[[File:Spirulina Capsules.jpg|thumb|As a capsule]]
[[File:B vitamin supplement tablets.jpg|thumb|As a tablet]]
[[File:Codliveroilcapsules.jpg|thumb|As a softgel capsule used for fish oil or large amounts of vitamin E]]
[[File:Vega protein powders.jpg|thumb|As a [[milkshake|shake]] and bottled powder]]
[[File:A Chemist Carries On- the work of Allen and Hanburys in the Production of Cod Liver Oil, 1942 D6761.jpg|thumb|Production of [[cod liver oil]], one of the first dietary supplement products manufactured, in the 18th century]]
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[[File:Iodine pills.jpg|thumb|錠剤として]]
<!-- Definition -->
[[File:Spirulina Capsules.jpg|thumb|カプセルとして]]
A '''dietary supplement''' is a manufactured product intended to supplement one's diet by taking a [[pill (pharmacy)|pill]], [[capsule (pharmacy)|capsule]], [[tablet (pharmacy)|tablet]], powder, or liquid. A supplement can provide [[nutrient]]s either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes [[vitamin]]s, [[Dietary mineral|minerals]], [[Dietary fiber|fiber]], [[fatty acid]]s, and [[amino acid]]s. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant [[pigment]]s or [[polyphenol]]s. Animals can also be a source of supplement ingredients, such as [[collagen]] from [[chicken]]s or [[fish]] for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The [[European Commission]] has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.
[[File:Vega protein powders.jpg|thumb|[[milkshake/ja|シェイク]]やボトル入りパウダーとして]]
[[File:A Chemist Carries On- the work of Allen and Hanburys in the Production of Cod Liver Oil, 1942 D6761.jpg|thumb|18世紀、[[cod liver oil/ja|タラ肝油]]が初めて製造された。]]
Creating an industry estimated to have a value of $151.9 billion in 2021, there are more than 50,000 dietary supplement products marketed in the United States, where about 50% of the American adult population consumes dietary supplements. [[Multivitamin]]s are the most commonly used product among types of dietary supplements. The United States [[National Institutes of Health]] states that supplements "may be of value" for those who are nutrient deficient from their diet and receive approval from their medical provider.
2021年には1,519億ドル規模になると推定される業界を生み出し、米国では50,000種類以上のサプリメント製品が販売されている。マルチビタミンは、栄養補助食品の中で最も一般的に使用されている製品である。米国[[National Institutes of Health/ja|国立衛生研究所]](National Institutes of Health)は、食事から摂取する栄養素が不足しており、かつ医療従事者の承認を得ている場合、サプリメントは「価値があるかもしれない」と述べている。
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<!-- Regulation -->
<!-- Regulation -->
In the United States, it is against federal regulations for supplement manufacturers to [[health claim|claim]] that these products prevent or treat any disease. Companies are allowed to use what is referred to as "Structure/Function" wording if there is substantiation of [[scientific evidence]] for a supplement providing a potential health effect. An example would be "_____ helps maintain healthy joints", but the label must bear a disclaimer that the [[Food and Drug Administration]] (FDA) "has not evaluated the claim" and that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease", because only a [[Medication|drug]] can legally make such a claim. The FDA enforces these regulations and also prohibits the sale of supplements and supplement ingredients that are dangerous, or supplements not made according to standardized [[good manufacturing practice]]s (GMPs).
米国では、サプリメント製造業者が、サプリメントが病気を予防したり治療したりすると主張することは、連邦規則に反している。しかし、サプリメントが潜在的な健康効果をもたらすという[[scientific evidence/ja|科学的根拠]]が立証されている場合には、「構造/機能」と呼ばれる表現を使用することが認められている。例えば、「○○は健康な関節を維持するのに役立ちます」というような表現であるが、ラベルには、[[Food and Drug Administration/ja|食品医薬品局]](FDA)は「その主張を評価していない」こと、また、栄養補助食品製品は「いかなる疾病の診断、治療、治癒、予防」を意図したものではないことを免責事項として記載しなければならない。というのも、そのような主張を法的に行うことができるのは[[Medication/ja|薬物]]だけだからである。FDAはこれらの規制を実施し、危険なサプリメントやサプリメント原料、あるいは標準化された[[good manufacturing practice/ja|適正製造規範]](GMP)に従って製造されていないサプリメントの販売も禁止している。
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==定義==
==Definition==
{{Anchor|Definition}}
In the United States, the [[Dietary Supplement Health and Education Act of 1994]] provides this description: "The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term "dietary supplement" to mean a product (other than [[tobacco]]) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, [[metabolite]], constituent, [[extract]], or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new [[drug]], [[antibiotic]], or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition."
