vitamin D analysis) were based on NHANES data. The serum data were
analyzed by the same valid vitamin D method for the survey period (Ref.
190).
    (Comment 374) One comment opposed the mandatory declaration of
vitamin D because, according to the

comment, testing for vitamin D is very challenging and expensive. Other
comments supported mandatory declaration of vitamin D, but said that
limited data is available on the vitamin D content in many foods and
ingredients, so manufacturers will need time and resources to obtain
data for purposes of revising their Nutrition Facts labels. Some
comments said that an analysis of the 7,189 foods in the USDA National
Nutrient Database reveals that approximately one-third of those foods
are missing values for vitamin D and that this does not take into
account the thousands of other ingredients that are also missing
vitamin D values.
    (Response) We acknowledge that performing an accurate vitamin D
analysis requires some expertise, but there are commercial laboratories
with expertise in the analysis. Having quality control food matrix
material certified for vitamin D is important, and the National
Institute of Standards and Technology (NIST) has worked and continues
to work to come up with better standard reference material for quality
control of vitamin D analysis. Under our preexisting regulations,
declaration of vitamin D was mandatory when vitamin D was added as a
nutrient supplement or claims are made about it on the label or
labeling. Therefore, manufacturers who have added vitamin D to their
products have already been using methods for testing and determining
vitamin D content of foods, so, with respect to those manufacturers,
additional time and resources to conduct analyses for vitamin D may not
be necessary.
    As for other products whose manufacturers have not added vitamin D
to the food, there is adequate methodology for determining vitamin D in
the foods. However, an analysis may not be needed for vitamin D where
reliable databases or scientific knowledge establish that a nutrient is
not present in the food. For example, there might not be a need to
analyze for vitamin D in foods that are not natural sources of vitamin
D, and to which our regulations, at Sec.  172.380 and Sec.  184.1950,
do not allow vitamin D to be added. Therefore, regarding the analytical
burden, if a manufacturer has adequate and reliable reasons to believe
that vitamin D is not present, there is no need to analyze for it: It
can be declared as zero or the manufacturer can state at the bottom of
the nutrition label ``not a significance source of vitamin D.'' Costs
associated with nutrition labeling will be contained by not analyzing
for a nutrient where there is no reasonable expectation that the
nutrient occurs in the food.
    We also agree that USDA nutrient databases may be missing vitamin D
values for nearly one-third of the products in those databases. Vitamin
D occurs naturally in a limited number of foods, such as mushrooms
exposed to UV light, egg yolks (often the feed is supplemented with
D3 or 25(OH)D3), and meats or other animal
products. There is usually a minimal amount of vitamin D in milk and
cheese unless the food is fortified. Many foods that would be reporting
vitamin D on labels greater than zero are fortified (with the exception
of foods listed previously or foods that contain them) and already
would have declarations. The USDA national nutrient database (standard
reference (SR)) provides a complete set of all nutrients (including
vitamin D) to use with NHANES database (Ref. 4). However, vitamin D may
not be always required to be filled in the SR. USDA is working with
various industries to determine the vitamin D values on meats and eggs,
and it plans to have these data available in future SR releases. We
intend to work with USDA to determine ways to have more values for
vitamin D on the SR databases.
    b. Potassium. Under our preexisting regulations, at Sec.
101.9(c)(5), the declaration of potassium content is voluntary, except
when a claim is made about it. In the preamble to the proposed rule (79
FR 11879 at 11922), we discussed how the scientific evidence regarding
potassium had changed, such that we recognized potassium's importance
in the risk reduction of certain chronic diseases. We also noted that
the 2010 DGA concluded that potassium is a nutrient of concern for the
general U.S. population. Given 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 concluded
that potassium is a nutrient of public health significance for the
general U.S. population and proposed to amend Sec.  101.9(c)(8)(ii) to
require the mandatory declaration of potassium.
    (Comment 375) Almost all comments supported the mandatory
declaration of potassium on the Nutrition Facts label.
    Some comments, however, supported mandatory declaration of
potassium for different reasons. Many comments would require mandatory
declaration of potassium because potassium is important for dialysis
and renal patients.
    (Response) While mandatory labeling of potassium may help patients
with chronic kidney disease, this was not a factor we considered when
we proposed the mandatory declaration of potassium on the Nutrition
Facts label. As we stated in the preamble to the proposed rule (79 FR
11879 at 11890) and maintain in this final rule, we consider mandatory
declaration appropriate for these types of nutrients when there is
public health significance and a quantitative intake recommendation
that can be used for setting a DV (DRV or RDI), although we also have
considered mandatory declaration based, in part, on evidence
highlighting the role of a nutrient in a specific relationship to
chronic disease risk. For potassium, we concluded 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, the final rule, at Sec.
101.9(c)(8)(ii), requires the mandatory declaration of potassium.
    (Comment 376) One comment stated that food manufacturers may start
to fortify their foods with potassium in an attempt to offset the
sodium content of a food product. The comment said we should monitor
how food manufacturers respond to this new requirement. The comment
also said that, as part of an overall consumer education campaign, we
should encourage consumers to obtain potassium through a diet high in
fruits and vegetables and recommend amounts of low-fat/fat-free dairy
products rather than obtain potassium from dietary supplements or
potassium fortified foods.
    (Response) The comment did not provide any evidence to suggest that
mandatory declaration of potassium on the Nutrition Facts label will
increase fortification of foods; consequently, we are unable to
determine whether such fortification is likely or the extent to which
it might occur. The final rule requires mandatory labeling of potassium
and other essential vitamins and minerals on the Nutrition Facts label
to assist consumers in maintaining health dietary practices.
    With respect to fortification, we note that we published a policy
statement on the rational addition of nutrients to foods (Sec.
104.20). We urge manufacturers, if they elect to add nutrients to a
food, to follow the guidelines stated in the fortification policy for
rational addition of nutrient to foods to preserve a balance of
nutrients in the diet of the U.S. population. We intend to continue
assessing the nutritional status

(inadequacy and excess) of potassium consumption, among other
nutrients, in the general healthy U.S. population after the final
rule's compliance dates. We also intend to monitor the market to assess
fortification practices in response to the revised Nutrition Facts
label. With respect to educational activities, we intend to work with
other Federal Agencies and organizations to emphasize the changes to
the Nutrition Facts label (see part II.B.1). However, consistent with
our mission, our educational activities will focus on the Nutrition
Facts label rather than fresh produce (i.e., fresh fruits and
vegetables). The reason for the mandatory declaration of potassium and
other essential vitamins and minerals on the Nutrition Facts label is
to assist consumers in maintaining health dietary practices rather than
to recommend consumption of specific foods or products.
    (Comment 377) Several comments suggested that potassium should
appear on the Nutrition Facts label after sodium. The comments said
that there is an association between potassium intake and reduced blood
pressure in certain individuals, so potassium should appear below
sodium. The comments said this placement will help consumers understand
that these two nutrients and their respective amounts in a food are
related.
    (Response) We decline to revise the rule as suggested by the
comment. We stated in the preamble to the 1993 final rule (58 FR 2079
at 2106) that, for essential vitamins and minerals, the decisions about
mandatory or voluntary declarations were based on public health
concerns relative to inadequate dietary intakes as well as the possible
association between several of these nutrients and the risk of chronic
disease. The main difference between the DRV and RDI nutrients was/is
that DRV nutrients are: (1) Nutrients to limit (e.g., sat fat,
cholesterol, and trans fat); or (2) based on a specific caloric intake
(e.g., fat, carbohydrate, protein, and dietary fiber). However, RDIs
have been and are being proposed based on age specific RDAs (and now
AIs). In 1993, there were not age specific RDAs for potassium.
Currently, there are age specific AIs for potassium that are based on
chronic disease risk. Thus, because potassium is now being assigned an
RDI, rather than a DRV, we are moving it down in the label with the
other essential vitamins and minerals that have RDIs. Furthermore, the
comment did not provide any evidence to support the claim that having
sodium and potassium near each other on the label would help consumers
understand that these two nutrients and their respective amounts in a
food are related. Consequently, we cannot evaluate the comment's claim
regarding placement and consumer understanding.
    (Comment 378) One comment said the mandatory declaration of
potassium on the Nutrition Facts label will pose challenges for very
small packages (because another line in the label would be needed).
Additionally, some comments noted that beverages, such as plain
unsweetened coffee and tea, are exempt from nutrition labeling (under
Sec.  101.9(j)(4)) because they contain insignificant amounts of all
nutrients required to be declared on the Nutrition Facts label.
According to the comments, plain coffee and tea may have low, but
declarable, levels of potassium, so the mandatory declaration of
potassium would cause plain coffee and tea to lose their current
exemption from nutrition labeling. The comments said we should examine
Sec.  101.9(j)(4) and make any necessary adjustments. The comment
suggested that, when levels of potassium are less than 5 percent of the
DV and on small packs with limited space, declaration of potassium
would be voluntary.
    (Response) We recognize the discrepancy between the exemption under
Sec.  101.9(j)(4) and the labeling that would be required for products
that have significant levels of nutrients. In the proposed rule, we did
not ask for comments specifically about the continued applicability of
this exemption from nutrition labeling provisions in light of what
would be a changing level of nutrients that will be considered
``insignificant'' as a result of this rule and the final rule entitled
``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed
at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments'' (Serving Size final
rule) published elsewhere in this issue of the Federal Register.
Therefore, we intend to consider the future applicability of the
exemption with respect to mandatory nutrition labeling on products that
would have been exempt under Sec.  101.9(j)(4) prior to the effective
date of this rule and the Serving Size final rule. After the effective
date of this final rule, we intend to consider the exercise of
enforcement discretion with respect to the use of mandatory nutrition
labeling on such products that would have been exempt under Sec.
101.9(j)(4).
    We understand that providing Nutrition Facts labels on packages
with limited space may be challenging for manufacturers; thus, our
preexisting regulation, at Sec.  101.9(j)(13), provides for special
labeling provisions for packages with limited space.
    (Comment 379) Several comments said that manufacturers would need
more than 2 years to gather nutrition data for potassium and to comply
with the mandatory declaration of potassium on the Nutrition Facts
label. Some comments said that the data are often lacking in many
company and public databases, so time will be needed to collect the
data.
    (Response) We disagree, in part, with the comments. There are
public databases, such as USDA Nutrient Data Database, that can provide
information regarding the potassium content of foods. For example, in
the USDA Nutrient Data Database for current Standard Reference (SR 27),
nearly 8,200 of the approximately 8,600 foods in the database, or
approximately 95 percent of the foods, have potassium values.
    Additionally, the operations involved and equipment required for
the methods for potassium determination are standard in analytical
laboratories. Nevertheless, we have revised the compliance dates for
the final rule (see part III).
    (Comment 380) One comment asked us to clarify the use of potassium
in dietary supplement products. The comment said that many dietary
supplement companies have been limiting potassium in their formulas to
99 mg per serving and that 99 mg of potassium is not an appreciable
fraction of the current (3,500 mg) or proposed (4,700 mg) reference
daily intake for potassium. The comment said that this limitation is
based on a position we took in 1975 that any capsule or coated tablet
of a potassium salt intended for oral ingestion (without prior dilution
with an adequate volume of liquid to preclude gastrointestinal injury)
should carry a warning statement regarding small-bowel lesions related
to the use of oral drug products containing 100 mg or more potassium.
The comment said we have not established an upper limit for potassium
in dietary supplement formulations, so the comment asked us to clarify
how potassium might be used in solid oral dietary supplements.
    (Response) We have not established any limits on potency or
recommended uses for dietary supplements that contain potassium salts.
Under the FD&C Act, a manufacturer or distributor is responsible for
ensuring that the dietary supplements are safe and meet other
applicable requirements of the FD&C Act and its implementing

