Product Review: Eye Health Supplements (with Lutein and Zeaxanthin) and Astaxanthin Supplements Initial Posting: 12/16/09 What It Is: Lutein, zeaxanthin, and astaxanthin are members of the carotenoid family — a group of natural plant pigments that includes beta-carotene and lycopene. Zeaxanthin is a stereoisomer of lutein and the two are often found in combination. They are unique in that they are the only carotenoids found in high concentration in the macula of the eye. Lutein and zeaxanthin are available from a wide variety of foods. However, most adults in the U.S. consume less lutein and zeaxanthin than the amount believed to lower their risk of macular degeneration. Consequently, dietary supplements are often used to increase lutein and zeaxanthin levels. Astaxanthin is naturally produced by a type of algae and, through the food chain, provides the pink coloration of salmon, trout, krill, shrimp and other crustaceans. What It Does: Lutein and Zeaxanthin: The macula is an area within the retina of the eye that is is responsible for conveying fine color images to the brain. The macula can degenerate with age, resulting in loss of vision. Age-related macular degeneration is the leading cause of blindness in the U.S. More than nine percent of people in the U.S. over age 40 show some form of macular degeneration; it affects 27% of adults 65 and older. It is believed that lutein and zeaxanthin, both of which are anti-oxidants, protect the macula by scavenging potentially damaging free radicals and absorbing certain high-energy light. Studies of populations generally show that people who get the most lutein and zeaxanthin from their diets tend to have lower rates of macular degeneration. One double blind, placebo controlled study (Richler 2004) showed that after one year of daily supplementation with 10 mg of lutein (or 10 mg of lutein plus a mixture antioxidants, vitamins and minerals) ocular pigment increased and vision improved in people with atrophic age-related macular degeneration. A subsequent study failed to find benefit with lutein, but it used a lower dose (6 mg daily) and involved fewer people (Bartlett 2007). Additional human studies suggest that among people with age-related macular degeneration, those with low blood levels of lutein may be more likely to benefit from taking lutein supplements, and lutein supplements continue to increase macular pigment optical density even after one year of supplementation. In addition to lutein and zeaxanthin, other ingredients may improve macular degeneration. See the section Eye Health Supplements with Zinc and Lutein. A preliminary study suggests that lutein may help treat retinitis pigmentosa (Bahrami 2006). Population studies also suggest a reduced risk of developing severe cataracts (clouding of the lens of the eye) in people consuming higher amounts of lutein in their diet, although it is not known if supplements offer the same potential benefit. There is also preliminary research suggesting that lutein and zeaxanthin may help protect skin from sun damage. Increased lutein intake has also been associated with a lower risk of colon and breast cancer. Astaxanthin: There is preliminary evidence suggesting astaxanthin might reduce blood pressure, help prevent heart disease, lower cholesterol, help prevent eye fatigue, protect the lens of the eye against cataracts, protect the stomach against ulcers, help with male infertility, and reduce risk of macular degeneration. However, more research is needed. See ConsumerTips for information about ingredient forms, dosage, and safety issues. See the Encyclopedia on this site for additional information about clinical studies with lutein/zeaxanthin and astaxanthin. Quality Concerns and What CL Tested for: No government agency is responsible for routinely testing lutein, zeaxanthin, or astaxanthin supplements for their contents or quality. ConsumerLab.com purchased and evaluated supplements to determine whether they contained the amounts of these compounds stated on their labels. All products were tested for potential contamination with lead and all non-chewable tablets also were tested to be sure that they would properly disintegrate. (See How Products Were Evaluated for information on testing methods and passing score.) What CL Found: Among the products selected by ConsumerLab.com, all were found to provide the amounts of lutein, zeaxanthin or astaxanthin claimed on their labels. In addition, none exceeded strict limits for lead contamination and all tablet products were able to disintegrate properly. What was most was striking about the supplements specifically marketed for "eye health" was the large variation in their formulas and in the suggested daily dosage of ingredients. For example, daily amounts of lutein ranged from 2 mg to 20 mg while amounts of zeaxanthin ranged from zero to 16 mg. Many of "eye health" products included other ingredients, such as zinc, resembling ingredients in the formula that successfully reduced the incidence of age-related macular degeneration in a major study known as AREDS. This formula is currently being used along with lutein/zeaxanthin and omega-3 fatty acids in a second major study, AREDS2. See the in-depth comparison of these products in the section "Comparison of Eye Health Supplements to AREDS / AREDS2." Test Results by Product: Listed alphabetically below are the test results for sixteen supplements containing lutein, zeaxanthin, and/or astaxanthin. Ten were selected by ConsumerLab.com and six others (each indicated with an asterisk) are included for having passed the same evaluation through ConsumerLab.com's Voluntary Certification Program. Also listed are two products similar to ones that passed but sold under different brand names. Products listed as "Approved" contained their listed amounts of for lutein, zeaxanthin, and astaxanthin, and met ConsumerLab.com's quality standards (See