Abstract
Background
Nearly a third of young US children take multivitamin/mineral (MVM) dietary supplements, yet it is unclear how formulations compare with requirements.
Objective
Describe the number and amounts of micronutrients contained in MVMs for young children and compare suggested amounts on product labels to micronutrient requirements.
Design
cross-sectional.
Setting
All 288 MVMs on the market in the United States in the National Institutes of Health’s Dietary Supplement Label Database in 2018 labeled for children 1 to <4 years old.
Main outcome measures
Number of MVM products and amounts per day of micronutrients in each product suggested on labels compared with requirements represented by age-appropriate Daily Values (DV). Micronutrients of public health concern identified by the Dietary Guidelines for Americans (DGA) 2015-2020 (DGA 2015) and DGA 2020-2025 (DGA 2020) or those of concern for exceeding the upper tolerable intake levels.
Statistical analyses
Number of products and percent DV per day provided by each micronutrient in each product.
Results
The 288 MVMs contained a mean of 10.1 ± 2.27 vitamins and 4.59 ± 2.27 minerals. The most common were, in rank order, vitamins C, A, D, E, B6, B12; zinc, biotin, pantothenic acid, iodine, and folic acid. For micronutrients denoted by the DGA 2015 and DGA 2020 of public health concern, 56% of the 281 products containing vitamin D, 4% of the 144 with calcium, and none of the 60 containing potassium provided at least half of the DV. The upper tolerable intake level was exceeded by 49% of 197 products with folic acid, 17% of 283 with vitamin A, and 14% of 264 with zinc. Most MVMs contained many of 16 other vitamins and minerals identified in national surveys as already abundant in children’s diets.
Conclusions
A reexamination of the amounts and types of micronutrients in MVMs might consider formulations that better fill critical gaps in intakes and avoid excess.
Keywords: Children, Multivitamin/mineral, Dietary supplement, Formulations, Daily Value, Dietary Guidelines
DIETARY SUPPLEMENT PRODUCTS ARE INTENDED to supplement the diet. Registered dietitians and nutritionists as well as other health professionals recommend consuming a wide variety of foods first to meet nutrient needs and using dietary supplements only to fill remaining gaps in nutrient intakes. Even when intakes are carefully planned to follow recommended food patterns, intakes may be marginal at ages 2 and older for vitamins D and E and choline.1 National surveys in the United States reveal that supplement use improves intakes of certain nutrients, providing concentrated sources of micronutrients that fill gaps in intakes.2,3
Multivitamin/mineral (MVM) supplements contain a combination of vitamins, minerals, and sometimes other ingredients. No standard or regulatory definition exists for their contents. Manufacturers are free to choose the ingredients and amounts to include in their products, and thus MVM products vary widely in their composition and characteristics.4,5
The US Food and Drug Administration (FDA) defines products targeting children 1 to <4 years of age (eg, 1-3.99 years) to be labeled as “MVMs for children.”5 In recent national surveys about 6% of toddlers 1 to 2 years old received infant drops, which are mainly multivitamins, and 11% were given an MVM or multivitamin tablets.6 Among children over 2 years, the prevalence of MVM use was 35%.7,8
Parents give their children dietary supplements primarily for health reasons, and so it is important for them and health professionals to know what they contain.9 However, meeting micronutrient needs is only one of many factors that influence MVM formulations. Others include marketing considerations, such as catering to consumers’ perceptions of the benefits of individual nutrients by displaying large percent Daily Values (DVs) on labels to show that products are potent, and various manufacturing constraints such as the cost, bulk, weight, form, and stability of ingredients in the products. However, from the nutritional standpoint, those factors should support and not detract from MVMs’ nutritional purpose, which is to supplement inadequate dietary intakes.
