[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Pages 72581-72585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29631]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 150

[Docket No. FDA-1997-P-0007 (formerly Docket No. 1997P-0142)]


Artificially Sweetened Fruit Jelly and Artificially Sweetened 
Fruit Preserves and Jams; Revocation of Standards of Identity

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is revoking the 
standards of identity for artificially sweetened jelly, preserves, and 
jams. We are taking this action primarily in response to a citizen 
petition submitted by the International Jelly and Preserve Association 
(IJPA). We also are taking this action because these standards are 
obsolete and unnecessary in light of our regulations for foods named by 
use of a nutrient content claim and a standardized term. This action 
will promote honesty and fair dealing in the interest of consumers.

DATES: The final rule is effective on November 20, 2015.

FOR FURTHER INFORMATION CONTACT: Terri Wenger, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    For more than 50 years, we have maintained standards of identity 
for fruit jelly (jelly) (Sec.  150.140 (21 CFR 150.140)) and fruit 
preserves and jams (preserves and jams) (Sec.  150.160). The standards 
establish the common or usual name for these products and provide that 
these products may contain nutritive sweeteners (e.g., sugar). In 1959, 
we added new standards of identity for artificially sweetened fruit 
jelly (artificially sweetened jelly) (Sec.  150.141) and artificially 
sweetened fruit preserves and jams (artificially sweetened preserves 
and jams) (Sec.  150.161) (24 FR 8896; October 31, 1959) that permit 
the use of non-nutritive sweeteners (e.g., saccharin). Notably, 
Sec. Sec.  150.141 and 150.161 limit the types of non-nutritive 
sweeteners that can be used in products that are governed by those 
standards of identity. Under Sec. Sec.  150.141 and 150.161, such 
products may only use saccharin,

[[Page 72582]]

sodium saccharin, calcium saccharin, or any combination thereof, and 
may not use newer forms of non-nutritive sweeteners that have been 
developed since the standard of identity regulations were issued.
    The Nutrition Labeling and Education Act (NLEA) of 1990 amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) to provide for a 
number of fundamental changes in food labeling, leading to a new 
regulatory framework for the naming of foods that do not fully comply 
with the relevant standards of identity. In response to NLEA, we 
established in part 101 (21 CFR part 101), among other things, 
definitions for specific nutrient content claims using terms such as 
``free'', ``low'', ''light'' or ``lite'', and ``less'', and provided 
for their use in food labeling (58 FR 2302; January 6, 1993). We also 
prescribed, in Sec.  130.10 (21 CFR 130.10), a general definition and 
standard of identity for foods named by a nutrient content claim 
defined in part 101, such as ``low calorie'' or ``sugar free'', in 
conjunction with a traditional standardized food term (58 FR 2431; 
January 6, 1993). A nutrient content claim applied to the standardized 
food ``grape jelly'', for example, could be ``low calorie grape 
jelly''. Section 130.10(d)(1) allows the addition of safe and suitable 
ingredients to a food named by use of a nutrient content claim and a 
standardized term when these ingredients are used to, among other 
things, add sweetness to ensure that the modified food is not inferior 
in performance characteristics to the standardized food even if such 
ingredients are not specifically provided for by the relevant food 
standard. Thus, under certain circumstances, Sec.  130.10 permits 
manufacturers to use safe and suitable artificial sweeteners (e.g., 
sucralose) that are not expressly listed in Sec. Sec.  150.141 and 
150.161 in the manufacture of jelly, fruit preserves, and jams 
(collectively, ``fruit spreads''). Therefore, fruit spread products 
named with a nutrient content claim (for example, ``low calorie grape 
jelly'') may contain newer artificial sweeteners to add sweetness to 
fruit spread products so that they are not inferior in their sweetness 
compared to their standardized counterparts (for example, ``grape 
jelly''). Section 130.10 does not require these products to declare the 
presence of such non-nutritive sweeteners within the name of these 
foods. We took this action to help consumers in maintaining healthy 
dietary practices by providing for a modified version of a traditional 
standardized food to achieve a nutrition goal (e.g., reduction in sugar 
consumption or calories) and that has a descriptive name that is 
meaningful to consumers. Section 130.10 does not, however, permit the 
use of nutrient content claims as part of the name of a food for foods 
governed by standards of identity that established the phrase 
``artificially sweetened'' as part of the standard of identity. 
Accordingly, jelly, preserves, and jams, that use saccharin, sodium 
saccharin, calcium saccharin, or any combination thereof as non-
nutritive sweeteners must still include the term ``artificially 
sweetened'' in their names and are not permitted to bear a nutrient 
content claim as part of the name. However, similar products that use 
newer non-nutritive sweeteners are governed by Sec.  130.10 and are not 
required to include the term ``artificially sweetened'' in their names.
    In the Federal Register of December 4, 2012, we proposed to revoke 
the standards of identity for artificially sweetened jelly, preserves, 
and jam in Sec. Sec.  150.141 and 150.161 (77 FR 71746). The proposed 
rule was in response to a citizen petition submitted by the IJPA 
requesting such a revocation. In issuing the notice of proposed 
rulemaking, we stated that we found merit in the argument made in 
IJPA's petition that revoking Sec. Sec.  150.141 and 150.161 would 
allow manufacturers to more accurately and consistently describe the 
attributes of the fruit spreads that currently conform to those 
regulations. We therefore tentatively concluded that revoking the 
standards of identity for artificially sweetened jelly, preserves, and 
jams would promote honesty and fair dealing in the interest of 
consumers and was thus appropriate under section 401 of the FD&C Act 
(21 U.S.C. 341). We tentatively reached this conclusion because we 
found that nutrient content claims such as ``low calorie'' or ``reduced 
sugar'' better characterize the nutritional profile of the affected 
fruit spreads than does the term ``artificially sweetened''. Further, 
we stated that revoking Sec. Sec.  150.141 and 150.161 would provide 
manufacturers with the flexibility to use the three non-nutritive 
sweeteners listed in those standards while also naming their products 
using FDA-defined nutrient content claims, in accordance with Sec.  
130.10. We also noted that other safe and suitable artificial 
sweeteners that might be developed in the future could be used in these 
products under Sec.  130.10 without the need to further revise relevant 
standards of identity, and that the proposed rule was consistent with 
FDA's proposed general principles for modernizing food standards (70 FR 
29214; May 20, 2005).

