How Much is Too Much?

Adequate vitamin and mineral intake from a balanced diet is essential for maintaining health and preventing diseases caused by dietary deficiencies, such as pellagra (triggered by a shortage of niacin) or night blindness in children who lack vitamin A. But at too high a level some nutrients can be toxic. Ingesting too much vitamin A during pregnancy can cause severe developmental abnormalities in the fetus, for example. Excessive zinc can suppress rather than stimulate the immune system. Large doses of niacin can produce symptoms that range from nausea and blurred vision to liver toxicity. 

A number of vitamins and minerals have been tested in clinical trials to investigate whether taking large amounts could prevent cancer and other diseases. Generally, excessive vitamin levels had no preventive effect and in some cases were associated with increased cancer deaths. The research highlights the importance of sufficient but not excessive intake of vitamins and minerals.

Vitamin A

People need adequate vitamin A to maintain normal immune function, eyesight, the reproductive system and many other aspects of health (Health Canada 2010). However, vitamin A deficiency is uncommon in the United States today (ODS 2013a; FDA 2014b), according to both the Office of Dietary Supplements of the National Institutes of Health and the FDA. As the FDA stated, “Vitamin A deficiency based on an assessment of vitamin A status is rare in the U.S. population” (FDA 2014b). In contrast, deficiencies remain a problem in some developing countries where diets do not provide sufficient amounts of vitamin A-rich animal foods. Insufficiency leads to vision problems, such as inability to see in low light or darkness. 

“Vitamin A deficiency based on an assessment of vitamin A status is rare in the U.S. population” (FDA 2014b).

A diet that includes five servings a day of carotenoid-rich fruits and vegetables as well as milk and meat products generally provides enough vitamin A without food fortification or supplementation (IOM 2001). Even in the U.S., however, some groups may not eat a sufficiently varied diet. American teenagers are a prime example; fewer than half get adequate vitamin A (Berner 2014). 

With widespread vitamin A-fortified food and increasing use of dietary supplements, however, many Americans, especially younger children, have the opposite problem: consuming more vitamin A than the Institute of Medicine considers safe (IOM 2001; IOM 2003; IOM 2005; ODS 2013a). 

Numerous case studies have shown the risks of excessive intake of vitamin A for infants, toddlers and children. Infants getting very high amounts can develop intracranial and skeletal abnormalities as well as increased cranial pressure. Among the more common signs of vitamin A toxicity are brittle nails, hair loss, fever, headaches and weight loss (IOM 2001). At high doses, vitamin A is also toxic to the liver, the body’s main storage site for vitamin A. 

Due to the particular risks of vitamin A to young children, the German Federal Institute for Risk Assessment and the Dutch National Institute for Public Health and the Environment have recommended against vitamin A fortification of foods in general (BfR 2005; Kloosterman 2007).

High intakes of preformed vitamin A may also be a health risk for older adults, particularly post-menopausal women at risk of osteoporosis and hip fractures (Tanumihardjo 2013; UK EVM 2003). Preformed vitamin A compounds, whether naturally occurring in foods such as liver or taken as dietary supplements, have been shown to alter bone metabolism and lead to bone loss and osteoporosis in humans and laboratory animals (Penniston 2006; Walker 1982). 

Five large-scale population studies in the United States and Sweden found that high dietary intake of vitamin A decreased bone density and increased the risk of hip fracture in both older women and men (Feskanich 2002; Lim 2004; Melhus 1998; Michaëlsson 2003; Promislow 2002). These studies prompted the United Kingdom Expert Group on Vitamins and Minerals, an independent committee that advises the British government’s Food Standards Agency, to set a Guidance Level for vitamin A in adults of 1,500 μg preformed vitamin A per day, half the Tolerable Upper Intake Level for adults set by the U.S. Institute of Medicine (UK EVM 2003). Eating just two snack bars with 50 percent of the adult Daily Value of preformed vitamin A would reach this level.

In the long-running, prospective Nurses’ Health Study of 72,337 postmenopausal women aged 34 to 77 years, those who ingested 2,000 micrograms or more of preformed vitamin A a day had nearly twice the rate of hip fractures of those who took less than 500 micrograms a day. Ingesting beta-carotene, a naturally occurring vitamin A precursor, did not contribute significantly to fracture risk (Feskanich 2002). 

In animal studies, high dietary intake of vitamin A has been shown to decrease bone mass and lead to bone thinning and spontaneous fractures. Retinoic acid, the active form of vitamin A, inhibits bone formation (Lind 2013). Getting enough calcium and vitamin D is important for bone health, but vitamin A counteracts the positive effects of vitamin D. (Johansson and Melhus 2001). 

Zinc

Zinc is involved in many aspects of cellular metabolism and normal growth and development. It also plays a role in the immune system. Severe zinc deficiency in malnourished people can suppress immune function and wound healing. Overt zinc deficiency is uncommon in North America, according to the National Institutes of Health’s Office of Dietary Supplements, but low levels can occur in vulnerable populations, such as people with gastrointestinal or sickle cell disease (ODS 2013b).

Zinc taken within 24 hours of developing a common cold, as in zinc lozenges, can shorten the duration of cold symptoms, even though it may be associated with unpleasant symptoms such as nausea (Science 2012; Singh 2013). But in healthy adults, routinely adding supplemental zinc beyond the amounts in the food supply has few, if any, long-term benefits for immunity (Hodkinson 2007). One 2011 study of healthy 7-to-13-year-old children found that eating breakfast cereal fortified with 25 mg of zinc per 100 gram serving (four times the recommended dietary allowance for 9-to-13-year-olds) had no influence on immune function (Nieman 2011).

