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Wikipedia

Dietary supplement

February 15, 2024

"Food supplement" redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.
This article is about supplemental nutrients and similar substances. For herbal medicine, see Herbal supplement.

A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill, capsule, tablet, powder, or liquid.[2] A supplement can provide nutrients either extracted from food sources, or that are synthetic (in order to increase the quantity of their consumption). The classes of nutrient compounds in supplements include vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, and so are not nutrients per se, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens 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.[3]

As a pill (iodine)
As a capsule (spirulina)
As a tablet (B vitamins)
As a softgel capsule (cod liver oil)
Production of cod liver oil, one of the first dietary supplement products manufactured, in the 18th century[1]

Creating an industry estimated to have a value of $151.9 billion in 2021,[4] there are more than 50,000 dietary supplement products marketed in the United States,[5] where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product among types of dietary supplements.[6] 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.[7]

In the United States, it is against federal regulations for supplement manufacturers to 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.[8] 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 drug can legally make such a claim.[8] 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 practices (GMPs).

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."[9]

Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including meal replacements), medical foods,[10] preservatives or pharmaceutical drugs. Products intended for use as a nasal spray, or 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, nutritionally essential minerals, amino acids, essential fatty acids and non-nutrient substances extracted from plants or animals or fungi or bacteria, or in the instance of probiotics, 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.[11] 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 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.[11]

Types

Vitamins

Main article: Vitamin
 
Pharmacies and supermarkets in the U.S. sell a large variety of vitamin dietary supplements.

A vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[12] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be 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, humans, guinea pigs and bats, but not for other mammals. Vitamin D is not an essential nutrient for people who get sufficient exposure to ultraviolet light, either from the sun or an artificial source, as they synthesize vitamin D in skin.[13] 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 K1 and K2). The list: vitamins A, C, D, E, K, Thiamine (B1), Riboflavin (B2), Niacin (B3), Pantothenic Acid (B5), Vitamin B6, Biotin (B7), Folate (B9) and Vitamin B12. 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.[14]

The U.S. Institute of Medicine sets tolerable upper intake levels (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),[15] but products are available without prescription at 10,000 IU.

Minerals

Main article: Mineral (nutrient)

Minerals are the exogenous chemical elements 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 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 B12). 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.[16]

  • "Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."
  • "Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."
  • "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."
  • "Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."

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.[17] The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate.[18] 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."[19]

Proteins and amino acids

Main articles: Protein (nutrient) and Amino acid

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,[20][21] to athletes who believe that strenuous physical activity increases protein requirements,[22] to people hoping to lose weight while minimizing muscle loss, i.e., conducting a protein-sparing modified fast,[23] and to people who want to increase muscle size for performance and appearance. Whey protein is a popular ingredient,[21][24][25] but products may also incorporate casein, soy, pea, 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.[26]

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.[27][28][29] Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength,[30][31][32] or conclude the opposite.[33] 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.[22] One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg.[28]

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".[34] 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.[35][10] Liquid medical food products – for example, Ensure – are available in regular and high protein versions.

Proteins are chains of amino acids. 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.[27] 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 acids leucine, valine and isoleucine is for stimulating muscle protein synthesis. A review of the literature concluded this claim was unwarranted.[36] In elderly people, supplementation with just leucine resulted in a modest (0.99 kg) increase in lean body mass.[37] 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.[38] 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.[39]

Bodybuilding supplements

This section is an excerpt from Bodybuilding supplement.[edit]
Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding, weightlifting, mixed martial arts, and athletics for the purpose of facilitating an increase in lean body mass. Bodybuilding supplements may contain ingredients that are advertised to increase a person's muscle, body weight, athletic performance, and decrease a person's percent body fat for desired muscle definition. Among the most widely used are high protein drinks, pre-workout blends, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB, whey protein, ZMA, and weight loss products.[40][41] Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages.

