Dietary supplement: Difference between revisions
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[[File:Springtime St. John's Wort (12610079565).jpg|thumb|St. John's wort petals used in natural product supplements]] | [[File:Springtime St. John's Wort (12610079565).jpg|thumb|St. John's wort petals used in natural product supplements]] | ||
Dietary supplements can be manufactured using intact sources or [[extract]]s from plants, animals, algae, fungi or lichens, including such examples as [[ginkgo biloba]], [[curcumin]], [[cranberry]], [[St. John's wort]], [[ginseng]], [[resveratrol]], [[glucosamine]] and [[collagen]]. Products bearing promotional claims of health benefits are sold without requiring a prescription in [[pharmacy|pharmacies]], [[supermarket]]s, specialist shops, military [[commissary|commissaries]], [[buyers club]]s, [[direct selling]] organizations, and the internet. | Dietary supplements can be manufactured using intact sources or [[extract]]s from plants, animals, algae, fungi or lichens, including such examples as [[ginkgo biloba]], [[curcumin]], [[cranberry]], [[St. John's wort]], [[ginseng]], [[resveratrol]], [[glucosamine]] and [[collagen]]. Products bearing promotional claims of health benefits are sold without requiring a prescription in [[pharmacy|pharmacies]], [[supermarket]]s, specialist shops, military [[commissary|commissaries]], [[buyers club]]s, [[direct selling]] organizations, and the internet. While most of these products have a long history of use in [[herbalism]] and various forms of traditional medicine, concerns exist about their actual efficacy, safety and consistency of quality. Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products. | ||
In 2019, sales of herbal supplements just in the United States alone were $9.6 billion, with the market growing at approximately 8.6% per year, with [[cannabidiol]] and mushroom product sales as the highest. Italy, Germany, and [[Eastern Europe]]an countries were leading consumers of botanical supplements in 2016, with [[European Union]] market growth forecast to be $8.7 billion by 2020. | In 2019, sales of herbal supplements just in the United States alone were $9.6 billion, with the market growing at approximately 8.6% per year, with [[cannabidiol]] and mushroom product sales as the highest. Italy, Germany, and [[Eastern Europe]]an countries were leading consumers of botanical supplements in 2016, with [[European Union]] market growth forecast to be $8.7 billion by 2020. | ||
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[[Prenatal vitamins]] are dietary supplements commonly given to pregnant women to supply nutrients that may reduce health complications for the mother and [[fetus]]. Although prenatal vitamins are not meant to substitute for dietary nutrition, prenatal supplementation may be beneficial for pregnant women at risk of nutrient deficiencies because of diet limitations or restrictions. The most common components in prenatal vitamins include vitamins [[Vitamin B6|B<sub>6</sub>]], [[folate]], [[Vitamin B12|B<sub>12</sub>]], [[Vitamin C|C]], [[Vitamin D|D]], [[Vitamin E|E]], [[Iron supplement|iron]] and [[calcium]]. | [[Prenatal vitamins]] are dietary supplements commonly given to pregnant women to supply nutrients that may reduce health complications for the mother and [[fetus]]. Although prenatal vitamins are not meant to substitute for dietary nutrition, prenatal supplementation may be beneficial for pregnant women at risk of nutrient deficiencies because of diet limitations or restrictions. The most common components in prenatal vitamins include vitamins [[Vitamin B6|B<sub>6</sub>]], [[folate]], [[Vitamin B12|B<sub>12</sub>]], [[Vitamin C|C]], [[Vitamin D|D]], [[Vitamin E|E]], [[Iron supplement|iron]] and [[calcium]]. | ||
Sufficient intake of vitamin B<sub>6</sub> can lower the risk of early pregnancy loss and relieve symptoms of [[morning sickness]]. Folate is also an essential nutrient for pregnant women to prevent [[neural tube defect]]s. | Sufficient intake of vitamin B<sub>6</sub> can lower the risk of early pregnancy loss and relieve symptoms of [[morning sickness]]. Folate is also an essential nutrient for pregnant women to prevent [[neural tube defect]]s. In 2006, the World Health Organization endorsed the recommendation for women of child-bearing age to consume 400 [[microgram]]s of folate through the diet daily if planning a pregnancy. A 2013 review found folic acid supplementation during pregnancy did not affect the mother's health other than a risk reduction on low pre-delivery serum folate and megaloblastic anemia. There is little evidence to suggest that vitamin D supplementation improves prenatal outcomes in hypertensive disorders and [[gestational diabetes]]. Evidence does not support the routine use of vitamin E supplementation during pregnancy to prevent adverse events, such as preterm birth, fetal or neonatal death, or maternal hypertensive disorders. | ||
Iron supplementation can lower the risk of [[Iron-deficiency anemia|iron deficiency anemia]] for pregnant women. In 2020, the World Health Organization updated recommendations for adequate calcium levels during pregnancy to prevent [[Hypertensive disease of pregnancy|hypertensive disorders]]. | Iron supplementation can lower the risk of [[Iron-deficiency anemia|iron deficiency anemia]] for pregnant women. In 2020, the World Health Organization updated recommendations for adequate calcium levels during pregnancy to prevent [[Hypertensive disease of pregnancy|hypertensive disorders]]. | ||
