[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Rules and Regulations]
[Pages 19619-19626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09476]


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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-AH92


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending 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 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 have sufficient time to complete and print updated 
Nutrition Facts labels for their products before they are expected to 
be in compliance with the final rules.

DATES: This rule is effective July 3, 2018. For the applicable 
compliance date(s), please see ``Effective/Compliance Date(s)'' in 
Supplementary Information.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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 Dr., College Park, MD 20740, 240-402-2579.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Final Rule
    C. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. Overview of the Final Rule
III. Comments on the Proposed Rule and FDA Response
    A. Comments Supporting or Opposing the Extension of Compliance 
Dates
    B. Comments Outside the Scope of the Proposed Rule
IV. Effective/Compliance Date(s)
V. Economic Analysis of Impacts
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. References

I. Executive Summary

A. Purpose of the Final Rule

    The final rule extends the compliance dates for two rules. 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). In those final rules the 
compliance date for manufacturers with $10 million or more in annual 
food sales was established as July 26, 2018; for manufacturers with 
less than $10 million in annual food sales, the compliance date was set 
as July 26, 2019.
    This final rule extends the compliance date for manufacturers with 
$10 million or more in annual food sales from July 26, 2018, to January 
1, 2020; for manufacturers with less than $10 million in annual food 
sales, the final rule extends the compliance date from July 26, 2019, 
to January 1, 2021.

B. Summary of the Final Rule

    The final rule extends the compliance date for manufacturers with 
$10 million or more in annual food sales from July 26, 2018, to January 
1, 2020; for manufacturers with less than $10 million in annual food 
sales, the final rule extends the compliance date from July 26, 2019, 
to January 1, 2021. We are extending the compliance dates for the 
Nutrition Facts Label Final Rule and the Serving Size Final Rule, which 
were issued consistent with our authority in sections 403(q), 
403(a)(1), 201(n), and 701(a) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 343(q), 343(a)(1), 321(n), and 371(a), 
respectively) and section 2(b)(1) of the Nutrition Labeling and 
Education Act (NLEA) (Pub. L. 101-535).

C. Costs and Benefits

    The impact of this final rule is summarized in the following table.

[[Page 19620]]



Table 1--Summary of the Cost Savings to Industry and Foregone Benefits to Consumers of This Final Rule To Extend
                                              the Compliance Dates
                                             [In billions of 2016$]
----------------------------------------------------------------------------------------------------------------
                                                                                                   Net benefits
                                                                                                  (cost savings--
                                                  Discount  rate   Cost  savings     Foregone         foregone
                                                                                     benefits        benefits)
 
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Notes: Cost savings to industry, foregone benefits to consumers, and net benefits reflect mean estimates. This
  final rule extends 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).

II. Background

A. Need for the Regulation/History of This Rulemaking

    In the Federal Register of May 27, 2016 (81 FR 33742 and 81 FR 
34000), we published the Nutrition Facts Label Final Rule and 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 label to 
increase the prominence of both the term ``Calories'' and the calories 
information;
     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 or unit, as applicable, in addition to the required 
column listing the quantitative amounts and percent DVs for a serving 
that is less than the entire container or unit, as applicable (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.
    The Final Rules established compliance dates for manufacturers with 
$10 million or more in annual food sales of July 26, 2018, and for 
manufacturers with less than $10 million in annual food sales, of July 
26, 2019.
    After we published the Nutrition Facts Label and the Serving Size 
Final Rules, companies and trade associations with members covered by 
the rules informed us that they had 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, in the Federal Register of 
October 2, 2017 (82 FR 45753), we proposed to extend the compliance 
dates to provide more time to comply with the Nutrition Facts Label and 
the Serving Size Final Rules. We proposed extending the compliance 
dates 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 the 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.

B. Summary of Comments to the Proposed Rule

    The proposed rule provided a 30-day comment period. We received 
approximately 50,000 comments. The comments came from individual 
consumers, consumer groups, industry, trade associations, academia, 
health professionals, and state/local government Agencies. Some 
comments sought an even longer extension of the compliance dates or 
said a compliance date should be aligned with the United States 
Department of Agriculture's (USDA) work to implement the National 
Bioengineered Food Disclosure Law. Comments opposing an extension 
(including those from state or local government Agencies) focused, in 
large part, on the Nutrition Facts label's role in helping consumers 
maintain a healthy lifestyle, possible consumer confusion if two 
versions of the Nutrition Facts label exist in the market, and a belief 
that firms had adequate time to comply. Comments supporting an 
extension of the compliance dates stressed that companies need 
additional time to update their labels. For example, some comments 
stressed that the process for relabeling may involve coordination 
between a variety of parties to test and analyze products, enter 
ingredient information into databases, develop new labels, and print

[[Page 19621]]

new labels. According to these comments, having more time to comply 
with the Nutrition Facts Label and the Serving Size Final Rules will 
help ensure the accuracy of the labels and will allow for consistent 
application and fuller compliance across industry.

