from the association

Position of the American Dietetic Association: Nutrient Supplementation

POSITION STATEMENT in particular is prevalent and growing ABSTRACT It is the position of the American Die- in the United States. Based on the 1999- It is the position of the American Di- tetic Association that the best nutri- 2000 National Health and Nutrition etetic Association that the best nutri- tion-based strategy for promoting op- Examination Survey, 52% of adults tion-based strategy for promoting op- timal health and reducing the risk of reported taking a dietary supplement timal health and reducing the risk of chronic disease is to wisely choose a in the past month and 35% said they chronic disease is to wisely choose a wide variety of foods. Additional nu- took a multivitamin/mineral supple- wide variety of nutrient-rich foods. trients from supplements can help ment (MVM) (5). Adults who used Additional nutrients from supple- some people meet their nutrition needs MVM supplements most often in- ments can help some people meet as specified by science-based nutrition cluded women, older adults, non-His- their nutrition needs as specified by standards such as the Dietary Refer- panic whites, people with more than science-based nutrition standards ence Intakes. a high-school education, people who such as the Dietary Reference In- rate their health as excellent/very takes. The use of dietary supplements good, and under- and normal-weight he focus of this American Die- in general, and nutrient supplements tetic Association (ADA) position people (5). Supplements of vitamin E, in particular, is prevalent and grow- Tpaper is the use of nutrient sup- vitamin C, calcium, and B-complex vi- ing in the United States, with about plements, particularly vitamin and tamins were used by at least 5% of one third of adults using a multivita- mineral supplements, in assisting adults. In the 1999-2004 National min and mineral supplement regu- people in meeting their nutrient Health and Nutrition Examination larly. Consumers may not be well in- needs. Fortified food, a topic previ- Survey, 34% of children and adoles- formed about the safety and efficacy ously included within this ADA posi- cents reported supplementing their of supplements and some may have tion paper, is discussed in ADA’s po- diets with some type of vitamin and difficulty interpreting product labels. sition paper on functional foods (1). mineral supplement (6). Factors asso- The expertise of dietetics practitio- Other nutrients such as fatty acids (2) ciated with greater use among chil- ners is needed to help educate con- and fiber (3) are also discussed in sep- dren included younger age, more sumers on the safe and appropriate arate ADA position papers. Supple- healthful diets, greater food security, selection and use of nutrient supple- mentation of non-nutrient ingredi- greater physical activity, and better ments to optimize health. Dietetics ents is covered in ADA’s practice access to health care (6). practitioners should position them- paper on dietary supplements (4). In 2007, dietary supplement sales selves as the first source of informa- The use of dietary supplements in grew to $23.7 billion (7). Sales of mul- tion on nutrient supplementation. To general and nutrient supplements tivitamins, the most commonly pur- accomplish this, they must keep up to date on the efficacy and safety of nu- trient supplements and the regula- This American Dietetic Association (ADA) position paper includes the authors’ independent review of the literature in addition to systematic tory issues that affect the use of these review conducted using ADA’s Evidence Analysis Process and information products. This position paper aims to from ADA’s Evidence Analysis Library (EAL). Topics from the EAL are increase awareness of the current is- clearly delineated. The use of an evidence-based approach provides impor- sues relevant to nutrient supple- tant added benefits to earlier review methods. The major advantage of the ments and the resources available to approach is the more rigorous standardization of review criteria, which assist dietetics practitioners in evalu- minimizes the likelihood of reviewer bias and increases the ease with which ating the potential benefits and ad- disparate articles may be compared. For a detailed description of the methods verse outcomes regarding their use. used in the Evidence Analysis Process, go to http://adaeal.com/eaprocess/. J Am Diet Assoc. 2009;109: Evidence-based information for this and other topics can be found on the 2073-2085. EAL at www.adaevidencelibrary.com and subscriptions for nonmembers are purchasable at www.adaevidencelibrary.com/store.cfm.). Conclusion statements are assigned a grade by an expert work group based on the systematic analysis and evaluation of the supporting research evidence. Grade IϭGood; Grade IIϭFair; Grade IIIϭLimited; Grade 0002-8223/09/10912-0013$36.00/0 IVϭExpert Opinion Only; and Grade VϭNot Assignable (because there is doi: 10.1016/j.jada.2009.10.020 no evidence to support or refute the conclusion).

© 2009 by the American Dietetic Association Journal of the AMERICAN DIETETIC ASSOCIATION 2073 chased of supplements, grew 3.9% in stituent, extract, or combination of Safety 2007 to $4.5 billion in sales for the any ingredient mentioned above (9). Manufacturers are responsible for en- year. Sales of single-nutrient supple- Dietary supplements are intended to suring their products are safe before ments, including calcium, B vitamins, be taken by mouth and can be in they put them on the market (12). vitamin C, vitamin A/beta carotene, many forms, including pills, capsules, Vitamins and minerals were sold as magnesium, and iron also grew dur- tablets, liquids, powders, or other ingredients in dietary supplements ing this period, whereas vitamin E forms as long as they are not repre- before DSHEA was implemented and supplement sales declined slightly sented for use as a conventional food are, therefore, presumed to be safe (7). Contributing to this industry’s or as a sole item of a meal or diet (9). based on their history of use. They do growth are the aging of the popula- They must also be identified on the not require an FDA premarket review tion and consumer desire to maintain label as a dietary supplement (9). of safety or efficacy (12). For any new good health and prevent disease. dietary ingredient (sold after DSHEA Although many Americans use di- was passed) and not recognized as a etary supplements, a 2009 report Label Claims food substance present in the food from the US Government Account- supply, the manufacturer (and dis- ability Office stated that “according to Dietary supplement labels can bear health claims (authorized and quali- tributor) must provide notification to experts, consumers are not well-in- the FDA of their intention to mar- formed about the safety and efficacy fied), nutrient content claims, and ket the product and provide them of dietary supplements and have dif- structure/function claims (10). Health with the information they used to con- ficulty interpreting labels on these claims can be used to characterize the clude the ingredient was generally products” (8). The Government Ac- relationship between a dietary ingre- safe to consume (12-14). Once mar- countability Office expressed concern dient and reducing the risk of a dis- keted, the FDA has the authority to that the uninformed use of dietary ease or health-related condition (10). remove a product if they prove it to supplements may expose consumers Nutrient content claims can be used be unsafe (12). The FDA monitors to health risks (8). The expertise of to characterize the amount of a nutri- dietetics practitioners is needed to ent (10). Both health claims and nu- safety, in large part, by collecting re- help educate consumers on safe and trient content claims must be pre- ports on adverse events from consum- appropriate selection and use of di- approved by the FDA. Structure/ ers, health professionals, and manu- etary supplements, including nutri- function claims are the most com- facturers through their MedWatch ent supplements. The primary objec- monly used claims on dietary sup- program—The FDA Safety Informa- tion and Adverse Event Reporting tive of this paper is to increase plement labels (4). They can be used Program (15). Reporting adverse awareness of the current issues rele- to describe the following: the effect a events associated with a dietary sup- vant to nutrient supplements and the dietary ingredient has on the struc- plement was voluntary for manufac- resources available to assist dietetics ture or function of the body; the way a turers until new legislation, the Di- practitioners in evaluating the poten- dietary ingredient acts to maintain a etary Supplement and Nonprescription tial benefits and adverse outcomes re- structure or function; general well-be- garding their use. Drug Consumer Protection Act (16), ing from consumption of a dietary went into effect December 22, 2007. ingredient; or a benefit related to a The new regulation requires the re- nutrient deficiency disease if the sponsible party (ie, the manufacturer, prevalence of the disease in the DEFINITION AND REGULATORY packer, or distributor whose name ap- FRAMEWORK United States is also indicated (10). pears on the label) to submit Serious Structure/function claims are not pre- Nutrient supplements, like other di- Adverse Event Reports to the FDA approved by the FDA. The manufac- within 15 business days of receiving a etary supplements, are regulated as a turer is responsible for ensuring the subcategory of food by the Food and report and to maintain records of all claims they make are truthful and not Drug Administration’s (FDA’s) Cen- adverse event reports for 6 years (17). misleading and must provide the ter for Food Safety and Applied Nu- Reporting of events not considered FDA with the text of structure/func- trition. The Dietary Supplement serious remains voluntary. Adverse Health and Education Act of 1994 tions claims no later than 30 days events are considered serious if they (DSHEA) (9), which amended the after marketing the supplement (10). result in death, a life-threatening ex- Federal Food, Drug, and Cosmetic Labels that contain structure/func- perience, inpatient hospitalization, a Act of 1938, defines and sets safety tion claims must also carry the dis- persistent or significant disability or and labeling requirements for dietary claimer that explains to the consumer incapacity, or a congenital anomaly or supplements. The DSHEA defines a that the FDA has not evaluated the birth defect; or require, based on rea- dietary supplement, in part, as a label claim and that the product is not sonable medical judgment, a medical product intended to supplement the intended to “diagnose, treat, cure, or or surgical intervention to prevent an diet that contains any of the following prevent any disease” (10). Although outcome listed above (18). The sub- dietary ingredients: a vitamin; a min- the FDA has the primary responsibil- mission of an adverse event report is eral; an herb or other botanical; an ity of claims on product labeling, the not an admission by the company that amino acid; a dietary substance for Federal Trade Commission has the the product involved caused or con- use by humans to supplement the diet responsibility of regulating claims tributed to the adverse event (17). by increasing the total dietary intake; made in the advertising of dietary According to a 2009 Government or a concentrate, metabolite, a con- supplements (11). Accountability Office report, the num-

