NTR, Chapter 12, Gateway fall'18

Adults older than 50: May Warrant Nutrient Supplementation

B12 and vitamin D supplements are recommended because B12 absorption tends to decline with age and older individuals synthesize less vitamin D when exposed to UV light

Dietary Supplement Structure/Function Claims

Companies can make a structure/function claim on the label about how that product could affect the body's structure or function. "Calcium builds strong bones" is an example of a structure-related claim, whereas "fiber maintains bowel regularity" or "antioxidants maintain cell integrity" are function-related claims. Alternatively, these claims may state that consuming a nutrient or dietary ingredient may improve general well-being. Labels containing these claims must state in a disclaimer that the FDA has not evaluated the claim, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Still, "more times than not, the label is going to be misleading, and the claims are going to be overly positive." The distinction between claims that describe how a food or supplement affect's the body's structure or its function, and those promising to "diagnose, treat, cure, or prevent disease" are often difficult to distinguish.

Herbal Supplement

Herbal Supplement - a type of dietary supplement that includes plants (botanicals), singly or in combination; typically dried preparations of flowers, leaves, roots, bark, and seeds. They are less popular in the United States than vitamin and mineral supplements, but more than one-fifth of U.S. adults take them. There are 550 primary herbs with 1,800 names, but examples of some of the most common herbs sold in this country include echinacea, flaxseed, ginseng, ginkgo, saw palmetto, St. John's wort, black cohosh, milk thistle, and garlic. From a medicinal perspective, herbs are less potent crude drugs and can have druglike effects, yet they do not undergo the same stringent approval process as drugs do. Sometimes, herbal supplements can contain biologically active ingredients and toxins in addition to their active "useful" components. Even though herbal supplements are often considered natural, they can still cause drug interactions and serious adverse effects and even exacerbate medical conditions; there is no legal definition for the term "natural," and it certainly does not mean a product is safe or effective.

Supplement Quality

How do we know if supplements on the market are pure and of high quality? The FDA does not monitor supplements for quality assurance, potency, purity, or efficacy—there are far too many supplements for the agency to handle—but the FDA does track reports of illness, injury, or reactions that might occur in consumers after taking supplements. Supplement manufacturers are now required to report serious harmful effects to the FDA, too. Supplements may be labeled as "pure," "natural," or "quality-assured," but, because the FDA does not regulate these terms, these claims may not be true. Supplements that claim to be "all natural," for instance, are not always better or safer than refined or synthetic substances, because natural and synthetic forms generally have the same chemical structure and do not differ in terms of how they are absorbed or used by the body. They may, however, differ in price—the "natural" forms are often costlier. Supplements may be labeled with words that are meant to make a product seem trustworthy such as "quality," "pure," or "natural," but these terms have no legal meaning. Independent labs such as United States Pharmacopeial Convention (USP)—NSF International (NSF) and ConsumerLab.com (CL) evaluate and set standards for dietary supplements. Consumers do have some ways of gauging supplement quality, though. Independent labs test supplements that manufacturers voluntarily submit; some labs also do product reviews. Organizations such as United States Pharmacopeial Convention (USP)—a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements distributed and consumed worldwide—provide seals of quality that companies can display on their products. Other independent labs that provide quality labels include NSF International (NSF) and ConsumerLab.com (CL). The latter publishes results of its tests in comprehensive online reports so that consumers can see exactly how pure some dietary supplements are.

Ingredients Listed Separately

Ingredients Listed Separately, not listed above, inactive ingredients - listed in descending order of predominance by weight. These are compounds used in the manufacture of the supplement, such as binders, colors, fillers, flavors, and sweeteners. Supplements must also include another ingredients panel. This lists all nondietary components found in the product such as fillers; water; artificial colors; sweeteners; flavors; and processing aids, such as binders, gelatin, and stabilizers. These ingredients are listed by common name or proprietary blend in descending order of predominance by weight. The ingredients listed in this panel may include the sources of the dietary ingredients if they are not identified in the Supplement Facts Panel—for instance, a label might list rose hips as the source of vitamin C.

Women who are pregnant; Women with heavy menstrual periods. Individuals who frequently donate blood, as well as those with some stomach and intestinal conditions (food sensitivity, hookworm): May Warrant Nutrient Supplementation

Iron supplementation may be necessary

Must all ingredients be declared on the label of a dietary supplement?