Supplements are effective only when nutritionally vulnerable individuals use formulations that fill nutrient deficiencies. From the public heath standpoint, it is important to know what gaps exist in young children’s diets in national surveys to evaluate how product formulations fit with micronutrient needs. The Feeding Infants and Toddlers Study (FITS) of 2004 found that the prevalence of inadequacy (eg, below the estimated average requirement) from food sources alone among children <4 years was low for micronutrients (<1%-2%), with the exception of vitamin E.10,11 More recent FITS surveys in 2008 and 2016 also reported a low prevalence of inadequacy for most micronutrients.12,13 In the National Health and Nutrition Examination Survey (NHANES) of 2011-2016, more than 50% of 1- to 3-year-old children had inadequate vitamin D and E intakes, and < 3% of the children’s intakes of calcium, iron, magnesium, zinc, vitamins A and C, folate, and potassium were below the Adequate Intake level.14 In the FITS 2016 survey, among 1- to 2-year-old children, the prevalence of inadequacy was 76% for vitamin D, 52% for vitamin E, and much less for calcium, iron, and potassium from food sources alone, while the prevalence of inadequacy was even lower among those 3 to 4 years old.13,15 Young children in poor and food insecure families are particularly vulnerable to micronutrient inadequacy.14,16-20
The Dietary Guidelines for Americans 2015-2020 (DGA 2015) classified vitamin D, calcium, potassium, and fiber as nutrients of public health concern because their under-consumption was linked to adverse health outcomes, including clinically evident deficiencies and increased risks of osteoporosis and cardiovascular disease in adulthood.21 It also identified vitamins A, C, D, and E and folate, calcium, magnesium, potassium, iron (for certain age groups), choline, and fiber as micronutrients falling short in the diets of individuals older than 2 years.
The 2020 Dietary Guidelines for Americans Advisory Committee (DGAC 2020) reported that vitamin D, calcium, and potassium were micronutrients of public health concern among individuals 1 year and older and that choline also posed challenges among some 1- to 2-year-old children.1 The Dietary Guidelines for Americans 2020-2025 (DGA 2020) also singled out vitamin D, calcium, and potassium as under-consumed by the entire population.22 It did not consider dietary supplements to be necessary to achieve dietary adequacy except for vitamin D for most healthy infants and young children. This conclusion agreed with other expert groups such as the American Academy of Pediatrics and the Centers for Disease Control and Prevention.23,24
Concerns about micronutrient intakes exceeding the tolerable upper intake level (UL) have been raised by several expert groups.25-27 In the United States, national surveys found that some toddlers and young children had total intakes from foods, infant formulas, fortified foods, and supplements exceeding the UL, especially for folic acid, vitamin A, and zinc.2,7 In the 2004 FITS children, intakes exceeded the UL for both supplement users and nonusers for vitamin A (97% vs 15% respectively), zinc (68% vs 38%), and 18% folate (only among supplement users).10 In the 2011-2016 NHANES, over 60% of children 1 to 3 years old were at risk of exceeding the UL for zinc and folic acid.14 However, the children who were most likely to use dietary supplements in the FITS 2016 were not the most nutritionally vulnerable; they were non-Hispanic Whites from more affluent and highly educated families whose intakes were already high from foods alone.13
For many years, some industry groups and trade associations have urged that food assistance program benefits should include MVMs. For example, a bill was introduced in Congress in 2019 to amend the Food and Nutrition Act of 2019 to permit Supplemental Nutrition Assistance Program (SNAP) food stamp benefits to be used for purchasing MVMs if the products conformed to certain criteria with respect to the number and amounts of micronutrients they contained.28 Suggestions have also been made that the Special Supplemental Nutrition Assistance Program for Women, Infants and Children (WIC) and other food programs include MVMs. An important consideration in evaluating these proposals is whether the formulations singled out for coverage and reimbursement in the bill would offer special health benefits such as filling critical micronutrient gaps of public health concern without risk of excess.
The Office of Dietary Supplements, National Institutes of Health curates the Dietary Supplement Label Database (DSLD).29 It provides the most comprehensive and representative source of all information available on labels of dietary supplement products marketed in the United States, including the Supplement Facts panel, amount and percent DV per serving, and the producer’s suggested servings per day.30,31
Clear and consistent labeling is important for providing guidance to the public, and so the Supplement Facts panel on dietary supplement labels provides both the actual amounts and the percent DV per serving for micronutrients to facilitate comparisons with nutrient requirements. DVs are reference amounts derived from Dietary Reference Intakes expressed as a percent of the approximate requirement that a serving of the product contributes, based on a young child’s energy needs.32 However, the DV is a concept some consumers may not understand, and they may find comparisons to the child’s daily nutrient needs particularly difficult if more than 1 serving is recommended since the percent DV is only provided per serving, not per day.
The study aim was to describe the number and amounts of vitamins and minerals provided in all MVMs in the DSLD labeled for young children that were on the market in 2018 and to compare their contents to micronutrient needs per day as represented by percent DV. Particular attention was devoted to micronutrients that were identified by the DGA 2015 and DGA 2020 to be of public health concern, those considered underconsumed by the DGA 2015, and micronutrients singled out by expert groups as raising concerns about excess.
