[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Pages 15342-15343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7973]
[[Page 15341]]
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Part VI
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
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21 CFR Parts 101 and 102
Foods and Drugs: Technical Amendments and Food Labeling: Soluble Fiber
From Whole Oats and Risk of Coronary Heart Disease Health Claims; Final
Rules
Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 / Rules
and Regulations
[[Page 15342]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 101 and 102
Foods and Drugs; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to correct those portions that pertain to foods. This
action is being taken to improve the accuracy and clarity of the
regulations.
EFFECTIVE DATE: March 31, 1997.
FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4561.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 101
and 102 (21 CFR parts 101 and 102) to correct certain portions that
pertain to foods.
1. In the Federal Register of April 2, 1993 (58 FR 17328), FDA
published corrections to the January 6, 1993, final rule entitled
``Food Labeling; Mandatory Status of Nutrition Labeling and Nutrient
Content Revision, Format for Nutrition Label'' (58 FR 2079). In the
April 2, 1993, document, FDA corrected the word ``Foods'' at the
beginning of the fourth sentence of paragraph (j)(4) in Sec. 101.9 to
read ``Examples of foods'' (58 FR 17328 at 17331). However, in the
August 18, 1993, technical corrections to Sec. 101.9 (58 FR 44063 at
44083), the April 2, 1993, correction to Sec. 101.9(j)(4) was
inadvertently omitted. In this document, the agency is correcting the
word ``Foods'' that occurs at the beginning of the fourth sentence in
Sec. 101.9(j)(4) to read ``Examples of foods''.
2. In the Federal Register of January 4, 1994 (59 FR 378), FDA
published a final rule entitled ``Food Labeling; Requirements for
Nutrient Content Claims for Dietary Supplements of Vitamins, Minerals,
Herbs, and Other Similar Nutritional Substances.'' In that document,
the agency amended Sec. 101.60 by redesignating paragraphs (c)(4) and
(c)(5) as paragraphs (c)(5) and (c)(6). In making this change, the
agency inadvertently failed to change a reference to old
Sec. 101.60(c)(4) in the first sentence of redesignated paragraph
(c)(6) to reflect that old paragraph (c)(4) had been redesignated as
paragraph (c)(5). In this document, the agency is correcting that
oversight.
3. In the Federal Register of January 6, 1993 (58 FR 2665), FDA
published a final rule entitled ``Food Labeling: Health Claims; Calcium
and Osteoporosis.'' This rule, among other things established the
requirements that must be met for a food to bear a health claim
regarding the relationship between calcium and osteoporosis. One of
these requirements, Sec. 101.72(c)(2)(ii)(A), specifies that the food
shall meet or exceed the requirements for a ``high'' level of calcium.
However, in Sec. 101.72(c)(2)(ii)(A) when referencing the section in
which the term ``high'' is defined in Sec. 101.54, the agency
inadvertently referred to paragraph (c), which defines the term ``good
source,'' instead of paragraph (b), which defines the term ``high.''
FDA is correcting this inadvertent error.
4. In the Federal Register of January 6, 1993 (58 FR 2302), FDA
published a final rule entitled ``Food Labeling: Nutrient Content
Claims, General Principles, Definition of Terms; Definitions of
Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol
Content of Food.'' This final rule, among other things, revoked
Sec. 101.25 (58 FR 2302 at 2413). In the Federal Register of June 3,
1996 (61 FR 27771), FDA published a final rule entitled ``Revocation of
Certain Regulations Affecting Food.'' This final rule, among other
things, revoked Secs. 105.67 and 105.69 (21 CFR 105.67 and 105.69) (61
FR 27771 at 27779). However, in issuing these two final rules, the
agency inadvertently neglected to remove the cross references to these
three sections in Sec. 101.108(a) and (b). In this document, FDA is
modifying Sec. 101.108(a) and (b) to correct this inadvertent omission.
5. In the Federal Register of July 2, 1991 (56 FR 30452), FDA
published a notice of proposed rulemaking entitled ``Food Labeling;
Declaration of Ingredients, Common or Usual Name for Nonstandardized
Foods; Diluted Juice Beverages.'' In that proposed rule, FDA proposed
to, among other things, establish common or usual name requirements for
beverages that contain less than 100 percent and more than 0 percent
fruit or vegetable juice. In response to comments to the proposal, in
the final rule, FDA acknowledged that the difference in phrasing that
appeared in Sec. 102.33(b) and (c) in the notice of proposed rulemaking
of July 2, 1991; i.e., ``diluted, multiple-juice'' versus ``multiple-
juice beverage'' was inadvertent, and that both should say ``diluted,
multiple-juice beverage'' (58 FR 2897 at 2918, January 6, 1993).
However, the agency inadvertently neglected to make the change in
Sec. 102.33(c). Additionally, in that proceeding, in response to a
comment, in the final rule FDA included a new paragraph (d) in
Sec. 102.33 that contained the phrasing ``multiple-juice beverage''
instead of the preferred phrasing ``diluted, multiple-juice beverage.''
FDA is correcting these inadvertent errors.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedure are unnecessary because FDA is merely correcting
nonsubstantive errors.
List of Subjects
21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
21 CFR Part 102
Beverages, Food grades and standards, Food labeling, Frozen foods,
Oils and Fats, Onions, Potatoes, Seafood.
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 is revised 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. 101.9 [Amended]
2. Section 101.9 Nutrition labeling of food is amended in paragraph
(j)(4) by removing the first word in the fourth sentence, ``Foods'',
and adding in its place ``Examples of foods''.
Sec. 101.60 [Amended]
3. Section 101.60 Nutrient content claims for the calorie content
of foods is amended in paragraph (c)(6) by removing the phrase ``in
paragraph (c)(4)'' and adding in its place ``in paragraph (c)(5)''.
Sec. 101.72 [Amended]
4. Section 101.72 Health claims: calcium and osteoporosis is
amended in paragraph (c)(2)(ii)(A) by removing the citation
``Sec. 101.54(c)'' and adding in its place ``Sec. 101.54(b)''.
Sec. 101.108 [Amended]
5. Section 101.108 Temporary exemptions for purposes of conducting
authorized food labeling experiments is amended in paragraph (a) by
removing the phrase ``Secs. 101.9 and 101.25 and
[[Page 15343]]
with Secs. 105.66, 105.67, and 105.69'' and adding in its place
``Secs. 101.9 and 105.66'' and in paragraph (b) by removing the phrase
``Secs. 101.9 and 101.25 and Secs. 105.66, 105.67, and 105.69'' and
adding in its place ``Secs. 101.9 and 105.66''.
PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
6. The authority citation for 21 CFR part 102 continues to read as
follows:
Authority: Secs. 201, 403, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 371).
Sec. 102.33 [Amended]
7. Section 102.33 Beverages that contain fruit or vegetable juice
is amended in paragraphs (c) and (d) by adding the word ``diluted,''
before the phrase ``multiple-juice beverage''.
Dated: March 24, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-7973 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F