C. Overview of the Final Rule

    The final rule extends the compliance date for the Nutrition Facts 
Label Final Rule and the Serving Size Final Rule for manufacturers with 
$10 million or more in annual food sales from July 26, 2018, to January 
1, 2020; for manufacturers with less than $10 million in annual food 
sales, the final rule extends the compliance date from July 26, 2019, 
to January 1, 2021. The Nutrition Facts Label Final Rule and Serving 
Size Final Rule were issued consistent with our authority in sections 
403(q), 403(a)(1), 201(n), and 701(a) of the FD&C Act and section 
2(b)(1) of the NLEA.

III. Comments on the Proposed Rule and FDA Response

    We have numbered each comment to help distinguish among different 
comments. We have grouped similar comments together under the same 
number, and in some cases, we have separated different issues discussed 
in the same comment and designated them as distinct comments for 
purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received.

A. Comments Supporting or Opposing the Extension of Compliance Dates

    (Comment 1) Many comments expressed concern that extending the 
compliance dates will delay the health and dietary benefits of the 
final rules because, for the period of the extension, the public would 
be precluded from making informed food choices based on the updated 
scientific information. Some comments expressed concern about the 
impact of the delay on people with certain medical conditions (such as 
cancer, diabetes, heart disease, high blood pressure, and obesity), 
stating that such people might be better able to follow medical advice 
using the new labels. The comments further stated that the extension 
means that until the new compliance dates consumers will not be able to 
follow advice in the 2015-2020 Dietary Guidelines for Americans and 
advice from other public health authorities on issues not reflected in 
the current Nutrition Facts label, such as limiting added sugar. Some 
comments asserted that consumers have a ``right to know'' what is in 
the product. Some comments also noted that the new labels are easier to 
understand and use for comparing products and making healthier choices.
    (Response) Both the old and new versions of the Nutrition Facts 
label provide information that must be truthful and accurate. While we 
agree that extending the compliance dates will mean that certain 
information required on the new Nutrition Facts label under the 
Nutrition Facts and Serving Size Final Rules will not be available to 
consumers on all foods as soon as originally anticipated, consumers can 
still use the old Nutrition Facts label to help guide them in their 
food choices in the interim. Consumers with medical conditions should 
continue to follow the advice they receive from a health care 
professional concerning their conditions.
    Although we are extending the compliance dates, this extension does 
not prevent companies from revising their labels before the new 
compliance dates. In fact, according to food labeling data from Label 
Insight, over 29,000 products have adopted the new Nutrition Facts 
label (Ref. 2).
    (Comment 2) Some comments stated that having both the old and new 
versions of the Nutrition Facts labels in the marketplace will confuse 
consumers and hinder their ability to compare products. The comments 
stated that extending the compliance dates will increase the transition 
period from old to new versions of the Nutrition Facts label.
    Some comments asserted that providing nutrition education is 
difficult when two versions of the Nutrition Facts label are in the 
marketplace. The comments also noted that the existence of old versions 
of the Nutrition Facts label on food packages delays the ability to 
teach people to make informed choices about their health.
    A comment supporting an extension of the compliance dates asserted 
that, from a foreign food manufacturer's perspective, the extension of 
the compliance dates is greatly appreciated because foreign 
manufacturers tend to have longer revision cycles for food packaging 
destined for the United States; the comment said that a longer 
transitional period will allow foreign firms to take more time in 
``picking the right look'' for their U.S. products.
    A comment supporting the extension of the compliance dates stated 
that, during the transition, FDA should work to ensure that consumers 
are aware of and educated about the importance of the changes. Some 
comments noted that the extension will allow FDA and stakeholders more 
time to prepare consumer education efforts and to raise awareness.
    (Response) We recognize that there will be a longer transition 
period when the two Nutrition Facts labels are in the marketplace. We 
also note that both labels must provide information that is truthful 
and accurate. To help consumers during the transition, we will be 
providing educational materials to help consumers understand 
information on the labels. Many nutrition education messages will 
remain similar for both labels (e.g., awareness of calories, serving 
size information, and using the daily values); for the new information 
for consumers (e.g., added sugars, potassium, vitamin D, and dual-
column labeling) we will be updating education material, especially as 
the new label is becoming more common in the marketplace. We are 
working with other Federal government Agencies (including other 
Agencies within the Department of Health and Human Services), health 
professional organizations, food manufacturers, retailers, and non-
profit organizations with an interest and focus on nutrition education 
and health promotion to develop and disseminate our educational 
materials on the new Nutrition Facts label.
    Furthermore, we are continuing a variety of activities, such as 
conducting and reporting on food labeling research. We plan to continue 
to build partnerships to develop, disseminate, and evaluate labeling 
education efforts that target specific groups, including low literacy 
consumers and sub-populations at high risk of nutrition-related chronic 
disease, in addition to the general public.
    (Comment 3) Several comments stated that companies have had 
sufficient time and resources to comply with the original compliance 
dates and that compliance by some companies shows that the original 
compliance dates can be met. The comments also pointed out that 
companies regularly change their packaging. The comments urged us not 
to be persuaded by industry to delay the compliance dates, stated that 
we provided no evidence to support industry's claims for the need for 
additional time, and expressed concerns that companies will use the 
delay to challenge the final rules. Another comment claimed that large 
companies are capable of developing new labels, but seek to extend the 
compliance date so that they can reformulate their products to remove 
or change ingredients or information before they

