FROM THE ACADEMY Position Paper

Position of the Academy of and Dietetics: Supplementation

ABSTRACT POSITION STATEMENT It is the position of the Academy of Nutrition and Dietetics that micronutrient supple- It is the position of the Academy of Nutrition ments are warranted when requirements are not being met through the alone. and Dietetics that micronutrient supple- ments are warranted when requirements are Those with increased requirements secondary to growth, chronic disease, not being met through the diet alone. Those use, , and lactation, and aging may be at particular risk for with increased requirements secondary to inadequate dietary intakes. However, the routine and indiscriminate use of micro- growth, chronic disease, medication use, supplements for the prevention of chronic disease is not recommended, given malabsorption, pregnancy and lactation, and fi fi aging may be at particular risk for inade- the lack of available scienti c evidence. A few speci c age and disease states that may quate dietary intakes. However, the routine benefit from micronutrient supplementation are discussed. The most common dietary and indiscriminate use of micronutrient supplements used by both children and adults in the contain micro- supplements for the prevention of chronic . Consumers may not be well informed about the safety and use of these disease is not recommended, given the lack of available scientific evidence. products, and some may have difficulty interpreting product labels. Thus, the expertise of registered nutritionists and nutrition and dietetic technicians, registered, is needed to guide the safe and appropriate selection and use of micronutrient supple- ments. To accomplish this, registered dietitian nutritionists and nutrition and dietetic technicians, registered, must keep up to date on efficacy, safety, and the regulatory issues influencing the use of these products. This position paper aims to increase awareness of current issues relevant to micronutrient supplementation and of the re- sources available to assist registered dietitian nutritionists and nutrition and dietetic technicians, registered, in evaluating their potential benefits and adverse outcomes. J Acad Nutr Diet. 2018;118(11):2162-2173.

HE FOCUS OF THIS ACADEMY previously by the manufacturer or by micronutrient supplements. To accom- of Nutrition and Dietetics po- researchers, but heterogeneity of the plish this, RDNs and NDTRs must keep sition paper is on the safe and MVM definition exists. However, to be up-to-date on efficacy, safety, and the T appropriate use of and consistent with the literature, MVM regulatory issues influencing the use of containing dietary supple- may be used in this position paper to these products. This position paper ments to help individuals meet their reflect the term used by investigators aims to increase awareness of current micronutrient requirements when di- and other sources. This position paper issues relevant to micronutrient sup- etary intake is insufficient. Micro- does not address other dietary supple- plementation, and of the resources nutrients are essential and ments such as amino acids, fatty acids, available to assist RDNs and NDTRs in required in small amounts enzymes, herbs, or other botanicals. evaluating the potential benefits and from the diet to sustain virtually all MVMs continue to be the most adverse outcomes of their use as part normal cellular and molecular func- commonly used in of the Nutrition Care Process. tions.1 For the purposes of this position the United States. According to one paper, the term micronutrient supple- authoritative estimate, total supple- ments is used to indicate a category of ment sales in 2016 were $41.2 billion, DEFINITION AND REGULATORY dietary supplements that contain sin- with the majority being composed of FRAMEWORK gle or multiple vitamins and minerals. micronutrient supplements.2 Despite Dietary supplements, and therefore The most common dietary supplement the widespread use, consumers may micronutrient supplements, are regu- used in the United States is the multivi- not be well informed about the safety lated by the and Adminis- tamin mineral (MVM); however, there and use of micronutrient supplements tration (FDA) Center for Food Safety is no legal or regulatory definition of and some may have difficulty inter- and Applied Nutrition as a subcategory MVM. MVMs have been defined preting product labels. Thus, the of food. The Dietary Supplement expertise of registered dietitian nutri- and Act of 1994 (DSHEA), tionists (RDNs) and nutrition and di- which amended the Federal Food, 2212-2672/Copyright ª 2018 by the etetic technicians, registered (NDTRs), Drug, and Cosmetic Act of 1938, defines Academy of Nutrition and Dietetics. is needed to guide the safe and and sets safety and labeling re- https://doi.org/10.1016/j.jand.2018.07.022 appropriate selection and use of quirements for dietary supplements.3