Although no adverse effects have been found from consuming naturally occurring zinc in food, excessive supplementation has been shown to suppress immune function. That’s because zinc interferes with copper absorption, leading to copper deficiency, anemia, changes in red and white blood cells and lowered immunity (IOM 2001). In clinical studies, high zinc intake has been associated with a significant increase in hospitalization for genitourinary causes (ODS 2013b). 

Because of such concerns, the German Federal Institute for Risk Assessment has recommended against fortifying food with zinc (BfR 2006).

Meanwhile, the zinc intake of US children has been increasing over the past two decades (Arsenault 2003; Butte 2010). In 2003, that led researchers at the University of California, Davis to warn that, “if zinc intake continues to increase because of the greater availability of fortified foods in the US food supply, the amount of zinc consumed by children may become excessive” (Arsenault 2003). Two years later, the Institute of Medicine said high intake of fortified zinc was a growing concern for young children (IOM 2005).

Today, 72 percent of 1-to-3-year-old children get too much zinc from diet and supplements (Butte 2010). The problem is particularly acute in families participating in the federal Women, Infants and Children (WIC) nutrition program and those in the lowest income category, because these groups often eat diets with limited fresh food and more processed, fortified foods (IOM 2005). 

Niacin

Niacin plays a role in a variety of metabolic reactions and is necessary for the activity of many enzymes. Niacin deficiency results in a disease called pellagra that affects skin, the digestive tract and the nervous system. The disease was common in the United States and parts of Europe in the early 20th century in areas where corn, a cereal low in both niacin and the amino acid tryptophan, was a dietary staple (IOM 1998b), but today it has virtually disappeared in the developed world. Alcoholism is currently the main cause of niacin deficiency in the United States, according to the University of Maryland Medical Center (UMM 2013). 

Excess niacin can lead to flushing reactions, tingling, itching and reddening of the skin, rashes and nausea. High doses can cause liver toxicity, with symptoms such as jaundice, glucose intolerance and blurred vision (IOM 1998).

In February of this year (2014), a case of niacin toxicity was reported after a shipment of enriched rice was apparently accidentally over-fortified by the manufacturer, Mars Foodservices. The company recalled its Uncle Ben’s Infused Rice products after students and teachers in some Texas public schools experienced burning, itching rashes, headaches and nausea 30-to-90 minutes after eating the rice. Similar cases have occurred in Illinois and North Dakota (FDA 2014d). Mars Foodservices acknowledged in a statement that the illnesses might have been related to high levels of niacin in its enriched rice (Sun 2014).

Recent experiments with vitamin supplementation have also illustrated the dangers of excessive vitamin intake and shown that supplements are generally ineffective for preventing deaths or disease due to major chronic diseases (Fortmann 2013; Guallar 2013; U.S. Preventive Services Task Force 2014). 

In several clinical trials, participants who took elevated amounts of β-carotene, vitamin E and vitamin A actually had a higher risk of cancer and higher mortality than a control group (Omenn 2007). One study, the beta-Carotene and Retinol Efficacy Trial, tested the effect of daily doses of β-carotene (30 mg) and retinyl palmitate (25,000 IU) on cancer incidence in 18,314 participants at high risk of lung cancer because of a history of smoking or asbestos exposure. This multi-center trial, sponsored by the Fred Hutchinson Cancer Research Center and the National Cancer Institute, began in 1985 and was halted in January 1996, 21 months ahead of schedule. It was stopped because of a clear link between vitamin intake and cancer incidence and mortality (ClinicalTrials.gov 2012). Participants who took the vitamins had a 28 percent higher lung cancer incidence, 17 percent more deaths overall and a higher rate of heart disease deaths than those who took a placebo (Goodman 2004). 

Similarly, the Selenium and Vitamin E Cancer Prevention Trial, conducted by the National Cancer Institute at 427 participating sites across the United States, Canada, and Puerto Rico, found no beneficial effect of selenium supplementation on prostate cancer risk, and instead found a 17 percent increased risk from taking vitamin E (Kristal 2014). In this study of 1,739 men with diagnosed prostate cancer, participants took 200 micrograms of selenium and 400 IU of vitamin E daily, either separately or in combination. This trial was also stopped once the data revealed there was no protective benefit for selenium and an increased risk of prostate cancer among those taking vitamin E. The researchers concluded that men should avoid selenium or vitamin E supplementation at doses above the recommended dietary intakes.

Even high exposure to folic acid, which is legally required to be added to flour and flour products in the United States to prevent fetal developmental defects, has been linked to unanticipated risks such as childhood allergy and asthma and elevated cancer risk (Brown 2014; Castillo 2012). In a study in Norway, where folic acid is not added to food, treatment with folic acid plus vitamin B12 was associated with higher cancer rates and all-cause mortality in patients with ischemic heart disease (Ebbing 2009).

In Australia, a study found that consuming synthetic folic acid was statistically associated with colon polyps in older men (Lucock 2011). A March 2014 study by the Roswell Park Cancer Institute in Rochester, N.Y., found an increased risk of breast cancer among European-American women who ingested the most synthetic folate from fortified foods. In contrast, eating foods naturally high in folate was associated with lower breast cancer risk (Gong 2014). In animal studies, folic acid has accelerated progression of mammary tumors (Deghan Manshadi 2014).

