misleading under sections 403(a)(1) and 201(n) of the FD&C Act. Thus,
we stated that the proposed recordkeeping requirements are designed to
ensure that the nutrient declarations are accurate, truthful and not
misleading, based on information known only to the manufacturer, and to
facilitate efficient and effective action to enforce the requirements
when necessary. Furthermore, the records would allow us to verify the
declared amount of each of these nutrients and that such amount is
truthful and not misleading. Thus, the proposed records requirements
would help in the efficient enforcement of the FD&C Act. We also noted
that our authority to establish records requirements has been upheld
under other provisions of the FD&C Act where we have found such records
to be necessary, and cited National Confectioners Assoc. v. Califano,
569 F.2d 690, 693 through 694 (D.C. Cir. 1978)) (79 FR 11879 at 11884
and 11957). In addition to having the authority to require the
maintenance of such records, we further stated that our authority also
provided for FDA to have access to such records because in order to
determine whether the food is misbranded and the manufacturer has
committed a prohibited act, we must have access to the manufacturer's
records that we are requiring be made and kept under sections 403(q),
403(a)(1), 201(n) and 701(a) of the FD&C Act. Without such authority to
access the records supporting the declarations, these nutrient
declarations that have been determined to be necessary to assist
consumers to maintain healthy dietary practices would be unenforceable.
    (Comment 62) While several comments supported our proposed
requirement, many comments broadly asserted that we do not have the
authority to require recordkeeping.
    (Response) The FD&C Act requires foods to bear truthful and not
misleading information about the amount of nutrients in the food to
assist consumers in maintaining health dietary practices (sections
403(q), 403(a)(1), and 201(n) of the FD&C Act). As we stated in the
preamble to the proposed rule (79 FR 11879 at 11956), under section
701(a) of the FD&C Act, we may issue regulations for the efficient
enforcement of the FD&C Act in order to ``effectuate a congressional
objective expressed elsewhere in the Act'' (Association of American
Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002)
(citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Supp. 1179, 1183 (D. Del.
1980))). The recordkeeping requirements are intended to ensure that the
nutrient declarations, which would be based on information known only
to the manufacturer, are truthful and not misleading, and to facilitate
efficient enforcement of the requirements for nutrient declaration when
necessary. The recordkeeping requirements are only for foods for which
official AOAC or other reliable and appropriate

analytical methods are not available. FDA access to information, in the
form of a record, required to support an added sugars, dietary fiber,
soluble fiber, insoluble fiber, vitamin E, and/or folate/folic acid
declaration, where the information is known only to the manufacturer,
is a practical alternative means by which we can verify that the
nutrient declarations comply with section 403(q) of the FD&C Act and
thus, assist in the efficient enforcement of the FD&C Act. Moreover,
such information would also be necessary for the manufacturer to
maintain in order to ensure the accuracy of the label.
    (Comment 63) Several comments stated that the FD&C Act does not
give us express authority to require recordkeeping for nutrition
labeling. Other comments specifically argued that sections 403(q),
403(a) and 201(n) of the FD&C Act do not provide for recordkeeping
authority and that Congress had exercised care in defining the scope of
our recordkeeping authority in the statute. Additionally, some comments
said that Congress has not given FDA general records authority and
Congress must grant specific authority to FDA to access manufacturing
records but declined to do so for nutrition labeling. Several comments
pointed out instances in the FD&C Act that provide express
recordkeeping authority, arguing that the fact that Congress provided
it in certain contexts means that it was not intended here.
    (Response) Courts have not found that a specific grant of authority
from Congress is necessary in order to promulgate every portion of
every regulation (see, e.g., American Trucking Ass'ns, Inc. v. United
States, 344 U.S. 298, 308-313 (1953) (``the promulgation of these rules
. . . falls within the Commission's power, despite the absence of
specific reference to leasing practices in the Act [citation omitted].
The grant of general rulemaking power necessary for enforcement compels
this result.'') and Permian Basin Area Rate Cases, 390 U.S. 747, 780
(1968) (``We are, in the absence of compelling evidence that such was
Congress' intention, unwilling to prohibit administrative action
imperative for the achievement of an Agency's ultimate purposes.'')).
This was also held to be true in Califano, where the court found that
Congress had not intended to immunize the manufacturers from
requirements, including recordkeeping, by not having an express
recordkeeping provision in the statute (Califano, 569 F.2d at 693; see
also Morrow v. Clayton, 326 F.2d 36, 44 (10th Cir. 1963) (Powers of an
Agency are not limited to those expressly granted by statutes--where
the end is required, appropriate means are given and every grant of
power carries with it the use of necessary and lawful means for its
effective execution) and Weinberger v. Bentex Pharmaceuticals, Inc.,
412 U.S. 645, 653 (1973) (Some Agency authority is ``implicit in the
regulatory scheme, not spelled out in haec verba'' in the statute)).
    Furthermore, we disagree that the express grant of records
authority in other contexts means that it was expressly contemplated
and rejected under the circumstances proposed here. The provision for
efficient enforcement of the FD&C Act in section 701(a) of the FD&C
Act, along with the authority to require or voluntary permit these
nutrient declarations under section 403(q) of the FD&C Act to prevent
misleading labeling, provides the ability to require such records to
effectuate the goal of enforcing nutrition labeling for those limited
products covered by the recordkeeping requirements.
    (Comment 64) Several comments stated that courts have repeatedly
explained that FDA cannot create records access using section 701(a) of
the FD&C Act, citing Association of American Physicians & Surgeons v.
FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) and National Confectioners
Association v. Califano, 569 F.2d 690, 695 (D.C. Cir. 1978).
    (Response) The comments' reading of these cases is not correct.
First, while the cited cases state that section 701(a) of the FD&C Act
is not an unlimited or stand-alone provision, neither case found that
maintenance of records was not a proper exercise of authority related
to section 701(a) of the FD&C Act, when combined with authority
provided in other substantive sections of the FD&C Act. In fact,
maintenance of records was one requirement that the court in Califano
upheld, stating, ``In our opinion however the coding and record-keeping
requirements here at issue clearly do not distend the scope of
regulation authorized by the Act'' (Califano, 569 F.2d at 695). One
section in Assn. Amer. Physicians & Surgeons that the comment quoted is
``Section 371 [701(a)] does not constitute an independent grant of
authority that permits FDA to issue any regulation the Agency
determines would advance the public health. Rather, 371 permits FDA to
use rules as a means of administering authorities otherwise delegated
to it by the Congress.'' Unlike the separate requirement to do testing
and include labeling that were discussed in Assn. Amer. Physicians &
Surgeons, the limited records requirement discussed here is for the
express purpose of administering the delegated authority in section
403(q) of the FD&C Act to require truthful and not misleading labeling
and accurate nutrition labeling for the purpose of assisting consumers
to maintain healthy dietary practices. In essence, it is a requirement
simply to document how the manufacturer complied with the substantive
requirements in certain circumstances.
    The cited cases support the requirement of records to simply
document how the manufacturer complies with the rule in this context.
The court in Califano even cites case law that specifically addresses
the relevance of remedying enforcement problems, which is the basis for
the recordkeeping requirement here, stating that ``. . . whether
statutory scheme as a whole justified promulgation of the regulation .
. . will depend not merely on an inquiry into statutory purpose, but
concurrently on an understanding of what types of enforcement problems
are encountered by FDA, the need for various sorts of supervision in
order to effectuate the goals of the Act, and the safeguards devised to
protect legitimate trade secrets'' (Califano, 569 F.2d at 693 (citing
Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158, 163 (1967))).
As we have discussed, in the case of the Nutrition Facts rule, the
purpose of the statute is to ensure truthful and not misleading
labeling as well as to assist consumers to maintain healthy dietary
practices by providing nutrition information on the labels of food. The
requirement to maintain these records would effectuate that purpose by
allowing enforcement of the declarations of certain required nutrients.
    (Comment 65) One comment argued that section 701(a) of the FD&C Act
cannot be reasonably construed to authorize records access because it
does not constitute a separate grant of authority and cannot be read to
authorize recordkeeping authority if that authority is not already
included in the other sections being used for authority, such as
sections 403(q), 403(a), and 201(n) of the FD&C Act, in this case.
    (Response) We agree that section 701(a) of the FD&C Act does not
constitute a completely separate grant of authority to promulgate any
regulation to protect the public health, but we disagree that it cannot
be used to authorize records access for the nutrient declarations
identified when there is no express authority in section 403(q) of the
FD&C Act to require and access these specific records, as the comment
argues. If there had to be an express provision in every relevant
substantive provisions of the statute, such as section

403(q) of the FD&C Act, reference to section 701(a) of the FD&C Act and
its use to effectuate the efficient enforcement of the FD&C Act would
never be necessary, and it would be rendered superfluous.
    Furthermore, as discussed in greater detail in our response to
comment 64, this notion was explicitly rejected in Califano, where the
court stated that it was rejecting the idea that the regulation must
stand or fall on the substantive section alone and found that Congress
had not intended to immunize the manufacturers from requirements,
including recordkeeping, by not having an express provision in the
statute (Califano, 569 F.2d at 693; see also Morrow v. Clayton, 326
F.2d 36, 44 (10th Cir. 1963) and Weinberger v. Bentex Pharmaceuticals,
Inc., 412 U.S. 645, 653 (1973)). In the current context, records access
is necessary to efficiently enforce the statutory requirements in
certain limited circumstances.
    (Comment 66) One comment argued that the case law we cited did not
support our records access authority because the cases were not
specific to nutrition labeling and were related to drug labeling. The
comment said that the cases have no bearing on the issues here. Another
comment argued that we should not have relied on National Confectioners
Association v. Califano because it was decided before the NLEA was
enacted.
    (Response) We first note that many cases cited by these and other
comments are not specific to nutrition labeling and were decided well
before the NLEA was enacted. We disagree with these comments and find
the cases, which many comments also cited, to be both applicable and
the best indication of the proper reading of the FD&C Act. While it is
rare to find case law that directly mirrors the situation at issue,
Califano is striking in that it specifically affirms our authority to
promulgate a recordkeeping requirement for certain food products when
needed to be able to effectuate the statutory purpose. Congress has not
acted to overturn that decision, which was the applicable existing
legal framework when Congress was enacting the NLEA.
    (Comment 67) Several comments referenced section 301(e) of the FD&C
Act, regarding what recordkeeping violations constitute a prohibited
act, as an exclusive list of what recordkeeping provisions are
authorized and as evidence that sections 403(q), 403(a), 201(n), and
701(a) of the FD&C Act do not authorize recordkeeping provisions.
    (Response) We disagree that the absence of the specified provisions
in the list of prohibited acts regarding records bears on whether we
have the authority to require records under the statute. Section 301(e)
of the FD&C Act, regarding prohibited acts, refers to the express
recordkeeping requirements in the FD&C Act. Moreover, a prohibited act
violation in section 301(e) of the FD&C Act is separate and distinct
from a misbranding violation in section 403(q) of the FD&C Act. It is a
prohibited act under section 301(a) of the FD&C Act to introduce, or
deliver for introduction, a misbranded food into interstate commerce.
Thus, the fact that there is not a prohibited act violation for access
to, and copying of, records related to the nutrient declarations for
these select nutrients under section 403(q) of the FD&C Act does not
mean that we do not have authority under sections 403(q) and 701(a) of
the FD&C Act to require these records under these circumstances. As we
explained earlier, express authority in section 403(q) of the FD&C Act
is not needed for these records (see Califano, 569 F.2d at 693).
Maintenance of and access to records for certain nutrition labeling
declarations only under certain circumstances is necessary for the
efficient enforcement of the Nutrition Facts labeling requirements,
whether or not compliance with the those requirements are included as
prohibited act under the statute.
    (Comment 68) Several comments referenced a statement in the
preamble to the 1993 nutrition labeling final rule stating that, to
support a misbranding charge for inaccurate nutrient content
information, we must have accurate, reliable, and objective data to
present in a court of law and that, to obtain that information, we rely
upon the work performed by our trained employees because we do not have
legal authority in most instances to inspect a food manufacturing
firm's records (58 FR 2079 at 2110, January 6, 1993). The comments
asserted that this statement was evidence that we recognized that we do
not have the authority to access manufacturing records as part of our
enforcement of the nutrition labeling requirements.
    (Response) We do not agree with this characterization of the
statement in the 1993 final rule. The cited statement was part of a
discussion of why we perform our own laboratory analyses and use those
results for enforcement, rather than looking at or verifying laboratory
analysis results kept in the records of a manufacturer. When there are
available reliable laboratory analyses in order to test for a specific
nutrient, we still rely on those analyses for compliance purposes. As
we have described, the records requirements in this final rule apply
only to the narrow circumstances where there are not any appropriate
reliable analytical methods that can be used to verify the compliance
of a nutrient declaration.
    Where there are appropriate reliable analytical methods, we would
not need to access manufacturing records in order to enforce the FD&C
Act. However, the narrow circumstances where we do have the authority
and are exercising the authority here are those circumstances where we
do not have access to appropriate reliable analytical methods.
    (Comment 69) While one comment pointed out that Sec.  101.9(g)(9)
already contemplates and provides a mechanism for the use of an
alternative means of compliance for nutrition labeling, supporting our
use of an alternative means to enforce compliance here, a few comments
took exception to the preamble to the proposed rule's reference to
situations where our regulations already provided for maintenance of
records in the nutrition context. The comments stated that those
instances regarding aeration to reduce fat and caloric content of foods
(58 FR 2229 at 2271, January 6, 1993) and caloric content of new
products with reduced digestibility (58 FR 2079 at 2111) were optional
recordkeeping in instances where a manufacturer chooses to depart from
the established regulations or to support a voluntary claim, rather
than the broad regulations we proposed here for all manufacturers.
    (Response) These examples were provided as illustrations of the use
of records in a compliance context, not to demonstrate our authority.
Any discussion of these other regulatory examples does not affect our
authority with regard to this particular records requirement. We do not
agree that these are broad regulations; rather, they are for a quite
limited purpose and scope--only required when the manufacturer is
including a mixture of products that cannot be distinguished by the
analytical methods detailed in the regulations. The requirements also
are quite flexible, not requiring any particular records and allowing
the manufacturer to determine the best records to establish and
maintain in order to comply. Furthermore, we disagree with the comment
that the cited existing regulations with reliance on records for
compliance purposes are all optional or voluntary. In the context of
calculating appropriate caloric content of new products with reduced
digestibility, the caloric declaration is a required declaration, and
products wishing to adjust the declared amount because they are using
certain novel