Essential fatty acids

Main article: Essential fatty acids

Fish oil is a commonly used fatty acid supplement because it is a source of omega-3 fatty acids.[42] 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; with one double bond (C=C), it is called monounsaturated; if there are two or more double bonds (C=C=C), it is called 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.[42][43] 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.[42] 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.[44] In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA.[45]

Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease.[46][47] Furthermore, studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes.[48] 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.[49]

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.[50]

Natural products

Main article: Natural product
See also: Phytochemical, Herbalism, and Traditional Chinese medicine
 
St. John's wort petals used in natural product supplements

Dietary supplements can be manufactured using intact sources or extracts from plants, animals, algae, fungi or lichens, including such examples as ginkgo biloba, curcumin, cranberry, St. John's wort, ginseng, resveratrol, glucosamine and collagen.[51][52][53] Products bearing promotional claims of health benefits are sold without requiring a prescription in pharmacies, supermarkets, specialist shops, military commissaries, buyers clubs, direct selling organizations, and the internet.[52] 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.[54][55][56] Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products.[57]

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,[58] with cannabidiol and mushroom product sales as the highest.[59] Italy, Germany, and Eastern European countries were leading consumers of botanical supplements in 2016, with European Union market growth forecast to be $8.7 billion by 2020.[60]

Probiotics

Main article: Probiotic

Claimed benefits of using probiotic supplements are not supported by sufficient clinical evidence.[61][62][63] Meta-analysis studies have reported a modest reduction of antibiotic-associated diarrhea and acute diarrhea in children taking probiotics.[64] 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.[65] Probiotic supplements are generally regarded as safe.[66]

Fertility

Main article: Fertility

A meta-analysis provided preliminary evidence that men treated with supplements containing selenium, zinc, omega-3 fatty acids, coenzyme Q10 or carnitines reported improvements in total sperm count, concentration, motility, and morphology.[67] A review concluded that omega-3 taken through supplements and diet might improve semen quality in infertile men.[68] A 2021 review also supported selenium, zinc, omega-3 fatty acids, coenzyme Q10 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."[69]

There is low quality and insufficient evidence for the use of oral antioxidant supplements as a viable treatment for subfertile woman.[70] A review provided evidence that taking dehydroepiandrosterone before starting an in vitro fertilization series may increase pregnancy rates and decrease miscarriage likelihood.[71]

Prenatal

Main article: Prenatal vitamins

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 B6, folate, B12, C, D, E, iron and calcium.[72]

Sufficient intake of vitamin B6 can lower the risk of early pregnancy loss and relieve symptoms of morning sickness.[73][74] Folate is also an essential nutrient for pregnant women to prevent neural tube defects.[73] In 2006, the World Health Organization endorsed the recommendation for women of child-bearing age to consume 400 micrograms of folate through the diet daily if planning a pregnancy.[75] 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.[76] There is little evidence to suggest that vitamin D supplementation improves prenatal outcomes in hypertensive disorders and gestational diabetes.[77][78] 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.[79][80]

Iron supplementation can lower the risk of iron deficiency anemia for pregnant women.[81] In 2020, the World Health Organization updated recommendations for adequate calcium levels during pregnancy to prevent hypertensive disorders.[82][83]

Pharmacotherapy

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.

Industry

In 2020, the American market for dietary supplements was valued at $140.3 billion,[4] with the economic impact in the United States for 2016 estimated at $122 billion, including employment wages and taxes.[84] A 2020 analysis projected that the global market for vitamins and dietary supplement products would reach $196.6 billion by 2028, where the growth in market size is largely attributed to recent technological advancements in product manufacturing, increased demand for products advertised as healthy, increased product availability, and population aging.[85]

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 events) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products,[86] with 92% of tested herbal supplements containing lead and 80% containing other chemical contaminants.[87] Using 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.[87] Consumer Reports also reported unsafe levels of arsenic, cadmium, lead and mercury in several protein powder products.[88] The Canadian Broadcasting Corporation (CBC) reported that protein spiking, i.e., the addition of amino acids to manipulate protein content analysis, was common.[89] Many of the companies involved challenged CBC's claim.[90]

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.[91] In a genetic analysis of herbal supplements, 78% of samples contained animal DNA that was not identified as an ingredient on the product labels.[55] 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.[55] 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.[92] According to the NY-AG, only about 20% of the herbal supplements tested contained the plants claimed.[92] 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.[92]

A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted pharmaceutical drugs, many of which could interact with other medications and lead to hospitalization.[93] 86% of the adulterated supplements were marketed for weight loss and sexual performance, with many containing prescription erectile dysfunction medication. Muscle building supplements were contaminated with anabolic steroids that can lead to health complications affecting the kidney, the heart, and cause gynecomastia.[94] Multiple bodybuilding products also contained antidepressants and antihistamines. Despite these findings, fewer than half of the adulterated supplements were recalled.[93]

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.[95]

