[Federal Register Volume 61, Number 57 (Friday, March 22, 1996)]
[Rules and Regulations]
[Pages 11730-11731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6942]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0216]
Food Labeling: Nutrient Content Claim for ``Extra''
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 ``extra'' as a synonym for the
term ``added.'' This action is in response to FDA's decision to grant a
citizen petition for the synonym filed by Darigold, Inc. FDA concludes
that the term ``extra'' is a clear and unambiguous synonym for ``more''
and is consistent with the term ``added.''
DATES: The regulation is effective March 22, 1996; comments by April
22, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), 12420 Parklawn Dr., rm 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5916.
SUPPLEMENTARY INFORMATION:
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''). That 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 March 21, 1995, FDA received a petition from Darigold, Inc.,
P.O. Box 79007, Seattle, WA 98119, to establish the term ``extra'' as a
synonym for the term ``more'' (Ref. 1). In accordance with procedures
established in Sec. 101.69(n), FDA concluded that the term ``extra'' is
a clear and unambiguous synonym for ``more'' and, in particular, is
consistent with the term ``added.'' To evaluate whether the term
``extra'' and existing terms, such as ``more'' and ``added,'' have the
same meaning, FDA reviewed definitions for the term ``extra'' in
current dictionaries and found that it is common for the term ``extra''
to be defined as ``more than is usual'' and ``additional.'' Both
meanings clearly relate ``extra'' to the defined terms ``more'' and
``added.'' Based on this information, FDA concluded that the term
``extra'' would be commonly understood to have the same meaning as
``more'' and ``added.'' It advised the firm of this in a letter dated
October 30, 1995 (Ref.2). The agency also explained in the October 30
letter that the term ``extra'' 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 ``extra'' as a relative claim must be used in the same
way that the term ``added'' is used, as specified under
(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 ``extra'' as a
synonym for the term ``added.''
I. References
The following references have been placed on 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. Darigold, Inc., ``Petition for Synonymous Term `Extra','' March
18, 1994 [CP1].
[[Page 11731]]
2. Scarbrough, F. Edward, CFSAN, FDA, Letter to Douglas C.
Marshall, Darigold, Inc., October 30, 1995 [PAV1].
II. 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.
III. Analysis of Impact
FDA has examined the economic implications of the final rule
amending 21 CFR part 101 as required by Executive Order 12866 and the
Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866
directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches which maximize net benefits (including potential
economic, environmental, public health and safety effects; distributive
impacts; and equity). The Regulatory Flexibility Act requires analyzing
options for regulatory relief for small businesses. This rule provides
added flexibility to existing rules governing nutrient content claims.
FDA finds that this final rule is not a significant rule as defined by
Executive Order 12866. In addition, in accordance with the Regulatory
Flexibility Act, the agency certifies that the final rule will not have
a significant impact on a substantial number of small businesses.
IV. 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.).
V. Public Comment
FDA, for good cause, finds that this final rule is announcing an
agency decision reached in accordance with a procedure established by
statute, and that notice and public procedure thereon are unnecessary.
However, in accordance with 21 CFR 10.40(e)(1), FDA is providing 30
days for comment on whether the announced action should be modified or
revoked.
Interested persons may, on or before April 22, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. 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.
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 ``extra,'' 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,' and `added''', and adding in their place the words
```enriched,' `added,' and `extra'''.
Dated: March 14, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-6942 Filed 3-21-96; 8:45 am]
BILLING CODE 4160-01-F