Dietary supplement
The examples and perspective in this article may not represent a worldwide view of the subject. (April 2020) |
A dietary supplement is a manufactured product intended to supplement a person's diet by taking a
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
Types
Vitamins
A vitamin is an
The
Minerals
Minerals are the
The essential nutrient minerals for humans, listed in order by weight needed to be at the
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
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
According to US and Canadian
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
Essential fatty acids
Fish oil is a commonly used fatty acid supplement because it is a source of
Plant oils, particularly seed and nut oils, contain ALA.
Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or 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.[50]
Natural products
Dietary supplements can be manufactured using intact sources or
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
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
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
Prenatal
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
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.
A study of dietary supplements sold between 2007 and 2016 identified 776 that contained unlisted
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
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
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
As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for
Legal regulation
United States
The regulation of food and dietary supplements by the U.S. Food and Drug Administration (FDA) is governed by various statutes enacted by the
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
Fraudulent products during the COVID-19 outbreak
During the
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
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]
- 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
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
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
- Bodybuilding supplement
- Nutrient
- Megavitamin therapy
- Nutraceutical
- Dietary Supplement Health and Education Act of 1994
- Multivitamin
- Alternative medicine
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- PMID 25539444.
- ^ "ODS Strategic Plan 2017-2021". Office of Dietary Supplements, US National Institutes of Health. December 2017. Retrieved 3 February 2018.
Further reading
- Food 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.