Position of the American Dietetic Association: Nutrient Supplementation
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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.