Passing Score). For three products (Icaps, VISUtein, and AstaREAL) that did not specifically list the amounts of certain carotenoids, the actual amounts found by ConsumerLab.com are reported in the results table below. Company Claimed Amount of Lutein, Zeaxanthin, and Astaxanthin Per Labeled Daily Serving OVERALL RESULTS: APPROVED (Passed) or NOT APPROVED (Failed) Lutein Products Bausch & Lomb PreserVision® Lutein (1 softgel, 2 per day) Ingredients Dist. by Bausch & Lomb, Inc. 10 mg lutein APPROVED Solgar® Vision Guard® with Lutein (1 vegetable capsule, 1 to 2 per day)* Ingredients Mfd. by Solgar Vitamin and Herb 6 – 12 mg lutein APPROVED Walgreens Ocutabs with Lutein (1 tablet, 1 to 2 per day) Ingredients Dist. by Walgreens, Co. 2 – 4 mg lutein APPROVED Lutein and Zeaxanthin Products EyePromise Restore (1 softgel, 1 to 2 per day) Ingredients Dist. by ZeaVision, LLC 4 – 8 mg lutein 8 – 16 mg zeaxanthin APPROVED Healthy America Lutein and Zeaxanthin Complex (1 softgel, 2 per day) Ingredients Dist. by Healthy America 8 mg lutein 0.34 mg zeaxanthin APPROVED ICaps® Lutein & Zeaxanthin (2 coated delayed release tablets, 2 per day) Ingredients Dist. by Alcon 4 mg combined lutein and zeaxanthin (Found to be 91% lutein) APPROVED Integrative Therapeutics, Inc. Tyler™ Vision Complex (3 capsules, 3 per day) Ingredients Dist. by Integrative Therapeutics, Inc. 10 mg lutein 2 mg zeaxanthin APPROVED Jarrow Formulas® Lutein (1 softgel, 1 per day) Ingredients Dist. by Jarrow Formulas 20 mg lutein 1 mg zeaxanthin APPROVED Nature's Bounty Lutein (1 softgel, 1 per day)* Ingredients Mfd. by Nature's Bounty, Inc. 20 mg lutein 0.16 mg zeaxanthin APPROVED Twinlab® OcuGuard® Plus (2 capsules, 2 per day)* Ingredients Mfd. by Ideasphere 20 mg lutein 0.8 mg zeaxanthin APPROVED USANA® Visionex™ (2 tablets, 4 per day)* Ingredients Dist. by USANA Health Sciences, Inc. 10 mg lutein 2 mg zeaxanthin APPROVED VISUtein® (2 capsules, 2 per day) Ingredients Dist. by Unicity International, Inc. 18 mg lutein 1.7 mg mixed carotenoids containing some zeaxanthin (Found to be 71% zeaxanthin) APPROVED Vitamin Shoppe M.D. Select Dr. Ronald Hoffman Advanced Ocular Support (2 veggie capsules, 2 per day)* Ingredients Dist. by The Vitamin Shoppe® 20 mg lutein 4 mg zeaxanthin APPROVED Puritan's Pride® Lutein 20 mg (1 softgel, 1 per day) Ingredients Mfd. by Puritan's Pride, Inc. 20 mg lutein 0.16 mg zeaxanthin Similar to: Nature's Bounty Lutein Vitamin World® Naturally Inspired® Lutein 20 mg (1 softgel, 1 per day) Ingredients Mfd. by Vitamin World, Inc. 20 mg lutein 0.16 mg zeaxanthin Similar to: Nature's Bounty Lutein Lutein and Astaxanthin Products astavita® AstaREAL® Astaxanthin (2 softgels, 2 per day) Ingredients Dist. by Astavita 4 mg "Natural Astaxanthin Complex (Astaxanthin, Lutein, Beta Carotene, Cantaxanthin, Other Carotenoids)" (Found to be ~75% astaxanthin and only 1% lutein.) APPROVED MD Formulas™ Hawaii BioAstin® Natural Astaxanthin Supreme (1 vegetarian softgel, 1 to 2 per day) Ingredients Dist. by Nutrex Hawaii, Inc. 0.06 – 0.12 mg lutein 6 – 12 mg astaxanthin APPROVED Lutein, Zeaxanthin and Astaxanthin Products Life Extension® Super Zeaxanthin Plus Astaxanthin (1 softgel, 1 per day)* Ingredients Dist. by Quality Supplements and Vitamins, Inc. 10 mg lutein 3.75 mg zeaxanthin 6 mg astaxanthin APPROVED *Tested through CL's Voluntary Certification Program prior to, at time of, or after initial posting of this Product Review. ** Product identical in formulation and manufacture to a product that has passed testing but sold under a different brand. For more information see CL's Multi-Label Testing Program. Unless otherwise noted, information about the products listed above is based on the samples purchased by ConsumerLab.com (CL) for this Product Review. Manufacturers may change ingredients and label information at any time. So be sure to check labels carefully when evaluating the products you use or buy. If a product's ingredients differ from what is listed above, it may not necessarily be the same as what was tested. The information contained in this report is based on the compilation and review of information from product labeling and analytic testing. CL applies what it believes to be the most appropriate testing methods and standards. The information in this report does not reflect the opinion or recommendation of CL, its officers or employees. CL cannot assure the accuracy of information provided to it by third parties. Liability to any person for any loss or damage caused by errors, omissions, or inaccuracies in this report is hereby disclaimed. Copyright ConsumerLab.com, LLC, 2009. All rights reserved. Not to be reproduced, excerpted, or cited in any fashion without the express written permission of ConsumerLab.com LLC. ConsumerTips™ for Buying and Using: Getting lutein and zeaxanthin from food: Lutein and zeaxanthin: There is no government recommended daily intake for lutein or zeaxanthin. Population studies suggest a reduced risk of both age-related macular degeneration and cataract formation in people who get about 6 mg per day of these compounds from foods. It is estimated that the average U.S. adult consumes a total of only 2 to 4 mg per day of lutein and zeaxanthin from foods. It is possible to get from food the amount of lutein and zeaxanthin associated with a decreased risk of macular degeneration and cataract formation. As little as a half-cup of cooked kale, Swiss chard, spinach, or collard greens will provide 6 mg or more of lutein and zeaxanthin, as they are among the richest food sources. Other foods with fairly high amounts of lutein and/or zeaxanthin are corn, celery, kiwi fruit, endive, grapes, zucchini, and broccoli. Even iceberg lettuce and green peas will contribute these anti-oxidants to your diet. Most foods contain more lutein than zeaxanthin, but orange pepper, oranges and orange juice typically contain more zeaxanthin than lutein. Specially