Must all ingredients be declared on the label of a dietary supplement? Dietary ingredients and inactive ingredients are listed on the label of a supplement.

Smokers, Alcohol-Dependent Individuals, and Those Taking Some Medications: May Warrant Nutrient Supplementation

Nutrient absorption, utilization, and excretion can be affected by prescription or recreational drug use, therefore an MVM supplement may be warranted

Does vitamin A supplementation prevent cancer?

Observational studies had shown that people eating more fruits and vegetables, which are rich in beta carotene (that the body can convert into retinol, or vitamin A), had lower rates of lung cancer. The Beta-Carotene and Retinol Efficacy Trial (CARET) tested the combination of beta-carotene and vitamin A supplements in men and women at high risk of developing lung cancer. The CARET intervention was stopped 21 months early because of clear evidence of no benefit and substantial evidence of possible harm.

Prebiotics and Probiotics

Prebiotics and Probiotics - Probiotics and prebiotics can reduce the risk of illness, because in order to establish infections, "bad" bacteria must adhere to the lining of the gut. As "good" bacteria increases in the gut in response to the ingestion of probiotics (or in response to prebiotics), they take up more and more real estate, making it difficult for the bad bacteria to find a home. In addition, as the number of good bacteria increases, they grab the majority of the available nutrients, leaving little for the unwanted microbes.

Probiotics

Probiotics - live bacteria that provide health benefits when administered in adequate amounts. These bacteria may be in foods, pills, or creams. Bacterial strains most commonly accepted as being health promoting are: *Bifidobacterium sp *Lactobacillus sp

Individuals on Restricted Diets: May Warrant Nutrient Supplementation

Those with low food intake or limited food choices may benefit from an MVM supplement

Tips for Choosing a Multivitamin Supplement

Tips for Choosing a Multivitamin Supplement: If you are in a category that might benefit from taking a multivitamin supplement these guidelines can help: *Read the label carefully - examine which nutrients are included and the amounts contained within each serving. In general, choose a supplement that provides 100% of the DV for most of the vitamins and minerals in that supplement. Some nutrients, like calcium and magnesium, are rarely included at 100% because the pill would be too large to swallow. *Look for quality products - the initials USP stand for U.S. Pharmacopeial Convention, and NSF stands for NSF International; both are reputable organizations that test dietary supplements for quality. *Look for the expiration date - select products that will have a long shelf life. *Consider formulas for men, women, and age groups - choose a multivitamin designed for your age and sex so that the nutrients included will be right for you. *Don't overdo it - avoid multivitamins that exceed 100% of daily values. Special Caveats: *Beware of Interactions - taking a combination of supplements together with medications could produce adverse effects. For example: Coumadin (a prescription drug), ginkgo biloba (an herbal supplement), aspirin (an OTC drug), and vitamin E (a vitamin supplement) can each thin the blood, and taking any of these products together can increase the potential for internal bleeding. The herbal supplement St. John's Wort may also reduce the effectiveness of prescription drugs for heart disease, depression, seizures, certain cancers, and oral contraceptives. *Some supplements may interfere with surgeries - Before elective surgery you may be asked to stop taking vitamins, minerals, or herbal supplements to avoid potentially dangerous supplement/drug interactions - such as changes in heart rate, blood pressure, and increased bleeding - that could adversely affect the outcome of your surgery.

Give an example of "some evidence of safety" that would NOT actually prove that the ingredient is safe.

To prove "some evidence of safety" a manufacturer could show that a dietary ingredient has been used for one purpose (for example, in small quantities used as a sweetener) without a reported problem and could be reasonably expected to be safe to consume in another context (for example, in larger quantities as a sleep aid).

Finnish study: Beta-Carotene + Vitamin E

lung cancer rates of people in the Finnish trial who had taken beta-carotene plus either vitamin E supplements or sugar pills beta-carotene had increased lung cancer risk by 18% compared with placebo in the Finnish trial, although vitamin E seemed to have no effect.