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DSHEA defines a dietary supplement as claims are not pre-approved by the event reports they receive for 6 years.10 a product intended to supplement the FDA.4 However, the manufacturer must As defined by the FDA, adverse events diet that contains any of the following: provide the FDA with the text of are considered serious if “they result in “a vitamin; a mineral; an herb or other structure/function claims no later than death, a -threatening experience, botanical; an ; a dietary 30 days after marketing the supple- inpatient hospitalization, a persistent substance for use by man to supple- ment and that the claims are or significant disability or incapacity, or ment the diet by increasing the total truthful and not misleading.4 Labels a congenital anomaly or birth defect, or dietary intake; or a concentrate, with structure/function claims must requires, based on reasonable medical metabolite, a constituent, extract, or carry this disclaimer: “These state- judgment, a medical or surgical inter- combination of any ingredient ments have not been evaluated by the vention to prevent an outcome” listed mentioned above.”3 However, there is Food and Drug Administration. This above.11 not a legal or regulatory definition of product is not intended to diagnose, The FDA received 6,307 mandatory the term micronutrient supplement or treat, cure, or prevent any disease.”6 serious AERs for dietary supplements MVM. Dietary supplements are avail- Although the FDA is responsible for from 2008 through 2011.12 Six of the 10 able as pills, capsules, tablets, liquids, product label claims, the Federal Trade dietary supplements receiving the powders, or other forms taken orally, Commission regulates dietary supple- most mandatory AERs were MVM as long as they are not represented for ments advertising claims.7 All claims supplements. However, an AER alone use as a conventional food or as a sole must be truthful, not misleading, and does not indicate a causal relationships item of a or diet.3 They must also substantiated by credible scientific ev- between adverse events and the asso- be identified as a dietary supplement idence.7 Health professionals can con- ciated product, because other products on the label.3 tact the Federal Trade Commission to consumed at the same time and pre- report products they believed are existing health conditions could each falsely advertised or labeled. contribute to the reported adverse Label Claims event.12 Like food labels, dietary supplement labels can bear authorized and quali- Safety fi Quality ed health claims, nutrient content Manufacturers and/or distributors are claims, and structure/function claims.4 Under DSHEA, the FDA established responsible for ensuring product safety good practices for di- Health claims characterize the rela- before placing them on the market.6 tionship between a supplement ingre- etary supplements to ensure proper Because were refer- identity, purity, strength, and compo- dient and reducing the risk of a disease enced and sold as dietary supplements 13 4 sition. Companies are responsible for or health-related condition. Nutrient before DSHEA was implemented, they content claims characterize the ensuring their products meet good are presumed to be safe based on their manufacturing practices, including ac- amount of a nutrient in a dietary sup- history of use; thus, they do not require plement.5 For example, “high potency curate labeling (eg, products contain an FDA premarket review of safety or the ingredients in the amounts stated , multimineral dietary efficacy. For any new dietary ingredient ” on their labels) and are free from con- supplement tablets can be used on a sold after DSHEA’s implementation and product label in the case that it con- taminants (eg, , pesticide, glass, not recognized as a food substance , and other ).13 In tains 100% or more of the Reference present in the food supply, the manu- Daily Intakes for at least two-thirds of addition to the FDA, independent or- facturer and distributor must notify ganizations such as ConsumerLab. the vitamins and minerals with Refer- the FDA of the intention to market the 14 15 5 com, NSF International, and US ence Daily Intakes in the product. Both product and provide the FDA with the 16 health claims and nutrient content Pharmacopeial Convention offer pro- information used to conclude that grams that evaluate supplement qual- claims must be preapproved by the the ingredient was generally regarded 4 ity. At a minimum, each organization FDA. Structure/function claims are the as safe to consume.6 Once marketed, most commonly used claims on sup- has a program that allows manufac- the FDA has the authority to remove a turers to pay a fee to have its products plement labels. There are three types of product in the case that they prove it to 5 tested. Supplements conforming to the structure/function claims, those that 6 be unsafe. The FDA monitors safety ’ describe: respective organization s quality spec- largely by collecting adverse event re- ifications can bear that organization’s the nutrient’s role on normal ports from consumers, health pro- seal of approval on their label.17 The structure or function of the body fessionals, and manufacturers through absence of a seal, does not indicate or means by which it works to MedWatch, the FDA Safety Information inferior quality because the high costs maintain a structure or function and Adverse Event Reporting Pro- 8 of analyzing each ingredient may pre- (eg, maintain cell gram. The Dietary Supplement and vent some manufacturers from having integrity); Nonprescription Drug Consumer Pro- its products tested. tection Act9 requires the responsible general well-being from intake party (ie, the manufacturers, packers, of a nutrient; or USAGE IN THE UNITED STATES or distributors whose name appears on a benefit related to a nutrient the label) to submit serious adverse Prevalence of Use deficiency. event reports (AERs) to the FDA within The prevalence estimates presented in Labels cannot make statements that 15 business days of receiving a report, this position paper focus on large, na- are disease claims. Structure/function and to maintain records of all adverse tional survey data to make population

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level generalizations, and characterize screen times (eg, television or com- the most common organ-specific rea- use of both dietary supplements in puter), and are more physically sons for supplement use.22 Similarly, general and specific micronutrient active.24,25 Only 16% of the dietary among older adults, the most common supplements, including MVM. Such supplements used by children are motivations for supplement use generalizations do not characterize based on the advice of a health care include to “improve overall health,” special groups like elite athletes18 and professional.24 Health care providers “maintain health,” and “bone individuals in the military,19 who are were most likely to recommend dietary health.”22,26 more likely to use dietary supplements supplements to children aged <2 years than the general population, and are compared with children of any other Micronutrient Supplements. The 24 more likely to stack products (ie, use age group. most common motivation for MVM use multiple products simultaneously). in children was to “improve overall Micronutrient Supplements. Of health” (44%). This same motivation Dietary Supplements. The National those using dietary supplements, MVM was reported for the use of multivi- Health and Nutrition Examination products are by far the most commonly tamin supplements (ie, a combination Survey (NHANES) is a continuous, used dietary supplement in children24 vitamin product without minerals) 24 federally supported monitoring proto- and adults.21,23 However, the defini- (35%). supplements, col coordinated by the National Center tion of MVM is not consistent across although low in overall use (2% over- for Health Statistics at the Centers for research studies.20,21,23 MVM and all), were reported by about half of Disease Control and Prevention. micronutrient products are used by those users (47%) to “boost immune NHANES has continuously monitored w90% of child dietary supplement system and prevent colds.” MVMs were dietary supplement use for more than users, representing 24% of US children primarily used by adults to “improve fi 50 years. Based on the NHANES nd- aged 19 years.24 Depending on the overall health” (48%). The majority of ings across time, just more than half of definition, about one-third of US adults adults who use supplements adults (aged 20 years among use a MVM product.21-23 Among older (4% of men and 19% of women) do so nonpregnant, nonlactating adults) adults (aged 60 years), MVM is the “for bone health” (75%). Similar to report using a dietary supplement in most frequently used supplement children, whereas the proportion of 20-22 general. (40%), followed by supplements con- adults using vitamin C was low overall In adult populations, dietary supple- taining (26%), calcium (9%) (7%), many did so to “boost immune ment use is more common in women or a vitamin D and calcium combina- system and prevent colds” (45%). than men, and by non-Hispanic whites tion (13%), vitamin B-12 (8%) and B when compared with by non-Hispanic 26 complex (5%), and vitamin C (11%). NUTRIENT AND FOOD blacks and Hispanic and Mexican About 75% of all pregnant women 22,23 RECOMMENDATIONS Americans. Dietary supplements report using a MVM in NHANES 1999- are used more often by nonsmokers, 2006.27 Folic acid or containing Optimal nutrient intakes are those that people who regularly, those supplements are most frequently promote health and reduce risk for with higher education and incomes, consumed during pregnancy, but very chronic disease, while minimizing risk and those who report better overall little is known about supplement use of excess. The Food and Nutrition Board 20,21 health. Use of dietary supplements in lactation.27 (FNB) of the National Academies of in adults does not vary significantly by Sciences, , and Medicine, weight status.21 In adults, supplement Health, and Medicine Division provides use is noted to be more of a personal Motivations for Use the best available evidence-based preference rather than a health care Dietary Supplements. Among chil- standards for estimating optimal professional’s recommendation.22 Most dren, 41% use supplements to “improve nutrient intakes. Dietary Reference In- adults (53%) use one dietary supple- overall health,” 37% to “maintain takes (DRIs) is an umbrella term used ment product,21 but 8% to 10% of adults health,” 23% for “supplementing the to represent four factors relevant to use more than four supplements diet,” 20% to “prevent health prob- nutrients: the Recommended Dietary regularly.23 lems,” and 14% to “boost immunity.”24 Allowances (RDAs), Adequate Intakes Consistently, about one-third of US In children aged <2 years, the most (AIs), Estimated Average Requirements children take a dietary supplement; common reason for using supplements (EARs), and Tolerable Upper Intake but, these are almost exclusively (95%) is for tooth health and cavity preven- Levels (ULs).28 The DRIs are used to confined to micronutrient supple- tion (14%), whereas children aged 16 to assess adequate and excess nutrient ments. Among children aged <2 years 19 years, “to get more energy” (10%) is intakes and plan diets for groups and (NHANES 2007-2010), 17% reported use the most common reason cited for individuals. of any dietary supplement, 45% in supplement use.24 For both men and The DRIs are recommendations for children ages 2 to 5 years, 35% in chil- women, “improve overall health,” healthy individuals. As such, higher dren ages 6 to 11 years, and w23% for “maintain health,”“supplement the requirements likely exist for in- those aged 12 to 19 years.24 Similar to diet,” and “prevent health problems” dividuals who are malnourished or trends observed in adults, dietary sup- are the most common motivations for have altered requirements due to a plement use in children is more prev- general dietary supplement use.22 health condition or use of a medica- alent in non-Hispanic whites, families Among men and women, “ tion. Clinical status and biochemical with private health , higher health, lower ” (18%) and indexes should be combined with di- incomes, and those less likely to have “bone health” (36%), respectively, were etary intake data to assess an

