Dietary Supplements

What are dietary supplements and why are they important and/or useful for optimizing health?

If you are not currently taking any dietary supplements or you never have, then you may want to know what a dietary supplement is. The definition of a dietary supplement has three basic components: (1) a product that is intended to supplement the diet, i.e., not food; (2) a product that contains one or more dietary ingredients, such as macronutrients (e.g., amino acids), vitamins, minerals, herbs, or other botanicals; and (3) it is intended to be taken by mouth. The Dietary Supplement Health and Education Act (DSHEA) was passed by the US Congress in 1994 with more than 70 Senate co-sponsors and more than half of the House of Representatives. It was supported by thousands of letters from consumers. DSHEA’s major provisions included: (1) dietary supplements were recognized as a new category of regulated food for the first time; (2) specified that the existing practice of regulating dietary supplements as food would continue, including good manufacturing practices, structure/function claims, and no premarket approval requirement; and (3) prohibited the US Food and Drug Administration (FDA) use of food additives process to regulate supplement ingredients. Although the FDA does not regulate dietary supplements to be approved for sale like it does medications, dietary supplements must adhere to safety standards that can fall under the FDA’s jurisdiction. Federal law allows the FDA to: (1) seize products that are adulterated or misbranded; (2) remove a product from the market that presents a “significant or unreasonable risk of injury or illness;” and (3) remove from the market a dietary supplement that poses “an imminent hazard to public health or safety.” In addition, FDA must be notified before a new dietary ingredient is introduced into the market. Dietary supplements may make several types of product and label claims: (1) structure/function claims must be submitted to FDA, and a disclaimer is required; (2) nutrient content claims; (3) full unqualified health claims – requires significant scientific agreement for the claim, such as an authoritative statement of a scientific body; and (4) qualified health claims – some scientific support exists, but not significant scientific agreement. Structure/function claims are defined as the following: (1) they affect a structure or function in humans, organs, or cells; (2) they define the mechanism by which the compound or molecule acts to maintain such structure or function; (3) they describe general well-being from consumption; (4) they may not claim to diagnose, treat, cure, mitigate, or prevent any disease; (5) they require mandatory disclaimer and post-marketing notification; and (6) they must have substantiation that the statement is truthful and not misleading. Finally, these claims are substantiated by several standards: (1) they must be derived from competent and reliable scientific evidence; (2) tests, analyses, research, studies, or other evidence that have been conducted and evaluated in an objective manner by persons qualified to do so, using generally accepted procedures in the profession to yield accurate and reliable results; and (3) four key issues determine whether a claim is substantiated – (a) the meaning of the claim; (b) the relationship of the evidence to the claim; (c) the quality of the evidence; and (d) the totality of the evidence.

Thus, dietary supplements are not represented as a conventional food or sole item of a meal or the diet, and they are prohibited from being sold with a drug claim (e.g., claims to diagnose, treat, cure, mitigate, or prevent a disease). Dietary supplements are categorized in several ways: micronutrients (vitamins and minerals); macronutrients (fatty acids, saccharides, and amino acids); phytochemicals (e.g., lycopene and isoflavones); herbs (e.g., Ginkgo biloba); zoochemicals (e.g., bee pollen); and miscellaneous (e.g., probiotics and melatonin).

About 80,000 dietary supplements are currently sold on the market. The US Institute of Medicine estimates that 1,000 new products are introduced into the market every year. Today, total yearly sales of dietary supplements in the US are approximately $40 Billion and continue climbing annually. Dietary supplement industry sales have been steadily increasing since the passage of the DSHEA and show no signs of abating (even with dot com and real estate crashes). Some of the best industry sellers include: multivitamins ($5.2 B), B vitamins ($1.5 B), calcium ($1.2 B), fish oil ($1.15 B), vitamin C ($1 B), and probiotics ($1 B). The best condition-specific sales include: sports, energy, and weight management ($7.4 B), general health ($4.5 B), heart health ($2.0 B), cold/flu – immune ($2.0 B), bone health ($1.8 B), joint health ($1.6 B), gastrointestinal health ($1.2 B), diabetes ($976 M), hair, skin, and nails ($556 M), and brain/mental health ($537 M). According to the US Centers for Disease Control and Prevention, approximately 40% of US adults take dietary supplements. Additionally, 56% of middle age and older (60≥ years) adults take at least one supplement daily. The typical dietary supplement user in the US is an older, non-Hispanic white female who is physically active and has a higher level of education than average. The number of dietary supplements taken by US adults (according to the percentage of the population) are: one (53%), two (20%), three (11%), four (6%), or five or more (10%).

