A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid. A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, as for example collagen from chickens or fish. These are also sold individually and in combination, and may be combined with nutrient ingredients. In the United States and Canada, dietary supplements are considered a subset of foods, and are regulated accordingly. The European Commission has also established harmonized rules to help insure that food supplements are safe and properly labeled. Among other countries, the definition of dietary supplements may vary as drugs or other classes of ingredients used in supplement products.
Creating an industry estimated to have a 2015 value of $37 billion, there are more than 50,000 dietary supplement products marketed just in the United States, where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product. For those who fail to consume a balanced diet, the United States National Institutes of Health states that certain supplements "may have value."
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."
Per DSHEA, dietary supplements are consumed orally, and are mainly defined by what they are not: conventional foods (including meal replacements), medical foods, 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 (example: melatonin). All products with these ingredients are required to be labeled as dietary supplements. Like foods and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer confirms the safety of dietary supplements but the government does not; and rather than requiring risk–benefit 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.
Supplement types
Vitamins
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. 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 then they synthesize vitamin D in skin. Humans require thirteen vitamins in their diet, most of which are actually groups of related molecules, "vitamers", (e.g. vitamin E includes tocopherols and tocotrienols, vitamin K includes vitamin 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 consumed as a dietary supplement by those who are healthy and consuming a nutritionally adequate diet.
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), but products are available without prescription at 10,000 IU.
Dietary minerals
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 which 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.
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 sarcopenia of old age, to athletes who believe that strenuous physical activity increases protein requirements, to people hoping to lose weight while minimizing muscle loss, i.e., conducting a protein-sparing modified fast, and to people who want to increase muscle size for performance and appearance. Whey protein is a popular ingredient, but products may also incorporate casein, soy, pea, hemp or rice protein.
According to US & Canadian Dietary Reference Intake guidelines, the protein Recommended Dietary Allowance (RDA) for adults is based on 0.8 grams protein per kilogram body weight. The recommendation is for sedentary and lightly active people. Scientific reviews can conclude that a high protein diet, when combined with exercise, will increase muscle mass and strength, or conclude the opposite. The International Olympic Committee recommends protein intake targets for both strength and endurance athletes at about 1.2-1.8 g/kg body mass per day. One review proposed a maximum daily protein intake of approximately 25% of energy requirements, i.e., approximately 2.0 to 2.5 g/kg.
The same protein ingredients marketed as dietary supplements can be incorporated into meal replacement and medical food products, but those are regulated and labeled differently from supplements. In the United States, "meal replacement" products are foods and are labeled as such. These typically contain protein, carbohydrates, fats, vitamins and minerals. There may be content claims such as "good source of protein", "low fat" or "lactose free." Medical foods, also nutritionally complete, are designed to be used while a person is under the care of a physician or other licensed healthcare professional. Liquid medical food products - 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. 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. In elderly people, supplementation with just leucine resulted in a modest (0.99 kg) increase in lean body mass. The non-essential amino acid arginine, consumed in sufficient amounts, is thought to act as a donor for the synthesis of nitric oxide, a vasodilator. A review confirmed blood pressure lowering. Taurine, a popular dietary supplement ingredient with claims made for sports performance, is technically not an amino acid. It is synthesized in the body from the amino acid cysteine.
Bodybuilding supplements
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. The intent is to increase muscle, increase body weight, improve athletic performance, and for some sports, to simultaneously decrease percent body fat so as to create better muscle definition. Among the most widely used are high protein drinks, branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, HMB, and weight loss products. Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public the frequency of use will differ when used specifically by bodybuilders. One meta-analysis concluded that for athletes participating in resistance exercise training and consuming protein supplements for an average of 13 weeks, total protein intake up to 1.6 g/kg of body weight per day would result in an increase in strength and fat-free mass, i.e. muscle, but that higher intakes would not further contribute. The muscle mass increase was statistically significant but modest - averaging 0.3 kg for all trials and 1.0–2.0 kg, for protein intake ≥1.6 g/kg/day.
Essential fatty acids
Fish oil is a commonly used fatty acid supplement because it is a source of omega-3 fatty acids. 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. ALA can be elongated in the body to create other omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Plant oils, particularly seed and nut oils, contain ALA. Food sources of EPA and DHA are oceanic fish, whereas dietary supplement sources include fish oil, krill oil and marine algae extracts. The European Food Safety Authority (EFSA) identifies 250 mg/day for a combined total of EPA and DHA as Adequate Intake, with a recommendation that women pregnant or lactating consume an additional 100 to 200 mg/day of DHA. In the United States and Canada are Adequate Intakes for ALA and LA over various stages of life, but there are no intake levels specified for EPA and/or DHA.
Supplementation with EPA and/or DHA does not appear to affect the risk of death, cancer or heart disease. Furthermore, studies of fish oil supplements have failed to support claims of preventing heart attacks or strokes. 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.
Natural products
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. 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. While most of these products have a long history of use in herbalism and various forms of traditional medicine, concerns exist about their actual efficacy, safety and consistency of quality. Canada has published a manufacturer and consumer guide describing quality, licensing, standards, identities, and common contaminants of natural products. In 2016, sales of herbal supplements just in the United States were $7.5 billion, with the market growing at about 8% per year. 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.
Probiotics
In humans, the large intestine is host to more than 1,000 species of microorganisms, mostly bacteria, numbering in the tens of trillions. "Probiotic" in the context of dietary supplements is the theory that by orally consuming specific live bacteria (or yeast) species, it is possible to influence the large intestine microbiota, with consequent health benefits. Although there are numerous claimed benefits of using probiotic supplements, such as maintaining gastrointestinal health, in part by lowering risk of and severity of constipation or diarrhea, and improving immune health, including lower risk of and severity of acute upper respiratory tract infections, i.e., the common cold, such claims are not all supported by sufficient clinical evidence. A review based on interviews with dozens of experts in microbiome research expressed concern about "...how biomedical research is co-opted by commercial entities that place profit over health." The concern is timely, as through 2021, probiotic supplements are expected to be the fastest growing segment of the dietary supplement market worldwide, while at the same time, the global health benefits market for probiotic-containing yogurt (a food, not a dietary supplement) is declining.
As with all dietary supplements, in the United States inappropriate label health claims such as preventing or treating disease are opposed by the FDA and deceptive advertisements by the Federal Trade Commission. Probiotic foods and dietary supplements are allowed to make claims using Structure:Function vocabulary as long as human trial evidence is adequate. In 2005, the FDA issued a Warning Letter to UAS Laboratories for disease treatment claims (colds, flu, ulcers, elevated blood cholesterol, colon cancer...). The company revised label and website content and continued to sell the product. In 2011 the company was found to have resumed the label and website claims, and the FDA seized product and stopped production. In 2010 a FTC action was brought against a probiotic food company for exaggerated health claims, resulting in a multimillion-dollar fine and revisions to future advertising. In the European Union a more restrictive approach has been taken by the EFSA. All proposed health claims were rejected on the grounds that the science was not sufficient, and no health claims are permitted. Foods with live microorganisms (yogurt, kefir) can be sold, but without claims.
Probiotic supplements are generally regarded as safe. The greatest concern, evidenced by reviews reporting on case studies, is that for people with compromised gut wall integrity there may be a risk of systemic infection. For this reason, probiotic research is expected to exclude bacteria species that are antibiotic resistant.