ingredients would need to submit documentation of their calculations to
FDA.
    (Comment 70) Several comments stated that, because they believed we
did not have a scientific basis for requiring the declaration of added
sugars, our authority to require records to verify the added sugars
declaration was questionable.
    (Response) Please see part II.H.3 for a more detailed discussion of
our scientific basis for requiring the declaration of added sugars.
Because the added sugar declaration is necessary to assist consumers in
maintaining healthy dietary practices, which is the statutory mandate,
the recordkeeping requirements are necessary and authorized for the
efficient enforcement of the FD&C Act.
    (Comment 71) Multiple comments argued that our authority excludes
access to ``recipes for food,'' among other proprietary information.
Some comments stated that we may not access or that we lack authority
to access recipes for food, or that recipes were protected by Congress.
Another comment stated that it is ``beyond the scope of the Agency to
inspect records related to product formulation.'' Other comments noted
that the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107-188) (BT Act), as well as section 414
of the FD&C Act, expressly carve out recipes as a record that we cannot
access even in food safety emergency situations.
    (Response) The exclusion of recipes that several comments referred
to is found in the BT Act, and there is no more general protection of
recipes by Congress. We further disagree that the parameters of the
recordkeeping authority in the BT Act affect our ability to require
records here. The purpose of the review of records under the BT Act is
distinct from the purpose of the record review for nutrition labeling,
and section 306 of the BT Act says that it shall not be construed to
limit the ability of the Secretary to require records under other
provisions of the FD&C Act.
    Furthermore, the final rule's recordkeeping requirement is flexible
and does not require any specific document to support the declarations.
While the preamble to the proposed rule provided some examples of
records that manufacturers may choose to maintain (see, e.g., 79 FR
11879 at 11956), they are not required to maintain any particular
record and would also be permitted to maintain redacted documents if
they established the necessary information. See part II.R.3 for a
description of the variety of records that manufacturers can establish
or maintain to meet the requirements.
    We discuss other comments regarding the proper handling and
confidentiality of any proprietary information that is submitted in
part II.R.3.
    (Comment 72) Some comments said that the recordkeeping authority
previously given to FDA, as in the case of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-
188), were unrelated to nutrition labeling.
    (Response) We agree that the BT Act authority is unrelated, and we
disagree that the scope of recordkeeping authority in the BT Act limits
our ability to require records. Section 306 of the BT Act states that
it shall not be construed to limit the ability of the Secretary to
require records under other provisions of the FD&C Act.
    (Comment 73) Some comments stated that we did not need records
access to enforce the nutrition declarations because companies are
already required to ensure that their labels are not false or
misleading under section 403(a)(1) of the FD&C Act and Sec.  101.9(g).
    (Response) While we agree with the comment that manufacturers are
already required to ensure that their labels are not false or
misleading, we are requiring that records be maintained that can
specifically support certain declarations required under Sec.  101.9(g)
because without access to those records, we are not able to verify the
accuracy of the required declared amounts.
    (Comment 74) Some comments argued that, even if we had the
authority to access records, we did not have the authority to copy
records, stating that copying of records is not required for the
efficient enforcement of the FD&C Act and that inspectors should be
able to inspect and evaluate records onsite at the manufacturing
facility without copying them.
    (Response) We disagree with this comment. As we stated in the
preamble to the proposed rule (79 FR 11879 at 11957), in order to
determine whether the food is misbranded and the manufacturer has
committed a prohibited act, we must have access to the manufacturer's
records that we are requiring be made and kept under sections 403(q),
403(a)(1), 201(n) and 701(a) of the FD&C Act. Without the authority to
access the records supporting the declarations, the nutrient
declarations that we have determined to be necessary to assist
consumers in maintaining healthy dietary practices would be
unenforceable. While we understand the concerns with confidentiality of
certain corporate information, and we discuss safeguards for such
information in part II.R.3, practically, we need to be able to copy the
records and access them at FDA headquarters in order to fully evaluate
them to determine compliance or the need for any further regulatory
action or enforcement proceedings (see FDA Regulatory Procedure Manual,
section 4-1-4, regarding Center concurrence for labeling violations).
Such full evaluation by us is not possible onsite at the facility.
    (Comment 75) One comment suggested that the inspectional authority
in section 704 of the FD&C Act did not provide for access to these
records.
    (Response) Section 704 of the FD&C Act states that the inspection
``shall'' extend to records when section 414 of the FD&C Act applies.
We do not interpret this as an exclusive extension. Section 414 of the
FD&C Act specifically states that it does not limit the authority of
the secretary to inspect records under other provisions of the FD&C
Act. This specific grant of authority applies to a single specific
statutory provision regarding food safety, and does not address false
and misleading labeling. It does not prevent us from accessing records
that we can require by other regulations.
5. Miscellaneous Comments
    Several comments raised other legal issues with respect to various
parts of the rule.
Dietary Fiber
    (Comment 76) One comment stated the definition of dietary fiber,
which requires a dietary fiber to have a physiological effect
beneficial to health, would ``prohibit the use of accurate, well
substantiated dietary fiber determinations in nutrition labeling for
many foods.'' The comment said that the restriction is not adequately
justified to advance FDA's labeling objectives, nor is adequately
tailored, to satisfy the First Amendment.
    (Response) We disagree that, by defining ``dietary fiber,'' we are
prohibiting the use of ``accurate, well substantiated dietary fiber
determinations'' as the comment suggests. As we explain in our response
to comment 252, the definition includes dietary fibers that have been
shown to have a physiological effect beneficial to human health, and
therefore, the declared amount of dietary fiber will include
information about the amount of fibers in a serving of food that are
necessary to maintain healthy dietary practices, consistent with our
authority in section 403(q)(2) of the FD&C Act. Manufacturers will be
able to petition

FDA to request that we amend the definition to include additional
fibers, as appropriate. If a substance is a fiber, but not a ``dietary
fiber'' that has a physiological effect beneficial to human health
(such that the fiber is not eligible to be, and not listed as, a
``dietary fiber'' in the codified definition of ``dietary fiber''), a
manufacturer may still declare the substance as part of total
carbohydrate. Furthermore, a manufacturer may make a statement about
the amount of these other fiber substances in the food, provided the
statement is truthful and not misleading. The comment did not provide
further explanation for why our definition for dietary fiber is not
adequately justified or adequately tailored under the First Amendment
and, based on the reasons we provide, we are not making any changes in
response to this comment.

D. Factors for Mandatory or Voluntary Declaration of Non-Statutory
Nutrients

    The preamble to the proposed rule (79 FR 11879 at 11890 through
11891) discussed the factors that we primarily considered in requiring
the declaration of most non-statutory nutrients or providing for the
voluntary declaration of such nutrients. Our discussion of these
factors in the proposed rule related to the nutrients for which there
is an independent relationship between the nutrient and risk of a
chronic disease, health-related condition, or physiological endpoint.
We did not consider these factors for added sugars because our
rationale for the declaration of added sugars differs and is not based
on an independent relationship between added sugars and risk of chronic
disease, health-related condition, or physiological endpoint. Thus, to
help clarify when we refer to a nutrient for which there is such an
independent relationship, we refer to the nutrient as ``this type of''
or ``this category of'' or, if plural, ``these types of'' nutrient(s),
or similar phrase. We discuss our rationale for requiring added sugars
separately because our rationale for added sugars is distinct from the
factors that applied more generally to these other types of nutrients.
In general, we continue to 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). However, we also have considered mandatory declaration
based, in part, on evidence highlighting the role of a nutrient (e.g.,
trans fat) in chronic disease risk. The preamble to the proposed rule
(79 FR 11879 at 11889) explained that, under section 403(q)(1)(C) and
(D) of the FD&C Act, nutrition information in food labeling must
include the total number of calories, derived from any source and
derived from the total fat, and the amounts of total fat, saturated
fat, cholesterol, sodium, total carbohydrates, complex carbohydrates,
sugars, dietary fiber, and total protein. We referred to the nutrients
that are explicitly required by the FD&C Act to be declared on the
Nutrition Facts label as ``statutorily required nutrients.'' Section
403(q)(2)(B) of the FD&C Act permits us to remove a statutorily
required nutrient from the label or labeling of food, by regulation, if
we determine the information related to that nutrient is not necessary
to assist consumers in maintaining healthy dietary practices.
    Section 403(q)(2)(A) of the FD&C Act also gives us the authority to
require, by regulation, other nutrients to be declared if the we
determine that a nutrient will provide information regarding the
nutritional value of such food that will assist consumers in
maintaining healthy dietary practices. The preamble to the proposed
rule explained that we consider such nutrients that are not statutorily
required, but subject to our discretion under section 403(q)(2)(A) of
the FD&C Act, to be ``non-statutory nutrients'' to distinguish them
from the ``statutorily required nutrients'' (79 FR 11879 at 11889).
Thus, insofar as ``non-statutory nutrients'' are concerned, previously
we have: (1) Required the declaration of certain essential vitamins and
minerals (such as vitamins A and C, iron, and calcium) for which an RDI
was established and that were determined to have public health
significance; and (2) permitted the declaration of the remaining
essential vitamins and minerals for which there was an established RDI
or DRV (i.e., vitamin E) or that had public health significance, and
permitted the declaration of certain subcategories of macronutrients
for which a DRV was not established (including monounsaturated fat,
polyunsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and
other carbohydrate) (id.).
    The preamble to the proposed rule (id. at 11890) explained that, to
help us determine whether a non-statutory nutrient, for which there is
an independent relationship between the nutrient and risk of chronic
disease, health-related condition, or physiological endpoint, should be
a required or permitted declaration, we consider: (1) The existence of
quantitative intake recommendations; and (2) public health
significance. Quantitative intake recommendations are reference intake
levels provided in consensus reports that can be used to set a DRV or
RDI. We expect these consensus reports to be published for the purpose
of setting quantitative intake recommendations (e.g., the IOM DRI
reports), but, if DRIs are not available for nutrients, other than
essential vitamins and minerals, then we consider the scientific
evidence from other U.S. consensus reports or the DGA. Public health
significance refers to two elements. First, we consider whether there
is evidence of a relationship between the nutrient and a chronic
disease, health-related condition, or health-related physiological
endpoint. This can be demonstrated either by well-established evidence
(in the form of U.S. consensus reports) or, for essential vitamins and
minerals, the health consequences of inadequacy of the nutrient.
Second, we consider whether there is evidence of a problem related to
health in the general U.S. population. This is demonstrated by both
evidence of a problem with the intake of the nutrient in the general
U.S. population and evidence of the prevalence of the chronic disease,
health-related condition, or health-related physiological endpoint that
is linked to that nutrient in the general U.S. population.
    For mandatory declaration of this type of non-statutory nutrient,
in general, we consider mandatory declaration appropriate when there is
public health significance and scientific evidence to support a
quantitative intake (which, for purposes of convenience, we will refer
to as ``a quantitative intake recommendation'') that can be used for
setting a DV (DRV or RDI). However, we have also considered mandatory
declaration based, in part, on evidence highlighting the role of a
nutrient (e.g., trans fat) in chronic disease risk.
    For voluntary declaration of a non-essential vitamin or mineral
(e.g., fluoride, soluble and insoluble fiber, monounsaturated fatty
acids and polyunsaturated fatty acids), we consider voluntary
declaration to be appropriate when the nutrient either has a
quantitative intake recommendation, but does not have public health
significance, or does not have a quantitative intake recommendation
available for setting a DRV but has public health significance. In
addition, we permit voluntary declaration for essential vitamins or
minerals that we determine do not fit within our considerations for
mandatory declaration, but that have an RDI.
    The preamble to the proposed rule also noted that we continue to be
mindful of factors such as the number