In summary, a variety of studies designed to investigate whether high vitamin doses could prevent disease have demonstrated that excessive intake can instead be harmful. These findings lend urgency to the need to protect young children from excessive vitamin and mineral supplementation.

How Much Is Too Much? 

For 1-to-3-year-olds, a single serving of food containing 20 percent of the adult Daily Value of vitamin A, zinc and niacin provides the full recommended dietary allowances of vitamin A and zinc and two-thirds of the recommended niacin intake. Avoiding excessive intakes is particularly important for children younger than 4 because their tolerable intake limits are low, reflecting their lower body weight.

For 4-to-8-year-old children, a single serving of cereal containing 20 percent of the adult Daily Value of vitamin A, zinc or niacin provides 50-to-75 percent of the recommended daily dietary allowance (Table 7). The Institute of Medicine defines Recommended Dietary Allowance as the amount that provides the nutrient needs of 97-to-98 percent of healthy individuals in a particular age group. 

Table 7: One serving with 20 percent of the adult Daily Value (DV) of certain nutrients supplies half or more of the Recommended Dietary Allowance (RDA) for 4-to-8-year-old children and the complete or nearly complete RDA for 1-to-3-year olds

* The current FDA daily value for vitamin A is expressed in the outdated form of international units (IU). 1,000 IU correspond to 300 mg (micrograms) of retinol activity equivalents (RAE), a measure for expressing vitamin A activity.

So long as outdated adult Daily Values are used for nutrition labeling, foods fortified with 50-to-100 percent of the adult Daily Value of vitamin A, zinc or niacin in a single serving pose the highest risk of overexposure for children 8 and younger. For pregnant women, foods with 50 percent or more of the adult Daily Value for vitamin A are also a risk, because ingesting excessive vitamin A during pregnancy can cause developmental defects in the fetus.

An additional complicating factor is that some cereals may contain more added vitamins and minerals than the label reflects, a situation that the 2003 Institute of Medicine report highlighted as a potential source of unsafe exposures (IOM 2003; UK EVM 2003). These “overages” occur when manufacturers deliberately add extra nutrient, either to ensure that it will be at the advertised level throughout the product’s shelf life or to compensate for expected breakdown of unstable vitamins (Ottaway 2008). 

Overages vary depending on the stability of the added ingredient. Unstable nutrients, such as vitamin A, generally require high overages (Wirakartakusumah 1998). Larger amounts are also sometimes added accidentally, which can cause illness (FDA 2014d). In 2001 Metabolife International recalled 1.5 million Diet & Energy Bars because they contained excessive amounts of vitamin A (Associated Press 2001), and in 2014 Mars Foodservices recalled the Uncle Ben’s Infused Rice products that were accidentally fortified with too much niacin (Sun 2014).

Studies in the U.S., the European Union and New Zealand have found that the actual level of fortified nutrients can be as much as double the amount on the label (Samaniego-Vaesken 2010; Thomson 2005; Thomson 2006; Thomson 2007; Whittaker 2001). A Dutch study published this year (2014) identified one fortified food that contained four times the amount of vitamin A listed on the label (Brandon 2014). In cereals that claim to provide 50-to-100 percent of the adult Daily Value, these “overages” can pose a significant health concern for young children, pregnant women and older adults.

Flawed and Outdated Daily Values, Industry Marketing, Put Children at Risk.

FDA’s Daily Values are outdated

Most consumers are familiar with the Nutrition Facts panel detailing the nutritional content of packaged foods. Most consumers are also familiar with the percent Daily Value numbers the panels listed for many nutrients. What most consumers don’t realize, however, is that these Daily Values were calculated only for adults, or that they were set in the 1960s and have never been updated. 

The FDA’s goal at that time was to help consumers avoid nutritional deficiencies. Over the last 50 years, however, such deficiencies have become uncommon, and the opposite problem has emerged. Today, the FDA’s Daily Values exceed the Tolerable Upper Intake Levels for children 8 and younger calculated by the federal Institute of Medicine (Table 8). (For a complete analysis, see Appendix C).

Table 8: FDA’s current adult Daily Values for vitamin A, zinc and niacin exceed IOM’s Tolerable Upper Intake levels for children 8 and younger

* Current FDA Daily Value for vitamin A is expressed in the outdated form of international units (IU). 5,000 IU corresponds to 1,500 μg (microgram) of Retinol Activity Equivalents (RAE).

FIGURE 1: Examples of 3 cereals that have displayed Daily Values for adults and children

Source: This sample Nutrition Facts panel, rendered by EWG, is based on the Nutrition Facts from Post C is for Cereal.

There are two major reasons that children are consuming excessive fortified nutrients in food. The first is that food manufacturers discovered that adding nutrients and putting health claims on packaging sells products, which has made voluntary fortification of certain types of foods ubiquitous. The second reason is simply that the FDA’s outdated dietary Daily Values on Nutrition Facts labels are based on adult dietary needs. They were set in 1968 – more than 40 years ago – when the primary concerns were still nutritional deficiencies (NRC 1968). The current disconnect between current Daily Values for nutrition labeling and children’s actual nutrition needs puts millions of American children at risk of excessive exposure to vitamin A, zinc and niacin.

