15390 Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Rules and Regulations

21 CFR Part 101

[Docket Nos. 96P–0500 and 91N–384H]

RIN 0910–AA19

Food Labeling: Nutrient Content

Claims, Definition of Term: Healthy

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial stay.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

partial stay of certain provisions of the

nutrient content claim regulations

pertaining to the use of the term

‘‘healthy.’’ This action is in response to

a citizen’s petition from ConAgra, Inc.

(the petitioner), to amend the definition

of this term.

DATES: Effective April 1, 1997 21 CFR

101.65(d)(2)(ii)(C) and (d)(4)(ii)(B) are

stayed until January 1, 2000. Written

comments by May 1, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 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, 202–205–5483.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 10, 1994 (59 FR

24232 at 24249), FDA published a final

rule to establish a definition of the term

‘‘healthy’’ under section 403(r) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 343(r)). Under

§ 101.65(d)(2)(ii) (21 CFR

101.65(d)(2)(ii)), for a food to qualify to

use the term ‘‘healthy,’’ or a derivative

of that term, on its label or in its

labeling, the food must contain no more

than 480 milligrams (mg) of sodium per

reference amount customarily

consumed (RACC) before January 1,

1998 (§ 101.65(d)(2)(ii)(A) and

(d)(2)(ii)(B)), and no more than 360 mg

of sodium per RACC after January 1,

1998 (§ 101.65(d)(2)(ii)(C)). Under

§ 101.65(d)(4)(ii), main dish and meal

products, to qualify to bear this term,

must contain no more than 600 mg of

sodium per RACC before January 1,

1998 (§ 101.65(d)(4)(ii)(A)), and no more

than 480 mg of sodium per RACC after

January 1, 1998 (§ 101.65(d)(4)(ii)(B)).

On December 13, 1996, FDA received

from the petitioner, ConAgra, Inc., 888

17th Street, suite 300, NW., Washington,

DC 20006, a petition requesting that

§ 101.65(d) be amended to ‘‘eliminate

the sliding scale sodium requirement for

foods labeled ‘healthy’ by eliminating

the entire second tier levels of 360 mg

sodium for individual foods and 480 mg

sodium for meals and main dishes.’’

Alternatively, the petitioner requested

that the effective date of January 1,

1998, in § 101.65(d)(2) through (d)(4), be

delayed until such time as food

technology ‘‘catches up’’ with FDA’s

goals to reduce the sodium content of

foods, and there is a better

understanding of the relationship

between sodium and hypertension.

The petitioner cited as grounds for its

requests: (1) A lack of scientific basis

supporting the Daily Reference Value

for sodium and the allowable levels of

sodium in § 101.65(d); (2) a lack of

consumer acceptance of products

containing low sodium levels; (3) a lack

of acceptable sodium substitutes and the

difficulties in manufacturing whole

lines of food products at low sodium

levels; and (4) FDA’s failure to provide

notice and comment on the ‘‘second

tier’’ sodium levels in the healthy

definition, to follow directives of the

Nutrition Labeling and Education Act of

1990 (the 1990 amendments), and to

consider all the science, stating that

recent studies indicate a concern if too

little sodium is consumed (Docket 96P–

0500, CP1, p. 3). While FDA finds little

merit in the first and last of these

grounds, the middle two raise questions

that merit further consideration.

Relative to the efforts of industry to

lower the sodium level in foods, the

petitioner stated that the technology

does not yet exist to manufacture certain

low fat products at the ‘‘healthy’’

definition levels of sodium that will be

required in 1998 and still provide foods

that will be acceptable to consumers.

The petitioner submitted the results of

a consumer survey that examined

consumer acceptance of several

products with different sodium levels.

While the survey found reductions in

consumer acceptance at levels of 480 mg

sodium compared to higher sodium

levels, much greater, i.e., statistically

significant, drops occurred at levels of

360 mg sodium per serving. As stated by

the petitioner:

If the sodium is so low in a product as to

render the product tasteless or even bad

tasting, consumers will not eat the product or

will reach for the table salt. This is counterproductive to the intent of the 1990

amendments and will not result in the goal

Congress envisioned; i.e., to improve the

eating habits of the American public, but

instead could result in even more salt

intake—not less.

Docket 96P–0500, CP1, p. 28

The petitioner also delineated several

technological concerns with lowering

sodium levels in foods related to the

functional role of salt, such as impacts

on the microbial stability of perishable

products, changes in product texture

and in water binding capacities, and

effects on flavor characteristics of other

ingredients and on total electrolyte

levels that play a critical role in product

safety.

Important issues have been raised in

this petition regarding the technological

feasibility of further reductions in the

sodium levels in certain foods that

currently meet FDA’s definition of

‘‘healthy’’ and regarding the palatability

of such foods after the sodium has been

reduced. The agency recognizes that the

food industry has made a significant

effort over the past few years to lower

both the fat and sodium levels in food

products while maintaining taste and

texture attributes that are acceptable to

consumers. The agency continues to

believe, however, that the scientific

evidence indicates further reductions in

fat and sodium intakes will result in

meaningful public health gains.

FDA has defined the term ‘‘healthy’’

to serve as a means to help consumers

identify food products that will help

them meet dietary guidelines for a

healthy diet. Consumers appreciate the

significance of this term, and thus many

make purchasing decisions based on its

presence on a food label. Because of this

fact, manufacturers have an incentive to

produce foods that qualify to bear this

term. If the petitioner is correct that the

technology does not yet exist that will

permit manufactures to produce certain

types of low fat foods that will contain

the lower levels of sodium required by

January 1, 1998, and still be acceptable

to consumers, then the possibility exists

that ‘‘healthy’’ will disappear from the

market for such foods. If this situation

comes to pass, FDA will have

squandered a significant opportunity.