[[Page 19622]]

have to declare those ingredients or information in a new Nutrition 
Facts label. Some comments also questioned whether extending the 
compliance dates would be fair to firms that have revised their 
Nutrition Facts labels already. One comment said that businesses that 
take advantage of an extended compliance date may have an unfair market 
advantage because of consumer familiarity with the old label, while 
another comment asserted that businesses that delay compliance with the 
new requirements might gain an advantage from consumers that may select 
a food based on the old label that they might not select based on the 
new label. Another comment stated that we should not extend the 
compliance dates and instead suggested rewarding companies that revised 
their Nutrition Facts labels in the original timeframe and penalizing 
companies that failed to revise their labels within a specific time 
period.
    Many other comments supported the extension of the compliance 
dates. Some comments supporting an extension of the compliance dates 
stated that companies need additional time to update their labels. For 
example, some comments stated that some products may need to be 
reformulated and the process for relabeling may involve coordination 
between a variety of parties to test and analyze products, enter 
ingredient information into databases, develop new labels, and print 
new labels. Additionally, some comments stated that printing companies 
complete the orders of larger companies or packing orders before 
completing the orders of small and mid-size companies, that the range 
of label changes necessitates additional time, and that products with 
more ingredients take longer to relabel. According to the comments, 
having more time will help ensure the accuracy of the labels and will 
allow for consistent application and fuller compliance across industry. 
Furthermore, some comments noted that additional time for compliance 
once FDA makes decisions regarding the citizen petitions for dietary 
fiber would help ensure that consumers have access to products that 
help to meet their dietary fiber needs.
    One comment suggested that we pause the compliance dates pending 
publication of the guidance documents or consider granting an 
additional extension in the future based on finalization of the 
guidance documents and future stakeholder concerns. Other comments 
suggested that we exercise enforcement discretion in cases where 
awaiting the guidance prevents companies from timely compliance with 
the original compliance dates. Some comments suggested that we base the 
dates on publication of the guidance documents, allowing firms 
additional time to implement the changes.
    (Response) We have carefully considered the comments supporting and 
opposing an extension of the compliance dates, and we are extending the 
compliance dates to allow manufacturers additional time to comply with 
the final rules. We are aware that a number of manufacturers are 
already using labels consistent with the new requirements; however, we 
also are aware that other manufacturers have explained why the original 
compliance dates would not be feasible. We note that manufacturers will 
need to change different parts of their labels depending on the 
products they make.
    The comments stating that an extension of the compliance dates is 
not warranted because some members of industry have already adopted the 
new labels did not explain why the fact that some manufacturers have 
had sufficient time to adopt the new labels means that all members of 
industry have had sufficient time to adopt the new labels. Based on the 
information available to FDA and the information provided by industry 
commenters, we understand that manufacturers' ability to meet the 
original compliance date is affected by many factors and that not all 
manufacturers are able to meet the original date.
    Extending the compliance dates by approximately 1.5 years is guided 
by the desire to give industry more time, balanced against minimizing 
the transition period during which consumers will see both the old and 
the new versions of the label in the marketplace. The compliance date 
is the date by which we expect firms to be in compliance with a 
specific regulatory requirement. It would be prudent for companies to 
take actions (such as working with suppliers to make sure they have the 
information they need to update their labels, redesigning labels, and 
printing new labels, if necessary) to meet their regulatory obligations 
when the compliance date is reached.
    With respect to comments that suggested factoring in when FDA 
issues guidance documents, we note that, in the Federal Register of 
March 2, 2018, we announced the availability of final guidance 
documents for industry entitled ``Reference Amounts Customarily 
Consumed: List of Products for Each Product Category'' and ``Scientific 
Evaluation of the Evidence on the Beneficial Physiological Effects of 
Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a 
Citizen Petition (21 CFR 10.30).'' We issued these guidance documents 
to address questions we received after we issued the final rules in 
order to address such questions and help firms with their decisions 
about how to comply with a particular requirement or what information 
to submit to FDA in a citizen petition to request a non-digestible 
carbohydrate be included in the definition of ``dietary fiber.''
    With regard to the unfair market advantage issue raised in the 
comments, we have no data or information to show whether companies that 
have revised their Nutrition Facts labels already have an unfair market 
advantage or, conversely, are disadvantaged compared to companies that 
have not revised their Nutrition Facts labels yet. Therefore, we 
decline to speculate on whether an unfair market advantage exists and 
for the reason the comment asserted.
    Finally, with regard to rewarding companies that revised their 
Nutrition Facts labels in the original timeframe and penalizing 
companies that failed to revise their labels within a specific time 
period, the comment provided no recommendation for how such a reward or 
penalty system could work or how such system would be implemented 
consistent with our existing authorities.
    (Comment 4) Several comments would have us align the compliance 
dates with the National Bioengineered Food Disclosure Standard (which 
is administered by USDA). Other comments supported a coordinated, 
uniform label compliance dates across agencies because, according to 
the comments, USDA's Food Safety and Inspection Service also has 
Nutrition Facts label requirements for meat and poultry. In addition, 
other comments urged us to finalize other pending labeling changes 
(such as vending machine labeling, ``natural'' labeling, revising the 
definition of ``healthy,'' and ``gluten-free'' for fermented or 
hydrolyzed food products) before the extended compliance dates.
    (Response) FDA and USDA collaborate to align compliance dates of 
regulations that require changes in food labeling. FDA is working to 
address, as appropriate and as time and resources permit, other 
regulatory issues that are outside the scope of this rulemaking in 
separate rulemaking actions. However, we do not agree that we need to 
ensure the alignment of compliance dates for other regulatory 
initiatives with those for the Nutrition Facts Label and Serving Size 
Final Rules.
    (Comment 5) Several comments suggested alternatives to basing the 
compliance dates on the amount of annual sales. One comment suggested

[[Page 19623]]