II. Comments to the Proposed Rule and FDA's Responses

    We received 21 comments to the proposed rule. The comments were 
from trade associations, food companies, and individuals. Two comments 
were identical, and another comment appeared to have been misdirected 
because it pertained to blogs. Most of the comments made general 
remarks supporting or opposing the rule and did not focus on a 
particular component of the rule.
    Six comments supported the proposed rule. One comment stated that 
the proposed rule would provide flexibility to industry to use 
artificial sweeteners and to not use the term ``artificially 
sweetened'' in the name of their products. The comment also stated that 
the proposed rule would provide consistency and uniformity in the 
labeling of fruit spreads. Several comments stated that Sec. Sec.  
150.141 and 150.161 limit the type of non-nutritive sweeteners, and 
that enactment of the NLEA and FDA's regulation in Sec.  130.10 allow 
flexibility. One of the comments also stated that the use of nutrient 
content claims such as ``reduced sugar'' in accordance with Sec.  
130.10 provides a better way to communicate with consumers to meet 
their nutritional goals.
    In contrast, other comments opposed the proposed rule. Several 
comments said that the rule would remove transparency that allows 
consumers to make knowledgeable decisions. Another expressed concern 
that the non-nutritive sweeteners would not be labeled and that 
consumers would be cheated. Still others stated that removing the term 
``artificially sweetened'' is deceitful, would allow harmful chemicals 
to be hidden in food, and would not protect consumers.
    The final rule will not result in the declaration of non-nutritive 
sweeteners being removed from labels and will not result in substances 
being hidden in food. In accordance with Sec.  101.4(a) (21 CFR 
101.4(a)), ingredients (including non-nutritive sweeteners) must be 
declared by common or usual name on either the principal display panel 
or the information panel of the label. Thus, for example, the 
ingredient panel must list any non-nutritive sweeteners, including, for 
example, the three saccharin products currently subject to Sec. Sec.  
150.141 and 150.161 and any of the newer non-nutritive sweeteners such 
as sucralose. What the final rule will do is require any food products 
currently subject to Sec. Sec.  150.141 and 150.161 to instead be 
subject to Sec.  130.10. Although Sec.  130.10 does not require 
products to declare the

[[Page 72583]]