of nutrients that can be listed in nutrition labeling, the possibility
that some individuals could interpret a long list of nutrients as
implying that a food has greater nutritional significance than is the
case, and that there is limited space for nutrition information on the
label (id.).
    (Comment 77) The preamble to the proposed rule (id. at 11891)
invited public comment on our factors for mandatory and voluntary
declarations of these types of nutrients. Some comments supported the
factors. One comment, however, also suggested that, if the 2015-2020
DGA is released before we publish a final rule, the vitamins and
minerals considered to be of public health significance should be based
on the most recent version of the DGA.
    (Response) As discussed in the preamble to the proposed rule (79 FR
11879 at 11890 and 11918), the factors that we consider for determining
the essential vitamins and minerals with the greatest public health
significance to be those for which the IOM based DRIs on a chronic
disease risk, or health related condition, or a nutrient deficiency
with clinical significance. Additionally, we consider whether nutrient
intake data, and/or, when available, biomarkers of nutrient status,
provide evidence of inadequate intakes in the general healthy U.S.
population (ages 4 years and older) and whether a substantial
prevalence of a disease, or health related condition or a nutrient
deficiency with clinical significance exists that was linked to the
particular nutrient. Our intake and status biomarker analysis is
conducted for the U.S. general population, ages 4 years and older,
which is the focus of the label, while the DGA focuses on the U.S.
population ages 2 years and older. The 2015 DGAC (Ref. 19) used a
three-pronged approach similar to our factors for determining the
nutrients of public health concern, including analysis of intake data,
available valid biochemical indices from NHANES dietary survey, and
data on the prevalence of health condition in the U.S. population.
Based on the scientific evidence in the 2015 DGAC approach, vitamin D,
calcium, potassium, iron, and fiber were considered as nutrients of
public health concern for under consumption.
    (Comment 78) Another comment agreed with the factors, but suggested
that we use the 2010 DGA or the 2015-2020 DGA (if it became available)
when a quantitative intake recommendation by the IOM is not available
and can be supported by a ``Nutrition Evidence Library Review system.''
    (Response) We agree that it is often appropriate to consider the
scientific information in the DGA when the IOM does not provide a
quantitative intake recommendation. The preamble to the proposed rule
stated that we will consider quantitative intake recommendations from
the IOM report, but if DRIs are not available for nutrients (other than
essential vitamins and minerals), we will consider science-based
recommendations from other U.S. consensus reports or the DGA policy
reports (id. at 11890).

E. Calories

    Under section 403(q)(1)(C)(i) of the FD&C Act, nutrition
information in food labels or labeling must include the total number of
calories derived from any source. Our preexisting regulations require
the total caloric content of a food to be declared on the Nutrition
Facts label (Sec.  101.9(c)(1)), and the proposed rule would not modify
the requirement to declare total calories. However, in the preamble to
the proposed rule (79 FR 11879 at 11891), we stated that we were
reconsidering a number of other requirements related to the declaration
of information about calories. The other requirements related to
``Calories from fat,'' ``Calories from saturated fat,'' the 2,000
reference calorie intake level, a percent DV for calories, and
requirements related to prominence of the calorie declaration and the
footnote statement and table of DVs for 2,000 and 2,500 calorie diets.
1. Calories From Fat
    Our preexisting regulations, at Sec.  101.9(c)(1)(ii), require the
declaration of ``Calories from fat'' on the label. This requirement
stems from section 403(q)(1)(C)(ii) of the FD&C Act which, in turn,
requires total calories from fat to be declared on the label or
labeling of food. However, section 403(q)(2)(B) of the FD&C Act gives
us the discretion to remove the requirement by regulation if we
determine that the requirement is not necessary to assist consumers in
maintaining healthy dietary practices. The preamble to the proposed
rule (79 FR 11879 at 11891) explained that we reviewed current
scientific evidence and consensus reports in determining whether
information on calories from fat is necessary to assist consumers in
maintaining healthy dietary practices. Current dietary recommendations
no longer emphasize total fat. Certain fatty acids are understood to be
beneficial, while others are understood to have negative health
effects, particularly related to cardiovascular disease. Consequently,
the proposed rule would no longer require, nor would it allow
voluntarily, the declaration of ``Calories from fat'' on the Nutrition
Facts label. In the preamble to the proposed rule (79 FR 11879 at
11891), we acknowledged that eliminating the declaration of ``Calories
from fat'' may appear to be a loss of information on the amount of fat
being consumed, but noted that the amount of fat being consumed can
still be obtained from the total fat declaration elsewhere on the
Nutrition Facts label, and consumers can still use the percent DV for
total fat to put fat content in the context of a total daily diet,
compare products, and plan diets. Thus, the proposed rule would remove
Sec.  101.9(c)(1)(ii), which requires declaration of calories from fat,
and redesignate Sec.  101.9(c)(1)(iii) as Sec.  101.9(c)(1)(ii).
    (Comment 79) Several comments supported removing the declaration of
``Calories from fat'' because current dietary recommendations emphasize
that the intake of total calories and the type of fat consumed are more
important than information on calories from fat in maintaining healthy
dietary practices.
    Many comments opposed removing the declaration of ``Calories from
fat'' because of the importance of knowing this information for
consumers who are diabetic, overweight, have high blood pressure, or
are at risk of heart disease. Several comments also noted that, in
general, the information was useful to monitor the amount of calories
from fat consumed in packaged foods. These comments noted that some
people use the ``Calories from fat'' information to make a choice
between similar products and that, because of fat's caloric density,
consumers need to be informed regarding the amount of calories they
were getting from fat. Other comments also suggested that we require
the declaration of ``Percent of calories from fat,'' and some comments
supported removing the ``Calories from fat'' declaration if a
declaration of monounsaturated and polyunsaturated fats was mandatory.
    A few comments opposed to removing the ``Calories from fat''
declaration stated that this information remains useful to consumers;
the comments, however, did agree that the total number of calories and
types of fatty acids consumed are more important than total fat
consumption in maintaining healthy dietary practices and reducing
cardiovascular risk. One comment stated that it is important for total
fat consumption to be within the acceptable range (i.e., 20 to 35
percent of daily caloric intake) established by the IOM, and that
``Calories from fat'' provides valuable information to help consumers
put the Dietary Guidelines into action. Another comment disagreed

with our assessment that removing ``Calories from fat'' does not
constitute a loss of information to consumers because there is
presently no other means for conveying differences in nutrient density
between macronutrients on the Nutrition Facts label. One comment
indicated that, as long as the ``Calories from fat'' declaration is
truthful and not misleading, the information is protected commercial
speech under the First Amendment and that there is no legal basis to
prohibit it. The comment said that ``Calories from fat'' should
continue to be allowed on the Nutrition Facts label on a voluntary
basis.
    (Response) We disagree that the labeling of ``Calories from fat''
is required for specific health conditions or that it is necessary for
consumers to monitor their calories from total fat. The Nutrition Facts
label is intended to provide nutrition information to the general U.S.
population and not for specific populations with specific diseases.
Current dietary recommendations no longer emphasize total fat.
Consumers already have information on the quantitative amount of total
fat on the label as well as information of its DV on the label. The
extra emphasis of calories from fat is not needed based on the new
science for total fat. As we stated in the preamble to the proposed
rule (79 FR 11879 at 11891), U.S. consensus reports recognized that
there are benefits to consuming moderate amounts of fat and that
different types of fat have different roles in chronic disease risk, so
the additional emphasis of ``Calories from fat'' is not warranted. The
results of these reports and dietary recommendations also establish why
a declaration of ``Percent of Calories from Fat'' is not necessary to
assist consumers in maintaining healthy dietary practices, because the
reports emphasize the intake of ``total calories'' and the type of fat
consumed. We also note that the information required for fats in the
Nutrition Facts label, in the absence of a declaration of ``Calories
from Fat,'' provides consumers with the information to compare similar
products and make healthy dietary choices.
    Information on monounsaturated and polyunsaturated fats is
voluntary on the Nutrition Facts label due to their role in health, and
information on saturated fat will still be required. Ultimately, we do
not think mandatory information on the amounts of monounsaturated and
polyunsaturated fats is necessary to help consumers maintain healthy
dietary practices because information on the quantitative amount and
the percent DV of total fat and saturated fat will still be required on
the Nutrition Facts label. We discuss monounsaturated and
polyunsaturated fats in greater detail in part II.F.4.
    We disagree that the declaration of ``Calories from fat'' should be
voluntary on the Nutrition Facts label. Based on current scientific
evidence and dietary recommendations, we have concluded that the
declaration of ``Calories from fat'' is not necessary to assist
consumers in maintain health dietary practices. Information on total
calories, the quantitative and percent DVs for total fat and saturated
fat, and quantitative amount of trans fat provides consumers with
information to maintain healthy dietary practices and to put total fat
and saturated fat in the context of a total daily diet, to compare
products, and to plan diets.
    (Comment 80) Some comments supporting the continued declaration of
``Calories from fat'' suggested requiring a declaration only for
certain foods that contained above a specified level of total fat or if
the food contained more than a certain amount of saturated and trans
fat.
    (Response) We decline to revise the rule as suggested by the
comments. To require a declaration for ``Calories from fat'' only on
certain products would not be consistent with our conclusion that
information on ``Calories from fat'' is not necessary to help consumers
in maintaining healthy dietary practices. Furthermore, the quantitative
amounts and percent DV for total fat and saturated fat are already
provided, as well as the quantitative amount of trans fat. Finally, the
DGAs and other consensus reports emphasize the importance of total
calories rather than the amount of calories from any particular
macronutrient.
2. Calories From Saturated Fat
    Under our preexisting regulations at Sec.  101.9(c)(1)(iii), the
declaration of ``Calories from saturated fat'' is voluntary. The
preamble to the proposed rule noted that saturated fat is known to
increase the risk of cardiovascular disease and, unlike ``Calories from
fat,'' which could include calories attributable to fatty acids that
decrease or increase the risk of certain diseases, ``Calories from
saturated fat'' would provide information about calories from a source
known to increase disease risk (79 FR 11879 at 11892). Although we
tentatively concluded that mandatory declaration of ``Calories from
saturated fat'' is not necessary because the amount of saturated fat
being consumed can be obtained from the total saturated fat declaration
elsewhere on the Nutrition Facts label and because consumers can still
use the percent DV for saturated fat to put saturated fat content in
the context of a total daily diet, compare products, and plan diets, we
decided that, due to the strong evidence associating higher intakes of
saturated fat with higher low-density lipoprotein (LDL) cholesterol
levels, information on ``Calories from saturated fat'' can assist
consumers in maintaining healthy dietary practices. Therefore, the
proposed rule would not change the current voluntary labeling of
``Calories from saturated fat'' in the Nutrition Facts label as
specified in Sec.  101.9(c)(1)(iii). However, considering our proposal
to eliminate the declaration of ``Calories from fat'' on the Nutrition
Facts label (see part II.E.1.), the proposed rule would revise Sec.
101.9(c)(1)(iii) and (d)(5) to specify that the statement ``Calories
from saturated fat,'' when declared, must be indented under the
statement of calories. In addition, the proposed rule would redesignate
Sec.  101.9(c)(1)(iii) as proposed Sec.  101.9(c)(1)(ii).
    We did not receive comments on this topic and have finalized the
revisions without change.
3. Two Thousand Calories as the Reference Caloric Intake Level
    Our preexisting regulations, at Sec.  101.9(c)(9), establish a
reference calorie intake level of 2,000 calories to set DRVs for total
fat, saturated fat, total carbohydrate, protein, and dietary fiber. In
addition, the preexisting regulation requires a footnote on the
Nutrition Facts label that states, ``Percent Daily Values are based on
a 2,000 calorie diet. Your daily values may be higher or lower
depending on your calorie needs,'' followed by a table with certain DVs
based on 2,000 and 2,500 calorie diets.
    The preamble to the proposed rule (79 FR 11879 at 11892) discussed
recommendations from the IOM macronutrient report that provided
estimated energy requirements (EERs) and the IOM labeling report (Refs.
24-25), as well as comments (Ref. 26) received in response to the 2007
ANPRM, in which we asked whether 2,000 calories should continue to be
used as the reference calorie intake level and asked questions related
to the use of the EERs. The preamble to the proposed rule explained
that an EER is a DRI set by the IOM for energy intake and is defined as
the dietary energy intake that is predicted to maintain energy balance
in a healthy adult of defined age, gender, weight, height, and level of
physical activity consistent with good health. The IOM set EERs for all

