weight, these values may be inappropriate for the general U.S.
population, which has a high percentage of overweight individuals. The
IOM Labeling Report stated that deriving a label reference value for
protein based on values from the EER predictive equations may not be
appropriate for large segments of the North American population for the
same reason (Ref. 25).
    Therefore, we tentatively conclude that the DRV for protein should
continue to be based on 10 percent of calories. Accordingly, we are not
proposing to change the DRV of 50 g for protein.

F. Sodium

1. Mandatory Declaration
    FDA regulations require the declaration of sodium content on the
Nutrition Facts label (Sec.  101.9(c)(4)). The 2007 ANPRM did not ask
any questions about the mandatory declaration of sodium, but one
comment that recommended the declaration of sodium should remain
mandatory because the information can help consumers who are concerned
about sodium and salt make appropriate food choices.
    Americans 4 years and older consume an average of approximately
3,650 mg sodium/d (NHANES 2003-2006), which is more than twice the
amount required to meet their adequate intake (1,500 mg/day for
individuals 9 to 50 years old). Evidence continues to support the
association between increased sodium consumption and increased blood
pressure. In 2005, the IOM noted the direct relationship between sodium
intake and increased blood pressure (Ref. 10). The 2010 DGAC and the
2013 IOM committee on Sodium Intake in Populations (Ref. 87) concluded
that a strong body of evidence has been documented in adults that as
sodium intake decreases, so does blood pressure (Ref. 30). We agree
with the comment that information about sodium content on the food
label can help consumers make appropriate food choices.
    Therefore, we tentatively conclude that declaration of sodium
should remain mandatory so consumers are provided information necessary
to assist them in maintaining healthy dietary practices. Accordingly,
we are not proposing to amend the current requirement for declaration
of sodium in Sec.  101.9(c)(4).
2. DRV
    a. Need to update the DRV--The DRV for sodium is 2,400 mg (Sec.
101.9(c)(9)). New scientific data and consensus reports on sodium
published since the 1993 final rule (58 FR 2206 at 2224) highlight the
need to reconsider the DRV. Recent key consensus reports and
recommendations that FDA reviewed in reconsidering the DRV are as
follows:
    i. IOM DRI Electrolytes Report. In 2005, the IOM established AIs
and ULs for sodium (Ref. 10). The IOM found that data from dose-
response trials for determining the daily requirement for sodium were
insufficient to establish an EAR for sodium and, thus, an RDA could not
be determined and an AI was set. The AIs for sodium are intake levels
that meet or exceed the daily nutrient requirement, i.e., the
recommended daily average intake levels that are needed to meet the
sodium needs of most healthy and moderately active individuals, are
1,500 mg/d for individuals 9 to 50 years, 1,300 mg/d for individuals 51
to 70 years, and 1,200 mg/d for individuals older than 70 years and for
children 4 to 8 years of age. AIs meet or exceed the intake levels
required to meet nutrient needs and there is no benefit in consuming a
nutrient in excess of its AI.
    Data available to the IOM showed that; (1) a carefully planned diet
that provided an average of approximately 1,500 mg/d of sodium can meet
recommended intakes of other nutrients; (2) 1,500 mg/d exceeds the
levels of sodium intake that have been associated with effects of
inadequacy, such as adverse effects on blood lipid concentrations and
insulin resistance; and (3) 1,500 mg/d allows for sodium sweat losses
in acclimatized individuals who are exposed to high temperatures or who
become physically active. The AI does not apply to individuals who are
highly active and workers who are exposed to heat stress that lose
large volumes of sodium in sweat (Ref. 10).
    ULs are the highest level of daily nutrient intake that is likely
to pose no risk of adverse health effects to almost all individuals in
the general population (Ref. 10). The major adverse and dose-dependent
effect of increased sodium intake is elevated blood pressure and the
IOM noted that the relationship between sodium intake and blood
pressure is continuous, making it difficult to set a precise UL because
other environmental factors (weight, exercise, potassium intake,
dietary pattern, and alcohol intake) and genetic factors also affect
blood pressure. The ULs for sodium are 2,300 mg/d for all individuals
ages 14 years and older, 1,900 mg/d for children 4 to 8 years old, and
2,200 mg/d for adolescents 9 to 13 years old. The UL is not intended to
be a recommended intake level to encourage, but rather a level not to
exceed.
    The IOM stated that the UL may be lower than 2,300 mg/d among
certain groups who are at increased risk of the blood pressure-raising
effects of increased sodium intake (e.g., older individuals, African
Americans, and individuals with hypertension, chronic kidney disease,
or diabetes), but insufficient data prevented IOM from defining a
specific UL for these groups. Instead, the IOM set the same UL for
these population groups as the one for the general population (i.e.,
2,300 mg/d), with the acknowledgment that the actual UL for this group
may be lower.
    ii. IOM Report on the Strategies to Reduce Sodium Intake in the
United States (IOM Sodium Strategies Report). After considering current
trends in hypertension, sodium consumption, sodium content of the food
supply, and existing strategies for sodium reduction, the IOM developed
various strategies for reducing dietary sodium intake to levels
recommended by the 2005 DGA. Among various recommendations to
Government Agencies, food manufacturers, consumers, and other
stakeholders, the IOM recommended that FDA adopt 1,500 mg as the DV for
sodium, given that sodium is an essential nutrient and that, unlike in
1993 (58 FR 2206 at 2224), a reference value of adequacy is now
available (i.e., the AI of 1,500 mg/d).
    iii. 2010 DGA. The 2005 DGA made a key recommendation for the
general U.S. population to consume less than 2,300 mg/d of sodium and
that individuals with hypertension, African-Americans, and middle-aged
and older adults should aim to consume no more than 1,500 mg/d of
sodium (Ref. 36). In 2010, the DGAC evaluated evidence considered in
the 2005 DGAC report in addition to new research on the relationship
between sodium intake and blood pressure, focusing on the strength of
the scientific evidence (Ref. 30). The 2010 DGAC report noted that
1,500 mg/d should be the intake goal for the

general U.S. population. Further, the DGAC noted that, given the
current U.S. marketplace and the resulting excessively high sodium
intake, it will be challenging to achieve the lower level. The 2010
DGA, considering the 2010 DGAC conclusions, recommended a reduction in
sodium intake to less than 2,300 mg/d and a further reduction to 1,500
mg/d among African Americans, individuals with hypertension, diabetes,
or chronic kidney disease, and individuals ages 51 years or older.
    iv. IOM Report on Sodium Intake in Populations, Assessment of
Evidence, 2013 (Ref. 87). The charge to the committee focused on
literature published since 2003, therefore they reviewed literature
between 2003 and 2012. The committee assessed the benefits and adverse
outcomes (if any) of reducing sodium intake, particularly in the range
of 1,500 to 2,300 mg/d, with an emphasis on the subgroups known to be
at increased risk of the blood pressure-raising effects of increased
sodium intake. Based on the review of studies that assessed
cardiovascular events and mortality, the committee found that evidence
from studies on direct health outcomes is inconsistent and insufficient
to conclude that lowering sodium intakes below 2,300 mg/d will increase
or decrease the risk of CVD outcomes or all-cause mortality in the
general U.S. population. The committee also concluded that the evidence
from direct health outcomes does not support recommendations for
subgroups (people with diabetes, chronic kidney disease and pre-CVD) to
lower their sodium intake to or even below 1,500 mg/d. No relevant
evidence was found on health outcomes for the other population
subgroups considered (i.e., African Americans and persons 51 years of
age and older).
    b. CSPI petition--In 2005, we received a citizen petition from CSPI
(2005 CSPI petition) requesting, among other sodium related issues,
that FDA initiate rulemaking to reduce the DRV for sodium from 2,400 to
1,500 mg (Docket No. FDA-2005-P-0196 (formerly Docket No. 2005P-0450))
(http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196). Citing
the 2005 DGA, the petition requested that FDA adopt a DV of 1,500 mg
because that is the recommended maximum intake for roughly one-half of
the adult population (i.e., people with hypertension, African-
Americans, and middle-aged and older people). According to the
petition, when recommended intake levels vary among population groups,
FDA has typically been conservative, choosing a DV that is most
protective. In this proposed rule, we are responding to the petition's
request to reduce the DRV for sodium from 2,400 mg to 1,500 mg. The
petition's other requests are outside the scope of this rulemaking.
    c. Comments to 2007 ANPRM--In the 2007 ANPRM, we asked whether a
new DV for sodium should be based on the UL or on the AI. We also asked
whether the UL, were it to be used, should reflect the same approach
(population-weighted or population-coverage) as the other DRIs. While a
few comments supported retaining the current DRV of 2,400 mg, the
majority of comments supported using the UL of 2,300 mg/d. Some other
comments recommended setting a DV for sodium based on the AI of 1,500
mg/d. One comment urged that we adopt a tiered two-phase, step-down
approach establishing an interim DRV of 2,000 mg in 2013 and a final
revised DRV of 1,500 mg by 2020. See also (Ref. 47).
    d. Options Considered--When the Nutrition Facts label was developed
in the early 1990s, no RDA or Estimated Safe and Adequate Daily Dietary
Intake (ESADDI) levels were available for consideration. While the
National Academy of Sciences established 500 mg/d as an estimated
minimum requirement for healthy adults in 1989, the Agency relied on
the recommendation from 1989 National Research Council Report Diet and
Health: Implications for Reducing Chronic Disease Risk (Ref. 88) that
provided a quantitative intake recommendation for salt, based on blood
pressure, that was equivalent to 2,400 mg/d as a value that consumers
should not exceed (58 FR 2206 at 2223, 2224). There is debate in the
scientific community about the appropriate DV for sodium, taking into
account its essentiality in relatively small amounts as well as its
association with increased blood pressure at greater but varying levels
of intake.
    Current recommendations recognize the benefits of reduced sodium
intake in the general population, despite the heterogeneity among
individuals in blood pressure responses to changes in sodium intake.
Although several factors influence inter-individual variability in
blood pressure responses to changes in dietary sodium, certain
population groups have been reported to have a higher prevalence of
salt sensitivity and are considered to be most at risk of sodium-
related chronic disease. Salt sensitivity is the extent of change in
blood pressure in response to a change in salt intake (Ref. 10). Salt
sensitivity differs among subgroups of the population as well as among
individuals within a subgroup. Subgroups that have been reported to
have a high prevalence of salt sensitivity include individuals 51 years
of age and older, African Americans, and individuals with hypertension,
diabetes or chronic kidney disease. The 2010 DGA recommended that
Americans reduce sodium intakes and also noted that these population
subgroups, representing nearly half of the U.S. population, would
benefit from even greater reductions in sodium intake than the general
population. We have considered the challenges related to lowering the
DV for sodium. For example, lowering the value on which the percent DV
declaration is based would likely require efforts to ensure consumer
understanding of the new percent DV declaration of sodium on the
Nutrition Facts label. Based on recent dietary recommendations from
consensus reports, currently available scientific evidence, comments in
response to the 2007 ANPRM, and the 2005 CSPI petition, we considered
the following options for updating the DV for sodium:
    (1) A DRV of 2,300 mg which reflects the UL for individuals aged 14
years and older;
    (2) An RDI of 1,500 mg which reflects the AI for individuals 9 to
50 years of age; and
    (3) Alternative approaches such as retaining a DRV of 2,400 mg,
using a tiered approach or setting a DRV of 1,900 mg based on the UL
for children 4 to 9 years of age.
    i. DRV of 2,300 mg/d. A DRV of 2,300 mg, which represents the UL
for the majority of the population (persons 14 years of age and older),
would be consistent with both the 2005 and 2010 DGA recommendations for
sodium intake for the general population, as well as the 2013 IOM
report on Sodium Intake in Populations. However, while a DRV of 2,300
mg would reflect the UL that is applicable to 88 percent of the U.S.
population, including those who are susceptible to the blood pressure-
raising effects of sodium, it would exceed the UL for children 4 to 13
years of age which is 1,900mg/day for children 4-8 years of age and
2,000mg/day for children 9-13 years of age.
    Setting the DV at 2,300 mg would classify the level as a DRV
(rather than an RDI) and represent a reference intake level not to
exceed. As such, it would be consistent with our current and proposed
approach to using DRVs for other nutrients that should be limited in
the diet and for which there are concerns of excess intake and risk of
chronic disease or health-related conditions, for example, saturated
fat