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individual’s dietary adequacy and relative to DRI exists across the popu- were much less likely than nonusers of nutritional status28 and need for lation and that underconsumption has micronutrient supplements to have micronutrient supplementation.29 A been linked to adverse health out- inadequate intakes of most minerals: comprehensive nutrition assessment comes in the scientific literature. Iron is (21% vs 66%), calcium (20% can inform RDNs and NDTRs when a of concern for adolescent and pre- vs 51%), ( <0.5% vs 20%), zinc micronutrient supplement is likely to menopausal women, including preg- (<0.5% vs 13%), and iron (<0.5% vs 8%) be of benefit or if its consumption nant women. Many Americans do not and vitamins: (1% vs 14%), places a client at risk of excess. consume the amount and types of vitamin C (3% vs 48%), (4% vs The EAR is the basis of micronutrient necessary to meet these recom- 58%), vitamin D (25% vs 96%), and recommendations at the group level mended nutrient intakes. Adherence to (5% vs 96%).37 (eg, meeting the needs of 50%), the DGAs is low; only about 3% to 4% of Unlike adults, micronutrient ade- whereas the RDA is for use at the in- Americans follow all of the DGAs.32 As quacy from foods sources did not vary dividual level (eg, meeting the needs of a result of low intakes of nutrient-rich among children who consumed vs who 97.5%). The RDA is determined as two foods and sedentary lifestyles, many did not consume dietary supplements standard deviations above the EAR. An Americans may be meeting or (ie, classified by any dietary supple- AI is set when there is not enough in- exceeding their energy requirements ment use).38 Children aged 2 to 8 years formation available to estimate an RDA. while falling short of meeting nutrient who use dietary supplements are more AIs represent intakes likely to exceed recommendations. Fortified foods and likely than older children to meet the the actual requirements of almost all micronutrient supplements may be micronutrient recommendations from healthy people. For the same reason, useful in bridging the gap of shortfall foods alone.38 Dietary supplement use usual intakes that fall below the AI nutrients as examined in detail is lowest among adolescents, which is recommendations should not be inter- below.33 paradoxical because nutrient intakes preted as inadequate. Rather, when an from food sources among this age individual’s usual intake meets or ex- NUTRIENT SUPPLEMENTATION group tend to be inadequate for many 38 ceeds recommended levels, it is likely Effect on Total Nutrient Intakes micronutrients. that their intake is adequate. The UL is used both at the individual Micronutrient supplements can have a substantial influence on a person’s to- Exceeding the ULs and at the group level to estimate risk 34,35 of excessive micronutrient intakes. The tal intakes. The extent to which a Micronutrient supplements have the UL is an important tool that RDNs and supplement can improve micro- potential to fill gaps in the diet but fl NDTRs can use to educate consumers nutrient adequacy is in uenced by the could potentially increase intakes fi in the safe use of nutrient supplements. nutritional pro le of the supplement above ULs. Intake from all supplements As average daily intakes exceed the UL, taken. For example, although MVMs and foods and beverages must be the risk of adverse health effects in- provide substantial amounts of some included when assessing usual nutrient creases. The ULs for vitamin E, , micronutrients (ie, folic acid and intake of individuals and groups. The and folic acid apply only to synthetic vitamin C), they often lack key minerals prevalence of the population that ex- forms of the nutrients found in sup- such as , calcium, and ceeds the UL is low for most micro- plements and fortified foods.30 The UL magnesium. nutrients (5% for folate; calcium; for magnesium applies only to intakes iron; vitamins A, D, C, and E; and ) from supplements or pharmacologic Filling Dietary Gaps when users and non-users of supple- agents.30 The UL for vitamin A is from National survey data have provided ments are combined as a group.33,35 preformed vitamin A (ie, insights on total usual micronutrient US adults typically do not have usual only).30 For all other nutrients, ULs exposures from all sources (ie, intrinsic intakes of micronutrients that exceed apply to total intake from food, bever- nutrients, fortified nutrients, and the UL from foods alone. However, ages, and supplements. For nutrients micronutrient supplements). NHANES micronutrient supplement users do for which data were insufficient to data reveal a high proportion of have an increased likelihood of intakes determine a UL (ie, , , Americans that have at risk intakes above the UL for iron (9%), zinc (9%), , riboflavin, thiamin, (>25% with intakes