2074 December 2009 Volume 109 Number 12 ber of all adverse event reports re- its some companies, particularly were insufficient to determine a UL ceived increased threefold after man- smaller companies, from having their (ie, biotin, carotenoids, pantothenic datory reporting went into effect products tested. acid, riboflavin, thiamin, vitamin compared to the previous year, but B-12, vitamin K) the IOM warns that underreporting remains a concern (8). caution may be warranted in consum- From December 2007 through Octo- OPTIMAL INTAKES ing levels above the RDAs and AIs ber 2008, the FDA received 596 man- Nutrient-Based Recommendations (26). See the Figure for IOM Web datory serious adverse event reports Optimal nutrient intakes are those sites that provide the UL values and (8). Of these reports, 66% were asso- that promote health and reduce risk the adverse effects of excess consump- ciated with combination products and for chronic disease while minimizing tion associated with each nutrient. products that did not fall under any of risk of excess. The Institute of Medi- DRI Updates. Experts have suggested the available categories, 40% with vi- cine’s (IOM’s) Dietary Reference In- the DRIs for vitamin D be updated tamins, and 19% with minerals (8). takes (DRIs) are the best available based on evidence accumulated since The percentages total more than evidence-based nutrient standards the 1997 release. Although consensus 100% because reports that involved for estimating optimal intakes. They has not been reached, some experts more than one product were counted include the Recommended Dietary indicate that the recommended in- in more than one category. No causal Allowances (RDAs), Adequate In- take should be increased to 1,000 IU/ relationships between adverse events takes (AIs), Estimated Average Re- day for all adults (27) and the UL be and the associated products could be quirements (EARs), and Tolerable increased from 2,000 IU to 10,000 IU made, in part, because of the variabil- Upper Intake Levels (ULs) (24). (28). The desirable blood concentra- ity in the quality and detail of the The RDAs and AIs (when data was tion for optimal vitamin D status has information provided in the reports (8). not sufficient to determine an EAR also been debated. According to some and thus an RDA) serve as intake experts, advantages begin at a 25-hy- goals for healthy individuals. These Quality droxyvitamin D (25[OH]D) concentra- levels may not be adequate to replete tion of 75 nmol/L (30 ng/mL), whereas In June 2007, the FDA, with author- individuals who are malnourished between 90 and 100 nmol/L (36 to 40 ity granted under DSHEA, published (24). In addition, levels higher, or ng/mL) is ideal for a variety of end- a final rule establishing current Good lower, than recommended levels may points (27). An IOM committee is cur- Manufacturing Practices for dietary be necessary to meet the needs of peo- rently assessing the relevant data to supplements (19). This rule estab- ple with specific health conditions or update the DRIs for vitamin D and lishes regulations that require the who take medications that alter their calcium as they find appropriate (29). consistent manufacturing of products requirement for a nutrient (24). The The report is scheduled to be released with regard to identity, purity, strength, recommended intakes can be used as by May 2010. and composition (20). Companies are goals for nutrients not affected by the The American Academy of Pediat- responsible for ensuring their prod- condition or medication; estimates of rics (AAP) released updated vitamin ucts meet quality standards, includ- other nutrients should be based on D recommendations in 2008. Recom- ing being accurately labeled (eg, prod- best evidence for the circumstance mendations for healthy infants and ucts contain the ingredients in the such as provided in hospital diet man- children were increased from a mini- amounts stated on their labels) and uals and from professional organiza- mum of 200 IU per day beginning in free from contaminants (eg, bacteria, tions (24). The recommended intake the first 2 months after birth to a pesticides, glass, lead, and other values and the endpoints on which heavy metals) and foreign materials the values were established have minimum of 400 IU per day beginning (19). The requirements are being been summarized in the IOM’s Di- soon after birth to prevent rickets and phased-in over a 3-year period de- etary Reference Intakes: The Essential vitamin D deficiency (30). The AAP pending on the company size. All com- Guide to Nutrient Requirements (25). recommends serum 25(OH)D concen- panies are expected to be in compli- The UL is the “maximum level of trations of 50 nmol/L (20 ng/mL) in ance by June 2010 (19). daily nutrient intake that is likely to infants and children (30). These rec- Independent organizations such as pose no risk of adverse effects” (26). It ommendations as they pertain to sup- ConsumerLab.com (a for-profit com- was determined there was a need for plementation are further discussed in pany), NSF International, and US ULs because of increased intakes of the “Nutrient Supplements in Prac- Pharmacopoeia offer programs that nutrients from fortified foods and di- tice” section. evaluate supplement quality (21-23). etary supplements (25). The ULs for Using DRIs to Assess Total Nutrient In- Each organization has, at a mini- vitamin E, niacin, and folate apply takes. The DRIs are used to assess mum, a program that allows manu- only to synthetic forms of the nutri- adequate and excess nutrient intakes facturers, if they choose, to pay a fee ents as is found in supplements and and plan diets for groups and individ- to have their products tested; those fortified foods (26). The UL for mag- uals. Dietary assessment information that conform to the organization’s nesium applies to intakes from phar- can be used to help dietetics practitio- quality specifications can bear that macological agents only (26). The UL ners determine if an individual is organization’s seal of approval on for vitamin A is from preformed vita- likely to benefit from or is at risk for their label. The absence of a seal does min A or retinol only (26). For all excess intakes from taking dietary not in and of itself indicate inferior other nutrients, ULs apply to total supplements and in appropriate prod- quality. High costs to analyze for each intake from food, water, and supple- uct selection. ingredient may be one factor that lim- ments. For nutrients for which data When an individual’s usual intake

December 2009 ● Journal of the AMERICAN DIETETIC ASSOCIATION 2075 Web Sites Organization URL Contents