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 products subject to compliance with current Good Manufacturing Practices (CGMP) and labeling with science-based ingredient descriptions and advertising.[96][97] When finding CGMP or advertising violations, FDA warning letters are used to notify manufacturers of impending enforcement action, including search and seizure, injunction, and financial penalties.[98] 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.[99][100][101]

The U.S. Federal Trade Commission, which litigates against deceptive advertising in marketed products,[102] established a consumer center to assist reports of false health claims in product advertising for dietary supplements.[103] In 2017, the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements.[104]

Adverse effects

In the United States, manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce.[105] Despite this caution, numerous adverse effects have been reported,[86] including muscle cramps, hair loss, joint pain, liver disease, and allergic reactions, with 29% of the adverse effects resulting in hospitalization, and 20% in serious injuries or illnesses.[86] The potential for adverse effects also occurs when individuals consume more than the necessary daily amount of vitamins or minerals that are needed to maintain normal body processes and functions.[106] The incidence of adverse effects reported to the 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.[86]

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.[56] The incidence of 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.[107] The most common liver injuries from weight loss and bodybuilding supplements involve hepatocellular damage with resulting jaundice, and the most common supplement ingredients attributed to these injuries are green tea catechins, anabolic steroids, and the herbal extract, aegeline.[107] Weight loss supplements have also had adverse psychiatric effects.[108] Some dietary supplements may also have adverse interactions with prescription medications that may enhance side effects or decrease therapeutic effects of medications.[109]

Society and culture

Public health

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.[110]

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.[111][112] 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.[113][114]

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 diets and a sedentary lifestyle.[115][116]: 10 

Legal regulation

United States

Main article: Regulation of food and dietary supplements by the U.S. Food and Drug Administration

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 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 additives, 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 Warning Letters[100] if not in compliance with GMPs, stop production, and if there is a health risk, require that the company conduct a recall.[117] 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.[118]

European Union

The European Union's (EU) Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[119] 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 claims and nutrition claims.[120]

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.[121] In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[122] referred to the European Court of Justice by the High Court in London.[123]

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,[124] 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.[125] 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.[126]

Fraudulent products during the COVID-19 outbreak

During the COVID-19 pandemic in the United States, the FDA and Federal Trade Commission (FTC) warned consumers about marketing scams of fraudulent supplement products, including homeopathic remedies, cannabidiol products, teas, essential oils, tinctures and colloidal silver, among others.[127][128] By August 2020, the FDA and FTC had issued 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"[127][129][130]

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,[3] the Office of Dietary Supplements of the United States National Institutes of Health,[7][131] the Natural and Non-prescription Health Products Directorate of Canada,[132] and the Therapeutic Goods Administration of Australia.[133] Together with public and private research groups, these agencies construct databases 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.[131]

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,[5] Dietary Supplement Ingredient Database,[134] and Dietary Supplement Facts Sheets of the United States.[135] 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.[136] The European Food Safety Authority maintains a compendium of botanical ingredients used in manufacturing of dietary supplements.[137]

In 2015, the 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.[138] 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.[139] 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.[140]

Quality and safety

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.[137][141] High-dose products have received research attention,[131][142] especially for emergency situations such as vitamin A deficiency in malnutrition of children,[143] and for women taking folate supplements to reduce the risk of breast cancer.[144]

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.[131] 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.[145] Particular attention has been given to use of folate supplements by young women to reduce the risk of fetal neural tube defects.[146][147]

Clinical studies

Limited human research has been conducted on the potential for dietary supplementation to affect disease risk. Examples:

A 2017 academic review indicated a rising incidence of liver injury from use of herbal and dietary supplements, particularly those with steroids, green tea extract, or multiple ingredients.[107]

Absence of benefit

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,[155] or tuberculosis.[156]

Reporting bias

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.[157] 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.[157][158] One review reported that fewer than half of the registered clinical trials resulted in publication in peer-reviewed journals.[159]

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 professionals, scientists, and policymakers.[160] 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., CONSORT guidelines).[131]

See also

References

  1. ^ "Cod liver oil". Encyclopædia Britannica. 2018. Retrieved 18 February 2018.
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Further reading

  • Food and Nutrition Information Center. (PDF). National Agricultural Library. Archived from the original (PDF) on 2008-12-16. List of resources that provides an overview of herbal and dietary supplements, including use, regulation, research, and cautionary information.
  • . nutrition.gov. Archived from the original on 2017-06-22.
  • "Dietary Supplement Fact Sheets". NIH Office of Dietary Supplements.