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==Adulteration, contamination and mislabeling== | ==Adulteration, contamination and mislabeling== | ||
Over the period 2008 to 2011, the [[Government Accountability Office]] (GAO) of the United States received 6,307 reports of health problems (identified as [[adverse event]]s) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products, with 92% of tested herbal supplements containing [[lead]] and 80% containing other chemical contaminants. Using [[undercover operation|undercover]] staff, the GAO also found that supplement retailers intentionally engaged in "unequivocal deception" to sell products advertised with baseless health claims, particularly to elderly consumers. | Over the period 2008 to 2011, the [[Government Accountability Office]] (GAO) of the United States received 6,307 reports of health problems (identified as [[adverse event]]s) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products, with 92% of tested herbal supplements containing [[lead]] and 80% containing other chemical contaminants. Using [[undercover operation|undercover]] staff, the GAO also found that supplement retailers intentionally engaged in "unequivocal deception" to sell products advertised with baseless health claims, particularly to elderly consumers. [[Consumer Reports]] also reported unsafe levels of [[arsenic]], [[cadmium]], lead and [[mercury (element)|mercury]] in several protein powder products. The [[Canadian Broadcasting Corporation]] (CBC) reported that protein spiking, i.e., the addition of amino acids to manipulate protein content analysis, was common. Many of the companies involved challenged CBC's claim. | ||
A 2013 study on herbal supplements found that many products were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances. In a [[Genetics|genetic]] analysis of herbal supplements, 78% of samples contained animal [[DNA]] that was not identified as an ingredient on the product labels. In some botanical products, undeclared ingredients were used to increase the bulk of the product and reduce its cost of manufacturing, while potentially violating certain religious and/or cultural limitations on consuming animal ingredients, such as cow, buffalo or deer. In 2015, the [[New York Attorney General]] (NY-AG) identified four major retailers with dietary supplement products that contained fraudulent and potentially dangerous ingredients, requiring the companies to remove the products from retail stores. According to the NY-AG, only about 20% of the herbal supplements tested contained the plants claimed. The methodology used by the NY-AG was disputed. The test involves looking for [[DNA]] fragments from the plants named as the dietary supplement ingredients in the products. One scientist said that it was possible that the extraction process used to create the supplements removed or destroyed all DNA. This, however, would not explain the presence of DNA from plants such as rice or wheat, that were not listed as ingredients. | A 2013 study on herbal supplements found that many products were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances. In a [[Genetics|genetic]] analysis of herbal supplements, 78% of samples contained animal [[DNA]] that was not identified as an ingredient on the product labels. In some botanical products, undeclared ingredients were used to increase the bulk of the product and reduce its cost of manufacturing, while potentially violating certain religious and/or cultural limitations on consuming animal ingredients, such as cow, buffalo or deer. In 2015, the [[New York Attorney General]] (NY-AG) identified four major retailers with dietary supplement products that contained fraudulent and potentially dangerous ingredients, requiring the companies to remove the products from retail stores. According to the NY-AG, only about 20% of the herbal supplements tested contained the plants claimed. The methodology used by the NY-AG was disputed. The test involves looking for [[DNA]] fragments from the plants named as the dietary supplement ingredients in the products. One scientist said that it was possible that the extraction process used to create the supplements removed or destroyed all DNA. This, however, would not explain the presence of DNA from plants such as rice or wheat, that were not listed as ingredients. | ||
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Substances which the FDA regulates as food are subdivided into various categories, including foods, [[food additive]]s, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances. | Substances which the FDA regulates as food are subdivided into various categories, including foods, [[food additive]]s, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances. | ||
Dietary supplement manufacture is required to comply with the good manufacturing practices established in 2007. The FDA can visit manufacturing facilities, send [[FDA warning letter|Warning Letters]] | Dietary supplement manufacture is required to comply with the good manufacturing practices established in 2007. The FDA can visit manufacturing facilities, send [[FDA warning letter|Warning Letters]] if not in compliance with GMPs, stop production, and if there is a health risk, require that the company conduct a recall. Only after a dietary supplement product is marketed, may the FDA's Center for Food Safety and Applied Nutrition (CFSAN) review the products for safety and effectiveness. | ||
====European Union==== | ====European Union==== | ||
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==Research== | ==Research== | ||