and cholesterol. The current and proposed DRVs for saturated fat and
cholesterol are based on quantitative intake recommendations and
underlying science that links the excess intake of these nutrients to
specific adverse health effects (Ref. 6) (see sections II.B.2 and
II.C.). We do note, however, that unlike saturated fat and cholesterol,
sodium is an essential nutrient and, in the DRI Electrolytes report,
the IOM established an AI for sodium.
    Results from the FDA Health and Diet Surveys have shown that
consumers are aware that too much sodium is unhealthy (Refs. 39 to 41)
and this awareness would suggest consumer acceptance of a DV based on a
level not to exceed would be consistent with a DRV of 2,300 mg.
Changing the DRV from 2,400 mg to 2,300 mg would likely result in less
consumer confusion than changing the DRV to an RDI (a level to achieve)
of 1,500 mg. Moreover, we have no data to suggest that lowering the
reference value for the percent DV could result in consumer confusion,
as claimed by a commenter (Ref. 47).
    ii. RDI of 1,500 mg. An RDI of 1,500 mg, based on the highest AI
(i.e., among adults aged 19 to 50 years), would provide a daily average
intake level that would reflect a low prevalence of inadequate sodium
intakes of healthy and moderately active individuals while allowing for
adequate intakes of other essential nutrients. As opposed to 2,300 mg,
a DV of 1,500 mg would classify the level as an RDI representing a
reference intake level to achieve. The 2005 IOM electrolytes report
reviewed the evidence on low sodium intake and blood lipid
concentrations and insulin resistance and noted that the AI of 1,500
mg/d exceeds the levels of sodium intake (typically less than 700 mg/d)
that have been associated in some studies with adverse effects of blood
lipid concentrations and insulin resistance (Ref. 10). The 2005 IOM
electrolytes report reviewed the evidence for plasma renin and
concluded that, in contrast to blood pressure, there is no consensus on
the interpretation of plasma renin activity and its role in guiding
therapy for high blood pressure (Ref. 10). Similar to plasma renin
activity, the evidence for the role of sympathetic nerve activity and
aldosterone is limited, and therefore neither is recognized as
surrogate endpoints for CVD risk. Therefore, the AI of 1,500 mg/d
exceeds the levels associated with low sodium intake and the previously
discussed adverse effects.
    Using the population-coverage AI to set the RDI for sodium would be
consistent with the proposed RDIs for other essential vitamins and
minerals for which AIs are established (e.g., vitamin K and choline)
(see section II.I.). AIs are similar to RDAs in that they meet the
needs of essentially all members of the population. Thus, using an AI
as a quantitative intake recommendation for setting an RDI would be
consistent with the proposed RDIs for other essential minerals that
have AIs or RDAs, such as potassium and calcium. Traditionally, we have
based the RDI for essential nutrients on quantitative intake
recommendations that reflect the intake level necessary to meet the
daily physiological needs for that nutrient. However, unlike the
consumption of other vitamins and minerals, the majority of the
population consumes sodium at levels that exceed the AI and the UL.
This makes sodium unique in comparison to other vitamins and minerals
for which people generally must strive to meet their daily needs.
    In addition, an RDI of 1,500 mg would be consistent with the 2010
IOM Sodium Strategies Report (Ref. 89). The IOM recommended that FDA
base the DV for sodium on the AI of 1,500 mg/d. First, the IOM stated
that using the AI is consistent with the approach used for all other
essential nutrients, where the DV is based on a reference value of
adequacy rather than a reference value of safety. Second, although
consumer data were not provided, the IOM strategies report argued that
the use of the AI could better inform consumers of the actual
contribution of sodium content to total sodium needs as an essential
nutrient. Third, the IOM stated that adopting the AI would avoid
misleading consumers into thinking that the sodium content of foods is
more favorable than is actually the case. As such, from a public health
perspective, the AI would provide a truer picture for the consumer of
the contribution of the particular foods in assembling a healthful diet
and is preferable for this purpose over the UL. Finally, the IOM opined
that lowering the DV might act as an incentive for companies to reduce
the sodium content of their foods because reducing the DV would result
in a higher value of percent DV declared on the label if sodium content
remained unchanged.
    The 2013 IOM Sodium Intake in Populations Committee concluded that
the evidence was insufficient and inconsistent to recommend sodium
intake levels below 2,300 mg/d for the general U.S. population based on
the direct outcomes of CVD or all-cause mortality. While this
recommendation does not address blood pressure or essentiality, it
provides a level that the general population should seek to reduce
their consumption to and therefore is a consideration in our proposal.
    ANPRM comments pointed out challenges related to the feasibility of
achieving a DV of 1,500 mg given the current marketplace and patterns
of sodium consumption as well as changes in our nutrient content
claims. If we were to adopt a DV of 1,500 mg, we anticipate that
consumer education efforts would be needed to help consumers understand
that the updated DV for sodium is a level to achieve rather than a
level to consume less than and also that consuming in excess of this
level would not be helpful. Additionally, the IOM set the AI, in part,
at a level that would allow individuals to meet the recommended intakes
of other nutrients if they adopted a carefully planned diet (Ref. 10)
and consumer education efforts would need to communicate that 1,500 mg/
d is a level that consumers should achieve rather than not exceed.
While the Agency is considering ways to support the reduction of sodium
in the food supply (76 FR 57050), significant changes in the food
supply would be needed to achieve this goal.
    An updated DV for sodium based on 1,500 mg/d would perhaps
necessitate revising other relevant regulatory requirements such as
nutrient content claims, however such revisions would be less likely if
the DV was updated to 2,300 mg. Previously, our decision to retain the
sodium level for a ``healthy'' claim (Sec.  101.65) at 480 mg/reference
amount customarily consumed (RACC) was based, in part, on technological
barriers and product acceptance issues by consumers with the more
restrictive level of 360 mg/RACC (70 FR 56828; September 29, 2005). We
acknowledge concerns from comments that consumers may find it difficult
to reduce dietary sodium levels to 1,500 mg/d.
    iii. Alternative approaches.
    A few comments suggested retaining 2,400 mg as the DRV for sodium.
Retaining the DRV of 2,400 mg would exceed the UL for sodium for the
entire population and there is no scientific evidence to support this
level. Therefore, we do not consider 2,400 mg an appropriate DRV for
sodium going forward. Also, based on ANPRM comments, we considered
setting an interim DRV of 2,300 mg that would be further lowered to an
RDI of 1,500 mg over time, providing companies a longer time to
manufacture new foods or reformulate existing products to lower the
sodium content. This approach would address concerns regarding the
feasibility of individuals being able to meet an RDI of 1,500 mg given
taste

preferences and sodium content of foods in the current marketplace. A
tiered approach would help to gradually achieve the adequate intake
level of 1,500 mg/d and would give manufacturers time to develop lower
sodium products and for consumers to adjust their taste preferences. In
addition, this approach would be consistent with the 2010 DGAC
recommendations which suggested that reduction in sodium intakes to
1,500 mg/d among Americans should occur gradually over time to allow
for adjustments in taste perceptions and to accompany changes in the
sodium content of foods in the marketplace.
    We tentatively conclude that there is inadequate justification in
consensus reports or arguments presented by comments (Ref. 47) to
propose a tiered option. While levels of sodium intake may need to
decrease gradually due to time needed for modifications to the sodium
content of the food supply and consumer taste preferences, the DV for
sodium should reflect an amount that will assist consumers in
maintaining healthy dietary practices and in understanding the relative
significance of the percent DV for a particular food in the context of
the total daily diet. Moreover, DVs are based on scientific data
supporting healthy dietary practices, not on the levels of a nutrient
present in the food supply.
    We also considered using 1,900 mg/d, the UL for children 4 to 8
years of age, to set the DRV for sodium. Using the lowest UL for a
population above 4 years of age is consistent with the population-
coverage approach discussed in section II.1.5. In this case, it is a
population-coverage approach that is protective for the age and gender
subpopulation with the lowest relative UL, providing an intake level
that is likely to pose no risk for any age or gender subpopulations.
This is in contrast to the population-coverage approach, using the RDA
or AI for other essential vitamins and minerals, to ensure that all age
and gender subpopulations consume adequate amounts. However, a DRV of
1,900 mg is not aligned with any recommendations from consensus reports
including the 2010 IOM Sodium Intake in Populations and was not
suggested by any comments.
    e. Proposed DV--After considering the options discussed previously,
we are proposing to set a DRV of 2,300 mg for sodium based on the UL
for individuals ages 4 years of age and older (proposed Sec.
101.9(c)(8)(iv)). First, a DRV of 2,300 mg would be consistent with the
current sodium intake recommendations from consensus reports. Second, a
DRV of 2,300 mg would be consistent with our current and proposed
approach for other nutrients that should be limited in the diet and for
which there are concerns of excess intake and risk of chronic disease
and health-related conditions. Third, consumers are generally aware
that too much sodium is not healthy and therefore the current consumer
education messaging is consistent with a DRV of 2,300 mg.
    For the reasons explained previously, we tentatively conclude that
a DRV of 2,300 mg for sodium is the most appropriate DV to assist
consumers in maintaining healthy dietary practices and in understanding
the relative significance of the sodium content within the context of a
total daily diet. We invite comment on our consideration of various
options and tentative conclusions presented in this section. In
particular, we invite comment on: (1) The rationale for the proposed
DRV of 2,300 mg of sodium; (2) whether an RDI of 1,500 mg would be more
appropriate and why; and (3) whether any alternative approaches for
selecting a DV for sodium and their public health bases for these
approaches could be more appropriate and why. We are also interested in
data and factual information on consumer understanding, interpretation,
and use of the percent DV of sodium declared on food labels, including
the understanding and potential influences of a DV that reflects an RDI
based on an AI (an intake level to not consume less of), instead of a
DRV based on a UL (an intake level not to exceed).

G. Fluoride

1. Voluntary Declaration
    FDA regulations do not require or permit the declaration of
fluoride on the Nutrition Facts label. In 1993, no U.S. consensus
report had set a quantitative intake recommendation for fluoride. The
2007 ANPRM did not ask questions regarding the declaration of fluoride,
but several comments supported the voluntary declaration of fluoride in
mg or mcg amounts (Ref. 47). We are considering in this proposed rule
whether fluoride should be required or permitted to be declared or
whether the lack of provisions should be maintained.
    Fluoride is a nonessential nutrient, but there is well established
evidence for the role of fluoride in reducing the risk of dental caries
(Ref. 90). The IOM set a quantitative intake recommendation for
fluoride based on its role in the reduction of risk of dental caries.
Additionally, in 2006, a FDAMA notification for a health claim for
fluoride in bottled water and dental caries was submitted to us under
section 403(r)(2)(G) of the FD&C Act (Ref. 91). We did not object to
the notification, indicating that we considered the evidence submitted
to be sufficient for bottled water that meets the standards of identity
and quality set forth in Sec.  165.110 and the general requirements for
health claims in Sec.  101.14 to bear the claim (Ref. 91). Given that
the positive health effects of fluoride are well-established, we
tentatively conclude that declaration of fluoride content of a food can
provide consumers with information to assist them in maintaining
healthy dietary practices. However, as discussed in section II.G.2., a
DRV cannot be established based on available quantitative intake
recommendations. Thus, while fluoride is a nutrient with public health
significance, an appropriate quantitative intake recommendation is not
available for setting a DRV.
    Therefore, consistent with the factors we consider for declaration
of non-statutory nutrients discussed in section I.C., we are proposing
to amend Sec.  101.9(c)(5) to provide for voluntary declaration of
fluoride. In addition, consistent with existing provisions for
voluntary declaration of other nutrients, we are proposing that the
declaration of fluoride would be mandatory when a claim about fluoride
is made on the label or in labeling of foods. We are also proposing
that when fluoride content is declared, it must be expressed as zero
when a serving contains less than 0.1 mg of fluoride, to the nearest
0.1 mg increment when a serving contains less than or equal to 0.8 mg
of fluoride, and the nearest 0.2 mg when a serving contains more than
0.8 mg of fluoride, consistent with how we have approached incremental
values for other nutrients that are present in food in small amounts.
2. DRV
    FDA regulations do not provide an RDI or DRV for fluoride. The 2007
ANRPM discussed the DRIs for fluoride and asked whether we should
establish a DV, given the availability of an AI. We considered current
recommendations and scientific evidence as well as comments received
(Ref. 47).
    In 1997, the IOM established DRIs (AIs and ULs) for fluoride (Ref.
90). The AI was set at 3 mg/d for women 19 years and older and 4 mg/d
for men 19 years or older, to represent the intake value that reduces
the occurrence of dental caries maximally in a group of individuals
without causing unwanted side effects. AIs for children are 0.7 mg/d (1
through 3 years), 1 mg/d (4 through

8 years), and 2 mg/d (9 through 13 years). In addition, the IOM set a
UL for fluoride at 10 mg/d (0.1 mg/kg/d) for individuals older than 8
years, based on data that suggest that increased risk of developing
early signs of skeletal fluorosis is associated with fluoride intakes
greater than 10 mg/d. The UL for children 4 through 8 years is 2.2 mg/d
based on risk of developing moderate enamel fluorosis.
    A recent report highlighted the potential adverse impact of excess
fluoride intake (Ref. 92). These adverse impacts include moderate
enamel fluorosis in children up to 8 years and skeletal fluorosis for
individuals older than 8 years. In 2010, the Environmental Protection
Agency (EPA) published a report on exposure of fluoride from various
sources. This report provided a benchmark of no more than 0.08 mg/kg/d
of total fluoride intake to protect 99.5 percent of the population from
severe dental fluorosis (Ref. 92). These benchmark levels (e.g., 1.68
mg/d for 4 to 7 years; 2.56 mg/d for 7 to 11 years; 4.08 mg/d for 11 to
14 years of age; and 5.6 mg/d for adults) are considerably lower than
the ULs set by IOM in 1997.
    Thus, although the IOM set AIs for fluoride based on its role in
reducing the risk of dental caries, more recent conclusions have
highlighted concern about dental fluorosis associated with excess
intakes. Because an RDI of 4 mg, using the population-coverage AI of 4
mg/d, exceeds or is equivalent to EPA's benchmark values for children 4
to 14 years of age (1.68 to 4.08 mg/d), we are not proposing to set a
DRV for fluoride.
    We considered concerns expressed by comments that a DRV should not
be established because fluoride is not an essential nutrient. That
fluoride is not essential is not, in itself, a justification for not
establishing a DV for fluoride, because there is evidence demonstrating
that dietary fluoride exposure is beneficial to public health owing to
its ability to inhibit the development of dental caries in both
children and adults (Ref. 90). However, we are not proposing to set a
DRV for fluoride for other reasons as explained previously. We also do
not consider that the DRV for fluoride should be set at zero because of
concerns with adverse health effects and toxicity, as suggested by a
comment. The IOM established an AI for fluoride based on risk reduction
of dental caries. In addition, the ULs for children and adults that are
set based on dental and skeletal fluorosis are greater than zero.
Moreover, FDA regulations other than those related to nutrition
labeling are intended to prevent excessive addition of fluoride in
foods (Sec. Sec.  165.110 and 170.45).

