Dietary Supplement

A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic 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, 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.

Creating an industry estimated to have a 2020 value of $140.3 billion, there are more than 50,000 dietary supplement products marketed in the United States, where about 50% of the American adult population consumes dietary supplements. Multivitamins are the most commonly used product among types of dietary supplements. The United States National Institutes of Health states that supplements "may be of value" for those who are nutrient deficient from their diet and receive approval from their medical provider.

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. 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. 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."

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.

Types

Vitamins

A vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.Lieberman, S and Bruning, N (1990). The Real Vitamin & Mineral Book. NY: Avery Group, 3, 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. 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.

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.

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 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.
* "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.
The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate. QHCs are supported by scientific evidence, but do not meet the more rigorous "significant scientific agreement" standard required for an authorized health claim. If dietary supplement companies choose to make such a claim then the FDA stipulates the exact wording of the QHC to be used on labels and in marketing materials. The wording can be onerous: "One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, one smaller study showed no reduction in risk. Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women."

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

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