regulations. The safety of or need for a warning statement on dietary
supplements with certain potencies of potassium are outside the scope
of this rulemaking.
    (Comment 381) Several comments did not support mandatory
declaration of potassium on the Nutrition Facts label. Some comments
said that consumers do not know what potassium is, so the declaration
of potassium on the label would not be helpful. The comments said it
would be better to omit potassium from the label so that the Nutrition
Facts label is less cluttered, can be better organized, and be less
likely to overwhelm the consumer with information.
    (Response) We decline to revise the rule as suggested by the
comments. We consider whether a vitamin or mineral is of public health
significance to be the key factor in deciding when to require mandatory
declaration on the Nutrition Facts label. Available quantitative
evidence suggests that the declaration of nutrients of public health
significance including vitamins and minerals can help consumers
maintain healthy dietary practices. We consider potassium to be a
nutrient of public health significance, and the final rule includes
potassium in the list of nutrients in Sec.  101.9(c)(8)(ii) for which a
quantitative amount by weight and percent of the RDI are required in
nutrition labeling to assist the consumers in maintaining healthy
dietary practices.
    As for the comment's mention of clutter, we consider clutter as a
matter of graphic design, but possible clutter is not our basis for
omitting or removing a nutrient of public health significance from the
Nutrition Facts label.
    (Comment 382) One comment suggested that potassium should be a
qualifying nutrient for ``Healthy'' claim criteria.
    (Response) Issues regarding labeling outside the Nutrition Facts
and Supplement Facts labels, such as nutrient content claims, are
outside the scope of this rulemaking (see part II.B.4).
4. Other Essential Vitamins and Minerals
    Under our preexisting regulations, at Sec.  101.9, several other
essential vitamins and minerals, in addition to vitamin D and
potassium, may be declared voluntarily 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 the preamble
to the proposed rule (79 FR 11879 at 11922 through 11923), we explained
how we had considered comments to the 2007 ANPRM recommending mandatory
declaration of vitamin E, folate, vitamin B12, magnesium,
and phosphorus and how, based on our analysis of available data and
using the factors we consider for mandatory and voluntary declaration
of non-statutory nutrients, we did not propose 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.
    Several comments addressed the voluntary declaration of specific
vitamins or nutrients, and we discuss those comments in this section.
    a. Phosphorus.
    (Comment 383) Most comments asked that we amend our regulations so
that declaration of phosphorus is mandatory rather than voluntary.
    Most comments said that many people have kidney problems, and
patients under dialysis have to watch their intake of phosphorous in
addition to potassium and calcium. The comments said that it can be
very difficult for individuals who are on a low potassium and
phosphorous diet to calculate their daily intake. The comments said
that dialysis patients are educated about foods high in phosphorus, but
it is difficult to manage one's phosphorus intake when phosphorus is
``in almost everything.'' The comments said that many dialysis patients
have neither the motivation nor the resources to be diligent about
monitoring phosphorus in their diet. One comment stated that phosphorus
can occur naturally in various forms of food, or as a component in
commonly used food additives, and that the processing of meat and fish
products increases the phosphorus content above the naturally occurring
levels in the protein itself. The comment said that the addition of
phosphorous to the Nutrition Facts label will help kidney patients to
be aware of the high amount of phosphorus in foods. The comment noted
that, in determining mandatory or voluntary labeling, FDA considers
whether there is evidence of a relationship between the nutrient and a
chronic disease, health-related condition, or health-related
physiological endpoint and whether there is evidence of a problem
related to health in the general U.S population. Thus, the comment
said, using these considerations, we should revise the rule to require
the mandatory declaration of phosphorus on the Nutrition Facts label.
    (Response) While a mandatory phosphorous declaration may aid
patients with chronic kidney disease and dialysis patients, the
Nutrition Facts label is not targeted to individuals with a particular
acute or chronic disease (see part II.B.2). The information on the
label is meant for the general healthy U.S. population. For determining
the nutrients of public health significance, we considered the factors
that were discussed in the proposed rule and determined that
phosphorous intakes are generally adequate and not of public health
significance in the general, healthy U.S. population (Ref. 204).
Furthermore, total intakes (food and supplement) among the general U.S.
population were not found to be above the UL (Ref. 199). Based on these
factors, we determined that phosphorous is considered a voluntary
nutrient for the general healthy U.S. population, and are not making
changes to the voluntary declaration of phosphorus in response to this
comment. Therefore, manufacturers can declare phosphorus on the
Nutrition Facts label voluntarily. However, if phosphorous is added as
a nutrient supplement or claims are made about it on the label or in
labeling of foods, then it must be declared on the label. All
ingredients, including phosphate compounds, must be declared in the
ingredient list on the label.
    b. Magnesium.
    (Comment 384) Several comments would revise the rule so that
declaration of magnesium on the Nutrition Facts label would be
mandatory instead of voluntary. Several comments stated that magnesium
is needed for dialysis patients. One comment said that, instead of
paying too much emphasis on calcium for adults, we should pay more
attention to magnesium because, according to the comment, nearly 90
percent of dialysis patients are deficient in magnesium.
    (Response) We decline to revise the rule as suggested by the
comments. As we stated in part II.B.2, the Nutrition Facts label is not
targeted to individuals who have a specific acute or chronic disease.
    (Comment 385) Some comments said that magnesium is an essential
mineral and necessary for maintaining more than 300 essential metabolic
reactions in the human body. One comment said that magnesium interacts
with calcium and potassium and foods and that dietary supplements are
frequently enriched with calcium. The comment

said that magnesium deficiency in the face of a normal calcium intake
can lead to soft tissue calcification in animals (Refs. 205-206). The
comment said that the most prominent feature of magnesium deficiency is
the calcification predominantly of arteries (Refs. 207-209) and that
magnesium inhibits the release of calcium ion from the sarcoplasmic
reticulum, blocks the influx of calcium ion into the cell by
inactivating the calcium channels in the cell membrane, and competes
with calcium ions at binding sites on troponin C and myosin, thereby
inhibiting the ability of calcium ions to stimulate myocardial tension
(Refs. 210-212). The comment noted that magnesium, a calcium
antagonist, substitutes itself for the calcium ions on hydroxyapatite,
producing more soluble phosphate salts and thus inhibiting bone
formation and perhaps aortic valve stenosis (Ref. 213).
    One comment stated that the absorption of calcium and magnesium may
be altered depending upon the levels and ratio between them. The
comment said that emerging evidence indicates that it may be better to
optimize one's intake of calcium and magnesium rather than
supplementing with either mineral alone. The comment said that the
mandatory declaration of magnesium on the Nutrition Facts label will
help consumers avoid an imbalance of calcium and magnesium by
highlighting to the consumer how inadequate his or her magnesium intake
is in relation to the calcium content of packaged foods (which the
comment said are frequently supplemented with calcium). The comment
also stated that the IOM has said that ``magnesium is necessary for
sodium, potassium-ATPase activity, which is responsible for active
transport of potassium'' (Ref. 214) and that magnesium regulates the
outward movement of potassium in myocardial cells (Ref. 215). The
comment further stated that magnesium inadequacy has a variety of other
adverse health effects and that dietary magnesium intake was found to
be inversely associated with mortality risk in individuals at high risk
of cardiovascular disease (Ref. 216). In addition, the comment said, a
higher dietary magnesium intake is associated with lower fasting
glucose and insulin (Ref. 217), and dietary magnesium intake is
inversely associated with plasma concentrations of the inflammation
indicator C-reactive protein (CRP).
    One comment stated that national survey data indicate that dietary
magnesium intake is inadequate in the general U.S. population,
particularly among adolescent girls, adult women, and the elderly. One
comment stated that the impact of adding another item to the label is
minimal compared to overall costs. The comment said that, given that
the costs are inevitable, it is better to add all mandatory
declarations to the label at one time. In other words, if a
manufacturer is already changing the label for potassium for example,
there is a minimal incremental cost to add magnesium at the same time.
    One comment noted that, from a food processing perspective, given
the label desirability of increasing potassium and reducing sodium
levels, manufacturers might replace a portion of currently used sodium
salts, such as sodium citrate and sodium phosphate, with the potassium
salts with equivalent functional characteristics. Thus, the comment
said, labeling of magnesium content becomes more important to avoid
creating an imbalance of potassium and magnesium.
    (Response) We agree that magnesium is an essential nutrient and
that it is important in many different pathways and functions of the
body (Ref. 218). However, consistent with our consideration of the
factors for mandatory and voluntary declaration of vitamins and
minerals (see part II.D), while magnesium dietary intake is currently
low, the IOM recommended intake is not set based on a public health
endpoint (e.g., a chronic disease), and the overt symptoms of magnesium
deficiency are rarely seen among general healthy U.S population.
Consequently, we do not consider magnesium to be a nutrient of public
health significance for the general U.S. population (Ref. 204). We
consider whether a vitamin or mineral is of public health significance
to be the key factor in deciding when to require mandatory declaration
on the Nutrition Facts label, cost consideration was not a factor in
determining nutrients of public health significant.
    In the case of magnesium, similar to our recommendation, the 2010
DGA and 2015 DGAC did not include magnesium as a nutrient of public
health concern for the general U.S. population. (The 2015-2020 DGA also
does not include magnesium as a nutrient of public health concern.)
Magnesium was considered as a shortfall nutrient. Although some
comments cited published articles, most articles cited by the comments
are either animal studies, not using valid surrogate endpoints (such as
C-reactive protein), or are based on single studies and emerging
evidence and the conclusions are not based on the totality of
scientific data.
    (Comment 386) One comment noted that some manufacturers already
include magnesium content on the Nutrition Facts label for their
products. The comment said that, for example, Kelloggs includes
magnesium content on Raisin Bran cereal (but not on its Corn Flakes),
Nestle includes magnesium content on its Instant Breakfast products,
and General Mills includes magnesium content on Cheerios cereal. The
comment suggested that these steps are to be encouraged and broadened.
    (Response) We are not making changes to the voluntary declaration
of magnesium in the final rule, and therefore, manufacturers may
declare magnesium voluntarily on the Nutrition Facts label. However, if
magnesium is added as a nutrient supplement or claims are made about it
on the label or in labeling of foods, then it must be declared on the
label.
    c. Vitamin K.
    (Comment 387) Several comments stated that declaration of vitamin K
on the Nutrition Facts label is necessary for individuals who are on
blood thinners.
    (Response) We decline to revise the rule as suggested by the
comment, and vitamin K remains a voluntarily declared nutrient in the
final rule. While information regarding vitamin K may help patients on
blood thinners, as we stated in part II.B.2, the Nutrition Facts label
is for the general, healthy U.S. population rather than for individuals
with acute or chronic disease.
    d. Choline.
    (Comment 388) In general, comments regarding the declaration of
choline on the Nutrition Facts label supported voluntary declaration.
    (Response) Because declaration of choline on the Nutrition Facts
label is already voluntary, no changes to the rule are necessary.
    e. Vitamin B12.
    (Comment 389) One comment stated that fortified foods and dietary
supplements are the only reliable way for individuals who avoid all
animal products to obtain vitamin B12. The comment said that
including the amount of vitamin B12 added to fortified foods
and dietary supplements would enable these individuals to monitor their
intake of this essential vitamin. The comment said that labeling also
would help individuals aged 50 years and older who are advised to meet
their RDA mainly by consuming foods fortified with crystalline vitamin
B12 or vitamin B12-containing dietary
supplements.
    (Response) Declaration of vitamin B12 on the Nutrition
Facts or Supplement Facts label is mandatory when vitamin
B12 is added as a nutrient supplement or

when claims are made about it on the label or in labeling of foods.
Thus, because the information is already available to consumers under
the circumstances described in the comment, no changes to the rule are
necessary.