H. Essential Vitamins and Minerals of Public Health Significance

    In addition to sodium, a statutorily required nutrient, FDA
regulations require the declaration of four essential vitamins and
minerals, namely, vitamin A, vitamin C, calcium, and iron (Sec.
101.9(c)(8)(ii)). Vitamins and minerals that may be declared
voluntarily are vitamin D, vitamin E, vitamin K, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, chloride, and potassium. In
1993, we identified vitamins A and C, calcium, and iron for mandatory
declaration because we considered them to be nutrients of public health
significance based on their inadequate dietary intakes among specific
segments of the U.S. population and because they were identified as
nutrients of potential public health significance in consensus reports
(Refs. 88, 93 to 95) (58 FR 2079 at 2106). We continue to consider,
consistent with the rationale put forth in 1993, that a vitamin or
mineral's public health significance should be the key factor in
mandatory labeling (58 FR 2079 at 2106).
    In this section of the proposed rule, we discuss essential vitamins
and minerals that are not expressly required to be declared by statute
(referred to as ``non-statutory''). We are using our discretion, as
described in this document, to propose mandatory declaration of certain
non-statutory essential vitamins and minerals and voluntary declaration
of others. Our tentative conclusions are based on an assessment of
scientific data available for these nutrients, and consideration of the
factors discussed in section I.C. (explained in this document). The
RDIs that we are proposing for the declaration of vitamins and minerals
are discussed in section II.I.
    We conducted an analysis of available data to determine the public
health significance of non-statutory essential vitamins and minerals.
The 2010 DGA identified nutrients of public health concern for the
general U.S. population using criteria that are similar to factors that
FDA considered in its own analysis (Ref. 6). The factors and the
evaluation process used in our analysis, discussed in greater detail in
Ref. 48, incorporate whether a DRI (i.e., RDA or AI) is based on a
chronic disease risk (e.g., osteoporosis), a health-related condition
(e.g., high blood pressure), or a nutrient deficiency with clinical
significance (e.g., low iron storage leading to iron deficiency anemia)
and whether national survey data on nutrient intake, and/or, when
available, biomarkers of nutrient status, provide evidence of
inadequate intakes in the general healthy U.S. population (4 years of
age and older). Furthermore, we consider whether a substantial
prevalence exists in the general population of a chronic disease,
health-related condition, or nutrient deficiency with clinical
significance that was linked to the particular nutrient (e.g.,
potassium and risk of high blood pressure).
    To estimate the prevalence of nutrient adequacy or inadequacy in
the U.S. population, we compared dietary intake data with the EAR or AI
(whichever is established by the IOM for a particular nutrient) (Ref.
96) and, when reliable biomarkers of nutritional status were available,
we compared the biomarker survey data with the data on adequacy of
nutrient intake. The use of reliable status biomarker data provides
assessments of nutrient status, independent of subjective factors
associated with assessing nutrient intake, such as underreporting of
food intake (Ref. 97 pp. 373, 513, 534, 602, and 606). In the 2007
ANPRM, we sought input on whether vitamin A, vitamin C, calcium, and
iron are still considered to be of public health significance; and (2)
whether there are other micronutrients of public health significance.
We received several comments in response to these questions (Ref. 47).
    Based on our analysis of data, and considering the factors for
mandatory and voluntary declaration discussed in section I.C. and the
comments received, as discussed in this document, we are proposing to:
(1) With respect to essential vitamins and minerals that are currently
required to be declared, retain mandatory declaration of calcium and
iron and provide for voluntary declaration of vitamins A and C; and (2)
with respect to essential vitamins and minerals that are permitted to
be declared, require the declaration of potassium and vitamin D and
retain voluntary declaration of others. We discuss these proposed
changes in this document.
1. Essential Vitamins and Minerals That Are Mandatory
    a. Calcium--Calcium content must be declared as a percent DV on the
Nutrition Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the
declaration of calcium in nutrition labeling because: (1) There were a
limited number of calcium-rich foods in the food supply; (2) calcium
intakes in the United States were generally marginal; (3) adequate
calcium intakes are needed to allow for

optimal bone mass development during childhood and young adulthood (55
FR 29487 at 29501); and (4) calcium was identified as a nutrient of
public health significance in the 1990 IOM report (Ref. 95) and in
other consensus reports (Refs. 88,93,94) (58 FR 2079 at 2106). In
response to the 2007 ANPRM, many comments maintained that calcium is
still considered a nutrient of public health significance, especially
in bone development, and therefore should be retained as a mandatory
nutrient on the Nutrition Facts label.
    Our analysis of NHANES (2003-2006) data shows that usual calcium
intakes among the U.S. population continue to be low. About 49 percent
of individuals ages 4 years and older have usual calcium intakes from
conventional foods below the EAR, and 37 percent have intakes from both
conventional foods plus supplements below the EAR (table 1). The 2010
DGA, too, recognized that low intakes of calcium are a public health
concern for the general U.S. population (Ref. 6). We are unable to
consider biomarker data because sensitive biochemical indicators
reflecting calcium nutritional status are lacking.
    In setting DRIs for calcium, the IOM reviewed various endpoints
(e.g., bone health, cancer, cardiovascular disease and diabetes), and
bone health was the only endpoint with sufficient evidence to set a DRI
(Ref. 22). Therefore, the IOM set age- and gender-specific DRIs based
on the level of calcium intake consistent with bone accretion,
achieving and maintaining bone calcium balance, minimizing the degree
of bone loss, and reducing the risk of fracture in later stages of life
(Ref. 22). The DRIs for calcium assume adequate intakes of vitamin D, a
nutrient which is essential for promoting calcium absorption in the gut
and for maintaining adequate calcium levels in the blood (Ref. 22).
Building strong bones during childhood and adolescence can help prevent
osteoporosis (the most common bone disease) later in life. Adequate
calcium intakes are needed to allow for optimal bone mass development
during childhood and young adulthood and to decrease rate of bone loss
in adults (Ref. 22). An estimated 10 million Americans over 50 years of
age have osteoporosis, while another 34 million are at risk and an
estimated 1.5 million people suffer an osteoporotic-related fracture
each year (Ref. 98). Furthermore, based on 2005-2006 NHANES data, about
5.3 million older men and women in the United States have osteoporosis
at the femur neck, and 34.5 million more have osteopenia (low bone
mass) in the femur neck (Ref. 99).
    In addition, we independently reviewed data related to calcium
intake and risk reduction of osteoporosis (Sec.  101.72) and authorized
two health claims for this association, signifying calcium's critical
role in the reduction of risk of this chronic disease in the general
healthy population.
    In view of the benefits of adequate calcium intake on bone health,
reflected in the IOM's DRIs, relatively low intakes of calcium, and the
high prevalence of osteoporosis and osteopenia among the U.S.
population, we tentatively conclude that calcium is a nutrient of
public health significance and its declaration continues to be
necessary to assist consumers in maintaining healthy dietary practices.
Therefore, consistent with the factors we consider for mandatory
declaration of non-statutory nutrients (see section I.C.), we are not
proposing any changes to the current requirement for declaration of
calcium on the Nutrition Facts label, as specified in Sec.
101.9(c)(8)(ii).
    b. Iron--Iron must be declared as a percent DV on the Nutrition
Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the
declaration of iron because (1) iron was identified as a nutrient of
public health significance in a 1990 IOM report (Ref. 95) and in other
consensus reports (Refs. 88,93,94); and (2) iron deficiency was a risk
for certain segments of the U.S. population (i.e., young children,
adolescents and women of childbearing age and pregnant women,
especially those with low incomes) (58 FR 2079 at 2106). In response to
the 2007 ANPRM, comments suggested retaining the mandatory declaration
of iron because it is a nutrient of concern for women of childbearing
age identified by the 2005 DGA (Ref. 36) and substantial numbers of
adolescent females and women of childbearing age are iron deficient.
    Our analysis of NHANES (2003-2006) intake data shows that about 3.5
percent of the population ages 4 years and older (excluding pregnant
and lactating women) have inadequate iron intakes from conventional
foods (i.e., an intake below the EAR), and about 3.3 percent have
inadequate iron intakes from conventional foods and dietary supplements
(table 1). Subpopulation analyses of these NHANES 2003-2006 data shows
that about 11.2 percent of women of childbearing age (12 to 49 years of
age) continue to have intakes below the EAR, from conventional foods
only and 10.4 percent continue to have intakes below the EAR from
conventional foods plus dietary supplements (table 1).
    We also considered data for several status biomarkers related to
iron nutrition, in addition to intake data. Serum ferritin is the major
iron-storage compound and its concentration declines in the early
stages of the development of iron deficiency (Refs. 100 and 101).
Although low serum ferritin concentration is an indicator of early iron
deficiency, it does not necessarily reflect the severity of iron
depletion as it progresses (Ref. 101). In addition to determining serum
ferritin, when relevant NHANES data were available, we also considered
iron deficiency based on estimating stored body iron using the ferritin
model and the body iron model (Ref. 102). Compared to the ferritin
model, the body iron model is reported to produce lower estimates of
prevalence of iron deficiency, better predict anemia, and be less
affected by inflammation, although this model has some limitations
(Ref. 103). Data from NHANES 1999-2002 for the general U.S. population
showed a prevalence of iron deficiency, based on serum ferritin
concentration (less than 15 nanograms (ng)/mL), body iron stores (based
on the ferritin model), and iron deficiency anemia (defined as having
iron deficiency and a low hemoglobin value) of 8.3, 6.5 and 1.9
percent, respectively (table 1). The IOM set age and gender specific
DRIs (EARs and RDAs) based on factorial modeling, which included basal
iron losses, menstrual losses, fetal requirements in pregnancy,
increased requirements during growth for the expansion of blood volume,
and/or increased tissue and storage iron (Ref. 100). Although the DRIs
were not based directly on a chronic disease risk, iron deficiency and
low iron stores over time will lead to iron deficiency anemia, an
advanced stage of iron deficiency (Ref. 100). Anemia is associated with
poor cognitive function, lower work performance, and low endurance in
the general population; delayed psychomotor development in infants; and
adverse pregnancy outcome (Ref. 100).
    Relevant biomarker data were available from NHANES 2003-2006 for
certain subpopulations such as women of childbearing age (12 to 49
years old). Analyses of these data showed that about 14 percent of
women of childbearing age (12 to 49 years) had serum ferritin
concentration less than 15 ng/mL, while 10 and 14.5 percent of women
had inadequate stores of body iron based on the body iron model or
ferritin model, respectively (table 1). In addition, about 4.7 percent
of these women had iron deficiency anemia. Based on these prevalence
rates, the absolute numbers of individuals with iron deficiency in
women of