米国では、1994年に制定された「[[:en:Dietary Supplement Health and Education Act of 1994|栄養補助食品健康教育法]](Dietary Supplement Health and Education Act of 1994)」に、次のような記述がある: 1994年栄養補助食品健康教育法(DSHEA)は、"栄養補助食品"という用語を定義している。"栄養補助食品 "とは、ビタミン、ミネラル、ハーブまたはその他の植物、アミノ酸、食事からの総摂取量を増やすことによって食事を補うために人間が使用するための栄養物質、または前述の成分の濃縮物、[[metabolite/ja|代謝物]]、成分、[[extract/ja|抽出物]]、またはその組み合わせの1つ以上を含む、食事を補うことを意図した製品([[:ja:タバコ|タバコ]]を除く)を意味する。さらに、栄養補助食品は、栄養補助食品として表示され、摂取を意図したものでなければならず、通常の食品として、または食事もしくは食事の唯一の項目として使用するために表示されたものであってはならない。さらに、栄養補助食品は、新[[drug/ja|薬]]、[[antibiotic/ja|抗生物質]]、生物学的製剤として承認または調査認可されることはできない。DSHEAの下では、栄養補助食品は薬物の定義の目的を除き、食品とみなされる。
Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including [[meal replacement]]s), [[medical food]]s, [[preservative]]s or [[pharmaceutical drugs]]. Products intended for use as a [[nasal spray]], or [[Topical medication|topically]], as a lotion applied to the skin, do not qualify. FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain [[vitamins]], [[Mineral (nutrient)|nutritionally essential minerals]], [[amino acid]]s, [[essential fatty acid]]s and non-nutrient substances extracted from [[plant]]s or [[animal]]s or [[Fungus|fungi]] or [[bacteria]], or in the instance of [[probiotic]]s, are live bacteria. Dietary supplement ingredients may also be synthetic copies of naturally occurring substances (for example: [[melatonin]]). All products with these ingredients are required to be labeled as dietary supplements. Like foods and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring [[Risk–benefit ratio|risk–benefit analysis]] to prove that the product can be sold like a drug, such assessment is only used by the FDA to decide that a dietary supplement is unsafe and should be removed from market.
A vitamin is an [[organic compound]] required by an [[organism]] as a vital [[nutrient]] in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be [[biosynthesis|synthesized]] in sufficient quantities by an organism and must be obtained from the diet. The term is conditional both on the circumstances and on the particular organism. For example, [[ascorbic acid]] (vitamin C) is a vitamin for anthropoid primates, [[human]]s, [[guinea pig]]s and [[bat]]s, but not for other mammals. Vitamin D is not an essential nutrient for people who get sufficient exposure to [[Ultraviolet light therapy|ultraviolet light]], either from the sun or an artificial source, as they synthesize vitamin D in skin. Humans require thirteen vitamins in their diet, most of which are actually groups of related molecules, "vitamers", (e.g. vitamin E includes tocopherols and tocotrienols, vitamin K includes vitamin K<sub>1</sub> and K<sub>2</sub>). The list: vitamins A, C, D, E, K, Thiamine (B<sub>1</sub>), Riboflavin (B<sub>2</sub>), Niacin (B<sub>3</sub>), Pantothenic Acid (B<sub>5</sub>), Vitamin B<sub>6</sub>, Biotin (B<sub>7</sub>), Folate (B<sub>9</sub>) and Vitamin B<sub>12</sub>. Vitamin intake below recommended amounts can result in signs and symptoms associated with vitamin deficiency. There is little evidence of benefit when vitamins are consumed as a dietary supplement by those who are healthy and have a nutritionally adequate diet.
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[[National Academy of Medicine/ja|米国医学研究所]]は、いくつかのビタミンについて[[tolerable upper intake level/ja|耐容上限摂取量]](UL)を設定している。これは、栄養補助食品会社が1食あたりの含有量をULよりも高く設定した製品を販売することを妨げるものではない。例えば、ビタミンDのULは100μg(4,000IU)だが、10,000IUの製品が処方箋なしで入手できる。
The [[National Academy of Medicine|U.S. Institute of Medicine]] sets [[tolerable upper intake level]]s (ULs) for some of the vitamins. This does not prevent dietary supplement companies from selling products with content per serving higher than the ULs. For example, the UL for vitamin D is 100 µg (4,000 IU), but products are available without prescription at 10,000 IU.
Minerals are the [[exogenous]] [[chemical element]]s indispensable for life. Four minerals – [[carbon]], [[hydrogen]], [[oxygen]], and [[nitrogen]] – are essential for life but are so ubiquitous in food and drink that these are not considered nutrients and there are no recommended intakes for these as minerals. The need for nitrogen is addressed by requirements set for protein, which is composed of nitrogen-containing amino acids. [[Sulfur]] is essential, but for humans, not identified as having a recommended intake per se. Instead, recommended intakes are identified for the sulfur-containing amino acids [[methionine]] and [[cysteine]]. There are dietary supplements that provide sulfur, such as [[taurine]] and [[methylsulfonylmethane]].
The essential nutrient minerals for humans, listed in order by weight needed to be at the [[Dietary Reference Intake|Recommended Dietary Allowance]] or [[Adequate Intake]] are [[potassium]], [[chlorine]], [[sodium]], [[calcium]], [[phosphorus]], [[magnesium]], [[iron]], [[zinc]], [[manganese]], [[copper]], [[iodine]], [[chromium]], [[molybdenum]], [[selenium]] and [[cobalt]] (the last as a component of vitamin B<sub>12</sub>). There are other minerals which are essential for some plants and animals, but may or may not be essential for humans, such as [[boron]] and [[silicon]]. Essential and purportedly essential minerals are marketed as dietary supplements, individually and in combination with vitamins and other minerals.