M. Reference Daily Intakes for Vitamins and Minerals

1. Need To Update RDIs
    Our preexisting regulations, at Sec.  101.9(c)(8)(iv), set forth
RDIs used to calculate the percent DVs for vitamins and minerals that
are required or permitted to be declared on the Nutrition Facts label.
RDIs are intended as general food labeling reference values and are not
intended to represent dietary allowances for individuals. 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.
    The preamble to the proposed rule discussed how new information
caused us to reconsider the RDIs and our approach to setting RDIs (79
FR 11879 at 11925 through 11928). In brief, the proposed rule would
revise the existing RDIs for vitamins and minerals based on the DRIs
set by the IOM (1997 to 2010) and would consider the RDAs, when
available, as the basis for establishing RDIs, instead of the EAR.
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 (see 79 FR 11879
at 11926 through 11927).
2. Approach To Setting RDIs: EAR Versus RDA
    In the preamble to the proposed rule (79 FR 11879 at 11926 through
11927), we explained our approach to setting RDIs. In brief, the
percent DV advises the consumer how much of the recommended intake of a
particular nutrient is provided by the food. The DV for a nutrient is
not to be interpreted as a precise recommended intake level for an
individual; instead, it is a general guide or a reference value that
the consumer can use to help judge a food's usefulness in meeting
overall daily nutrient requirements or recommended consumption levels
and to compare nutrient contributions of different foods (id. at
11926). Two types of reference values, the Reference Daily Intakes
(RDIs) for vitamins and minerals and Daily Reference Values (DRVs) for
certain nutrients, are used to declare nutrient contents as percent DVs
(id. at 11883, 11926), and the RDIs for vitamins and minerals have been
based primarily on RDAs (or on other available quantitative intake
recommendations if an RDA has not been established for a particular
vitamin or mineral).
    The preamble to the proposed rule also stated that 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 (id. at 11926). 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 (id.).
    In contrast, the EAR 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 (id.). The EAR is a quantitative intake
recommendation that is used to derive target nutrient intake goals for
the planning of diets for groups (such as planning diets in an assisted
living facility for senior citizens or planning menus for a school
nutrition program), but is not used as a target intake goal for
individuals. The EAR is not intended to be a target intake level for
individuals because an individual does not know how his or her needs
relate to the EAR. Therefore, if the RDI were to be based on the EAR,
the RDI would not meet the daily nutrient requirements for some
consumers and would understate target intake levels. In contrast, an
RDI that is based on a RDA would meet the daily nutrient requirements
for most individuals 4 years of age and older. 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. As a result, in the preamble to the
proposed rule (id. at 11927), we stated that RDAs, when available,
provide the most appropriate basis for establishing RDIs and, using
corresponding RDAs, we proposed, at Sec.  101.9(c)(8)(iv), to 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.
    (Comment 390) Several comments supported using the RDA, rather than
the EAR, as the basis for establishing RDIs.
    In contrast, one comment opposed using the RDA and supported using
the EAR. The comment asserted that we should not dismiss the
recommendations of the IOM Labeling report (Ref. 219) to use the EAR as
the basis for setting DVs, in favor of the 2003 IOM Planning report
(Ref. 220) recommendation to use RDAs to plan diets of individuals. The
comment stated that there is no better reference value against which to
appraise the nutritional contribution of a product than a DV based on a
population weighted EAR and that any other basis for the DV will either
understate or overstate the nutritional contribution of a food product
when considered in comparison to the population weighted EAR. The
comment said that we misinterpreted the purpose of the 2003 IOM
Planning report recommendation to use the RDA to plan diets and that
there is no reason to assume that the very specific notion of dietary
planning for individuals (as described in the 2003 IOM Planning report)
is what consumers mean when they say they use the label for planning
purposes. The comment further stated that the DVs are not appropriate
to use for planning an individual's entire diet because they do not
represent the individual's age and sex, and that this nutrition
information is only provided on packaged foods (not fresh fruits and
vegetables, meat, poultry, fish). The comment also said that this
information is only available for nutrients that are mandatory on the
Nutrition Facts label.
    (Response) We continue to believe that the RDA is the most
appropriate reference value to use to establish RDIs, considering the
purpose of the DV. As we noted in the preamble to the proposed rule (79
FR 11879 at 11926), the percent DV advises the consumer how much of the
recommended intake of that nutrient is provided by the food. While the
DV for a nutrient is not to be interpreted as a precise recommended
intake level for an individual, it is a general guide or a reference
value that the consumer can use to help judge a food's usefulness in
meeting overall daily nutrient requirements or recommended consumption
levels and to compare nutrient contributions of different foods (id.).
The EAR is not intended to be a target intake level for individuals
because an individual does not know how his or her needs relate to the
EAR. While the RDA may not be the best estimate of any given
individual's nutrient requirements, which are usually unknown, the RDA
was developed as a target intake level for individuals. The RDA is
designed to meet the needs of practically all (97 to 98 percent)
individuals within a life stage and gender group. If the RDI was

based on the EAR, the RDI would not meet the daily nutrient
requirements for some consumers and would understate target intake
levels.
    We also disagree with the comment's characterization of the 2003
IOM Planning report recommendations. The 2003 IOM 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 healthy diet. The
2003 IOM Planning report gave several examples of dietary plans such as
the Nutrition Facts label, the U.S. 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. 220). The 2003 IOM
Planning report noted that, when food guides are used, reference
standards for nutrients such as the RDAs are implicitly used in
planning individual diets (see 79 FR 11879 at 11926). Therefore, we
disagree with the comment's suggestion that the 2003 IOM Planning
report is somehow at odds with the use of the RDA as a reference value
for establishing RDIs. Furthermore, we disagree with the comments'
assertion that the DVs are not appropriate to use for planning an
individual's entire diet because nutrition information is only provided
on packaged foods (and not on fresh fruits and vegetables, meat,
poultry, or fish). Retail stores that sell raw fruits, vegetables, and
fish participate in the voluntary point-of-purchase nutrition
information program (Sec. Sec.  101.42 through 101.45). Additionally,
we have developed posters that provide nutrition information for the 20
most commonly consumed fruits, vegetables and seafood that are
available to consumers and industry (Ref. 221). Similarly, USDA
requires that retail stores that sell meat and poultry to label
products with nutrition information or to post point-of-purchase
nutrition information. USDA also has developed posters for nutrition
information for meat and poultry that are available for use by
consumers and industry (75 FR 82148) (Ref. 222). For these reasons, we
are making no changes to the rule based on the comment.
    We address comments on specific vitamins and minerals at parts
II.M.6 and II.M.7.
3. Approach To Setting RDIs: Adequate Intake
    In the preamble to the proposed rule (79 FR 11879 at 11927), we
explained that, in the absence of RDAs, AIs represent the best estimate
of an 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. Consequently, we proposed to use the AI to set RDIs for
biotin, chloride, choline, chromium, manganese, pantothenic acid,
potassium, and vitamin K.
    (Comment 391) Several comments supported using the AI as the basis
for establishing RDIs for those vitamins and minerals where data were
insufficient to determine a RDA. However, other comments opposed using
the AI for potassium to establish an RDI of 4,700 mg and recommended
that we retain the current DRV of 3,500 mg. The comments stated that
the AI is established at a level assumed to ensure nutritional adequacy
in all members of a healthy population when there is insufficient
scientific evidence to develop an RDA. The comments said that using a
reference value based on inadequate quantity or quality science would
be providing inconclusive information to consumers. A few comments
noted that there is now additional evidence (Refs. 223-224) that is
more reflective of the current state of the science and recognizes the
sodium to potassium ratio. Some comments also suggested that the IOM
should re-assess the DRI for potassium in light of the new data to
determine if the current AI is truly reflective of the actual
requirements. One comment suggested that increasing the RDI could
result in increased reliance on fortification or use of dietary
supplements.
    (Response) We agree with the comments that support the use of the
AI to set the RDIs for nutrients that do not have a RDA. We disagree
that we should not use the AI to set an RDI for potassium and that the
existing DV of 3,500 mg should be retained. The existing DV for
potassium was set in 1993 based on the 1989 Diet and Health report and
no longer represents the most current recommendations for potassium
intake. As discussed in the preamble to the proposed rule (79 FR 11879
at 11927), while there is more uncertainty with an AI than an EAR or
RDA, in the case of nutrients without established RDAs, the AI reflects
the most current scientific recommendations for intake (id.). When
establishing RDIs, we consider the quantitative intake recommendations
from U.S. consensus reports (e.g., the IOM DRI reports) (see 79 FR
11879 at 11890).
    We disagree that the sodium and potassium ratio should be used to
set a DV for potassium. First, sodium is not presented on the label as
a ratio of sodium and potassium. As discussed in part II.L.3.b, the
final rule requires the declaration of potassium on the label. Thus, if
consumers are interested in the sodium and potassium ratio, they will
have both the absolute amounts as well as the percent DV for both
nutrients. In addition, the Aburto et al., 2013 systematic review and
meta-analysis cited by the comment concluded that daily potassium
intakes in the range of 90 to 120 mmol (3,519 mg to 4,700 mg) were
associated with lower risk of stroke (Ref. 223). This range is
consistent with the AI of 120 mmol (4,700 mg/day) that was based on
potassium's ability to blunt the effects of sodium intake on blood
pressure and to reduce the risk of kidney stones. Furthermore, Aburto
et al. 2013 noted their analysis of randomized trials that examined how
sodium intakes influence potassium's effect on blood pressure shows
there was no statistically different effect among subgroups based on
sodium intake. A majority of the individual studies cited in the Aburto
et al., 2013 meta-analysis were reviewed in the 2005 Electrolytes
report which concluded that data on the sodium and potassium ratio was
insufficient to be used to set requirements (Ref. 223). The other
article cited in the comment (Ref. 224) is a review article that does
not include the totality of the scientific evidence and does not
provide sufficient information for FDA to review. While we recognize
that the intakes of sodium and potassium are interrelated, we do not
consider the evidence to be sufficient to set an RDI based on the
sodium and potassium ratio, and we continue to consider that the AI set
by the IOM is appropriate to use for setting the RDI. Additionally,
given the extensive reviews already conducted by the IOM, we do not
agree that it is necessary to ask the IOM to reevaluate the existing
evidence for potassium.
    As for the comment regarding fortification, the comment did not
provide any evidence, and we are not aware of any evidence, that
suggests using the AI would lead to excessive fortification and
increased use of dietary supplements. Currently, the adequacy of
intakes for potassium is very low (see 79 FR 11879 at 11922). Only 1.9
percent of the general population has usual potassium intake above the
AI from conventional foods only, and 2.4 percent have intakes above the
AI from conventional foods plus dietary supplements. RDIs which are
expressed on the label as a percent DV, give a consumer a general idea
how much of a nutrient they should consume. While RDIs may influence
the vitamin or

mineral content of foods, 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 (e.g., 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. Manufacturers must
comply with relevant regulations, and we urge them to follow the
principles stated in our fortification policy. We conclude that the AIs
set by the IOM provide an appropriate basis for selecting RDIs for
those vitamins and minerals where available data are insufficient to
determine RDAs and will not be making a change as a result of this
comment.
4. Approach To Setting RDIs: Tolerable Upper Intake Level
    The preamble to the proposed rule (79 FR 11879 at 11928) explained
that 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. The UL can be used to estimate the percentage of
the population at potential risk of adverse effects from excess
nutrient intake, but it 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 no established benefit for consuming amounts of
nutrients above the RDA or AI. Thus, we do not consider the UL to be an
appropriate basis for setting RDIs for vitamins and minerals.
    We did not receive comments on this topic.
5. Approach To Setting RDIs: Population-Weighted Versus Population-
Coverage
    In the preamble to the proposed rule (id.), we discussed how we
considered recommendations of current consensus reports, scientific
review articles, and comments to the 2007 ANPRM. We tentatively
concluded that RDIs for vitamins and minerals should continue to be
based on a population-coverage approach (rather than a population-
weighted approach), using the highest RDA and, where an RDA has not
been established, the highest AI (79 FR 11879 at 11928). We explained
that using a population-coverage approach would avoid a higher risk of
nutrient inadequacy among certain segments of the population because
the RDA/AI value is not derived from averaging the requirements for
populations with lower needs (children and elderly) and those with
greater needs (adolescents or adults). We acknowledged that, for some
nutrients, the population-coverage RDA approach would result in RDIs
that are higher than the nutrient requirements for some consumers, but
said that the RDA, by definition, is the target intake goal for
nutrient intakes for individuals (id.).
    We proposed to amend Sec.  101.9(c)(8)(iv) to update RDIs and to
present the updated RDIs in a table.
    (Comment 392) Several comments supported the use of the population-
coverage approach, using the highest RDA or AI to set the RDIs. Other
comments, however, said we should use the population-weighted approach.
Comments supporting the use of a population-weighted approach asserted
that a DV derived from the population-coverage RDA will result in
setting target intakes for nutrients above the needs for the majority
of the population, that the use of a population-weighted RDA would
still result in an increase in the RDIs for calcium, vitamin D, and
potassium, and that the RDI for iron would decrease from 18 mg to 11
mg, but that this level would still exceed or meet the RDA for 80
percent of the population.
    One comment supporting use of a population-weighted EAR disagreed
with our rationale that using a population-coverage approach ensures
that vulnerable groups are covered; the comment stated that, with the
exception of iron, the highest RDAs are those for young men who are not
vulnerable to nutrient inadequacies.
    A few comments suggested that using a population-coverage approach
would set nutrient targets unnecessarily too high and would make it
harder for consumers to meet their nutrient requirements while staying
within energy needs. Another comment suggested that using a population-
coverage approach might lead to consumer confusion and frustration.
    (Response) As we discussed in the preamble to the proposed rule (79
FR 11879 at 11928), 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. Furthermore, in addition to iron, the proposed RDIs for
calcium and vitamin D were based on vulnerable groups. The RDI for
calcium was based on the highest RDA of 1,300 mg/day for 9 to 18 year
olds, and the proposed RDI of 20 mcg for vitamin D was based on the RDA
for adults 70 years and older. All three nutrients have been identified
as nutrients of public health concern (see 79 FR 11879 at 11918 through
11922). We continue to use the population-coverage approach to set RDIs
and decline to make a change based on this comment.
    As for the comment suggesting that using a population-coverage
approach would set nutrient targets unnecessarily too high and would
make it harder for consumers to meet their nutrient requirements while
staying within energy needs, we acknowledge that, for some nutrients,
the population-coverage RDA approach will result in RDIs that are
higher than the nutrient requirements for some consumers. However, the
RDA, by definition, is the target intake goal for nutrient intakes for
individuals. In addition, 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 (see 79 FR 11879 at
11928). Furthermore, because many of the new RDAs and AIs established
by the IOM are now lower than the older RDAs or ESADDIs that were used
in the past to develop RDIs, the new RDIs established in the final rule
based on a population-coverage RDA for many nutrients will be lower. We
are not aware of, nor did the comment provide, any evidence to suggest
that retaining the population-coverage approach would make it harder
for consumers to meet their nutrient requirements while staying within
energy needs.
    As for the assertion that consumers confusion may result, the
comments did not provide any data or information that such difficulties
or consumer confusion exists or the extent to which such

