 19 GR (1200 mg)
|
2/24/03
|
"Helps
support healthy liver."
|