Although as a general rule, dietary supplement labeling and marketing are not allowed to make disease prevention or treatment claims, the U.S. FDA has for some foods and dietary supplements reviewed the science, concluded that there is significant scientific agreement, and published specifically worded allowed health claims. An initial ruling allowing a health claim for calcium dietary supplements and [[osteoporosis]] was later amended to include calcium supplements with or without vitamin D, effective January 1, 2010. Examples of allowed wording are shown below. In order to qualify for the calcium health claim, a dietary supplement must contain at least 20% of the Reference Dietary Intake, which for calcium means at least 260 mg/serving.
In the same year, the European Food Safety Authority also approved a dietary supplement health claim for calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss.
The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and [[Chromium(III) picolinate|chromium picolinate]]. QHCs are supported by scientific evidence, but do not meet the more rigorous "significant scientific agreement" standard required for an authorized health claim. If dietary supplement companies choose to make such a claim then the FDA stipulates the exact wording of the QHC to be used on labels and in marketing materials. The wording can be onerous: "One study suggests that selenium intake may reduce the risk of [[bladder cancer]] in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women."
Protein-containing supplements, either ready-to-drink or as powders to be mixed into water, are marketed as aids to people recovering from illness or injury, those hoping to thwart the [[sarcopenia]] of old age, to athletes who believe that strenuous physical activity increases protein requirements, to people hoping to lose weight while minimizing muscle loss, i.e., conducting a [[protein-sparing modified fast]], and to people who want to increase muscle size for performance and appearance. [[Whey protein]] is a popular ingredient, but products may also incorporate [[casein]], [[Soy protein|soy]], [[Pea protein|pea]], [[Hemp protein|hemp]] or [[rice protein]]. A meta-analysis found a moderate degree of evidence in favor of whey protein supplements use as a safe and effective adjunct to an athlete's training and recovery, including benefits for [[endurance]], average power, [[muscle mass]], and reduced perceived [[exercise intensity]].
According to US and Canadian [[Dietary Reference Intake]] guidelines, the protein [[Recommended Dietary Allowance]] (RDA) for adults is based on 0.8 grams protein per kilogram body weight. The recommendation is for sedentary and lightly active people. Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength, or conclude the opposite. The International Olympic Committee recommends protein intake targets for both strength and endurance athletes at about 1.2–1.8 g/kg body mass per day. One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg.
The same protein ingredients marketed as dietary supplements can be incorporated into [[meal replacement]] and [[medical food]] products, but those are regulated and labeled differently from supplements. In the United States, "meal replacement" products are foods and are labeled as such. These typically contain protein, carbohydrates, fats, vitamins and minerals. There may be content claims such as "good source of protein", "low fat" or "lactose free". Medical foods, also nutritionally complete, are designed to be used while a person is under the care of a physician or other licensed healthcare professional. Liquid medical food products – for example, [[Ensure]] – are available in regular and high protein versions.
Proteins are chains of [[amino acid]]s. Nine of these proteinogenic amino acids are considered essential for humans because they cannot be produced from other compounds by the human body and so must be taken in as food. Recommended intakes, expressed as milligrams per kilogram of body weight per day, have been established. Other amino acids may be conditionally essential for certain ages or medical conditions. Amino acids, individually and in combinations, are sold as dietary supplements. The claim for supplementing with the [[branched chain amino acid]]s leucine, valine and isoleucine is for stimulating muscle protein synthesis. A review of the literature concluded this claim was unwarranted. In elderly people, supplementation with just [[leucine]] resulted in a modest (0.99 kg) increase in lean body mass. The non-essential amino acid [[arginine]], consumed in sufficient amounts, is thought to act as a donor for the synthesis of nitric oxide, a vasodilator. A review confirmed blood pressure lowering. [[Taurine]], a popular dietary supplement ingredient with claims made for sports performance, is technically not an amino acid. It is synthesized in the body from the amino acid [[cysteine]].
Fish oil is a commonly used fatty acid supplement because it is a source of [[omega-3 fatty acid]]s. Fatty acids are strings of carbon atoms, having a range of lengths. If links are all single (C-C), then the fatty acid is called ''[[saturated fat|saturated]]''; with one double bond (C=C), it is called ''[[monounsaturated fat|monounsaturated]]''; if there are two or more double bonds (C=C=C), it is called ''[[polyunsaturated fat|polyunsaturated]]''. Only two fatty acids, both polyunsaturated, are considered essential to be obtained from the diet, as the others are synthesized in the body. The "essential" fatty acids are [[alpha-linolenic acid]] (ALA), an omega-3 fatty acid, and [[linoleic acid]] (LA), an [[omega-6 fatty acid]]. ALA can be elongated in the body to create other omega-3 fatty acids: [[eicosapentaenoic acid]] (EPA) and [[docosahexaenoic acid]] (DHA).