life-stage and gender groups and based these EERs on normal weight
individuals (i.e., Body Mass Index (BMI) < 25) (Ref. 24). The IOM
Labeling Committee considered whether there was a basis to use the EERs
for developing a new reference calorie intake level for macronutrients
in nutrition labeling. The IOM Labeling Committee found that the data
necessary to use the EER concept as the basis for a reference calorie
intake level for nutrition labeling were incomplete and that retaining
the current 2,000 reference calorie intake level would be the best
approach as it would provide continuity and would not encourage higher
calorie intake and overconsumption of energy (Ref. 25). The proposed
rule would not suggest any changes to the current use of 2,000
reference calorie intake level as the basis for setting DRVs for total
fat, saturated fat, total carbohydrate, dietary fiber, and protein.
    (Comment 81) Many comments supported using 2,000 calories as the
reference caloric intake levels based on the same rationale provided by
U.S. consensus reports and the IOM labeling report mentioned in the
preamble to the proposed rule and agreed that the EER was not an
appropriate way to set a reference caloric intake level.
    In contrast, many other comments opposed using 2,000 calories as a
reference caloric intake level. The comments said that many individuals
do not consume 2,000 calories (i.e., individuals may need more or less
depending on age, sex, weight, height and physical activity level).
Other comments wanted us to use a different reference calorie intake
level (i.e., 1,400 calories, 1,800 calories or more than 2,000
calories) or to eliminate the concept of a reference calorie intake
level because, according to the comments, it is not useful or accurate
because all individuals do not consume 2,000 calories per day.
    (Response) We agree that an individual's caloric needs can vary;
however, we disagree that the reference caloric intake level should be
a value other than 2,000 calories or that there should not be one at
all. As we stated in the preamble to the proposed rule, the reference
calorie intake level is not used as a target for caloric intake, but
rather to set DVs for total fat, saturated fat, total carbohydrate,
protein, and dietary fiber (see 79 FR 11879 at 11892). We agree with
the IOM labeling report (Ref. 25) that a reference caloric intake level
of 2,000 calories provides continuity and would not encourage higher
calorie intake and overconsumption of energy (id.).
    We also use 2,000 calories because a rounded value is easier for
other consumers to use and is less likely suggest an inappropriate
level of precision as would 1,500 calories, 1,800 calories, or 2,350
calories. The comments supporting a different reference caloric intake
level did not provide evidence to support these values for our
consideration; consequently, we do not have sufficient information to
determine the advantages or disadvantages associated with a different
value or how the values compare against the 2,000 calorie value used
now.
4. Percent DV Declaration for Calories
    Our preexisting regulations do not provide for a DRV for calories.
The preamble to the proposed rule (79 FR 11879 at 11892 through 11893)
explained that setting a DRV for calories would necessitate determining
a quantitative intake recommendation for calories, but also noted that
there is no appropriate quantitative intake recommendation and that we
were not aware of any other data or information on which a DRV for
calories could be determined. Thus, the proposed rule would not set a
DRV for calories and, as a result, neither require nor permit a percent
DV declaration for calories.
    (Comment 82) Many comments agreed with our rationale for not
providing a percent DV for calories. Some comments said that a percent
DV for calories would be misleading, not accurate, or not useful
because not all individuals consume 2,000 calories a day.
    In contrast, other comments supported a declaration for percent DV
because, according to the comments, this information would be useful to
consumers by allowing them to learn about the relationship between
portion size and calorie intake. Another comment noted that an optional
declaration of a percent DV for calories would allow consumers to make
more informed decisions regarding selection of processed foods. Some
comments suggested having different percent DVs for calories (i.e., one
for men and woman, or one for growing children and adults, or two DVs
of 1,500 and 2,000 calories).
    (Response) We do not agree that a DV for calories, for purposes of
nutrition labeling, should be set at any caloric level. We continue to
believe that, to provide a DV, a DRV based on quantitative intake
recommendations for calories would need to be set. Quantitative intake
recommendations for calories are called estimated energy requirements
(EERs), and they are based on normal weight healthy individuals of
defined age, gender, weight, height, and level of physical activity. It
would be difficult to combine the EERs into a single reference calorie
level applicable to the general population because calorie needs vary
based on many factors.
    As for the comments suggesting that a DV could help consumers with
the relationship between portion size and calorie intake and to make
informed food selections, we note that the declaration of ``Calories''
can by itself alert consumers to the amount of calories in a serving of
a food and assist consumers to make informed decisions about their food
selections based on the calorie content.
    As for the comments suggesting different percent DVs for calories,
the comments did not indicate what those DVs would be or how we might
calculate them. Therefore, for the same reasons we expressed earlier in
this response, we do not have sufficient information to set a DV or
multiple DVs, and so the final rule does not establish a percent DV for
calories. However, we consider that a statement about daily calorie
intake (2,000 calories) should be a necessary part of the footnote in
the Nutrition Facts label because 2,000 calories is consistent with
widely used food plans and will serve as a basis for menu labeling (79
FR 71156, December 1, 2014). Likewise, the second sentence of the
footnote will state: ``2,000 calories a day is used for general
nutrition advice'' (see part II.Q.11).

F. Fat

    The preamble to the proposed rule (79 FR 11879 at 11893 through
11899) discussed considerations related to definitions, declaration,
and DRVs for total fat, saturated fat, trans fat, monounsaturated fat,
and polyunsaturated fat.
1. Total Fat
    a. Definition. Our preexisting regulations at Sec.  101.9(c)(2)
define ``fat, total'' or ``total fat'' as a statement of the number of
grams (g) of total fat in a serving defined as total lipid fatty acids
and expressed as triglycerides.
    In the preamble to the proposed rule (79 FR 11879 at 11893), we
discussed a 1997 citizen petition submitted by Nabisco, Inc. (Docket
No. FDA-1997-P-0476) asking us to amend the definitions of ``total
fat'' and ``saturated fat'' to clarify that acetic, propionic, and
butyric acids may be excluded when calculating the amount of fat in a
food product. We tentatively concluded that the petitioner did not
provide a scientific basis on which we could rely to propose to exclude
acetic, propionic,

and butyric acids from the definition of total fat based on differences
in chemical composition. We therefore, did not propose any changes to
the definition of ``total fat'' found in Sec.  101.9(c)(2).
    To clarify what we consider to be a fatty acid, we proposed to
define ``fatty acids'' in Sec.  101.9(c)(2) as ``aliphatic carboxylic
acids consisting of a chain of alkyl groups and characterized by a
terminal carboxyl group.'' We explained that this definition is
consistent with other similar definitions found in nutrition and
chemistry references (79 FR 11879 at 11893).
    (Comment 83) Several comments supported our current definition of
``total fat'' and our proposed definition of ``fatty acids.'' The
comments also agreed with our tentative conclusion that acetic,
propionic, and butyric acids should continue to be included in the
definition of total fat because they are short-chain fatty acids and
that the basic chemical group (i.e., the terminal carboxyl group
attached to a chain of alkyl groups containing carbon atoms) should
remain the main defining factor of a fatty acid.
    However, one comment suggested that acetic and propionic acids
should not be considered fatty acids, but that butyric acid should be
considered both a fatty acid and a saturated fatty acid. The comment
cited the International Union of Pure Applied Chemistry (IUPAC)
definition of fatty acids, which indicates that ``natural fatty acids
commonly have a chain of 4 to 28 carbons'' (Ref. 27). The comment noted
that acetic and propionic acid have 2 and 3 carbon chains,
respectively, so the comment said extending the definition of fatty
acids to these two substances is unjustified. Furthermore, the comment
said that acetic and proprionic acids are not functionally fatty acids
because acetic acid is a primary component of vinegar and propionic
acid is most commonly used as a food stabilizer or anti-microbial agent
in the form of sodium or ammonium salts, and is also used in its free
form as a taste additive.
    (Response) We agree that butyric acid should be considered both a
fatty acid and a saturated fatty acid. However, we disagree that acetic
acid and propionic acid should be excluded from the declaration of
total fat based on their carbon chain length. The IUPAC definition
provided says that fatty acids ``commonly'' have a chain length of 4 to
28 carbons, but this definition does not exclude the possibility that
there may be fatty acids with carbon chain lengths of less than 4
carbons. Furthermore, other definitions of fatty acids include
monocarbonic acids with chain lengths between 1 and nearly 30 carbon
atoms (79 FR 11879 at 11893). The final rule, therefore, does not
change our pre-existing definition of ``total fat.''
    The comment noted that acetic acid is most commonly found in the
human diet in vinegar, either separately or as an ingredient, and is
responsible for its distinctive odor and taste. The comment noted that
propionic acid is used in food as a stabilizer, anti-microbial agent,
and as a taste additive. The comment used this information to explain
why these acids are not functionally fatty acids rather than explaining
how the function of acetic and propionic acids differ from those of
other fatty acids. Therefore, the comment did not provide sufficient
information for us to consider in determining whether acetic and
propionic acid should be excluded from the declaration based on their
functional attributes, and we have finalized the definition of ``fatty
acids'' in Sec.  101.9(c)(2) without change.
    (Comment 84) One comment recommended that consumer education is
warranted to make consumers aware that the physiological effects of
acetic, propionic, and butyric acids are different from the health
effects that have been linked to longer-chain fatty acids.
    (Response) The health effects of acetic, propionic, and butyric
acids have not been well established in the scientific literature.
Therefore, it would be premature to provide consumer education on
acetic, propionic, and butyric acids until more is known about these
acids.
    b. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act
requires the declaration of the amount of total fat on food labels.
Consequently, the Nutrition Facts label includes the mandatory
declaration of the gram amount for total fat in Sec.  101.9(c)(2).
    The preamble to the proposed rule (79 FR 11879 at 11893) stated
that the 2010 DGA recognizes that the types of fatty acids consumed are
more important in influencing the risk of CVD than the total amount of
fat in the diet. It also stated that current dietary recommendations
and clinical guidelines encourage replacing saturated and trans fatty
acids with beneficial fats, such as polyunsaturated and monounsaturated
fatty acids, and that a high intake of most types of saturated fatty
acids, trans fatty acids, and cholesterol can increase LDL cholesterol
levels, which in turn may increase the risk of CHD (id.). Although we
concurred with the 2010 DGA that consuming a diet low in saturated
fatty acids and cholesterol is more important for reducing CVD risk
than consuming a diet low in total fat, we tentatively concluded in the
preamble to the proposed rule that mandatory declaration of total fat
on the Nutrition Facts label continues to be necessary to assist
consumers in maintaining healthy dietary practices (id.) for the
following reasons:
     Total fat is a calorie-yielding macronutrient and an
important piece of the macronutrient profile of a food;
     Consumption of a low fat, high carbohydrate diet can
increase the risk of chronic diseases such as CHD and type 2 diabetes;
and
    Increased fat intake, as a result of increased saturated fat
intake, has been shown to increase LDL cholesterol concentrations, and
therefore risk of CHD.
    (Comment 85) Several comments supported the mandatory declaration
of total fat on the Nutrition Facts label. The comments suggested that
retaining the declaration of total fat also would help consumers who
are trying to consume foods with a lower calorie density because foods
higher in fat have a higher caloric density. (Caloric density is the
amount of calories per unit of food weight.) Some comments provided
evidence to show that consumption of a lower-fat, lower-calorie diet
promotes weight loss, weight maintenance, and the reduction in risk of
diabetes. Other comments stated that consumers can use a food's total
and saturated fat content to estimate its unsaturated fat content. As
discussed in part II.F.4, replacing saturated fats with unsaturated
fats can lower LDL cholesterol levels and the risk of CVD.
    Other comments disagreed with our conclusion and suggested that,
rather than listing total fat on the label, we should require the
declaration of the amount of each type of fat (i.e., saturated fat,
trans fat, polyunsaturated fat, and monounsaturated fat). The comments
noted that total fat consumption is no longer emphasized in the DGA.
Instead consumers are advised to limit their consumption of saturated
and trans fats, and replace them with monounsaturated and
polyunsaturated fats. One comment questioned whether including total
fat on the label may inadvertently discourage consumers from selecting
foods that appear to be high in fat without regard to the source of
fat.
    (Response) We agree, in part, and disagree, in part, with the
comments. As we stated in the preamble to the proposed rule (79 FR
11879 at 11893), we agree with the recommendations of the 2010 DGA that
the types of fatty acids consumed are more important in influencing the
risk of CVD than the total amount of fat in the diet. However,