childbearing age using 2010 projected U.S. Census data translate into
7.2 or 11.6 million women of childbearing age (12 to 49 years of age)
with inadequate iron stores based on body iron model or ferritin model,
respectively. About 3.76 million of these women are considered to have
iron deficiency anemia. Thus, iron continues to be of public health
significance among women of childbearing age and pregnant women, who
account for 26 percent of the general U.S. population.
    Iron is also identified as a nutrient of public health significance
in consensus reports. For example, Healthy People 2020 identified iron
as a nutrient of public health significance among young children (1 to
4 years of age), women of childbearing age (12 to 49 years of age), and
pregnant women, and announced an objective of a ten percent reduction
in iron deficiency (using the body iron model) by the year 2020 (Ref.
104). Similarly, the 2010 DGA identified iron as a nutrient of concern
among women capable of becoming pregnant and recommends choosing foods
that supply heme iron, which is more readily absorbed by the body,
additional iron sources, and enhancers of iron absorption such as
vitamin C-rich foods (Ref. 6).
    Given the importance of the role of iron in public health and
continued significance of inadequate intakes and deficiency among women
of childbearing age, a significant portion of the general healthy
population, we tentatively conclude that iron is a nutrient of public
health significance and its declaration continues to be necessary to
assist consumers in maintaining healthy dietary practices. Therefore,
consistent with the factors used for mandatory declaration of non-
statutory nutrients (see section I.C.), we are not proposing any
changes to the current requirement for declaration of iron on the
Nutrition Facts label, as specified in Sec.  101.9(c)(8)(ii).
    c. Vitamin A--Vitamin A must be declared as a percent DV on the
Nutrition Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the
declaration of vitamin A in nutrition labeling because (1) it was found
in a limited number of foods within the food supply, and (2) a 1990 IOM
labeling report (Ref. 95) identified vitamin A as a nutrient of
potential public health significance and stated that certain
subpopulations (children under 5 years of age) were still at risk of
deficiency for this vitamin (58 FR 2079 at 2106). In response to the
2007 ANPRM, several comments recommended retaining the mandatory
declaration of vitamin A, with some noting that the 2005 DGA identified
it as a nutrient of concern (Ref. 36). Our analysis of intake data from
NHANES 2003-2006 estimated that about 45 percent of the general U.S.
population has usual vitamin A intakes from conventional foods below
the EAR, and 34 percent have intakes from conventional foods plus
dietary supplements below the EAR (table 1). However, the prevalence of
vitamin A deficiency is not apparent. Only about 0.3 percent of those
ages 6 years and older (excluding pregnant and lactating women) have a
serum retinol concentration (a biomarker of vitamin A status) below 20
mcg/dL, a cutoff level that is used as an indicator of vitamin A
deficiency (table 1) (Refs. 6 and 105). Because serum retinol levels
are tightly regulated (homeostatically controlled) and do not always
reflect total body status, using serum vitamin A for assessment of
vitamin A status of individuals may not be useful (Ref. 101). However,
the distribution of serum retinol levels in a population plus the
prevalence of individuals with serum retinol levels below a given
cutoff point may offer a better picture of the vitamin A status of a
population (Ref. 101). Based on the analysis of distribution of serum
retinol (NHANES 2003-2006), and the prevalence of those below the
cutoff of 20 mcg/dL (0.3 percent), we estimated that the prevalence of
vitamin A deficiency in the general U.S. population is not apparent.
    The IOM recognized that vitamin A deficiency is rarely seen in the
healthy U.S. population (Ref. 105). Furthermore, the specific age and
gender DRIs (EAR and RDA) set by the IOM were based on the amount of
dietary vitamin A required to maintain adequate liver stores in well-
nourished subjects, rather than on a specific adverse public health
endpoint (Ref. 105). The DRIs represent an amount that will assure
vitamin A reserves to cover periods of increased needs such as stress
and low vitamin A intake (Ref. 105). In addition, the 2010 DGA does not
include vitamin A among the list of nutrients of public health concern
for the general U.S. population (Ref. 6).
    We also considered whether any changes are necessary to the
provision for voluntary declaration of the portion of vitamin A
activity derived from [beta]-carotene, including whether its mandatory
declaration is appropriate, as suggested by a comment. One comment
noted that [beta]-carotene intake, in particular, needs to be
increased, but the comment provided no further explanation. The IOM did
not set DRIs for [beta]-carotene and other carotenoids due to limited
scientific data (Ref. 18). The only known function of provitamin A
carotenoids (i.e., [alpha]-carotene, [beta]-carotene, and [beta]-
cryptoxanthin, which can be converted into vitamin A (retinol) in the
body) in humans is to act as a source of vitamin A in the diet (Ref.
18). Furthermore, there is no clear evidence that suggests a protective
association between dietary vitamin A or [beta]-carotene and risk
reduction of chronic diseases, such as cardiovascular disease and
cancers (Ref. 105). In addition, evidence from large clinical trials
suggests that [beta]-carotene supplementation increases the incidence
of lung cancer in a high-risk population (e.g., current or former
smokers, asbestos workers) (Refs. 106 and 107). Further, the IOM
introduced mcg of RAEs (retinol activity equivalents) as a new unit for
expressing vitamin A activity to account for the reduced absorption for
provitamin A carotenoids, including [beta]-carotene (Ref. 105). This
new unit, which would be the appropriate unit for declaring vitamin A
on the Nutrition Facts label, takes into consideration vitamin A from
all sources as well as the bioavailability of [beta]-carotene and other
provitamin A carotenoids (see section II.J.3.).
    Our analysis demonstrates that, even though vitamin A intakes
appear to be low, vitamin A deficiency based on an assessment of
vitamin A status is rare in the U.S. population. The IOM did not set a
quantitative intake recommendation for vitamin A based on a public
health endpoint. Thus, we tentatively conclude that vitamin A is no
longer a nutrient of public health significance for the general U.S.
population. Therefore, consistent with the factors for declaration of
non-statutory nutrients (see section I.C.), we are proposing to amend
101.9(c)(8)(ii) to no longer require, but to permit voluntary
declaration of vitamin A on the Nutrition Facts label. However, vitamin
A declaration would remain mandatory when vitamin A is added as a
nutrient supplement or claims are made about it on the label or in
labeling of foods. We are also not proposing to change the current
provision for voluntary declaration of the percent of vitamin A that is
present as [beta]-carotene, as specified in Sec.  101.9(c)(8)(vi). We
request comment about whether there is an appropriate alternative
analysis to application of the factors in section I.C. regarding the
mandatory declaration of vitamin A.
    d. Vitamin C--Vitamin C must be declared as a percent DV on the
Nutrition Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the
declaration of vitamin C because (1) a 1990 IOM labeling report (Ref.
95) identified vitamin C as a nutrient of potential

public health significance and stated that certain subpopulations were
considered at risk of deficiency (such as elderly individuals on
inadequate diets and infants fed cow's milk exclusively) (58 FR 2079 at
2106), and (2) vitamin C was thought to play a role in promoting the
intestinal absorption of non-heme iron, meaning that vitamin C in the
same food as iron was considered to help prevent iron deficiency
anemia, while excess vitamin C was considered to increase the risk of
excessive iron absorption (55 FR 29487 at 29501, July 19, 1990). In
response to the 2007 ANPRM about whether vitamin C is still a nutrient
of public health significance, several comments recommended retaining
the mandatory declaration of vitamin C, with some stating that vitamin
C should be retained because it is a nutrient of concern identified by
the 2005 DGA (Ref. 36), and is an enhancer of iron absorption for women
of childbearing age.
    Our analysis of NHANES 2003-2006 estimated that about 35 percent of
the general U.S. population has usual vitamin C intakes below the EAR,
from conventional foods only and 27.5 percent have intakes below the
EAR from conventional foods and supplements (table 1). While the
prevalence of inadequate intake is high, prevalence of vitamin C
deficiency is not apparent in the U.S. population. Only about 6 percent
of the general population had serum vitamin C concentrations below 11.4
micromoles ([mu]mol)/L, a cutoff level that is used as an indicator of
vitamin C deficiency (Ref. 97 p.534; Ref. 101). The EAR for vitamin C
is based on estimates of body pool or tissue levels of vitamin C that
are required for antioxidant protection with minimal urinary loss, not
on a public health endpoint (Ref. 18).
    The effects of vitamin C on risk of chronic diseases, such as
cardiovascular disease or cancer, are not conclusive at this time (Ref.
18). We issued a letter of enforcement discretion on qualified health
claims for vitamin C supplement intake and reduced risk of cancers, in
which we concluded that there was no credible evidence on the risk
reduction from vitamin C for most cancers (squamous cell cancer of the
esophagus, colorectal, laryngeal, lung, oral cavity, pancreatic,
pharyngeal, renal cell, and salivary gland cancers), and very limited
evidence for an association between vitamin C supplement intake and
gastric cancer (Ref. 108).
    The 2010 DGA does not include vitamin C among the list of nutrients
of public health concern for the general U.S. population (Ref. 6).
However, the 2010 DGA recommends that women capable of becoming
pregnant choose foods that are enhancers of iron absorption, such as
vitamin C-rich foods (Ref. 6). While we agree that vitamin C enhances
iron absorption, the prevalence of vitamin C deficiency in this
subpopulation is not apparent. Only about 6 percent of this subgroup
had serum vitamin C concentrations below 11.4 [mu]mol/L (table 1).
    Based on the previous analysis and information, we tentatively
conclude that while vitamin C intakes are low, vitamin C deficiency is
uncommon and vitamin C is no longer a nutrient of public health
significance for the general U.S. population. Therefore, consistent
with the factors we consider for declaration of non-statutory nutrients
(see section I.C.), we are proposing to amend Sec.  101.9(c)(8)(ii) to
no longer require, but to permit voluntary declaration of vitamin C on
the Nutrition Facts label. However, vitamin C declaration would remain
mandatory when vitamin C is added as a nutrient supplement or claims
are made about it on the label or in labeling of foods. We request
comment about whether there is an appropriate alternative analysis to
the application of the factors in section I.C. regarding the mandatory
declaration of vitamin C.
2. Essential Vitamins and Minerals That Are Voluntary
    a. Vitamin D--The declaration of vitamin D content in nutrition
labeling is voluntary, unless vitamin D is added as a nutrient
supplement or claims are made about it (Sec.  101.9(c)(8)(ii)). In
1993, we determined that vitamin D is not of particular public health
significance in the United States because the human requirement for
vitamin D could be met with sufficient exposure to sunlight and milk
and other foods that were fortified with vitamin D. As a result,
deficiencies in this vitamin were very rare (58 FR 2079 at 2107). In
response to the 2007 ANPRM about what, if any, other micronutrients are
of public health significance, several comments recommended vitamin D
for mandatory declaration citing vitamin D inadequacy; relationship of
vitamin D to chronic disease risk (e.g., rheumatoid arthritis, multiple
sclerosis, and cancers, such as prostate, breast, lung, colon, and
colorectal cancers); and the 2005 DGA, which identified vitamin D as a
nutrient of concern for certain subpopulations (e.g., older adults,
people with dark skin, and those exposed to insufficient ultraviolet
band radiation) (Ref. 36).
    The IOM set age and gender specific DRIs (EAR and RDA) for vitamin
D at a level that would achieve and maintain serum 25-hydroxy vitamin D
(25(OH)D) concentrations above a defined level (40 to 50 nanomoles
(nmol)/L) in order to maintain bone health (Ref. 22). Vitamin D has a
role in bone health through calcium absorption and uptake by bones
(Ref. 22). In addition, in 2008, we authorized a health claim for
calcium and vitamin D intake and reduced risk of osteoporosis (Sec.
101.72), signifying vitamin D's critical role in the risk reduction of
this chronic disease.
    Vitamin D can be obtained through dietary sources, such as fish
(e.g., salmon, rockfish, and tuna) and shellfish, which are the primary
natural food sources of vitamin D. FDA affirmed certain uses of vitamin
D food ingredients as Generally Recognized as Safe (GRAS) with specific
limitations as listed in Sec.  184.1950. Under Sec.  184.1(b)(2), an
ingredient affirmed as GRAS with specific limitations may be used in
food only within such limitations, including the category of food,
functional use, and level of use. Any addition of the ingredient to
food beyond the limitations set out in Sec.  184.1950 requires either a
food additive regulation or an amendment of Sec.  184.1950. In this
way, FDA can ensure that the vitamin D ingredients are added to food at
safe levels. For detail on estimating dietary intake of substances in
food, see FDA's Guidance for Industry: Estimating Dietary Intake of
Substances in Food (Ref. 109). Under FDA regulations (Sec. Sec.
172.380 (21 CFR 172.380) and 184.1950), vitamin D can be added in
specific amounts to foods such as breakfast cereals, grain products and
pastas, fluid milks and milk products, and calcium-fortified juices. As
for any vitamin or mineral, when vitamin D is added to a food, the
total amount per serving must be declared in the Nutrition Facts label.
In addition to dietary sources of vitamin D from conventional foods and
dietary supplements, vitamin D is synthesized in the skin following
direct exposure to the sun. Therefore, sunlight exposure is an
important source of vitamin D.
    Serum concentration of 25(OH)D is widely considered as a biomarker
of total vitamin D nutritional status and is recommended to be used for
assessing vitamin D total exposure from all sources, including
conventional foods, dietary supplements, synthesis from sun, and
conversion of vitamin D from adipose stores in liver (Ref. 22). Our
analysis of NHANES 2003-2006 data showed that about 18 percent of the
U.S. population 4 years and older (excluding pregnant and lactating
women) have serum 25(OH)D levels below the 40 nmol/L (a level set by
IOM as equivalent to EAR), which indicates an increased risk of
inadequate vitamin D exposure.