Dietary Supplement

A dietary supplement is a food or substance that supplements the diet and contains one or more dietary ingredients (including vitamins, minerals, herbs, amino acids, and certain other substances) or their constituents. Dietary supplements can come in the form of pills, capsules, tablets, liquids, powders, and bars. This diverse array of products are grouped together and called "dietary supplements" because they are regulated by a common set of rules. As defined by Congress in the 1994 Dietary Supplement Health and Education Act (DSHEA), dietary supplements are intended to be taken by mouth and contain one or more dietary ingredients or their constituents: vitamins; minerals; herbs or other botanicals; amino acids; or other dietary substances, such as enzymes. Essentially any substance that is found in any food, even if present only in minute quantities, can be extracted or concentrated and then sold as a dietary supplement. Therefore, these substances are often being consumed at levels far exceeding those ever achieved from the intake of foods. Dietary supplements are a more than 30 billion dollar a year industry, more than 65,000 varieties are sold in the United States today, and more than half of all Americans take supplements in an attempt to stay healthy. The most common supplements are multivitamin and multimineral supplements, followed by calcium, omega-3 fatty acid supplements (fish oil), and vitamin D. Yet fewer than a quarter of Americans who take supplements do so at the recommendation of a qualified health care provider. According to NHANES data, the percentage of the U.S. population who used at least one dietary supplement increased from 42% in 1988-1994 to 53% in 2003-2006.

Pregnant Women: May Warrant Nutrient Supplementation

A folic acid supplement is recommended during pregnancy. A multivitamin/mineral (MVM) supplement is recommended for anemia, women carrying multiple fetuses, or women consuming little or no animal proteins

Identify at least three underlying reasons why supplements might be necessary in these circumstances.

Answers may include: Pregnant women are recommended to take a folic acid supplement to prevent neural tube birth defects. They may also need to take iron supplements because their body will need to create and maintain a higher volume of blood. Individuals who regularly donate blood may need iron supplements to compensate for blood loss. Infants who are breastfed may need a vitamin D supplement because breast milk contains insufficient vitamin D, and supplements are preferable to sun exposure for gaining sufficient vitamin D. Individuals consuming a vegan diet need to consume vitamin B12 from fortified foods or supplements because animal products are the only natural sources of vitamin B12 in our diets.

Are Dietary Supplements Harmful?

Are Dietary Supplements Harmful? The National Cancer Institute studies led by Omenn and his colleagues suggest that some supplements are not only ineffective, but can actually be harmful. A small subset of studies, however, suggests that supplements may be beneficial for preventing certain conditions. For instance, in 1997, researchers at Harvard University and its affiliated hospitals and schools began a clinical trial as part of the Physicians Health Study II to test whether moderate doses of multivitamins might prevent cancer or heart disease. "When you think about individual vitamin supplements tested in trials, there's been an emphasis on high doses," explains Howard Sesso, one of the study's leaders and an associate professor of epidemiology at the Harvard School of Public Health. "We thought it would be interesting to have the opposite approach: It might be more appropriate to test a standard common multivitamin that has all the essential vitamins and minerals in combination, but in lower, more usual, doses that you would get in your diet." To do this, the Harvard researchers tracked the health of nearly 15,000 physicians older than 50 years who had been randomly assigned to take either a standard multivitamin or a sugar pill every day for an average of 11 years. Although the multivitamin takers did not end up with a reduced risk for heart disease, they were 8% less likely to develop cancer during the follow-up period than the doctors who did not take multivitamins. A separate arm of the study that evaluated the effects of taking 400 mg vitamin C every day and 400 IU vitamin E every other day did not, however, find that the two vitamins reduced cancer risk. It seemed to be the combination of many vitamins, at lower doses, that made a positive difference. Sesso and his colleagues were very pleased with their study results, "But what we were immediately trying to think through was: How do you explain the findings?" Indeed, one major question is exactly how vitamins may protect against cancer. Another question is whether a person is better off getting vitamins through whole foods or through pills. "I think a lot of people would argue that the natural approach through food is the way to go," Sesso says, but more research is needed to prove this point. Supplements seem to pose the highest risks when they are what are known as "high-potency supplements," which include one or more nutrients or ingredients in amounts significantly in excess of recommendations. These supplements include the mega-doses of beta-carotene (30 mg) and vitamin A (25,000 IU) that the participants were taking as part of Omenn's CARET trial. Sometimes, these supplements also exceed the established Tolerable Upper Intake Limit (UL), the maximum level of daily intake that is likely to cause no risk of adverse health effects to almost all individuals in the population. No laws establish or cap potency for any supplements, except potassium. But high doses of some supplements can cause fatigue, diarrhea, hair loss, kidney stones, liver and nerve damage, and birth defects. They can lead to nutrient imbalances or interactions, reducing the absorption and utilization of other nutrients. And taking high doses of many minerals—as well as the fat-soluble vitamins A, D, and E—can be toxic. Even high doses of the water-soluble vitamin B6 are toxic, potentially causing permanent nerve damage. It's important to remember that even if you don't exceed the UL for a nutrient through supplement use, you may exceed it when you combine the amount you're getting from a supplement with the amount you're getting from food.