presence of non-nutritive sweeteners within the name of these foods 
(e.g., Sec.  130.10 does not require a jam made with a non-nutritive 
sweetener to be named ``artificially sweetened jam''), it does require 
foods subject to that provision to be named by use of a nutrient 
content claim defined in part 101 (e.g., ``reduced calorie'' or ``no 
sugar added''). Nutrient content claims such as ``low calorie'' or ``no 
sugar added'' better characterize the nutritional profile of the fruit 
spreads currently subject to Sec. Sec.  150.141 and 150.161 than does 
the term ``artificially sweetened.'' The final rule will also allow 
better comparison to other jams, jellies, and preserves currently 
modified under the provisions of Sec.  130.10. For example, under 
current requirements, a jelly that is sweetened with saccharin must be 
called ``artificially sweetened jelly'' (in accordance with Sec.  
150.141), whereas a similar jelly sweetened with sucralose may be named 
as ``reduced sugar jelly'' (in accordance with Sec.  130.10 and 
provided it meets the requirements for the nutrient content claim 
``reduced sugar'' in Sec.  101.60(c)(5) to distinguish it from the 
standardized food (jelly in Sec.  150.140). Revoking the standards will 
provide consistency and uniformity among such products because all 
fruit spreads sweetened with non-nutritive sweeteners will be subject 
to the same requirements. For these reasons, the final rule will 
promote honesty and fair dealing in the interest of consumers 
consistent with section 401 of the FD&C Act.
    As for the comment that artificial sweeteners are ``toxic'' or 
``dangerous,'' that comment does not address the merits of revoking 
Sec. Sec.  150.141 and 150.161.

III. Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, 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 Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because we have concluded, as set forth in this 
document, that this rule will not generate significant compliance 
costs, we certify that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

A. Need for This Regulation

    We are revoking the standards of identity for artificially 
sweetened jelly, preserves, and jams because these standards are 
obsolete and unnecessary. The current standards of identity for 
artificially sweetened jelly (Sec.  150.141) and artificially sweetened 
preserves and jams (Sec.  150.161) provide that they may be 
manufactured only with specific, non-nutritive artificial sweeteners: 
Saccharin, sodium saccharin, calcium saccharin, or any combination 
thereof. These standards of identity, therefore, do not permit the use 
of newer, safe, and suitable artificial sweeteners, such as sucralose.
    The development of newer artificial sweeteners and the enactment of 
the NLEA have made the current standards of identity for artificially 
sweetened jelly, preserves, and jams obsolete. The NLEA and Sec.  
130.10 permit the modification of a traditional standardized food to 
achieve a nutrition goal, such as a reduction in calories. Section 
130.10(d)(1) allows the addition of safe and suitable ingredients to a 
food named by use of a nutrient content claim and a standardized term 
when these ingredients are used to, among other things, add sweetness 
to ensure that the modified food is not inferior in performance 
characteristic to the standardized food, even if such ingredients are 
not specifically provided for by the relevant food standard.
    Standardized jelly and standardized preserves and jams products 
modified under Sec.  130.10 must use nutrient content claims to 
communicate the modified standardized product's nutritional profile to 
consumers. Under Sec.  130.10, nonspecific, safe, and suitable 
artificial sweeteners other than the three named in Sec. Sec.  150.141 
and 150.161 can be used to make reduced calorie or reduced sugar 
products labeled with a nutrient content claim that is established in 
FDA regulations. Revoking the standards of identity means that any 
product subject to Sec. Sec.  150.141 and 150.161 will instead be 
subject to Sec.  130.10. This will allow consumers to better compare 
any fruit spreads currently covered by Sec. Sec.  150.141 and 150.161 
with other spreads that are named and modified under the provisions of 
Sec.  130.10. Revoking the standards also gives manufacturers the 
flexibility to use the three non-nutritive sweeteners listed in 
Sec. Sec.  150.141 and 150.161, while naming their products under Sec.  
130.10 using a defined nutrient content claim.

B. Regulatory Options

    In assessing our regulatory options, we considered the option of 
taking no action and the option of implementing this final rule. We 
conclude that the rule is not an economically significant regulatory 
action. We are not quantitatively estimating the benefits and costs of 
the regulatory alternatives to the rule. In the following paragraphs, 
we qualitatively compare the costs and benefits of the regulatory 
options to the costs and benefits of the rule.
1. The Option of Taking No Action
    By convention, we treat the option of taking no new regulatory 
action as the baseline for determining the costs and benefits of the 
other options. Therefore, we associate neither costs nor benefits with 
this option. The consequences of taking no action are reflected in the 
costs and benefits associated with taking the action set forth in this 
rule.
2. The Option of Implementing the Final Rule
    By revoking Sec. Sec.  150.141 and 150.161, products that are 
currently subject to the requirements of these standards of identity 
will no longer be required to use the phrase ``artificially sweetened'' 
as part of their product name. Furthermore, revoking Sec. Sec.  150.141 
and 150.161 means that these same products will be permitted to bear 
nutrient content claims along with a standardized term (e.g., ``reduced 
calorie jelly'' or ``no sugar added jam''), in accordance with Sec.  
130.10.
    The costs of this rule result from the need to relabel any existing 
jelly, preserves, and jams that conform with Sec. Sec.  150.141 and 
150.161. Any products currently manufactured in accordance with the 
standards in Sec. Sec.  150.141 and