NHANES data collection normally does not include serum levels in the
northern regions of the United States in the winter months, when one
would expect a lower serum vitamin D level. Therefore, analysis of
NHANES data may underestimate the prevalence of low serum vitamin D
levels in the Unites States population. Analysis of NHANES 2005-2008
dietary data showed that, about 94 percent of the U.S. population have
usual vitamin D intakes below the EAR from conventional foods only and
62 percent have intakes below the EAR from conventional foods and
supplements (table 1). The IOM set the DRIs (e.g., EAR) assuming
minimal sun exposure (Ref. 22).
    Furthermore, approximately 24 percent of the U.S. population ages 4
years and older have serum 25(OH)D concentrations between 30 and 50
nmol/L, levels that indicate risk for inadequacy according to the IOM
and CDC (Refs. 22 and 101). Approximately 32 percent of the U.S.
population have serum 25(OH)D levels below 50 nmol/L (a level set by
IOM as equivalent to RDA and associated with optimal benefit for nearly
all the population) (Ref. 22). Also, about 8 percent have serum 25(OH)D
levels below IOM's cutoff of 30 nmol/L and may be at increased risk of
vitamin D deficiency. Vitamin D deficiency results in inadequate bone
mineralization or demineralization of the skeleton including rickets,
osteomalacia, and osteoporosis (Ref. 22). The 2010 DGA, too,
highlighted vitamin D as a nutrient of concern for the U.S. population,
in general, rather than for specific population groups alone (Ref. 6).
    We do not agree with some comments that suggested that vitamin D
intake should be mandatory on the label because of its relationship to
disease risk reduction, generally. The IOM did not set DRIs for vitamin
D based on its protective effect against diseases, such as cancers,
cardiovascular disease, and diabetes, because the scientific evidence
does not support a role other than that associated with bone health
(Ref. 22).
    In view of the benefits of adequate vitamin D intakes on bone
health, reflected in the IOM's DRIs, data indicating inadequate
intakes, poor vitamin D status, and high prevalence of osteoporosis and
osteopenia (discussed previously in the calcium section, (Refs. 98 and
99) among the general U.S. population, we tentatively conclude that
vitamin D is a nutrient of ``public health significance,'' as described
in section I.C., and its mandatory declaration is necessary to assist
consumers in maintaining healthy dietary practices. Therefore,
consistent with the factors we consider for mandatory declaration of
non-statutory nutrients (see section I.C.), we are proposing to amend
Sec.  101.9(c)(8)(ii) to require the mandatory declaration of vitamin D
on the Nutrition Facts label. We request comment about whether there is
an appropriate alternative analysis to the application of the factors
in section I.C. regarding the mandatory declaration of vitamin D.
    b. Potassium--The declaration of potassium content is voluntary,
except when a claim is made about it (Sec.  101.9(c)(5)). In 1993,
potassium did not meet our considerations for inclusion as a mandatory
element of nutrition labeling because no quantitative intake
recommendations were available in national consensus reports (58 FR
2079 at 2095). In response to our question in the 2007 ANPRM about
what, if any, other micronutrients are of public health significance,
several comments supported mandatory declaration of potassium on the
Nutrition Facts label because the 2005 DGA identified it as a nutrient
of concern (Ref. 36). One comment also pointed out that scientific
evidence from three meta-analyses of over 30 clinical trials shows that
high potassium intake is associated with reduced blood pressure in non-
hypertensive and hypertensive individuals (Refs. 110 to 112).
    Our analysis of data from NHANES 2003-2006 shows that the usual
mean intakes of potassium from conventional foods only (2,644 mg/d) and
from conventional foods plus dietary supplements (2,651 mg/d) are below
the population-weighted AI of 4,622 mg/d. Where the mean usual intake
is at or above the AI, we consider that there is probably a low
prevalence of nutrient inadequacy in the population assessed. However,
where the mean usual intake is below the AI, the population's
prevalence of inadequacy cannot be estimated (Ref. 96). Therefore, the
likelihood of nutrient inadequacy cannot be estimated. Only about 1.9
percent of the general population has usual potassium intakes above the
AI from conventional foods only and 2.4 percent has intakes above the
AI from conventional foods plus dietary supplements (table 1),
indicating that the adequacy of intakes is very low. In the absence of
a sensitive biochemical indicator of potassium nutritional status, we
could not consider biomarker data to inform the determination of
prevalence of potassium deficiency. However, the IOM set age- and
gender-specific AIs for potassium based on risk of chronic disease. The
AI was set at a level that would maintain blood pressure, reduce the
adverse effects of sodium chloride intake on blood pressure, and reduce
the risk of recurrent kidney stones (Ref. 21). According to the CDC,
about one out of three U.S. adults has high blood pressure (Ref. 113).
    In 2000, a FDAMA notification for a health claim about potassium,
blood pressure, and stroke was submitted to us under section
403(r)(2)(g) of the FD&C Act (Ref. 114). We did not object to the
notification and this meant that manufacturers could include the
following claim ``Diets containing foods that are good sources of
potassium and low in sodium may reduce the risk of high blood pressure
and stroke,'' on the label or labeling of any food that meets the
eligibility criteria described in the notification and meets the
general requirements for health claims (Sec.  101.14(e)(6)). Thus, we
recognize the importance of potassium in the risk reduction of these
chronic diseases. The 2010 DGA also concluded that potassium is a
nutrient of concern for the general U.S. population (Ref. 6).
    In view of the benefits of adequate potassium intake in lowering
blood pressure, reflected in IOM's DRIs, and data indicating low
likelihood of potassium adequacy and high prevalence of hypertension
among the general population, we tentatively conclude that potassium is
a nutrient of public health significance for the general U.S.
population and its declaration is necessary to assist consumers in
maintaining healthy dietary practices. Therefore, consistent with the
factors we consider for mandatory declaration of non-statutory
nutrients (see section I.C.), we are proposing to amend Sec.
101.9(c)(8)(ii) to require the mandatory declaration of potassium.
3. Other Essential Vitamins and Minerals
    Several other essential vitamins and minerals, in addition to
vitamin D and potassium, may be declared on the Nutrition Facts label,
i.e., vitamin E, vitamin K, vitamin B6, vitamin
B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, and chloride. In response to
the 2007 ANPRM about what, if any, other micronutrients are of public
health significance, several comments recommended mandatory declaration
of these voluntarily declared essential vitamins and minerals: Vitamin
E, folate, vitamin B12, magnesium, and phosphorus. The
reasons cited in

comments included: (1) The 2005 DGA identification of these nutrients
as nutrients of concern (Ref. 36); (2) the need to provide information
to patients; (3) the need to heighten consumer awareness; and (4) the
intakes of these nutrients are inadequate in the U.S. population or
subpopulations (Ref. 47).
    Based on FDA's analysis of available data using the factors we
consider for mandatory and voluntary declaration of non-statutory
nutrients (see section I.C.) and comments received on essential
vitamins and minerals that are currently voluntarily declared, we are
not proposing any changes to the current provisions for voluntary
declaration (for detailed information and the analysis of each of the
vitamins and minerals see Ref. 115). We reviewed data related to the
intake and status of nutrients where available standards allow for such
calculations (table 1). Consistent with the factors (see section I.C.),
essential vitamins and minerals (with the exception of potassium and
vitamin D discussed previously) that are voluntarily declared should
continue to be permitted to be voluntarily declared (Ref. 115).
Therefore, we are not proposing any changes to the provisions for
voluntary declaration of vitamin E, vitamin K, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, and chloride.
    In addition, several comments recommended mandatory declaration of
choline, which is currently not permitted to be declared on the
Nutrition Facts label. Based on the factors we consider (see section
1.C.) and comments that asked us to provide for its declaration on the
Nutrition Facts label (Ref. 115), we tentatively conclude that the
voluntary declaration of choline is consistent with the factors we
consider for voluntary declaration (table 1) and, therefore, we are
proposing to permit the voluntary declaration of choline on the
Nutrition Facts label.
4. Summary
    In summary, based on an analysis of the factors FDA considered (as
described in section I.C.), comments received, and other data and
information set forth previously, FDA tentatively concludes that
calcium, iron, vitamin D and potassium are nutrients of public health
significance and their declarations on the Nutrition Facts label are
necessary to assist consumers in maintaining healthy dietary practices.
Calcium is considered a nutrient of public health significance due to
the benefits of adequate calcium intake on bone health, and the
relatively low intakes of calcium and the high prevalence of
osteoporosis and osteopenia among the U.S. population. Iron is
considered a nutrient of public health significance due to the
continued inadequate intakes and deficiency (using relevant biomarker
data) among women of childbearing age, who comprise a significant
portion of the general healthy U.S. population. Although the DRIs for
iron were not based on a chronic disease risk, iron deficiency and low
iron stores over time will lead to iron deficiency anemia, an advanced
stage of iron deficiency. Anemia is associated with poor cognitive
function, lower work performance, and low endurance in the general
population; delayed psychomotor development in infants; and adverse
pregnancy outcome. Vitamin D is considered a nutrient of public health
significance due to the benefits of adequate vitamin D intake on bone
health, data indicating inadequate intakes and status (both from total
exposure (serum data) and dietary intake data), and the high prevalence
of osteoporosis and osteopenia among the U.S. population. Adequate
intake of vitamin D is essential for promoting calcium absorption in
the gut and for maintaining adequate calcium levels in the blood and
thus promoting bone health. Potassium is considered a nutrient of
public health significance due to the benefit of adequate intake of
potassium in lowering blood pressure, reducing the adverse effects of
sodium chloride intake on blood pressure and reducing the risk of
recurrent kidney stones, and due to data indicating a low likelihood of
potassium adequacy and a high prevalence of hypertension among the
general U.S. population.
    Although we continue to consider, consistent with our rationale put
forth in 1993, that a vitamin or mineral's public health significance
should be the key factor in mandatory labeling (58 FR 2079 at 2106),
the proposed vitamins and minerals of public health significance (i.e.,
potassium, calcium, vitamin D, and iron) and dietary fiber (listed on
the label as a nutrient to increase) do represent various food groups.
For example, potassium is found in most food groups, especially
vegetables, fruits, and milk and milk products. Milk and milk products
contribute substantially to calcium intake. Sources of heme iron
include lean meat, poultry and seafood, while the non-heme sources of
iron come from plants foods, such as beans, lentils and spinach.
Although vitamin D is mostly found in fortified foods in the United
States, such as fluid milk and some milk products (e.g., yogurt), its
natural sources include seafood. Dietary fiber is generally found in
most fruits and vegetables, whole grains and beans.
    The 2010 DGA recommends increasing the amount and variety of
seafood in place of some meat and poultry (Ref. 6). As mentioned, fish/
seafood is the primary source of naturally occurring vitamin D (Ref.
6). Data shows that fish/seafood only provides 9 percent of the total
vitamin D intake in the United States (Ref. 116). Therefore, we
tentatively conclude that the proposed mandatory declaration of vitamin
D on the label would allow consumers to understand the relative
significance of the contribution of vitamin D from natural food
sources, in addition to fortified foods, in the context of the total
daily diet and also is necessary to assist consumers in maintaining
healthy dietary practices.
    We are not aware of any unintended consequences of mandatory
listing, in general, of vitamins and minerals. We invite comment,
including the submission of data and information on whether the
mandatory listing of vitamins and minerals somehow impacts food
fortification practices. We invite comment on the proposed mandatory
declaration of vitamin D, potassium, calcium and iron on the label,
including how we consider the public health significance of each. We
also invite comment on whether the presence of these nutrients presents
concerns related to label space or the need for consumer education.