Examples of ongoing government research organizations to better understand the potential health properties and safety of dietary supplements are the [[European Food Safety Authority]], | Examples of ongoing government research organizations to better understand the potential health properties and safety of dietary supplements are the [[European Food Safety Authority]], the Office of Dietary Supplements of the United States [[National Institutes of Health]], the [[Natural Health Products Directorate|Natural and Non-prescription Health Products Directorate]] of Canada, and the [[Therapeutic Goods Administration]] of Australia. Together with public and private research groups, these agencies construct [[database]]s on supplement properties, perform research on quality, safety, and population trends of supplement use, and evaluate the potential clinical efficacy of supplements for maintaining health or lowering disease risk. | ||
===Databases=== | ===Databases=== | ||
As continual research on the properties of supplements accumulates, databases or fact sheets for various supplements are updated regularly, including the Dietary Supplement Label Database, | As continual research on the properties of supplements accumulates, databases or fact sheets for various supplements are updated regularly, including the Dietary Supplement Label Database, Dietary Supplement Ingredient Database, and Dietary Supplement Facts Sheets of the United States. In Canada where a license is issued when a supplement product has been proven by the manufacturer and government to be safe, effective and of sufficient quality for its recommended use, an eight-digit Natural Product Number is assigned and recorded in a Licensed Natural Health Products Database. The European Food Safety Authority maintains a [[compendium]] of botanical ingredients used in manufacturing of dietary supplements. | ||
In 2015, the [[Department of Health (Australia)|Australian Government's Department of Health]] published the results of a review of herbal supplements to determine if any were suitable for coverage by [[health insurance]]. Establishing guidelines to assess safety and efficacy of botanical supplement products, the [[European Medicines Agency]] provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements. In the United States, the [[National Center for Complementary and Integrative Health]] of the National Institutes of Health provides fact sheets evaluating the safety, potential effectiveness and side effects of many botanical products. | In 2015, the [[Department of Health (Australia)|Australian Government's Department of Health]] published the results of a review of herbal supplements to determine if any were suitable for coverage by [[health insurance]]. Establishing guidelines to assess safety and efficacy of botanical supplement products, the [[European Medicines Agency]] provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements. In the United States, the [[National Center for Complementary and Integrative Health]] of the National Institutes of Health provides fact sheets evaluating the safety, potential effectiveness and side effects of many botanical products. | ||
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===Population monitoring=== | ===Population monitoring=== | ||
In the United States, the [[National Health and Nutrition Examination Survey]] (NHANES) has investigated habits of using dietary supplements in context of total nutrient intakes from the diet in adults and children. | In the United States, the [[National Health and Nutrition Examination Survey]] (NHANES) has investigated habits of using dietary supplements in context of total nutrient intakes from the diet in adults and children. Over the period of 1999 to 2012, use of multivitamins decreased, and there was wide variability in the use of individual supplements among subgroups by age, sex, race/ethnicity, and educational status. Particular attention has been given to use of folate supplements by young women to reduce the risk of [[fetus|fetal]] [[neural tube defect]]s. | ||
===Clinical studies=== | ===Clinical studies=== | ||
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===Future=== | ===Future=== | ||
Improving public information about use of dietary supplements involves investments in professional training programs, further studies of population and nutrient needs, expanding the [[database]] information, enhancing collaborations between governments and universities, and translating dietary supplement research into useful information for consumers, [[health professional]]s, scientists, and policymakers. Future demonstration of efficacy from use of dietary supplements requires high-quality [[clinical research]] using rigorously qualified products and compliance with established guidelines for reporting of clinical trial results (e.g., [[Consolidated Standards of Reporting Trials|CONSORT guidelines]]). | Improving public information about use of dietary supplements involves investments in professional training programs, further studies of population and nutrient needs, expanding the [[database]] information, enhancing collaborations between governments and universities, and translating dietary supplement research into useful information for consumers, [[health professional]]s, scientists, and policymakers. Future demonstration of efficacy from use of dietary supplements requires high-quality [[clinical research]] using rigorously qualified products and compliance with established guidelines for reporting of clinical trial results (e.g., [[Consolidated Standards of Reporting Trials|CONSORT guidelines]]). | ||
== See also == | == See also == | ||