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Dietary eference ntakes and
Nutrition abeling Updating te Daily
alues for
itamins and inerals and te
Implications for Industry and Consumers
By Taylor C. Wallace, Ph.D. and Rend Al-Mondhiry, Esq.
nderstanding that our knowledge of nutrition recommended three important changes to food and supple-
science has almost completely transformed since ment labels:
1968, the FDA and Health Canada requested 1. he Nutrition Facts Panel should contain both the
specific guidance from the Institute of Medicine (IOM) on actual amount of a nutrient by weight and percent-
the appropriate use of Dietary Reference Intakes (DRIs) age Daily Value (%DV) (mimicking the Supplement
in nutrition and supplement labeling in 2002. In 2003, the Facts Panel).
IOM issued the report, Dietary Reference Intakes: Guiding 2. he %DV should be based on the estimated average
1
Principles for Nutrition Labeling and Fortification , which requirement (EAR) as opposed to the traditionally
aylor C allace hD FACN is end Alondhiry is ¡eulatory
the Senior irector Scientiic ¨ Counsel at the Council for
¡eulatory ffairs at the Council for ¡esponsible utrition C¡ in
¡esponsible utrition C¡. Washinton C.
FDLI March/April 2013 UPDATE 23
Annual
used Recommended Daily Al- women 19-30 and 31-50 years of age. should FDA move to the population-
lowance (RDA). his is known as a population coverage weighted EAR model.
3. he EAR used should be a approach because all subpopulations Adoption of the EAR model would
population-weighted mean of and 97.5% of the subpopulation requir- have important implications for food
EARs, rather than selecting the ing the greatest amount of a given and supplement labeling claims. As
highest value of an EAR for any nutrient are covered. In comparison, authorized by the Nutrition Labeling
age and/or gender group. a population-weighted approach is the and Education Act of 19904, nutrient
average of all subpopulations. A popu- content claims can be used to charac-
In 2007, FDA announced its plans lation-weighted EAR would thus relect terize or describe the level of a nutri-
to update the daily values (DVs) in the mean value for the entire popula- ent or dietary substance in a product,
response to the IOM’s recommenda- tion (i.e., all subpopulations com- using terms such as free, high, and low,
tions to relect the current DRI values bined), whereby half the population or terms such as more, reduced, and lite
2
for nutrients. Since that time, a debate would still require a greater amount to when comparing the level of a nutrient
within the scientiic and nutrition successfully meet their target intake. in a food to that of another food. Nutri-
communities has emerged and various ent content claims are linked to refer-
stakeholders have weighed in regarding mlications for ndustry
and Consumers ence values on the label and determine
the appropriate methodology that FDA whether a food or dietary supplement
should adopt: a population coverage Newly published data supports the
position that FDA should continue to is eligible to bear such a claim. Any
approach using the RDA, or a popula- change to the current reference value
tion-weighted approach using the EAR. utilize the highest RDA in nutrition
labeling vs. a population-weighted EAR amounts will require FDA to reevaluate
RDA vs. EAR approach.3 he EAR approach is also its current approach to nutrient content
he IOM sets individual DRI values likely to have signiicant implications claims. However, if FDA adopts the
(i.e., the RDA and EAR) for subpopula- for product labeling, consumer educa- EAR model, there is a greater risk that
tions based on their gender and age. tion, and public health. For nearly the amount of a nutrient required for a
For example, the DRI values for iron 40 years, consumers and healthcare food to be considered a “good” or “ex-
are higher for menstruating women professionals have become accustomed cellent” source would be signiicantly
than for adolescent boys. Recall basic to the DV relecting the population lower, resulting in less nutritious foods
calculus principles and the normal dis- weighted RDA. here is no question or using nutrient content claims.