produced eggs, from chickens fed marigold petals, may also provide high levels of lutein. For an extensive listing of the amounts of lutein, zeaxanthin in foods, see the USDA-NCC Carotenoid Database at http://www.nal.usda.gov/fnic/foodcomp/Data/car98/car98.html. Getting astaxanthin from food: Salmon and trout are excellent sources of astaxanthin. A typical 4-ounce serving of farmed Atlantic salmon provides approximately 1 mg of astaxanthin and a similar serving of wild Pacific salmon provides about 4.5 mg. Krill oil is another food source of astaxanthin. (Krill oil will be included in the next Product Review of Fish Oil/Omega-3 Supplements in 2010.) Getting lutein and zeaxanthin from supplements: Based on population studies, supplements were often designed in the past to provide 6 mg of lutein. But more recent research specifically using supplements showed that 10 mg of lutein appears to be an effective dose for improving vision in people with atrophic age-related macular degeneration — although it does not seem to prevent disease progression. Consequently, some products now provide 10 mg of lutein, along with lesser amounts of zeaxanthin. Some promotional literature on the Internet suggests that a higher (20 mg) dose be taken by people with advanced macular degeneration. There is no evidence yet to support this recommendation, although it is known that larger doses do increase levels of these anti-oxidants in the blood. Research from the National Eye Institute using supplements containing free form lutein (see "Forms of Lutein: Free vs. Ester" below) show that normal adult blood serum levels of lutein double with a daily dose of just 2.5 mg, almost triple with 5 mg, and quadruple with a daily dose of 10 mg. This would suggest, however, a diminishing return with even higher doses. Nevertheless, a six-week study using 20 mg of lutein in people suffering from retinitis pigmentosa, another sight–robbing condition, experienced improvements in their vision (Bahrami 2006). Be aware that some manufacturers sell supplements providing very small amounts of lutein — often just a fraction of milligram — sometimes as part of a larger formula. The multivitamin Centrum Silver, for example, provides just 0.25 mg of lutein. While this allows the product to promote lutein as an ingredient, it is questionable whether such a small dose provides health benefit. If you already get a high amount of lutein from your diet, evidence suggests that you may not get additional benefit from supplements. When using supplements, lutein levels in the blood rise over time, peaking at 3 months. Once stopped, blood levels fall over a period of months and return to normal in about six months. Forms of Lutein: Free vs. Ester Lutein in supplements comes as either lutein "esters" (such as the trademarked XANGOLD lutein) or the free form of lutein (such as the trademarked FloraGLO lutein). Lutein and zeaxanthin found in green vegetables, fruits and egg yolk exist in non-esterfied (free) form. Both forms are equally well absorbed by the body, but are best absorbed when taken with fats or oils. Consequently, it is generally recommended to take supplements with meals — preferably high-fat rather than low-fat meals. Getting astaxanthin from supplements: Most astaxanthin in supplements for human use is naturally derived from algae (typically Haematococcus pluvialis), as is the case with the supplements tested in this Review. Other sources include yeast and krill. Synthetic astaxanthin is also produced and differs slightly chemically from natural astaxanthin in the predominance of specific isomeric forms. In some studies, astaxanthin has been given in doses ranging from 4-16 mg daily, but research remains preliminary. Some evidence suggests that astaxanthin is better absorbed when consumed in an oily base. SPECIAL SECTION: Eye Health Formulas with Zinc and Lutein: AREDS: A large study known as AREDS (Age-Related Eye Disease Study) looked at the effects of supplements on eye health. Although it did not evaluate lutein or zeaxanthin, the study found that zinc alone or with anti-oxidants can slow the progression of age-related macular degeneration when taken on a daily basis. The tablets used in AREDS were manufactured to contain the following minimum contents throughout their shelf-life: 7,160 IU of vitamin A (from beta carotene), 113 mg of vitamin C (ascorbic acid), 100 IU of vitamin E (dl-alpha tocopheryl acetate), 17.4 mg of zinc (zinc oxide), and 0.4 mg of copper (cupric oxide). Four tablets were taken daily, providing a total of 28,640 IU of vitamin A, 452 mg of vitamin C, 400 IU of vitamin E, 69.6 mg of zinc, and 1.6 mg of copper. (The copper in the formula was included to prevent zinc-induced copper deficiency — see Concerns and Cautions below.) [NOTE: Some articles about the AREDS report suggest that the supplement used contained slightly higher amounts of ingredients, such as 80 mg of zinc per day, but the actual specifications for the product are those described above. The higher numbers include the non-active salt portion of each ingredient, which is not typically included in product labeling. For example, 80 mg of “zinc oxide” actually provides 69.6 mg of active zinc.] AREDS 2: Currently, the National Institutes of Health (NIH) is running an AREDS2 study (to be completed in 2012) to assess the effects of daily supplementation with 10 mg of lutein and 2 mg of zeaxanthin and/or 1,000 mg of omega-3 fatty acids (650 mg EPA and 350 mg of DHA) for the treatment of age-related macular degeneration and cataract. In addition, since the original AREDS formulation is now considered the standard of care, it is being given as a separate supplement to many of the study participants in conjunction with the other treatments. However, some who get the AREDS formulation will receive a version with a lower amount of zinc (21.8 mg per day – also shown as 25 mg of “zinc