having just one extended compliance date to show impartiality and hold 
all businesses to the same standards, and some comments suggested other 
timeframes for the compliance dates. One comment would allow extensions 
on a case-by-case basis rather than a blanket extension. One comment 
suggested basing the date on the number of products sold as companies 
with more products may need more time to relabel, regardless of their 
total sales, than companies with fewer products. One comment would 
support extending the compliance date for small manufacturers only; the 
comment said that larger manufacturers (with over $10 million in annual 
food sales) do not need an extension because they have greater access 
to scientific information about their products as well as nutritional 
information compared to smaller companies. One comment suggested 
limiting the extension to honey products and products that contain 
fiber and not extending the compliance dates for all other products 
because, the comment stated, issues pertaining to added sugars in honey 
and the definition of fiber must be resolved before we establish 
compliance dates for honey products and products that contain fiber.
    Other comments suggested that we stagger the compliance dates based 
on the type of business. According to the comments, ingredient 
manufacturers would comply first with finished goods manufacturers 
complying at least 1 year later. The comments indicated that providers 
of nutrition analysis and manufacturers of finished products need the 
information from ingredient manufacturers to relabel their products. 
One comment said extending the compliance dates may cause suppliers to 
delay revising their Nutrition Facts label, which would prohibit a 
company from keeping its existing timeline for label updates and could 
require the company to invest in off-cycle printing fees of old 
nutrition labels, leading to higher costs and compromising the ability 
to provide complete nutrition information on customer facing labels.
    (Response) In the Nutrition Facts Label and Serving Size proposed 
rules (79 FR 11879 and 79 FR 11989; March 3, 2014), we originally 
proposed one compliance date of 2 years after the effective date, 
regardless of annual amount of sales. However, comments to the proposed 
rule for the Nutrition Facts Label suggested that small businesses may 
need more time or may face different challenges, compared to large 
businesses, in complying with the final rules. Because the comments 
emphasized the rules' potential impact on small businesses, we agreed 
that the impacts to smaller businesses may be more substantial than 
those on larger businesses, and so we provided a 3-year compliance date 
for manufacturers with less than $10 million in annual food sales. 
Thus, in the final Nutrition Facts label and Serving Size rules, the 
compliance date for manufacturers with $10 million or more in annual 
food sales was set at July 26, 2018; the compliance date for 
manufacturers with less than $10 million in annual food sales was set 
at July 26, 2019.
    Regarding the comments suggesting alternative timeframes for 
compliance and comments suggesting alternative approaches to extended 
compliance dates (such as basing the dates on the number of products 
sold or having ingredient suppliers comply before other entities), the 
comments did not provide information that would enable us, as part of 
this rulemaking, to revise or alter our approach. For example, the 
comments did not explain what total number of products sold would be 
used as a basis for setting compliance dates.
    With respect to ingredient suppliers, we note that bulk ingredient 
suppliers are not required to comply with the Nutrition Facts label 