Agency for Healthcare Research www.ahrq.gov/clinic/epcindex.htm#dietsup ● AHRQ produced evidence-based reviews on nutrient supplements and Quality (AHRQ) American Dietetic Association www.eatright.org ● Position papers ● Practice paper on dietary supplements ● Evidence Analysis Library ● Other documents: Guidelines Regarding the Recommendation and Sale of Dietary Supplements, Code of Ethics for the Profession of Dietetics Cochrane Collaboration www.cochrane.org/reviews/ ● Free access to abstracts and links to full reviews of evidence- based health care topics including vitamins and minerals used for disease prevention and treatment Food and Drug Administration www.fda.gov/Food/DietarySupplements/ ● Dietary supplement alerts and safety information default.htm ● Adverse event reporting ● Guidance, compliance, and regulatory information ● Other documents: Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information, Tips for the Older Dietary Supplement Users Institute of Medicine Elements: ● Tables that include Dietary Reference Intake values and adverse www.iom.edu/Object.File/Master/7/ effects of excessive consumption 294/0.pdf Electrolytes and water: www.iom.edu/Object.File/Master/20/ 004/0.pdf Vitamins: www.iom.edu/Object.File/Master/7/296/ webtablevitamins.pdf Micronutrient Information Center, lpi.orst.edu/infocenter ● Evidence-based monographs on vitamins, minerals, other Linus Pauling Institute, Oregon nutrients, and dietary phytochemicals that include information on State University nutrient function, deficiency symptoms, interactions, recommended intakes, supplements, and safety National Agricultural Library www.nal.usda.gov/fnic/pubs/bibs/gen/ ● Dietary Supplements: Resources for Professionals (January 2008) dietarysupplementsprofessionals08.pdf ● Listing of resources (bibliographies/databases, books/book chapters, newsletters, Web resources, agencies and organizations) providing technical and professional-level information on dietary supplements including nutrition information National Library of Medicine dietarysupplements.nlm.nih.gov/dietary ● The Dietary Supplements Labels Database (DSID)—Information about label ingredients in Ͼ3,000 selected brands of dietary supplements www.nlm.nih.gov/medlineplus/ ● MedlinePlus for Vitamin and Mineral Supplements vitaminandmineralsupplements.html Office of Dietary Supplements, ods.od.nih.gov ● International Bibliographic Information on Dietary Supplements National Institutes of Health (IBIDS) Database—Published, scientific literature on dietary (NIH) supplements including vitamins, minerals, and botanicals ● Expert reviewed Facts Sheets on vitamins, minerals and botanicals that include information on medication interactions and signs and symptoms of deficiency and toxicity ● Computer Access to Research on Dietary Supplements (CARDS)—Database of federally-funded research projects pertaining to dietary supplements. Therapeutic Research Center www.naturaldatabase.com ● Natural Medicines Comprehensive Database (subscription required)—Includes evidence-based monographs that contain information on ingredient safety, effectiveness, adverse reactions and interactions US Department of Agriculture, dietarysupplementdatabase.usda.nih.gov/ ● Dietary Supplement Ingredient Databases (DSID)—Estimates Agricultural Research Service, levels of ingredients in dietary supplement products Office of Dietary Supplements, NIH, and other federal agencies

Books

Coates PM, Blackman MR, Cragg GM, Levine M, Moss J, White JD. Encyclopedia of Dietary Supplements, New York, NY: Marcel Dekker; 2005. Fragakis AS, Thomson CA. The Health Professional’s Guide to Popular Dietary Supplements. 3rd ed. Chicago, IL: American Dietetic Association; 2006. Hendler S, Rorvik D, eds. PDR for Nutritional Supplements. 2nd ed. Montvale, NJ: Thomson Reuters; 2008. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington, DC: National Academies Press; 2006.

Figure. Resources for information related to dietary supplements.

2076 December 2009 Volume 109 Number 12 meets or exceeds recommended lev- Human Services and the US Depart- groups; vitamins B-6 for older adult els, it is likely that their intake is ment of Agriculture’s 2005 Dietary females; zinc for all older adults and adequate; that is, they are likely to be Guidelines for Americans (DGA) pro- teenaged females; and phosphorus for consuming an amount of a nutrient vide guidance on diet and physical preteen and teenaged females (36). In needed to maintain the specific ade- activity to promote health and de- addition, the following nutrients may quacy endpoint for which the value crease the risk of chronic disease (32). also be of concern because a low per- was derived. This is because RDAs The DGA will be revised in 2010. My- centage of intakes were above AI lev- meet or exceed the estimated require- Pyramid provides recommended food els (adequacy cannot be determined ment of all but 2% to 3% of the popu- intake patterns for 12 energy levels because the EARs needed for assess- lation, and AIs represent intakes that range from 1,000 to 3,200 kcal ing adequacy have not been estab- likely to exceed the actual require- per day (33). These food-based recom- lished for these nutrients): vitamin K, ments of almost all healthy people mendations incorporate advice from calcium, potassium, and dietary fiber (24). For the same reason, usual in- the DGA and use DRIs as nutrient (36). This analysis included intakes takes that fall below recommended intake goals. One alternative to the from food sources only. levels should not be interpreted as MyPyramid plan for meeting nutrient According to national survey data, inadequate (24). Clinical status and needs is the National Heart, Lung, inadequate intakes from food sources biochemical indexes should be among and Blood Institute’s Dietary Ap- are most prevalent for vitamin E and the factors included with intake data proaches to Stop Hypertension Eat- magnesium. Overt symptoms of vita- to assess an individual’s dietary ade- ing Plan (32). min E deficiency are uncommon in quacy and nutritional status (24). The the United States (37). According to totality of information should be used the IOM, actual vitamin E intakes to determine if a person is likely to DIETARY GAPS may be higher than reported in na- benefit from nutrient supplementa- Many Americans do not consume the tional surveys for several reasons, tion. The UL is an important tool that amount and types of foods necessary including respondents underreport dietetics practitioners can use to as- to meet recommended micronutrient energy and fat intakes (source of sist consumers in the safe use of di- intakes. Adherence to the DGA is low; vitamin E), inaccurately estimate etary supplements. As average daily only about 3% to 4% of Americans amounts of fats and oils they add dur- intakes exceed the UL, the risk of ad- follow all of the DGA (34). As a result ing food preparation and uncertainty verse health effects increases (24). of low intakes of nutrient-rich foods about the types fats or oils consumed It is important to note that when and sedentary lifestyles, many Amer- (37). Authors of a balance study sug- comparing a person’s intake to DRIs icans may be meeting or exceeding gested that the EAR for magnesium is to assess adequacy, one is actually their energy requirements while fall- set too high and that it should be low- assessing apparent adequacy because ing short of vitamin and mineral rec- ered from 330 to 350 mg/day for men an individual’s true requirement and ommendations. In assessing the diets and 255 to 265 mg/day for women to true intake of a nutrient are not of population groups, the proportion 165 mg/day for healthy persons re- known (24). Day-to-day variability in with intakes less than the EAR (not gardless of age or sex (38). intakes and limitations in methods of the RDA) are interpreted as esti- collecting intake data and nutrient mates of the prevalence of inadequacy NUTRIENT SUPPLEMENTATION databases all affect intake estimates, (24). The DGA identify calcium, po- Effect on Total Nutrient Intakes and various factors including genetics tassium, magnesium, vitamin E, and affect true nutrient requirements. fiber in adults and children, and vita- Nutrient supplements can have a The IOM published Dietary Reference mins A and C in adults only, as nu- substantial impact on a person’s total Intakes: Applications in Dietary As- trients of concern (ie, nutrients for nutrient intake (39). Supplements sessment (24) to provide guidance on which the prevalence of inadequate have the potential to fill dietary gaps using the DRIs to assess intakes. intakes were high—in this case but, at the same time, may increase Ն40%—or for which low intakes were intakes above ULs. Thus, intake from associated with public health prob- supplements must be included along Food-Based Recommendations lems) (35). Also identified as nutri- with intakes from conventional and Wise selection of nutrient-rich foods ents of concern were vitamin B-12 in fortified foods and beverages when as- is generally the best strategy for older adults; vitamin D in older sessing nutritional adequacies and meeting nutrient needs. Foods, par- adults, people with dark skin, and excesses of individuals and popula- ticularly plant foods such as fruits, people with inadequate exposure to tion groups. With regard to supple- vegetables, whole grains, beans, nuts, sunlight; iron in adolescent females ments, The DGA state that: seeds, and teas, provide an array of and women of childbearing age who Supplements may be useful when other health-promoting substances may become pregnant; and folic acid they fill a specific identified nutri- beyond vitamins and minerals, in- in women of childbearing age and ent gap that cannot or is not other- cluding carotenoids and polyphenols pregnant women (32). wise being met by the individual’s such as flavonoids. Data suggest that An analysis of intake data from intake of food. Nutrient supple- ments cannot replace a healthful positive health outcomes are related What We Eat in America, National diet. Individuals who are already more to dietary patterns, the types Health and Nutrition Examination consuming the recommended amo- and amounts of foods consumed, than Survey 2001-2002 indicated potential unt of a nutrient in food will not to intakes of individual nutrients (31). for problems for vitamins A, E, and C achieve any additional health bene- The US Department of Health and and magnesium for most age/sex fit if they also take the nutrient as a