oxide”), as the original amount was very high in zinc, exceeding the 40 mg per day Upper Tolerable Intake Level associated with increased the risk of adverse effects such as anemia and heart problems. Some participants will also receive a version with no beta-carotene. In fact, current or former smokers will only receive the version with no beta-carotene because high-dose beta-carotene supplementation has been associated with an increased risk of lung cancer, strokes and death from heart disease in smokers. Comparison of Tested Eye Health Supplements to AREDS / AREDS2 Formulas: Results of AREDS2 are not expected until after 2012 but should be helpful in identifying optimal supplement intakes for eye health. In the meantime, if you are interested in using ingredients that resemble those used in AREDS2, see the comparison table below. It summarizes the ingredients used in AREDS and compares these to those being used in AREDS2 and found in AREDS2-like products (i.e., those that include zinc in addition to lutein) tested in this Review. You'll notice that several of the tested products have reduced or eliminated the very high amount of vitamin A from beta-carotene in the AREDS formula, similar to what is being tested in some people in AREDS2. Also like what is being given to a subgroup of AREDS2 participants, many of the products have reduced zinc -- although some go lower than ARED2's low-zinc formulation (21.8 mg/day), providing daily doses as low as 5 to 12.5 mg. Several of the products with reduced zinc correspondingly have reduced copper, which seems appropriate because the role of copper in the AREDS formulation is not for eye health but to offset the the negative effect of high-dose zinc on copper absorption. If you want to take the original AREDS formulation, it is found in Bausch & Lomb’s PreserVision AREDS and ICaps AREDS, both of which passed testing by ConsumerLab.com in 2008 (see Zinc Supplement Review). Be aware that those products are different from Bausch & Lomb’s PreserVision Lutein and Icaps Lutein & Zeaxanthin tested in this Review, which include lutein and more closely resemble what some people in AREDS2 are receiving. If you stick with one of the original AREDS formulation products, you can add lutein/zeaxanthin as a separate supplement with one of the quality approved lutein/zeaxanthin products by Jarrow, Life Extension, Nature’s Bounty, Puritan’s Pride, Vitamin Shoppe, or Vitamin World listed in the results table above. Alternatively, the Healthy America Lutein and Zeaxanthin Complex below should provide everything in the AREDS formula as well as some lutein and a little zeaxanthin. If you want to add 1,000 mg of omega-3 fatty acids, as is being tried in AREDS2, you'll need to take a separate supplement such as one that has passed passed ConsumerLab.com's Fish Oil / Omega-3 Product Review. One of the tested products (EyePromise Restore) provides a smaller amount (up to 250 mg per day) of omega-3 fatty acids. Concerns and Cautions: Lutein supplementation appears to be safe at a dose of 10 mg. A six-month study using 20 mg of lutein also showed no safety problems (Bahrami 2006). However, a study based on subject’s memory of the previous 10 years suggests that long term use of supplementation with lutein as well as vitamin A (from beta-carotene or retinol) was associated with an increased risk of lung cancer (Satia 2009). Long-term use should not be recommended for lung cancer prevention, particularly among smokers. Simultaneous consumption of the fat substitute olestra, found in fat-free chips, may decrease the absorption of lutein and zeaxanthin. Beta-carotene from food and supplements may also decrease the absorption of lutein, zeaxanthin, and astaxanthin. There are no reports of side effects with astaxanthin, although clinical research is limited. More information about the uses and clinical studies with lutein/zeaxanthin and astaxanthin is found in the Encyclopedia on this website. To further assist consumers, ConsumerLab.com licenses its flask-shaped CL Seal of Approved Quality (see The CL Seal) to manufacturers for use on labels of products that have passed its testing. ConsumerLab.com will periodically re-evaluate these products to ensure their compliance with ConsumerLab.com's standards. Product Review of Supplements for Cancer Prevention (Green Tea, Lycopene, and Selenium) Initial Posting: 4/19/06 Some supplements may reduce the risk of developing certain types of cancers. Many of these potential "chemopreventive" ingredients act directly or indirectly as antioxidants, helping to neutralize dangerous free radicals. Others offer potential benefits through hormonal effects or other mechanisms. The evidence that specific compounds can help prevent cancer generally comes from observational studies, in which populations that consume higher amounts of a natural substance (typically from diet and not from supplements) are found to have lower cancer rates. Such studies don't show cause and effect and must be considered preliminary evidence. In some cases, additional supporting evidence comes from test tube and animal studies. Double-blind, placebo-controlled studies are the gold standard for determining effectiveness of a treatment. Only three ingredients have some direct clinical evidence (from double-blind clinical trials) to support their use in for cancer prevention: vitamin E, lycopene and selenium. However, even in these cases the evidence remains far from conclusive. Other ingredients with potential benefit include folate, garlic, green tea, soy isoflavones and other isoflavones, indole-3-carbinol (I3C), diindolylmethane (DIM), vitamin C and vitamin D. Those highlighted in blue are the subjects of other reviews from ConsumerLab.com (click on their names to get their reports). This review focuses on three ingredients � green tea, lycopene, and selenium. Green tea is made from the plant Camellia