difficulties or confusion exists, so we are unable to determine the
nature or severity, if any, of such consumer difficulties or confusion.
We do note that the current DVs on the label are based on a population-
coverage approach, and we are not aware of any data and information
that the population-coverage approach, which we have used for decades,
has caused consumer confusion.
    We conclude that setting RDIs based on a population-coverage
approach is more appropriate than a population-weighted approach, and
we are not making changes to the rule based on these comments. Thus,
the final rule, at Sec.  101.9(c)(8)(iv), updates the RDIs for various
nutrients and presents them in table form, although we have, on our own
initiative, elected to use non-italicized numbers for RDI values that
were italicized in the proposed rule and deleted the footnote regarding
the declaration of a percent daily value for ``bolded'' (italicized)
nutrients.
    (Comment 393) Some comments agreed that using the population-
coverage RDA does not lead to excessive intakes of nutrients due to
over fortification of foods. The comments noted several recent analyses
that support our analysis and conclusions that a population coverage
RDA would not lead to excessive intakes of nutrients from fortified
foods (Refs. 194-195, 225). One comment pointed out that RDIs would
likely reset levels of vitamins and minerals in discretionary enriched/
fortified foods as manufacturers adjust absolute levels to maintain
current label claims. The comment said that, based on diet modeling
done by Murphy et al. that assumes that discretionary enrichment/
fortification levels reset, a population-coverage RDA would be likely
to result in a greater percentage of Americas meeting their nutrient
requirements compared to a population-weighted EAR (Ref. 225).
Furthermore, the comment said, the results of diet modeling conducted
by Murphy that assumed that discretionary enrichment/fortification
levels would reset indicated that using a population-coverage approach
would result in less than 1 percent of the total populations 4 years of
age and older having intakes above the ULs (Ref. 225).
    Some comments suggested that the use of a population-coverage RDA
could result in over-fortification of products. One comment noted that
intakes of zinc exceed the UL for young children. The comment stated
that we should not dismiss this finding by challenging the basis for
the UL, because doing so fails to recognize the extent to which many
American children's intakes currently exceed the UL. The comment stated
that the proposed RDI (11 mg) is more than two times the RDA for
children 4 to 8 years (5 mg/day) and almost four times the RDA for
children 1 through 3 years (3 mg/day). The comment said that a product
with 20 percent of the DV for zinc (e.g. 11 mg x 0.20 = 2.2 mg)
declared on the label would provide almost 100 percent of the zinc RDA
for a young child (3 mg/day).
    (Response) We disagree with the comment that stated that the use of
a population-coverage RDA would lead to excessive fortification and
intakes of nutrients. Instead, we agree with the comments that stated
that a population-coverage RDA would not lead to excessive intakes of
nutrients from fortified foods. As noted in the preamble to the
proposed rule (79 FR 11879 at 11928) and the accompanying memorandum to
the file (Ref. 199), intakes of vitamins and minerals generally do not
exceed the ULs under current RDIs that are based on a population-
coverage RDA approach, except for zinc, vitamin A (preformed), iodine,
and folic acid among children 4 to 8 years. In these 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 (Ref. 199). Analyses done by other groups
also have determined that fortified foods contribute to the nutrient
intakes and adequacy of many nutrients without leading to excessive
intakes for most vitamins and minerals (Refs. 194-195, 225).
Furthermore, because many of the new RDAs and AIs established by the
IOM are now lower than the older RDAs or ESADDIs that were used in the
past to develop RDIs, the final rule's RDIs, based on population-
coverage RDAs for many nutrients, will be lower. 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. As discussed in the 2014
memo to the file, we acknowledge that total usual zinc intakes from
conventional foods and dietary supplements exceed the UL for
approximately 33 percent of children 4 to 8 years of age. The UL for
zinc of 12 mg/day was extrapolated upward from the UL set for infants
based on decreased copper absorption (Ref. 226). In addition to intake
data, we considered whether there is public health significance to
exceeding the UL. As noted in the 2014 memo to the file, no reports on
adverse effects of zinc on copper absorption have been reported in
children and adolescents (Ref. 199). A dose response intervention study
published in 2013 found that supplementation with 5 to 15 mg/day of
zinc for 4 months did not alter copper status in healthy Canadian boys
aged 6 to 8 years (Ref. 227). Furthermore, the proposed RDI for zinc of
11 mg, which is based on the highest new RDA, decreases by 27 percent
from the current RDI of 15 mg. In addition, the proposed RDI for zinc
of 11 mg does not exceed the UL for children 4 to 8 years of age. The
RDIs are currently intended for adults and children 4 or more years of
age and not younger children because children over the age of 4 years
consume the same foods that the rest of the population consumes.
However, as discussed in part II.O.6.k, we also are establishing a RDI
of 3 mg for zinc for younger children 1 through 3 years of age.
    (Comment 394) Several comments opposed any revision to the RDIs
that would lower the RDIs. The comments stated that Americans need more
vitamins and minerals because toxin intake is increasing and nutrient
intake is decreasing. The comments suggested that our goal was to
harmonize our food laws to Codex standards and guidelines and stated
that this has been specifically prohibited by Congress. The comments
requested that we obey the law and withdraw the proposal rule for
revision and bring it in line with modern science which, according to
the comments, shows that we need higher daily intake of vitamin B and
other vitamins as well as more minerals such as magnesium and selenium.
    (Response) We disagree that the RDIs should not be revised. As we
discussed in the preamble to the proposed rule, we are revising the
RDIs based on our consideration of the RDA or AI set in the most recent
IOM DRI reports that are U.S. consensus reports (see 79 FR 11879 at
11926). The comments did not provide any data, information, or
explanation to support the various assertions made, including that
Americans need more vitamins and minerals due to increased toxins, that
the IOM DRI reports are incorrect, that our proposed actions are not
consistent with the law and the proposed rule should be withdrawn, or
that our goal is to harmonize food labeling with Codex standards and
guidelines. We are unaware of new consensus research that would lead us
to change our proposed approach to revise the RDIs. Therefore,