we decline to remove the declaration of total fat from the label as
some comments suggested. Total fat continues to be associated with the
risk of chronic disease and so a declaration of total fat provides
important information about the nutrient profile of a food (79 FR 11879
at 11893). Increased fat intake, as a result of increased saturated fat
intake, has been shown to increase LDL cholesterol concentrations, and
therefore risk of CHD.
    As for the comment asserting that including total fat on the label
may inadvertently discourage consumers from selecting healthful foods
because of the amount of total fat declared on the label, the comment
did not provide any data or other information to support the assertion.
We recognize that how a total fat declaration may be understood and
used by consumers could have important implications for how we focus
our consumer education.
    c. DRV. The DRV for total fat is 30 percent of calories (65 grams/
day) (Sec.  101.9(c)(9)). The proposed rule would not change the DRV.
The preamble to the proposed rule (79 FR 11879 at 11894) discussed the
absence of an AI and RDA for total fat and how the IOM established an
AMDR for total fat intake of 20 to 35 percent of energy for adults and
an AMDR of 25 to 35 percent of energy for children age 4 to 18 years.
(The AMDRs are associated with reduced risk of chronic diseases, such
as CHD, while providing for adequate intake of essential nutrients.) We
noted that the 2010 DGA acknowledged the IOM's AMDR and indicated that
total fat intake should fall within the AMDRs set by the IOM. We
explained that the IOM Labeling Committee recommended a population-
weighted midpoint of the AMDR because AMDRs vary with age; thus, a
population-weighted mid-point of the AMDR for adults, i.e., 20 to 35
percent, yields a DRV of 28 percent or 62 grams of total fat. However,
we declined to adjust the DRV because we concluded, in the preamble to
the proposed rule (79 FR 11879 at 11894), that the upper level of the
AMDR of 35 percent of 2,000 calories as the basis for a DRV would
provide no meaningful health benefit and that a population-weighted
mid-point of 28 percent of the AMDR (28 percent of calories) as the
basis for the DRV is not significantly different from a public health
outcome standpoint than the current value of 30 percent of calories.
    (Comment 86) One comment agreed that we should not change the DRV
for total fat. The comment noted that there is little or no advantage
to making a change on this basis because the actual change in the DRV
amount is minimal compared to the cost and effort required to educate
consumers about the rationale for the change and its significance
related to dietary choices.
    One comment said we should reduce the DRV for total fat to 40
grams/day (18 percent of calories based on a 2,000 calorie diet), but
the comment did not provide a rationale or other information to support
the recommended change.
    Another comment suggested that we eliminate the DRV for total fat
to allow consumers to focus on replacing saturated fats with
unsaturated fats. The comment stated that the types of fat consumed are
more important in influencing the risk of heart disease than is the
total amount of fat. The comment noted that current dietary
recommendations and clinical guidelines recommend replacing saturated
and trans fats with polyunsaturated and monounsaturated fats to reduce
the risk of heart disease.
    (Response) Since we published the proposed rule in the Federal
Register, new information and evidence has become available that
corroborates the position that the types of fats consumed are more
important in influencing the risk of heart disease than is the total
amount of fat. The 2015 DGAC concluded that strong and consistent
evidence from randomized controlled trials shows that replacing
saturated fatty acids with unsaturated fats, especially polyunsaturated
fatty acids, significantly reduces total and LDL cholesterol. The 2015
DGAC also concluded that there is strong evidence that dietary patterns
that are lower in saturated fat, cholesterol, and sodium and richer in
fiber, potassium, and unsaturated fats are beneficial for reducing CVD
risk. The 2015 DGAC noted that, in low-fat diets, fats are often
replaced with refined carbohydrates and this is of particular concern
because such diets are generally associated with changes in blood
cholesterol levels associated with an increased risk of disease. The
2015 DGAC suggested that dietary advice should put the emphasis on
optimizing types of dietary fat consumed and not on reducing total fat
intake. The 2015-2020 DGA did not include a recommendation that
Americans should reduce their intake of total fat, but did recommend
that sources of saturated fat should be replaced with unsaturated fat,
particularly polyunsaturated fatty acids (Ref. 28). These
recommendations and conclusions are supported by the Lifestyle
Management Report and the evidence reviewed for the NHLBI Lifestyle
Evidence Review (Refs. 17-18).
    We disagree with the comment recommending the elimination of the
declaration of the percent DV for total fat because we have concluded
that the declaration of the amount of total fat is necessary to assist
consumers in maintaining healthy dietary practices and the percent DV
declaration can help consumers put the gram amount of total fat
declared on the label into the context of their total daily diet.
Furthermore, the comment did not explain how removing the declaration
of the percent DV for total fat from the label will help consumers
focus on replacing saturated fats with monounsaturated fats, especially
if the total gram amount of total fat in a serving of a product is
still declared on the label. Therefore, we decline to remove the
declaration of the percent DV for total fat from the label.
    We also disagree that the DRV for total fat should be decreased
from 65 grams/day to 40 grams/day. The comment did not provide a basis
for the change, so, absent data or evidence to support decreasing the
DRV, we do not have sufficient information to support the change and
also are unable to determine if the change would be appropriate.
    Although we disagree with the comment suggesting that we eliminate
the percent DV declaration for total fat, we are reconsidering our
position that increasing the DRV for total fat to 35 percent, which is
the upper end of the AMDR range, would provide no meaningful health
benefit. The scientific community continues to focus on the types of
fats consumed and less on the total amount of fat consumed. Current
clinical guidelines and dietary recommendations do not include guidance
or recommendations to limit total fat. We do not place limitations on
the total amount of fat. We are concerned that keeping the DRV for
total fat of 30 percent of calories may be misinterpreted as advising
consumers to limit their intake of total fat to 30 percent or less. It
is also conceivable that consumers could view foods which are good
sources of mono and polyunsaturated fats negatively because their
percent DV declaration for total fat is high. Given that current
dietary recommendations and clinical guidelines corroborate our action
to not place limitations on the total amount of fat which should be
consumed and acknowledge that replacing total fat in the diet with
carbohydrates can have negative health effects, we have reconsidered
our statement that the upper level of the AMDR of 35 percent would
provide no meaningful health benefit compared to the current value of
30 percent calories. Thus, we are increasing the DRV for total fat from
30 percent of calories to 35 percent of

calories, which results in a DRV of 78 grams.
    d. Declaration of total fat. The proposed rule would not change the
preexisting requirement for mandatory declaration of total fat on the
Nutrition Facts label.
    (Comment 87) Several comments recommended decreasing the prominence
of total fat on the label while increasing the prominence of saturated
and trans fatty acids because the scientific evidence shows that the
type of fat consumed is more important than the total amount consumed.
The comments stated that more emphasis on saturated and trans fatty
acids could help consumers reduce their intake of these types of fats.
One comment recommended that the total fat declaration should be listed
right after protein and carbohydrate on the label to reduce its
prominence. The comment suggested that this change is necessary because
high fat diets have been proven to reduce body weight, normalize blood
sugars for diabetics, improve cardiac risk profiles, and reduce the
risk for other comorbidities, such as the risk of stroke.
    (Response) We decline to change the order of nutrients on the label
to decrease the prominence of total fat. Fat is one of three major
macronutrients in the diet. The listing of the amount of total fat in a
product provides valuable information to the consumer about the
nutrient profile of a food. While we agree that it is important for
consumers to consider the amount of saturated and trans fat in a
product, these fatty acids are components of total fat. They are
indented and listed below total fat on the Nutrition Facts label so
that consumers can see that they are part of the total fat declaration.
If the declaration of the amount of total fat in a product is separated
from the declaration of its components, as suggested in the comment
recommending its placement below carbohydrate and protein, it could
appear as though saturated and trans fat are not part of the total fat
declaration.
    As for the comment suggesting that high fat diets have been proven
to be beneficial for weight loss and to have other beneficial health
effects, the comment did not provide evidence related to how the order
of nutrients on the label may impact consumers wishing to follow a high
fat diet. Without such evidence, we are unable to evaluate the impact
of the suggested change in the order of nutrients declared on the
label.
    (Comment 88) Some comments recommended declaring total fat as a
percentage of the total weight of a product or as a percentage of
calories in a serving of the product. One comment expressed concern
that some manufacturers are making false claims about the percentage of
fat in a product, and the comment suggested that knowing the percentage
attributed to the total weight of the food by the fat in the product
would be beneficial for consumers. The comment also stated that most
calculations of body fat and daily intakes are expressed as
percentages.
    (Response) We decline to require the declaration of total fat as a
percentage of the weight of the food or as a percentage of calories in
a serving of the product.
    We disagree that declaration of the amount of fat as a percentage
of weight or as a percentage of calories would be helpful to consumers
in maintaining healthy dietary practices. Information found on the
label can be used to determine the amount of a nutrient in a food so
that it can be used for product comparison or to determine how the food
contributes towards recommended amounts of nutrients (see part I.B).
The declaration of a percentage of weight that is attributable to the
total fat content of a food product would not allow for easy product
comparison and would not allow a consumer to determine how the product
compares to dietary recommendations for total fat. Dietary
recommendations for total fat are provided in grams rather than in
percentages (Ref. 29).
    Additionally, as discussed in part II.E.1, we are removing calories
from fat from the label because the type of fat consumed is more
relevant in reducing the risk of CHD than overall total fat intake.
Therefore, the declaration of a percentage of calories from fat also is
unwarranted.
2. Saturated Fat
    a. Definition. Our preexisting regulations define ``Saturated fat''
in Sec.  101.9(c)(2)(i) as the sum of all fatty acids containing no
double bonds. We did not propose to change the definition.
    (Comment 89) Most comments supported our decision not to revise the
definition of saturated fat. However, one comment argued that we should
exclude the short-chain fatty acids, acetic acid and proprionic acid,
from the definition of both total fat and saturated fat, but another
short-chain fatty acid, butyric acid, could remain in the definitions.
The comment argued that both acetic acid and proprionic acid have
carbon chains shorter than four carbons and that the International
Union of Pure Applied Chemistry (IUPAC) has a definition of fatty acids
which indicates that ``natural fatty acids commonly have a chain of 4
to 28 carbons'' (Ref. 27).
    (Response) We decline to exclude acetic and propionic acid from the
declaration of saturated fat based on the length of the carbon chains
for reasons already discussed in part II.F.1.
    b. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act
requires the declaration of the amount of saturated fat on food labels.
Accordingly, our preexisting regulations require mandatory declaration
of the gram amount for saturated fat (Sec.  101.9(c)(2)). We did not
propose any changes to the mandatory declaration of the gram amount for
saturated fat.
    (Comment 90) Most comments supported our decision not to change the
mandatory declaration of saturated fat.
    Other comments opposed listing saturated fats because, the comments
said, saturated fats are not detrimental to health. One comment that
suggested we should break down saturated fat further into medium chain
and long chain saturated fatty acids because medium chain saturated
fatty acids are beneficial to health, while long chain saturated fatty
acids are not.
    (Response) We disagree that the Nutrition Facts label no longer
needs to list saturated fats and also decline to break down saturated
fat further into medium chain and long chain saturated fatty acids.
Section 403(q)(1)(D) of the FD&C Act requires the declaration of the
amount of saturated fat on food labels, and, in the preamble to the
proposed rule (79 FR 11879 at 11895), we described how dietary
recommendations continue to recognize the well-established relationship
between consumption of saturated fat, which include all saturated fatty
acids chain lengths, and its effect on blood cholesterol levels. In
addition, the 2010 DGA provided scientific evidence supporting a
quantitative intake recommendation for saturated fat which likewise,
include all saturated fatty acid chain lengths.
    The comments suggesting that saturated fat did not need to be
declared or should be further broken down by chain length did not
provide any information that could be used to contradict the dietary
recommendations, nor did they provide information that would enable us
to determine that the nutrient information is no longer necessary to
assist consumers in maintaining healthy dietary practices (as section
403(q)(2)(B) of the FD&C Act requires when removing nutrient
information). Thus, based on the science and dietary recommendations
and the absence of evidence indicating that the