External links

 
Wikimedia Commons has media related to Dietary supplements.

February 15, 2024
dietary, supplement, food, supplement, redirects, here, food, additions, that, alter, flavor, color, longevity, food, food, additive, this, article, about, supplemental, nutrients, similar, substances, herbal, medicine, herbal, supplement, examples, perspectiv. Food supplement redirects here For food additions that alter the flavor color or longevity of food see Food additive This article is about supplemental nutrients and similar substances For herbal medicine see Herbal supplement The examples and perspective in this article may not represent a worldwide view of the subject You may improve this article discuss the issue on the talk page or create a new article as appropriate April 2020 Learn how and when to remove this template message A dietary supplement is a manufactured product intended to supplement a person s diet by taking a pill capsule tablet powder or liquid 2 A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption The classes of nutrient compounds in supplements include vitamins minerals fiber fatty acids and amino acids Dietary supplements can also contain substances that have not been confirmed as being essential to life and so are not nutrients per se but are marketed as having a beneficial biological effect such as plant pigments or polyphenols Animals can also be a source of supplement ingredients such as collagen from chickens 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 3 As a pill iodine As a capsule spirulina As a tablet B vitamins As a softgel capsule cod liver oil Production of cod liver oil one of the first dietary supplement products manufactured in the 18th century 1 Creating an industry estimated to have a value of 151 9 billion in 2021 4 there are more than 50 000 dietary supplement products marketed in the United States 5 where about 50 of the American adult population consumes dietary supplements Multivitamins are the most commonly used product among types of dietary supplements 6 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 7 In the United States it is against federal regulations for supplement manufacturers to 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 8 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 drug can legally make such a claim 8 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 practices GMPs Contents 1 Definition 2 Types 2 1 Vitamins 2 2 Minerals 2 3 Proteins and amino acids 2 4 Bodybuilding supplements 2 5 Essential fatty acids 2 6 Natural products 2 7 Probiotics 2 8 Fertility 2 9 Prenatal 2 10 Pharmacotherapy 3 Industry 4 Adulteration contamination and mislabeling 5 Regulatory compliance 6 Adverse effects 7 Society and culture 7 1 Public health 7 2 Legal regulation 7 2 1 United States 7 2 2 European Union 7 3 Fraudulent products during the COVID 19 outbreak 8 Research 8 1 Databases 8 2 Quality and safety 8 3 Population monitoring 8 4 Clinical studies 8 5 Absence of benefit 8 6 Reporting bias 8 7 Future 9 See also 10 References 11 Further reading 12 External linksDefinitionIn 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 9 Per DSHEA dietary supplements are consumed orally and are mainly defined by what they are not conventional foods including meal replacements medical foods 10 preservatives or pharmaceutical drugs Products intended for use as a nasal spray or 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 nutritionally essential minerals amino acids essential fatty acids and non nutrient substances extracted from plants or animals or fungi or bacteria or in the instance of probiotics 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 11 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 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 11 TypesVitamins Main article Vitamin nbsp Pharmacies and supermarkets in the U S sell a large variety of vitamin dietary supplements A vitamin is an organic compound required by an organism as a vital nutrient in limited amounts 12 An organic chemical compound or related set of compounds is called a vitamin when it cannot be 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 humans guinea pigs and bats but not for other mammals Vitamin D is not an essential nutrient for people who get sufficient exposure to ultraviolet light either from the sun or an artificial source as they synthesize vitamin D in skin 13 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 K1 and K2 The list vitamins A C D E K Thiamine B1 Riboflavin B2 Niacin B3 Pantothenic Acid B5 Vitamin B6 Biotin B7 Folate B9 and Vitamin B12 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 14 The U S Institute of Medicine sets tolerable upper intake levels 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 15 but products are available without prescription at 10 000 IU Minerals Main article Mineral nutrient Minerals are the exogenous chemical elements 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 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 B12 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 16 Adequate calcium throughout life as part of a well balanced diet may reduce the risk of osteoporosis Adequate calcium as part of a healthful diet along with physical activity may reduce the risk of osteoporosis in later life Adequate calcium and vitamin D throughout life as part of a well balanced diet may reduce the risk of osteoporosis Adequate calcium and vitamin D as part of a healthful diet along with physical activity may reduce the risk of osteoporosis in later life 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 17 The U S FDA also approved Qualified Health