Plant oils, particularly seed and nut oils, contain ALA. Food sources of EPA and DHA are oceanic fish, whereas dietary supplement sources include fish oil, krill oil and [[marine algae]] extracts. The [[European Food Safety Authority]] (EFSA) identifies 250 mg/day for a combined total of EPA and DHA as Adequate Intake, with a recommendation that women pregnant or lactating consume an additional 100 to 200 mg/day of DHA. In the United States and Canada are [[Adequate Intake]]s for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA.
Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease. Furthermore, studies of fish oil supplements have failed to support claims of preventing [[Myocardial infarction|heart attacks]] or [[stroke]]s. In 2017, the American Heart Association issued a science advisory stating that it could not recommend use of omega-3 fish oil supplements for primary prevention of [[cardiovascular disease]] or stroke, although it reaffirmed supplementation for people who have a history of [[coronary heart disease]].
Manufacturers have begun to include long chain polyunsaturated fatty acids DHA and [[arachidonic acid]] (AA) into their formula milk for newborns, however, a 2017 review found that supplementation with DHA and AA does not appear to be harmful or beneficial to formula-fed infants.
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===天然製品===
===Natural products===
{{Main/ja|Natural product/ja}}
{{Main|Natural product}}
{{See also/ja|Phytochemical/ja|Herbalism/ja|Traditional Chinese medicine/ja}}
{{See also|Phytochemical|Herbalism|Traditional Chinese medicine}}
[[File:Springtime St. John's Wort (12610079565).jpg|thumb|天然サプリメントに使用されるセイヨウオトギリソウの花びら]]
[[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. 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.
Claimed benefits of using [[probiotic]] supplements are not supported by sufficient clinical evidence. Meta-analysis studies have reported a modest reduction of antibiotic-associated diarrhea and acute diarrhea in children taking probiotics. There is limited evidence in support of adults using mono-strain and multi-strain containing probiotics for the alleviation of symptoms associated with [[irritable bowel syndrome]]. Probiotic supplements are generally regarded as safe.
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=== 出生力 ===
=== Fertility ===
{{Main articles/ja|Fertility/ja}}
{{Main articles|Fertility}}
メタアナリシスでは、[[selenium in biology/ja|セレン]]、[[zinc/ja|亜鉛]]、[[omega-3 fatty acid/ja|オメガ3脂肪酸]]、[[coenzyme Q10/ja|コエンザイムQ<sub>10</sub>]]、[[carnitine/ja|カルニチン]]を含むサプリメントを摂取した男性において、精子の総数、濃度、運動率、形態が改善したという予備的証拠が報告された。あるレビューでは、サプリメントや食事から摂取したオメガ3が不妊男性の精液の質を改善する可能性があると結論づけている。2021年のレビューでは、セレン、亜鉛、オメガ3脂肪酸、コエンザイムQ10、カルニチンも支持されているが、"抗酸化物質の過剰使用は精子機能に有害である可能性があり、市販のサプリメントの多くは不妊改善効果が科学的に証明されていない "と警告している。
A meta-analysis provided preliminary evidence that men treated with supplements containing [[selenium in biology|selenium]], [[zinc]], [[omega-3 fatty acid]]s, [[coenzyme Q10|coenzyme Q<sub>10</sub>]] or [[carnitine]]s reported improvements in total sperm count, concentration, motility, and morphology. A review concluded that omega-3 taken through supplements and diet might improve semen quality in infertile men. A 2021 review also supported selenium, zinc, omega-3 fatty acids, coenzyme Q<sub>10</sub> or carnitines, but warned that "excessive use of antioxidants may be detrimental to the spermatic function and many of the over-the-counter supplements are not scientifically proven to improve fertility."
There is low quality and insufficient evidence for the use of oral antioxidant supplements as a viable treatment for [[subfertile]] woman. A review provided evidence that taking [[Dehydroepiandrosterone (dietary supplement)|dehydroepiandrosterone]] before starting an ''in vitro'' fertilization series may increase pregnancy rates and decrease miscarriage likelihood.
[[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. 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.
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鉄の補給は、妊婦の[[Iron-deficiency anemia/ja|鉄欠乏性貧血]]のリスクを低下させる。2020年、世界保健機関(WHO)は、[[Hypertensive disease of pregnancy/ja|高血圧性障害]]を予防するため、妊娠中の適切なカルシウム濃度に関する勧告を更新した。
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]].
Individuals with [[hypokalemic sensory overstimulation]] are sometimes diagnosed as having attention deficit hyperactivity disorder (ADHD), raising the possibility that a subtype of ADHD has a cause that can be understood mechanistically and treated in a novel way. The sensory overload is treatable with oral [[potassium gluconate]].
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==産業==
==Industry==
{{Anchor|Industry}}
In 2020, the American market for dietary supplements was valued at $140.3 billion, with the [[Economic impact analysis|economic impact]] in the United States for 2016 estimated at $122 billion, including employment wages and taxes. A 2020 analysis projected that the global market for [[vitamin]]s and dietary supplement products would reach $196.6 billion by 2028, where the growth in [[Market (economics)|market size]] is largely attributed to recent technological advancements in product manufacturing, increased demand for products advertised as healthy, increased product availability, and [[Population ageing|population aging]].
{{Anchor|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. [[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.