The Daily Values for nutrition labeling, used on a vast majority of products, are defined by the FDA as “reference values, based on a 2,000 calorie intake, for adults and children 4 and more years of age.” The FDA also publishes a table with Daily Values for infants, children younger than four and pregnant and lactating women, but these are almost never used on product labels (FDA 2007). 

The current FDA Daily Value for adults and children 4 and older is 2.5-to-3.75 times the recommended dietary allowance for the 4-to-8-year-old group for vitamin A, zinc, and niacin. The FDA Daily Values for children less than 4 years are 1.5-to-2.7 times the Institute of Medicine’s recommended dietary allowances. 

The FDA tried to update its Daily Values in 1991-1992 in the process of implementing the Nutrition Labeling and Education Act of 1990 (IOM 2010). At the time, the FDA proposed to reset the Daily Values to the IOM’s Recommended Dietary Allowances, which would have brought the Daily Values on nutrition labels in line with then-current science. However, on Oct. 6, 1992, under heavy lobbying by the vitamin and supplement manufacturers, Congress passed the Dietary Supplement Act of 1992 that instructed the FDA not to promulgate for at least one year any regulations based upon updated Recommended Dietary Allowances (IOM 2010).

As a result, the window of opportunity provided by the law’s implementation was lost and the 1968 Daily Values remained the basis of the Nutrition Label. In the absence of political will, FDA has never implemented any of the Institute of Medicine recommendations, particularly recommendations on protecting children from excessive exposure to fortified vitamins and minerals (IOM 2003; IOM 2005). The FDA’s fortification policy dates back to 1980 and has not been revised based on new science, even as fortification of food products has expanded significantly (Dwyer 2014; FDA 1980; Yamini 2012).

Despite the evidence of potential risks, manufacturers of vitamins and fortified food continue to advocate for fortification. Publications by manufacturers and industry-supported scientists overemphasize the nutritional deficiencies of some groups and downplay the reality that young children today are at greater risk from excessive intake from fortified foods and dietary supplements (CRN 2014; McBurney 2013; Murphy 2013; Yates 2006). 

FDA’s proposed changes to nutrition labels must go further

In order to protect children from the risks of excessive intake of fortified nutrients, it is urgent to update the dietary values used for nutrition labeling to reflect the latest science. It is also important for Nutrition Facts labels to list the actual amounts of micronutrients added, rather than only the percent Daily Values, since dietary needs vary significantly by age and gender. A single set of dietary values cannot address this diversity. Products specifically developed for children should be required to list age-specific Daily Values. 

In March 2014, the FDA proposed revisions to the Nutrition Facts label (FDA 2014b). These revisions are a good start but are insufficient to protect children’s health from exposure to excessive fortified nutrients. Under the proposed rules, the Daily Value for nutrition labeling for 1-to-3-year-old children would be set at the Institute of Medicine’s Recommended Dietary Allowance for this age. This is an important step forward, and EWG strongly supports FDA’s decision to update the Daily Values for 1-to-3-year-olds based on the Institute’s recommendations.

In contrast, the FDA’s proposed Daily Values are inappropriate for 4-to-8-year-old children. The proposed vitamin A Daily Value for adults and children 4 or older is the same as the Tolerable Upper Intake Level for 4-to-8-year old children. The proposed Daily Value for niacin is higher than the Tolerable Upper Intake Level for this age group (Table 9).

Table 9: Proposed FDA Daily Values do not protect 4-to-8-year-olds

FDA. Food Labeling: Revision of the Nutrition and Supplement Facts Labels. Fed. Reg. Vol 79, No. 41, 11879 -11987, March 3, 2014.

The Daily Values used for nutrition labeling must be age-specific for 1-to-3-year-olds and 4-to-8-year-olds. Children 4-to-8-years-old cannot be grouped with adults, as is currently the case. They eat a different diet than adults do; their bodies are smaller; their vitamin and mineral needs are different; and their tolerance for excessive intake of vitamins and minerals is much lower. Combining 4-to-8-year-olds with adults for the purpose of nutrition labeling makes no scientific sense and leads to potentially harmful over-exposures to fortified vitamins and minerals.

For 17 vitamins and minerals, the FDA’s recently proposed Daily Values are at least twice the Recommended Dietary Allowances (RDA) for 4-to-8-year-old children. This is clearly problematic. (See Appendix C for a detailed analysis.) 

EWG’s review of 1,556 cereals found that the vast majority of Nutrition Facts labels reflect only the adult Daily Values, including on products clearly marketed to children. A few products do list daily values for children younger than four. For example, Post Foods Sesame Street C is for Cereal and some General Mills’ Cheerios products (original formulation) list both adult and daily values on the label and display Nutrition Facts based on FDA’s Daily Values for children under four (General Mills 2014; Post Foods 2013). EWG also found a Kellogg’s Sesame Street Rice Krispies cereal from late 1990s that listed daily values for children under 4. Such practices are entirely voluntary, however, and are rare. 

FIGURE 2: Examples of 3 cereals that have displayed Daily Values for adults and children

Source: Products purchased by EWG. General Mills Cheerios cereal was bought in Washington, DC in April 2014. Post C is for Cereal and Kellogg’s Rice Krispies were bought online, as cereal boxes. While the original purchase date for these two products is not available, the dates stamped on the box indicate that Post C for Cereal is a current formulation (expiration date Jan 22 2014) and Kellogg’s Rice Krispies is a formulation from 1990s (expiration date Feb 05 2001).