sinensis. It contains compounds called catechin polyphenols that in test tube studies show antioxidant, anticarcinogenic, antitumorigenic, and anti-microbial properties. Green tea is made from the same plant as black tea, but green tea is made by lightly steaming freshly cut leaves, while black tea is fermented and has lower amounts of polyphenols. The main catechin polyphenol found in green tea is epigallocatechin gallate (EGCG). Lycopene is a red pigment and powerful antioxidant found in tomatoes, pink grapefruit, watermelons, apricots, and pink guavas. On a per gram basis, lycopene is about twice as power an anti-oxidant as another well-know carotenoid, beta-carotene. Selenium is a trace mineral that our bodies use to produce glutathione peroxidase � part of the body's own antioxidant defense system. It works with vitamin E to protect cell membranes from damage caused by free radicals. Test tube and animal studies hint that tea constituents might help prevent cancers of the stomach, lung, esophagus, duodenum, pancreas, liver, breast, and colon. However, results from observational studies in humans have varied. One study found that Japanese women who drank more than ten cups of green tea daily had a delay in the onset of cancer and also a 43% lower total rate of cancer occurrence. An effect was also seen in men but it was not statistically significant. A study in China found that those who drank green tea had significantly less risk of developing cancers of the rectum and pancreas, but not colon cancer. Another Chinese study found that green tea drinkers were 29% less likely to get stomach cancer than nondrinkers, with those drinking the most tea having the least risk. However, observational studies in both Japan and Hawaii have found no reduction in stomach cancer. A small pilot study in humans found that oral green tea extracts might be able to reduce prostate cancer rates in men who already have pre-cancerous changes in the prostate. There is preliminary laboratory evidence suggesting that the green tea catechin, EGCG, may help prevent skin cancer if applied directly to the skin. However, a double-blind, placebo controlled study failed to find that a combination of oral and topical green tea extracts reduced signs of precancerous sun-damage in skin. There is evidence suggesting a cancer-preventing benefit for lycopene, but it is indirect and far from definitive. A large observational study of men found a reduced incidence of prostate cancer among those eating high levels of tomatoes, tomato sauce, and pizza � all of which contain lycopene. In addition, a study of elderly Americans was conducted and found a diet high in tomatoes was associated with a 50% reduction in cancer. People who ate at least seven servings of tomatoes weekly developed less stomach and colorectal cancers compared to those who ate only two servings weekly. These observational studies involved tomato-based foods and not lycopene supplements. One preliminary controlled (but not blinded) study in humans did test lycopene supplements; when taken at a dose of 4 mg twice daily they appeared to help prevent precancerous cells in the prostate from turning cancerous. Regarding other medical conditions, lycopene has shown some promise for treatment of asthma. It has been observed that in parts of China where the soil is depleted of selenium, the incidence of various types of cancer is much higher than in the rest of the country. This observation has given rise to a theory that selenium deficiency is a common cause of cancer and selenium supplements can reduce this risk. In North America, however, selenium deficiency is uncommon. In people with adequate selenium intake, it is not clear whether or not additional selenium is helpful. One study indicated a 50% reduction in overall cancer deaths when additional selenium was taken � with significant decreases in cancer of the lung, colon, and prostate. However, results of this study have been tempered by further analysis indicating that most of the benefits were seen in study participants with somewhat lower levels of selenium to begin with. Selenium has not been shown to reduce the risk of skin cancer and selenium supplements do not appear to reduce the risk for colorectal cancer. However, early data suggests that there may be more effective and less toxic forms of organic selenium for preventing colorectal cancer than those used previously. In addition, animal trials have found anti-cancer benefits. Other potential benefits of selenium have been indicated. Low selenium levels have been associated with the development of rheumatoid arthritis � although selenium supplements don't seem to help rheumatoid arthritis once it has developed. There is preliminary evidence that selenium supplements may improve fertility in males who are selenium deficient. There is weak evidence that selenium might be helpful for diabetic neuropathy. Selenium does not appear to be helpful for preventing heart disease. One fairly large double-blind study failed to find that use of selenium improved general sense of well-being. Like other supplements, neither the FDA nor any other federal or state agency routinely tests supplements for quality prior to sale. However, quality issues can include the following: Labeled Amount � Does the product really contain the labeled amount of ingredient? Too little may not work. Too much may cause toxicity, particularly with selenium. Purity � Is the product free of lead � a contaminant found in many types of supplements. Ability to Break Apart for Absorption � Will the product break apart properly so that it can release its ingredient in the body? For a tablet to be most useful, it must fully disintegrate prior to leaving the stomach, delivering its contents for absorption in the gut. Some tablets are not properly made and can pass through your body completely or partially intact, depriving you of its