we are not making changes or taking any action in response to these
comments.
    (Comment 395) Several comments objected to lowering the RDIs for
specific nutrients such as biotin, niacin, pantothenic acid,
riboflavin, thiamin, vitamin B6, chromium, copper,
molybdenum, selenium, and zinc. One comment suggested that we did not
outline our specific reasoning for lowering the RDIs for these
particular nutrients. Another comment stated that we should reevaluate
more recent science that evaluates the effects of high doses of
nutrients from foods and supplements and look at clear differences
between synthetic and naturally occurring vitamins. Another comment
stated that the proposed changes will lead to consumer confusion and a
drop in intake as consumers will now perceive foods and supplements to
contain a much larger percentage of these nutrients when, in reality,
the nutrient level is the same.
    (Response) We disagree that RDIs for biotin, niacin, pantothenic
acid, riboflavin, thiamin, vitamin B6, chromium, copper,
molybdenum, selenium, and zinc should not be revised. As discussed in
the preamble to the proposed rule (see 79 FR 11879 at 11890), we are
revising the RDIs based on our consideration of the RDA or AIs set in
the IOM DRI reports that are U.S. consensus reports. We consider the
quantitative intake recommendations from these reports when
establishing RDIs.
    As for the comment suggesting that we consider new more recent
science, the comment did not identify any new references for us to
consider, and we are unaware of any new consensus from a body of
research that would lead us to change the rule. However, with respect
to synthetic and naturally occurring nutrients, in establishing RDAs or
AIs, the IOM does consider the various sources of nutrients (synthetic
and naturally occurring) when establishing the nutrient requirements.
    As for possible consumer confusion or lower intakes by consumers,
we are not aware of any data or information about that outcome, nor did
the comment provide any to support its assertions. Although the final
rule lowers many RDIs, using the population-coverage RDA to set the
RDIs would cover the needs of most individuals in the population. For
these reasons, we are making no further changes to the rule based on
these comments.
    (Comment 396) One comment stated that the current RDIs which are
largely based on preventing deficiency diseases are out of date and do
not consider nutrient intakes over the lifespan and do not provide
consumers with information on optimal amounts of nutrients for good
health. The comment cited a review by McCann and Ames that suggest
modest deficiency of selenium my increase the risk of age-associated
diseases (Ref. 228).
    (Response) We agree that the current RDIs are out of date and
should be revised. The RDAs set by the IOM which are the basis for the
new RDIs, did consider intakes over the lifespan and to the extent
possible based on available data consider the relationship between
optimal health and intakes of nutrients. The article cited by the
comment was a review article and does not include the totality of the
scientific evidence for FDA to review. The RDIs are based on our
consideration of the RDA or AIs set in the IOM DRI reports that are
U.S. consensus reports and we are not aware of any new consensus from a
body of research that would lead us to change our proposed approach to
revise the RDI for selenium. Therefore, we are not making changes or
taking any action in response to this comment.
    (Comment 397) Some comments questioned why we are increasing the DV
for vitamin C from 60 mg to 90 mg when we determined that the
declaration of vitamin C on the Nutrition Facts or Supplement Facts
label should no longer be mandatory. A few comments suggested that
increasing the DV for vitamin C may negatively impact the consumer
perception of this vitamin and result in consumer confusion. The
comments suggested the percent DV declaration will be lower because the
DV is higher for vitamin C, and so consumers may perceive that the
product has changed when it has not. A few comments also suggested
that, if the higher DV for vitamin C is adopted, we should engage in
consumer education.
    (Response) The preexisting RDI of 60 mg was based on the 1968 RDA
which is outdated and does not reflect current recommendations for
intake of vitamin C. We disagree that the RDI for vitamin C should not
be increased because we are no longer requiring mandatory declaration.
As we stated in the preamble to the proposed rule (79 FR 11879 at
11928), we are basing the RDIs for vitamins and minerals, including
vitamin C, on the highest RDA set by the IOM. Thus, for vitamin C, we
set the RDI at 90 mg. The RDIs, which are expressed on the label
through the percent DV, give a consumer a general idea how much of a
nutrient they should consume.
    We recognize that consumer education on the various changes to the
label will be important (see part II.B.1). Furthermore, we are not
aware of, nor did the comment provide, any data or information that
increasing the RDI for vitamin C will lead to consumer confusion.
6. Declaration of Absolute Amounts of Vitamins and Minerals
    Our preexisting regulations, at Sec.  101.9(d)(7)(i), require the
declaration of mandatory nutrients and, when declared, voluntary
nutrients by their absolute amounts in weight on the Nutrition Facts
label, except for vitamins and minerals (other than sodium and
potassium). 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 proposed rule would 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 include their quantitative amounts (in addition
to the requirement for corresponding percent DV declaration) (proposed
Sec.  101.9(c)(8)). We address the comments to this proposed
requirement in part II.Q.9.
    The proposed rule also would remove the specific requirements for
the declaration of potassium in Sec.  101.9(c)(5) and provide, instead,
for the declaration of fluoride. The proposed rule also would 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 stated that we saw 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).
    We also invited 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 rounding
increments (79 FR 11879 at 11930, 11961).
    (Comment 398) For conventional foods, we specify 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.
    One comment said that quantitative amounts less than 2 percent of
the DV should be exempt from declaration as such amounts are
nutritionally insignificant. Other comments suggested that we should
not allow for the amount of a nutrient to be declared as zero. These
comments suggested that, if there is even the smallest amount of the
nutrient in a serving of the product, the amount should be declared.
    (Response) We decline to revise the rule to require the declaration
of small, quantitative amounts of vitamins and minerals on the
Nutrition Facts label. While it may be desirable to have a precise
nutrient value on the label, such precision is impractical. There is
variability inherent in the food supply. Nutrients found in foods can
vary slightly due to many factors such as the season of the year, soil
type, variety (cultivar), and weather conditions. The processing that a
food undergoes also can alter its nutrient content. The rounding rules
were established to avoid the impression of unwarranted accuracy as
well as to make a label easier for the consumer to review and
understand.
    Furthermore, very small quantities of nutrients in a food product
do not contribute significantly to nutrient requirements for the total
daily diet. A consumer would most likely exceed their calorie needs
trying to obtain the recommended amount of a certain nutrient if their
diet is made up of only foods that contribute less than 2 percent of
the DV for that nutrient. To obtain the recommend amount of that
nutrient for the day, the consumer would need to consume other foods
containing larger quantities (at least more than 2 percent of the DV
for that nutrient) of the nutrient.
    (Comment 399) We proposed to use the same declaration increments
for the Nutrition Facts label as 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). The
proposed rule, at Sec.  101.9(c)(8)(iii), would require that the
quantitative amounts of vitamins and minerals on the Nutrition Facts
label, excluding sodium, be the amount of the vitamin or mineral
included in one serving of the product, using the units of measure and
the levels of significance given in Sec.  101.9(c)(8)(iv), except that
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 milligrams, but the quantitative amount may be declared
in tenths of a milligram).
    Several comments would change the rule's declaration increments.
Two comments asked us to ensure that there is consistency between the
rounded absolute amount and the declared percent DV. One comment stated
that any declaration of quantitative amounts of vitamins and minerals
should provide for declaration of a quantitative amount that
corresponds to the nearest whole number of the percent DV beginning
with 2 percent. Another comment said that most consumers will not do
the math to convert the absolute amount of the percent DV, but
providing both absolute amount and percentages could result in
different values for similar products in the marketplace.
    (Response) We agree that the rounded absolute amount and the
declared percent DV may be slightly inconsistent. For example, if the
quantitative amount of the vitamin or mineral is rounded after the
rounding rules for the percent DV declaration are applied, it could
result in a rounded value that is significantly different than the
actual amount of the nutrient in a serving of a food. For example, if a
product is determined by analytical methods to have 1,550 mg of
potassium per serving, the percent DV declaration would be determined
by dividing 1,550 mg by the RDI of 4,700 mg for a value of 33 percent.
After application of the rounding requirements for the percent DV
declaration, the declared percent DV value would be rounded to 35
percent. If the declared quantitative amount of potassium in a serving
of the product is then multiplied by 35 percent by the RDI of 4,700,
the declared quantitative amount of would be 1,645 mg of potassium.
This is a difference of 95 mg between the value obtained before and
after applying the rounding rules for the percent DV declaration.
    In addition, requiring a declaration of the amount of the nutrient
that corresponds to the nearest whole number of the percent DV
calculated before rounding could result in declared quantitative
amounts that are different than what has been determined by analytical
methods, but still not correspond with the rounded percent DV
declaration. For example, if testing is done to determine that a
product contains 300 mg of potassium per serving, the calculated
percentage of the RDI for potassium of 4,700 is 6.4 percent. If that
percentage is then rounded to the nearest whole number of 6 percent and
then multiplied by the RDI for potassium, it would result in a declared
value of 282 mg, which is different than the value which is determined
by analytical methods.
    The approaches suggested by comments to make the quantitative
amount of a vitamin or mineral declared on the label as close as
possible to the quantitative amount calculated from the percent DV
declaration would either result in a declared value that is either less
accurate or no better that the proposed approach. Therefore, we decline
to make changes to our label declaration increments.
    (Comment 400) One comment said that nutrients with ``equivalents,''
such as Vitamin A, folate, and niacin, make it impossible to simply
convert a numerical value to a percentage and could create consumer
confusion.
    (Response) We disagree with the comment. For those nutrients with
``equivalents,'' the equivalent amount should already be determined for
the purposes of the amount declared on the label. For calculation of
the percent DV, the declared amount should be divided by the RDI for
that nutrient and multiplied by 100. The equivalent amount should
already be determined for the label declaration and would not prevent a
manufacturer from determining the percent DV declaration for vitamin A,
niacin, folate, or folic acid.
    (Comment 401) Some comments suggested that less precision is needed
for declaration of quantitative amounts of nutrients declared on the
label. One comment suggested that the declared amounts should be
rounded to whole numbers because they are easier for consumers to
understand.
    Another comment suggested that any nutrient in an amount greater
than 10 units (e.g., 10 mg or 10 mcg) should be rounded to the nearest
1 (unless a larger increment is specified in the proposed

rule, such as ``Calories from saturated fat '' for which 5 calorie
increments are specified for amounts up to and including 50 calories),
those in an amount greater than 100 units should be rounded to the
nearest 10 units (unless a larger increment is specified in the rule),
and those in amounts greater than 1,000 units should be rounded to the
nearest 100 (unless a larger increment is specified in the rule). The
comment suggested that rounding should be based on the declared
quantity of a nutrient rather than on the RDI or DRV for the nutrient.
    One comment recommended that numbers ending in ``5'' should be
rounded up. The comment suggested that we could consider alternatively
allowing for numbers ending in 5 to be rounded to the nearest even
number, but said this could be confusing and counterintuitive for most
members of industry.
    Other comments suggested that more precision is needed for
declaration of quantitative amounts of nutrients declared on the label.
One comment recommended that quantitative amounts be rounded to the
nearest tenth instead of to the nearest integer. The comment indicated
that rounding errors can occur when quantitative amounts are rounded to
the nearest integer.
    Another comment also recommended that nutrients be rounded to the
nearest tenth of a gram for quantities under 10 grams per serving.
    (Response) We disagree that the same rounding increments should be
used for quantitative amounts of all vitamins and minerals. Some
nutrients, such as potassium, have a relatively large RDI value (4,700
mg) while others, such as thiamin, have a relatively small RDI value
(1.2 mg). The declaration of those nutrients with relatively smaller
RDI values requires greater specificity than those with relatively
larger RDI values. Furthermore, for some nutrients with relatively
larger RDI values, it may not be possible, given current analytical
methods, to determine the amount of the nutrient with precision when
very small quantities are present (e.g., at a level of less than 1 mg).
    The comments recommending specific rounding increments of all
nutrients based on the number of units in the RDI or DRV value did not
explain why those increments are appropriate so that we might determine
if the approaches suggested are merited. By using the levels of
significance provided in the RDI table in Sec.  101.9(c)(8)(iv),
allowing for zeros following decimal points to be dropped, and allowing
for additional levels of significance to be used when the number of
decimal places indicated is not sufficient to express lower amounts for
those nutrients with small RDI values, we are giving manufacturers some
flexibility to determine if the value should be rounded to the nearest
whole number or to a fraction of a whole number based on the nutrient
and the quantity present in a serving of the food.
    We recognize that determining the appropriate value to declare for
quantitative amounts of vitamins and minerals could be confusing to
manufacturers when the rule provides some flexibility based on the RDI
and the quantity of the nutrient present in a serving of food,
especially for nutrients with relatively small RDIs. For example, the
rounding requirements allow a manufacturer to declare an amount of zinc
as 2 mg or 2.4 mg per serving. Additionally, consumers use the
information found on the label in different ways. Some may use it to
get enough of certain nutrients whereas others may be more concerned
with not exceeding a certain calorie level. There has always been built
in variability in the label declarations due to variation in the food
supply and variance in the analytical methods used to determine the
amount of nutrients in a serving of a food. The amount of vitamins and
minerals declared on a label is not always the exact amount of the
nutrient in a serving of the food. Therefore, we decline to revise the
increments used for declaration of quantitative amounts of vitamins and
minerals as suggested by the comments.
    (Comment 402) One comment said that, if the final rule requires the
declaration of quantitative amounts of vitamins and minerals, we should
provide sufficient guidance regarding rounding rules and how to
quantify amounts of naturally occurring substances that inherently are
subject to variability (e.g., vitamins and minerals from plants that
are subject to variable growing conditions that affect nutrient
content).
    (Response) There may be different ways in which manufacturers may
want to consider the variability in the foods they produce.
Manufacturers should know how much variability to expect in the foods
they produce based on adequate sampling. Manufacturers should consider
the range of nutrients which may be in a finished food product and
determine the label value which they think will best meet the
requirements for class II nutrients in Sec.  101.9(g).
    (Comment 403) One comment suggested we should test any rounding
rules which are adopted to ensure that consumers are not confused.
    (Response) We established the rounding rules to provide an accurate
representation of the amount of a nutrient in the product so that
consumers can determine how the nutrients in a serving of a food
contribute to their total daily diet. The rounding rules also allow for
natural variability in the nutrient content of foods, analytical
variability in test methods, and statistical probability, and we have
set practical limits of variation in nutrient levels since 1973 (see 38
FR 2125 at 2128 (January 19, 1973) (final rule titled ``Regulations for
the Enforcement of the Federal Food, Drug, and Cosmetic Act and the
Fair Packaging and Labeling Act Nutrition Labeling'')). We appreciate
the need for consumers to be able to understand the information on a
product label, yet the comment did not provide information to show how
our rounding rules have confused consumers nor did it suggest how such
tests would be done. We do not consider the changes we are making to
the rounding rules to require consumer testing.
    (Comment 404) Our preexisting regulations, at Sec.  101.9(c),
provide for the rounding of quantitative amounts of calories and
macronutrients declared on the Nutrition Facts label. The requirements
vary based on the nutrient. For example, our regulations state that
quantitative amounts in milligrams may be listed on the Nutrition Facts
label for only two minerals: Sodium (Sec.  101.9(c)(4)) and potassium
(Sec.  101.9(c)(5)). Our regulations state that, when a serving
contains less than 5 mg of sodium or potassium, the value must be
declared as zero; when a serving contains 5 to 140 mg of sodium or
potassium, the declared value must be rounded to the nearest 5
milligram increment; and when a serving contains greater than 140 mg of
sodium or potassium, the declared value must be rounded to the nearest
10 mg increment.
    We did not propose any changes to these requirements.
    One comment suggested that the amount of calories in a serving of a
product should not be rounded because people who are counting calories
need to know exactly how many calories are in the product.
    (Response) We disagree with the comment. As with quantitative
amounts of nutrients, determining the exact amount of calories in a
serving of a specific package of food is not possible or practical. The
determination of calories is a somewhat imprecise measure. The exact
amount of calories per serving in a given food may vary from package to
package. Therefore, providing an exact amount of calories

