[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]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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