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exceed the UL for folic acid and zinc prescribed amount of calcium was Infants and Young Children. The from food sources alone.38 1,000 to 1,200 mg. In 2012, the USPSTF American Academy of Pediatrics rec- recommended vitamin D supplemen- ommends 1 mg/kg daily iron supple- Effect of Nutrient tation (based on median dose of 800 mentation for exclusively breastfed Supplementation on Chronic IU) to help prevent falls in community- full-term infants from age 4 months Disease Prevention dwelling adults 65 years of age or older until infants begin iron- who are at increased fall risk.43 How- containing complementary foods, such Although supplementation can be ever, in 2018 the USPSTF recommended as iron-fortified cereals.46 They also effective in meeting recommended against daily supplementation of 400 recommend 1 mg/kg/day supplemental intake of some micronutrients, it has IU or less of vitamin D and 1,000 mg or iron beginning at age 4 months for in- not been proven effective in preventing less of calcium for the primary pre- fants who receive more than one-half chronic disease. In 2006, a National vention of fractures in postmenopausal of their daily feedings as human Institutes of Health State-of-the- women. They also concluded that evi- and who are not receiving iron- Science Panel, after reviewing evi- dence was insufficient to assess bene- containing complementary foods.46 dence on the health benefits and risks fits or harm of higher amounts in of MVM supplements, concluded that postmenopausal women and at any there was insufficient evidence to Infants and Children, Including dose for fracture prevention among determine whether taking MVM sup- Adolescents. The American Academy community-dwelling men and pre- plements was beneficial for preventing of Pediatrics recommends all infants menopausal women.44 chronic disease in generally healthy who are exclusively or partly breastfed people.39 receive 400 IU of supplemental vitamin fi The Agency for Healthcare Research D daily beginning the rst few days of MICRONUTRIENT SUPPLEMENTS life, and continued unless infant is and Quality conducted a systematic IN PRACTICE review on the use of or weaned to at least 1 qt/day vitamin D- fi single and functionally related pairs of When to Consider forti ed formula or, if older than age 12 nutrients (including MVM) for cardio- Supplementation months, whole milk or low- milk vascular disease and cancer prevention Micronutrient supplements can be when appropriate; all nonbreastfed to inform US Preventive Services Task used to help individuals meet a infants and older children who < fi Force (USPSTF) recommendations. nutrient requirement or to treat a consume 1 qt/day vitamin D-forti ed Based on this review, the USPSTF diagnosed deficiency. A person’s formula or milk and adolescents with < 47 concluded in 2014 that the current micronutrient intake may be inade- dietary intakes 400 IU/day. If a baby evidence is insufficient to assess the quate when they are restricting energy is drinking at least 32 oz formula, balance of benefits and harms of the intake for /control, not vitamin D supplementation is not use of multivitamins or single- or consuming an adequate amount of needed. Children at an increased risk fi paired-micronutrient supplements food to meet energy requirements for vitamin D de ciency, such as those (including MVM) and recommended resulting from poor appetite or illness, with fat malabsorption and those tak- against the use of beta carotene or eliminating one or more food groups ing seizure , may need vitamin E supplements for the pre- from their diet on a regular basis, or higher amounts to achieve normal 47 vention of or consuming a diet low in micronutrient- serum vitamin D levels. cancer.40 rich foods despite adequate or exces- In 2011, the FNB updated the DRIs for sive energy intakes. Groups most Women of Childbearing Age Who calcium and vitamin D.41 The FNB re- vulnerable to micronutrient in- May Become Pregnant. The FNB ported that although data indicated a adequacy are older adults, pregnant recommends that women who can key role for calcium and vitamin D in women, alcohol-dependent in- become pregnant consume 400 mg/day skeletal health and provided a sound dividuals, strict vegetarians and folic acid from fortified foods and/or basis for determining DRIs, it did not vegans, and those with increased re- supplements daily, in addition to folate provide convincing evidence of other quirements secondary to health con- obtained from eating a varied diet to health outcomes beyond bone or that ditions or the chronic use of a reduce the risk of neural tube defects 48 intakes greater than the DRIs have medication that alter nutrient absorp- (eg, spina bifida and anencephaly). health benefits. In fact, emerging evi- tion, , or .45 The USPSTF recommends women dence indicated that too much of these Academy of Nutrition and Dietetics planning or capable of pregnancy take nutrients may result in harmful position papers that focus on partic- a daily supplement of 400 to 800 mg 49 outcomes.41 ular segments of the population or folic acid (grade A). Folic acid is the The American Geriatrics Society ad- conditions often include recommen- form of the vitamin found in supple- vises clinicians to recommend vitamin dations on micronutrient supplemen- ments and fortified foods, and folate is D supplementation of at least 1,000 IU/ tation. In addition, some government the form found naturally occurring in day and calcium supplementation to and professional organizations and foods. community-dwelling adults aged 65 expert workgroups provide recom- years or older to reduce risk of frac- mendations for micronutrient sup- Older Adults. The FNB recommend tures and falls.42 The workgroup plementation. The following are that people older than age 50 years get recommendation was based on specific examples of micronutrient 2.4 mg/day vitamin B-12 mainly from studies in which the most commonly supplement recommendations. the crystalline form found in fortified