on a food label would give the consumer the incorrect impression that
the declared amount is a precise value. Furthermore, providing an exact
amount of calories rather than a rounded value is unlikely to provide
consumers who count their calories for weight management purposes more
helpful information because consumption of an extra 5 or 10 calories in
a given food is unlikely to have a significant impact on body weight
when most adults need to consume well over 1,000 calories per day, even
when trying to lose weight.
    (Comment 405) Our preexisting regulations, at Sec.  101.9(g)(5),
state, in part, that a food with a label declaration of calories,
sugars, total fat, saturated fat, trans fat, cholesterol, or sodium
shall be deemed to be misbranded under section 403(a) of the FD&C Act
if the nutrient content of the composite is greater than 20 percent in
excess of the value for that nutrient declared on the label. The
regulation goes on to say ``Provided, That no regulatory action will be
based'' on a determination of a nutrient value that falls above this
level by a factor less than the variability generally recognized for
the analytical method used in that food at the level involved.
    The proposed rule would amend Sec.  101.9(g)(5) to insert ``added
sugars'' after the word ``sugars'' and delete the words ``Provided,
That.''
    One comment would revise Sec.  101.9(g)(5) to stipulate that
products labeled in accordance with the rounding or increment
requirements are not misbranded if the use of such rounding or
increments causes the content of calories, sugars, total fat, saturated
fat, trans fat, cholesterol, or sodium to be understated by more than
20 percent. The comment explained that Sec.  101.9(g)(5) leaves
companies vulnerable to lawsuits under state consumer protection laws
because a company could be sued for selling a ``misbranded'' product
labeled as containing 5 calories per serving when the actual caloric
content is just over 6 calories per serving, despite the fact that the
product's labeling meets our requirement to express the number of
calories to the nearest 5 calories.
    (Response) We decline to revise the rule as suggested by the
comment. Section 101.9(g)(6) states that reasonable deficiencies of
calories under labeled amounts are acceptable within current good
manufacturing practice. We continue to consider the variability
generally recognized for the analytical method used and reasonable
deficiencies of declared amounts acceptable within current good
manufacturing practice when evaluating label compliance and making
determinations regarding misbranding charges. We also recognize that
Sec.  101.9(c)(1) provides several methods for determining calories,
which also allows manufacturers flexibility in determining the declared
calorie value. Thus, the regulations provide for variability that is
acceptable under our regulations.
    (Comment 406) One comment recommended that fractions of quantities
should be shown per serving for nutrients such as trans fat because
some people consume multiple servings of a product at the same time and
may not realize that they add up to greater than 1 gram per serving.
    (Response) We decline to revise the rule as suggested by the
comment. We note that the requirements of Sec.  101.9(c) do require the
declaration of total fat, saturated fat, trans fat, and monounsaturated
fat be expressed using fractions, which are the nearest 0.5 gram
increment below 5 grams. For many macronutrients, it is not possible
for manufacturers to declare fractions of a gram or mg amount on the
label due to the level of variability inherent in the analytical
methods used to determine the amount of the nutrient.
    Similar comments recommended that we require manufacturers to
declare amounts of trans fat when present at less than 0.5 grams per
serving of a food. We address those comments in part II.F.3.d.
    (Comment 407) One comment suggested that we allow for grams of
dietary fiber to be rounded to the nearest 0.5 grams. The comment noted
that the proposed DV for children 1 through 3 years of age is 14 grams.
Therefore, the comment said, 10 percent of the DV for that age group
would be equivalent to 1.5 grams of dietary fiber, and 20 percent of
the DV for that age group would be 2.5 grams. The comment also noted
that 10 percent of the current DV for the general population of 25 g
would be 2.5 grams. The comment suggested that allowing for fiber to be
declared in 0.5 gram increments up to 5 grams could help facilitate
consumer communication and help reduce any confusion with respect to
claims.
    (Response) We decline to revise the rule as suggested by the
comment. The declaration of dietary fiber is expressed in increments of
1 gram due to the level of precision of analytical methods for dietary
fiber. The level of precision of the methods for determining dietary
fiber do not allow for the accurate determination of the amount of
dietary fiber in increments of less than 1 gram per serving.
7. Issues Concerning Specific Vitamins and Minerals
    The preamble to the proposed rule discussed issues related to RDIs
for vitamin K, chloride, potassium, choline, and vitamin B12
(79 FR 11879 at 11930).
    a. Vitamin K. The preamble to the proposed rule noted that there
are three general forms of vitamin K: Phylloquinone (vitamin
K1), menaquinone (vitamin K2), and menadione
(vitamin K3) (id.). For labeling purposes, there is no
specific definition for vitamin K and the AI for vitamin K is based on
the intake of phylloquinone, the major form of vitamin K in the diet.
The proposed rule, at Sec.  101.9(c)(8)(iv), would establish 120 mcg as
the RDI for vitamin K.
    (Comment 408) One comment supported using the AI for vitamin K
which pertains only to phylloquinone.
    Other comments objected to limiting the RDI for vitamin K to
phylloquinone (Vitamin K1). The comments stated that
menaquinone contributes to the nutritional requirements for vitamin K
and should be included in the definition. One comment stated that
inclusion of menaquinone would be in line with other regulatory bodies
such as EFSA and Health Canada. One comment also noted that dairy and
meat products are important sources of menaquinone and contribute to
the daily intake of vitamin K. The comment stated that the
bioavailability of menaquinone has been demonstrated using both in
vitro and in vivo studies. The comment also stated that menaquinone is
rapidly absorbed intact from the gastrointestinal tract (Ref. 229) and
is more bioavailable than phylloquinone, which is strongly bound to
vegetable fiber (Refs. 229-230). The comment also noted that it has
been well-established that dietary intake of phylloquinone meets the
nutritional requirements necessary for coagulation through the
activation of biochemical pathways in the liver. The comment also noted
that menaquinone has similar activity as phylloquinone in the blood
coagulation system (Ref. 229), and data also suggest an important role
for menaquinone in extra-hepatic processes. The comment stated that
menaquinone intake has been shown to have a protective effect against
CHD (Ref. 231), helps regulate bone metabolism, and plays a role in
reducing the risk of osteoporotic fractures (Refs. 229, 232). The
comment pointed out that the USDA database (2014) now includes vitamin
K2. The comment also requested that we include phytonadione,
which is an additional

name for vitamin K1, in the definition of vitamin K.
    (Response) We agree that the AI should be used as the basis for the
RDI for vitamin K. However, we disagree that the definition of vitamin
K should include menaquinones. While the comment referred to actions by
Health Canada, we note that Health Canada also is proposing using the
AI for the RDI for vitamin K (Ref. 233). Furthermore, the EFSA review
cited by the comment was a safety assessment for vitamin K2
as a source of vitamin K added to foods and was not an assessment of
the possible nutritional benefits of vitamin K2 (Ref. 229).
One study (Ref. 232) submitted by a comment was a review article on
menaquinone-4 and osteoporosis and did not provide data for us to
evaluate. It does not represent the totality of the scientific evidence
on menaquinones and does not provide sufficient information for FDA to
review. The other two studies, Gast et al., 2009 and Geleijnse et al.,
2004, were prospective cohort studies that showed an association of
menaquinone intake and reduced risk of CHD. Intakes for menaquinone in
these two studies were estimated from food frequency questionnaires
and, because food composition data for menaquinones is limited, the
results of these studies should be interpreted with caution (Refs. 230-
231). As we stated in the preamble to the proposed rule (79 FR 11879 at
11930), the AI for vitamin K does not account for the intake of
menaquinone or menadione because: (1) The NHANES data that was used as
the basis for the AI only included the 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. In
addition, menaquinones are poorly understood in terms of vitamin K
absorption and utilization (Refs. 234-236). Unlike phylloquinone, there
have been no stable isotope studies conducted with menaquinones that
are needed to improve the understanding of menaquinone bioavailability
and metabolism (Ref. 235). While the USDA National Nutrient Database
for Standard Reference Release 27 includes data on one form of
menaquinones (menaquinone-4), there are limited food composition data
available (490 foods out of 8,618 or <6 percent in USDA NND SR27) (Ref.
4), and estimates of intakes of menaquinones are very limited.
Furthermore, we generally consider U.S. dietary recommendations,
consensus reports, and U.S. national survey data to develop our
regulations.
    While we decline to include menaquinone in a definition of vitamin
K, we note that information about menaquinones that might be added to a
food may be listed in the ingredient list to alert consumers that other
forms of vitamin K are present in the product. We also discuss the
labeling of menaquinone as a dietary ingredient in part II.P (Dietary
Supplements).
    We also disagree that the term phytonadione should be included in
the definition for vitamin K. ``Phytonadione'' is U.S. Pharmacopeia
Convention's (USP) nomenclature for ``phylloquinone,'' and both have
the same structure (Ref. 237). In the Nutrition Facts label,
phylloquinone is declared as vitamin K (Sec.  101.9(c)(8)).
Furthermore, for dietary supplements, labeling representations that the
source ingredient conforms to an official compendium may be included
either in the nutrition label or the ingredient list (e.g., calcium (as
calcium carbonate USP) (Sec.  101.36(d)(3)).
    Thus, the final rule establishes, in Sec.  101.9(c)(8)(iv), an RDI
for vitamin K of 120 mcg based on the AI that pertains only to
phylloquinone. We are making no changes to the rule based on these
comments.
    b. Chloride. The preamble to the proposed rule (79 FR 11879 at
11930) stated that, under our preexisting regulations, the RDI for
chloride is 3,400 mg (Sec.  101.9(c)(8)(iv)) and is based on the
midpoint of the range (1,700 to 5,100 mg/day) of the ESADDI. The
proposed rule would have chloride remain a RDI, but based on a
population-coverage AI of 2,300 mg/day.
    We did not receive comments on the RDI for chloride and have
finalized it without change.
    c. Potassium. The preamble to the proposed rule (id.) explained
that the DRV of 3,500 mg for potassium was established based on its
beneficial health effects (e.g., reduction in blood pressure) and that
we established a DRV rather than an RDI because an RDA for specific age
and gender groups was not established in 1990 (when we issued various
regulations related to nutrition information on food labels). However,
because potassium is an essential mineral and because age- and gender-
specific AIs became available in 2005, we proposed to establish an RDI
for potassium, instead of the DRV, and thus revise Sec.
101.9(c)(8)(iv) to set the RDI for potassium at 4,700 mg.
    We did not receive comments directly on the RDI for potassium,
although some comments opposed using the AI for potassium to establish
an RDI of 4,700 mg. We address those comments in part II.M.3 (see
comment 391). The final rule, at Sec.  101.9(c)(8)(iv), establishes an
RDI of 4,700 mg for potassium.
    d. Choline. Our existing regulations do not establish a reference
value for choline. The preamble to the proposed rule noted that the IOM
established age- and gender-specific AIs for choline based on intakes
necessary to maintain liver function and that, 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 (79 FR 11879 at
11930). The FDAMA notification identified the DV for choline as 550 mg,
which was based on the population-coverage AI for choline. Thus, the
proposed rule, at Sec.  101.9(c)(8)(iv), would set an RDI of 550 mg for
choline based on the population-coverage AI.
    (Comment 409) Several comments agreed with the proposed RDI for
choline.
    (Response) The final rule, at Sec.  101.9(c)(8)(iv), establishes an
RDI of 550 mg for choline.
    e. Vitamin B12. The proposed rule would lower the RDI for Vitamin
B12 from 6 mcg/day to 2.4 mcg/day to reflect the population-
coverage RDA for Vitamin B12 established by the IOM in 2000
(Ref. 238). We acknowledged that lowering the RDI from 6 to 2.4 mcg
could result in a reduction of the fortification level in foods, such
as ready-to-eat breakfast cereals, thereby decreasing the overall
amount of crystalline vitamin B12 in the food supply (see 79
FR 11879 at 11930). (The preamble to the proposed rule (id.) also noted
that individuals older than 50 years of age meet their RDA mainly by
consuming foods fortified with crystalline vitamin B12 or
vitamin B12-containing supplements.)
    (Comment 410) Some comments supported our use of the RDA set by the
IOM to revise the RDI for vitamin B12. One comment noted
that, if the proposed RDI was adopted, manufacturers of fortified
ready-to-eat cereals and other products may adjust fortification levels
of vitamin B12 to maintain their current DV claim levels,
thereby reducing the amount of crystalline vitamin B12 in
the food supply. However, the comment stated that, based on an analysis
by Murphy et al., this change would not lead to a significant increase
in the proportion of the population with inadequate dietary intakes of
vitamin B12. The comment said that the Murphy study
indicated that the difference in the proportion of the total population
with usual intakes