The FDA has also proposed to change the portion sizes listed on nutrition labels for some foods and beverages to more accurately reflect the amounts that Americans, including children, actually eat (FDA 2014c). For cereals, however, the agency did not propose any changes for serving sizes. FDA’s own data show that the average American eats 30 percent more than the labeled serving sizes for the most popular category of cold cereals, medium-density cereals weighing between 20 and 43 grams. The FDA’s reference serving size amount for these cereals is 30 grams, but its analysis of food consumption data from the 2003-2008 National Health and Nutrition Examination Survey (NHANES) showed that the 

medium amount eaten is actually 39 grams. The 30 percent difference between the amount actually eaten and the reference serving size exceeds FDA’s 25 percent bar for updating serving sizes (FDA 2014c).

Given that many American children eat more cereal at a sitting than the unrealistically small serving sizes listed on labels, children are getting even more nutrients than it appears. EWG calls on the FDA to update the cereal serving sizes cited on Nutrition Facts labels to accurately reflect the larger amounts that Americans actually eat.

FDA should curb the use of excessive fortification as a marketing tool

The FDA’s non-enforceable food fortification policy was published in 1980 and has not been updated since, despite the growth of the fortified food market (Dwyer 2014; FDA 1980; Yamini 2012). There is no official guidance in the United States today on how much fortification is safe in foods eaten by various age groups.

With no legal limits for fortification of most products, manufacturers are essentially allowed to add virtually any amount of vitamin A and zinc to breakfast cereals or snacks. And many add much higher amounts of niacin than the FDA requires in enriched grain-based products. The lack of food fortification regulation in the United States contrasts with official policy in other developed countries. For example, Germany’s  Federal Institute for Risk Assessment recommends against vitamin A fortification of foods other than margarine and butter spreads and against any food fortification with zinc (BfR 2005; BfR 2006).

In August 2013, the FDA announced that it would study how nutrient content claims affect consumers’ attitudes about food products, saying that the agency “does not encourage the addition of nutrients to certain food products (including sugars or snack foods such as [cookies] candies, and carbonated beverages). The agency said it wants to examine whether “fortification of these foods could cause consumers to believe that substituting fortified snack foods for more nutritious foods would ensure a nutritionally sound diet” (FDA 2013). The newfound concern over this now common practice is welcome, but it is also “too little, too late.” 

As a result of unregulated food fortification, heavy industry marketing using added nutrients and associated health claims, and frequent use of dietary supplements, American children 8 and younger are getting too much vitamin A, zinc and niacin, which could lead to negative health effects (Bailey 2012b; Butte 2010; Fulgoni 2011; IOM 2003; IOM 2005). Consuming too much vitamin A from fortified food and supplements could also pose health risks to pregnant women and to older adults.

Some important dietary inadequacies still exist, such as insufficient intake of vitamin A, C, D and E, calcium and magnesium among adults and teenagers (see Appendix B). But with the exception of vitamins D and E and calcium, dietary inadequacies are rare among children 8 and younger. 

EWG compared the prevalence of vitamin and mineral insufficiency among Americans with fortification levels in two of the most commonly fortified foods, ready-to-eat breakfast cereals and snack bars. It reveals a clear disconnect between what Americans actually need and the amounts found in the most heavily fortified foods. (See Appendix B)  

EWG also identified 20 cereals that contain multiple vitamins and minerals added at 100 percent of the current adult Daily Value in a single serving. (See Table A3 in Appendix A for the full list.) Nineteen feature a claim advertising their vitamin and mineral content. Two cereals use the number “100” in the product name itself (Food Lion Whole Grain 100 and Stop & Shop Source 100). Four products highlight the 100 percent Daily Value per serving for specific nutrients such as vitamin C, vitamin E or iron. Fourteen highlight the presence of multiple fortified vitamins with terms such as “100 percent Daily Value”, “Excellent Source,” “Good Source,” “With/Provides Essential Vitamins and Minerals” or “Antioxidants.”

Such marketing strategies, fully legal under the FDA’s outdated policy, drive excessive fortification and pose a risk of over-exposure for some age groups, particularly children 8 and younger. In its 2003 report on the Guiding Principles for Nutrition Labeling and Fortification, the prestigious Institute of Medicine wrote, “Manufacturers often adjust the quantities of particular ingredients or discretionary fortificants so that their products can be shown in the Nutrition Facts box to have a higher percent DV for some nutrients and a lower percent DV for others.” The report highlighted that some manufacturing practices may result in unnecessary, excessive intake of fortified nutrients. The potential harmful effects are of greatest concern for nutrients for which the Daily Value used on nutrition labels is close to or exceeds the Tolerable Upper Intake Level for young children (IOM 2003). 

The concern over excessive fortification of food as a marketing tool is not new. As far back as 1990, the Institute of Medicine’s Committee on the Nutrition Components of Food Labeling wrote that “the use of [Daily Value] percentages creates undesirable incentives for manufacturers to over-fortify foods in order to achieve ‘100 percent of your [or the government’s] requirements’” (IOM 1990).

EWG believes the FDA should update its food fortification policy to bring it in line with current science and with the Institute of Medicine’s recommendations on the necessary and safe intakes of added vitamins and minerals. The agency should also rein in the use of excessive fortification as a marketing tool. So long as food fortification remains at the discretion of manufacturers, EWG recommends that parents give their children 8 and younger foods with not more than 20-to-25 percent of the adult Daily Value for vitamin A, zinc and niacin. 