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foods and supplements.48 Age is asso- has the highest and/or utilization of another nutrient, ciated with conditions like atrophic concentration of calcium among cal- can result from the consumption of gastritis that may reduce a person’s cium , but requires an acidic me- high-dose or simultaneous consump- ability to digest food-bound vitamin B- dium for optimal absorption. Thus, it is tion of nutrient supplements. For 12.48 recommended that it be consumed example, high-dose iron supplements with .56 Calcium citrate can be can decrease zinc absorption and high People with Intermediate or taken with or without foods and can be amounts of zinc can inhibit copper Advanced Age-Related Macular used by those with achlorhydria.57 absorption.62 The absorption of both Degeneration. The American Acad- Maximum absorption is obtained with heme- and nonheme iron is inhibited emy of Ophthalmology recommends doses 500 mg, so splitting a 1,000-mg by calcium supplements, but the clin- 41 ophthalmologists consider dose in two is advisable. ical significance of iron status is vitamin and mineral supplementation unclear.63 as per the Age-Related Eye Disease Contraindications of Nutrient Study (AREDS) and AREDS2 trials for Supplement Use Medication Interactions. Medications patients with intermediate or RDNs and NDTRs must be aware of can interfere with absorption or meta- advanced age-related macular degen- possible situations in which individual bolism of certain nutrients, altering the eration to slow progression of the dis- clients must temporarily or perma- nutrients requirements and compro- ease.50 AREDS formulation contains nently limit or avoid specific micro- mising nutritional status. Medication vitamin C, vitamin E, beta carotene, nutrient supplements due to the interactions for most micronutrients zinc, and copper, and the AREDS2 potential for adverse effects. For can be found in the monographs on the formulation substitutes /zeax- example, people who smoke should ODS website. For example, proton pump anthin for beta carotene,51 because avoid supplementation with beta inhibitors used to treat gastroesopha- beta carotene was associated with carotene due to an increased risk of geal reflux disease slow the release of increased risk of lung cancer in lung cancer.52,53 Health risks from gastric acid into the stomach have the smokers.51-53 excessive nutrient intake and potential potential to interfere with vitamin B-12 nutrient/nutrient and nutrient/medi- absorption from food, potentially Genetic Polymorphisms and Dis- cation interactions are provided for affecting serum vitamin B-12 levels.64 orders. Individuals that have a genetic individual vitamins and minerals in the Corticosteroids (eg, prednisone) may predisposition that impairs digestion, Office of Dietary Supplements (ODS) deplete calcium64 and impair vitamin D absorption, or metabolism may benefit Fact Sheets for Health Professionals. metabolism.65 Certain diuretics, antibi- from micronutrient supplements under Some examples are listed below. otics, and proton pump inhibitors can the care and direction of a health care affect magnesium status.66 Poly- practitioner. However, it is the position Nutrient Excess. Healthy post- , particularly among older of the Academy of Nutrition and Di- menopausal women and adult men adults, can increase the likelihood of etetics that nutritional genomics is still and individuals homozygous for he- drugenutrient interactions and influ- emerging and its practice, including mochromatosis generally should avoid ence the need for certain micro- the use of commercial or consumer- 58 iron supplements. In post- nutrients. Individuals taking based nutrigenetic testing, to provide menopausal women, intakes >1,500 medications on a regular basis should dietary advice is premature.54 mg/day retinol (below the UL), but not discuss their micronutrient supple- beta carotene, have been associated ments with their health care providers. Special Considerations for with reduced bone mineral density and Micronutrient supplements can in- 59,60 Micronutrient Supplements increased risk of hip fracture. Thus, fluence the dosage and bioactivity of Certain forms of micronutrients have women who take supplements con- medications. For example, high doses differential bioavailability based on taining vitamin A should consider a of vitamin E supplements (likely in their molecular structure and chemical product that contains a majority of the doses >400 IU) can inhibit platelet formula. For example, folic acid from vitamin A from the beta carotene form aggregation and therefore interfere supplements and fortified foods is rather than retinol. Excessively high with anticoagulant thinning more bioavailable than folate from supplemental intakes of vitamin B-6 medications such as coumadin.55 foods due to the ease of absorption of have been reported to result in sensory Vitamin K supplementation can also 48 the unconjugated form.48 For vitamin neuropathy. interact with the blood-thinning med- E, consumption of about 50% more ications; thus, supplementation should units of synthetic alpha Micronutrient Interactions. RDNs be avoided or used with caution and from dietary supplements and fortified and NDTRs must be aware of and under the care of a health care provider foods are needed to obtain the same document the potential because a consistent intake of the amount of the vitamin as from the nutrientenutrient and drugenutrient vitamin is critical. Additional resources natural form (dl-alpha tocopherol).55 interactions that can occur with the that provide information on pre- Furthermore, the effectiveness of min- chronic use of micronutrient supple- cautions, contraindications, and po- eral supplements is influenced by their ments.61 An imbalance of micro- tential interactions with , food, or form and the amount of the elemental nutrients, such that the amount of one other supplements are provided in the mineral present in the mineral . nutrient interferes or alters absorption Figure.

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Organization Website Contents

Academy of Nutrition and Dietetics www.eatrightpro.org Position papers Evidence Analysis Library Other documents: Guidelines Regarding the Recommendation and Sale of Dietary Supplements, Code of Ethics for the Profession of Dietetics a AHRQ Department of Health and https://archive.ahrq.gov/clinic/ AHRQ-produced evidence-based reviews Human Services tp/multivittp.htm on nutrient supplements

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

Epocrates www.epocrates.com/index.html Private company with proprietary in- formation on medications and dietary supplements, available free and for purchase for mobile devices and online

Federal Trade Commission www.ftc.gov Site to file a complaint when adver- tising for a dietary supplement is misleading or false

Food and Drug Administration www.fda.gov/Food/ Dietary supplement alerts and safety DietarySupplements/default. information 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 User Warnings and safety information Consumer educational materials information and guidance Labeling regulations and claims

National Academy of Medicine www.nam.edu Tables that include values and adverse effects of excessive consumption

MedWatch www.fda.gov/Safety/ The Food and Drug Administration MedWatch/ Safety Information and Adverse Event Reporting Program. Health pro- fessionals and consumers can report adverse events from dietary supplements.

(continued on next page) Figure. Select evidence-based resources for information related to dietary supplements.

