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Chart: Dietary Supplement Structure/Function Claims

This article was originally published in The Tan Sheet

Executive Summary

Dietary Supplement Structure/Function Claims



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

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."

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

"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."

Source Naturals

AHCC (Active Hexose Correlated Compound)

3/14/03

"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

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."

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