   Table 1--Prevalence of Adequacy and Inadequacy (From Conventional Foods and Water) and Total Intake (Conventional Foods, Water, and Supplement) and
                         Status Biomarkers for Essential Vitamins and Minerals Among the U.S. Population, Ages 4 Years and Older
                                                      [Excluding pregnant and lactating women] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Usual nutrient intake \2\                                Status biomarkers
                                                --------------------------------------------------------------------------------------------------------
                                                      % Below weighted EAR \4\         % above weighted AI \5\ (mean
          Nutrients             Weighted EAR/AI ------------------------------------              intake)
                                      \3\                                           -----------------------------------    Biomarker      % Below cutoff
                                                       Food            Food plus                          Food plus          cutoff
                                                                      supplement           Food           supplement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Vitamins
--------------------------------------------------------------------------------------------------------------------------------------------------------
Choline (NHANES 2005-2008)...  460 mg (AI).....  ................  ................  10 (mean = 311    10 (mean = 312   NA.............  NA
                                                                                mg).              mg).
Folate.......................  304 mcg DFE.....  8.7.............  7.3.............  ................  ...............  Serum folate <   0
                                                                                2 ng/mL.
                                                                                RBC folate < 95  0.26
                                                                                ng/mL
                                                                                Women 12-49 yrs
                                                                                Serum folate <   0
                                                                                2 ng/mL
                                                                                RBC folate < 95  0.36
                                                                                ng/mL
Niacin 6 7...................  11 mg NE........  2.1.............  1.7.............  ................  ...............  NA.............  NA
Riboflavin 6 7...............  0.9 mg..........  1.5.............  1.3.............  ................  ...............  NA.............  NA
Thiamin 6 7..................  0.9 mg..........  5.6.............  3.8.............  ................  ...............  NA.............  NA
Vitamin A....................  531 mcg RAE.....  45..............  34..............  ................  ...............  Serum A < 20     0.3 \8\
                                                                                mcg/dL.
Vitamin B6 6 7...............  1.1 mg..........  9.4.............  7.3.............  ................  ...............  NHANES 2005-     10
                                                                                2006 < 20 nmol/
                                                                                L.
Vitamin B12..................  1.9 mcg.........  2.3.............  2.2.............  ................  ...............  Serum B12 < 200  2.0
                                                                                picograms (pg)/
                                                                                mL.
                                                                                19-50 yrs......  0.7-2.5
                               2 mcg (51 yrs     Women 51 yrs and                                                       51 yrs and       3.3-5.2
                                and older).       older.                                                                 older.
                                                 6.4-7.5
                                                 Men 51 yrs and
                                                  older
                                                 0.6-0.7.........
Vitamin C....................  61 mg...........  35..............  27.5............  ................  ...............  Serum C < 11.4   6.1 \8\
                                                                                [micro]mol/L.
                                                 Women 12-49 yrs.  Women 12-49 yrs.  ................  ...............  Women 12-49 yrs  6.00
                                                 41..............  30..............
Vitamin D....................  10 mcg..........  93.7 (NHANES      62 (NAHNES 2005-  ................  ...............  Serum 25 (OH)D:  17.6
                                                  2005-2008).       2008).                                               <40 nmol/L.
                                                                                30-50 nmol/L...  24
                                                                                < 30 nmol/L....  8.3
Vitamin E....................  11 mg [alpha]-    92..............  64..............  ................  ...............  Serum E < 11.6   0.9 \8\
                                tocopherol.                                                                              [micro]mol/L.
Vitamin K 6 7................  95 mcg (AI).....  ................  ................  27.2 (mean =      30.9 (mean = 88  NA.............  NA
                                                                                82.9 mcg).        mcg).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Minerals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calcium......................  885 mg..........  49..............  37..............  ................  ...............  NA.............  NA
Copper 6 7...................  0.7 mg..........  5.2.............  4.9.............  ................  ...............  NA.............  NA
Iron (probability approach     See footnote 3..  3.5.............  3.3.............  ................  ...............  NHANES 1999-
 method) \9\.                                                                                2002 \10\.
                                                                                Serum ferritin   8.3
                                                                                < 15 mcg/L.
                                                                                Ferritin model.  6.5
                                                                                Anemia.........  1.9
                                                                                Women, 12-49
                                                                                yrs
                                                                                NHANES 2003-
                                                                                2006:.
                                                 Women 12-49 yrs.  Women 12-49 yrs.                                     Serum Ferritin   14
                                                 11.2............  10.4............                                      < 15 mcg/L      10
                                                                                Body Iron model  14.5
                                                                                Ferritin Model   4.7
                                                                                Anemia.
Iodine 6 7...................  91 mcg..........  2.3 \11\........  2.3.............  ................  ...............  Urinary iodine
                                                                                NHANES 2007-
                                                                                2008:.

                                                                                <50 ng/mL \12\.  8.7 \8\.
                                                                                <100 ng/mL \13\  Median =
                                                                                165 ng/mL.
Magnesium....................  283 mg..........  56..............  53..............  ................  ...............  NA.............  NA.
Phosphorus...................  640 mg..........  3...............  2.6.............  ................  ...............  NA.............  NA.
Potassium....................  4,622 mg (AI)...  ................  ................  1.9 (mean =       2.4 (mean =      NA.............  NA.
                                                                                2,644 mg).        2,654 mg).
Selenium 6 7.................  43 mcg..........  1.4.............  1.1.............  ................  ...............  NA.............  NA.
Zinc 6 7.....................  7.7 mg..........  13.4............  9.1.............  ................  ...............  NA.............  NA.
--------------------------------------------------------------------------------------------------------------------------------------------------------
NA = Data is not available in NHANES; mg = milligrams; mcg = micrograms; DFE = Dietary folate equivalents; NE = Niacin equivalents; RAE = Retinol
  activity equivalents.
\1\ All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003-2006 unless otherwise is reported. All data
  analysis are based on ages 4 years and older (excluding pregnant and lactating women), unless reported otherwise.
\2\ Usual nutrient intake distributions from conventional foods or conventional foods plus supplements are determined using the National Cancer
  Institute statistical method for all nutrients except iron (see footnote 9 to this table and Ref. 48).
\3\ Weighted Estimated Average Requirement (EAR) and Adequate Intake (AI) for all nutrients (except iron) are based on the U.S. population ages 4 years
  and older using U.S. Census Bureau, Population Projection for 2005, Middle Series Data (NP-D1-A) (Ref. 48,117). For iron, the published IOM tables
  (tables I-6 and I-7) of probability of iron requirement distribution were used (Ref. 100).
\4\ EAR cut-point method used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy.
\5\ For nutrients with an AI, prevalence of nutrient adequacy was determined when mean usual nutrient intakes are at or above the AI or based on the
  percent of those above the AI.
\6\ The Agency did not receive any comments for these nutrients (which voluntary declaration is permitted) in response to the 2007 ANPRM. In addition,
  dietary intake or status biomarker data were not provided in the NHANES database for chromium, biotin, pantothenic acid, molybdenum, manganese and
  chloride and, therefore, these nutrients are not listed in this table.
\7\ The DRIs for these nutrients were not based on a public health endpoint (e.g., chronic disease).
\8\ Ages 6 years and older.
\9\ Probability approach method was used to determine the prevalence of nutrient inadequacy for iron. The PC-SIDE software developed by the Iowa State
  University was used to determine the usual intake distribution for iron.
\10\ Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum
  ferritin, and erythrocyte protoporphyrin). Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to
  ferritin. Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. NHANES 1999-2002 did not measure transferrin
  receptor, therefore body iron model could not be analyzed for the general population (ages 4 years and older). NHANES 2003-2006 did not measure all
  iron biomarkers for all ages (4 years and older), thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during
  this time period.
\11\ Iodine nutrient intake data are calculated from the Total Diet Study 2003-2008 and intake data are calculated from NHANES 2003-2008 (http://www.nutrientdataconf.org/PastConf/NDBC36/7-3_Juan_NNDC2012.pdf).
\12\ One criterion for iodine adequacy is that not more than 20 percent be below the urinary iodine cutoff of 50 ng/mL (indicator of moderate
  deficiency) (Ref. 118).
\13\ WHO categories for median urinary iodine concentrations are widely used to define iodine intake (Ref. 118). Median intake levels below 100 ng/mL
  may indicate mild iodine deficiency.

I. Reference Daily Intakes for Vitamins and Minerals

1. Need To Update RDIs
    RDIs used to calculate the percent DVs for vitamins and minerals
that are required or permitted to be declared on the Nutrition Facts
label are codified in Sec.  101.9(c)(8)(iv). We established the RDIs in
1993 and in 1995, and explained our rationale and relevant
considerations during those rulemakings (58 FR 2079; 60 FR 67164; see
also Ref. 1). We noted specifically that the purpose of establishing
RDIs for vitamins and minerals was to provide ``label reference
values'' intended to help consumers to understand nutrient levels in
the context of the total daily diet, to compare foods, and to plan
general diets (58 FR 2206 at 2213). We recognized that nutritional
needs vary considerably among consumers, but noted that no other viable
option existed other than a single reference value (58 FR 2206 at
2213). Thus, RDIs are intended as general food labeling reference
values and are not intended to represent dietary allowances for
individuals (55 FR 29476 at 29478). While RDIs are not precise values
for certain age and sex groups, they function as an overall population
reference to help consumers judge a food's usefulness in meeting
overall daily nutrient requirements or recommended consumption levels
and to compare nutrient contributions of different foods (55 FR 29476).
    IOM reports published since 1997 provide new information for our
use in reconsidering the RDIs. The DRIs revised many of the previously
set RDAs for vitamins and minerals. Four types of DRIs are relevant to
the discussion on RDIs for vitamins and minerals: EAR, RDA, AI, and UL.
We describe each of these DRIs in section I.B.2. According to the new
DRI reports, some nutrients that had RDAs now have an AI because it was
determined that data were not sufficient to set a new RDA (e.g.,
vitamin K), whereas others that had ESADDIs now have either an RDA
(copper and molybdenum) or an AI (manganese, fluoride, and chromium).
    The IOM Labeling Report (Ref. 25) recommended that FDA use a
population-weighted EAR or, in its absence, a population-weighted AI as
the basis for establishing DVs for vitamins and minerals. In developing
these recommendations, the IOM

indicated that the reference values on food labeling are to enable
consumers to compare the nutrient content of different food products
and to determine the relative contributions of a food to an overall
health promoting diet. The IOM Labeling Committee did not consider that
the information in nutrition labeling is used to plan individual diets.
The IOM recommended that the DVs should be based on a population-
weighted value of the EAR for the different life stage and gender
groups so that the DVs are representative of the various population
groups in proportion to their contribution to the overall population. A
DV defined this way would represent a central value of the requirements
of the population, with individual requirements varying around this
value. The IOM Labeling Committee further stated that the EAR
represents the most accurate representation of the true contribution of
food to total nutrient needs of the general population, whereas the RDA
provides an exaggerated impression of Americans' daily needs and, thus,
would systematically under-represent the true contribution of an
individual food to many consumers' needs. The IOM Labeling Committee
concluded that the EAR is the best estimate of any given individual's
requirements, because the EAR is the median of the estimated
distribution of requirements for a particular life stage and gender
group. Therefore, the IOM Labeling Committee stated that setting the DV
at the EAR is most likely to help individuals understand nutrition
information about vitamins and minerals on the Nutrition Facts label in
the context of their total daily diet. The IOM Labeling Committee
further recommended that, in the absence of an available EAR, a
population-weighted AI should be used as the basis for a DV.
    The IOM Dietary Planning Report noted that intake goals (i.e.,
RDAs) should be translated into dietary plans to help individuals
choose foods that will make up a healthful diet. The IOM Dietary
Planning Report gave several examples of dietary plans such as the
Nutrition Facts label, United States Food Guide Pyramid and the Dietary
Guidelines for Americans that are intended to help consumers choose
foods that are part of a healthful diet (Ref. 26). This report noted
that when food guides such as those mentioned previously are used,
reference standards for nutrients, such as RDAs, are implicitly used in
planning individual diets (Ref. 26). The recommendations in the IOM
Labeling Report and the IOM Dietary Planning Report have been the
subject of much debate in the scientific community, and several review
articles about the basis for selecting the DRI values that are most
appropriate for setting DVs (i.e., RDIs) have been published in
scientific journals (Refs. 119 to 126).
    The 2007 ANPRM asked for public comment on whether the DV should be
based on an EAR or RDA; how AIs should be used for determining DVs for
vitamins and minerals without an EAR or RDA; and whether DVs should be
based on a population-coverage or population-weighted approach. We
received several comments both on the overall approach for setting the
RDIs and on the DRIs for specific vitamins and minerals (Ref. 47).
    We tentatively conclude that the existing RDIs for vitamins and
minerals should be revised based on the DRIs set by the IOM that
reflect the most current science regarding nutrient requirements. Our
consideration of the DRIs, relevant recommendations, and comments
received in updating the RDIs is presented in this document.
2. Approach to Setting RDIs: EAR Versus RDA
    The percent DV advises the consumer how much of the recommended
intake of that nutrient is provided by the food (58 FR 2206 at 2213).
The DV for the nutrient, on which the percent DV declaration is based,
is not to be interpreted as a precise recommended intake level for an
individual; it is for use as a general guide or reference value that
can help the consumer judge a food's usefulness in meeting overall
daily nutrient requirements or recommended consumption levels and to
compare nutrient contributions of different foods (55 FR 29476). We
established the RDIs for vitamins and minerals based primarily on RDAs,
and using other available recommendations for those vitamins and
minerals for which an RDA was not established (55 FR 29476; 58 FR 2206;
60 FR 67164). Overall, comments to the 2007 ANPRM supported continuing
to use the RDA as the basis for the DVs for vitamins and minerals,
whereas some other comments supported using the EAR instead (Ref. 47).
    Considering the purpose of the DV, and for the reasons explained in
this document, we tentatively conclude that RDAs, when available,
continue to provide the most appropriate basis for establishing RDIs.
RDAs are available for calcium, copper, folate, iodine, iron,
magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium,
thiamin, vitamins A B6, B12, C, D, and E, and
zinc (Refs. 16 to 19,22).
    The EAR, by definition, is the median requirement that is most
likely to be close to an individual's actual needs within a particular
life stage and gender group, with the needs of half of the individuals
within that group falling above or below the EAR. The EAR is a
quantitative intake recommendation that is used to derive target
nutrient intake goals for the planning of diets for groups, but is not
used as a target intake goal for individuals. Examples of planning for
groups include planning diets in an assisted living facility for senior
citizens or planning menus for a school nutrition program (Ref. 26).
However, the EAR is not intended to be a target intake level for
individuals because an individual does not know how their needs relate
to the EAR. While the RDA may not be the best estimate of any given
individual's nutrient requirement, which is usually unknown, the RDA
was developed as a target intake level for individuals and is designed
to meet the nutrient needs of practically all (97 to 98 percent)
individuals within a life stage and gender group. Therefore, if the RDI
were to be based on the EAR, the RDI would not meet the daily nutrient
requirements for some consumers and understate target intake levels. In
contrast, an RDI that is based on a RDA would meet the daily nutrient
requirements for the majority of all individuals 4 years of age and
older. As we explained during the NLEA rulemaking, while RDIs are not
precise values for specific age and sex groups, they function as an
overall population reference to help consumers judge a food's
usefulness in meeting overall daily nutrient requirements or
recommended consumption levels and to compare nutrient contributions of
different foods (55 FR 29476). An RDI based on the RDA would mean that
a product with 100 percent of the DV would have a higher probability of
meeting an individual's nutrient needs than if the RDI was based on the
EAR.
    In addition, consumers have indicated that they use the label,
among other things, to make dietary judgments about a food and to plan
meals. Our 2008 Diet and Health Survey reported that, among consumers
who use the label when they buy a product for the first time, 62
percent often or sometimes use the label to help in meal planning; 85
percent often or sometimes use the label to get a general idea of the
nutritional content of the food; and 90 percent often or sometimes use
the label to see how high or low the food is in things like calories,
salt, vitamins, or fat (Ref. 41). A series of surveys conducted by the