METHODS
Design and Setting
This was a cross-sectional study of all vitamin- and mineral-containing products labeled for 1- to <4-year-old children on the market.29
Of the 52,470 dietary supplement labels for all age groups listed as “on market” on the date the DSLD was accessed (March 2018), a total of 572 products specifically labeled for children 1 to <4 years old were identified. Of those products, 72 duplicates (different package sizes of the same products), 40 that did not provide micronutrient amounts, and 172 others were eliminated because they were devoid of the micronutrients (eg, probiotics, botanicals, or other supplements) or did not conform to the NHANES definition of an MVM (eg, containing ≥3 vitamins and ≥1 mineral ± botanicals), leaving 288 products for further analysis.
MVM Product Definitions
Two definitions were used to identify MVM products. First was the traditional definition of MVMs as used in the NHANES—a dietary supplement containing at least 3 vitamins and at least 1 mineral, with or without botanicals—although this was neither a regulatory definition nor agreed upon by all researchers.33 The second definition was an MVM that met the additional criteria in the bill before Congress in 2019 designating MVMs for reimbursement under SNAP: any product containing at least 14 nutrients providing ≥50% DV for that nutrient without exceeding the UL for any micronutrient.28
Main Outcome Measures
The main outcome measure was the frequency of micronutrient ingredients in the products and amounts of each micronutrient. They were compared with requirements expressed as percent DV. Micronutrients identified as of public health concern or underconsumed by the DGA 2015 or DGA 2020 were of particular interest.
Coding Procedures
The labels examined were those on market in 2018, close to the time that the 2019 SNAP bill was filed. This was during the transition between the original old Supplement Facts label and the new revised label conforming to FDA’s updated regulations. Some products used the prior label with DVs based largely on outdated 1968 dietary standards, and others used the updated label based on current dietary reference intakes, and so calculations were necessary to express all data in current age-appropriate percent DVs and ULs. The percent DV was calculated by dividing the amount of a nutrient in a serving size by its new DV and multiplying that number by 100. All label values were converted to the appropriate new labeling units and DV values specified in the latest FDA regulations and guidance documents for conversion of units of measure for vitamins.32
Information that was needed to calculate nutrient content from the MVM was incomplete on many MVM products. Missing data included missing servings per day, percent DV listed but not the nutrient amount, or a missing source/chemical form (which was needed for conversions of carotenoids to vitamin A or various forms of vitamin E to alpha tocopherol). Simply excluding those labels would threaten the representativeness of study results, since so many MVMs would have been discarded due to incomplete information. Therefore, defaults were created to fill in the missing values based on existing label information employing standard conventions or reasonable assumptions when they were not available. A complete list of defaults employed is available from the authors.
Categorization of Micronutrients
The micronutrients in the MVMs were categorized into 4 groups for analytical purposes based on public health interest:
1. Micronutrients of Public Health Concern.
Vitamin D, calcium, and potassium, which had been singled out by the DGA 2015 and DGA 2020 because they were underconsumed by the general population compared with the estimated average requirement or the adequate intake and linked to biomarkers or health outcomes.21,22
2. Underconsumed Micronutrients.
Vitamins A, C, D, and E and folate, iron, magnesium, and choline, which were identified by the DGA 2015 as underconsumed in certain life stages and considered of concern by the DGAC 2020.21,22
3. Nutrients of Potential Concern About Excess.
Vitamin A (retinol), folic acid, and zinc, which had been identified frequently by expert groups as posing particular risk when intakes were over the UL.25-27
4. Other Nutrients.
The other essential micronutrients with DVs (thiamin; riboflavin; vitamins B6, B12, K; biotin; niacin; pantothenic acid; chromium; copper; iodine; manganese; molybdenum; phosphorus; and selenium).
Statistical Analyses
The means and SDs of vitamins and minerals in the NHANES and SNAP-eligible products were calculated and a 2-sample t test was performed using the Python mathematical statistics package for data analysis.34
Amounts of each micronutrient per serving were multiplied by the manufacturer’s suggested servings of the product per day on the label for children and expressed as the percent DV per day for each of the vitamins, minerals, and choline. To describe how product formulations compared with public health guidance, amounts per day for each micronutrient were then categorized into 6 groups: <25% DV, 25% to <50% DV, 50% to <75% DV, 75% to <100% DV, 100% DV-UL, and >UL. The number of products in each of these categories was tabulated for each micronutrient, and the number and percent of products providing the percent DV or exceeding the UL were noted.