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Organization Website Contents

Micronutrient Information Center, Linus lpi.orst.edu/infocenter Scientific information on the role of Pauling Institute, Oregon State University vitamins, minerals, and in preventing disease and promoting health

National Agricultural Library www.nutrition.gov/dietary- Listing of resources (bibliographies/ supplements databases, books/book chapters, newsletters, web resources, and agencies and organizations) providing technical and professional-level information on dietary supplements, including nutrition information

National Library of Medicine www.nlm.nih.gov/medlineplus/ MedlinePlus for Vitamin and Mineral vitaminandmineralsupplements. Supplements html

Office of Dietary Supplements, National ods.od.nih.gov Expert reviewed facts sheets on vita- Institutes of Health https://ods.od.nih.gov/ mins, minerals, and product types (eg, Research/PubMed_Dietary_ multivitamins and sports supplements) Supplement_Subset.aspx that include information on medica- https://ods.od.nih.gov/ tion interactions, signs, and symptoms Research/CARDS_Database.aspx of deficiency and toxicity Subset of PubMed specific to infor- mation on dietary supplements, Office of Dietary Supplements and National Library of Medicine Computer Access to Research on Di- etary Supplements database of feder- ally funded research projects pertaining to dietary supplements

Operation Supplement Safety http://hprc-online.org/dietary- Provides interactive tools to assess supplements/opss potential adverse effects for some types of dietary supplements

Office of Dietary Supplements, National https:// Dietary Supplement Ingredient Data- Institutes of Health, and Department of dietarysupplementdatabase. base estimates levels of ingredients in Agriculture, and other federal agencies usda.nih.gov dietary supplement products https://dsld.nlm.nih.gov/dsld/ Dietary Supplement Label Database offers label information for >70,000 different product types

Therapeutic Research Center www.naturaldatabase.com Natural Medicines Comprehensive Database (subscription required) in- cludes evidence-based monographs that contain information on ingredient safety, effectiveness, adverse reactions, and interactions

(continued on next page) Figure. (continued) Select evidence-based resources for information related to dietary supplements.

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Organization Website Contents Books Coates PM, Betz JM, Blackman MR, Cragg GM, et al. Encyclopedia of Dietary Supplements. 2nd ed. New York, NY: Marcel Dekker; 2010. Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington, DC: National Academies Press; 2006. aAHRQ¼Agency for Healthcare Research and Quality. Figure. (continued) Select evidence-based resources for information related to dietary supplements.

Reporting Adverse Effects PRACTICE POINTERS evaluating the potential benefit RDNs and NDTRs are urged to counsel Total Micronutrient Intakes or harm of micronutrient sup- plementation given the client’s clients to report adverse reactions of Intake assessment must include all micronutrient supplements to the nutritional and health status; micronutrient sources, including those evaluating the safety of the manufacturer and to the FDA. Health fi naturally occurring and forti ed in micronutrient supplement given care professionals are also encouraged foods and beverages and dietary sup- to report adverse effects experienced the form, dose, its potential for plements. Both micronutrient ade- interaction with food, other di- by their clients from the use of any quacy and excess could be biased in the ’ etary supplements, and over- dietary supplements using the FDA s case that only conventional and forti- 8 the-counter and prescribed MedWatch program. The Health In- fied food sources are considered. To surance Portability and Accountability medications; accomplish this, practitioners should Act Privacy Rule permits health care educating clients as to the po- routinely collect use of micronutrient tential benefit of receiving professionals to report adverse events supplements as part of any dietary and other information related to micronutrients through conven- assessment, including the frequency of fi the quality, effectiveness, and safety tional and forti ed foods; use, typical dose, and the duration of of FDA-regulated products both to recommending micronutrient use. Given the potential for in- supplementation when the the manufacturers and directly to teractions, collecting information on all FDA.67 client does not consume the dietary supplements used is of utility. amount of types of foods neces- sary to obtain recommended PROFESSIONAL RESOURCES Stacking and Similar Practices micronutrient intakes; AND TRAINING OPPORTUNITIES Clients using multiple supplements can evaluating research regarding The ODS, which was created in part to be asked to bring in the containers of micronutrient supplementation; promote research aimed at deter- supplements used, particularly when and the health benefits and risks of products with multiple ingredients are being aware of regulatory, legal, dietary supplements, provides several used. Using multiple supplements that and ethical issues of recom- tools that researchers, RDNs, and have common ingredients could result mending and selling of micro- NDTRs can use to increase their in levels that exceed the UL. nutrient supplements. knowledge of dietary supplements, Continuing education and inclusion including micronutrient supplements. How to Discuss Use of of dietary supplements and specifically These include the Dietary Supplement Supplements with Clients and micronutrient supplements in didactic Research Practicum on dietary supple- Patients curricula are essential to ensuring ment issues for academic faculty and RDNs and NDTRs have the skills 68 Given the high use of micronutrient students ; the PubMed Dietary Sup- necessary to perform these functions. plement Subset,69 which allows a supplements by the public, RDNs and literature search limited to dietary NDTRs need to keep up to date on the fi supplements, a Dietary Supplement safety and ef cacy of these products to CONCLUSIONS Labels Database (https://www.dsld. assist consumers in the safe and The dietary intakes of many Americans nlm.nih.gov/dsld-mobile/index.jsp) appropriate use of these supplements. are inadequate in some micronutrients. and expert-reviewed fact sheets on The roles and responsibilities of the It is among the roles and re- dietary supplement ingredients and NDTRs under the supervision of the sponsibilities of RDNs and NDTRs un- specific product classes, like the RDN and RDNs within their individual der the supervision of an RDN to help MVM.45 These and other resources scope of practice may include: educate the public on healthful dietary such as those listed in the Figure can be assessing nutritional status of patterns and on the safe and appro- used by RDNs and NDTRs to stay clients to determine likelihood priate selection and use of micro- informed on issues related to dietary of inadequate or excessive intake nutrient supplements to meet their and micronutrient supplements. of vitamins and minerals; micronutrient needs and optimize

