[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