DSHEA (Dietary Supplement Health and Education Act)

As defined by Congress in the 1994 Dietary Supplement Health and Education Act (DSHEA), dietary supplements are intended to be taken by mouth and contain one or more dietary ingredients or their constituents: vitamins; minerals; herbs or other botanicals; amino acids; or other dietary substances, such as enzymes. Essentially any substance that is found in any food, even if present only in minute quantities, can be extracted or concentrated and then sold as a dietary supplement. Therefore, these substances are often being consumed at levels far exceeding those ever achieved from the intake of foods. Although dietary ingredients found in supplements are federally regulated, ingredients and additives that were already in the food supply prior to when DSHEA went into effect on October 15, 1994, were grandfathered in as "generally recognized as safe" (GRAS). GRAS substances don't need FDA approval before being marketed, so many long-standing supplement ingredients have not actually endured FDA scrutiny for safety. For new dietary ingredients, DSHEA requires that manufacturers must notify the FDA 75 days before the product is to be introduced and provide the agency with evidence that the supplement is "reasonably expected to be safe". Unfortunately, it is common for supplement distributors and manufacturers to ignore this requirement, as well as other regulations.

Dairy Free Individuals: May Warrant Nutrient Supplementation

Because milk and other dairy products are an important source of vitamin D and calcium, a supplement providing these nutrients may improve bone health

Benefits of Probiotics

Benefits of Probiotics - *Enhances mineral absorption *Promotes immune system health *Improves the health of mucosa in the gut *Retrieves some energy from undigested carbohydrates *Synthesizes vitamin K, folate, biotin *Displaces pathogenic ("bad") bacteria

Beta-Carotene and Retinol Efficacy Trial (CARET)

Beta-Carotene and Retinol Efficacy Trial (CARET): testing whether large doses of beta-carotene plus vitamin A could prevent lung cancer in more than 18,000 people who either currently smoked, had smoked in the past, or had been exposed to asbestos. The combination of beta-carotene and vitamin A was increasing participants' risk of lung cancer by a whopping 28% compared with sugar pills. For the safety of everyone enrolled, Omenn immediately stopped the trial, 21 months ahead of schedule. Looked at another way, Omenn's results, which were published in the Journal of the National Cancer Institute later that year, suggested that the people had a 1 in 1,000 increased chance of developing cancer each year as a direct result of taking the beta-carotene/vitamin A supplements.

Botanicals

Botanicals - a plant or plant part valued for its health-promoting properties, flavor, and/or scent. Herbs are a subset of botanicals.

Infants and Children: May Warrant Nutrient Supplementation

Breastfed children and any child consuming less than 1 qt/day of vitamin D fortified milk should receive a vitamin D supplement

Effects of Long-term Use of Multivitamin/Mineral Supplements on Mortality

Effects of Long-term Use of Multivitamin/Mineral Supplements on Mortality: Neither the long-term use of full-spectrum multivitamin/mineral supplements, nor the administration of more narrowly formulated vitamin/mineral supplements decrease the risk of death.

Examples of Functional Foods

Examples of Functional Foods - *Orange Juice with added calcium to improve bone health *Blueberries and blackberries contain high amounts of anthocyanins that promote cardiovascular health *Yogurt with live bacterial cultures to promote gastrointestinal health *Margarine with plant sterols added to lower blood cholesterol

FDA Regulations Governing the Introduction of New Dietary Ingredients in Supplements

