How Much is Too Much?

Excess Vitamins and Minerals in Food Can Harm Kids’ Health

June 19, 2014

How Much is Too Much? : Flawed and Outdated Daily Values, Industry Marketing, Put Children at Risk

FDA’s Daily Values are outdated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

Fortified nutrient

FDA Daily Value for adults and children 4 or older

The IOM Tolerable Upper Intake Level for 4-to-8-year-olds

FDA Daily Value for children less than 4 years

The IOM Tolerable Upper Intake Level for 1-to-3-year-olds

Vitamin A*

5,000 IU (1500 mg RAE)

900 mg/d RAE

2,500 IU (750 mg RAE/d)

600 mg/d RAE

Zinc

15 mg/day

12 mg/d

8 mg/day

7 mg/d

Niacin

20 mg/day

15 mg/d

9 mg/day

10 mg/d

* Current FDA Daily Value for vitamin A is expressed in the outdated form of international units (IU). 5,000 IU corresponds to 1,500 μg (microgram) of Retinol Activity Equivalents (RAE).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

Labels

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 The second reason is simply that the FDA’s outdated dietary Daily Values on Nutrition Facts labels are based on adult dietary needs.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


Fortified nutrient

Tolerable Upper Intake Level for 4-to-8-year-olds

Current FDA Daily Value for adults and children 4 or older

Proposed FDA Daily Value for adults and children 4 older

Vitamin A

900 mg/day RAE

1,500 mg/day RAE

900 mg/day RAE

Zinc

12 mg/day

15 mg/day

11 mg/day

Niacin

15 mg/day

20 mg/day

16 mg/day

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

Labels

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.