The study was deemed exempt by the Abt Associates Institutional Review Board because no human subjects were involved.
RESULTS
Table 1 shows the number of MVM products containing each of the micronutrients, using both the NHANES definition and the definition proposed in the SNAP bill. There were 288 products for children 1 to <4 years old that met the NHANES definition for an MVM. By rank order, the 15 most common micronutrients in the products were vitamins C, A, D, E, B6, and B12 and zinc, biotin, pantothenic acid, iodine, folic acid, magnesium, calcium, choline, and niacin. For micronutrients deemed of public health concern by the DGA 2015 and DGA 2020, 281 of the 288 formulations contained vitamin D but fewer had calcium (144) and potassium (60). For other micronutrients singled out by the DGA 2015 and DGAC 2020 as underconsumed, many products contained vitamins A (283), C (286), and E (279) but fewer contained magnesium (150), choline (140), iron (100), and folate (63).
Table 1.
Number of MVMa products containing various micronutrients on the market in 2018 for 1- to <4-year-old children
Nutrient | MVM Products for 1- to 4-Year-Old Children |
|
---|---|---|
NHANESb definition: ≥3 vitamins + ≥1 mineral + botanicals33 (n = 288) |
Proposed SNAPc purchase eligibility definition: ≥14 vitamins and minerals >50% Daily Value < upper level28 (n = 11) |
|
←————————n————————→ | ||
Vitamin C | 286 | 11 |
Vitamin A | 283 | 11 |
Vitamin D | 281 | 11 |
Vitamin E | 279 | 11 |
Vitamin B6 | 274 | 11 |
Vitamin B12 | 267 | 11 |
Zinc | 264 | 11 |
Biotin | 258 | 11 |
Pantothenic acid | 247 | 11 |
Iodine | 243 | 11 |
Folic acid | 197 | 2 |
Magnesium | 150 | 11 |
Calcium | 144 | 10 |
Choline | 140 | 6 |
Niacin | 140 | 11 |
Thiamin (B1) | 137 | 11 |
Riboflavin (B2) | 134 | 11 |
Iron | 100 | 6 |
Copper | 85 | 8 |
Manganese | 83 | 10 |
Selenium | 80 | 7 |
Vitamin K | 65 | 4 |
Folate | 63 | 9 |
Potassium | 60 | 4 |
Chromium | 49 | 9 |
Molybdenum | 32 | 7 |
Phosphorus | 29 | 3 |
Chloride | 3 | 0 |
MVM ¼ multivitamin/mineral supplement.
NHANES ¼ National Health and Nutrition Examination Survey.
SNAP ¼ Supplementary Nutrition Assistance Program.
Table 2 presents the total number of products containing each micronutrient and the number providing each amount expressed as percent DV. For micronutrients of public health concern in the DGA 2015 and DGA 2020, virtually all (281 of 288) of the product formulations contained some vitamin D and 157 of them (56%) contributed half or more of the DV. In contrast, only 4% of the 144 products containing calcium and none of the 60 products containing potassium contributed this much of the DV.
Table 2.
