[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