Claims QHCs for various health conditions for calcium selenium and chromium picolinate 18 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 19 Proteins and amino acids Main articles Protein nutrient and Amino acid 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 20 21 to athletes who believe that strenuous physical activity increases protein requirements 22 to people hoping to lose weight while minimizing muscle loss i e conducting a protein sparing modified fast 23 and to people who want to increase muscle size for performance and appearance Whey protein is a popular ingredient 21 24 25 but products may also incorporate casein soy pea 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 26 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 27 28 29 Scientific reviews can conclude that a high protein diet when combined with exercise will increase muscle mass and strength 30 31 32 or conclude the opposite 33 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 22 One review proposed a maximum daily protein intake of approximately 25 of energy requirements i e approximately 2 0 to 2 5 g kg 28 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 34 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 35 10 Liquid medical food products for example Ensure are available in regular and high protein versions Proteins are chains of amino acids 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 27 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 acids leucine valine and isoleucine is for stimulating muscle protein synthesis A review of the literature concluded this claim was unwarranted 36 In elderly people supplementation with just leucine resulted in a modest 0 99 kg increase in lean body mass 37 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 38 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 39 Bodybuilding supplements This section is an excerpt from Bodybuilding supplement edit Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding weightlifting mixed martial arts and athletics for the purpose of facilitating an increase in lean body mass Bodybuilding supplements may contain ingredients that are advertised to increase a person s muscle body weight athletic performance and decrease a person s percent body fat for desired muscle definition Among the most widely used are high protein drinks pre workout blends branched chain amino acids BCAA glutamine arginine essential fatty acids creatine HMB whey protein ZMA and weight loss products 40 41 Supplements are sold either as single ingredient preparations or in the form of stacks proprietary blends of various supplements marketed as offering synergistic advantages Essential fatty acids Main article Essential fatty acids Fish oil is a commonly used fatty acid supplement because it is a source of omega 3 fatty acids 42 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 with one double bond C C it is called monounsaturated if there are two or more double bonds C C C it is called 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 42 43 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 42 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 44 In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life but there are no intake levels specified for EPA and or DHA 45 Supplementation with EPA and or DHA does not appear to affect the risk of death cancer or heart disease 46 47 Furthermore studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes 48 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 49 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 50 Natural products Main article Natural product See also Phytochemical Herbalism and Traditional Chinese medicine nbsp St John s wort petals used in natural product supplementsDietary supplements can be manufactured using intact sources or extracts from plants animals algae fungi or lichens including such examples as ginkgo biloba curcumin cranberry St John s wort ginseng resveratrol glucosamine and collagen 51 52 53 Products bearing promotional claims of health benefits are sold without requiring a prescription in pharmacies supermarkets specialist shops military commissaries buyers clubs direct selling organizations and the internet 52 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 54 55 56 Canada has published a manufacturer and consumer guide describing quality licensing standards identities and common contaminants of natural products 57 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 58 with cannabidiol and mushroom product sales as the highest 59 Italy Germany and Eastern European countries were leading consumers of botanical supplements in 2016 with European Union market growth forecast to be 8 7 billion by 2020 60 Probiotics Main article Probiotic Claimed benefits of using probiotic supplements are not supported by sufficient clinical evidence 61 62 63 Meta analysis studies have reported a modest reduction of antibiotic associated diarrhea and acute diarrhea in children taking probiotics 64 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 65 Probiotic supplements are generally regarded as safe 66 Fertility Main article Fertility A meta analysis provided preliminary evidence that men treated with supplements containing selenium zinc omega 3 fatty acids coenzyme Q10 or carnitines reported improvements in total sperm count concentration motility and morphology 67 A review concluded that omega 3 taken through supplements and diet might improve semen quality in infertile men 68 A 2021 review also supported selenium zinc omega 3 fatty acids coenzyme Q10 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 69 There is low quality and