of vitamin B12 less than the EAR would be about 3 percent
regardless of whether the revised RDI was based on a population-
weighted EAR or a population-coverage RDA, and this would be within 2
percentage points of the percentage calculated by using the current DV.
The comment noted that the results for older adults and teenage girls
were a little higher, but similar regardless of the approach. The
comment recommended that we continue to promote vitamin B12
intake in at-risk subpopulation groups and to continue monitoring
population intake.
    Other comments opposed lowering the RDI for vitamin B12
and said we should retain the RDI of 6 mcg for vitamin B12.
The comments expressed concern that a substantial decrease in the RDI
would result in lower amounts of crystalline vitamin B12 in
food and dietary supplements. The comments stated that this decrease
would make it more difficult for those at-risk for deficiency,
including older adults, vegetarians, and vegans, to achieve adequacy
for this nutrient. The comments noted that the IOM and DGA recommended
these at-risk groups should consume the crystalline forms.
    (Response) The final rule adopts an RDI for vitamin B12
of 2.4 mcg based on the RDA. The RDA was established by the IOM in 2000
for all adults and can be met by consuming natural and crystalline
forms. While the IOM noted that it is advisable that individuals older
than 50 years of age meet their RDA mainly by consuming foods fortified
with crystalline vitamin B12 or vitamin B12-
containing supplements, less than 1 percent of men and 6.4 to 7.5
percent of women older than 50 years of age consume below the EAR for
vitamin B12, while only 3 to 5 percent of men and women in
this age group have serum vitamin B12 levels that are
considered to be inadequate (2003-2006 NHANES) (see 79 FR 11879 at
11930). Based on the data provided by the comment in support of
lowering the RDI, it is unlikely that lowering the RDI will result in a
significant increase in the proportion of the population with
inadequate dietary intakes of vitamin B12. If we became
aware that foods are formulated as a result of this final rule, leading
to lower amounts of crystalline B12 are in the food supply,
we would consider the need for consumer education, particularly for at-
risk individuals who may need to increase intake of certain foods to
meet nutrient needs.

N. Units of Measure, Analytical Methods, and Terms for Vitamins and
Minerals

    The preamble to the proposed rule (79 FR 11879 at 11931) discussed
how the IOM set DRIs using new units of measure for vitamin A, vitamin
E, and folate and provided recommendations on the use of International
Units (IUs) and the expression of weight amounts for sodium, potassium,
copper, and chloride. The new units of measure for vitamin A, vitamin
E, and folate affect how total amount of each nutrient is measured.
1. General Comments
    (Comment 411) While we did not request comment on using teaspoons
or tablespoons as units of measure, several comments supported using
teaspoons (tsp) and tablespoons (tbsp) in addition to or instead of
grams (g) for nutrients. The comments said that consumers use these
common household measures in recipes and can visualize them.
    In contrast, other comments recommended using only metric units,
such as grams, only because they are more precise and used by other
countries.
    (Response) We address this issue in part II.B.3.
2. Sodium, Potassium, Copper, and Chloride
    Our preexisting regulations at Sec.  101.9(c)(9) and (c)(8)(iv)
express the units of measurement for sodium, potassium, copper, and
chloride in milligrams. Although the preamble to the proposed rule (79
FR 11879 at 11931) discussed IOM recommendations to use grams rather
than milligrams (mg) and how comments to the 2007 ANPRM supported
retaining mg instead of using grams, we declined to propose any changes
to the units of measure for these nutrients.
    (Comment 412) Several comments supported retaining the declaration
of ``mg'' for sodium and potassium. Other comments recommended the use
of ``mg'' for calcium and phosphorus, but did not explain their
reasoning.
    (Response) For reasons stated in the preamble to the proposed rule
(79 FR 11879 at 11931), we agree with retaining ``mg'' for the units of
measure for sodium, potassium, copper, and chloride, so the units of
measure in Sec.  101.9(c)(8)(iv) and (c)(9) remain unchanged.
    As for calcium and phosphorus, we did not propose changing the
units of measure, and so the final rule continues to use ``mg'' as the
unit of measure for calcium and phosphorus.
3. Folate and Folic Acid
    a. Units of measure. Our preexisting regulations, at Sec.
101.9(c)(8)(iv), have the RDI for ``folate'' in micrograms. In the
preamble to the proposed rule (79 FR 11879 at 11931 through 11932), we
explained how, in 1998, the IOM set the RDA for folate expressed as
microgram (mcg) Dietary Folate Equivalents (DFE) and how the IOM
Labeling Committee recommended that the use of similar units of measure
in nutrition labeling. The preamble to the proposed rule explained how
the IOM developed the new term, DFE, to account for the greater
bioavailability of synthetic folic acid that is added to fortified
foods or dietary supplements than folate that occurs naturally in foods
(food folate) and that mcg DFE is equivalent to mcg food folate + (1.7
x mcg synthetic folic acid) (id. at 11932). The proposed rule would
amend Sec.  101.9(c)(8)(iv) to use mcg DFE to declare the amount of
total folate (food folate and synthetic folic acid) on the Nutrition
Facts label. The proposed rule would make a similar change, at Sec.
101.36(b)(2)(ii)(B), with respect to the declaration of folic acid on
the Supplement Facts label.
    The preamble to the proposed rule (79 FR 11879 at 11932) also
stated that we are aware that education efforts should be provided to
help consumers understand the new ``equivalent'' units of measurement
for folic acid. We said that one option to help ensure consumer
understanding would be to allow the declaration of the mcg amount of
folic acid in parentheses in addition to declaring the amount of folate
in mcg DFE and percent DV based on mcg DFE.
    (Comment 413) Although one comment supported using DFEs as the unit
of measure, many comments said we should retain the preexisting DV of
400 mcg folate or folic acid and not adopt DFEs as the unit of measure.
    Several comments stated that using mcg DFE as the unit of measure
will confuse the public, limit the ability to monitor folate/folic acid
intake and safety, and could negatively impact birth outcomes. The
comments said that entities such as the IOM, the Centers for Disease
Control and Prevention, the U.S. Public Health Service (USPHS), and the
March of Dimes have educated the public on the importance of women of
child-bearing age consuming at least 400 mcg of synthetic folic acid
daily to help prevent neural tube defects. The comments said that
changing the unit of measure may promote suboptimal intake of the
nutrient, especially if women do not understand the difference in the
bioavailability of

naturally occurring folate versus synthetic folic acid.
    Other comments stated that an educational campaign would be
necessary, especially for obstetricians and women of child-bearing age,
to teach them how to achieve adequate dietary folate levels if we were
to use mcg DFE as the unit of measure. The comments said we should
continue to declare the amount of folic acid in micrograms along with
the percent of DV (based on the PHS recommendation) in both the
Nutrition and Supplement Facts.
    (Response) As we stated in the preamble to proposed rule (79 FR
11879 at 11932), the IOM developed the DFEs to reflect the most current
recommendation for folate/folic acid for the general healthy U.S.
population. The DFE accounts for the differences in bioavailability
between food folate (natural folate) and folic acid which is more
bioavailable (about 1.7 times more bioavailable). Use of mcg DFE on the
label is important to make sure that the consumer is aware of the total
amount of folate in a serving of food. For example, assume that the
level of total folate in a packaged cereal is approximately 200 mcg
folate per serving. If all of the folate in the cereal is added folic
acid, then the amount of folate would be 340 mcg DFE (200 mcg x 1.7)
because folic acid is more bioavailable than folate. This value is
higher than the RDA set by IOM for children 4 to 8 years of age (200
mcg DFE). Thus, if we retained mcg as the only unit of measure for
folate, we would not differentiate between folic acid and food folate
in food, and we would underestimate the contribution of fortified foods
to the folate requirement; consequently, consumers may think they need
more folate/folic acid than they receive from a food that contains both
folate and folic acid.
    As for the comment suggesting that we allow the use of both mcg and
mcg DFE as units of measure, we agree that declaring the amount of
folic acid in mcg will provide information that women of childbearing
age need in order to understand the unique contribution of synthetic
folic acid from a food, given the differences in bioavailability
compared to folate and nutrition recommendations for risk reduction of
neural tube defects (Ref. 238).
    With respect to dietary supplement labeling, if a dietary
supplement has added synthetic folate or a claim is made about folate,
the manufacturer must include the declaration of folate as a
quantitative amount by weight of folate (mcg DFE folate), and the
percent DV based on mcg DFE folate in the Supplement Facts label. If a
dietary supplement has added folic acid (alone or in combination with
natural or synthetic folate), or a claim is made about folic acid, the
nutrient declaration must include folate as a quantitative amount by
weight of folate (mcg DFE folate), and the percent DV based on mcg DFE
folate, in addition to the quantitative amount by weight of folic acid
(mcg folic acid) in parentheses. If a dietary supplement has naturally
occurring folate (with no folic acid added) and a claim is not made
about folate, the manufacturer may voluntarily declare folate as a
quantitative amount by weight in mcg DFE and percent DV based on mcg
DFE folate.
    With respect to conventional food labeling, if a conventional food
has naturally occurring folate (with no folic acid added) and there is
no claim made about folate, the manufacturer can voluntarily declare
folate in the Nutrition Facts label. If the manufacturer voluntarily
declares folate, the manufacturer may declare folate followed by the
percent DV based on mcg DFE folate, or alternatively, can declare the
quantitative amount by weight in mcg DFE folate followed by the percent
DV based on mcg DFE folate. If a claim is made about folate, the
manufacturer must declare folate either by declaring folate as the
percent DV folate based on mcg DFE folate, or as the quantitative
amount by weight in mcg DFE folate followed by the percent DV based on
mcg DFE folate. If folic acid is added to the conventional food, the
manufacturer must declare folate either by declaring folate as the
percent DV folate based on mcg DFE, or as the quantitative amount by
weight in mcg DFE folate followed by the percent DV based on mcg DFE
folate, in addition to the quantitative amount of folic acid in mcg in
parentheses. This will provide the needed information about the amount
of folic acid in a conventional food or dietary supplement for women
who are capable of becoming pregnant. Declaring folate, either as a
quantitative amount in mcg DFE followed by the percent DV or only as a
percent DV based on mcg DFE, and, mcg folic acid, in circumstances when
folic acid is added or claims are made about folic acid, the
declaration of folate/folic acid should provide adequate and correct
information for the general U.S. population, including the women of
childbearing age.
    As for the comments regarding the need for an educational campaign,
we agree that it is important for changes to the labeling to be
accompanied by education efforts to help consumers understand the new
labels (see part II.B.1). We intend to coordinate education and
outreach efforts with Federal Agencies and other organizations with an
interest in nutrition and health to emphasize, among other things, the
newly adopted units of measure for folate in mcg DFE, percent DV based
on mcg DFE, and mcg of folic acid for the first time on the Nutrition
Facts and Supplement Facts labels.
    (Comment 414) Several comments were concerned about the removal of
mcg folic acid from the food label. Some comments stated that, by only
reporting mcg DFE folate on the label, it would no longer be possible
to measure the percentage of a subpopulation that consumes in excess of
the UL for folic acid. The comments said that intake data is obtained
through the NHANES, which uses food labels to collect information on
the type and amount of micronutrients (including folic acid) contained
in food products.
    Other comments stated that limiting the units of measure to mcg DFE
would make it difficult for consumers to make an informed decision
regarding their actual folic acid intake. The comments said that this
is a particular concern for older adults who are at greater risk for
developing macrocytic anemia due to a deficiency of vitamin
B12 and that this condition could be masked by excessive
intake of folic acid from fortified foods and/or supplements. Other
comments stated that the introduction of mcg DFE as the unit of measure
for folic acid may prompt some manufacturers (who currently provide 100
percent of the DV for folic acid) to reduce the amount of folic acid in
their products. For example, the manufacturer of a dietary supplement
that currently contains 100 percent of DV for folic acid (400 mcg folic
acid) may reduce the amount to 235 mcg folic acid or 400 mcg DFE to
retain 100 percent DV.
    (Response) As stated in our response to comment 413, we are not
limiting the units of measure for folic acid to mcg DFE folate on the
Nutrition Facts label. If folic acid is added or claims are made about
folic acid, the Nutrition Facts label must include the declaration of
folic acid as a quantitative amount by weight in mcg folic acid.
    With respect to measuring the percentage of a subpopulation that
consumes in excess of the UL for folic acid, we note that the rule was
not intended nor designed to facilitate such research. The Nutrition
Facts label provides information to assist consumers in maintaining
healthy dietary practices. By having only mcg DFE or mcg of folic acid
on the label,

