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Position of the Academy of Nutrition and Dietetics: Micronutrient Supplementation

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Position of the Academy of Nutrition and Dietetics: Micronutrient Supplementation FROM THE ACADEMY Position Paper Position of the Academy of Nutrition and Dietetics: Micronutrient 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 diet alone. and Dietetics that micronutrient supple- ments are warranted when requirements are Those with increased requirements secondary to growth, chronic disease, medication not being met through the diet alone. Those use, malabsorption, pregnancy 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, nutrient 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 United States contain micro- supplements for the prevention of chronic nutrients. 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 dietitian 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 vitamin and consistent with the literature, MVM regulatory issues influencing the use of mineral 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 vitamins and ments such as amino acids, fatty acids, available to assist RDNs and NDTRs in minerals 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 dietary supplement 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 Food and Drug 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 Health expertise of registered dietitian nutri- and Education 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 2162 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS ª 2018 by the Academy of Nutrition and Dietetics. FROM THE ACADEMY 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 life-threatening experience, botanical; an amino acid; a dietary 30 days after marketing the supple- inpatient hospitalization, a persistent substance for use by man to supple- ment and ensure 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 meal 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 manufacturing 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 micronutrients 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 multivitamin, 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, bacteria, pesticide, glass, not recognized as a food substance lead, and other heavy metals).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.
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