EWG’s Recommendations 

For parents

• Parents should exercise caution with products with more than 20-25 percent of the adult Daily Value for vitamin A, zinc or niacin, and monitor their children’s intake of these and other foods to ensure that kids do not get too much of these nutrients. As long as the outdated adult Daily Values continue to be used for nutrition labeling, parents must be watchful of the ingredients in the foods their children eat, particularly fortified vitamins and minerals, sugar and trans-fats. Under realistic diet scenarios, products with 20-25 percent or less of the adult Daily Value for vitamin A, zinc or niacin are not likely to pose a risk of excessive intake for children. Products that contain more than 20-25 percent of the adult Daily Value may pose a risk, especially if a child also takes a multivitamin. 

• Educate yourself about the different forms of vitamin A. There are several forms of vitamin A. The danger of overexposure applies to preformed vitamin A; it does not apply to products with naturally occurring high levels of carotenoids, which are vitamin A precursors. For example, products that contain carrots or pumpkin, which are naturally high in carotenoids, may have a very high percentage of the vitamin A Daily Value on the nutrition label but are considered safe. Preformed vitamin A can appear on the nutrition label as retinyl palmitate, retinyl acetate, vitamin A palmitate, vitamin A acetate or retinol. 

• Read labels carefully to identify what form of vitamin A the product contains and the overall amount added. If the label lists preformed vitamin A at more than 20-25 percent of the adult Daily Value, it could give a child too much vitamin A.

For Policymakers

• The FDA should finalize its new nutrition label and adjust the adult Daily Values and children’s Daily Values to be in line with current science and the recommendations of the Institute of Medicine.

• The FDA should require the nutrition labels on products marketed for children to display age-specific percent Daily Values, such as for 1-to-3-year-olds and 4-to-8-year-olds.
• The FDA should update the cereal serving sizes cited on Nutrition Facts labels to accurately reflect the larger amounts that Americans actually eat.
• The FDA should modernize its 1980s guidelines on voluntary food supplementation, particularly for products that children eight years old and younger may eat, in order to avoid excessive nutrient exposure from fortified foods.
• The FDA should limit the use of fortification and nutrient claims as marketing tools.  

For food manufacturers

• Responsible food manufacturers should avoid over-fortifying products marketed to children.
• Products children eat should contain no more than the recommended daily allowance for each age group and should never exceed the children’s Tolerable Upper Intake Levels determined by the Institute of Medicine.
• For products eaten by both children and adults, food manufacturers should list in the nutrition label age-specific daily values for: 1-to-3-year-olds, 4-to-8-year-olds and adults.

Appendix A: Fortification of Cereals and Snack Bars 

Table A1: 114 cereals contain 30 percent or more the adult Daily Value for zinc, niacin and/or vitamin A per serving

1. With the exception of two products identified in footnotes 2 and 3 or products with 0 percent of the Daily Value for vitamin A, all other products have vitamin A palmitate (retinol palmitate) as the form of vitamin A added, according to the ingredient labels.
2. For five cereals, single-serve packaging versions have higher amounts of fortified nutrients per serving compared to the same product sold in a multi-serving cardboard box. These cereals are Kellogg’s Cocoa Krispies (single serving 2.3 oz container); Kellogg’s Krave (single serving 1.87 oz container); General Mills Cheerios (single serving 1.1 oz container); Post Fruity Pebbles (single 2 oz serving in a plastic container); Post Honey Bunches of Oats with Almonds (single 2.25 oz serving in a plastic container).
3. The Nutrition Facts label indicates that, of 25 percent adult Daily Value of vitamin A per serving, 10 percent of Daily Value is in the form of beta-carotene.
4. The ingredient list indicates that both vitamin A palmitate and beta-carotene are added. The Nutrition Facts label does not indicate what percent of added vitamin A is in the form of beta-carotene.

Table A2: 27 snack bars contain 50 percent or more of the adult Daily Value for zinc, niacin and/or vitamin A

* When two numbers are listed in a column, the first number is the amount on the package label in FoodEssentials database (corresponding primarily to 2013 formulations); the number in parenthesis is the amount currently listed for the product on the manufacturer’s website, as reviewed by EWG in April 2014.
** Products with no added vitamin A and products containing added only provitamin A in the form of beta-carotene excluded from the analysis.

Table A3: Cereals with highest fortification levels. Check mark indicates a single serving contains 100 percent of the adult Daily Value for a particular nutrient, as indicated in Nutrition Facts label.

Appendix B: Vitamin and Mineral Deficiencies in the U.S.

Some American adults get too little vitamin D, vitamin E, magnesium, calcium, vitamin A and vitamin C (Table B1). More than 40 percent of adults have dietary intakes of vitamin A, C, D and E, calcium and magnesium below the average requirement for their age and gender.

Inadequate intake of vitamins and minerals is most common among 14-to-18-year-old teenagers. Adolescent girls have lower nutrient intake than boys (Berner 2014; Fulgoni 2011). But nutrient deficiencies are rare among younger American children; the exceptions are dietary vitamin D and E, for which intake is low for all Americans, and calcium. Approximately one-fifth of 2-to-8-year-old children don’t get enough calcium in their diets, compared to a half of adults and four-fifths of 14-to-18-year-old girls.