Amounts of micronutrients provided per day by 288 MVMaproducts for 1- to <4-year-old children in 2018, expressed as percent DVb and compared with the ULc d
Reason for public health interest |
Nutrient | Number of products |
MVM Products Providing These Amounts per Day of the DV and UL for 1-to <4-Year-Old Children |
|||||
---|---|---|---|---|---|---|---|---|
≤25% DV | ≥25%-49% DV | ≥50%-75% DV | ≥75-100% DV | ≥100% DV-UL | >ULd | |||
←————————————————n (%)————————————————→ | ||||||||
Micronutrients considered of public health concern by the Dietary Guidelines for Americans 2015 and 20201,21,22 | Calcium | 144 | 136 (94) | 2 (>1) | 5 (4) | 1 (<1) | ||
Potassium | 60 | 60 (100) | ||||||
Vitamin D | 281 | 43 (15) | 81 (29) | 132 (47) | 15 (5) | 10 (4) | ||
Micronutrients considered underconsumed by the Dietary Guidelines for Americans 2015 and Dietary Guidelines for Americans Advisory Committee 20201,21,22 | Folate | 63 | 22 (35) | 2 (3) | 15 (24) | 4 (6) | 20 (32) | |
Iron | 100 | 2 (2) | 14 (14) | 45 (45) | 2 (2) | 37 (37) | ||
Magnesium | 150 | 120 (80) | 10 (7) | 11 ( ) | 3 (2) | 6 (4) | ||
Vitamin C | 286 | 2 (<1) | 8 (3) | 39 (14) | 236 (83) | 1 (<1) | ||
Vitamin E | 279 | 3 (1) | 1 (<1) | 4 (>1) | 8 (3) | 263 (94) | ||
Choline | 140 | 139 (99) | 1 (1) | |||||
Micronutrients of particular concern about excess25-27 | Folic acid | 197 | 7 (4) | 1 (<1) | 3 (>1) | 4 (2) | 86 (44) | 96 (49) |
Vitamin A | 283 | 10 (4) | 45 (16) | 32 (11) | 148 (52) | 48 (17) | ||
Zinc | 264 | 6 (2) | 83 (31) | 32 (12) | 69 (26) | 38 (15) | 36 (14) | |
Other micronutrients | Biotin | 258 | 2(1) | 256 (99) | ||||
Chloride | 3 | 3 (100) | ||||||
Chromium | 49 | 1 (2) | 2 (4) | 1 (2) | 12 (25) | 33 (67) | ||
Copper | 85 | 28 (33) | 6 (7) | 6 (7) | 4 (5) | 38 (45) | 3 (3) | |
Iodine | 243 | 84 (35) | 63 (26) | 13 (5) | 41 (17) | 42 (13) | ||
Manganese | 83 | 35 (42) | 4 (5) | 16 (20) | 16 (19) | 11 (13) | 1 (1) | |
Molybdenum | 32 | 2 (6) | 2 (6) | 11 (35) | 1 (3) | 16 (50) | ||
Niacin | 140 | 3 (2) | 8 (6) | 6 (4) | 6 (4) | 53 (38) | 64 (46) | |
Pantothenic acid | 247 | 4(2) | 3 (1) | 3 (1) | 237 (96) | |||
Phosphorus | 29 | 29 (100) | ||||||
Riboflavin (B2) | 134 | 2 (1) | 5 (4) | 6 (5) | 43 (32) | 78 (58) | ||
Selenium | 80 | 5 (6) | 37 (46) | 9 (12) | 11 (14) | 17 (21) | 1 (1) | |
Thiamin (B1) | 137 | 4 (3) | 5 (4) | 42 (31) | 10 (7) | 76 (55) | ||
Vitamin B6 | 274 | 5(2) | 4 (2) | 56 (20) | 115 (42) | 94 (34) | ||
Vitamin B12 | 267 | 2 (<1) | 2 (<1) | 263 (99) | ||||
Vitamin K | 65 | 8(12) | 39(60) | 6 (9) | 12(19) |
MVM = multivitamin/mineral.
DV = Daily Value.
UL = tolerable upper intake level.
Conforming to the National Health and Nutrition Examination Survey.33
Among the micronutrients identified as underconsumed by the DGA 2015, virtually all the MVMs contained vitamins in amounts that were at least half of the DV (98% of 279 products with vitamin E, 99% of 266 with vitamin C, 95% of 283 with vitamin A, 84% of 100 with iron, and 62% of the 63 products containing folate). However, only 13% of 150 products with magnesium and 0% of 140 choline-containing products contributed half or more of the DV.
Table 2 also shows that 49% of 197 products with folic acid, 17% of the 283 with vitamin A, and 14% of the 264 products containing zinc exceeded the UL. Levels of other micronutrients also exceeded the UL in 46% of 140 products with niacin, 4% of 50 with magnesium, 4% of 85 with copper, 1% of 83 with manganese, 1% of 80 with selenium, and <1% of 286 containing vitamin C. Additionally, micronutrient amounts that were greater than the DV but below the UL were common in many of the products containing folate, iron, vitamins C and E, biotin, chromium, copper, iodine, manganese, molybdenum, niacin, pantothenic acid, riboflavin, selenium, and thiamine.