December 2009 ● Journal of the AMERICAN DIETETIC ASSOCIATION 2077 supplement. In fact, in some cases, women aged Ն71 years and from 10% to randomized controlled studies, on supplements and fortified foods to 24% in men of the same age group the health benefits and risks of MVM may cause intakes to exceed the when intakes of supplements were supplements (defined as “any supple- safe levels of nutrients (32). added to their intakes from food (40). ment containing three or more vi- National survey data suggests that Exceeding ULs. There is potential for tamins and minerals but no herbs, supplements may be taken by those supplement users to exceed the ULs hormones, or drugs, with each compo- who have healthful diets and life- of some nutrients when they take nent at a dose less than the Tolerable styles more often than those at a high dose supplements or multiple Upper Intake Level”) (43). The panel greater risk for vitamin and mineral products with the same ingredients, concluded that evidence, at the time, inadequacies. and even when MVMs are taken was insufficient to determine whether Filling Dietary Gaps. When taken regu- along with a diet rich in fortified or not taking MVM supplements was larly, MVMs can be an effective way foods. As daily intakes exceed the UL, beneficial in preventing chronic dis- to increase nutrient intakes to meet risk of adverse health effects in- ease in generally healthy people (43). recommended levels of multiple nu- crease. In the Hawaii Los Angeles The evidence on supplemental cal- trients. The extent to which a MVM Multiethnic Cohort 1999-2001, the cium and vitamin D in relation to bone health has been favorable, particularly can improve nutrient adequacy is im- nutrients identified as those most in older women. The National Insitutes pacted by the nutrient profile of the likely to exceed the ULs were: iron, of Health State-of-the-Science Panel on supplement taken. Of the nutrients zinc, vitamin A, and niacin (39). The MVM supplements concluded that previously identified as being low percentage of supplement users with when used in combination, calcium and enough in diets to be of concern, MVM intakes above the UL for folate was vitamin D supplements increase bone supplements have been shown to de- not estimated because intake from mineral density and decrease risk of crease the prevalence of nutrient in- supplements only was not available. Based on 1994-1996 Continuing Sur- hip and nonvertebral fracture in post- adequacy most notably for vitamin E, menopausal women (43). An evidence- vitamin A, zinc, and vitamin B-6 (39). vey of Food Intakes by Individuals data, the percentages of groups of based analysis of the literature on vita- MVMs are less likely to substantially min D and bone health outcomes found increase intakes of key nutrients such older adult supplement users that ex- ceeded the ULs ranged between 8% that vitamin D-3 (700 to 800 IU daily) as calcium, magnesium, and pota- with calcium (500 to 1,200 mg) resulted ssium. Increasing consumption of and 17% for iron, 4% and 15% for zinc, and 4% and 9% for vitamin A in small increases in bone mineral den- foods rich in these nutrients will still sity and reduced fall risk in older be necessary to meet recommended (40). Excess folate and niacin was not assessed. The percentages above UL adults and reduced risk of fractures in amounts. In some cases such as with levels for vitamin B-6, vitamin C, and elderly women living in nursing homes calcium, an additional supplement calcium were Ͻ3%. In the 2002 Feed- (44). may be considered to help meet rec- ing Infants and Toddlers Study, in- ommended intakes, particularly in at- takes of toddlers between 12 and 24 risk groups (eg, older adults) where NUTRIENT SUPPLEMENTS IN PRACTICE months old using supplements ex- supplementation has been shown to ceeded the ULs for vitamin A, zinc, When to Consider Supplementation have positive outcomes. and folate more often than nonusers Nutrient supplements can be used to Based on 1994-1996 Continuing (41). The percentage of intakes ex- help meet a nutrient requirement or Survey of Food Intakes by Individuals ceeding the ULs for toddlers among to treat a diagnosed deficiency dis- data, when intake from supplements nonusers compared to users were 15% ease. A person’s micronutrient intake were added to food intakes of users, and 97% for vitamin A, 38% and 68% may be inadequate when they are re- the percentage of older adults with for zinc, and Ͻ1% and 18% for folate, stricting energy intake for weight inadequate intakes was reduced by at respectively (41). loss/control, not consuming an ade- least three quarters for vitamin B-6, quate amount of food to meet energy folate, vitamin C, and zinc in both requirements as a result of poor ap- men and women and vitamins A and Effect of Supplementation on Chronic petite or illness, eliminating one or E in men only (40). In addition, the Disease Prevention more food groups from their diet on a prevalence of inadequate magnesium Although MVM supplementation can regular basis, or consuming a diet low intakes was reduced from 71% to 41% be effective in helping meet recom- in nutrient-rich foods despite ade- in men aged Ն71 years and 64% to mended levels of some nutrients, evi- quate or excessive energy intakes. 29% in women (40). The prevalence dence has not proven them to be ef- Among the groups most vulnerable to rates for inadequacy in these women fective in preventing chronic disease. inadequacy of one or more nutrients were also reduced from 18% to 6% for A study published in 2009 from the are older adults; pregnant women; vitamin A and 93% to 17% for vitamin Women’s Health Initiative found no people who are food insecure (ie, they E. Most already met the EAR for iron association between MVM supple- are,“at times, uncertain of having, or and vitamin B-12 from food intakes, mentation and cancer or cardiovascu- unable to acquire, enough food for all thus supplementation did not have a lar disease risk or total mortality in household members because they had great influence on the proportion of postmenopausal women (42). In 2006, insufficient money and other re- subjects with adequate intakes. For a National Institutes of Health State- sources for food”) (45); alcohol-depen- calcium, the use of supplements in- of-the-Science Panel reviewed evi- dent individuals; strict vegetarians creased the percentage with intakes dence, including an evidence-based and vegans; and those with increased above the AI from Ͻ3% to 14% in review of literature that was limited needs due to a health condition or the