Besides considering the importance of structure/function claims and how much research has supported the efficacy of a dietary supplement, another key characteristic of a dietary supplement is its level of bioavailability. Bioavailability essentially refers to the proportion or amount of any active ingredient in a product that can be absorbed by the body. Certain innovative technologies, such as emulsions, liposomes, and micelles, are used to enhance the bioavailability of dietary supplements, medications, and skin care products, among others. Additionally, bioavailability is affected by many factors, such as whether a compound is fat-soluble (poorer) or water-soluble (better), dietary habits, health/disease status, possibly exercise, being overweight or obese, alcohol use, smoking, use of illicit drugs, age, the microbiome, and even genetics. Typically, the nutrients and dietary compounds that we consume must be assimilated into mixed micelles as a necessary step before they are transported into the cells, which the state of science shows occurs primarily in the small intestine.

You might not know what a micelle is. Micelles are very important compounds that our digestive system uses to allow us to ultimately absorb fat-soluble molecules. A micelle is formed with a fatty acid, a salt of a fatty acid, phospholipids, or other similar molecules. A micelle essentially has the active ingredient in the inside of a molecule surrounded by an outer shell that is typically of a fat, or lipid, material. When we eat fat-soluble substances, the body’s digestive, gastric, and small intestine phases ultimately result in the creation of micelles that allow these nutrients to be absorbed into the bloodstream to be utilized by our cells. Otherwise, they would be excreted into the urine or feces and not used for our health.

Bioavailability directly relates to how your food and dietary supplements are utilized, which ultimately significantly affects your health. Through what we eat and drink (our dietary intake), we supply all nutrients to our body. As mentioned, absorption of nutrients takes place primarily in the small intestines. These cells are covered with a fine water film. Only water-soluble substances that can permeate this water film are directly absorbed. The bioavailability of highly water-soluble substances, such as saccharides, salts, and vitamin C, is therefore optimal.

The bioavailability of hardly soluble and many fat-soluble substances is not optimal. These include important and essential nutrients, such as curcumin, β carotene, vitamins A, D, E, and K, lutein, and coenzyme Q10. Fat-soluble substances cannot permeate the intestinal water film and have to be “pre-treated.” This pre-treatment takes place indirectly in the intestine by the formation of micelles using gall salts.

The precondition for digesting fat is the formation of micelles. This process takes time. Micelle formation therefore only covers a portion of hardly soluble and fat-soluble substances. This means most substances of low solubility are excreted undigested and unused. Typically, the bioavailability of hardly soluble and many fat-soluble substances is low and less than 25%. Thus, approximately 75% of the amount of these ingested substances are excreted in the urine or feces and unused. For example, anyone taking almost all brands of coenzyme Q10 excretes at least 75% of what is consumed without being utilized by the body. In addition, as we age, the body’s ability to absorb fat-soluble substances decreases.

This simplistic physiology and biochemistry lesson simply means that dietary supplements that have been formulated using micelles, liposomes, or other similar mixed substances can provide your body distinct benefits, particularly for fat-soluble substances. These products allow you to better absorb the active ingredients, which means that you get the most for your health and your dollar.

With so many dietary supplement choices, how do you decide what to buy? Purchasing a dietary supplement is no different than any other consumer decision, e.g., an automobile, so you have to do your homework on the company selling the product. Two of the biggest problems associated with the typical product on the market is the lack of science supporting claims and the low level of bioavailability of the active ingredient(s). Thus, you really have to take your time to decide what you need based on your current health status, what your health goals are, and if you can determine what the bioavailability of the product is. We can help you make the decision to supplement your diet with the products that are best for you.

All statements made about any products or services mentioned on this website have not been evaluated by the FDA. Products and services are not intended to diagnose, treat, cure, or prevent any disease.
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.

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