information is no longer necessary to assist consumers in maintaining
healthy dietary practices, we are retaining the declaration of
saturated fat in the Nutrition Facts label.
    c. DRV. Under our preexisting regulations at Sec.  101.9(c)(9), the
DRV for saturated fat is 20 grams, which is 10 percent of calories
based on a 2,000 reference calorie intake level. In the preamble to the
proposed rule (79 FR 11879 at 11895), we discussed how current
consensus reports, such as the IOM DRIs, the 2010 DGA, and a 2002
report from the National Cholesterol Education Program of the NIH
National Heart, Lung, and Blood Institute, continue to recommend
saturated fat intakes of no more than 10 percent of calories, based on
risk of CVD. Additionally, the scientific evidence in the 2015-2020 DGA
supports limiting calories from saturated fat which corroborates the
consensus reports. Consequently, we did not propose to change the DRV
for saturated fat in Sec.  101.9(c)(9).
    (Comment 91) Many comments supported our decision to keep the
existing saturated fat DRV of 20 grams, but some comments would have us
lower the DRV to 6 or 7 percent of calories. The comments indicated
that this range would calculate to a DRV of approximately 13 to 15
grams of saturated fat. Other comments noted that recent guidelines
published by the American Heart Association and American College of
Cardiology, in collaboration with the National Heart, Lung, and Blood
Institute, concluded that no more than 5 to 6 percent of calories
should come from saturated fat. One comment also argued that the
saturated fat DRV was too low and that human diets, both historical and
among different cultures, are consistent with diets higher in saturated
fat and that current science supports higher levels of intake.
    Two comments suggested that we remove stearic acid from any
calculation of the percent DV. The comments argued that the DRV is
based on adverse physiological effect and that each saturated fatty
acid should be considered individually regarding these effects. The
comments suggested that a percent DV for saturated fat of an individual
food could be calculated using different weighting factors for
saturated fatty acids dependent on the level of adverse effect of each
individual fatty acid. The comments also argued that, because stearic
acid is neutral in regard to effects on levels of serum total and LDL-
cholesterol compared to other saturated fatty acids, stearic acid would
end up being left out of the calculation for the percent DV.
    (Response) We decline to revise the DRV for saturated fat. As we
discussed in the preamble to the proposed rule (79 FR 11879 at 11895),
current consensus reports reviewing the scientific evidence related to
saturated fatty acid intake continue to support saturated fat intakes
of no more than 10 percent of calories, based on risk of CVD. For
example, the scientific evidence in the 2010 DGA (Ref. 30) supports
reducing saturated fatty acid intake to less than 10 percent of
calories, and the scientific evidence in the 2015 DGAC supports
retaining the 10 percent upper limit for saturated fat intake. These
guidelines apply to intake levels for the general population. Other
guidelines that support lower than 10 percent of calories do exist for
therapeutic uses, which would apply to specific populations in need of,
for example, lowering of LDL cholesterol levels in the blood (Ref. 31).
These are specific populations such as those with diagnosed heart
disease or type 2 diabetes, those with family histories of high blood
cholesterol, and others with high risk for CVD (Ref. 32).
    As for the comment claiming that the DRV for saturated fat is too
low, the comment did not provide evidence for increasing the DRV, and
we are unaware of current scientific information that would support an
increase. The current dietary recommendations for intake of saturated
fatty acids, of less than 10 percent of calories, are still applicable
to the general U.S. population. Thus, the existing DRV of 20 grams is
consistent with the scientific evidence supporting a maximum intake
level that covers the general U.S. population.
    We also disagree with comments that would exclude stearic acid from
the calculation of an individual food's percent DV for saturated fat.
The scientific evidence supporting the current dietary recommendations
for saturated fat, does not differentiate among the individual
saturated fatty acids. The scientific evidence relates to the intake of
all saturated fatty acids combined, and this would include stearic
acid. We note that the 2015-2020 DGA recommendation to consume less
than 10 percent of calories from saturated fatty acids makes no
specific exclusion of stearic acid and, instead, relates to the intake
of total saturated fatty acids (Ref. 28). Because the DRV is based on
the intake of all saturated fatty acids, determination of percent DV is
also based on content of all saturated fatty acids in the individual
food.
3. Trans Fat
    a. Definition. Our preexisting regulations, at Sec.
101.9(c)(2)(ii), define ``Trans fat'' or ``Trans'' as the sum of all
unsaturated fatty acids that contain one or more isolated (i.e., non-
conjugated) double bonds in a trans configuration. The proposed rule
would not change the definition.
    (Comment 92) Most comments supported our decision to retain the
definition of trans fat.
    One comment, however, said that the physiological effects of trans
fat from ruminant sources differs from the effects of trans fat from
industrial sources (i.e., partially hydrogenated oils). The comment
said we should exclude trans fat from ruminant sources from the
definition of trans fat.
    (Response) We decline to exclude trans fat from ruminant sources
from the definition of trans fat. Trans fat is generally understood to
be any unsaturated fatty acid that contains a double bond, regardless
of source (Ref. 29). Additionally, as we stated in the preamble to the
proposed rule (79 FR 11879 at 11896), the chemical definition is
consistent with how we define polyunsaturated fat as cis, cis-
methylene-interrupted (Sec.  101.9(c)(2)(ii)).
    We also note that, in the Federal Register of June 17, 2015 (80 FR
34650), we issued a declaratory order making a final determination that
there is no longer a consensus among qualified experts that partially
hydrogenated oils (PHOs), which are the primary dietary source of
industrially produced trans fatty acids (IPTFA) are generally
recognized as safe (GRAS) for any use in human food. The major
provisions of our declaratory order were that:
     PHOs are not GRAS for any use in human food;
     Any interested party may seek food additive approval for
one or more specific uses of PHOs with data demonstrating a reasonable
certainty of no harm of the proposed use(s); and
     For the purposes of the declaratory order, FDA defined
PHOs as those fats and oils that have been hydrogenated, but not to
complete or near complete saturation, and with an iodine value (IV)
greater than 4.
    We established a compliance date of June 18, 2018 for the
declaratory order.
    b. Mandatory declaration. Our preexisting regulations, at Sec.
101.9(c)(2)(ii), require the declaration of trans fat on the Nutrition
Facts label (Sec.  101.9(c)(2)(ii)). In the preamble to the proposed
rule (79 FR 11879 at 11896), we tentatively concluded that information
on the amount of trans fat in food products allows consumers to

reduce their intake of trans fat, and thus, reduce the risk of CHD, so
we did not propose to change this requirement. However, we also stated
that, in the Federal Register of November 8, 2013 (78 FR 67169), we had
published a tentative determination that partially hydrogenated oils
(PHOs), the source of industrially produced trans fat, may not be
generally recognized as safe (GRAS), and we invited comment on whether
mandatory labeling of trans fat would still be necessary if we
finalized our determination (79 FR 11879 at 11896).
    (Comment 93) Regarding the mandatory declaration of trans fat, all
comments supported our decision to continue requiring the declaration
of trans fats.
    With respect to the GRAS determination of PHOs, the comments were
divided. Some comments supported requiring the declaration of trans
fats on the label regardless of the final GRAS determination; other
comments supported removing the declaration of trans fat from label if
PHOs are no longer GRAS.
    The comments supporting the declaration of trans fat on the label,
even if PHOs are no longer declared GRAS, discussed the continued
presence of trans fat in products even after PHOs are removed from
foods. The comments explained that trans fat could come from both
natural sources, such as the trans fat in dairy products, and from uses
of oils that are either currently allowed as food additives or could
potentially be permitted in the future. The comments said that trans
fat content is still information that consumers need even if total
overall presence in the food supply is reduced.
    Other comments supporting removal of the trans fat declaration if
PHOs are no longer GRAS said that, if PHOs are no longer GRAS, most
foods would not have any trans fat, except for the trans fat that comes
from animal sources. Thus, to these comments, few foods would have
declarable levels of trans fat, and most foods would indicate a trans
fat content of zero. Because so few foods would contain trans fat, the
comments stated, a trans fat declaration would no longer be needed on
the label. Some comments also noted that animal products, such as
dairy, are considered part of normal, healthful diets, and trans fat
information on those products is not necessary. Some comments, however,
did suggest that if trans fat from animal sources exceeded a certain
level, such as 1.0 g per serving, then we should require its disclosure
on the label.
    (Response) Based on the available scientific evidence and the
findings of expert scientific panels, in the Federal Register of June
17, 2015 (80 FR 34650), we published a declaratory order stating that
PHOs are not GRAS for any use in human food. Although we have made this
determination regarding PHOs, some trans fats will continue to be
present in foods. For example, the declaratory order provided a
compliance date of June 18, 2018; this gives manufacturers up to 3
years to remove PHOs, and the accompanying trans fats in PHOs, from
foods. The 3 years also provides time for manufacturers to petition us
for approval of PHOs as food additives, which could allow PHOs to be
included in food in certain circumstances. Moreover, trans fat will
always be naturally present in foods from ruminant sources (e.g., beef
products and dairy foods). Using the latest data from the Gladson
database (data current as of March 2015), we calculate that, based on
the Gladson values, there could potentially be more than 5,000 foods
remaining with declarable levels of trans fat, after removal of PHOs.
Thus, it is premature to consider removing trans fat from the Nutrition
Facts label at this time. We expect there to be a great deal of
reformulation of products over the next 3 years, and we will need to
evaluate the remaining trans fat content in foods, both from approved
or potentially approved food additive uses of PHOs and from naturally
occurring trans fat, after the expected reformulations have occurred.
We will then be able to consider whether, in light of any remaining
trans fat content in foods, declaring trans fat on the label continues
to assist consumers in maintaining healthy dietary practices. Until
such time, however, the scientific evidence continues to support the
need to inform consumers about the continued presence of trans fat in
foods.
    c. DRV. Our preexisting regulations do not provide a DRV for trans
fat. In the preamble to the proposed rule (79 FR 11879 at 11896 through
11897), we described various efforts (such as the use of ANPRMs) to
consider determining a DRV for trans fat, including the use of food
composition data, menu modeling and data from dietary surveys, and a
potential joint percent DV for trans fat and saturated fat. We
described how a number of evaluations of the existing scientific
evidence were not able to set a definitive quantitative intake
recommendation for trans fat. We tentatively concluded that there was
not a basis for setting a DRV for trans fat, and so we did not propose
a DRV for trans fat.
    (Comment 93a) Most comments agreed that the scientific evidence is
insufficient to set a DRV. In contrast, two comments said we should set
a DV for trans fat, but did not provide information that would enable
us to establish a DRV.
    (Response) We decline to revise the rule to establish a DV for
trans fat. The comments did not provide information that would enable
us to establish a DV, and, as we discussed in the preamble to the
proposed rule (id.), consensus reports were unable to determine a
specific level of trans fat intake that would likely pose no risk of
adverse health effects. The IOM, for example, said that a DV for trans
fat could not be established because ``any increase in trans fat intake
increases CHD risk but because trans fats are unavoidable in ordinary
diets, consuming zero percent of calories would require significant
changes in dietary intake patterns that may introduce undesirable
effects and unknown and unquantifiable health risks'' (Ref. 29). We
continue to adhere to the recommendation from the IOM that trans fatty
acid consumption be as low as possible while consuming a nutritionally
adequate diet.
    d. Declaring the amount of trans fat. Our preexisting regulations,
at Sec.  101.9(c)(2)(ii), state that, if the serving contains less than
0.5 grams, the content declared on the Nutrition Facts label must be
expressed as zero. For most nutrients, the maximum amount permitted for
a zero declaration is governed by the limitations associated with
analytical methods available, and, in the preamble to the proposed rule
(79 FR 11879 at 11896), we said that validated analytical methodologies
that provide sensitive and reliable estimates of trans fatty acids in
all foods at levels below 0.5 grams per serving are currently not
available. Thus, we did not propose to change the requirements for a
zero declaration of trans fat.
    (Comment 94) Several comments asked us to lower the maximum amount
permitted for a zero declaration. The comments provided several
different values, such as 0.0 grams, 0.05 grams, 0.1 grams, and 0.2
grams, as alternatives to the preexisting value of 0.5 grams. The
comments argued that even very small amounts of trans fat in a food
(i.e., less than 0.5 grams) could be harmful to consumers' health, and
consumers should know if foods contained any trans fat at all. Most
comments did not address the issue of a lack of validated analytical
methodologies. One comment did, however, state that a validated
analytical methodology did exist to detect trans fat below 0.5 grams
per