2013年に行われたハーブサプリメントに関する調査では、多くの製品が低品質であり、3分の1は主張されている有効成分を含んでおらず、3分の1は未記載の物質を含んでいた。ハーブサプリメントの[[Genetics/ja|遺伝子]]分析では、サンプルの78%に、製品ラベルに成分として明記されていない動物の[[DNA/ja|DNA]]が含まれていた。一部の植物性製品では、製品の嵩を増やし製造コストを下げるために未申告の成分が使用されていたが、一方で、牛、バッファロー、鹿などの動物性成分を摂取することに対する特定の宗教的・文化的制限に抵触する可能性があった。2015年、[[:en:New York Attorney General|ニューヨーク州司法長官]](NY-AG)は、不正で潜在的に危険な成分を含む栄養補助食品を扱う大手小売業者4社を特定し、同社に小売店から製品を撤去するよう求めた。NY州司法長官によると、検査されたハーブサプリメントのうち、主張する植物が含まれていたのは約20%に過ぎなかった。NY州司法省が使用した方法論には異論があった。この検査では、サプリメントの成分として記載されている植物の[[DNA/ja|DNA]]断片が製品に含まれているかどうかを調べる。ある科学者は、サプリメントを製造する際の抽出工程で、すべてのDNAが取り除かれたか、破壊された可能性があると述べた。しかし、これでは原材料として記載されていない米や小麦などの植物のDNAが含まれていることの説明がつかない。
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 study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted [[pharmaceutical drug]]s, many of which could interact with other medications and lead to hospitalization. 86% of the adulterated supplements were marketed for weight loss and sexual performance, with many containing prescription [[erectile dysfunction]] medication. [[Bodybuilding|Muscle building]] supplements were contaminated with [[anabolic steroid]]s that can lead to health complications affecting the kidney, the heart, and cause [[gynecomastia]]. Multiple bodybuilding products also contained [[antidepressant]]s and [[antihistamine]]s. Despite these findings, fewer than half of the adulterated supplements were recalled.
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==規制遵守==
==Regulatory compliance==
{{Anchor|Regulatory compliance}}
The [[European Commission]] has published harmonized rules on supplement products to assure consumers have minimal health risks from using dietary supplements and are not misled by advertising.
米国とカナダでは、栄養補助食品は食品の一部とみなされ、それに応じて規制されている。米国食品医薬品局(FDA)は、サプリメント製品の広告や表示が正確かどうかを監視している。ダイエタリーサプリメントは、現行の[[Good Manufacturing Practice/ja|適正製造基準]](CGMP)を遵守し、科学的根拠に基づく成分表示と広告を行うことを条件とする食品として、FDAによって規制されている。CGMPや広告の違反が発見された場合、[[:en:FDA warning letter|FDAの警告状]]は、[[:en:search and seizure|捜索・差し押さえ]]、[[:en:injunction|差し止め]]、[[:en:fine (penalty)|金銭的罰則]]を含む差し迫った強制措置をメーカーに通知するために使用される。2016年から2018年にかけての栄養補助食品メーカーによるCGMP違反や広告違反の例には、ビタミンやミネラルの違法な配合や広告がいくつか含まれている。
In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The U.S. Food and Drug Administration (FDA) monitors supplement products for accuracy in advertising and labeling. Dietary supplements are regulated by the FDA as [[food product]]s subject to compliance with current [[Good Manufacturing Practice]]s (CGMP) and labeling with science-based ingredient descriptions and advertising. When finding CGMP or advertising violations, [[FDA warning letter]]s are used to notify manufacturers of impending enforcement action, including [[search and seizure]], [[injunction]], and [[fine (penalty)|financial penalties]]. Examples between 2016 and 2018 of CGMP and advertising violations by dietary supplement manufacturers included several with illegal compositions or advertising of vitamins and minerals.
The U.S. [[Federal Trade Commission]], which litigates against deceptive advertising in marketed products, established a consumer center to assist reports of false health claims in product advertising for dietary supplements. In 2017, the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements.
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==副作用==
==Adverse effects==
{{Anchor|Adverse effects}}
In the United States, manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce. Despite this caution, numerous adverse effects have been reported, including muscle cramps, hair loss, joint pain, [[liver disease]], and [[allergy|allergic reactions]], with 29% of the adverse effects resulting in hospitalization, and 20% in serious injuries or illnesses. The potential for adverse effects also occurs when individuals consume more than the necessary daily amount of [[vitamin]]s or [[mineral]]s that are needed to maintain normal body processes and functions. The incidence of adverse effects reported to the [[Food and Drug Administration|FDA]] were due to "combination products" that contain multiple ingredients, whereas dietary supplements containing a single vitamin, mineral, lipid product, and herbal product were less likely to cause adverse effects related to excess supplementation.
Among general reasons for the possible harmful effects of dietary supplements are: a) absorption in a short time, b) manufacturing quality and contamination, and c) enhancing both positive and negative effects at the same time. The incidence of [[hepatotoxicity|liver injury]] from herbal and dietary supplements is about 16–20% of all supplement products causing injury, with the occurrence growing globally over the early 21st century. The most common liver injuries from weight loss and bodybuilding supplements involve [[Hepatocyte|hepatocellular]] damage with resulting [[jaundice]], and the most common supplement ingredients attributed to these injuries are green tea [[catechin]]s, [[anabolic steroid]]s, and the herbal [[extract]], [[Aegle marmelos|aegeline]]. Weight loss supplements have also had adverse [[psychiatry|psychiatric effects]]. Some dietary supplements may also have adverse interactions with prescription medications that may enhance side effects or decrease therapeutic effects of medications.
Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing [[vitamin deficiencies]], and preventing conditions like [[neural tube defects]] by supplementation and [[food fortification]] with [[folic acid]], no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.
For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like [[antioxidants]], vitamins, or minerals, do not help and some have been found to be harmful in some cases. In general, as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.
As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for [[healthy eating]] urge people to eat a [[plant-based diet]] of whole foods, minimizing [[ultra-processed food]], salt and sugar and to get exercise daily, and to abandon [[Western pattern diet]]s and a sedentary lifestyle.
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===法的規制===
===Legal regulation===
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====米国====
====United States====
{{Main/ja|Regulation of food and dietary supplements by the U.S. Food and Drug Administration/ja}}
{{Main|Regulation of food and dietary supplements by the U.S. Food and Drug Administration}}
米国食品医薬品局(FDA)による食品と栄養補助食品の規制は、[[:ja:米国議会|米国議会]]が制定した様々な法律によって規定されている。[[:en:Federal Food, Drug, and Cosmetic Act|連邦食品・薬物・化粧品法]]およびそれに付随する法律に従い、FDAは米国内で食品として販売される物質の品質を監督し、食品の成分および健康上の利点に関する[[:en:Packaging and labeling|表示]]上の主張を監視する権限を有する。
The regulation of food and dietary supplements by the U.S. Food and Drug Administration (FDA) is governed by various statutes enacted by the [[United States Congress]]. Pursuant to the [[Federal Food, Drug, and Cosmetic Act]] and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the [[Packaging and labeling|labeling]] about both the composition and the health benefits of foods.
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]] 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.
The [[European Union]]'s (EU) Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity. Only those supplements that have been proven to be safe may be sold in the EU without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear [[health claim]]s and nutrition claims.
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EU加盟28カ国のひとつである[[:ja:イギリス|イギリス]](UK)のサプリメント業界は、この指令に強く反対した。加えて、英国内の100万人以上を含むヨーロッパ中の多くの消費者、そして様々な医師や科学者が、2005年までに、[[:en:consumer choice|消費者の選択]]を不当に制限するものとして反対する請願書に署名した。2004年、英国の2つの業界団体とともに、[[:en:Alliance for Natural Health|自然健康同盟]](ANH)は食品サプリメント指令に対する法的異議をロンドンの高等法院から[[:ja:欧州司法裁判所|欧州司法裁判所]]に付託された。
The dietary supplements industry in the [[United Kingdom]] (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of [[consumer choice]]. In 2004, along with two British trade associations, the [[Alliance for Natural Health]] (ANH) had a legal challenge to the Food Supplements Directive referred to the [[European Court of Justice]] by the High Court in London.
Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of [[vitamins]] and food supplements should be scrapped, he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting [[public health]]. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet. Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.
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===COVID-19流行時の詐欺製品===
===Fraudulent products during the COVID-19 outbreak===
米国で[[:en:COVID-19 pandemic|COVID-19が大流行]]した際、[[Food and Drug Administration/ja|FDA]]と[[:en:Federal Trade Commission|連邦取引委員会]](FTC)は、[[homeopathy/ja|ホメオパシー療法]]、[[cannabidiol/ja|カンナビジオール製品]]、お茶、[[essential oil/ja|エッセンシャルオイル]]、[[tincture/ja|チンキ剤]]、[[colloidal silver/ja|コロイダルシルバー]]などを含む詐欺的サプリメント製品の[[:en:fraud|マーケティング詐欺]]について消費者に警告した。2020年8月までに、FDAとFTCは、「医薬品、医療機器、ワクチンである」と称する詐欺製品を宣伝する数十の企業に[[:en:FDA warning letter|警告書]]を発行した。病気を治す、緩和する、治療する、診断する、または予防すると主張するが、それらの目的に対する安全性と有効性が証明されていない製品は、消費者から金銭を詐取し、消費者を深刻な危害の危険にさらす可能性がある」。
During the [[COVID-19 pandemic]] in the United States, the [[Food and Drug Administration|FDA]] and [[Federal Trade Commission]] (FTC) warned consumers about [[fraud|marketing scam]]s of fraudulent supplement products, including [[homeopathy|homeopathic remedies]], [[cannabidiol|cannabidiol products]], teas, [[essential oil]]s, [[tincture]]s and [[colloidal silver]], among others. By August 2020, the FDA and FTC had issued [[FDA warning letter|warning letters]] to dozens of companies advertising scam products, which were purported "to be drugs, medical devices or vaccines. Products that claim to cure, mitigate, treat, diagnose or prevent disease, but are not proven safe and effective for those purposes, defraud consumers of money and can place consumers at risk for serious harm"
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==研究==
==Research==
{{Anchor|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]], 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.