FDA Regulations Governing the Introduction of New Dietary Ingredients in Supplements : Many dietary ingredients legally present in supplements have not been reliably demonstrated to be safe. The 2011 Food Safety Modernization Act expands the authority of the FDA to oversee new dietary ingredients, but has not yet been fully implemented. Current Regulations: *Manufacturers must submit to the FDA info regarding the 'safety and efficacy' of a dietary supplement containing a new dietary ingredient *The manufacturer needs only to demonstrate that the new dietary ingredient can 'reasonably be expected to be safe' by providing some evidence of safety but not actually proving safety *The FDA does not approve new dietary ingredients or supplements - they are free to be marketed 75 days after the information was submitted to the FDA Proposed New Regulations: *Safety must be established by a documented history of use at the same or higher dosage, frequency, and duration of use *Laboratory or animal studies would be require for products marketed for consumption at higher than historical intakes *No human studies are required, even for substances without any documented historical use *The company is not obligated to report results showing adverse effects. They need only to submit positive results supporting their claim of safety

FDA-Approved Health Claims and Qualified Health Claims

FDA-Approved Health Claims and Qualified Health Claims - When there is significant scientific agreement that evidence supports a link between a diet or nutrient and a disease, the FDA establishes approved health claims. When the evidence is not as strong, the FDA allows qualified health claims. Supplement manufacturers can't make claims that their product treats, prevents, or cures disease unless it has been approved for a health claim or qualified health claim.

Food Sources of Prebiotics

Food Sources of Prebiotics - *Chicory *Jerusalem artichokes *Onion *Garlic *Leeks *Wheat *Barley *Rye *Oats *Lentils *Black beans *Kidney beans *Soybeans *Breast milk

Food Sources of Probiotics

Food Sources of Probiotics - Fermented dairy foods: *Yogurts with live cultures *Buttermilk *Kefir *Cottage cheese Other Fermented Foods: *Soy *Tempeh *Miso *Fresh sauerkraut *Kimchi Nonfermented Foods: *Breast milk

Functional Food

Functional Food - a food that provides additional health benefits beyond basic nutrition that may reduce disease risk or promote good health. Food manufacturers may opt to add additional nutrients to food products to boost nutritional value and potential health benefits. These products fall under a class of foods called functional foods (also called nutraceuticals). Functional foods contain nutrients or other constituents, such as phytochemicals, that may enhance their contribution to health and disease prevention beyond their basic nutritional content. Functional foods may be whole foods or processed foods that have been touted to decrease the risk of cancer, heart disease, diabetes, or obesity, or to slow the aging process. Some of these claims may be overhyped, but some may be accurate. Functional foods include whole foods, like vegetables, berries, and fish; enriched grains; fortified juices and milks; and enhanced foods, such as sports bars and sports drinks designed to help you run longer or play sports harder. Sports supplements are also known as ergogenic aids. The Academy of Nutrition and Dietetics noted, in its 2013 position statement on functional foods, that "all food is essentially functional at some level as it provides energy and nutrients needed to sustain life. However, there is growing evidence that some food components, not considered nutrients in the traditional sense, may provide positive health benefits." Nutrient-dense plant-based functional foods may, for instance, contain disease-fighting phytochemicals, or phytonutrients, which are biologically active constituents in foods. More than 2,000 phytochemicals have been found in plant-based foods, and many have antioxidant or hormonelike actions and may help to reduce the risk of certain types of cancer and other chronic diseases. Or, functional foods might contain prebiotics (nondigestible carbohydrates broken down by colon bacteria) or probiotics (live beneficial bacteria found in fermented foods). The United States currently has no statutory legal definition for functional foods, nor any specific regulatory policies for them, so they can be categorized as conventional foods, dietary supplements, or medical foods. Functional foods are common, representing the largest percent of new food products introduced to the market over the past decade. Many packaged functional foods include health claims on their labels that are regulated by the FDA, and most are high in nutrients in relation to calories, so they can contribute to dietary quality, optimal health, and disease prevention when consumed as part of a varied, balanced diet and healthy lifestyle. Dietary supplements can be important and potentially life-saving products for individuals who cannot get enough nutrients through foods—for instance, vegans, whose only source of vitamin B12 is fortified foods, may not get enough through their diet alone. But because supplements are not as tightly regulated as drugs, and because in some cases scientists do not fully understand their potential effects, supplements do not come without risks. "The great majority of the time people are taking supplements and it's just a waste of money," Cohen says. "And a small percentage of the time, they're taking something that's actually dangerous."