serving and cited AOAC 996.06 (Ref. 33).
    (Response) We agree that consumers should be informed of trans fat
content in foods. With the current analytical methodologies, however,
quantification of trans fat content in foods is limited. When
determining the maximum amount permitted for a zero declaration, we
need to consider, for compliance purposes, whether the trans fat
content at those low levels can be reliably and accurately measured in
all foods by an analytical method(s) that has been validated to do so.
Currently, there are no validated analytical methods to determine trans
fat content at levels less than 0.5 grams for all foods.
    With respect to the comment that cited AOAC 996.06 as a methodology
to detect trans fat, AOAC 996.06 does not provide validation data for
trans fatty acids. AOAC 996.06 does provide validation data for total
fat, saturated fat, and monounsaturated fat (Ref. 33). We are aware of
ongoing efforts for validation of improved analytical methods for trans
fat (Ref. 34), and if new validated methods become available, we may
reevaluate the threshold for a zero declaration of trans fat.
4. Monounsaturated Fat and Polyunsaturated Fat
    a. Voluntary declaration. Our preexisting regulations, at Sec.
101.9(c)(2)(iii) and (iv), permit, but do not require, the declaration
of monounsaturated fat (defined as cis-monounsaturated fatty acids
(e.g., oleic acid)) and the declaration of polyunsaturated fat (defined
as cis, cis-methylene-interrupted polyunsaturated fatty acids) on the
Nutrition Facts label.
    The preamble to the proposed rule (79 FR 11879 at 11897 through
11899) described how we considered recommendations in current consensus
reports, as well as comments received in response to the 2007 ANPRM in
which we requested comment on whether declaration of monounsaturated
fat and polyunsaturated fat should remain voluntary or be made
mandatory. We noted that we have been unable to set a DRV for
monounsaturated fat and polyunsaturated fat due to the absence of DRIs
for both (id.)
    Consistent with the 2010 DGA, the 2015-2020 DGA recommends that
foods high in saturated fats should be replaced with foods high in
unsaturated fats (Ref. 28).
    (Comment 95) One comment supported voluntary declaration of
monounsaturated and polyunsaturated fats and said that omitting
unsaturated fats would reduce label clutter.
    (Response) While it is possible that omitting unsaturated fats
would reduce label clutter, our reason for not requiring the
declaration of monounsaturated or polyunsaturated fats is due to the
lack of a DRV and our consideration of the factors for mandatory and
voluntary declaration for these types of nutrients. We consider
voluntary declaration to be appropriate when the nutrient either has a
quantitative intake recommendation, but does not have public health
significance or does not have a quantitative intake recommendation
available for setting a DRV, but has public health significance.
    (Comment 96) Some comments supported voluntary declaration of
monounsaturated and polyunsaturated fats because, according to the
comments, they were a key recommendation in the 2010 DGA, ``Consume
less than 10 percent of calories from saturated fatty acids by
replacing them with monounsaturated and polyunsaturated fatty acids.''
    Other comments supporting mandatory declaration of monounsaturated
and polyunsaturated fats also referred to the 2010 DGA recommendation.
Some comments asserted that being a key recommendation was sufficient
for mandatory listing of added sugars and claimed that we were being
inconsistent with the use of dietary guidance recommendations,
especially because the scientific evidence is stronger for
monounsaturated and polyunsaturated fats than for added sugars.
    (Response) We proposed to retain the voluntary declaration of
monounsaturated and polyunsaturated fats based on the factors
identified for the mandatory and voluntary listing of these types of
non-statutory nutrients. While added sugars is not a statutory
nutrient, we are requiring the declaration of added sugars based on the
need for consumers to have this information, which relates to a dietary
pattern, to assist consumers to maintain healthy dietary practices and
not based on a specific relationship of added sugars to chronic disease
risk. Thus, the basis for requiring the declaration of added sugars
differs from that for monounsaturated and polyunsaturated fats. We
acknowledge that the 2010 DGA provided a key recommendation for
monounsaturated and polyunsaturated fats because of the strong evidence
(79 FR 11879 at 11898); however, some evidence supporting this is
replacing saturated fat with monounsaturated and polyunsaturated fats.
Because saturated fat is on the label, we believe consumers can use
that information in addition with total fat DV to maintain healthy
dietary practices. The scientific evidence for added sugars (and solid
fats) is based on the modeling of dietary patterns to ensure adequate
consumption of nutrient dense foods and avoidance of excess empty
calories that can lead to weight management issues and obesity.
    (Comment 97) One comment supporting mandatory declaration noted
that the 2010 DGA stated that there is well established evidence that
replacing saturated fat with monounsaturated and polyunsaturated fat
lowers LDL cholesterol and has health benefits.
    (Response) We agree that there is well established evidence that
replacing saturated fat with monounsaturated and polyunsaturated fats
lowers LDL cholesterol and therefore reduces the risk of heart disease,
and the preamble to the proposed rule (79 FR 11879 at 11897 through
11898) discussed how replacing saturated fatty acids with
monounsaturated or polyunsaturated fats reduced blood LDL cholesterol
levels. A quantitative intake recommendation, however, is not available
for either monounsaturated or polyunsaturated fat. Therefore, in
considering the factors for mandatory or voluntary declaration, we
determined that monounsaturated and polyunsaturated fat warrants
voluntary declaration.
    An FDA health claim is available for the labeling of foods:
``Replacing saturated fat with similar amounts of unsaturated fats may
reduce the risk of heart disease. To achieve this benefit, total daily
calories should not increase'' (see ``Health Claim Notification for the
Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids
and Reduced Risk of Heart Disease'') (Ref. 35).
    (Comment 98) One comment supported mandatory declaration of
polyunsaturated fat because, according to the comment, polyunsaturated
fat includes essential nutrients.
    (Response) We agree that polyunsaturated fat includes essential
fatty acids (i.e., linoleic and alpha linolenic acid). We disagree,
however, that the listing of polyunsaturated fat should be mandatory
for this reason. Essentiality of a nutrient is not factor considered
for the mandatory or voluntary labeling of these types of non-statutory
nutrients, other than essential vitamins and minerals. The basis for
proposing voluntary declaration of polyunsaturated fat was because of
its role in reducing the risk of CVD when replacing saturated fat,
which has public health significance.

    (Comment 99) One comment supporting mandatory declaration noted
that the 2002 IOM report (Ref. 29) concluded that the type of fat,
rather than total fat, was relevant to health and the 2010 DGA shifted
the focus from total fat to the type of fat. Another comment noted that
we were no longer requiring ``Calories from fat'' because the focus is
more on the type of fat. Several comments supporting mandatory
declaration of monounsaturated and polyunsaturated fats noted that it
is not possible to identify these types of fats which have health
benefits, and, therefore, it is not possible to differentiate from
unhealthy fats. One comment said that listing these fats can help
people distinguish between fatty foods that can be eaten more often
compared to those with higher saturated fat content to be eaten less
often.
    Other comments supporting mandatory declaration claimed that
consumers need to be able to compare products and select foods that are
not only lower in saturated fat but contain monounsaturated and
polyunsaturated fats.
    (Response) We agree that the four chemically defined categories of
type of fat (i.e., saturated, trans, monounsaturated fat, and
polyunsaturated fat), rather than total fat, are relevant to health,
specifically CVD risk. Current dietary recommendations no longer
emphasize total fat. Certain categories of fatty acids are beneficial,
while others categories have negative health effects, particularly
related to CVD (see 79 FR 11879 at 11891). We recognize that
monounsaturated and polyunsaturated fat have public health relevance
when they replace saturated fat (id. at 11898). There is not a
quantitative intake recommendation available, however, that identifies
how much monounsaturated and polyunsaturated fat must replace saturated
fat, and there is no dose-response relationship between mono- and
polyunsaturated fats to risk of CHD, independent of saturated fat,
similar to the relationship between trans fat and risk of CHD.
Therefore, we decline to require the declaration of monounsaturated and
polyunsaturated fat. A quantitative intake recommendation is a factor
we considered for mandatory declaration of these types of non-statutory
nutrients (79 FR 11879 at 11890).
    b. DRV. The proposed rule would not establish DRVs for either
monounsaturated or polyunsaturated fat because quantitative intake
recommendations are not available for setting DRVs (79 FR 11879 at
11897, 11899).
    (Comment 100) One comment agreed with not setting a DRV for
monounsaturated or polyunsaturated fat because there is no agreed upon
scientific basis for establishing a DV due to diverse nature of these
fatty acids.
    (Response) We maintain that there is an insufficient basis to set a
DRV for either monounsaturated or polyunsaturated fat, so the final
rule does not establish a DRV for either monounsaturated or
polyunsaturated fat.
    c. Declaration of individual polyunsaturated fatty acids.
Polyunsaturated fats represent two general categories: n-6 and n-3
polyunsaturated fatty acids. The most common n-6 and n-3
polyunsaturated fatty acid in food is linoleic acid and [alpha]-
linolenic acid, respectively. Other n-3 fatty acids found in foods,
particularly in fish, are the long chain fatty acids, eicosapentaeneoic
acid (EPA) and docosahexaenoic acid (DHA).
    The preamble to the proposed rule (79 FR 11879 at 11898) discussed
the possibility of establishing separate DRVs for linoleic acid and
[alpha]-linolenic acid, and, if so, whether the declaration of these
nutrients should be voluntary or made mandatory. We decided that,
because of the lack of well-established evidence for a role of n-3 or
n-6 polyunsaturated fatty acids in chronic disease risk and the lack of
a quantitative intake recommendation, the declarations of n-3 and n-6
polyunsaturated fatty acids are not necessary to assist consumers to
maintain healthy dietary practices. Thus, the proposed rule would not
provide for the individual declaration of either n-3 or n-6
polyunsaturated fatty acids on the Nutrition Facts label. Similarly,
because of the lack of well-established evidence for a role of EPA and
DHA in chronic disease risk and the lack of a quantitative intake
recommendation, the proposed rule would not provide for the
declarations of EPA and DHA.
    (Comment 101) Although some comments agreed with our decision not
to require the declaration of n-3 or n-6 polyunsaturated fatty acids,
other comments would revise the rule to allow for the voluntary
declaration of the n-3 polyunsaturated fatty acids, eicosapentaeneoic
acid (EPA), and docosahexaenoic acid (DHA). One comment supported the
voluntary declaration of EPA and DHA because humans have a limited
capability to synthesize, elongate, and desaturate [alpha]-linolenic
acid (ALA) to EPA and DHA.
    (Response) While humans may have a limited capability to elongate
and desaturate ALA to EPA and DHA, we do not have evidence to
demonstrate that biosynthesis of EPA and DHA is insufficient in the
general population such that EPA and DHA are essential in the diet.
Therefore, there is no basis on which we can rely to support a
voluntary declaration.
    (Comment 102) Other comments supporting the voluntary declaration
of n-3 and n-6 polyunsaturated fatty acids noted that monounsaturated
fat, polyunsaturated fat, sugars, soluble fiber, insoluble fiber, sugar
alcohols, and added sugars are being allowed or required on the label
but do not have a DV. Therefore, the comments argued, we should treat
n-3 and n-6 polyunsaturated fatty acids in the same manner.
    (Response) There is well-established evidence for the role of
sugars, monounsaturated fat, polyunsaturated fat, soluble fiber,
insoluble fiber, and sugar alcohols in reducing the risk of chronic
disease or providing a beneficial physiological effect. Therefore,
these nutrients have public health relevance, which is the basis for
voluntary labeling. Specifically, there is strong evidence for sugars
increasing the risk of dental caries (see 79 FR 11879 at 11902), as
well as reducing the risk of dental caries when sugar alcohols replace
sugar in the diet (id. at 11908). There also is well established
evidence that replacing saturated fat with monounsaturated and
polyunsaturated fat reduces the risk of CVD (Ref. 35). There is strong
evidence that soluble fibers reduce the risk of CHD (see 79 FR 11879 at
11911). There is well established evidence that insoluble fibers can
improve laxation, a beneficial physiological effect (Ref. 36).
Moreover, the scientific evidence for added sugars differs from that
for n-3 and n-6 polyunsaturated fatty acids. There is a strong
association between a healthy dietary pattern characterized by a lower
intake of sugar sweetened foods and beverages, as compared to less
healthy dietary patterns, and a reduced risk of CVD. A DV is being
provided for added sugars (see part II.H.3).
    In contrast, there is supportive, but not conclusive, evidence to
suggest that n-3 polyunsaturated fatty acids reduce the risk of CHD
(Ref. 37). Furthermore, there is no conclusive evidence for an
independent role of n-6 polyunsaturated fatty acids in reducing blood
cholesterol levels, and consequently, risk of CHD (see 79 FR 11879 at
11898). Therefore, we disagree that there is a sufficient basis to
treat n-3 and n-6 polyunsaturated fatty acids the same as