International Food Information Council over the past several years also
showed that approximately 65 percent of respondents used the Nutrition
Facts label to decide whether to purchase or consume a food, and
different individuals focus on different aspects of the label (e.g.,
calories, fat, or sodium) (Refs. 127 to 130).
    We recognize that the recommendations of the 2003 IOM Labeling
Report (Ref. 25) differ from the conclusions of the 2003 IOM Planning
Report (Ref. 26). The IOM Labeling Report recommends using the EAR as
the basis for developing DVs, whereas the IOM Planning Report indicated
that the RDAs are appropriate targets for nutrient intakes for
individuals. Inadequate intakes of some nutrients continue to be of
public health significance, as noted by the 2010 DGA, which identified
potassium, calcium, and vitamin D as nutrients of public health concern
for general U.S. population and iron, folic acid, and vitamin
B12 for certain segments of the population (Ref. 6). Based
on these concerns of inadequate nutrient intakes, we find that the IOM
Dietary Planning Report discussion supports the use of RDAs as the
basis for establishing reference values for the purposes of food
labeling. We continue to believe that given the greater coverage
provided by the RDAs compared to the EARs, more individuals who use the
percent DV information to select foods, compare foods, or plan diets
will have greater assurance that their nutrient needs are being met (58
FR 2206 at 2213). RDAs and AIs, not EARs, are also cited in both the
2010 DGA and the USDA's Food Patterns, which were formerly known as the
MyPyramid Food Patterns (Refs. 6 and 131). It is important to
reiterate, however, that the RDIs are not the same as RDAs. The RDAs
are recommended intake levels set for different age and gender groups,
whereas the RDIs are intended to provide an overall population
reference value for use in calculating the percent DV for the food
label that can help consumers understand the nutritional content of
foods in the context of the total daily diet (55 FR 29476 at 29481 and
58 FR 2206 at 2213).
    Finally, we considered the potential for the RDIs to influence the
vitamin or mineral content of foods, as suggested by several comments
(Ref. 47). We are not persuaded that using an EAR will promote rational
fortification and that using the RDA as the basis for the RDI will lead
to overconsumption of vitamins and minerals, as was suggested by a
comment (Ref. 47). FDA's principles of rational fortification are
expressed in our fortification policy (Sec.  104.20). The addition of
nutrients to foods is also governed by the requirements established in
food standards of identity (21 CFR parts 130 to 169), nutrition quality
guidelines (21 CFR part 104), substitute food regulations (Sec.
101.3(e)), and relevant specifications in food additive and food
substance regulations (for example, folic acid (Sec.  172.345) and
vitamin D (Sec. Sec.  184.1950 and 172.380)). Consistent with our
previous position (58 FR 2206 at 2210), we acknowledge that some
manufacturers may fortify products to a specific percentage of the DV
(e.g., 25 percent) and, to the extent this practice continues, nutrient
levels in these foods would be affected by updated RDI values. Changing
the basis from the current RDA approach to EARs would lower RDIs for
many important nutrients. Regardless of whether the basis for the RDI
is the RDA or EAR, manufacturers must comply with relevant regulations,
and we urge them to follow the principles stated in our fortification
policy. With respect to the concern for risk of excessive intakes of
vitamins and minerals, we conducted a thorough analysis of available
data to determine whether intakes of vitamins and minerals from both
foods and dietary supplements exceed established ULs. An analysis of
NHANES (2003-2006) data showed that usual total nutrient intakes (from
both conventional foods and dietary supplements) at the 90th percentile
do not exceed the ULs for most vitamins and minerals at any age group,
except for zinc intake, vitamin A (preformed), iodine intake and folic
acid intake among children 4 to 8 years (Ref. 132).
    While there were a few exceptions, we have determined that such
intakes are not of public health significance, and for some nutrients,
are not a result of discretionary fortification. Therefore, we do not
consider that the existing approach of using RDAs as the basis for RDIs
leads to widespread overconsumption of vitamins and minerals. Moreover,
about half of the proposed RDIs decrease when compared to the current
RDIs (table 2) because many of the new RDAs and AIs established by the
IOM are now lower than previously set RDAs or ESADDIs. Most of the RDIs
proposed in this rulemaking that would increase (i.e., calcium, vitamin
D, dietary fiber, and potassium) have also been proposed by FDA to be
nutrients of public health significance for the general U.S. population
(see section II.H.). Furthermore, none of the RDIs proposed in this
rulemaking exceed the ULs for children 4 to 8 years of age (see tables
11a and 11b of the 2007 ANPRM).
    Therefore, we tentatively conclude that RDAs, when available,
provide the most appropriate basis for establishing RDIs. Using
corresponding RDAs, proposed Sec.  101.9(c)(8)(iv) would update the
RDIs for calcium, copper, folate, iodine, iron, magnesium, molybdenum,
niacin, phosphorus, riboflavin, selenium, thiamin, vitamins A,
B6, B12, C, D, and E, and zinc, as shown in table
2. We request comment on our analysis and request data and factual
information, including any additional data on what role, if any, the
basis of the DV (EAR or RDA) has in consumption of nutrients above the
UL and in discretionary fortification of foods.
3. Approach to Setting RDIs: Adequate Intake
    We consider that, in the absence of RDAs, AIs represent the best
estimate of adequate daily nutrient intake level based on available
science and, as such, they provide an appropriate basis for selecting
RDIs for those vitamins and minerals where available data are
insufficient to determine RDAs. While the prevalence of inadequacy of a
nutrient with an AI cannot be determined, AIs, like RDAs, are goals for
nutrient intakes and AIs are expected to meet the nutrient needs of
most healthy people. The IOM noted that usual individual intakes for a
nutrient that are equal to or above the AI can be assumed adequate
(Ref. 25). We acknowledge that there is more uncertainty with an AI
than an EAR or RDA. However, in the case of nutrients without
established RDAs, AIs reflect the most current scientific
recommendations for intake (Ref. 25).
    Moreover, using the AIs (where RDAs are not available) would ensure
consistency in the basis of setting RDIs. We agree with comments to the
ANPRM that RDIs for vitamins and minerals and consequently, percent DVs
declared on the label, should have comparable meanings in order to
enable consistent use. RDIs should not be based on average requirements
(i.e., EAR) for some nutrients, but goals for intakes (i.e., RDAs) for
others. AIs, in the absence of RDAs, would provide uniformity in
setting RDIs for vitamins and minerals based on goals for their
intakes. Most of the comments in response to the 2007 ANPRM supported
the AI as the basis for the DV for those nutrients for which no EARs or
RDAs have been established (i.e., biotin, chloride, choline, chromium,
manganese, pantothenic acid, potassium, and vitamin K) (Ref. 47).

    Therefore, we tentatively conclude that AIs provide an appropriate
basis for selecting RDIs for those vitamins and minerals where
available data are insufficient to determine RDAs. Accordingly, we are
proposing to use AIs to set the RDIs for biotin, chloride, choline,
chromium, manganese, pantothenic acid, potassium, and vitamin K.
4. Approach to Setting RDIs: Tolerable Upper Intake Level
    The UL is the highest average daily intake level likely to pose no
risk of adverse health effects for nearly all people in a particular
group. As intake increases above the UL, potential risk of adverse
effects may increase (Ref. 96). The UL can be used to estimate the
percentage of the population at potential risk of adverse effects from
excess nutrient intake (Ref. 25). However, the UL is not intended to be
a recommended level of intake for vitamins and minerals where excess
intake is not a concern, as there is generally (with the exception of
folate in the prevention of neural tube defects) no established benefit
for consuming amounts of nutrients above the RDA or AI (Ref. 96).
Therefore, we do not consider the UL to be an appropriate basis for
setting RDIs. However, as the IOM noted, ULs can be used to plan diets
to ensure usual intakes of vitamins and minerals are below the UL for
individuals or to plan diets for groups to minimize the proportion of
the population at risk of excess nutrient intake (Ref. 25).
    Therefore, we tentatively conclude that the UL does not provide an
appropriate basis for establishing RDIs for vitamins and minerals. As
noted previously (sections II.I.2. and II.I.3.), we tentatively
conclude that the RDAs and, for nutrients where an RDA has not been
established, AIs are the most appropriate quantitative intake
recommendations for setting RDIs that can help consumers to plan
general diets and understand the nutritional content of the foods they
buy in the context of the total daily diet.
5. Approach to Setting RDIs: Population-Weighted Versus Population-
Coverage
    As discussed in the 2007 ANPRM, we set the RDIs based on a
population-coverage approach, after concluding that this approach was
more appropriate than a population-weighted approach, in part, so that
vulnerable or at-risk groups would be sufficiently covered by the DV
(72 FR 62149 at 62150). In determining an approach for setting RDIs in
this proposed rule, we considered recommendations of current consensus
reports, scientific review articles, and comments to the 2007 ANPRM. We
presented a comparison of potential RDIs based on the various
established DRIs and applying the population-coverage versus
population-weighted approaches (see tables 11A and 11B of the 2007
ANPRM). As discussed in this document, we tentatively conclude that
RDIs for vitamins and minerals should continue to be based on a
population-coverage approach, using the highest RDA and, where an RDA
has not been established, the highest AI.
    We continue to agree with the rationale we set forth in 1993 that
the population-coverage approach would sufficiently cover the
vulnerable or at-risk groups (58 FR 2206 at 2211). Using the highest
age and gender group RDA/AI value (i.e., a population-coverage
approach) would avoid a higher risk of nutrient inadequacy among
certain segments of the population because such a value is not derived
from averaging the requirements for populations with lower needs
(children and elderly) and those with greater needs (adolescents or
adults). While incidences of deficiency diseases, such as pellagra, are
now rare, intakes and status biomarkers of certain nutrients continue
to be inadequate and of public health significance (see section II.H.).
Although, for some nutrients, the population-coverage RDA approach
would result in RDIs that are higher than the nutrient requirements for
some consumers, RDA, by definition, is the target intake goal for
nutrient intakes for individuals. In addition, as noted by one comment,
unlike the population-weighted approach, the population-coverage
approach would not be susceptible to changes in age demographics of the
population. Therefore, any future revisions to RDIs would be based
primarily on new scientific data related to nutrition or new dietary
recommendations, and we would not need to revise RDIs solely based on
the availability of new census data.
    We also considered concerns that the population-coverage approach
may lead to excessive intakes of nutrients. As in the case of the RDA
approach (discussed previously), we find such concerns unfounded.
Intakes of vitamins and minerals generally do not exceed the ULs under
current RDIs that are based on a population-coverage RDA approach. In a
few instances where total usual intakes of vitamins and minerals by
children 4 to 8 years exceed corresponding ULs, we have determined that
such intakes are not of public health significance, and for some
nutrients, are not as a result of fortification (see accompanying Ref.
115). Furthermore, because many of the new RDAs and AIs established by
the IOM are now lower than previously set RDAs or ESADDIs, the RDIs
based on a population-coverage RDA for many nutrients will decrease
(see table 2). We consider that, from a public health perspective, it
is more important for the DV of vitamins and minerals to cover the
intake needs of most consumers than it is for certain age and gender
groups to be covered by the DV based on their proportion of the overall
population. We are also not aware of any data indicating that use of a
population-coverage approach versus a population-weighted approach
results in increases in nutrient consumption. Therefore, we tentatively
conclude that the population-coverage approach using the highest RDA
or, in its absence, the highest AI continues to provide an appropriate
basis for setting RDIs for vitamins and minerals. We are proposing to
amend Sec.  101.9(c)(8)(iv) to update RDIs as presented in table 2.
6. Declaration of Absolute Amounts of Vitamins and Minerals
    Currently, mandatory nutrients and, when declared, voluntary
nutrients must be declared by their absolute amounts in weight on the
Nutrition Facts label, except for vitamins and minerals (other than
sodium and potassium) (see Sec.  101.9(d)(7)(i)). Thus, except when the
linear label format is used (Sec.  101.9(j)(13)(ii)(A)(2)), listings
for sodium and potassium (when declared) appear above the third bar and
include both weight amounts and percent DVs, while vitamins A and C,
calcium, and iron appear below the third bar and include percent DVs
only. In the case of dietary supplements, both the quantitative amount
by weight and percent DV (if available) are required to be declared on
the Supplement Facts label (Sec.  101.36(b)(2)(ii) and (iii)). The 2007
ANPRM invited comment on whether the absolute amounts (e.g., grams or
milligrams) of mandatory and voluntary vitamins and minerals should be
included on the Nutrition Facts and Supplement Facts labels (72 FR
62149 at 62170). Most comments supported including the absolute amounts
of these nutrients in addition to the requirement of listing percent
DVs.
    Research suggests that consumers, in general, and physicians who
prescribe nutrient supplements for specific medical reasons have
difficulty understanding how percent DVs relate to the absolute amounts
of nutrients listed on the Nutrition Facts label (Ref.