2078 December 2009 Volume 109 Number 12 chronic use of a medication that de- ciency anemia or poor-quality diets, a conclusion statement for each ques- creases nutrient absorption or in- consume no or small amounts of an- tion. The workgroup used ADA’s pro- creases metabolism or excretion. imal sources, are carrying two or cess to answer a total of seven qu- Some government and professional more fetuses and smoke or abuse estions related specifically to the organizations and expert workgroups alcohol or drugs. The ADA position supplementation of vitamins B-12 provide recommendations for nutri- paper also recommends supplemen- and D in older adults. ent supplementation. ADA position tation with 27 mg iron daily (60 mg To identify and select articles for papers that focus on particular seg- daily if she has anemia) and with review, the National Library of Med- ments of the population, nutrients, or vitamin B-12 in some vegans or icine’s PubMed database was sear- conditions often include recommenda- lacto-ovo vegetarians (47). ched using the term older adults and tions on nutrient supplementation. ● Older adults The DGA and IOM the name of the respective vitamin The following are examples of these recommend that people over age 50 (eg, vitamin D or cholecalciferol and nutrient supplement recommenda- get 2.4 ␮g/day vitamin B-12 mainly vitamin B-12 or cobalamin or cyano- tions. from the crystalline form found in cobalamin). All study designs, except fortified foods and supplements case studies, were included in the ● Infants and children, including (32,46). Age is associated with con- search. Articles published from Janu- adolescents The AAP recom- ditions like atrophic gastritis that ary 2006 to January 2008 with sam- mends the following groups of may reduce a person’s ability to di- ple size Ն20 individuals per study healthy infants and children re- gest food-bound vitamin B-12 (46). group and with less than a 20% drop- ceive 400 IU daily of supplemental The DGA recommend older adults out rate were searched. Studies were vitamin D: all infants who are ex- consume extra vitamin D from vita- also identified by screening the refer- clusively or partly breastfed (begin- min D–fortified foods and/or supple- ence lists of the selected papers. Iden- ning the first few days of life and ments (32). This is because older tified papers were then excluded if continued unless infant is weaned adults are at risk for low serum they did not provide an answer di- to at least 1 qt/day vitamin D–for- 25(OH)D concentrations because rectly related to the question. In ad- tified formula or, if older than 12 they have a decreased ability of the dition, for questions related to vita- months, whole milk or low-fat milk skin to synthesize vitamin D from min D, a decision was made after the when appropriate); all non-breast- sunlight (ultraviolet B radiation) initial search to exclude papers pub- fed infants and older children who compared to younger adults (48) lished before January 2006 due to the consume less than 1qt/day vitamin and some may have limited ex- inclusion of a 2007 Agency for Health- D–fortified formula or milk; and ad- posure to sunlight. The Modified care Research and Quality evidence- olescents with dietary intakes Ͻ400 MyPyramid for Older Adults devel- based review that incorporated re- IU/day (30). Children at an in- oped by researchers at Tufts Uni- search before this date. creased risk for vitamin D defi- versity, includes a flag on top of the The detailed search plan and re- ciency, such as those with fat mal- pyramid to alert people older than sults and information on the process absorption and those taking seizure age 70 years of the potential need to and how the conclusions of the Forti- medications, may need higher supplement the diet with vitamins fication and Supplements Evidence amounts to achieve normal vitamin B-12 and D and calcium (49). Cal- Analysis Project were reached are D status as determined by lab re- cium was included in the flag be- available at the EAL Web site (50). sults (30). cause the diets of many older adults The conclusion statements and grade ● Women of childbearing age who are below recommended levels. for the strength of the evidence for may become pregnant The DGA ● People at risk for suboptimal vi- each question are provided below. and IOM recommend that women tamin D status The DGA recom- In addition to the Fortification and who can become pregnant consume mend that in addition to older Supplements Evidence Analysis 400 ␮g/day of folic acid from forti- adults, people with dark skin (be- project, several other ADA evidence fied foods and/or supplements daily, cause they have a decreased ability analysis projects have included ques- in addition to folate obtained from to synthesize vitamin D from sun- tions related to the use of vitamins eating a varied diet, to reduce the light), and those exposed to insuffi- and minerals as they pertain to die- risk of neural tube defects (eg, cient sunlight, consume extra vita- tetics practice. To date, most ques- spina bifida and anencephaly) min D from vitamin D–fortified tions on the EAL on micronutrient (35,46). foods and/or supplements (35). supplementation relate to cardiovas- ● Pregnant women The DGA rec- cular disease and oncology. ommend pregnant women consume 600 ␮g/day of folic acid from forti- ADA EAL fied foods or supplements in addi- This portion of the position paper in- Vitamin B-12 tion to dietary folate (32). The RDA cludes the results of a systematic re- What is the evidence regarding the ef- of dietary folate equivalents for view of literature conducted using fect of oral vitamin B-12 supplemen- pregnant women is 600 ␮g/day (46). ADA’s Evidence Analysis Process and tation and/or fortification on serum The ADA position paper, “Nutrition information from ADA’s EAL. In this cobalamin levels in deficient older and Lifestyle for a Healthy Preg- process, an expert work group identi- adults? nancy Outcome” (47), recommends fied dietetic practice related ques- Conclusion statement Thirteen MVM supplementation for preg- tions, performed a systematic review studies (eight randomized control tri- nant women who have iron defi- of the literature and made and rated als [RTCs], one non-RTC, three cohort

