[Federal Register Volume 59, Number 232 (Monday, December 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29733]


[[Page Unknown]]

[Federal Register: December 5, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 90N-0134 and 91N-0162]
RIN 0905-AD08

 

Food Labeling: Mandatory Status of Nutrition Labeling and 
Nutrient Content Revision, Format for Nutrition Label; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting the 
regulations that require nutrition labeling on most foods that are 
regulated by FDA. In the Federal Register of August 18, 1993 (58 FR 
44063), the agency published a document entitled ``Food Labeling: 
Mandatory Status of Nutrition Labeling and Nutrient Content Revision, 
Format for Nutrition Label; Technical Amendment.'' The document was 
published with an inadvertent error in the amendatory language. This 
document corrects that error.

EFFECTIVE DATE: May 8, 1994.

FOR FURTHER INFORMATION CONTACT: Virginia L. Wilkening, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5763.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 18, 1993, 
FDA published a document that amended the regulations that require 
nutrition labeling on most foods regulated by FDA. The agency intended 
to revise the introductory text of Sec. 101.9(c)(1)(i) (21 CFR 
101.9(c)(1)(i)) to specify that when either specific or general food 
factors are used in calculating caloric content, the factors should be 
applied to actual amounts (i. e., before rounding) of food components. 
The agency inadvertently omitted the words ``introductory text'' from 
amendatory statement 2 (58 FR 44076). Consequently, the actual methods 
for calculating caloric content were removed from the Code of Federal 
Regulations. Accordingly, this document corrects Sec. 101.9(c)(1)(i) to 
restore the methods.

List of Subjects in 21 CFR Part 101

    Food labeling, 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 corrected by making the following correcting amendments:

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).

    2. Section 101.9 is amended by revising paragraph (c)(1)(i) to read 
as follows:


Sec. 101.9  Nutrition labeling of food.

 * * * * *
    (c) * * *
    (1) * * *
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i. e., the Atwater method) 
given in Table 13, ``Energy Value of Foods--Basis and Derivation,'' by 
A. L. Merrill and B. K. Watt, United States Department of Agriculture 
(USDA) Handbook No. 74 (slightly revised, 1973), which is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and 
is available from the Office of Food Labeling (HFS-150), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, or may be inspected at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, 
DC.;
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51 (the availability of this incorporation by reference is given 
in paragraph (c)(1)(i)(A) of this section);
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA Handbook No. 74 
(slightly revised 1973) pp. 9-11, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of 
this incorporation by reference is given in paragraph (c)(1)(i)(A) of 
this section;
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of this chapter, or by other means, as 
appropriate; or
    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the 
availability of this incorporation by reference is given in paragraph 
(c)(1)(i)(A) of this section).
* * * * *

    Dated: November 28, 1994.
William K. Hubbard,
Interim Deputy Commisioner for Policy.
[FR Doc. 94-29733 Filed 12-2-94; 8:45 am]
BILLING CODE 4160-01-F