Therefore, the agency finds that, before

the new sodium levels for ‘‘healthy’’ go

into effect, it needs to explore whether

it has created an unattainable standard

for many types of foods.

Under the provisions of § 10.35(a) and

(d)(1), the Commissioner of Food and

Drugs (the Commissioner) may at any

time stay or extend the effective date of

a pending action if the Commissioner

determines that it is in the public

interest to do so. As discussed

previously in this document, the

petition has raised significant issues

that have public health implications.

FDA also recognizes, as mentioned in

the petition, that manufacturers must

begin very soon to revise the

formulations and the labeling, if they

have not already done so, for those

products that do not currently comply

with the requirements that must be met

after January 1, 1998, for a product to

bear the claim ‘‘healthy.’’ Time is
Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Rules and Regulations 15391

needed for the agency to complete its

review of the issues raised by the

petition. Additionally, FDA believes

that it should seek comment on these

issues from other interested persons.

Given these factors, the agency is

persuaded that it is in the public

interest to stay the provisions for the

lower standards for sodium in the

definition of ‘‘healthy’’ in § 101.65

while the agency endeavors to resolve

the issues raised by the petition.

Therefore, the agency is staying the

provisions for further reducing the

sodium level in foods labeled as

‘‘healthy’’ until January 1, 2000, to

allow time for FDA to reevaluate the

standard, including the data contained

in the petition and any additional data

that the agency may receive, to conduct

any necessary notice-and-comment

rulemaking, and for industry to respond

to the rule or to any change in the rule

that may result from the agency’s

reevaluation.

To assist the agency in its

reevaluation, FDA intends to issue an

advance notice of proposed rulemaking

(ANPR) in the near future to ask for

comments on the petition as well as for

additional data regarding the

technological feasibility of reducing the

sodium content of individual foods to

360 mg per RACC and of meals and

main dishes to 480 mg sodium per

RACC. The agency will also be seeking

comments on other approaches to

reduce the amount of sodium in foods

labeled ‘‘healthy.’’ It is important that

consumers seeking to eat a healthpromoting diet have food choices that

enable them to further reduce the

amount of sodium in their diet.

Interested persons need not wait for the

publication of the ANPR but should feel

free to review the petition and to submit

to the agency any information or views

they have on consumer acceptance of

foods with low sodium levels and on

the lack of acceptable sodium

substitutes and the difficulties in

manufacturing lines of food products

with low sodium levels.

Accordingly, FDA is announcing a

stay of the provisions in

§ 101.65(d)(2)(ii)(C) and (d)(4)(ii)(B)

until January 1, 2000. Interested persons

may also submit comments regarding

the appropriateness of the basis of this

stay. In doing so, however, FDA

encourages manufacturers who can meet

the lower sodium levels for particular

foods and still produce an acceptable

product to do so even as the agency

reevaluates the issues discussed

previously in this document.

Interested persons may, on or before

May 1, 1997 submit to the Dockets

Management Branch (address above)

written comments regarding this

document. 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.

This document is issued under

sections 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).

For the reasons set forth in the

preamble, 21 CFR 101.65(d)(2)(ii)(C) and

(d)(4)(ii)(B) are stayed until January 1,

2000.

Dated: March 26, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–8127 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 556 and 558

Animal Drugs, Feeds, and Related

Products; Tilmicosin Phosphate Type

A Medicated Article; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of December 27, 1996 (61 FR

68147). The document amended the

animal drug regulations to reflect

approval of Elanco Animal Health’s new

animal drug application (NADA) 141–

064 for use of a Type A medicated

article containing tilmicosin phosphate

in manufacturing a Type B or Type C

medicated feed indicated for the control

of swine respiratory disease associated

with certain bacterial organisms. The

document was published with some

errors. This document corrects those

errors.

EFFECTIVE DATE: December 27, 1996.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

In FR Doc. 96–32881, appearing on p.

68147, in the Federal Register of Friday,

December 27, 1996, the following

corrections are made:

§ 556.735 [Corrected]

1. On page 68148, in the second

column, in line 2, ‘‘7.2’’ is corrected to

read ‘‘7.5’’.

§ 558.618 [Corrected]

2. On page 68148, in the second

column, in paragraph (d)(1), ‘‘181.8’’

and ‘‘363.6’’ are corrected to read ‘‘181’’

and ‘‘363’’, respectively.

Dated: February 7, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–8116 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1309 and 1310

[DEA No. 132C]

RIN 1117–AA33

Consolidation, Elimination, and

Clarification of Various Regulations;

Correction

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Correction to final regulations.

SUMMARY: This document contains

corrections to the final regulations (DEA

132) which were published on Monday,

March 24, 1997 (62 FR 13938). The

regulations related to the consolidation,

elimination, and clarification of DEA’s

regulations as part of the President’s

National Performance Review,

Regulatory Reinvention Initiative.

EFFECTIVE DATE: April 1, 1997.

FOR FURTHER INFORMATION CONTACT:

G. Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, D.C. 20537,

Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The final

regulations that are the subject of these

corrections revise Title 21, Code of

Federal Regulations (CFR), Chapter II in

accordance with the President’s

Regulatory Reinvention Initiative. As

published, the final regulations contain

errors that could cause confusion in the

regulated industry. Specifically, the

final regulations did not take into

account the amendment of certain

definitions and the amendment of 21

CFR 1310.09 that were included in an

Interim Rule published by DEA on

February 10, 1997 (62 FR 5914), which