insufficient evidence for the use of oral antioxidant supplements as a viable treatment for subfertile woman 70 A review provided evidence that taking dehydroepiandrosterone before starting an in vitro fertilization series may increase pregnancy rates and decrease miscarriage likelihood 71 Prenatal Main article Prenatal vitamins 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 B6 folate B12 C D E iron and calcium 72 Sufficient intake of vitamin B6 can lower the risk of early pregnancy loss and relieve symptoms of morning sickness 73 74 Folate is also an essential nutrient for pregnant women to prevent neural tube defects 73 In 2006 the World Health Organization endorsed the recommendation for women of child bearing age to consume 400 micrograms of folate through the diet daily if planning a pregnancy 75 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 76 There is little evidence to suggest that vitamin D supplementation improves prenatal outcomes in hypertensive disorders and gestational diabetes 77 78 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 79 80 Iron supplementation can lower the risk of iron deficiency anemia for pregnant women 81 In 2020 the World Health Organization updated recommendations for adequate calcium levels during pregnancy to prevent hypertensive disorders 82 83 Pharmacotherapy 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 IndustryIn 2020 the American market for dietary supplements was valued at 140 3 billion 4 with the economic impact in the United States for 2016 estimated at 122 billion including employment wages and taxes 84 A 2020 analysis projected that the global market for vitamins and dietary supplement products would reach 196 6 billion by 2028 where the growth in market size is largely attributed to recent technological advancements in product manufacturing increased demand for products advertised as healthy increased product availability and population aging 85 Adulteration contamination and mislabelingOver the period 2008 to 2011 the Government Accountability Office GAO of the United States received 6 307 reports of health problems identified as adverse events from use of dietary supplements containing a combination of ingredients in manufactured vitamins minerals or other supplement products 86 with 92 of tested herbal supplements containing lead and 80 containing other chemical contaminants 87 Using 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 87 Consumer Reports also reported unsafe levels of arsenic cadmium lead and mercury in several protein powder products 88 The Canadian Broadcasting Corporation CBC reported that protein spiking i e the addition of amino acids to manipulate protein content analysis was common 89 Many of the companies involved challenged CBC s claim 90 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 91 In a genetic analysis of herbal supplements 78 of samples contained animal DNA that was not identified as an ingredient on the product labels 55 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 55 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 92 According to the NY AG only about 20 of the herbal supplements tested contained the plants claimed 92 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 92 A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted pharmaceutical drugs many of which could interact with other medications and lead to hospitalization 93 86 of the adulterated supplements were marketed for weight loss and sexual performance with many containing prescription erectile dysfunction medication Muscle building supplements were contaminated with anabolic steroids that can lead to health complications affecting the kidney the heart and cause gynecomastia 94 Multiple bodybuilding products also contained antidepressants and antihistamines Despite these findings fewer than half of the adulterated supplements were recalled 93 Regulatory complianceThe 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 95 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 products subject to compliance with current Good Manufacturing Practices CGMP and labeling with science based ingredient descriptions and advertising 96 97 When finding CGMP or advertising violations FDA warning letters are used to notify manufacturers of impending enforcement action including search and seizure injunction and financial penalties 98 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 99 100 101 The U S Federal Trade Commission which litigates against deceptive advertising in marketed products 102 established a consumer center to assist reports of false health claims in product advertising for dietary supplements 103 In 2017 the FTC successfully sued nine manufacturers for deceptive advertising of dietary supplements 104 Adverse effectsIn the United States manufacturers of dietary supplements are required to demonstrate safety of their products before approval is granted for commerce 105 Despite this caution numerous adverse effects have been reported 86 including muscle cramps hair loss joint pain liver disease and allergic reactions with 29 of the adverse effects resulting in hospitalization and 20 in serious injuries or illnesses 86 The potential for adverse effects also occurs when individuals consume more than the necessary daily amount of vitamins or minerals that are needed to maintain normal body processes and functions 106 The incidence of adverse effects reported to the 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 86 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 56 The incidence of 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 107 The most common liver injuries from