ingredients. Remnants of such products are sometimes found in the stool. This happens, for example, when a tablet is too tightly compressed (too "hard") or is too thickly coated. ConsumerLab.com, as part of its mission to independently evaluate products that affect health, wellness, and nutrition, purchased green tea, lycopene, and selenium supplements sold in the U.S. and Canada and tested them to determine whether they 1) possessed the claimed amount of key ingredient, 2) were able to disintegrate fully to be available for absorption and 3) were free from unacceptable levels of lead (see Testing Methods and Passing Score). In green tea products, the amount of caffeine was also determined. Only one of the green tea products selected by CL passed testing, as did three products tested through CL's Voluntary Certification Program. Among products selected by CL, problems were found with the following: Futurebiotics Premium Standardized Green Tea Extract was contaminated with 4.5 mcg of lead per daily serving of three tablets. Herbal Select Standardized Green Tea Extract was contaminated with 3.3 to 6.6 mcg of lead per daily serving of one to two capsules. Food Science of Vermont Green Tea Extract was found to contain only 50 mg of EGCG per capsule � 71% of the 70 mg claimed. The State of California's "no significant risk level" for lead is 0.5 mcg of lead per day (see Passing Score). California requires products exceeding this level to provide a warning label � which these products did not. It has been reported that children can show signs of lead poisoning when exposed to more than 6 mcg or more of lead per day. Since children get approximately 1 to 2 mcg of lead each day from environmental exposure (water, food, air), additional exposure from this product could put some children at risk for lead toxicity and should be avoided. Although adults can tolerate higher amounts of lead (about 70 mcg per day), lead can build up in the body and such exposure should be avoided. Pregnant women should particularly avoid lead, as it can be transferred to the fetus. All five of the selected lycopene products passed testing, as did two products tested through CL's Voluntary Certification Program. One product, Canadian Sun Selenium, failed testing: It contained only 18.9 mcg of selenium � 38% of the 50 mcg claimed. Four other products selected by CL passed testing, as did three products tested through CL's Voluntary Certification Program. Listed below are the test results for twenty-two supplements. Products are grouped by key ingredient and listed alphabetically within each group. ConsumerLab.com selected fourteen of these products. Eight other products (each indicated with an asterisk) were tested at the request of their manufacturers/distributors through the Voluntary Certification Program and are included for having passed testing. Also listed are four products that are the same as ones that passed but sold under different brand names. Shown for each product are the claimed amount and form of the tested ingredient(s) and serving size recommended on its label. Products listed as "Approved" met their label claims and ConsumerLab.com's quality criteria (see Passing Score). For green tea products, the amount of caffeine found in a daily dose is also shown since caffeine occurs naturally in green tea. To put these amounts in perspective, a can of cola contains about 40 mg of caffeine and a cup of coffee has about 100 mg of caffeine. RESULTS OF CONSUMERLAB.COM TESTING OF GREEN TEA SUPPLEMENTS � TEST RESULTS � Food Science of Vermont Green Tea Extract (500 mg extract per vegetarian capsule, 2 per day) Ingredients Dist by Food Science of Vermont 140 mg EGCG NOT APPROVED Found only 99.1 mg EGCG (70.8% of claim) 5 mg Futurebiotics Premium Standardized Green Tea Extract (100 mg extract and 400 mg leaf per tablet, 2 per day) Ingredients Dist by Futurebiotics 40 mg polyphenol catechins from extract NOT APPROVED Found 50 mg EGCG 4.50 mcg of lead per daily serving 25 mg Herbal Select Standardized Green Tea Extract, 50% Polyphenols (500 mg extract per capsule, 1-2 per day) Ingredients Dist. by Herbal Select 250 - 500 mg polyphenols NOT APPROVED Found 43.5 - 87 mg EGCG 3.30-6.60 mcg of lead per daily serving NA 36-72 mg Life Extension Mega Green Tea Extract (725 mg extract per capsule, 1 per day) Ingredients Dist. by Quality Supplements and Vitamins, Inc 246.5 mg EGCG 427.75 mg polyphenols APPROVED NA 2 mg Nature's Bounty� Green Tea Extract (315 mg extract per capsule, 4 per day)* Ingredients Mfd. by Nature's Bounty, Inc. 190 mg polyphenols APPROVED Found 68.8 mg EGCG N/A 108 mg Pharmanex� Tegreen� 97 (250 mg per capsule, 1-4 per day)* Ingredients Dist. by Nu Skin Enterprises 95 - 380mg EGCG 242.5 - 970 mg polyphenols APPROVED NA 0.75-3.0 mg Puritan's Pride� Green Tea Extract 315 mg (315 mg per capsule, 4 per day)* Ingredients Mfd. by Puritan's Pride, Inc. 90 mg Polyphenols APPROVED Found 57.6 mg EGCG NA 77 mg *Tested through CL's Voluntary Certification Program prior to, at time of, or after initial posting of this Product Review. �Minimum amounts of catechins expected for green tea is 10% (wt/wt). Extracts may have more depending on concentration. See ConsumerTips� for more information about catechins and dose. RESULTS OF CONSUMERLAB.COM TESTING OF LYCOPENE SUPPLEMENTS Bluebonnet Lycopene 20 mg (20mg per softgel, 1 per day) Ingredients Dist. by Bluebonnet Nutrition Corporation 20 mg APPROVED NA NA GNC Natural Brand� Lycopene (10 mg per softgel, 1 per day) Ingredients Dist. by GNC 10 mg APPROVED NA NA Jarrow Formulas� Lyco-Sorb� (10 mg per softgel, 1-2 per day) Ingredients Mfd. by Jarrow Formulas 10 - 20 mg APPROVED NA NA KAL� Lycopene 10 mg (10 mg softgels, 1 per day) Ingredients Mfd. by Nutraceutical Corp. for Makers of KAL 10 mg APPROVED NA NA Nature's Answer� Lycopene (5 mg per mL, 1 mL per day) Ingredients Dist. by Nature's Answer� 5 mg APPROVED NA