requirements unless, among other requirements, the bulk ingredients are 
going directly to the consumer (see 21 CFR 101.9(j)(9)). Furthermore, 
as stated in our responses to comments 1 and 3, an extension of the 
compliance dates does not prevent manufacturers from revising their 
Nutrition Facts labels before the extended compliance dates.
    Based on the comments received regarding the processes involved in 
obtaining nutrient information from suppliers and timing involved for 
various size businesses to gain access to equipment for developing and 
printing new labels, we consider the extended compliance dates in this 
final rule to provide adequate time for the coordination between 
suppliers, manufacturers, and labelers to ensure that new labels are 
ready and in use by the compliance dates.
    (Comment 6) Some comments opposing the extension of the compliance 
dates asserted that the need for guidance is not a reason to delay the 
compliance dates because guidance documents are only recommendations 
and not enforceable. In contrast, comments supporting an extension of 
the compliance dates said that companies need guidance from FDA to 
address technical questions on issues such as dietary fiber, added 
sugars, serving sizes, small package labeling, and allulose before they 
can relabel and reformulate certain products. Some comments asserted 
that if food companies and manufacturers are given time to comply with 
the rules after they receive guidance from FDA, they would not need to 
make additional label changes. Other comments urged us to issue 
guidance documents as soon as possible, and some comments asserted that 
we need to publish the final guidance documents on dietary fiber and 
added sugars before we finalize a rule regarding the compliance dates.
    (Response) After careful consideration, we have determined that 
extending the compliance dates by approximately 1.5 years, until 
January 1, 2020, or January 1, 2021 (depending on annual sales), would 
help ensure that all manufacturers covered by the final rules have time 
to use guidance from FDA to address, for example, certain technical 
questions we received after publication of the final rules. To the 
extent we issue a guidance document on a specific topic in advance of 
the applicable compliance date, we intend to issue such guidance 
document in draft form with an opportunity for public comment and, 
where appropriate, to finalize the guidance before those parties are 
expected to comply with the final rules. Additional time will also help 
to ensure that manufacturers have time to coordinate with various 
parties to complete and print updated Nutrition Facts labels for their 
products before they are expected to be in compliance with the final 
rules.
    With regard to the comments about the enforceability of guidance, 
we agree that our guidance documents do not establish legally 
enforceable responsibilities. Instead, guidance documents describe our 
current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements 
are cited. Furthermore, as we stated in our response to comment 3, in 
the Federal Register of March 2, 2018, we announced the availability of 
final guidance documents for industry entitled ``Reference Amounts 
Customarily Consumed: List of Products for Each Product Category'' (83 
FR 9000) (Ref. 3) and ``Scientific Evaluation of the Evidence on the 
Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 
10.30)'' (83 FR 8997) (Ref. 4). In addition to the final guidance 
documents, in the Federal Register of January 5, 2017, we announced the 
availability of draft guidance to address issues related to added 
sugars entitled, ``Questions and Answers on the Nutrition and 
Supplement Facts Labels Related to the Compliance Date, Added