weight loss and bodybuilding supplements involve hepatocellular damage with resulting jaundice and the most common supplement ingredients attributed to these injuries are green tea catechins anabolic steroids and the herbal extract aegeline 107 Weight loss supplements have also had adverse psychiatric effects 108 Some dietary supplements may also have adverse interactions with prescription medications that may enhance side effects or decrease therapeutic effects of medications 109 Society and culturePublic health 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 110 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 111 112 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 113 114 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 diets and a sedentary lifestyle 115 116 10 Legal regulation United States Main article Regulation of food and dietary supplements by the U S Food and Drug Administration 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 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 additives 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 Warning Letters 100 if not in compliance with GMPs stop production and if there is a health risk require that the company conduct a recall 117 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 118 European Union The European Union s EU Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe both in dosages and in purity 119 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 claims and nutrition claims 120 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 121 In 2004 along with two British trade associations the Alliance for Natural Health ANH had a legal challenge to the Food Supplements Directive 122 referred to the European Court of Justice by the High Court in London 123 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 124 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 125 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 126 Fraudulent products during the COVID 19 outbreak During the COVID 19 pandemic in the United States the FDA and Federal Trade Commission FTC warned consumers about marketing scams of fraudulent supplement products including homeopathic remedies cannabidiol products teas essential oils tinctures and colloidal silver among others 127 128 By August 2020 the FDA and FTC had issued 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 127 129 130 ResearchExamples of ongoing government research organizations to better understand the potential health properties and safety of dietary supplements are the European Food Safety Authority 3 the Office of Dietary Supplements of the United States National Institutes of Health 7 131 the Natural and Non prescription Health Products Directorate of Canada 132 and the Therapeutic Goods Administration of Australia 133 Together with public and private research groups these agencies construct databases 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 131 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 5 Dietary Supplement Ingredient Database 134 and Dietary Supplement Facts Sheets of the United States 135 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 136 The European Food Safety Authority maintains a compendium of botanical ingredients used in manufacturing of dietary supplements 137 In 2015 the 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 138 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 139 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 140 Quality and safety 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 137 141 High dose products have received research attention 131 142 especially for emergency situations such as vitamin A deficiency in malnutrition of children 143 and for women taking folate supplements to reduce the risk of breast cancer 144 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 131 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 145 Particular attention has been given to use of folate supplements by young women to reduce the risk of fetal neural tube defects 146 147 Clinical studies Limited human research has been conducted on the potential for dietary supplementation to affect disease risk Examples vitamin D acute respiratory tract infections 148 iron maternal iron deficiency anemia and adverse effects on the fetus 149 multiple supplements no evidence of benefit to lower risk of death cardiovascular diseases or cancer 150 magnesium supplementation in reducing all cause and cancer mortality 151 as well as improving glucose parameters in people with diabetes and insulin sensitivity parameters in those at high risk of diabetes 152 folate alone or with B vitamins stroke 153 154 A 2017 academic review indicated a rising incidence of liver injury from use of herbal and dietary supplements particularly those with steroids green tea extract or multiple ingredients 107 Absence of benefit 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 155 or tuberculosis 156 Reporting bias 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 157 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 157 158 One review reported that fewer than half of the registered clinical trials resulted in publication in peer reviewed journals 159 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 professionals scientists and policymakers 160 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 CONSORT guidelines 131 See also nbsp Food portalBodybuilding supplement Nutrient Megavitamin therapy Nutraceutical Dietary Supplement Health and Education Act of 1994 Multivitamin Alternative medicineReferences 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challenges and opportunities Advances