Table B1: Ranking of vitamins and minerals according to the degree of dietary inadequacy among adults. Nutrients from food alone include those that are naturally occurring; those used for mandatory enrichment of certain products, such as enriched flour and grain products; and those used for voluntary fortification.

* Dietary intake information originally derived from the National Health and Nutrition Examination Survey (NHANES). For children and adolescents, data from Berner 2014. For adults, data from Fulgoni 2011. All percentages greater than 1 were rounded to a whole number. Phosphorus data were excluded. According to Fulgoni 2011, 17 percent of 2–to-18-year-old children and adolescents and 2 percent of adults have phosphorus deficiency. There are many hidden sources of phosphorus in American diet, such as food additives in processed food (Uribari and Calvo 2003). Berner 2014 and Fulgoni 2011 did not account for this hidden phosphorus because, according to a publication from the FDA Center for Food Safety and Applied Nutrition, nutrient content databases and software programs currently used in large population studies do not consider these additional sources (Calvo and Uribarri 2013).
** Information on the dietary sources of vitamins and minerals from the website of the National Institutes of Health Office of Dietary Supplements http://ods.od.nih.gov/factsheets/list-all/

EWG compared the occurrence of vitamin and mineral deficiencies among Americans with our findings on vitamin A, zinc and niacin fortification levels in two of the most commonly fortified foods, ready-to-eat breakfast cereals and snack bars.

Zinc

Zinc deficiency is rare in the United States, with only 10 percent of all Americans aged 2 and older having intakes below the estimated average requirement (Fulgoni 2011). The dietary needs for zinc can be addressed through natural sources and, as an alternative, low levels of fortification. Yet, as EWG found, 3 percent of cold cereals have zinc fortification levels at 30 percent or more of the adult Daily Value, and nearly a third of cold cereals have zinc fortification at 20-to-25 percent of the adult Daily Value. The FDA classifies such fortification levels as “high” (FDA 2004). The result of high zinc fortification of breakfast cereals, a food commonly eaten by children, is that 13-to-17 million American children are ingesting amounts of zinc that exceed the tolerable upper intake levels set by the Institute of Medicine.

Niacin

Niacin is one of five nutrients (together with thiamin, riboflavin, iron and folate) whose addition is mandatory in all flour and flour products labeled “ enriched."  The enrichment is common practice for products sold in the U.S. because flour products, particularly bleached white flour products, lose a lot of essential vitamins and minerals during processing*. The standardized flour enrichment dramatically reduces the occurrence of inadequate intake of these five nutrients. Among all Americans older than 2, less than 2 percent get too litle niacin; 2 percent get too little riboflavin; 6 percent get too little thiamin; 7 percent get too little iron; and 11 percent get too little folate.

The low occurrence of inadequate intake of the nutrients added to processed grain products testifies to the success of the currently mandated flour enrichment policy (Yamini 2012). However, food manufacturers add much higher amounts to many processed foods than is required by law. EWG identified 20 cereals that add 100 percent of the adult Daily Value for multiple vitamins and minerals in a single serving. Sixty-seven percent of cold cereals and 64 percent of instant hot cereals fortify niacin to 20 percent or more of the adult Daily Value. As a result of this excessive fortification, nearly 5 million children ingest niacin in amounts exceeding the tolerable upper intake levels set by the Institute of Medicine.

Vitamin A

Some Americans get too much Vitamin A while others get too little. On one side, more than half of American adults and American teenagers have low dietary vitamin A intake (Berner 2014; Fulgoni 2011). On the other side, at least 13 percent of children 8 and younger ingest vitamin A in amounts exceeding the tolerable upper intake level set by the Institute of Medicine. Adequate intake of vitamin A is essential for good health, but excessive intake of preformed vitamin A from fortified foods and supplements are dangerous for infants, children, pregnant women and older adults. The difference between the necessary and the toxic amount is smaller for vitamin A than for many other vitamins.

Standardized vitamin-A fortified foods such as milk and butter spreads can be a good vehicle for providing the necessary amounts of vitamin A to people who might lack it in their diet, but great care must be exercised to avoid excessive vitamin A in children. The safest way of getting vitamin A is in the form of provitamin A carotenoids found in bright orange and yellow vegetables, tomatoes and green leafy vegetables (Tanumihardjo 2013). In contrast, eating cereals or snack bars with high levels of preformed vitamin A such as retinyl palmitate or retinyl acetate can easily lead to excessive exposures in young children and pregnant women.

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* This page was updated May 29, 2018

Appendix C: FDA’s Proposed Daily Values for Nutrition Labeling 

Table C1: Comparing current and proposed Daily Values for adults and children 4 or more years of age with Recommended Dietary Allowances (RDAs) or Adequate Intake values (AI) for 4-to-8-year-old children. All intakes are per day.

Source: FDA. Food Labeling: Revision of the Nutrition and Supplement Facts Labels. Fed. Reg. Vol 79, No. 41, 11879 -11987, March 3, 2014.
* RDAs for iron and iodine not included. Under the FDA’s proposal, the daily values for iron (currently at 18 mg/d) and iodine (currently at 150 mg/d) would not change. For 4-to-8-year-old children, RDA for iron is 10 mg/d; RDA for iodine is 90 mg/d.
** For some vitamins there are no RDAs. Only Adequate Intake values (AI) are available. These cases are indicated with AI in parenthesis.