December 2009 ● Journal of the AMERICAN DIETETIC ASSOCIATION 2079 studies, one cross-sectional study) on bone density in postmenopausal falls in older adult men and women. found a dose–response effect in the women and older adult men? Further research is needed to deter- administration of oral cobalamin to Conclusion statement One meta- mine the role of vitamin D-2 or D-3 cobalamin-deficient older adults. Two analysis (a systematic review of 19 alone in preventing falls in older .Limited؍of these studies used multivitamin studies), five RCTs, and two cross-sec- adults. Grade III mineral supplements containing 6 ␮g tional studies found an association Are specific circulating concentra- vitamin B-12 and the remaining stud- between supplemental vitamin D and tions of 25(OH)D associated with bone ies used oral cobalamin ranging from bone mineral density in postmeno- health outcomes in postmenopausal 2.5 ␮g to 2,000 ␮g per day. Research pausal women and older adult men. women and older adult men? endpoints were measured using se- Vitamin D dosage ranged from 400 IU Conclusion statement Two RCTs rum cobalamin or serum methylma- to 1,400 IU (10 ␮gto35␮g) per day; and one meta-analysis (a systematic lonic acid levels. Four studies com- however, it is difficult to determine review of 42 papers) found that evi- pared oral B-12 supplementation to the optimal dosage and the effect of dence is inconclusive regarding the intramuscular injection and con- vitamin D alone, since varying combi- association of specific circulating con- cluded that oral supplementation was nations of nutrients were used includ- centrations of 25(OH)D and bone as effective as intramuscular supple- ing calcium and vitamin K. One ad- health outcomes in postmenopausal mentation. All of the studies used ditional RCT with a supplement women and older adult men. In those doses of vitamin B-12 greater than containing 200 IU (5 ␮g) vitamin D studies reporting a positive associa- the current RDA of 2.4 ␮g per day for and other nutrients found an im- tion in the meta-analysis, specific older adults. Further research is provement in bone turnover markers, 25(OH)D concentrations ranging needed to define serum cobalamin de- but no effect in bone mineral density. from 40 to 80 nmol/L were shown to ficiency and to determine appropriate Further research is needed to deter- have declines in bone health out- levels of oral cobalamin supplementa- mine the independent association be- comes (fractures, falls, and bone loss). tion in deficient older adults. Grade tween supplemental vitamin D and Further research is needed to deter- -Fair. bone mineral density in postmeno- mine the association of specific cir؍II Are serum cobalamin concentra- pausal women and older adult men. culating concentrations of 25(OH)D Fair. with bone health outcomes. Grade؍tions associated with cognitive func- Grade II .Limited؍tion in older adults? What is the evidence regarding the III Conclusion statement Research effect of supplemental vitamin D on What is the effect of vitamin D sup- is inconclusive regarding specific se- fractures in postmenopausal women plementation on circulating 25(OH)D rum cobalamin levels associated with and older adult men? in postmenopausal women and older cognitive function in older adults. Conclusion statement One meta- adult men? Five studies (one RCT, one non-RCT, analysis/systematic review, combin- Conclusion statement Two RCTs two cross-sectional studies, and one ing the results of 13 RCTs, suggests and one meta-analysis (systematic re- prospective cohort study) found an as- that supplementation with vitamin view of 44 RCTs) found a direct effect sociation between low serum cobal- D-3 (400 IU to 800 IU) plus calcium of oral vitamin D-3 supplementation amin levels and impaired cognitive (500 mg to 1,200 mg) may be bene- on circulating levels of 25(OH)D in function in older adults. Four studies ficial in reducing the incidence of postmenopausal women and older (one cross-sectional, three RCTs) fractures in institutionalized older adult men. In studies reporting a found no significant difference in cog- adults. The reduction of fractures treatment effect, specific doses rang- nitive function in individuals with might be accounted for by higher ing from 5 ␮gto50␮g (200 to 2,000 normal and deficient cobalamin lev- mean serum levels of 25(OH)D (at IU) vitamin D-3 were utilized. Meta- els. One additional study (an RCT) least 74 nmol/L), due to good volun- regression results suggested that 100 found a decline in cognitive function teer compliance. One RCT concluded IU (2.5 ␮g) vitamin D-3 will increase with supplementation in cobalamin that supplementation with 100,000 the serum 25(OH)D concentrations by deficient adults compared to placebo IU vitamin D-2 every 4 months does 1 to 2 nmol/L suggesting doses of 400 and another study (cross-sectional) not significantly reduce fractures in to 800 IU (10 to 20 ␮g) daily may be found deteriorating cognitive function institutionalized older adults. Fur- inadequate to prevent vitamin D de- in cobalamin- and folate-deficient in- ther research is needed to determine ficiency in at-risk individuals. It is dividuals. the role of vitamin D-3 and D-2 sup- difficult to determine adequate intake Current research is limited by lack plementation alone in reducing the since there is a lack of agreement re- garding optimal levels of serum ؍of a standardized definition of vita- incidence of fractures. Grade II min B-12 deficiency and lack of stan- Fair. 25(OH)D. Additional research is dardized measures of cognitive func- What is the evidence regarding the needed to determine the vitamin D tion. Further research is needed to effect of supplemental vitamin D on dosage necessary to reach optimal se- establish the role of vitamin B-12 in falls in postmenopausal women and rum 25(OH)D levels in postmeno- cognitive function in older adults. older adult men? pausal women and older adult men. .Limited. Conclusion statement One meta- Grade II-Fair؍Grade III analysis/systematic review, one RCT, and one prospective cohort study Vitamin D found that evidence is inconsistent re- Assessing Need for Nutrient Supplements What is the evidence regarding the garding the effect of supplemental vi- To support an optimal nutritional sta- effect of supplemental vitamin D tamin D-2 or D-3 on the reduction of tus, nutrient consumption should ad-

2080 December 2009 Volume 109 Number 12 equately meet requirements includ- zinc, manganese, and selenium (57). the potential benefits of supplemental ing any metabolic demands such as Additional laboratory tests can be folate with respect to homocysteine those that may be a result of genetics, helpful in assessing nutrient status metabolism and reduction of cardio- age, stress, and infection and disease for some nutrients. For example, se- vascular disease risk where a gene states. The strategies of nutrition as- rum ferritin is a sensitive indicator of variant decreases the activity of sessment, the first of the four steps of body iron status except in situations methylenetetrahydrofolate reductase, a the Nutrition Care Process, enable a of inflammation, infections, or neo- folate-metabolizing enzyme (60). As a dietetics practitioner to gauge the plastic disorders (53). Serum iron and result, homocysteine accumulates un- need for nutrient supplementation transferrin saturation are also useful less folate supplements are pre- (51,52). The assessment process in evaluating iron status. In the prac- scribed (53). In the future, use of DNA should include a comprehensive eval- tical setting, however, laboratory microarrays (61) to identify individ- uation of medical, social, and food and analyses of most vitamins and miner- ual genetic variation may be among nutrition-related history, anthropo- als are not generally available. Cost the assessment tools used to advise metric measurements, biochemical and lack of cut-off points for defining clients of their nutrient and supple- data, medical tests and procedures suboptimal nutritional status for ment needs and to measure the effi- and nutrition-focused physical exam- some nutrients limit their use in prac- cacy of nutrition prescriptions (61). ination (53). tice. Nutrition-focused physical find- Ultimately, by taking into account ings can also be useful when assess- the known genetic variability in pa- ing nutritional status for some tients and clients, nutrient supple- Issues to Consider nutrients including vitamins A, C, D, mentation can be better tailored to riboflavin, niacin, and vitamins B-6 the individual with the goal of disease Total Nutrient Intakes. Intake assess- and B-12 (57). prevention. ments must include all nutrient sources including natural and forti- Genetics/Genomics. The evolving sci- Contraindications. Dietetics practition- fied foods and dietary supplements; ence of nutrigenomics examines the ers must be aware of possible situa- both nutrient adequacy and excess interaction between specific genes tions in which individuals may need could be underestimated if only con- and nutrients (58). This emerging sci- to temporarily or permanently limit ventional food sources are considered. ence may provide insight into how nu- or avoid specific nutrient supple- One way to do this is to include open- trition influences metabolic pathways ments due to the potential for adverse ended questions about the consump- and homeostatic control, and how di- effects. For example, healthy post- tion of nutrient supplements when etary intervention strategies can be menopausal women and adult men collecting nutrition data. Questions used to promote health and prevent generally should not take iron supple- pertaining to dietary supplement use disease in individuals with different ments. The prevalence of inadequate may include the name and manufac- genotypes (58). Micronutrients such iron intakes among older adults is low turer of the product, the frequency, as calcium, zinc, selenium, folate, and (40). Thus, concern of excess iron in- the dose, and the duration of use (54). vitamins C and E are known to mod- takes may be greater than inade- Clients using multiple supplements ify disease-related processes such as quate intakes. Avoiding iron supple- can be asked to bring in the contain- carcinogen metabolism, hormonal mentation is particularly important ers of supplements used, particularly balance, cell signaling and cycle con- for individuals homozygous for hemo- if products with multiple ingredients trol, apoptosis, and angiogenesis (59). chromatosis and those with blood are used. For example, the reduced incidence of disorders requiring frequent blood Food and nutrition-related histo- a variety of cancer types linked to transfusions (62,63). To be cautious, ries, food records, 24-hour recalls, and supplementation with selenium is in- smokers should avoid supplementa- food frequency questionnaires are fluenced by genetic variability that tion with beta carotene because in- methods often used to assess dietary governs individual responses (59). creased risk of lung cancer and intakes. New methods to analyze to- Methylation of DNA, influenced by in- increased mortality have been associ- tal nutrient intakes are being used take of micronutrients such as sele- ated with high-dose beta carotene with varying degrees of success. One nium; vitamin A, B-6, and B-12; cho- supplements in this group (64). Post- method, a Web-based automated 24- line; zinc; methionine; and others, can menopausal women who take supple- hour recall, is available from the Na- influence epigenetic processes which ments containing vitamin A should tional Cancer Institute (55). Food fre- affect gene expression or activation consider a product that contains a quency questionnaires that include without changing DNA sequence (59). majority of the vitamin A from beta information on nutrient content of This has been looked at in relation to carotene sources rather than retinol. fortified foods and nutrient supple- the role of maternal diet on the sus- Intakes of more than 1,500 ␮g/day vi- ments, such as the validated self- ceptibility of the offspring to diseases tamin A from retinol, but not beta administered Short Calcium Ques- and nutrition-related conditions such carotene, compared to intakes of 500 tionnaire, are available to quickly as diabetes and cancer (59). Identifi- ␮g/day, have been associated with in- estimate calcium intake (56). cation of single nucleotide polymor- creased risk of hip fracture and re- Laboratory Analyses. Laboratory analy- phisms in individuals may enhance duced bone mineral density in post- ses can be performed for vitamins A, our understanding of why someone menopausal women (65). In addition, C, D, E, K, thiamin, riboflavin, niacin, with a genetic variant could react some dietary supplements are contra- vitamins B-6 and B-12, and folic acid negatively or favorably to supplemen- indicated during surgery. For exam- and the minerals iron, copper, iodine, tation. This is particularly relevant to ple, it has been recommended that