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health. To this end, RDNs and NDTRs 12. US Government Accountability Office. 27. Branum AM, Bailey R, Singer BJ. Dietary must keep abreast of research findings Dietary supplements: FDA may have op- supplement use and folate status during portunities to expand its use of reported pregnancy in the United States. J Nutr. on potential benefits and safety of health problems to oversee products. 2013;143(4):486-492. micronutrient supplements, and on the http://www.gao.gov/products/ 28. Institute of Medicine Subcommittee on regulatory issues that influence the use GAO-13-244. Published March 18, 2013. Interpretation and Uses of Dietary Refer- Accessed August 27, 2017. of these products. ence Intakes, Institute of Medicine 13. US Food and Drug Administration. Standing Committee on the Scientific Manufacturing - facts about the current Evaluation of Dietary Reference Intakes. References good manufacturing practices (CGMPs). DRI Dietary Reference Intakes: Applications 1. West KP, Stewart CP, Caballero B, http://www.fda.gov/Drugs/Development in Dietary Assessment. Washington, DC: Black RE. Nutrition. In: Merson MH, ApprovalProcess/Manufacturing/ucm169 National Academies Press; 2000. 105.htm. Accessed September 10, 2016. Black RE, Mills AJ, eds. : 29. Institute of Medicine Subcommittee on Diseases, Programs, Systems, and Policies. 14. Consumerlab.com. How products were Interpretation and Uses of Dietary Refer- 3rd ed. Burlington, MA: Jones & Bartlett evaluated. http://www.consumerlab.com/ ence Intakes, Institute of Medicine Learning; 2011:271-304. methods_index.asp. Accessed September Standing Committee on the Scientific 2. Nutrition Business Journal. NBJ’s Supple- 10, 2016. Evaluation of Dietary Reference Intakes. ment Business Report 2017. New York, NY: 15. NSF International. Product and ingredient Dietary Reference Intakes: Applications in Penton Media, Inc; 2017. certification. http://www.nsf.org/services/ Dietary Planning. Washington, DC: Na- 3. Dietary Supplement Health and Education by-industry/nutritional-products/dietary- tional Academies Press; 2003. Act of 1994 42 USC 287C-11 (1994). supplements-testing. Accessed April 22, 30. Institute of Medicine, Food and Nutrition 2018. 4. US Food and Drug Administration. Label- Board. Dietary Reference Intakes: The ing & nutrition - label claims for conven- 16. USP verified. http://www.usp.org/verifi Essential Guide to Nutrient Requirements. tional foods and dietary supplements. cation-services. Accessed September 10, Washington, DC: National Academies https://www.fda.gov/Food/LabelingNutri 2016. Press; 2006. tion/ucm111447.htm. Accessed March 17. Akabas SR, Vannice G, Atwater JB, 31. US Depts of Health and Human Services 29, 2018. Cooperman T, Cotter R, Thomas L. Quality and Agriculture. 2015-2020 Dietary 5. US Food and Drug Administration. Dietary certification programs for dietary sup- Guidelines for Americans. 8th edition. supplements - dietary supplement label- plements. J Acad Nutr Diet. 2016;116(9): https://health.gov/dietaryguidelines/2015/ ing guide: Chapter VI. Claims. https:// 1370-1379. guidelines/. Published December 2015. Accessed October 7, 2016. www.fda.gov/Food/GuidanceRegulation/ 18. Knapik JJ, Steelman RA, Hoedebecke SS, GuidanceDocumentsRegulatoryInformation/ Austin KG, Farina EK, Lieberman HR. 32. King JC, Dietary Guidelines Advisory DietarySupplements/ucm070613.htm. Acc- Prevalence of dietary supplement use by Committee. An evidence-based approach essed April 22, 2018. athletes: Systematic review and meta- for establishing dietary guidelines. J Nutr. 6. US Food and Drug Administration. Infor- analysis. Sports Med Auckl NZ. 2016;46(1): 2007;137(2):480-483. mation for consumers—Questions and 103-123. 33. Fulgoni VL, Keast DR, Bailey RL, Dwyer J. answers on dietary supplements. https:// 19. Lieberman HR, Stavinoha TB, McGraw SM, Foods, fortificants, and supplements: www.fda.gov/Food/DietarySupplements/ White A, Hadden LS, Marriott BP. Use of Where do Americans get their nutrients? UsingDietarySupplements/ucm480069.htm. dietary supplements among active-duty J Nutr. 2011;141(10):1847-1854. Accessed April 22, 2018. US Army soldiers. Am J Clin Nutr. 34. Murphy SP, White KK, Park S-Y, Sharma S. 7. Federal Trade Commission. Dietary sup- 2010;92(4):985-995. Multivitamin-multimineral supplements’ plements: An advertising guide for in- 20. Radimer K, Bindewald B, Hughes J, effect on total nutrient intake. Am J Clin dustry. https://www.ftc.gov/tips-advice/ Ervin B, Swanson C, Picciano MF. Dietary Nutr. 2007;85(suppl 1):280S-284S. business-center/guidance/dietary-supple supplement use by US adults: Data from 35. Blumberg JB, Frei BB, Fulgoni VL, ments-advertising-guide-industry. Acc- the National Health and Nutrition Exam- essed September 10, 2016. Weaver CM, Zeisel SH. Impact of fre- ination Survey, 1999-2000. Am J Epi- quency of multi-vitamin/multi-mineral 8. US Food and Drug Administration. Med- demiol. 2004;160(4):339-349. supplement intake on nutritional ade- Watch: The FDA Safety Information and 21. Bailey RL, Gahche JJ, Lentino CV, et al. quacy and nutrient deficiencies in U.S. Adverse Event Reporting Program. Dietary supplement use in the United adults. Nutrients. 2017;9(8):1-12. https://www.fda.gov/safety/medwatch/. States, 2003-2006. J Nutr. 2011;141(2): Accessed August 26, 2017. 36. Bailey RL, Fulgoni VL, Keast DR, Dwyer JT. 261-266. Dietary supplement use is associated with 9. US Food and Drug Administration. 22. Bailey RL, Gahche JJ, Miller PE, Thomas PR, higher intakes of minerals from food Selected amendments to the FD&C Act - Dwyer JT. Why US adults use dietary sources. Am J Clin Nutr. 2011;94(5): Dietary Supplement and Nonprescription supplements. JAMA Intern Med. 2013; 1376-1381. Drug Consumer Protection Act. http:// 173(5):355-361. www.fda.gov/RegulatoryInformation/Legis 37. Bailey RL, Fulgoni VL, Keast DR, Dwyer JT. lation/SignificantAmendmentstotheFDCAct/ 23. Kantor ED, Rehm CD, Du M, White E, Examination of vitamin intakes among US ucm148035.htm. Accessed October 8, 2016. Giovannucci EL. Trends in dietary sup- adults by dietary supplement use. J Acad plement use among US adults from 1999- Nutr Diet. 2012;112(5):657-663.e4. 