
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Proposed Rules]
[Pages 45753-45756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. FDA-2012-N-1210 and FDA-2004-N-0258]
RIN 0910-ZA49


Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at 
One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and 
Establishing Certain Reference Amounts Customarily Consumed; Serving 
Size for Breath Mints; and Technical Amendments; Proposed Extension of 
Compliance Dates

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
extend the compliance dates by approximately 1.5 years for the final 
rules providing updated nutrition information on the label of food, 
including dietary supplements; defining a single-serving container; 
requiring dual-column labeling for certain containers; updating, 
modifying, and establishing certain reference amounts customarily 
consumed (RACCs); and amending the label serving size for breath mints. 
The final rules appeared in the Federal Register of May 27, 2016. We 
are taking this action because, after careful consideration, we have 
tentatively determined that additional time would help ensure that all 
manufacturers covered by the final rules have guidance from FDA to 
address, for example, certain technical questions we received after 
publication of the final rules, and that they are able to complete and 
print updated Nutrition Facts labels for their products before they are 
expected to be in compliance with the final rules.

DATES: Submit either electronic or written comments on the proposed 
rule by November 1, 2017.

ADDRESSES: You may submit comments on the extension of the compliance 
period as follows. Please note that late, untimely filed comments will 
not be considered. Electronic comments must be submitted on or before 
November 1, 2017. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
November 1, 2017. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2012-N-1210 and FDA-2004-N-0258 for ``Food Labeling: Revision of 
the Nutrition and Supplement Facts Labels and Serving Sizes of Foods 
That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column 
Labeling; Updating, Modifying, and Establishing Certain Reference 
Amounts Customarily Consumed; Serving Size for Breath Mints; and 
Technical Amendments; Extension of Compliance Date.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula Trumbo, Center for Food Safety 
and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 
Campus

[[Page 45754]]

Dr., College Park, MD 20740, 240-402-2579.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
II. Description of the Proposed Rule
III. Proposed Compliance Dates
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. References

I. Background

    In the Federal Register of May 27, 2016 (81 FR 33742 and 81 FR 
34000), we published two final rules entitled ``Food Labeling: Revision 
of the Nutrition and Supplement Facts Labels'' (the Nutrition Facts 
Label Final Rule) and ``Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; 
Updating, Modifying, and Establishing Certain Reference Amounts 
Customarily Consumed; Serving Size for Breath Mints; and Technical 
Amendments'' (the Serving Size Final Rule). The Nutrition Facts Label 
Final Rule revises the Nutrition Facts label by:
     Removing the declaration of ``Calories from fat'' because 
current science supports a view that the type of fat is more relevant 
than overall total fat intake in increased risk of chronic diseases;
     Requiring the declaration of the gram amount of ``Added 
Sugars'' in a serving of a product, establishing a Daily Reference 
Value (DRV), and requiring the percent Daily Value (DV) declaration for 
added sugars;
     Changing ``Sugars'' to ``Total Sugars'' and requiring that 
``Includes `X' g Added Sugars'' be indented and declared directly below 
``Total Sugars'' on the label;
     Updating the list of vitamins and minerals of public 
health significance. For example, the Nutrition Facts Label Final Rule 
requires the declaration of vitamin D and potassium and permits, rather 
than requires, the declaration of vitamins A and C;
     Updating certain reference values used in the declaration 
of percent DVs of nutrients on the Nutrition Facts and Supplement Facts 
labels;
     Revising the format of the Nutrition Facts and Supplement 
Facts labels to increase the prominence of the term ``Calories;''
     Removing the requirement for the footnote table listing 
the reference values for certain nutrients for 2,000 and 2,500 calorie 
diets; and
     Requiring the maintenance of records to support the 
declarations of certain nutrients under specified circumstances.
    The Serving Size Final Rule requires all containers, including 
containers of products with ``large'' RACCs (i.e., products with RACCs 
of at least 100 grams (g) or 100 milliliters (mL)), containing less 
than 200 percent of the RACC to be labeled as a single-serving 
container. Except for when certain exceptions apply, the Serving Size 
Final Rule further requires that containers and units that contain at 
least 200 percent and up to and including 300 percent of the RACC be 
labeled with a column of nutrition information within the Nutrition 
Facts label that lists the quantitative amounts and percent DVs for the 
entire container, in addition to the required column listing the 
quantitative amounts and percent DVs for a serving that is less than 
the entire container (i.e., the serving size derived from the RACC). 
The Serving Size Final Rule also updates, modifies, and establishes 
RACCs for certain foods and product categories.