栄養補助食品の潜在的な健康特性と安全性をよりよく理解するために現在進行中の政府研究機関の例としては、[[:en:European Food Safety Authority|欧州食品安全局]]、[[:en:National Institutes of Health|米国国立衛生研究所]]の栄養補助食品局、カナダの[[:en:Natural Health Products Directorate|天然および非処方保健製品局]]、オーストラリアの[[:en:Therapeutic Goods Administration|治療用品局]]がある。官民の研究グループとともに、これらの機関はサプリメントの特性に関する[[:ja:データベース|データベース]]を構築し、品質、安全性、サプリメント使用の集団傾向に関する研究を行い、健康維持や疾病リスク低下に対するサプリメントの潜在的臨床効果を評価している。
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===データベース===
===Databases===
サプリメントの特性に関する継続的な研究が蓄積されるにつれ、米国の栄養補助食品ラベルデータベース、栄養補助食品成分データベース、栄養補助食品ファクトシートなど、様々なサプリメントのデータベースやファクトシートが定期的に更新されている。カナダでは、サプリメント製品が安全で効果的であり、推奨される用途に十分な品質であることが製造業者と政府によって証明された場合にライセンスが発行され、8桁の天然製品番号が割り当てられ、Licensed Natural Health Products Databaseに記録される。欧州食品安全機関は、栄養補助食品の製造に使用される植物成分の[[compendium/ja|大要]]を管理している。
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.
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2015年、[[:en:Department of Health (Australia)|オーストラリア政府の保健省]]は、[[health insurance/ja|健康保険]]の適用に適したハーブサプリメントがあるかどうかを検討した結果を公表した。[[:en:European Medicines Agency|欧州医薬品庁]](European Medicines Agency)は、植物性サプリメント製品の安全性と有効性を評価するためのガイドラインを制定し、ハーブサプリメントに関するモノグラフを作成する際に、臨床研究の質を評価・格付けする基準を示した。米国では、国立衛生研究所の[[:en:National Center for Complementary and Integrative Health|国立補完統合医療センター]]が、多くの植物性製品の安全性、潜在的有効性、副作用を評価したファクトシートを提供している。
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.
To assure supplements have sufficient quality, standardization, and safety for public consumption, research efforts have focused on development of reference materials for supplement manufacturing and monitoring. High-dose products have received research attention, especially for emergency situations such as [[vitamin A]] deficiency in malnutrition of children, and for women taking folate supplements to reduce the risk of [[breast cancer]].
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===集団モニタリング===
===Population monitoring===
米国では、[[:en:National Health and Nutrition Examination Survey|国民健康栄養調査]](NHANES)が、成人および小児の食事からの総栄養摂取量との関連で、栄養補助食品の使用習慣を調査している。1999年から2012年にかけて、マルチビタミンの使用は減少し、個々のサプリメントの使用には、年齢、性別、人種/民族、教育状況によるサブグループ間で大きなばらつきがみられた。特に、[[fetus/ja|胎児]]の[[neural tube defect/ja|神経管欠損症]]のリスクを減らすために、若い女性が葉酸サプリメントを使用することが注目されている。
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.
* magnesium supplementation {{ndash}} in reducing all-cause and cancer mortality, as well as improving glucose parameters in people with diabetes and insulin-sensitivity parameters in those at high risk of diabetes.
A 2017 academic review indicated a rising [[Incidence (epidemiology)|incidence]] of liver injury from use of herbal and dietary supplements, particularly those with [[steroid]]s, [[green tea extract]], or multiple ingredients.
The potential benefit of using essential nutrient dietary supplements to lower the risk of diseases has been refuted by findings of no effect or weak evidence in numerous clinical reviews, such as for [[HIV]], or [[tuberculosis]].
A review of clinical trials registered at [[clinicaltrials.gov]], which would include both drugs and supplements, reported that nearly half of completed trials were sponsored wholly or partially by industry. This does not automatically imply bias, but there is evidence that because of selective non-reporting, results in support of a potential drug or supplement ingredient are more likely to be published than results that do not demonstrate a statistically significant benefit. One review reported that fewer than half of the registered clinical trials resulted in publication in peer-reviewed journals.
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===将来===
===Future===
栄養補助食品の使用に関する一般情報の改善には、専門家養成プログラムへの投資、人口および栄養素のニーズのさらなる調査、[[:ja:データベース|データベース]]情報の拡大、政府と大学の協力体制の強化、栄養補助食品研究を消費者、[[health professional/ja|医療専門家]]、科学者、政策立案者にとって有益な情報に変換することが必要である。栄養補助食品の使用による有効性を将来的に実証するためには、厳密に適格とされた製品を使用した質の高い[[clinical research/ja|臨床研究]]と、臨床試験結果の報告に関する確立されたガイドライン([[:en:Consolidated Standards of Reporting Trials|CONSORTガイドライン]]など)の遵守が必要である。
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]]).