in Nutrition 6 1 124 31 doi 10 3945 an 114 007443 PMC 4288271 PMID 25593151 Iannotti LL Trehan I Manary MJ September 2013 Review of the safety and efficacy of vitamin A supplementation in the treatment of children with severe acute malnutrition Nutrition Journal 12 125 doi 10 1186 1475 2891 12 125 PMC 3850897 PMID 24028603 Chen P Li C Li X Li J Chu R Wang H April 2014 Higher dietary folate intake reduces the breast cancer risk a systematic review and meta analysis British Journal of Cancer 110 9 2327 38 doi 10 1038 bjc 2014 155 PMC 4007237 PMID 24667649 Kantor ED Rehm CD Du M White E Giovannucci EL October 2016 Trends in Dietary Supplement Use Among US Adults From 1999 2012 JAMA 316 14 1464 74 doi 10 1001 jama 2016 14403 PMC 5540241 PMID 27727382 Obeid R Koletzko B Pietrzik K April 2014 Critical evaluation of lowering the recommended dietary intake of folate Clinical Nutrition 33 2 252 59 doi 10 1016 j clnu 2013 12 013 PMID 24503418 Wilson RD Wilson RD Audibert F Brock JA Carroll J Cartier L et al June 2015 Pre conception Folic Acid and Multivitamin Supplementation for the Primary and Secondary Prevention of Neural Tube Defects and Other Folic Acid Sensitive Congenital Anomalies Journal of Obstetrics and Gynaecology Canada 37 6 534 52 doi 10 1016 S1701 2163 15 30230 9 PMID 26334606 Martineau AR Jolliffe DA Hooper RL Greenberg L Aloia JF Bergman P et al February 2017 Vitamin D supplementation to prevent acute respiratory tract infections systematic review and meta analysis of individual participant data BMJ 356 i6583 doi 10 1136 bmj i6583 PMC 5310969 PMID 28202713 O Brien KO Ru Y December 2017 Iron status of North American pregnant women an update on longitudinal data and gaps in knowledge from the United States and Canada The American Journal of Clinical Nutrition 106 Suppl 6 1647S 54S doi 10 3945 ajcn 117 155986 PMC 5701721 PMID 29070557 Schwingshackl L Boeing H Stelmach Mardas M Gottschald M Dietrich S Hoffmann G Chaimani A January 2017 Dietary Supplements and Risk of Cause Specific Death Cardiovascular Disease and Cancer A Systematic Review and Meta Analysis of Primary Prevention Trials Advances in Nutrition 8 1 27 39 doi 10 3945 an 116 013516 PMC 5227980 PMID 28096125 Bagheri Amir Naghshi Sina Sadeghi Omid Larijani Bagher Esmaillzadeh Ahmad 2021 03 03 Total Dietary and Supplemental Magnesium Intakes and Risk of All Cause Cardiovascular and Cancer Mortality A Systematic Review and Dose Response Meta Analysis of Prospective Cohort Studies Advances in Nutrition Oxford University Press OUP 12 4 1196 1210 doi 10 1093 advances nmab001 ISSN 2161 8313 PMC 8321838 PMID 33684200 Veronese N Dominguez LJ Pizzol D Demurtas J Smith L Barbagallo M November 2021 Oral Magnesium Supplementation for Treating Glucose Metabolism Parameters in People with or at Risk of Diabetes A Systematic Review and Meta Analysis of Double Blind Randomized Controlled Trials Nutrients 13 11 4074 doi 10 3390 nu13114074 PMC 8619199 PMID 34836329 Li Y Huang T Zheng Y Muka T Troup J Hu FB August 2016 Folic Acid Supplementation and the Risk of Cardiovascular Diseases A Meta Analysis of Randomized Controlled Trials Journal of the American Heart Association 5 8 e003768 doi 10 1161 JAHA 116 003768 PMC 5015297 PMID 27528407 Ingles David Perez Cruz Rodriguez Jose B Garcia Hernando 2020 02 14 Supplemental Vitamins and Minerals for Cardiovascular Disease Prevention and Treatment Current Cardiology Reports Springer Science and Business Media LLC 22 4 22 doi 10 1007 s11886 020 1270 1 ISSN 1523 3782 PMID 32067177 S2CID 211139054 Visser ME Durao S Sinclair D Irlam JH Siegfried N May 2017 Micronutrient supplementation in adults with HIV infection The Cochrane Database of Systematic Reviews 2017 5 CD003650 doi 10 1002 14651858 CD003650 pub4 PMC 5458097 PMID 28518221 Grobler L Nagpal S Sudarsanam TD Sinclair D June 2016 Nutritional supplements for people being treated for active tuberculosis The Cochrane Database of Systematic Reviews 2016 6 CD006086 doi 10 1002 14651858 CD006086 pub4 PMC 4981643 PMID 27355911 a b Dunn AG Coiera E July 2014 Should comparative effectiveness research ignore industry funded data Journal of Comparative Effectiveness Research 3 4 317 20 doi 10 2217 cer 14 31 PMID 25275226 Knottnerus JA Tugwell P October 2013 The potential impact of unpublished results Journal of Clinical Epidemiology 66 10 1061 63 doi 10 1016 j jclinepi 2013 08 001 PMID 23993310 Zarin DA Tse T Sheehan J January 2015 The proposed rule for U S clinical trial registration and results submission The New England Journal of Medicine 372 2 174 80 doi 10 1056 NEJMsr1414226 PMC 4344313 PMID 25539444 ODS Strategic Plan 2017 2021 Office of Dietary Supplements US National Institutes of Health December 2017 Retrieved 3 February 2018 Further readingFood and Nutrition Information Center Dietary Supplements General Resources for Consumers PDF National Agricultural Library Archived from the original PDF on 2008 12 16 List of resources that provides an overview of herbal and dietary supplements including use regulation research and cautionary information Questions to Ask Before Taking Vitamin and Mineral Supplements nutrition gov Archived from the original on 2017 06 22 Dietary Supplement Fact Sheets NIH Office of Dietary Supplements External links nbsp Wikimedia Commons has media related to Dietary supplements Herbs and Supplements MedlinePlus United States National Library of Medicine Using Dietary Supplements Wisely U S National Center for Complementary and Integrative Health Retrieved from https en wikipedia org w index php title Dietary supplement amp oldid 1203553542, wikipedia, wiki, book, books, library,

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