Further scrutiny of the 11 products that conformed to the definition proposed for SNAP eligibility revealed that the rank order was similar to the products conforming to the NHANES definition. The sole exception was that folic acid was deleted and manganese was included (data not shown). The SNAP-eligible products provided a greater number of vitamins and minerals than those defined using the broader NHANES definition (vitamins 12.36 ± 9.5 SD, n = 11 vs 10.1 ± 2.27 SD, n = 288, P = .0001; minerals 8.82 ± 1.4 SD, n = 11 vs 4.59 ± 2.94 SD, n = 288, P = .0001). No SNAP-eligible product exceeded the UL for any micronutrient, although several exceeded the DV. For the micronutrients of public health concern, the products proposed for SNAP eligibility all contained vitamin D (1 with ≤25% DV per day, 9 between 25% and 75% DV, and 1 >100% DV but<UL); 10 contained calcium (all ≤25% DV); and 4 contained potassium (all <25% DV). Also, 6 of the products contained iron (3 between 25% and 75% DV and 3 >100% DV but <UL).
DISCUSSION
The MVM product formulations varied in how well they would provide for children’s micronutrient needs without risk of excess, especially for micronutrients of public health importance. They were heterogenous in how many, which, and how much of the micronutrients they contained. Virtually all (281 out of 288) of the product formulations contained some vitamin D, and most of them (56%) contributed half or more of a young child’s vitamin D requirement. These products might help to fill this critical micronutrient gap identified in national surveys and by the DGA 2015 and DGA 2020. However, far fewer products contained calcium (144) and potassium (60) and in much smaller amounts. Perhaps this was because formulations with milligram, rather than microgram, quantities would create size and other difficulties.
Among the other vitamins identified by the DGA 2015 as underconsumed, virtually all of the 288 products included vitamins E (279) and C (286) in amounts that were usually over the DV (94% and 83%, respectively). For iron, 84% of the 100 products containing it also had amounts that exceeded the DV. Folate was also less commonly present, but of the 63 products containing it, 62% provided half or more of the DV. In contrast, fewer products contained magnesium (150) and choline (140), and in smaller amounts.
The FDA is not currently authorized to approve dietary supplements for safety before they are available in the marketplace. The finding that many products contained micronutrients that exceeded the UL underscores the need for consumers to be vigilant and to avoid selecting products that provide excessive amounts of some micronutrients, such as folic acid, vitamin A, and zinc. Many products containing them exceeded the UL (49% of 197 products containing folic acid, 17% of 283 with vitamin A, and 14% of 264 of those with zinc). The risk of excessive total micronutrient intakes is enhanced in children who are MVM users because they tend to have higher intakes of some nutrients from food alone than nonusers, even before the contribution of supplements is considered.2,7,12-14 Moreover, the amounts on product labels may be underestimates since the “overage” above declared amounts is not accounted for on labels, although estimates of overages are available.35 Independent chemical analyses of a large and representative sample of MVMs for children 1 to <4 years old showed that many micronutrients, particularly folic acid and vitamin A, exceeded labeled values.34
Although there are no known advantages from consuming micronutrient amounts that are more than the DV, it was exceeded by large percentages in products containing micronutrients viewed as underconsumed by the DGA 2015 and DGAC 2020, including vitamin E (94%), vitamin C (84%), iron (37%), and folate (32%), as well as folic acid (93%). However, the DVs were also exceeded by many other micronutrients already present in ample amounts from food sources, including biotin (99%), vitamin B12 (99%), vitamin A (69%), pantothenic acid (96%), niacin (84%), thiamin (55%), riboflavin (58%), chromium (67%), copper (48%), molybdenum (50%), and vitamin B6 (34%). The additions of these micronutrients to products would not be expected to meaningfully enhance dietary status because in recent NHANES surveys so few young children were at risk of deficiency from their lack.
The 11 MVMs conforming to the definition proposed for reimbursement under SNAP contained more vitamins and minerals than the others. They contained some of the micronutrients of public health concern, with substantial amounts of vitamin D and lesser amounts of calcium and potassium. No micronutrient was present in levels that exceeded the UL. They did not appear to offer any other special health benefits.
Most health professionals do not subscribe to the view that MVMs are necessary for healthy children who are growing normally, and so there are no recommended standards at present from professional societies on MVM formulations for young children.21,23,24,36 However, MVMs account for many purchases by parents for health reasons. Recommendations might be useful to lessen consumer confusion and provide guidance to manufacturers. Data from national surveys and populations at nutritional risk might serve as the basis for agreement on reasonable ranges of these micronutrients in products for young children that fill key micronutrient gaps while avoiding excess.