[[Page 19624]]

Sugars, and Declaration of Quantitative Amounts of Vitamins and 
Minerals. '' Further, in the Federal Register of March 2, 2018, we 
announced the availability of draft guidance entitled ``The Declaration 
of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products 
'' (83 FR 8953) (Ref. 5). We issued these guidance documents to address 
questions we received after we issued the final rules, and these 
guidance documents should address the questions and help firms with 
their decisions about how to comply with particular requirements such 
as serving sizes or the declaration of added sugars or what information 
to submit to FDA in a citizen petition to request a non-digestible 
carbohydrate be included in the definition of ``dietary fiber.''
    (Comment 7) One comment stated that giving large food manufacturers 
an additional 18 months to conform seems excessive. The comment noted 
that, to satisfy the requirement under 5 U.S.C. 553 (the section of the 
Administrative Procedure Act (APA) pertaining to rulemaking), the 
notice of proposed rulemaking should include all relevant studies and 
data used to make the rule. The comment requested additional 
information regarding the complexity of the burdens being placed on 
food manufacturers to support an extension of the compliance dates. The 
comment said that such information is necessary to satisfy the 
requirement under 5 U.S.C. 553 that the notice of proposed rulemaking 
include all relevant studies and data used to make the rule. The 
comment cited American Radio Relay League, Inc. v. Fed. Communications 
Comm. 524 F.3d 227 (D.C. Cir. 2007).
    Another comment expressed concern that the extension of the 
compliance dates may violate the APA. The comment said that the 
proposed rule did not ask for comments relating to breath mints and did 
not refer to what a reformulation of products would look like or why a 
reformulation is necessary.
    (Response) We believe that we have provided an adequate basis for 
the extension of the compliance dates. Thus, we disagree that the APA 
requires us to provide information, in addition to what we have already 
made available in the public docket for notice and comment, to support 
the extension of the compliance dates. In addition, the case the 
comment relies on concerns a situation where an agency engaged in 
rulemaking failed to make information on which it relied publicly 
available for notice and comment (American Radio Relay League, 524 F.3d 
at 237 through 239). The information on which we rely in this final 
rule to extend the compliance dates for the Nutrition Facts Label Final 
Rule and the Serving Size Final Rule, in contrast, was made publicly 
available for comment in the public docket for the proposed rule, which 
is the same docket as this final rule. We are not withholding 
information from the public docket on which we rely for our decision to 
extend the compliance dates.
    As discussed in the preamble to the proposed rule to extend the 
compliance dates for the Nutrition Facts Label and Serving Size Final 
Rules (82 FR 45753 at 45754), we are taking this action because, after 
careful consideration, we have 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. We also are taking this 
action so that manufacturers may complete all the necessary steps and 
print updated Nutrition Facts labels for their products before they are 
expected to be in compliance with the rules. Companies and trade 
associations have informed us that they have significant concerns about 
their ability to update all their labels by the original 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 (82 FR 45753 at 45754). 
Comments in response to the proposed rules reiterated the basis for the 
requests for additional time. Based on the information in the public 
docket, we have a sufficient basis on which to extend the compliance 
dates for the final rules.
    In addition, as discussed in the Preliminary Regulatory Impact 
Analysis referenced in the proposed rule to extend the compliance dates 
for the Nutrition Facts Label and Serving Size Final Rules (82 FR 
45753), we analyzed regulatory alternatives and considered two options 
for the time period of the extension of the compliance dates and 
presented the estimates for what the cost savings to industry would be. 
We concluded that extending the compliance date by approximately 1.5 
years for both categories of manufacturers is a means to balance the 
importance of ensuring that industry has sufficient time to comply with 
complex new requirements 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.
    With regard to the comment about breath mints and product 
reformulation, this comment is outside the scope of this rulemaking. 
The Serving Size Final Rule changed the label serving size for breath 
mints to ``1 unit.'' The amendments to the Nutrition Facts label 
regulations became effective on July 26, 2016. This rulemaking, as 
explained in the preamble to the proposed rule of October 2, 2017, 
pertains solely to the compliance dates for the Nutrition Facts Label 
and Serving Size Final Rules (82 FR 45753 at 45754).