NA Nature's Bounty� Lycopene 5 mg (5 mg per softgel, 1 per day)* Ingredients Mfd. by Nature's Bounty, Inc. 5 mg APPROVED NA NA Puritan's Pride� Lycopene 10 mg (10 mg softgel, 1 per day)* Ingredients Dist. by Puritan's Pride, Inc. 10 mg APPROVED NA NA Similar to APPROVED Products:** Vitamin World� Lycopene 10 mg (10 mg per softgel, 1 per day) Ingredients Mfd. by Vitamin World, Inc *Tested through CL's Voluntary Certification Program prior to, at time of, or after initial posting of this Product Review. ** Product identical in formulation and manufacture to a product that has passed testing but sold under a different brand. For more information see CL's Multi-Label Testing Program. Canadian Sun Selenium 50 mcg (50 mcg per tablet, 1 per day) Ingredients Mfd. by Canadian Sun Health Products Ltd. 50 mcg NOT APPROVED Found only 18.9 mcg per tablet (37.8% of claim) Country Life� Vegetarian Selenium (100 mcg tablet, 1 per day) Ingredients Dist by Country Life 100 mcg APPROVED Metabolic Maintenance Selenium 200 mcg (200 mcg per capsule, 1 per day) Ingredients Mfd. by Metabolic Maintenance Products 200 mcg APPROVED NA Nature's Bounty� Natural Selenium 200 mcg (200 mcg per tablet, 1 per day)* Ingredients Mfd. by Nature's Bounty, Inc. 200 mcg APPROVED Puritan's Pride� Natural Selenium 50 mcg (50 mcg per tablet, 1-2 per day)* Ingredients Dist. by Puritan's Pride, Inc. 50 - 100 mcg APPROVED Puritan's Pride� Natural Selenium 100 mcg (100 mcg per tablet, 4 per day)* Ingredients Dist. by Puritan's Pride, Inc. 400 mcg APPROVED Schiff� Natural Selenium (200 mcg per tablet, 1 per day) Ingredients Dist. by Schiff Products 200 mcg APPROVED Whole Foods� Selenium (100 mcg per tablet, 1-2 per day) Ingredients Dist by Whole Foods Market 100 - 200 mcg APPROVED Similar to APPROVED Products:** Puritan's Pride� Selenium 200 mcg (200 mcg per tablet, 1 per day) Ingredients Dist. by Puritan's Pride, Inc Vitamin World� Selenium 200 mcg (200 mcg per tablet, 1 per day) Ingredients Dist. by Vitamin World, Inc Vitamin World� Natural Selenium 100 mcg (100 mcg per tablet, 2 per day) Ingredients Dist. by Vitamin World, Inc *Tested through CL's Voluntary Certification Program prior to, at time of, or after initial posting of this Product Review. ** Product identical in formulation and manufacture to a product that has passed testing but sold under a different brand. For more information see CL's Multi-Label Testing Program. Manufacturers may change ingredients and label information at any time. So be sure to check labels carefully when evaluating the products you use or buy. If a product's ingredients differ from what is listed above, it may not be the same as what was tested. CL cannot assure that results for other samples will be the same as those listed above because because there may be a lack of consistency both within and across lots. The information contained in this report is based on the compilation and review of information from product labeling and analytic testing. CL applies what it believes to be the most appropriate testing methods and standards. The information in this report does not reflect the opinion or recommendation of CL, its officers or employees. CL cannot assure the accuracy of information provided to it by third parties. Liability to any person for any loss or damage caused by errors, omissions, or inaccuracies in this report is hereby disclaimed. Copyright ConsumerLab.com, LLC, 2006. All rights reserved. This study is reproduced with the express written permission of ConsumerLab.com LLC. ConsumerTips�: Three cups of green tea per day is believed to contain 240 to 320 mg of polyphenols. It may be advisable to look for products that state the amount of "EGCG." More broadly, you may see the term "catechins" or "flavonols" � types of compounds that include EGCG. Catechins or flavonols are themselves part of a larger class of compounds called "polyphenols" � another term that you might see on labels. These compounds are anti-oxidants and may help explain the link between green tea consumption and reduced incidence of cancer. However, it is impossible to say how much of these compounds may be best. A dose sometimes suggested for green tea extract is 300 to 400 mg per day containing 80% total polyphenols and 55% epigallocatechin. This would yield about 150 to 200 mg of EGCG daily. As seen in this Review, the amount of EGCG in a recommended daily serving can vary considerably among products. The minimum suggested daily serving of a green tea extract ranged from 43.5 to 246.5 mg of EGCG. One product suggested as much as 380 mg of EGCG at the upper end of its suggested daily serving range of 1 to 4 capsules. The amount of EGCG in a serving is a function of the amount of extract in a dose and the concentration of EGCG in the extract. In this Review, EGCG concentrations ranged from 5% to 38%; less concentrated products tended to recommend higher doses. Possible weight loss benefit was shown in one study using a green tea extract standardized to contain 25% epigallocatechin gallate (EGCG). Lycopene exists naturally in fresh fruits and vegetables in the trans- configuration, which is poorly absorbed. Cooking tomatoes might make lycopene more bioavailable (more readily used by the body). Heat processing of raw foods into products such as tomato paste, juice, ketchup, changes lycopene from the trans- to the cis-configuration, which has better bioavailability. Tomatoes are the best source of lycopene. One cup (240 mL) of tomato juice, for example, provides about 23 mg of lycopene. Relatively high amounts of lycopene are also found in watermelon, guava, and pink grapefruit. Below are approximate amounts of lycopene in some foods. Tomato paste: 8 mg / ounce Tomato sauce: 9.6 mg / 1/4 cup Catsup: 2.9 mg / tbsp One medium tomato: 4.5 mg One pink grapefruit: 2.3 mg One sixteenth of a medium watermelon: 13.6 mg As a supplement: Lycopene supplements seem to