Appendix D: Tolerable Upper Intake Limits Set in the U.S. and EU

The Tolerable Upper Intake Levels were based on a comprehensive effort by the National Academy of Sciences to define safe and adequate vitamin and mineral intakes. The majority of the research was done in the 1990s, when the broad scientific community came to recognize the risks of over-exposure. In 1994, the Institute of Medicine Food and Nutrition Board organized a symposium titled “Should the Recommended Dietary Allowances Be Revised?”, which pointed to the need to define safe maximum intake levels. In 1998 the Institute followed up by publishing a risk assessment model for determining safe upper limits for vitamins and minerals.

Across the Atlantic, the European Union and the United Kingdom conducted their own risk assessments and published upper intake levels for vitamins and minerals between 2000 and 2005 (EFSA 2006; SCF 2000; UK EVM 2003). The Institute of Medicine and the European agencies used comparable methodologies to assess the risks of excessive intake and arrived at largely similar conclusions. For 4-to-8-year-old children, the EU’s tolerable limit for vitamin A is 20 percent higher than the U.S. level; for zinc, the U.S. limit is 20 percent higher than the EU’s. The Institute of Medicine set a single upper level for all forms of niacin, while the European agencies set two, a lower one for more toxic nicotinic acid and a higher one for much safer niacinamide (see Appendix D for details).

A variety of studies were used for establishing the Tolerable Upper Intake Levels. They include case studies of individuals who had taken large-dose dietary supplements for months or years; small group studies with a few to a few dozen participants taking supplements in a controlled setting for a number of weeks; and large-scale cohort and case-control studies assessing the effects in large populations.

For vitamin A, many individual reports of adults and children ingesting high-dose dietary supplements were published from the 1950s to the 1990s, along with eight large population studies of pregnant women conducted in 1990s. Several small group studies of adults taking zinc supplements were done from 1989 to 2002, as well as a 1976 study of infants ingesting zinc in formula. For niacin, there is one 1938 small group controlled exposure study and at least two known cases of food poisoning from niacin over-fortification of grain-based products (CDC 1983; Sun 2014)

There are still limitations to the data for defining the adequate and safe intake for vitamins and minerals and establishing effective and safe food fortification amounts (Carriquiry and Camaño-Garcia 2006; Zlotkin 2006). The Tolerable Upper Intake Levels set by the Institute of Medicine, however, represent the best science available for preventing excessive and unsafe intakes (Taylor 2012).

Table D1: Risk assessment methodology and Tolerable Upper Intake Limits set by the Institute of Medicine, the European Commission Scientific Committee on Food and the United Kingdom Expert Group on Vitamins and Minerals. Data sources listed below.

* The Institute of Medicine conducted separate risk assessments of vitamin A toxicity in pregnant women and non-pregnant adults. The risk assessment for adults was based on case studies of adults taking daily vitamin A supplements. The risk assessment for pregnant women was based on multiple cohort and case control studies of fetal developmental effects caused by excessive vitamin A intake. The Institute of Medicine set final Tolerable Upper Intake Levels for pregnant women and for adults generally at 3000 mg/d, same as the European Commission vitamin A UL for all adults, including pregnant women.
** The Institute of Medicine set a single UL for all forms of niacin, while the European Commission  Scientific Committee on Food and the United Kingdom Expert Group on Vitamins and Minerals set two ULs, a low UL for more toxic nicotinic acid and a higher UL for safer nicotinamide (niacinamide). The EU and UK ULs for niacinamide do not apply to pregnant women because there are no data on the safety of niacinamide in pregnancy.

Data sources for Table D1

EFSA (European Food Safety Authority). 2006. Tolerable upper intake levels for vitamins and minerals. Available: http://www.efsa.europa.eu/en/ndatopics/docs/ndatolerableuil.pdf

IOM (Institute of Medicine). 1998b. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. A Report of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline and Subcommittee on Upper Reference Levels of Nutrients, Food and Nutrition Board, Institute of Medicine. Available: http://www.nap.edu/catalog/6015.html

IOM (Institute of Medicine). 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Panel on Micronutrients, Subcommittees on Upper Reference Levels of Nutrients and of Interpretation and Use of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Available: http://www.nap.edu/catalog/10026.html

SCF (European Commission Scientific Committee on Food). 2000. Guidelines of the Scientific Committee on Food for the development of tolerable upper intake levels for vitamins and minerals (adopted on 19 October 2000). Available: http://ec.europa.eu/food/fs/sc/scf/out80a_en.pdf

SCF (European Commission Scientific Committee on Food). 2002a. Opinion of the Scientific Committee on Food on the Tolerable Intake Levels of Nicotinic Acid and Nicotinamide (Niacin) (expressed on 17 April 2002). Available: http://ec.europa.eu/food/fs/sc/scf/out80j_en.pdf

SCF (European Commission Scientific Committee on Food). 2002b. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Preformed Vitamin A (retinol and retinyl esters) (expressed on 26 September 2002). Available: http://ec.europa.eu/food/fs/sc/scf/out145_en.pdf

SCF (European Commission Scientific Committee on Food). 2003 Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Zinc (expressed on 5 March 2003). Available: http://ec.europa.eu/food/fs/sc/scf/out177_en.pdf

UK EVM (Expert Group on Vitamins and Minerals). 2003. Safe Upper Levels for Vitamins and Minerals. May 2003. Available: http://cot.food.gov.uk/pdfs/vitmin2003.pdf