10. US Food and Drug Administration. Guid- 2012. JAMA. 2016;316(14):1464-1474. ance for industry - questions and answers 38. Bailey RL, Fulgoni VL, Keast DR, 24. Bailey RL, Gahche JJ, Thomas PR, Dwyer JT. Lentino CV, Dwyer JT. Do dietary supple- regarding adverse event reporting and fi recordkeeping for dietary supplements as Why US children use dietary supple- ments improve micronutrient suf ciency required by the Dietary Supplement and ments. Pediatr Res. 2013;74(6):737-741. in children and adolescents? J Pediatr. Nonprescription Drug Consumer Protec- 25. Shaikh U, Byrd RS, Auinger P. Vitamin and 2012;161(5):837-842. tion Act. http://www.fda.gov/downloads/ mineral supplement use by children and 39. Huang H-Y, Caballero B, Chang S, et al. Food/GuidanceRegulation/GuidanceDocu adolescents in the 1999-2004 National Multivitamin/Mineral Supplements and mentsRegulatoryInformation/DietarySup Health and Nutrition Examination Sur- Prevention of Chronic Disease. Washing- plements/UCM381121.pdf. Accessed vey: Relationship with nutrition, food ton, DC: Agency for Healthcare Research September 10, 2016. security, physical activity, and health care and Quality; 2006. 11. Federal Food, Drug, and Cosmetic Act. access. Arch Pediatr Adolesc Med. 40. US Preventive Services Task Force. Final SEC. 761. 21 USC §379aae1. Serious 2009;163(2):150-157. update summary: Vitamin supplementa- adverse event reporting for dietary sup- 26. Gahche JJ, Bailey RL, Potischman N, tion to prevent cancer and CVD: Preven- plements. http://uscode.house.gov/view. Dwyer JT. 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seling?ds¼1&s¼supplement. Accessed Reference Intakes for Thiamin, Riboflavin, for the Study of Diseases. Diagnosis October 9, 2016. Niacin, , Folate, , and management of hemochromatosis: 41. Institute of Medicine Committee to Re- Pantothenic Acid, Biotin, and . 2011 practice guideline by the American view Dietary Reference Intakes for Washington, DC: National Academies Association for the Study of Liver Dis- Vitamin D and Calcium. Dietary Reference Press; 1998. eases. Hepatol Baltim Md. 2011;54(1): Intakes for Calcium and Vitamin D. Wash- 49. Wolff T, Witkop CT, Miller T, Syed SB. Folic 328-343. ington, DC: National Academies Press; Acid Supplementation for the Prevention of 59. Melhus H, Michaëlsson K, Kindmark A, 2011. Neural Tube Defects: An Update of the Evi- et al. Excessive dietary intake of vitamin A is associated with reduced bone mineral 42. American Geriatrics Society Consensus. dence for the U.S. Preventive Services Task density and increased risk for hip frac- Vitamin D for prevention of falls and their Force. Rockville, MD: Agency for Health- ture. Ann Intern Med. 1998;129(10): consequences in older adults. https:// care Research and Quality; 2009. 770-778. geriatricscareonline.org/ProductAbstract/ 50. Age-related PPP - american-geriatrics-society-consensus- Updated 2015. American Academy of 60. National Institutes of Health, Office of statement-vitamin-d-for-prevention-of-falls- Ophthalmology. http://www.aao.org/ Dietary Supplements. Vitamin A. https:// and-their-consequences-in-older-adults/ preferred-practice-pattern/age-related- ods.od.nih.gov/factsheets/VitaminA-Health CL009. Accessed August 30, 2017. macular-degeneration-ppp-2015. Pub- Professional/. Accessed October 9, 2016. 43. US Preventive Services Task Force. Final lished January 29, 2015. Accessed October 61. Yetley EA. 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AUTHOR INFORMATION This Academy of Nutrition and Dietetics position was adopted by the House of Delegates Leadership Team on October 29, 1995, and reaffirmed on September 28, 1998; June 19, 2003; May 17, 2007; and January 2012. This position is in effect until December 31, 2022. Position papers should not be used to indicate endorsement of products or services. All requests to use portions of the position or republish in its entirety must be directed to the Academy at [email protected]. Authors: Melissa Ventura Marra, PhD, RDN, West Virginia University, Morgantown, WV; Regan L. Bailey, PhD, MPH, RD, Purdue University, West Lafayette, IN. STATEMENT OF POTENTIAL CONFLICT OF INTEREST R. L. Bailey has received funding from the National Institutes of Health/National Cancer Institute (grant no. U01CA215834) and serves as a scientific consultant to the National Institutes of Health, Office of Dietary Supplements; she has received a travel support from the Council of Responsible Nutrition to present her research. FUNDING/SUPPORT There is no funding to report. Reviewers: Mary Beth Arensberg, PhD, RDN, LDN, FAND (Abbott Nutrition, Division of Abbott, Columbus, OH); Feon Cheng, PhD, MPH, RDN (Academy Research, International and Scientific Affairs, Chicago, IL); Emily K. Farina, PhD, RD (Henry Jackson Foundation/US Army Research Institute of Environmental Medicine, Natick, MA); Sharon Denny, MS, RD (Libertyville, IL); Sarah Picklo Halabu, RDN, LDN (Academy Publications and Resources, Chicago, IL); Lisa Moloney, MS, RD (Academy Research, International, and Scientific Affairs, Chicago, IL); in Integrative and Functional Medicine Dietetic Practice Group (Kelly Morrow, MS, RDN, Bastyr University, Kenmore, WA); Tracy L. Oliver, PhD, RDN, LDN (Villanova University, Villanova, PA); and Medical Nutrition Therapy Dietetic Practice Group (Colene Stoernell, MS, RD, Scripps Health, La Jolla, CA). Academy Positions Committee Workgroup: Valaree Williams, MS, RD, FAND (University of Colorado Cancer Center, Aurora, CO) (chair); Ainsley Malone, MS, RD, LD, FAND, FASPEN (Mt. Carmel West , Columbus, OH); Mary Marian, DCN, RDN, FAND (University of Arizona, Tucson, AZ); Mridul Datta, PhD, MS, RD, (Purdue University, West Lafayette, IN) (content advisor). ACKNOWLEDGEMENTS 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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