have a similar bioavailability to foods; lycopene supplements can provide serum lycopene levels similar to those provided by tomato juice when ingested in equivalent amounts. Synthetic lycopene appears to be as well absorbed as natural-source lycopene. Most individuals in the U.S. and Canada are believed to consume more than enough selenium. Foods containing significant and reliable amounts of selenium include animal products like meat, seafood, and dairy foods, as well as whole grains and vegetables grown in selenium-rich soils. These include wheat germ, nuts (particularly Brazil nuts), oats, whole-wheat bread, bran, red Swiss chard, brown rice, turnips, garlic, barley, and orange juice. The selenium content of food varies depending on the selenium content of the soil in which it was grown. Studies suggest that many people in certain developed countries, including New Zealand, Belgium, and Scandinavia, do not get enough selenium in their diets. Selenium supplements are available in organic and inorganic forms. Some research suggests that the inorganic form, selenite, is harder for the body to absorb than organic forms such as selenomethionine (selenium bound to methionine, an essential amino acid) or high-selenium yeast (which contains selenomethionine). A recent clinical trial found that selenomethionine had 19% better absorption than selenite; absorption from selenium yeast was about 10% better than selenite. Selenized yeast is brewer's yeast that has been grown in selenium rich broth and then used as a selenium supplement. Studies inconsistently suggest that 3 cups of green tea daily might provide protection against cancer. As discussed above, the dosage suggested by manufacturers varies widely from product to product. Whether these amounts are ideal or these extracts offer any benefit remains unknown. Most tend to provide about 75 mg of EGCG per day, but twice that amount has also been suggested, so you might consider adjusting the dose to get about 150 mg of EGCG. The optimum dosage for lycopene has not been established, but the amount found potentially helpful in studies generally fell in the range of 4 to 6.5 mg daily. For reducing the risk of prostate cancer, at least one study found potential benefit with 4 mg of lycopene supplement per day. A possible reduction in the risk of lung cancer in non-smokers has been seen with 12 mg of lycopene (from food) per day in men and about 6 mg per day in women. The Recommended Daily Allowance (RDA) for selenium is 20 mcg for children 1 to 3, 30 mcg for those 4 to 8, and 40 mcg for those 9 to 13. For individuals 14 and older the RDA is 55 mcg. However, the RDA for pregnant woman is 60 mcg and for nursing women it is 70 mcg per day. Since it is the deficiency of selenium that is potentially associated with cancer risk, getting the RDA should be sufficient to have benefit. However, a higher dose (200 mcg of selenium supplied as a 0.5 gram high-selenium brewer's yeast tablet daily) has also been used in studies. For patients infected with human immunodeficiency virus (HIV), 250 mcg of L-selenomethionine daily has been used for 12 months, although it is not clear that this provides any benefit. Bear in mind that certain digestive conditions, such as Crohn's disease, short-bowel syndrome and ulcerative colitis, might impair selenium absorption. Medications that reduce stomach acid might also reduce absorption of selenium. At very high doses selenium can cause hair loss and tissue damage (see Concerns and Cautions below). Green tea contains a significant amount of caffeine and can cause caffeine-related side effects and interfere with drugs that are MAO inhibitors. Even products listed as "decaffeinated" may contain up to 2% caffeine, and "caffeine free" products can contain small amounts. To help those sensitive to caffeine, we measured caffeine in the products and the results are shown in the results table. Liver toxicity has been associated with green tea supplements. There are recent reports of several cases of toxicity beginning from five days to four months after beginning use. Liver function returned to normal in most cases after discontinuation. However, one patient required liver transplant � the specific extract taken (Exolise from Arkopharma) is reported to have been removed from the market. Toxicity has not been reported with green tea beverage and it is possible that certain extraction processes, such as ethanolic extraction, may contribute toxic compounds. Green tea contains vitamin K, which directly counteracts Coumadin's blood-thinning action, but enormous quantities of green tea would be necessary to provide a significant amount of vitamin K. Preliminary research has raised concerns that lycopene might worsen established prostate cancer by increasing metastasis. However, lycopene is otherwise generally believed to be a safe supplement. Maximum safe dosages are not known. Maximum safe doses of selenium for individuals with severe liver or kidney disease have not been established. Excessive selenium intake, beginning at about 900 mcg daily, can cause selenium toxicity. Signs include depression, nervousness, emotional instability, nausea, vomiting, and brittleness or loss of hair and fingernails. At doses above the tolerable upper intake level (UL) of 400 mcg per day for adults and children 14 and older, hair and nail brittleness and loss occur. The UL is lower for younger individuals. The tolerable upper intake level (UL) for infants up to age 6 months is 45 mcg per day; for infants 7 to 12 months, 60 mcg per day; for children 1 to 3 years, 90 mcg per day; for children 4 to 8 years, 150 mcg per day; for children 9 to 13 years, 280 mcg per day. Note that these dosages apply to combined dietary and supplemental intake of selenium; when deciding how much selenium it's safe to take, keep in mind that most adults already receive about 100 mcg of selenium in the daily diet.