More up-to-date information is needed on the current contents of MVMs, since formulations are always changing, and products today may be different than they were at the time of this study. Some MVMs contained additional dietary ingredients such as botanicals that were not examined in this study and they may also have health implications. Additional research is also needed on the synergistic or antagonistic actions of the multiple nutrients and other bioactive constituents that MVMs contain.
The health effects of MVMs on young children need further study beyond their possible utility in remedying dietary inadequacy and avoiding excess. At present, randomized trials do not support use of vitamin and mineral supplements to reduce the risk of noncommunicable diseases, but this is another important area for further research.37
This study is the first analysis of a representative sample of MVM formulations for young children using DSLD, the most complete publicly available dietary supplement database. Health professionals can use this information in advising patients on which MVM formulations are likely to fill the most critical shortfalls in micronutrient intakes while avoiding excess. The analyses of the MVM formulations presented in this study may also be helpful to legislators in considering proposals for spending public funds.
A major study limitation was that the contributions of MVM formulations to children’s total micronutrient intakes were not studied directly. Also, MVM product turnover is rapid and a reevaluation of label contents on the market today might produce different results. New reference standards for calculating the percent DV on the Supplement Facts label have been required by the FDA for most manufacturers to adopt since early 2021, and the DVs for most micronutrients now more closely match the current Dietary Reference Intakes except for potassium.32 Those changes presented an opportunity for manufacturers to reexamine product formulations and may have led to readjustments.
The DSLD may not have included all supplements on the market in 2018 because submissions to the database were largely voluntary. Data on missing label information needed to estimate amounts of some micronutrients in some products were imputed by the research team, and defaults might have misrepresented exposures, although we consider this unlikely.
CONCLUSIONS
Collectively these results support the need for a reexamination of the amounts of micronutrients in MVMs. Reformulation of MVMs might better meet critical micronutrient gaps of public health interest in young children’s intakes without exceeding the ULs.
RESEARCH SNAPSHOT.
Research Question:
How do multivitamin/mineral supplements (MVMs) labeled for young children compare with their micronutrient needs?
Key Findings:
The 288 MVMs for children 1 to <4 years old in the National Institutes of Health’s Dietary Supplement Label Database contained a mean of 10 vitamins and 5 minerals. For micronutrients of public health concern in Dietary Guidelines for Americans 2015 and 2020, 281 products contained vitamin D (56% providing half or more the Daily Value) and only 144 contained any calcium and 60 any potassium. Of the 197 products containing folic acid 96% provided ≥50% Daily Value and 49% exceeded the upper level.
FUNDING/SUPPORT
Office of Dietary Supplements, National Institutes of Health, US Department of Health and Human Services, and Agricultural Research Service, US Department of Agriculture.
Footnotes
STATEMENT OF POTENTIAL CONFLICT OF INTEREST
J. T. Dwyer holds stock in several food and drug companies; unrelated to this submission she serves on the scientific advisory boards of McCormick and Company, the Mushroom Council, as a nonpaid advisor to the bioactives committee of International Life Sciences Institute, North America (now IFANS); and was a one-time consultant for Nestle (2020). Unrelated to this submission, Regan L. Bailey has served as a consultant in the past to the National Institutes of Health Office of Dietary Supplements, Nestle/Gerber, the General Mills Bell Institute, RTI International, and Nutrition Impact; has received travel support to present her research on dietary supplements; and is a trustee of the International Food Information Council. All other authors have nothing to disclose.
Contributor Information
Johanna T. Dwyer, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD..
Leila G. Saldanha, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD..
Richard A. Bailen, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD..
Jaime J. Gahche, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD..
Nancy Potischman, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD..
Regan L. Bailey, Department of Nutrition Science, Purdue University, West Lafayette, IN..
Shinyoung Jun, Department of Nutrition Science, Purdue University, West Lafayette, IN..
Yue Long, Abt Associates, Rockville, MD..
Emily Connor, Abt Associates Rockville, MD..
Karen W. Andrews, Beltsville Human Nutrition Research Center, Agricultural Research Service, US Department of Agriculture, Bethesda MD..
Pamela R. Pehrsson, Food Composition Laboratory, Beltsville Human Nutrition Research Center, Agricultural Research Service, US Department of Agriculture, Bethesda MD..
Pavel A. Gusev, Beltsville Human Nutrition Research Center, Agricultural Research Service, US Department of Agriculture, Bethesda MD..
References
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