[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





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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