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== こちらも参照 ==
== See also ==
{{Portal|Food}}
{{Portal|Food}}
{{Div col}}
{{Div col}}
* [[Bodybuilding supplement]]
* [[Bodybuilding supplement/ja]]
* [[Nutrient]]
* [[Nutrient/ja]]
* [[Food fortification]]
* [[Food fortification/ja]]
* [[Megavitamin therapy]]
* [[Megavitamin therapy/ja]]
* [[Nutraceutical]]
* [[Nutraceutical/ja]]
* [[Dietary Supplement Health and Education Act of 1994]]
* [[:en:Dietary Supplement Health and Education Act of 1994]]
* [[Multivitamin]]
* [[Multivitamin/ja]]
* [[Dietary Supplements (database)]] (PubMed)
* [[Dietary Supplements (database)/ja]] (PubMed)
* [[Alternative medicine]]
* [[Alternative medicine/ja]]
* [[ConsumerLab.com]]
* [[:en:ConsumerLab.com]]
* [[Examine.com]]
* [[:en:Examine.com]]
* [[Natural Standard]]
* [[:en:Natural Standard]]
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{{div col end}}
{{div col end}}
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== 参考資料 ==
== Further reading ==
* {{cite web | url = http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietarysupplementsconsumers06.pdf | title = Dietary Supplements: General Resources for Consumers | author = Food and Nutrition Information Center | publisher = [[United States National Agricultural Library|National Agricultural Library]] | archive-url = https://web.archive.org/web/20081216224858/http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietarysupplementsconsumers06.pdf | archive-date = 2008-12-16 }} List of resources that provides an overview of herbal and dietary supplements, including use, regulation, research, and cautionary information.
* {{cite web | url = http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietarysupplementsconsumers06.pdf | title = Dietary Supplements: General Resources for Consumers | author = Food and Nutrition Information Center | publisher = [[United States National Agricultural Library|National Agricultural Library]] | archive-url = https://web.archive.org/web/20081216224858/http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietarysupplementsconsumers06.pdf | archive-date = 2008-12-16 }} List of resources that provides an overview of herbal and dietary supplements, including use, regulation, research, and cautionary information.
* {{cite web | url = https://www.nutrition.gov/dietary-supplements/questions-ask-taking-vitamin-and-mineral-supplements | title = Questions to Ask Before Taking Vitamin and Mineral Supplements | work = nutrition.gov | archive-url = https://web.archive.org/web/20170622161438/https://www.nutrition.gov/dietary-supplements/questions-ask-taking-vitamin-and-mineral-supplements | archive-date = 2017-06-22 }}
* {{cite web | url = https://www.nutrition.gov/dietary-supplements/questions-ask-taking-vitamin-and-mineral-supplements | title = Questions to Ask Before Taking Vitamin and Mineral Supplements | work = nutrition.gov | archive-url = https://web.archive.org/web/20170622161438/https://www.nutrition.gov/dietary-supplements/questions-ask-taking-vitamin-and-mineral-supplements | archive-date = 2017-06-22 }}
* {{cite web | url = http://ods.od.nih.gov/factsheets/list-all/ | title = Dietary Supplement Fact Sheets | work = NIH Office of Dietary Supplements }}
* {{cite web | url = http://ods.od.nih.gov/factsheets/list-all/ | title = Dietary Supplement Fact Sheets | work = NIH Office of Dietary Supplements }}
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== 外部リンク ==
== External links ==
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2021年には1,519億ドル規模になると推定される業界を生み出し、米国では50,000種類以上のサプリメント製品が販売されている。マルチビタミンは、栄養補助食品の中で最も一般的に使用されている製品である。米国国立衛生研究所(National Institutes of Health)は、食事から摂取する栄養素が不足しており、かつ医療従事者の承認を得ている場合、サプリメントは「価値があるかもしれない」と述べている。
米国では、1994年に制定された「栄養補助食品健康教育法(Dietary Supplement Health and Education Act of 1994)」に、次のような記述がある: 1994年栄養補助食品健康教育法(DSHEA)は、"栄養補助食品"という用語を定義している。"栄養補助食品 "とは、ビタミン、ミネラル、ハーブまたはその他の植物、アミノ酸、食事からの総摂取量を増やすことによって食事を補うために人間が使用するための栄養物質、または前述の成分の濃縮物、代謝物、成分、抽出物、またはその組み合わせの1つ以上を含む、食事を補うことを意図した製品(タバコを除く)を意味する。さらに、栄養補助食品は、栄養補助食品として表示され、摂取を意図したものでなければならず、通常の食品として、または食事もしくは食事の唯一の項目として使用するために表示されたものであってはならない。さらに、栄養補助食品は、新薬、抗生物質、生物学的製剤として承認または調査認可されることはできない。DSHEAの下では、栄養補助食品は薬物の定義の目的を除き、食品とみなされる。
サプリメントの特性に関する継続的な研究が蓄積されるにつれ、米国の栄養補助食品ラベルデータベース、栄養補助食品成分データベース、栄養補助食品ファクトシートなど、様々なサプリメントのデータベースやファクトシートが定期的に更新されている。カナダでは、サプリメント製品が安全で効果的であり、推奨される用途に十分な品質であることが製造業者と政府によって証明された場合にライセンスが発行され、8桁の天然製品番号が割り当てられ、Licensed Natural Health Products Databaseに記録される。欧州食品安全機関は、栄養補助食品の製造に使用される植物成分の大要を管理している。