December 2009 ● Journal of the AMERICAN DIETETIC ASSOCIATION 2081 because vitamin E acts as a blood drug/nutrient interactions and influ- speak to the pressing need for up- thinner, supplements of the vitamin ence the need for certain nutrients. dated guidelines for the treatment of should be avoided at least 1 week be- Nutrient supplements can influ- vitamin D insufficiency in healthy fore surgery (53). ence the dosage and/or bioactivity of adults (81). Nutrient Excess. Certain vitamins have medications. For example, vitamin K The effectiveness of mineral sup- been associated with adverse effects supplementation can decrease the ef- plements is affected by the amount of at high doses. For example, excess fo- fectiveness of anticoagulant medica- the elemental mineral present in the lic acid may mask or exacerbate tions like warfarin. Supplements con- mineral salt. Due to the bulk of cal- symptoms of a vitamin B-12 defi- taining vitamin K should be avoided cium salt, it is impossible for calcium ciency (66). Excessively high supple- or used with caution and under the at recommended amounts to be in- mental intakes of vitamin B-6 have medical care of a physician by those cluded in a reasonably sized MVM been reported to result in sensory taking such medications as a consis- supplement (82). Calcium carbonate neuropathy (46). Gastrointestinal dis- tent intake of the vitamin is critical. has the highest concentration of cal- turbances, kidney stones, and excess Vitamin E, which can inhibit platelet cium among calcium salts but re- iron absorption, particularly for indi- aggregation and antagonize the ac- quires an acid medium for optimal viduals with excessive iron absorp- tions of vitamin K, may also interact absorption. Thus it is recommended tion due to hereditary hemochromato- with anticoagulant and antiplatelet that it be consumed with meals (83). sis, is cited as the possible adverse medications (74). High-dose vitamin Calcium citrate can be taken with or effects of excessive consumption of vi- E supplements may increase the risk without foods and can be used by tamin C (37). of bleeding in individuals taking those with achlorhydria (84). Calcium Nutrient Interactions. Dietetics practi- these medications (74). Resources lactate and gluconate are less useful tioners should also be aware of and that provide information on precau- due to the minimal content of calcium document the potential nutrient/nu- tions, contraindications, and poten- in these supplements. Maximum ab- trient and drug/nutrient interactions tial interactions with drugs, food or sorption is obtained with doses Յ500 that can occur with the chronic use of other supplements include the Office mg, so splitting a 1,000 mg dose into nutrient supplements (67). An imbal- of Dietary Supplements’ fact sheets two doses is advisable (85). Magne- ance of nutrients, such that the (75) and the PDR for Nutritional Sup- sium chloride and magnesium lactate amount of one nutrient interferes or plements (76). Additional sources are are more bioavailable than magne- alters absorption and/or utilization of provided in the Figure. sium oxide (71). In addition, enteric another nutrient, can result from the Supplement Forms and Dosages. Certain coating on supplements can block the consumption of high-dose nutrient forms of nutrients are more likely absorption and bioavailability of mag- supplements. For example, high-dose than others to contribute to nutrient nesium supplements (71). iron supplements can decrease zinc adequacy based on their molecular absorption and high amounts of zinc structure and chemical formula. For can inhibit copper absorption (68). example, folic acid from supplements Reporting Adverse Effects and fortified foods is more bioavail- The absorption of supplemental mag- Dietetics practitioners are urged to able than folate from foods due to the nesium in the form of magnesium counsel clients to report adverse reac- ease of absorption of the unconju- salts is inhibited by iron supple- tions to nutrient supplements to the gated form (46). Other issues of sup- ments, whereas the absorption of manufacturer and to the FDA. Health both heme- and non-iron is inhibited plement selection, such as the chem- care professionals are also encour- by calcium supplements (62); thus, in- ical form, can affect both adverse aged to report adverse effects experi- dividual supplements of minerals, if effects and efficacy. For example, the enced by their clients from the use of indicated, should be taken separately. pharmacological use of niacin (nico- dietary supplements using the FDA’s Drugs can increase the require- tinic acid), may be effective as a lipid- MedWatch program. The Health In- ment for certain nutrients and com- lowering agent, but may also cause surance Portability and Accountabil- promise nutritional status. For exam- side effects such as flushing and itch- ple, anticonvulsant medications can ing (77). Strategies such as slowly in- ity Act Privacy Rule permits covered increase the need for folate (69). Cor- creasing doses and taking aspirin entities to “report adverse events and ticosteroids can deplete calcium (48) may help prevent or minimize the dis- other information related to the qual- and impair vitamin D metabolism comforts of niacin therapy (78). The ity, effectiveness, and safety of FDA- (70). Certain diuretics, antibiotics, effects of the two forms of supplemen- regulated products both to the manu- and antineoplastic medication can tal vitamin D (D-2 or ergocalciferol facturers and directly to the FDA” cause a magnesium deficiency (71). made from yeast and D-3 or cholecal- (86). Reports can be made by tele- Chronic alcohol consumption can in- ciferol from animal sources) on serum phone by calling 800-FDA-1088 or on- crease the requirement for B vitamins levels of 25(OH)D have been com- line at www.fda.gov/Safety/MedWatch/ and magnesium due to decreased ab- pared. Some studies report a signifi- HowToReport/ucm085568.htm (87). sorption, increased diuresis, and in- cantly greater effect of vitamin D-3 on creased metabolism of these nutri- increasing the levels of serum ents (69,71-73). Multiple medications 25(OH)D (44,79) while a more recent PROFESSIONAL RESOURCES managing multiple diseases (polyp- study found that the two forms of the The Office of Dietary Supplements at harmacy), particularly among older vitamin were equally effective (80). the National Institutes of Health, adults, can increase the likelihood of These discrepancies in the literature which was created in part to promote