GRAS Generally Recognized as Safe

GRAS: any substance intentionally added to food that is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use; not subject to premarket review and approval by the FDA

Selected FDA Approved Health Claims for Dietary Supplements

Selected FDA Approved Health Claims for Dietary Supplements: *Calcium and Osteoporosis - Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis *Dietary Fat and Cancer - Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers. *Sodium and Hypertension - Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors. *Dietary Saturated Fat and Cholesterol, and risk of Coronary Heart Disease - Although many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease. *Fiber-Containing Grain Products, Fruits, and Vegetables and Cancer - Low-Fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors *Fruits, Vegetables, and Grain Products that Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease - Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors. *Folate and Neural Tube Defects - Healthful diets and adequate folate may reduce a woman's risk of having a child with a brain or spinal cord defect *Potassium and the Risk of High Blood Pressure and Stroke - Diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke. *Whole Grain Foods and Risk of Heart Disease and Certain Cancers - Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers.

Selected FDA Approved Qualified Health Claims for Dietary Supplements

Selected FDA Approved Qualified Health Claims for Dietary Supplements: (Nutrient and Disease, Eligible Foods, Claim Statement) *Green Tea and Cancer - Green Tea and conventional foods and dietary supplements that contain green tea - Green tea may reduce the risk of breast or prostrate cancer. The FDA has concluded that there is very little scientific evidence for this claim. *Selenium and Cancer - Dietary supplements containing selenium - Selenium may produce anticarcinogenic effects in the body. Some scientific evidence suggests that consumption of selenium may produce anticarcinogenic effects in the body. However, the FDA has determined that this evidence is limited and not conclusive. *Antioxidant Vitamins and Cancer - Dietary supplements containing vitamin E and/or vitamin C - Vitamin C may reduce the risk of gastric cancer. The FDA has concluded that there is very little scientific evidence for this claim. Vitamin E may reduce the risk of colorectal cancer. The FDA has concluded that there is very little scientific evidence for this claim. *Omega-3 Fatty Acids and Coronary Heart Disease - Conventional foods and dietary supplements that contain EPA and DHA omega-3 fatty acids - Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.

Studies Examining Multivitamin/Mineral Supplements

Studies Examining Multivitamin/Mineral Supplements: *Of 8 observational studies that examined the effect of long-term multivitamin/mineral (MVM) supplements on mortality, 6 studies found no effect of MVM use, while 2 studies observed an increased risk of death in those taking MVM supplements. *In a recent randomized clinical trial, approximately 10 years of MVM administration caused no decrease in deaths from cardiovascular disease or cancer. MVM supplements did not affect the occurrence of CVD, though there was a slight decrease in the occurrence of all cancers. *An earlier randomized clinical trial found no decrease in mortality following the administration of an MVM supplement to a poorly nourished population for 6 years, nor was there any affect on mortality 20 years later. *Analysis of data pooled from 78 clinical trials involving nearly 300,000 participants found no benefit of antioxidant vitamins and minerals on the risk of death; however, consuming supplements of beta-carotene and vitamin E were found to increase the risk of death. *The analysis of pooled data from 21 studies that had administered supplements containing three or more vitamins and minerals to more than 90,000 participants found no effect on mortality risk. From the research findings summarized here, identify perhaps the best reason to NOT use vitamin/mineral supplements: There appears to be no decrease in mortality risk from taking vitamin/mineral supplements, and, in some cases, supplement use may be harmful.

The FDA does not approve dietary supplements for their effectiveness or safety

The manufacturer of a dietary supplement or ingredient is responsible for ensuring product safety.

Supplement Facts Panel

Supplement Facts Panel - package label that must indicate that the product is a supplement, not a conventional food, and must include serving size and amount of product per serving size, the percent of Daily Value that a particular ingredient or nutrient provides per serving, and a list of the product's dietary ingredients. If a dietary ingredient is a botanical, the panel must list the scientific name of the plant or the common name that has been standardized in the reference book Herbs of Commerce (2000 edition). The panel must also include name of the plant part that has been used. If the dietary ingredient is a proprietary blend, meaning a blend that is exclusive to the manufacturer, the Supplement Facts Panel must list the total weight of the blend and its components in descending order of predominance by weight. One of the most significant differences between the "Facts Panel" for a supplement versus a food is that substances and ingredients that do not have recommendations are allowed on the supplement panel.