B. Comments Outside of Scope of the Proposed Rule

    Some comments raised issues that were outside the scope of the 
proposed rule. In brief, we received comments asking about:
     Changing the label;
     Requiring schools to have education programs relating to 
the label;
     Requesting FDA to reopen the comment period on the 
Nutrition Facts Label and Serving Size Final Rules asserting a 3-year 
stay is needed to obtain additional empirical research data for 
substantiation of changes to the label made in the final rules; and
     Extending the compliance date for the front-of-package 
calorie labeling of items sold in vending machines to align with the 
proposed extension of the Nutrition Facts Label Final Rule.
    The final rule pertains solely to the compliance dates for the 
Nutrition Facts Label and Serving Size Final Rules. Therefore, the 
comments are outside the scope of this rulemaking.

IV. Effective/Compliance Date(s)

A. Effective Date

    The final rule is effective on July 3, 2018.

B. Compliance Date

    The compliance date for manufacturers with $10 million or more in 
annual food sales is January 1, 2020. The compliance date for 
manufacturers with less than $10 million in annual food sales is 
January 1, 2021.

V. Economic Analysis of Impacts

    We have examined the impacts of the final 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

[[Page 19625]]

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.'' This final rule is an 
economically 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 issues 
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 final rule is an Executive Order 13771 
deregulatory action. We estimate that this rule generates approximately 
$61 million in annualized cost savings, discounted relative to year 
2016 and using a 7 percent discount rate, over a perpetual time 
horizon. Details on the estimated cost savings of this final 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. We have analyzed this final rule under the Regulatory 
Flexibility Act and certify that, because this final rule only extends 
the compliance dates for the Nutrition Facts Label and Serving Size 
Final Rules, this final 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 issuing ``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 most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    The principal benefit of this final 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 
final rule to extend the compliance dates over the next 20 years is $1 
billion using either a 3 percent or 7 percent discount rate (2016$). 
This is illustrated in table 2. 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 foregone benefits 
of this final 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 2. We estimate that, at 
the mean, the present value of the net benefits (that is, cost savings 
minus foregone benefits) of this final 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 2.

Table 2--Summary of the Cost Savings to Industry and Foregone Benefits to Consumers of This Final Rule To Extend
                                              the Compliance Dates
                                             [In billions of 2016$]
----------------------------------------------------------------------------------------------------------------
                                                                                                   Net benefits
                                                                                                       (cost
                                                  Discount  rate   Cost  savings     Foregone        savings--
                                                                                     benefits        foregone
                                                                                                     benefits)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Notes: Cost savings to industry, foregone benefits to consumers, and net benefits reflect mean estimates. This
  final rule extends 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).

    The full analysis of economic impacts is available in the docket 
for this final rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VI. 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.

VII. Paperwork Reduction Act of 1995

    This final 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.

VIII. Federalism

    We have analyzed this final 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

[[Page 19626]]

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)). The final rule creates 
requirements that fall within the scope of section 403A(a) of the FD&C 
Act.

IX. References

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

1. FDA. Final Regulatory Impact Analysis, Regulatory Flexibility 
Analysis for Final 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.'' April 2018. 
Available from https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.
2. Sheahan, M. ``FDA Blog Post.'' Label Insight. April 5, 2018. 
Available at https://blog.labelinsight.com/growing-new-label-adoption-provides-transparency-for-consumers.
3. Food and Drug Administration, ``Reference Amounts Customarily 
Consumed: List of Products for Each Product Category; Guidance for 
Industry; Availability.'' 83 FR 9000 (March 2, 2018). Guidance 
available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm535368.htm.
4. Food and Drug Administration, ``Scientific Evaluation of the 
Evidence on the Beneficial Physiological Effects of Isolated or 
Synthetic Non-Digestible Carbohydrates Submitted as a Citizen 
Petition; Guidance for Industry; Availability. '' 83 FR 8997 (March 
2, 2018). Guidance available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm528532.htm.
5. Food and Drug Administration, ``The Declaration of Added Sugars 
on Honey, Maple Syrup, and Certain Cranberry Products; Draft 
Guidance for Industry; Availability.'' 83 FR 8953 (March 2, 2018). 
Guidance available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm595578.htm.

    Dated: April 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09476 Filed 5-3-18; 8:45 am]
 BILLING CODE 4164-01-P2