tribution, or “bell”, curve. he EAR is debate that nutrition labeling should In addition, some manufacturers
the mean or number at which half the be updated to relect actual amounts may choose to reformulate products
subpopulation, assuming normality, in addition to the %DV and the cur- by reducing nutrient levels in order to
meets the target for a nutrient. Because rent science surrounding DRI values. meet the new reference standards. A
the EAR is the mean value, it is the Healthcare professionals and consum- de-fortiication of foods and supple-
closest estimate of what any one indi- ers have traditionally utilized the DV ments could have a detrimental impact
vidual in a normal population would on the Nutrition and Supplement Facts on public health given that fortiied
require to prevent deiciency (i.e., 50% Panels as a goal for an individual. To foods and dietary supplements con-
will require more and 50% will require support the position that FDA should tribute signiicantly to micronutrient
less). he RDA is the value at which continue to utilize the population cov- intakes, with an even greater impact
97.5% of the population is suicient for erage RDA in nutrition labeling, actual on subpopulations with special dietary
a nutrient (2 standard deviations above population-weighted EAR and RDA needs. Studies conirm that a signii-
the EAR or mean). values were calculated using the cur- cant percentage of the population still
DVs are currently calculated by rent IOM’s method, the current DRI does not meet the EAR for essential
selecting the highest RDA among all values, and the 2010 U.S. Census data. nutrients.5 Using the EAR efectively
the subpopulations excluding pregnant hese values indicate that large por- lowers the DV for many important
and/or lactating women. For example, tions of the population that would have nutrients by establishing target intake
the DV for iron relects the RDA for a greater requirement for each nutrient values that meet the needs of only 50%
26 UPDATE March/April 2013 www.fdli.org
Annual
of the population – further contribut- reference values and mandatory nutri- Values and Mandatory Nutrients, 72
ing to this problem. ents. In its 2012 Semiannual Regulato- Fed. Reg. 62149 (Nov. 2, 2007).
7 3. Wallace TC. Dietary reference intakes
From an individual consumer ry Agenda , the agency had announced and nutrition labeling: updating the
standpoint, population coverage values its intention to publish a Notice of daily values for vitamins and minerals.
using RDA are necessary because Proposed Rulemaking for comment by J Amer Coll Nutr 2013 (accepted; in
press).
many consumers use label values as December 2012, which is now expected 4. Nutrition Labeling and Education Act,
their personal target intakes, rather by Q1 of 2013. As FDA continues to Pub. L. No. 101-535, 104 Stat. 2353
than a midpoint of the population. evaluate its approach to updating the (1990).
Labels assist consumers in comparing daily values, any changes to the current 5. Fulgoni VL, Keast DR, Bailey RL
et al. Foods, fortiicants and supple-
the nutrient content between foods and nutrition labeling scheme should not ments: where do American’s get their
assessing the nutrient contribution of only be scientiically valid, but also nutrients? J Nutr. 2011;141:1847-1854.
a given food within their overall diet, help consumers easily and accurately 6. Food Labeling: Revision of Reference
Values and Mandatory Nutrients, 72
e.g., a product that contains 100% DV meet their nutritional targets. he Fed. Reg. 62149 (Nov. 2, 2007).
for vitamin C would provide 100% updated labeling system should also 7. Department of Health and Human
of that nutrient. Consumers have the be consistent with other public health Services Semiannual Regulatory
Agenda, 77 Fed. Reg. 7945, 7947 (Feb.
most familiarity with the RDA as their recommendations and nutrition policy 13, 2012).
reference value, and FDA would be initiatives, such as the Dietary Guide- 8. U.S. Department of Agriculture and
8 9 U.S. Department of Health and Hu-
tasked with a considerable amount lines for Americans and MyPlate.
FDLI man Services, Dietary Guidelines for
of consumer education if the agency Americans, available at: http://www.
shits its nutrient value calculations to 1. Food and Nutrition Board. Institute of cnpp.usda.gov/dietaryguidelines.htm
the EAR. Medicine: “Dietary Reference Intakes: (last accessed on January 9, 2013).
FDA received nearly 700 comments Guiding Principles for Nutrition La- 9. U.S. Department of Agriculture, My-
beling and Fortiication.” Washington, Plate, available at: http://www.cnpp.
to its 2007 Advanced Notice of Pro- DC: National Academy Press, 2003. usda.gov/MyPlate.htm (last accessed
posed Rulemaking6 2. Food Labeling: Revision of Reference on January 9, 2013).
on the revision of
FDLI March/April 2013 UPDATE 27
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