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, 19619-19626 [2018-09476]
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Rules and Regulations
Paragraph 6004 Class E Airspace Areas
Designated as an Extension to a Class D or
Class E Surface Area
*
*
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ANM ID E4
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Pocatello, ID [Removed]
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 feet or More
Above the Surface of the Earth
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ANM ID E5
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Pocatello, ID [Amended]
Pocatello Regional Airport, ID
(Lat. 42°54′35″ N, long. 112°35′45″ W)
That airspace extending upward from 700
feet above the surface within 7.8 miles
northwest and 5 miles southeast of the 045°
bearing from Pocatello Regional Airport
extending to 21 miles northeast of the airport,
and within 7.8 miles northwest and 5 miles
southeast of the 225° bearing from the airport
extending to 10.8 miles southwest of the
airport. That airspace extending upward from
1,200 feet above the surface within 15 miles
northwest and 5 miles southeast of the 045°
bearing from Pocatello Regional Airport
extending to 43 miles northeast of the airport,
and within 15 miles northwest and 5 miles
southeast of the 225° bearing from the airport
extending to 15 miles southwest of the
airport.
Issued in Seattle, Washington, on April 23,
2018.
B. G. Chew,
Acting Manager, Operations Support Group,
Western Service Center.
[FR Doc. 2018–09107 Filed 5–3–18; 8:45 am]
BILLING CODE 4910–13–P
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]
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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.
The Food and Drug
Administration (FDA or we) is
SUMMARY:
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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
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19619
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 $10
million in annual food sales, the final
rule extends the compliance date from
July 26, 2019, to January 1, 2021. We are
extending the compliance dates for the
Nutrition Facts Label Final Rule and the
Serving Size Final Rule, which were
issued consistent with our authority in
sections 403(q), 403(a)(1), 201(n), and
701(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
343(q), 343(a)(1), 321(n), and 371(a),
respectively) and section 2(b)(1) of the
Nutrition Labeling and Education Act
(NLEA) (Pub. L. 101–535).
C. Costs and Benefits
The impact of this final rule is
summarized in the following table.
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Rules and Regulations
TABLE 1—SUMMARY OF THE COST SAVINGS TO INDUSTRY AND FOREGONE BENEFITS TO CONSUMERS OF THIS FINAL
RULE TO EXTEND THE COMPLIANCE DATES
[In billions of 2016$]
Discount
rate
Present Value ..................................................................................................
Annualized Amount ..........................................................................................
Cost
savings
3
7
3
7
$1.0
1.0
0.07
0.09
Foregone
benefits
$0.9
0.9
0.06
0.08
Net benefits
(cost savings—
foregone
benefits)
$0.1
0.1
0.01
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
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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.
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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
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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
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Rules and Regulations
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.
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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
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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
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19621
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 subpopulations at high risk of nutritionrelated 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
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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 midsize 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
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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
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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 nondigestible 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
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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
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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
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19623
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
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Rules and Regulations
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 nondigestible 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
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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,
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Fmt 4700
Sfmt 4700
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
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Rules and Regulations
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
19625
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$]
Discount
rate
Present Value ..................................................................................................
Cost
savings
3%
7
3
7
Annualized Amount ..........................................................................................
$1.0
1.0
0.07
0.09
Foregone
benefits
$0.9
0.9
0.06
0.08
Net benefits
(cost
savings—
foregone
benefits)
$0.1
0.1
0.01
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).
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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.
environmental assessment nor an
environmental impact statement is
required.
VI. Analysis of Environmental Impact
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.
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
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VII. Paperwork Reduction Act of 1995
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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
E:\FR\FM\04MYR1.SGM
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Rules and Regulations
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.
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/
GuidanceDocumentsRegulatory
Information/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/
GuidanceDocumentsRegulatory
Information/ucm595578.htm.
IX. References
Food and Drug Administration
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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/growingnew-label-adoption-providestransparency-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/Guidance
DocumentsRegulatoryInformation/
ucm535368.htm.
4. Food and Drug Administration, ‘‘Scientific
Evaluation of the Evidence on the
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 880
[Docket No. FDA–2017–N–6216]
General Hospital and Personal Use
Devices; Reclassification of Sharps
Needle Destruction Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or the Agency) is
issuing a final order to reclassify the
needle destruction device, renaming the
device to ‘‘sharps needle destruction
device,’’ a postamendments class III
device (regulated under product code
MTV), into class II (special controls),
subject to premarket notification. FDA is
also identifying the special controls that
the Agency believes are necessary to
provide a reasonable assurance of safety
and effectiveness of the device. FDA is
finalizing this reclassification on its
own initiative based on new
information. The Agency is classifying
the device into class II (special controls)
to provide a reasonable assurance of
safety and effectiveness of the device.
This order reclassifies these types of
devices from class III to class II and will
reduce regulatory burdens on industry
because these types of devices will no
longer be required to submit a
premarket approval application (PMA),
but can instead submit a less
burdensome premarket notification
(510(k)) before marketing their device.
SUMMARY:
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DATES:
This order is effective June 4,
2018.
FOR FURTHER INFORMATION CONTACT:
Christopher K. Dugard, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2561,
Silver Spring, MD 20993, 240–402–
6031, christopher.dugard@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended, establishes
a comprehensive system for the
regulation of medical devices intended
for human use. Section 513 of the FD&C
Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting
the regulatory controls needed to
provide reasonable assurance of their
safety and effectiveness. The three
categories of devices are class I (general
controls), class II (special controls), and
class III (premarket approval).
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices) are
automatically classified by section
513(f)(1) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, the device is reclassified into class
I or II, or FDA issues an order finding
the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807).
A postamendments device that has
been initially classified in class III
under section 513(f)(1) of the FD&C Act
may be reclassified into class I or class
II under section 513(f)(3). Section
513(f)(3) of the FD&C Act provides that
FDA acting by order can reclassify the
device into class I or class II on its own
initiative, or in response to a petition
from the manufacturer or importer of
the device. To change the classification
of the device, the proposed new class
must have sufficient regulatory controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use.
Reevaluation of the data previously
before the Agency is an appropriate
basis for subsequent action where the
reevaluation is made in light of newly
available regulatory authority (see Bell
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