[[Page 72584]]

150.161 will have to be relabeled in order to comply with Sec.  130.10. 
Our review of supermarket scanner data for the years 2001 through 2010, 
however, revealed that no such products are currently being sold. Sales 
for products manufactured and labeled in accordance with Sec. Sec.  
150.141 and 150.161 were last reported in 2002. A memorandum 
summarizing the results of this scanner data can be found in Reference 
1. The data support our conclusion that most manufacturers most likely 
have discontinued production of jelly, preserves, and jams that must be 
labeled as ``artificially sweetened,'' presumably because of a 
perception that the phrase ``artificially sweetened'' is unattractive 
to consumers. The data also support our conclusion that it is unlikely 
that the rule will generate significant compliance costs due to the 
need to relabel products. In fact, removal of the artificially 
sweetened standards of identity will allow manufacturers to re-
introduce products covered under Sec. Sec.  150.141 and 150.161 to be 
sold as products covered by Sec.  130.10. That is, such products would 
be named by use of a nutrient content claim in conjunction with a 
standardized term (e.g., ``reduced calorie jelly'' or ``no sugar added 
jam''), in accordance with Sec.  130.10. Therefore, we conclude that 
any relabeling compliance costs will be negligible.
    We do not classify as anticipated costs of this rule any expenses 
that firms might voluntarily incur if they choose to change their 
product formulas or manufacturing practices. Any such costs are not 
costs that would be required by the rule. Instead, these costs would 
result from voluntary business decisions made by manufacturers.
    We conclude that the principal benefits that will result from the 
rule derive from increased information and flexibility. Revoking the 
artificially sweetened standards of identity will provide producers of 
jelly, preserves, and jams with the flexibility to use saccharin, 
sodium saccharin, calcium saccharin, or any combination thereof, in 
their formulations without having to include the term ``artificially 
sweetened'' in their product names. Manufacturers could instead name 
their products in accordance with approved nutrient content claims, as 
provided for under Sec.  130.10, thus providing consumers with 
additional information about the nutritional profile of affected 
products. Additionally, revoking Sec. Sec.  150.141 and 150.161 will 
help consumers compare products covered by the standards with other 
similar jelly, preserves, and jams manufactured in accordance with 
Sec.  130.10.
    Accordingly, while we do not quantify the costs and benefits of the 
rule, we conclude that potential benefits will outweigh any potential 
costs associated with the rule.

C. Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because compliance costs, if any, generated by this 
rule are expected to be negligible, we conclude that this rule will not 
have a significant economic impact on a substantial number of small 
entities. The following analysis, in conjunction with the discussion in 
this document, constitutes our final regulatory flexibility analysis as 
required by the Regulatory Flexibility Act.
    The rule revokes the standards of identity for artificially 
sweetened jelly, preserves, and jams. The revocation of these 
artificially sweetened standards of identity gives small fruit spread 
firms the flexibility to use the three non-nutritive sweeteners listed 
in Sec. Sec.  150.141 and 150.161 and to name their products with FDA-
defined nutrient content claims in accordance with Sec.  130.10, as is 
currently done for fruit spread products manufactured with other non-
nutritive sweeteners.
    We do not classify as costs of this rule any expenses that some 
small firms might voluntarily incur because they choose to change their 
product formulas or manufacturing practices. As discussed in this 
document, any such costs would not be costs required by this rule.

IV. 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 
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 any requirement for a food which is the subject of 
a standard of identity established under section 401 (of the FD&C Act) 
that is not identical to such standard of identity or that is not 
identical to the requirement of section 403(g) of the FD&C Act (21 
U.S.C. 343(g)). 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 NLEA, Pub. L. 101-535, 104 Stat. 2353, 2364 (1990)).
    This final rule will impose requirements that fall within the scope 
of section 403A(a) of the FD&C Act.

V. Environmental Impact

    We have determined under 21 CFR 25.32(a) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act

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

VII. Reference

    The following reference is on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852 and is available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it 
is also available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. A.C. Nielsen Scantrack data, (2001-2010). The Nielsen 
Company, 770 Broadway, New York, NY 10003-9595 (http://www.acnielsen.com/).

List of Subjects in 21 CFR Part 150

    Food grades and standards, Fruits.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
150 is amended as follows:

PART 150--FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS

0
1. The authority citation for 21 CFR part 150 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

[[Page 72585]]

Sec.  150.141  [Removed]

0
2. Remove Sec.  150.141.


Sec.  150.161  [Removed]

0
3. Remove Sec.  150.161.

    Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29631 Filed 11-19-15; 8:45 am]
 BILLING CODE 4164-01-P