2082 December 2009 Volume 109 Number 12 research aimed at determining the critical roles and responsibilities for 8. Dietary supplements: FDA should take fur- health benefits and risks of dietary dietetics practitioners. Continuing ther actions to improve oversight and con- sumer understanding. US Government Ac- supplements, provides several tools education and inclusion of dietary countability Office Web site. http://www. dietetics practitioners can use to in- supplements in didactic curricula are gao.gov/new.items/d09250.pdf. Published crease their knowledge of dietary sup- essential to ensuring dietetics practi- November 2009. Accessed June 1, 2009. plements. These include a 1-week tioners have the skills necessary to 9. Dietary Supplement Health and Education Act of 1994. Public L No. 103-417 (codified at practicum on dietary supplement is- perform these functions. 42 USC 287C-11). sues for nutrition and health-related 10. Claims that can be made for conventional faculty and graduate students (88); CONCLUSIONS foods and dietary supplements. US Food and the International Bibliographic Infor- Consumption of a wide variety of nu- Drug Administration Web site. http://www. mation on Dietary Supplements data- fda.gov/Food/LabelingNutrition/LabelClaims/ tritious foods is the best way to main- ucm111447.htm. Accessed June 1, 2009. base, which contains citations and ab- tain health and prevent chronic dis- 11. Dietary supplements: An advertising guide stracts from the scientific literature ease. The dietary intakes of many for industry. Federal Trade Commission on dietary supplements (89); and ex- Americans do not meet recommended Web site. http://www.ftc.gov/bcp/edu/pubs/ pert-reviewed fact sheets on dietary business/adv/bus09.shtm. Accessed June 26, nutrient intake levels. It is among the 2009. supplement ingredients (75). These roles and responsibilities of dietetics 12. Overview of dietary supplements. US Food and other resources such as those practitioners to help educate the pub- and Drug Administration Web site. http:// listed in the Figure can be used by lic on healthful dietary patterns and www.fda.gov/Food/DietarySupplements/ dietetics practitioners to stay in- ConsumerInformation/ucm110417.htm. Ac- on the safe and appropriate selection cessed June, 1, 2009. formed on issues related to dietary and use of nutrient supplements to 13. Dietary supplements: Background infor- supplements. meet their nutrient needs and opti- mation. Office of Dietary Supplements mize health. To this end, dietetics Web site. http://ods.od.nih.gov/factsheets/ DietarySupplements_pf.asp. Accessed June practitioners must keep abreast of re- ROLES AND RESPONSIBILITIES OF 1, 2009. search findings on potential benefits DIETETICS PRACTITIONERS 14. New dietary ingredients in dietary supple- and safety of nutrient supplements ments—Background for industry. US Food Given the prevalent use of nutrient and on the regulations that govern and Drug Administration Web site. http:// supplements by the public, dietetics these products. www.fda.gov/Food/DietarySupplements/ practitioners need to keep up-to-date ucm109764.htm. Accessed June 1, 2009. 15. MedWatch: The FDA Safety Information on the safety and efficacy of these To obtain references used for the evi- and Adverse Event Reporting Program. US products to assist consumers in the dence analysis sections of this posi- Food and Drug Administration Web site. safe and appropriate use of supple- tion, go to www.eatright.org/cps/rde/ http://www.fda.gov/Safety/Medwatch/defalt. ments. The roles and responsibilities htm. Accessed June 1, 2009. xchg/ada/hs.xsl/advocacy_15986_ENU_ 16. Dietary Supplement and Nonprescription of dietetics practitioners include: HTML.htm. Drug Consumer Protection Act. Pub L No. 109-462. ● assessing nutritional status of cli- 17. Questions and answers regarding adverse References event reporting and recordkeeping for dietary ents to determine likelihood of in- 1. American Dietetic Association. Position of supplements as required by the Dietary Sup- adequate or excessive intake of vi- the American Dietetic Association: Func- plement and Nonprescription Drug Consumer tamins and minerals; tional foods. J Am Diet Assoc. 2009;109:735- Protection Act. US Food and Drug Admi- ● evaluating the potential benefit or 746. nistration Web site. http://www.fda.gov/For harm of nutrient supplementation 2. American Dietetic Association. Position of Consumers/ConsumerUpdates/ucm072966. the American Dietetic Association and Die- htm#serious. Accessed June 1, 2009. given a client’s nutritional and titians of Canada: Dietary fatty acids. JAm 18. Federal Food, Drug, and Cosmetic Act. SEC. health status; Diet Assoc. 2007;107:1599-1611. 761. [21 USC §379aa–1] Serious adverse ● evaluating the safety of a nutrient 3. American Dietetic Association. Position of event reporting for dietary supplements. US supplement given the form, dose, the American Dietetic Association: Health Food and Drug Administration Web site. implications of dietary fiber. J Am Diet As- http://www.fda.gov/RegulatoryInformation/ its potential for interaction with soc. 2008;108:1716-1731. Legislation/FederalFoodDrugandCosmetic food, other dietary supplements 4. American Dietetic Association. Practice pa- ActFDCAct/FDCActChapterVIIGeneral and over-the-counter and prescri- per of the American Dietetic Association: Di- Authority/ucm111158.htm. Accessed June 1, bed medications; etary supplements. J Am Diet Assoc. 2005; 2009. 19. Current good manufacturing practice in ● 105:460-470. educating clients as to the potent- 5. Radimer K, Bindewald B, Hughes J, Rad- manufacturing, packaging, labeling, or hold- ial benefit of receiving nutrients imer K, Bindewald B, Hughes J, Ervin B, ing operations for dietary supplements. Fi- through conventional and fortified Swanson C, Picciano MF. Dietary supple- nal Rule. 72 Federal Register 34751 (2007). foods; ment use by US adults: Data from the Na- 20. Dietary supplement Current Good Manufac- turing Practices (CGMPs) and Interim Final ● tional Health and Nutrition Examination recommending nutrient supple- Survey, 1999-2000. Am J Epidemiol. 2004; Rule (IFR) facts. Food and Drug Adminis- mentation when food intake is in- 160:339-349. tration Web site. http://www.fda.gov/Food/ adequate; 6. Shaikh U, Byrd RS, Auinger P. Vitamin and DietarySupplements/GuidanceCompliance ● evaluating research regarding nu- mineral supplement use by children and ad- RegulatoryInformation/RegulationsLaws/ olescents in the 1999-2004 National Health ucm110858.htm#fr. Accessed May 31, 2009. trient supplementation; and and Nutrition Examination Survey: Rela- 21. About ConsumerLab.com. 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This American Dietetic Association (ADA) position was adopted by the House of Delegates Leadership Team on October 29, 1995 and reaffirmed on September 28, 1998; June 19, 2003; and May 17, 2007. This position is in effect until December 31, 2013. ADA authorizes republication of the position, in its entirety, provided full and proper credit is given. Readers may copy and distribute this paper, providing such distribution is not used to indicate an endorsement of product or service. Commercial distribution is not permitted without the permission of ADA. Requests to use portions of the position must be directed to ADA headquarters at 800/877-1600, ext. 4835, or [email protected]. Authors: Melissa Ventura Marra, PhD, RD, LDN (nutrition consultant, Private Practice, Boynton Beach, FL); Andrea P. Boyar, PhD, RD, CDN (associate professor, Lehman College, City University of New York, Bronx, NY). Reviewers: Stacey J. Bell, DSc, RD, consultant, Belmont, MA; Mary H. Hager, PhD, RD, FADA (ADA Government Relations, Washington, DC); Douglas Kalman, PhD, RD (Miami Research Associates, Miami, FL); Nutrition in Complementary Care dietetic practice group (DPG) (Leslie K. Kay, MS, RD, consultant, Orange, CA); Toni Kueh- neman, MS, RD, Alegent Health Heart & Vascular Institute, Omaha, NE; Public Health Nutrition/Community Nutrition DPG (Lauren Melnick, MS, RD, LD, The Ohio State University Extension, Cleveland, OH); Esther Myers, PhD, RD, FADA (ADA Research & Strategic Business Development, Chicago, IL); Kathie Swift, MS, RD, Kripalu Center for Yoga and Health, Stockbridge, MA; Women’s Health DPG (Diane Whelan, MPH, RD, Private Practice, Los Angeles, CA). Association Positions Committee Workgroup: Andrea Hutchins, PhD, RD (chair); Moya Peters, MA, RD; Lanah Jo Brennan, RD (content advisor). The authors thank the reviewers for their many constructive comments and suggestions. The reviewers were not asked to endorse this position or the supporting paper.

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