the other nutrients discussed in the comment, so the final rule does
not provide for voluntary declaration of n-3 and n-6 polyunsaturated
fatty acids.
    (Comment 103) One comment supporting the voluntary declaration of
n-3 polyunsaturated fatty acids said that we could have reached the
same conclusion for n-3 polyunsaturated fatty acid in the same way that
we did for vitamin D. The 2010 DGA recommendation to increase the
amount and variety of seafood in place of some meat and poultry was
made to increase EPA and DHA in the American diet, as well as the total
package of benefits seafood provides, including vitamin D.
    (Response) We disagree that n-3 polyunsaturated fatty acids were
handled differently than vitamin D. There is strong evidence for a
relationship between vitamin D intake and risk of osteoporosis (see 79
FR 11879 at 11921). Furthermore, the IOM provided a quantitative intake
recommendation (i.e., RDA) for vitamin D (Ref. 38). We considered the
scientific evidence for this recommendation when setting an RDI (see
our response to comment 372). In contrast, the evidence for n-3
polyunsaturated fatty acids is not well-established, and a quantitative
intake recommendation is not available (see 79 FR 11879 at 11897
through 11899).
    (Comment 104) Several comments supporting the voluntary declaration
of n-3 polyunsaturated fatty acids stated that not providing
information on n-3 polyunsaturated fatty acids affords the consumer
little opportunity to apply important dietary guidance as in the 2010
DGA. The comments said that, while the IOM did not set a DRI for EPA
and/or DHA, this is an insufficient reason for disallowing the
voluntary declaration of these essential fatty acids on the Nutrition
Facts label. The comments said that the DGA concluded that moderate
evidence indicates that 250 mg EPA and DHA daily is associated with
reduced cardiac deaths among individuals with and without preexisting
CVD and this recommendation contributes to prevention of heart disease.
The comments also noted that, while we have not authorized a health
claim regarding EPA and DHA and CVD risk, we have allowed the use of
qualified health claims for 10 years.
    (Response) The 2010 DGA concluded that moderate evidence shows that
the consumption of 8 ounces per week of a variety of seafood, which
provides an average consumption of 250 mg per day of EPA and DHA, is
associated with reduced cardiac deaths among individuals with and
without preexisting CVD. A DGA key recommendation was not provided for
EPA and DHA, but rather for seafood. It is not clear whether EPA and
DHA per se, or other substances in fish contribute to cardiac deaths.
The qualified health claim on EPA and DHA and CVD risk is supportive,
but not conclusive, evidence to suggest that n-3 polyunsaturated fatty
acids reduce the risk of CHD (Ref. 37). The factors for mandatory and
voluntary labeling of these types of non-statutory nutrients on the
Nutrition Facts label depend on strong (rather than moderate or
inconclusive) evidence. Therefore, we disagree that the information
provided in the 2010 DGA report is sufficient to warrant the voluntary
declaration of EPA and DHA.
    (Comment 105) One comment supporting the voluntary declaration of
n-3 polyunsaturated fatty acids noted that an article on a summary of a
workshop stated that, ``National public health initiatives to increase
n-3 fatty acid consumption are needed: The working group believes that
data are currently sufficient to indicate that intake of n-3 fatty
acids is suboptimal and a national and international initiative should
be launched to shift n-3 fatty acid intake upward'' (Ref. 39). Another
comment cited a paper which concluded that a large percentage of the
U.S. adult population is not meeting recommendations for omega-3 fatty
acid consumption set forth by the 2010 DGA (Ref. 40). One comment cited
an article that evaluated intakes of ALA, EPA, and DHA intake in
children 4 to 8 years of age (Madden et al., 2009).
    (Response) We disagree with the comments' interpretation of the
cited articles. With respect to the cited articles, we note that the
Akabas and Decklebaum article did not provide information to explain
the basis for concluding that the intake of n-3 polyunsaturated fatty
acids is suboptimal. The Papanikolaou article used 250 mg/day to assess
adequacy of intake, however, the value was not a recommendation put
forth by the 2010 DGA. The article by Madden et al. (2009) used the AI
of 900 mg/day to assess adequacy of ALA, and 10 percent of this value
(90 mg/day) was used to assess intake adequacy for EPA and DHA. We
disagree with how Madden (Ref. 41) assessed nutrient intake for EPA and
DHA because the IOM did not set an AI or EAR for EPA and DHA. The IOM
only noted that EPA and DHA contribute approximately 10 percent of the
total n-3 polyunsaturated fat intake (Ref. 29). There is no
quantitative intake recommendation (i.e., EAR) available for assessing
inadequate intake in populations. Furthermore, there are a number of
nutrients for which there is suboptimal intake which was considered as
part of the factors for mandatory or voluntary declaration. However, we
did not rely on suboptimal intake alone for such voluntary declarations
in the Nutrition Facts label.
    (Comment 106) Other comments supporting the voluntary declaration
of n-3 polyunsaturated fats cited published articles or gave Web site
addresses to discuss the health benefits of these fatty acids.
    (Response) We have reviewed the articles and Web sites and, based
on our review, decline to revise the rule to provide for the voluntary
declaration of n-3 polyunsaturated fats.
     Many articles were review articles or meta-analyses that
included studies that tested individuals who had a previous coronary
event; therefore, the studies were evaluating the effect of the n-3
polyunsaturated fatty acids on secondary prevention of CVD (Refs. 42-
47). Furthermore, some articles included observational studies on the
association between the intake of polyunsaturated fatty acids and CVD
risk. Scientific conclusions from such studies are not sufficient to
support conclusions about the causal role of these n-3 polyunsaturated
fatty acids on CHD risk in the general population.
     One article (Ref. 48) was a one-page abstract from a
meeting. The Web site address that was cited (http://www.goedomega3.com/healthcare) is a general resource for health care
professionals. Another Web site provided a list of organizations that
have intake recommendations for EPA and DHA (http://www.goedomega3.com/index.php/files/download/304). None of the citations provided
information that we would consider for voluntary declaration of EPA and
DHA related to a relationship between these nutrients and risk of CHD.
     One article (Ref. 49) evaluated the relationship between
plasma phospholipid EPA and DHA as a biomarker of intake and mortality.
Figure 2 of this article showed that the dose-response relationship
between EPA and DHA intake and plasma phospholipid EPA and DHA was not
linear and plateaued at around 0.5 grams/day. Therefore, plasma
phospholipid EPA and DHA is not a reliable indicator of EPA and DHA
consumption, and scientific conclusions could not be drawn from such as
study.
     One article (Ref. 50) was on an animal study that tested
the effect of DHA on melanoma. The article did not present the totality
of the evidence on DHA and risk of melanoma.

Furthermore, we would not rely on animal data for evaluating the
efficacy of DHA to reduction of risk to melanoma in humans to establish
a nutrient declaration.
     One article (Ref. 51) was a meta-analysis on EPA and DHA
intake and blood pressure. There are several limitations of this meta-
analysis including: (1) Not providing all of the relevant studies on
EPA and DHA and blood pressure; (2) including studies that lacked an
appropriate control group; and (3) including studies that conducted
inappropriate statistical analyses.
     One article (Ref. 52) was an European Food Safety
Association (EFSA) scientific opinion on a labeling reference value for
n-3 and n-6 polyunsaturated fatty acids in which EFSA provided a
recommended intake level of 250 mg/day of EPA and DHA. The article did
not discuss the scientific evidence in detail to show how this
quantitative intake recommendation was determined. Furthermore, while
the scientific opinion cited several references to support 250 mg/day,
a number of these included observational data in which information was
obtained on fish consumption. The IOM did not set a DRI for EPA or DHA
because much of the observational evidence measured fish or fish oil
intake as a proxy for n-3 polyunsaturated fat intake, and other
components in fish may have effects that are similar to n-3 fatty acids
and therefore may confound the results of the observational studies
(Ref. 29).
    (Comment 107) Some comments supporting the voluntary declaration of
individual polyunsaturated fatty acids discussed consumer use or
consumer understanding as reasons for allowing voluntary declaration.
    One comment cited the 2014 IFIC Food and Health survey data to
assert that the data suggests that voluntary declaration of individual
polyunsaturated fatty acids is necessary for the consumer to make the
purchase decisions that they intend. The comment indicated that 21
percent of consumers are looking to increase their omega-3 intake.
    Some comments stated that a distinction between the different n-3
polyunsaturated fatty acids is necessary so that consumers seeking
specifically EPA or DHA are not misled by voluntary declaration of
polyunsaturated fat, because the levels are inflated by the presence of
n-6 polyunsaturated fatty acids and ALA. The comments said that, while
85 percent of Americans are aware the n-3 polyunsaturated fatty acids
reduce the risk CHD, not all n-3 polyunsaturated fatty acids are equal.
    Other comments said that, while manufacturers may express the
content of EPA and DHA in a product bearing a claim, doing so outside
the Nutrition Facts label denies the consumer an opportunity to
recognize if a meaningful amount of these fatty acids are provided
relative to the other fats in the product.
    (Response) We recognize that the 2014 IFIC survey concluded that 21
percent of consumers are trying to increase their consumption of omega-
3 fats. We also recognize that the majority of polyunsaturated fats in
foods are in the form of n-6 polyunsaturated fatty acids and that not
all n-3 polyunsaturated fatty acids have the same effect on CHD risk.
However, because of the lack of well-established evidence for a role of
n-3 or n-6 polyunsaturated fatty acids in chronic disease risk and the
lack of a quantitative intake recommendation, the declarations of n-3
and n-6 polyunsaturated fatty acids are not necessary to assist
consumers to maintain healthy dietary practices. Because neither of
these factors for voluntary declaration for these types of nutrients
has been met, and the comments provided no scientific basis on which we
could rely to support the declaration, we disagree that meaningful
amounts of EPA and DHA should be voluntarily listed to provide its
amount relative to the other fats in the product.
    (Comment 108) Some comments supporting the voluntary declaration of
n-3 polyunsaturated fatty acids stated that the recognition of only
polyunsaturated fat may have unintended consequences of consumers
failing to understand differences in biopotency of n-3 long-chain
polyunsaturated fatty acids compared to other polyunsaturated fatty
acids. According to the comments, not declaring n-3 polyunsaturated
fatty acids may confuse consumers who are not aware of differences
among individual polyunsaturated fatty acids with respect to their
ability to reduce heart disease risk.
    (Response) We disagree that potential differences in biopotency of
n-3 polyunsaturated fatty acids is a basis for voluntary declaration.
While there may be differences in biopotency with respect to CHD risk,
there is insufficient scientific evidence and information to warrant
voluntary declaration.
    With respect to possible consumer confusion and unintended
consequences, the comments did not describe the extent to which
consumers might be confused or what the unintended consequences might
be, so we do not have sufficient information to evaluate those aspects
of the comments.

G. Cholesterol

1. Mandatory Declaration
    Section 403(q)(1)(D) of the FD&C Act requires the declaration of
the amount of cholesterol on food labels, and cholesterol content must
be declared on the Nutrition Facts label in accordance with Sec.
101.9(c)(3). In the preamble to the proposed rule (79 FR 11879 at
11899), we explained that current dietary recommendations continue to
recognize the well-established relationship between consumption of
cholesterol and its effect on blood cholesterol levels, which are a
surrogate endpoint for CHD risk and that we were unaware of evidence
that would support a change to the requirement for mandatory
declaration of cholesterol on the Nutrition Facts label in Sec.
101.9(c)(3). Consequently, we did not propose any changes to the
requirement for mandatory declaration of cholesterol.
    Relying on information provided in the NHLBI Lifestyle Evidence
Review (Ref. 17), the 2015 DGAC Report concluded that cholesterol is
not a nutrient of public health concern (Ref. 19). The 2015-2020 DGA
noted that, while adequate evidence is not available for a quantitative
limit for dietary cholesterol specific to the Dietary Guidelines,
individuals should eat as little dietary cholesterol as possible while
consuming a healthy dietary pattern that includes eggs and shellfish
(Ref. 28).
    Much of the published evidence, as was analyzed and reported by the
IOM (Ref. 53), has demonstrated a positive association between
cholesterol intake and total cholesterol in the blood. The IOM
conducted a dose-response analysis of clinical trials to evaluate the
relationship between dietary cholesterol and blood total cholesterol
because most of the available evidence was on total cholesterol (Ref.
53). From this IOM analysis, it was concluded that, on average, an
increase of 100 mg/day of dietary cholesterol is predicted to result in
a 0.05 to 0.1 mmol/L increase in total serum cholesterol, of which
approximately 80 percent is in the LDL fraction. The IOM cited evidence
showing that the majority of the increase in serum total cholesterol
with increased dietary cholesterol was due to an increase in LDL
cholesterol (rather than HDL) concentration, therefore adversely
affecting the cholesterol profile. The IOM analysis was the basis for
the IOM concluding that cholesterol consumption should be as low as

possible while consuming a nutritionally adequate diet.
    Data from NHANES (2007-2010) show that, for all individuals over 1
year of age, 32 percent consume cholesterol in excess of the DRV of 300
mg. For men and women 19 years of age and older, 59 percent and 17
percent consume in excess of 300 mg/day of cholesterol, respectively.
These findings are indicative that a significant portion of the U.S.
population consumes amounts of cholesterol in excess of the DRV of 300
mg.
    We do not consider there to be new information that alters the
conclusions of the 2002 IOM report. Therefore, we conclude that the
declaration of cholesterol on the Nutrition Facts label can assist
consumers in maintaining healthy dietary practices and therefore should
remain mandatory.
    (Comment 109) One comment supporting mandatory declaration of
cholesterol noted that the 2002 IOM report (Ref. 53) showed a strong
positive relationship between cholesterol intake and increased LDL
cholesterol levels. The comment cited a meta-analysis of clinical
studies in which people consumed eggs or a cholesterol-free egg
substitute found that LDL cholesterol rose by 2 mg/dL for every 100 mg
of cholesterol consumed (Ref. 54).
    (Response) While the 2002 IOM report provided its own analysis that
evaluated the relationship between dietary cholesterol and cholesterol
levels, it specifically evaluated total cholesterol levels, rather than
LDL cholesterol levels. The IOM reported a positive association between
change in cholesterol intake and change in total cholesterol levels
which supports our position for mandatory listing. We recognize that
the meta-analysis cited in the comment (Weggemans et al. 2001 (Ref.
54)) estimated that each additional 100 mg of dietary cholesterol would
increase serum LDL cholesterol by 0.036 (1.4 mg/dL) in the studies with
a background diet low in saturated fat and by 0.061 (2.4 mg/dL) in the
studies with a background high in saturated fat (P = 0.03). However,
this study only evaluated the effect of cholesterol from eggs rather
than total dietary cholesterol. Thus, this meta-analysis, by itself, is
insufficient to evaluate the effect of total cholesterol intake on
blood cholesterol levels, and therefore CVD risk.
    (Comment 110) Some comments opposed mandatory declaration of
cholesterol because, the comments said, saturated fat has the biggest
negative impact on blood cholesterol. The comments said that the EFSA
concluded that, ``Although there is a positive-dose-dependent
relationship between the intake of dietary cholesterol with blood LDL
cholesterol concentrations, the main dietary determinant of blood LDL
cholesterol concentrations is saturated fat.'' Other comments said
there is not enough evidence on the effect of dietary cholesterol on
blood cholesterol, the relationship between cholesterol consumption and
blood cholesterol levels is weak and has been overestimated, and
cholesterol intake does not raise blood cholesterol levels. Some
comments cited several meta-analyses that concluded that there were
small, modest reductions in serum cholesterol with reductions (e.g.,