it would not be possible to determine the percentage of a subpopulation
that exceeds the UL for folic acid. To determine the percentage of a
subpopulation with folic acid intake in excess of the UL, one would
have to perform an analysis using the consumption data from NHANES and
the UL set by IOM for various age and gender groups.
    As for the comment's statements regarding NHANES, What We Eat in
America (WWEIA)/NHANES does not use only food labels to collect
information on the type and amount of micronutrients contained in food
products. The preexisting Nutrition Facts label declares folate in mcg
which represents both natural folate and synthetic folic acid, without
taking into account differences in bioavailability factors. The WWEIA/
NHANES currently reports the amount of folate consumed as mcg DFE, as
well as folic acid (mcg), food folate (mcg), and total folate (mcg).
Thus, the Nutrition Facts label is not the sole source of information
for folate and folic acid for this database.
    As for older adults and the risk of developing macrocytic anemia
due to a deficiency of vitamin B12, we disagree that using
mcg DFE on the label will put older adults at greater risk. The current
Nutrition Facts label does not differentiate between synthetic folic
acid and naturally occurring folate in the food label. The folate RDA
for individuals 19 years of age and older is 400 mcg DFE, and not 400
mcg folic acid. The DFE accounts for the differences in bioavailability
between food folate (natural folate) and folic acid (which is
approximately 1.7 times more bioavailable than food folate). Therefore,
by declaring folate as mcg DFE and percent DV based on mcg DFE folate,
as applicable, on the Nutrition Facts label, the total folate will be
reported and will provide the majority of the general, healthy U.S.
population (including older individuals) a more accurate amount of
their intake. Furthermore, by requiring the mandatory declaration of
the amount of folic acid as mcg folic acid in parentheses, when folic
acid is added or a claim is made about it, women of childbearing age
will have the information they need to understand the unique
contribution of synthetic folic acid from a food to adhere to nutrition
recommendations to reduce the risk of neural tube defects. In addition,
other consumers, such as older adults, can determine how much folic
acid is in a serving of food.
    With respect to reformulation, the comment did not provide any
evidence to suggest that reformulation would occur, and so we have no
basis to determine the extent to which reformulation might occur or
whether reformulation would present any potential issues with respect
to consumption of folate. We note, however, that if manufacturers
decrease the amount of folic acid from 400 mcg folic acid to 400 mcg
DFE to retain the 100 percent DV, the needs of the majority of the U.S.
population will be met. For the majority of U.S. population, the RDA
and its unit of measure is mcg DFE folate and not mcg of folic acid.
Therefore, reporting total folate as mcg DFE folate and percent DV
based on mcg DFE is more accurate.
    (Comment 415) Several comments stated that, for a dietary
supplement that is ingested on an empty stomach, 1 mcg DFE is
equivalent to 0.5 mg folic acid and is therefore subject to the
conversion factor of 2.0 not 1.7. The comment said we should clarify
this in the final rule if we adopt DFEs as the unit of measure.
    (Response) We are not limiting the units of measure to DFEs in the
final rule. The IOM defined DFE as follows: 1 mcg DFE = 1 mcg food
folate; 1 mcg DFE = 0.6 mcg folic acid from fortified foods or dietary
supplements consumed with foods; 1 mcg DFE = 0.5 mcg folic acid from
dietary supplements taken on an empty stomach. We do not know how many
people take a supplement containing folic acid on an empty stomach or
with a meal. To ensure consistency in the labeling of conventional
foods fortified with folic acid, dietary supplements containing folic
acid, and dietary supplements containing folic acid that may also
contribute calories and other nutrients, we conclude that using the
conversion factor of 0.6 mcg (multiply by 1.7) for folic acid is
appropriate. The final rule requires dietary supplements to include the
declaration of the quantitative amount of folic acid, when added or
when a claim is made about folic acid, in addition to folate in mcg DFE
and percent DV based on mcg DFE. The final rule also states that 1 mcg
DFE is equal to 1 mcg naturally occurring folate and equal to 0.6 mcg
folic acid.
    (Comment 416) Some comments said that mcg DFE fails to take into
consideration the higher bioavailability of synthetic folates compared
with naturally occurring dietary folate and should not be used on
labels. The comments said that added L-5-methyltetrahydrofolate (also
known as L-5-MTHF or L-MTHF) would be assigned the same bioavailability
as naturally occurring folate and would underestimate the true
bioavailability of the folate in the food. The comments noted that both
the calcium and glucosamine salts of L-5-MTHF have bioavailabilities
similar to folic acid. The comments said we should support a conversion
factor equivalent to that for folic acid (x 1.7) for the labeling of
these synthetic folates in dietary supplements and conventional foods.
    (Response) The use of synthetic folates (i.e., calcium and
glucosamine salts of L-MTHF) in dietary supplements, and the
appropriate conversion factor for these substances, warrants further
review. We are not aware of the use of any synthetic folates, including
calcium and glucosamine salts of L-5-MTHF, in conventional food. We
note that folic acid is regulated as a food additive under Sec.
172.345; the additive is identified as (N-[4-[[(2-amino-1,4-dihydro-4-
oxo-6-pteridinyl) methyl]amino]benzoyl]-L-glutamic acid; CAS Reg. 59-
30-3) for use as a nutrient in foods and may be added to conventional
foods subject to a standard of identity when the standard provides for
the addition of folic acid; to breakfast cereal and corn grits at
specified levels; and to infant formula according to applicable
regulations (Sec.  172.345). Conditions of use of folic acid in medical
foods, foods for special dietary use, and for meal-replacement products
also are included in Sec.  172.345. Additional uses of folic acid as
described in Sec.  172.345 would require submission of a food additive
petition asking us to amend the regulations to allow for the additional
use. Information on submitting a food additive petition is described in
Sec.  171.1. Manufacturers of food products that contain other forms of
folic acid or synthetic folate, such as calcium and/or glucosamine
salts of L-5-MTHF should consult the Office of Food Additive Safety to
determine the appropriate regulatory pathway for the lawful use of
their products.
    Although we asked for comment in the 2007 ANPRM about whether the
current DV units for folate (mcg folate) should be consistent with the
IOM DRI reports for folate (mcg DFE) (72 FR 62149 at 62170), we did not
ask about the use of synthetic folate, such as calcium and/or
glucosamine salts of L-5-MTHF in food, including dietary supplements,
or invite comment about the conversion factor for synthetic folate
compared to that for folic acid. Therefore, we intend to consider the
comparability of synthetic folates in dietary supplements and the need
for a conversion factor for each in a separate rulemaking. Until such
rulemaking is completed, we do not intend to object to a manufacturer
using its own established conversation factors, provided that the
declaration is truthful and not misleading. We would not

expect a conversion factor to exceed 1.7 (comparable to folic acid)
when reporting mcg DFE on the Supplement Facts label. Any declaration
of mcg DFE for a dietary supplement that represents in whole or in part
the amount of synthetic folate present, for which a conversion factor
was applied, must be truthful and not misleading under section 403(a)
and 201(n) of the FD&C Act. We will be able to determine the conversion
factor used through information obtained from records required by this
final rule for natural folate, folic acid, and synthetic folate present
in the product and the declared mcg DFE on the label.
    (Comment 417) The preamble to the proposed rule also stated that we
are aware that education efforts should be provided to help consumers
understand the new ``equivalent'' units of measure for folic acid (79
FR 11879 at 11932). We also said that one option to help ensure
consumer understanding would be to allow the declaration of the amount
of folic acid in parentheses in addition to declaring the amount in mcg
DFE, and we invited comment on this option (id.).
    Several comments stated that, if DFEs are to be included on food
labels, the mcg of folic acid must be included in parentheses. The
comments said that the IOM recommended that women who may become
pregnant consume 400 mcg of folic acid in addition to the RDA. The
comments also said that using mcg DFE alone as the unit of measure will
make it difficult for women to discern how much of their daily intake
is from folic acid and which foods would be best choices for ensuring a
daily intake of 400 mcg folic acid a day. The comments added that this
approach could put women at higher risk for having a neural tube defect
affecting a pregnancy. Some comments also noted that there may also be
conventional foods containing only added folic acid, such as meal
replacement foods based on protein concentrates that do not contain
significant levels of naturally occurring folate.
    (Response) We agree that including the mcg folic acid when added to
a food or when a claim is made about folic acid is necessary to help
women of childbearing age determine the amount of folic acid in each
food. Thus, we have revised Sec.  101.9(c)(8)(iv) and (c)(8)(vii) to
require the declaration of folic acid in mcg under such circumstances.
    (Comment 418) Some comments stated that we should retain the
current DV of 400 mcg as folate or folic acid without adopting a DFE
approach, along with the percent DV (based on the PHS recommendation)
in both the Nutrition and Supplement Facts labels. One comment
suggested that an educational campaign would be necessary, especially
for obstetricians and women of child-bearing age, to teach them how to
achieve adequate dietary folate levels if we adopt the mcg DFE unit of
measure.
    (Response) We agree that consumer education regarding the new unit
of measure will be helpful (see part II.B.1 for a discussion of
educational activities). We disagree that we should retain the DV and
the percent DV based on the amount of mcg of folic acid. The DV and the
percent DV should be based on mcg DFE, which reflects the most current
recommendation for folate/folic acid for the general U.S. population
and takes into account the differences in bioavailability between food
folate and folic acid which is more bioavailable.
    b. Analytical methods. The preamble to the proposed rule (79 FR
11879 at 11932) noted that available analytical methods cannot
distinguish between naturally occurring folate in conventional food and
folic acid that is added to conventional food products. To calculate
DFEs, the preamble to the proposed rule (id.) explained that it is
necessary to know both the amount of folate and folic acid in the food
product, and so proposed Sec.  101.9(g)(10) would require manufacturers
to make and keep records to verify the amount of folic acid added to
the food and folate in the finished food, when a mixture of both
naturally occurring folate and added folic acid are present in the
food.
    (Comment 419) We did not receive any comments with respect to
scientifically valid methods for determining folate and folic acid
separately. However, one comment objected to the proposed recordkeeping
requirement.
    (Response) We decline to revise the rule to remove the
recordkeeping requirement. In the absence of an analytical method that
distinguishes between folate and folic acid, records are necessary to
demonstrate compliance with the label declaration and include written
records of the amount of folic acid added to the food (conventional
food or dietary supplement), the amount of synthetic folate, if added
to the dietary supplement, and naturally occurring folate in the
finished product. Without such records, we would be unable to determine
or verify the amounts and also would not be able to determine whether
the mcg DFE value listed on the label is correct.
    (Comment 420) Proposed Sec.  101.9(g)(10)(vii) would require
manufacturers to make and keep written records of the amount of folic
acid added to the food and folate in the finished food when a mixture
of folate and folic acid is present in that food. One comment would
revise Sec.  101.9(g)(10)(vii) to state that, when folic acid and/or
purified folate salts (e.g., L-methylfolate) is added to a food,
manufacturers must make and keep written records of the amount of folic
acid, and/or purified folate salt, added to the food, as well as the
amount of naturally occurring folate if present. The comment noted that
these records will be necessary any time folic acid or folate salt is
added to food to justify the calculation of the declared mcg DFE, even
if no naturally occurring folate is present.
    (Response) We agree that when folic acid is added to a conventional
food or dietary supplement and synthetic folate (e.g., L-5-MTHF) is
added to a dietary supplement, manufacturers must keep written records
of the amount of synthetic folate added to a dietary supplement and the
amount of folic acid added to the conventional food or dietary
supplement as well as the amount of naturally occurring folate in the
finished conventional food or dietary supplement. We have revised Sec.
101.9(g)(10)(vii) accordingly.
    c. Terms to declare folate. Our preexisting regulations identify
``folic acid'' and ``folacin'' as synonyms of folate and allow these