II. Description of the Proposed Rule

    We are proposing to extend the compliance date for manufacturers 
with $10 million or more in annual food sales in the final rules 
published on May 27, 2016, from July 26, 2018, to January 1, 2020, and 
the compliance date for manufacturers with less than $10 million in 
annual food sales in the final rules published on May 27, 2016, from 
July 26, 2019, to January 1, 2021.
    We emphasize that this proposed rule would only extend the 
compliance dates. Therefore, comments to this proposed rule should 
pertain to the extension of the compliance dates only. We are proposing 
to extend the compliance dates for the Nutrition Facts Label Final Rule 
and the Serving Size Final Rule, consistent with our authority in 
sections 403(q) and 701(a) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 343(q) and 371(a), respectively).

III. Proposed Compliance Dates

    This proposed rule would extend the compliance date for 
manufacturers with $10 million or more in annual food sales in the 
final rules published on May 27, 2016, from July 26, 2018, to January 
1, 2020, and the compliance date for manufacturers with less than $10 
million in annual food sales in the final rules published on May 27, 
2016, from July 26, 2019, to January 1, 2021. We are taking this action 
because, after careful consideration, we have tentatively determined 
that additional time would help ensure that all manufacturers covered 
by the rules have guidance from FDA to address, for example, certain 
technical questions we received after publication of the final rules 
(see Docket No. FDA-2016-D-4414 (pertaining to a draft guidance 
entitled ``Questions and Answers on the Nutrition and Supplement Facts 
Labels Related to the Compliance Date, Added Sugars, and Declaration of 
Quantitative Amounts of Vitamins and Minerals: Guidance for 
Industry'')), and that they are able to complete and print updated 
Nutrition Facts labels for their products before they are expected to 
be in compliance with the rules. Companies and trade associations with 
members covered by the rules have informed us that they have 
significant concerns about their ability to update all their labels by 
the compliance dates due to issues regarding (among other things) the 
need for upgrades to labeling software, the need to obtain nutrition 
information from suppliers, the number of products that would need new 
labels, and a limited time for reformulation of products. Consequently, 
we are proposing to extend the compliance dates to provide more time to 
comply with the Nutrition Facts Label and the Serving Size Final Rules. 
We propose extending the compliance date by approximately 1.5 years for 
both categories of manufacturers as a means to balance the importance 
of ensuring that industry has sufficient time to comply with complex 
new requirements, and the importance of decreasing costs, against the 
importance of minimizing the transition period during which consumers 
will see both the old and the new versions of the label in the 
marketplace.
    We are taking this action consistent with Executive Orders 13771 
and 13563 and in response to the continued concern that companies and 
trade associations have shared with us regarding the time needed for 
implementation of the final rules and the need for FDA to provide 
further guidance to manufacturers subject to the final rules. 
Consistent with the policies set forth in these executive orders with 
respect to reducing burdens, reducing costs, maintaining flexibility, 
and improving effectiveness, we are therefore proposing to extend the 
compliance date for manufacturers with $10 million or more in annual 
food sales to January 1, 2020, and the compliance date for 
manufacturers with less than $10 million in annual food sales to 
January 1, 2021.
    Our goal is to complete this rulemaking as quickly as possible. 
However, we are aware that firms are working under the current 
compliance dates to come into compliance. Pending

[[Page 45755]]

completion of this rulemaking, we intend to exercise enforcement 
discretion with respect to the current July 26, 2018, and July 26, 
2019, compliance dates.