133). More recently, in a report on labeling and fortification, the IOM
recommended listing both absolute amounts (e.g., mg/serving) and
percent DVs to assist consumers who have difficulty understanding how
to interpret the percent DV declaration (Ref. 25). This IOM report also
stated that absolute amounts declaration for all micronutrients would
maintain consistency in how nutrients are declared on the Nutrition
Facts label.
    Based on the IOM's recommendation, research findings, and comments
received, we are proposing to require that, similar to the requirement
for dietary supplements (Sec.  101.36(b)(2)(i)(A)), all vitamins and
minerals declared on the Nutrition Facts label must include their
quantitative amounts (in addition to the requirement for corresponding
percent DV declaration) (proposed Sec.  101.9(c)(8)). We request
comments on this tentative conclusion, and seek input on the
appropriate placement of the quantitative amounts of nutrients on the
Nutrition Facts label.
    Further, with the proposed requirement for declaration of absolute
amounts of vitamins and minerals, it is necessary to establish when a
vitamin or mineral is present in an insignificant amount as well as
increments for declaration of the quantitative amounts of vitamins and
minerals on the Nutrition Facts label. In determining requirements for
vitamins and minerals present in insignificant quantities, as well as
increments for declared vitamins and minerals, we looked to
requirements that have already been established for declaration of
quantitative amounts of sodium and potassium, vitamins and minerals
declared on the Supplement Facts label, and percent DVs.
    Quantitative amounts in milligrams may currently be listed on the
Nutrition Facts label for only two minerals: Sodium, a mandatory
nutrient (Sec.  101.9(c)(4)) and potassium (Sec.  101.9(c)(5)), which
may be voluntarily declared on the Nutrition Facts label. We require in
Sec.  101.9(c)(4) and (c)(5) that when a serving contains less than 5
mg of sodium or potassium, the value shall be declared as zero; when a
serving contains 5 to 140 mg of sodium or potassium, the declared value
shall be rounded to the nearest 5 milligram increment; and when a
serving contains greater than 140 mg of sodium or potassium, the
declared value shall be rounded to the nearest 10 mg increment. We are
now proposing to establish an RDI for potassium. Since potassium will
now have an RDI, rather than a DRV, we are proposing to remove the
specific requirements for the declaration of potassium in Sec.
101.9(c)(5), and replace the section with requirements for the
declaration of fluoride. Requirements for the declaration of
quantitative amounts of other nutrients with an established RDI
discussed in this document will apply to potassium, if finalized.
    The quantitative amounts by weight per serving of vitamins and
minerals are also required to be declared on the Supplement Facts label
(Sec.  101.36(b)(2)(ii)). The amounts of vitamins and minerals,
excluding sodium and potassium, that are declared on the Supplement
Facts label are the amount of the vitamin or mineral included in one
serving of the product, using the units of measurement and levels of
significance given in Sec.  101.9(c)(8)(iv). Section
101.36(b)(2)(ii)(B) also specifies that for declaration of vitamins and
minerals on the Supplement Facts label, zeros following decimal points
may be dropped, and additional levels of significance may be used when
the number of decimal places indicated is not sufficient to express
lower amounts (e.g., the RDI for zinc is given in whole mg, but the
quantitative amount may be declared in tenths of a mg).
    For conventional foods, FDA specifies in Sec.  101.9(c)(8)(iii)
that the percent DV declaration for vitamins and minerals present at
less than 2 percent of the RDI is not required for nutrition labeling,
but may be declared as zero or by the use of an asterisk (or other
symbol) that refers to another asterisk (or symbol) that is placed at
the bottom of the table and that is followed by the statement
``Contains less than 2 percent of the Daily Value of this (these)
nutrient (nutrients).'' Alternatively, the statement ``Not a
significant source of (listing the vitamins or minerals omitted)'' may
be placed at the bottom of the table of nutrient values.
    For the purpose of determining when a vitamin or mineral is present
in an insignificant amount, we tentatively conclude that the cutoff
used for declaration of percent DV of less than 2 percent of the RDI
(Sec.  101.9(c)(8)(iii)) can reasonably be applied to the declaration
of quantitative amounts of vitamins and minerals on the Nutrition Facts
label. We find that, if a product contains less than 2 percent of the
RDI per serving, it is appropriate to express the declared vitamin or
mineral quantitative amount as zero. The manufacturer may choose to use
an asterisk (or other symbol), instead of a declaration of zero, that
refers to another asterisk (or symbol) placed at the bottom of the
table and that is followed by the statement ``Contains less than 2
percent of the Daily Value of this (these) nutrient (nutrients).''
Alternatively, the statement ``Not a significant source of (listing the
vitamins or minerals omitted)'' (``not a significant source''
statement) may be placed at the bottom of the table of nutrient values.
    As previously discussed, manufacturers have the option of using an
asterisk (or symbol), instead of a declaration of zero, that directs
the consumer to a statement indicating that the product is not a
significant source of certain vitamins or minerals found at the bottom
of the table of nutrient values when the calculated percent DV is less
than 2 percent. We are concerned that it may be confusing to consumers
if the manufacturer chooses to declare the quantitative amount of a
vitamin or mineral as zero, and also chooses to use an asterisk
referring the reader to a statement at the bottom of the label instead
of in the percent DV column on the Nutrition Facts label. Therefore, we
are proposing to require that, when a product contains less than 2
percent of the RDI for a vitamin or mineral, the manufacturer must
declare the quantitative amount of the vitamin or mineral and the
percent DV in the same manner. For example, if a serving of the product
contains less than 2 percent of the RDI for calcium, both the
quantitative amount and the percent DV for calcium may be listed as
zero or an asterisk (or symbol) directing the consumer to a statement
at the bottom of the label may be used in place of both the
quantitative amount and the percent DV declaration for calcium.
    We see no reason to provide different declaration increments for
the Nutrition Facts label than those that have already been established
for the declaration of quantitative amounts of vitamins and minerals on
the Supplement Facts label in Sec.  101.36(b)(2)(ii). Therefore, we
tentatively conclude that, as with the declaration of quantitative
amounts of vitamins and minerals on the Supplement Facts label, the
levels of significance given in Sec.  101.9(c)(8)(iv) should be used.
Zeros following decimal points may be dropped, and additional levels of
significance may be used when the number of decimal places indicated is
not sufficient to express lower amounts (e.g., the RDI for zinc is
given in whole mg, but the quantitative amount may be declared in
tenths of a mg).
    We acknowledge that for some vitamins and minerals with RDIs that
contain three or four digits (e.g., phosphorous has a proposed RDI of
1,250 mg), a difference of 1 mg per serving may not be meaningful in
terms

of health impacts. We request comment on whether quantitative amounts
for nutrients with RDI values that contain three or four digits should
be rounded, what the rounding increments should be, and data to support
suggested rounding increments for such vitamins and minerals.
7. Issues Concerning Specific Vitamins and Minerals
    In this section, we address issues related to RDIs for specific
vitamins and minerals, including those received in comments to the 2007
ANPRM. We discussed the declaration of these vitamins and minerals in
section II.H. (and in accompanying Ref. 115).
    a. Vitamin K--There are three general forms of vitamin K:
Phylloquinone (vitamin K1), menaquinone (vitamin
K2), and menadione (vitamin K3). For labeling
purposes, there is no specific definition for vitamin K. The AIs for
vitamin K are based on median intakes from NHANES data, which
specifically represents the intake of phylloquinone, the major form of
vitamin K in the diet (Ref. 134). The AI for vitamin K does not account
for the intake of menaquinone or menadione because (1) NHANES data only
includes phylloquinone content of foods, (2) the contribution of
menaquinones, which can be produced by bacteria in the gut, to the
maintenance of vitamin K status has not been established, and (3)
menadione is a synthetic form of vitamin K that can be converted to a
form of menaquinone in animal tissues. Because the AI for vitamin K is
specific to phylloquinone, our proposed RDI for vitamin K, 120 mcg in
proposed Sec.  101.9(c)(8)(iv), that is based on the AI pertains only
to phylloquinone.
    b. Chloride--The RDI for chloride of 3,400 mg/d (Sec.
101.9(c)(8)(iv)) was established in 1995 and is based on the midpoint
of the range (1,700 to 5,100 mg/d) of the ESADDI set in the 1980 RDA
report (Ref. 135; 59 FR 427). The RDI for chloride is proportional to
the DRV for sodium, considering that chloride losses tend to parallel
losses of sodium and almost all dietary chloride comes from sodium
chloride (60 FR 67164). The IOM set AIs and ULs for chloride on an
equimolar basis to the AI and UL for sodium (Ref. 10). The 2007 ANPRM
requested comment on whether (1) the DV for chloride should continue to
be an RDI, or should be a DRV like the current DV for sodium and (2)
the DV for chloride should be based on the same DRI (AI versus UL) as
used to set a DV for sodium.
    A few comments supported setting a DRV for chloride on an equimolar
basis to the UL for sodium. We disagree because the UL for chloride was
not based on adverse effects associated with excess intake of chloride.
Furthermore, the UL was not based on a public health endpoint specific
to chloride intake, which is a basis for setting a DRV. Because
chloride is an essential mineral and has age- and gender-specific AIs,
we tentatively conclude that chloride should remain a RDI and be based
on population-coverage AI (see section II.I.5.). Therefore, we are
proposing to set an RDI for chloride using the population-coverage AI
of 2,300 mg/d (proposed Sec.  101.9(c)(8)(iv)).
    c. Potassium--The DRV of 3,500 mg/d for potassium was established
based on its beneficial health effects (e.g., reduction in blood
pressure) (55 FR 29487 at 29500). We established a DRV rather than an
RDI because an RDA for specific age and gender groups was not
established at that time. In 2005, the IOM established age- and gender-
specific AIs for potassium based on data showing that potassium lowers
blood pressure, blunts the adverse effects of sodium chloride intake on
blood pressure, reduces the risk of recurrent kidney stones, and
possibly decreases bone loss (Ref. 136). Because potassium is an
essential mineral and age- and gender-specific AIs are available, we
tentatively conclude that an RDI should be established in place of the
DRV. Therefore, using the population-coverage AI, we are proposing to
establish an RDI for potassium of 4,700 mg/d (proposed Sec.
101.9(c)(8)(iv)).
    d. Choline--FDA regulations do not establish a reference value for
choline. In 1998, the IOM established age- and gender-specific AIs for
choline based on intakes necessary to maintain liver function (Ref.
137). In 2001, we received a FDAMA notification under section
403(r)(2)(G) of the FD&C Act for the use of certain nutrient content
claims for choline (Ref. 138). The FDAMA notification identified the DV
for choline as 550 mg, which was based on the population-coverage AI
for choline. Because the IOM established age- and gender-specific AIs
for choline, we tentatively conclude that an RDI should be established.
Thus, we are proposing in Sec.  101.9(c)(8)(iv) to set an RDI of 550 mg
for choline based on the population-coverage AI.
    e. Vitamin B12--We are proposing to lower the RDI for
Vitamin B12 from 6 to 2.4 [mu]g/day which reflects the
population-coverage RDA for Vitamin B12. The RDAs for
Vitamin B12 were established by the IOM in 2000. The IOM
noted that 10 to 30 percent of individuals older than 50 years of age
are estimated to have atrophic gastritis with low stomach acid
secretion which can decrease the bioavailability of naturally occurring
vitamin B12 in food (Ref. 17). The bioavailability of
crystalline vitamin B12 that is added to food is not altered