[Federal Register Volume 62, Number 110 (Monday, June 9, 1997)]
[Rules and Regulations]
[Pages 31338-31339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97P-0031]


Food Labeling: Nutrient Content Claim for ``Plus''

AGENCY: Food and Drug Administration, HHS.

Action: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its food 
labeling regulations to include the term ``plus'' as a synonym for the 
term ``added.'' This action is in response to FDA's decision to grant a 
petition for the synonym filed by Nestle USA-Beverage Division Inc. FDA 
concludes that the term ``plus'' is a clear and unambiguous synonym for 
``more,'' and is consistent with the terms ``added'' and ``extra.''

DATES: The regulation is effective July 9, 1997; written comments by 
July 9, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Carole L. Adler, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C. St. SW., Washington, DC 20204, 202-205-5483.

SUPPLEMENTARY INFORMATION:

 I. Background

    Section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the 
act) provides that any person may petition the Secretary of Health and 
Human Services (and by delegation, FDA) to approve nutrient content 
claims that are not specifically provided for in FDA's regulations. In 
the Federal Register of January 6, 1993 (58 FR 2302), FDA published a 
final rule entitled, ``Food Labeling: Nutrient Content Claims, General 
Principles, Petitions, Definition of Terms; Definitions of Nutrient 
Content Claims for the Fat, Fatty Acid, and Cholesterol Content of 
Food'' (hereinafter referred to as ``nutrient content claims final 
rule''). The nutrient content claims final rule, among other things, 
defined specific nutrient content claims that included the terms ``good 
source,'' ``high,'' and ``more'' (Sec. 101.54 (21 CFR 101.54)) and 
established procedures for the submission and review of petitions 
regarding the use of nutrient content claims (Sec. 101.69 (21 CFR 
101.69)). Section 101.69(n) establishes the procedures to petition for 
use of a synonymous term.
    On January 14, 1997, FDA received a petition from Nestle USA-
Beverage Division, Inc., 345 Spear St., San Francisco, CA 95105, to 
establish the term ``plus'' as a synonym for the terms ``more,'' 
``added,'' and ``extra'' (Ref. 1). In accordance with procedures 
established in Sec. 101.69(n), FDA evaluated the petition and concluded 
that the term ``plus'' is a clear and unambiguous synonym for the term 
``more'' and, in particular, is consistent with the terms ``added'' and 
``extra.'' Nestle USA-Beverage Division, Inc., stated in its petition 
that according to the definitions in current dictionaries, the word 
``plus'' signifies ``increased by'' or ``with the addition of.'' Based 
on this information, FDA concluded that the term ``plus'' would be 
commonly understood to have the same meaning as ``more,'' and more 
specifically, ``added'' and ``extra.'' FDA advised the firm of this in 
a letter dated March 26, 1997 (Ref. 2). The agency also explained in 
the March 26, 1997, letter that the term ``plus'' is most closely 
synonymous with the term ``added'' in that it suggests that the labeled 
food has been altered compared to a similar reference food. Therefore, 
the agency concluded that the term ``plus'' as a relative claim must be 
used in the same way that the term ``added'' is used as specified in 
Sec. 101.13(j)(1)(i)(B) (21 CFR 101.13(j)(1)(i)(B)).
    In Sec. 101.69(n)(4), FDA stated that as soon as practicable 
following the agency's decision to either grant or deny a petition for 
a synonymous term, it would publish a notice in the Federal Register 
informing the public of its decision, and that if it grants the 
petition, FDA will list the term in its nutrient content claims 
regulation. Therefore, in this document, the agency is amending 
Secs. 101.13(j) and 101.54(e) to include the term ``plus'' as a synonym 
for the terms ``added'' and ``extra.''

[[Page 31339]]

II. Public Comment

    This final rule announces an agency decision that FDA reached in 
accordance with a procedure established by statute. Notice and public 
procedure therefore are unnecessary. However, in accordance with 21 CFR 
10.40(e)(1), FDA is providing 30 days for public comment on whether the 
announced action should be modified or revoked.
    Interested persons may, on or before July 9, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this final rule. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act

    This rule contains no information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) 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.

V. Analysis of Impacts

    FDA has examined the economic implications of the final rule as 
required by Executive Order 12866 and the Regulatory Flexibility Act (5 
U.S.C. 601-612). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select the regulatory approach that 
maximizes net benefits (including potential economic, environmental, 
public health and safety effects; distributive impacts; and equity). 
Executive Order 12866 classifies a rule as significant if it meets any 
one of a number of specified conditions, including having an annual 
effect on the economy of $100 million or adversely affecting in a 
material way a sector of the economy, competition, or jobs, or if it 
raises novel legal or policy issues. If a rule has a significant impact 
on a substantial number of small entities, the Regulatory Flexibility 
Act requires agencies to analyze options that would minimize the 
economic impact of that rule on small entities. FDA finds that this 
final rule is not a significant rule as defined by Executive Order 
12866, and finds, under the Regulatory Flexibility Act, that the final 
rule will not have a significant impact on a substantial number of 
small entities (Ref. 3).
    The costs of this regulation are anticipated to be small. FDA is 
aware that some firms are already using the term ``plus'' on product 
labels. The agency does not have sufficient information to determine 
how many of these claims satisfy the criteria described in this 
rulemaking. If any labels need revision, this rule will impose a small 
cost. Because FDA does not know the number of labels currently using 
the term ``plus'' that do not meet FDA's criteria, the agency cannot 
estimate the total costs of this regulation.
    The benefit of this rule is increased flexibility on the part of 
manufacturers to inform consumers of the nutritional content of foods. 
The rule also provides the benefit of ensuring that the term will be 
used in food labeling in a truthful and nonmisleading way and in a way 
that will help consumers to construct a healthy diet.
    The Regulatory Flexibility Act requires analyzing options for 
regulatory relief for small entities. According to the information 
currently available to the agency, of the relatively small number of 
products which use the term ``plus'' on their labels, none are produced 
by small entities. Accordingly, under the Regulatory Flexibility Act (5 
U.S.C. 605(b)), the Commissioner of Food and Drugs certifies that this 
tentative final rule will not have a significant impact on a 
substantial number of small entities.

VI. References

    The following references have been placed on public display in the 
Dockets Management Branch (address above) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Nestle USA-Beverage Division, Inc., ``Petition for Synonymous 
Term `Plus','' January 9, 1997.
    2. Scarbrough, F. Edward, CFSAN, FDA, Letter to Kristin Adrian, 
Nestle USA-Beverage Division Inc., March 26, 1997.
    3. Memorandum from L. M. Bush, FDA, Factual Basis for Small 
Business Certification of ``Plus,'' April 18, 1997.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101-- FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).


Sec. 101.13  [Amended]

    2. Section 101.13 Nutrient content claims--general principles is 
amended in paragraph (j)(1)(i)(B) by adding the word ``plus,'' before 
the word ``fortified''.


Sec. 101.54  [Amended]

    3. Section 101.54 Nutrient content claims for ``good 
source,''``high,'' and ``more'' is amended in the first sentence of the 
introductory text of paragraphs (e)(1) and (e)(2) by removing the words 
```enriched,' `added,' and `extra''' and by adding in their place the 
words ```enriched,' `added,' `extra,' and `plus'''.

    Dated: May 2, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-14893 Filed 6-6-97; 8:45 am]
BILLING CODE 4160-01-F