IV. Economic Analysis of Impacts

    We have examined the impacts of this proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this proposed rule is a significant regulatory action as 
defined by Executive Order 12866.
    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017. Section 
2(a) of Executive Order 13771 requires an Agency, unless prohibited by 
law, to identify at least two existing regulations to be repealed when 
the Agency publicly proposes for notice and comment or otherwise 
promulgates a new regulation. In furtherance of this requirement, 
section 2(c) of Executive Order 13771 requires that the new incremental 
costs associated with new regulations shall, to the extent permitted by 
law, be offset by the elimination of existing costs associated with at 
least two prior regulations. This proposed rule is expected to be an 
Executive Order 13771 deregulatory action. Details on the estimated 
cost savings of this proposed rule can be found in the rule's economic 
analysis.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities when ``the agency publishes a general notice of proposed 
rulemaking'' (5 U.S.C. 601(2)). We have analyzed the proposed rule 
under the Regulatory Flexibility Act and propose to certify that, 
because the proposed rule only would extend the compliance dates for 
the Nutrition Facts Label and Serving Size Final Rules, the proposed 
rule would not have a significant economic impact on a substantial 
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $148 million, using the 2016 Implicit Price Deflator 
for the Gross Domestic Product. We have determined that the proposed 
rule would not result in any expenditure by industry in any year that 
meets or exceeds this amount.
    The principal benefit of this proposed rule to extend the 
compliance dates is the reduction in the costs to industry of meeting 
the compliance dates of the Nutrition Facts Label Final Rule and the 
Serving Size Final Rule. This reduction in costs can be attributed to a 
reduction in the relabeling and reformulation costs of the Nutrition 
Facts Label and Serving Size Final Rules. We estimate that, at the 
mean, the present value of the benefits (i.e., cost savings) of this 
proposed rule to extend the compliance dates over the next 20 years is 
$1.0 billion using either a 3 percent or 7 percent discount rate 
(2016$). This is illustrated in table 1. Extending the compliance dates 
by approximately 1.5 years would reduce the estimated benefits of the 
Nutrition Facts Label and Serving Size Final Rules because it would 
delay the realization by consumers of the full annual welfare gains of 
the Nutrition Facts Label and Serving Size Final Rules. More 
specifically, an extension of the compliance dates would delay the 
incorporation of the provisions of the Nutrition Facts Label and 
Serving Size Final Rules by food manufacturers into their products. We 
estimate that, at the mean, the present value of the forgone benefits 
of this proposed rule to extend the compliance dates over the next 20 
years is $0.9 billion using either a 3 percent or 7 percent discount 
rate (2016$). This is also presented in table 1. We estimate that, at 
the mean, the present value of the net benefits (that is, cost savings 
minus forgone benefits) of this proposed rule to extend the compliance 
dates over the next 20 years is $0.1 billion using either a 3 percent 
or 7 percent discount rate (2016$). This is shown in table 1.

  Table 1--Summary of the Cost Savings to Industry and Foregone Benefits to Consumers of This Proposed Rule To
                                           Extend the Compliance Dates
                                              [In billions of 2016]
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                                                                                                   Net benefits
                                                   Discount rate                     Foregone     (cost savings-
                                                     (percent)     Cost savings      benefits        foregone
                                                                                                     benefits)
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Present Value...................................               3            $1.0            $0.9            $0.1
                                                               7             1.0             0.9             0.1
Annualized Amount...............................               3            0.07            0.06            0.01
                                                               7            0.09            0.08            0.01
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Notes: Cost savings to industry, foregone benefits to consumers, and net benefits reflect mean estimates. This
  proposed rule to extend the compliance dates would extend the compliance dates of the Nutrition Facts Label
  and Serving Size Final Rules by approximately 1.5 years. Annualized Amount = Amount/Annualizing Factor. 3
  percent annualizing factor = 14.88. 7 percent annualizing factor = 10.59. The annualizing factors are
  calculated by summing the inverse of 1 plus the discount rate to the power of the year (t = 1 through t = 20).

    For purposes of this analysis, we use the same methodology for 
estimating costs and benefits that we used in the original Regulatory 
Impact Analysis for the Final Rules. We previously acknowledged 
potential shortcomings with that approach (see 2016 Regulatory Impact 
Analysis at 79 n.34) but have not received comments about ways to

[[Page 45756]]

improve that analysis. We thus follow the same basic approach here.
    The full analysis of economic impacts is available in the docket 
for this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains no collection of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires Agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Section 403A of the FD&C Act (21 U.S.C. 343-1) 
is an express preemption provision. Section 403A(a) of the FD&C Act 
provides that: ``* * * no State or political subdivision of a State may 
directly or indirectly establish under any authority or continue in 
effect as to any food in interstate commerce--(4) any requirement for 
nutrition labeling of food that is not identical to the requirement of 
section 403(q) * * *.'' The express preemption provision of section 
403A(a) of the FD&C Act does not preempt any State or local requirement 
respecting a statement in the labeling of food that provides for a 
warning concerning the safety of the food or component of the food 
(section 6(c)(2) of the Nutrition Labeling and Education Act of 1990, 
Pub. L. 101-535, 104 Stat. 2353, 2364 (1990)). If this proposed rule is 
made final, the final rule would create requirements that fall within 
the scope of section 403A(a) of the FD&C Act.

VIII. References

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. United States Department of Health and Human Services. United 
States Food and Drug Administration. Preliminary Regulatory Impact 
Analysis, Preliminary Regulatory Flexibility Analysis for Proposed 
Rule on ``Food Labeling: Revision of the Nutrition and Supplement 
Facts Labels and Serving Sizes of Foods That Can Reasonably Be 
Consumed At One Eating Occasion; Dual-Column Labeling; Updating, 
Modifying, and Establishing Certain Reference Amounts Customarily 
Consumed; Serving Size for Breath Mints; and Technical Amendments; 
Extension of Compliance Dates.'' September 2017. Available from 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

    Dated: September 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21019 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P