Dietary Supplement Health Claims

Supplement labels can also include health claims that describe a relationship between a dietary supplement ingredient and a reduced risk of a disease or condition. The FDA must pre-approve these claims based on Significant Scientific Agreement (SSA) about the publicly available scientific evidence. A supplement containing calcium and vitamin D can legally claim that it reduces the risk of osteoporosis, for instance, and a folic acid supplement can say that it may prevent fetal neural tube defects. The FDA also allows the use of qualified health claims for conventional foods and dietary supplements when the evidence linking a food, food component, or supplement to a reduced risk of a disease is emerging but not well enough established to meet the SSA standard for a true health claim. For example, the number of studies demonstrating a beneficial effect may be limited, or the results of studies may be inconsistent. Qualifying language is included to indicate that the evidence supporting the relationship is limited—for instance, you might read on a label that "supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease." But even qualified claims have to be approved by the FDA based on the quality and strength of the scientific evidence.

Women Who May Become Pregnant: May Warrant Nutrient Supplementation

Supplemental folic acid reduces the occurrence of neural tube defects

Supplements for athletes

Supplements for athletes - (ergogenic aids) Energy gels, bars and powders are used by athletes to improve performance, or to last through a grueling workout.

Regulation of Dietary Supplements

The FDA regulates both dietary supplement products and the ingredients found within them, and it does so under a different set of regulations than those governing "conventional" foods and drugs. Unlike drug regulation, the FDA does not approve dietary supplements for their effectiveness or safety before they are made available to consumers. Dietary supplements do not undergo the rigorous testing for effectiveness, interaction, or safety requirements that prescription and over-the-counter drugs do. In fact, as DSHEA dictates, the manufacturer of a dietary supplement or ingredient is responsible for ensuring that the product is safe, unadulterated, produced with good manufacturing practices, and properly and truthfully marked with a label that identifies the product as a dietary supplement and includes specific information about the supplement and its use. Because the FDA does not regulate dietary supplements as rigorously as it does drugs, supplements are sometimes sold contaminated with banned substances or prescription drugs. In 2010, for instance, the agency warned consumers not to take the Chinese weight-loss supplement Fruita Planta, because FDA testing had revealed it contained sibutramine, a drug that had been withdrawn from the United States market earlier that year for safety reasons. And in a 2013 study, Pieter Cohen, an assistant professor of medicine at Harvard Medical School who studies dietary supplement safety, and his colleagues found traces of a methamphetamine-like substance in a popular workout supplement. The FDA is responsible for taking action against unsafe or improperly labeled dietary supplements after they go to market, but this is not easy to do: The agency has to prove that the product is unsafe to restrict its use or remove it, and "there's no effective system that the FDA has to identify these supplements, so hazardous supplements stay on the marketplace for years," Cohen says. Even when the FDA announces that a supplement is unsafe, it may not cease being sold. In a 2011 study, Cohen and his colleagues found that after the FDA recalled a popular weight-loss supplement called Pai You Guo in 2009, women were able to continue buying it for years. This all said, the 2011 Food Safety Modernization Act expanded some of the FDA's authority over supplement manufacturers.

FDA Required General Information on Supplement Packages

The general information required on the package includes the name of the product; the word "supplement" or a statement that the product is a supplement; the quantity of the package contents; the name and location of the manufacturer, packer, or distributor; and directions for using the product. Supplement labels may also contain cautionary statements about potential side effects, but if a supplement does not have a cautionary statement, it does not mean that the product is completely safe. Unlike conventional drugs, supplement manufacturers do not have to list known adverse effects on their labels.

Vegans: May Warrant Nutrient Supplementation

The only source of B12 is animal proteins and fortified foods, so vegans who eat no animal products may need a supplement as well as supplementary calcium, iron, and zinc

Those With Dark Skin: May Warrant Nutrient Supplementation

Vitamin D supplements are recommended because skin pigments block UV light and decrease the synthesis of vitamin D

What is the difference between the statements "calcium builds strong bones" and "calcium reduces the risk of osteoporosis"?

What is the difference between the statements "calcium builds strong bones" and "calcium reduces the risk of osteoporosis"? "Calcium builds strong bones" makes a claim that calcium affects the body's structure (bones). It is an acceptable structure/function claim. "Calcium reduces the risk of osteoporosis" is not an acceptable structure/function claim because it promises to prevent the disease of osteoporosis.

What types of grain products are most likely to have prebiotic properties?

What types of grain products are most likely to have prebiotic properties? Oats, wheat, barley, and rye have prebiotic properties.