17202 Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations

PART 200—ORGANIZATION;

CONDUCT AND ETHICS; AND

INFORMATION AND REQUESTS

1. The authority citation for part 200,

subpart B, is revised to read as follows:

Authority: 5 U.S.C. 552b; 15 U.S.C. 78d–

1 and 78w.

2. Section 200.40 is revised to read as

follows:

§ 200.40 Joint disposition of business by

Commission meeting.

Any meeting of the Commission that

is subject to the provisions of the

Government in the Sunshine Act, 5

U.S.C. 552b, shall be held in accordance

with subpart I of this part. The

Commission’s Secretary shall prepare

and maintain a Minute Record reflecting

the official action taken at such

meetings.

§§ 200.41 and 200.42 [Redesignated as

§§ 200.42 and 200.43]

3. Sections 200.41 and 200.42 are

redesignated as §§ 200.42 and 200.43,

and § 200.41 is added to read as follows:

§ 200.41 Quorum of the Commission.

A quorum of the Commission shall

consist of three members; provided,

however, that if the number of

Commissioners in office is less than

three, a quorum shall consist of the

number of members in office; and

provided further that on any matter of

business as to which the number of

members in office, minus the number of

members who either have disqualified

themselves from consideration of such

matter pursuant to § 200.60 or are

otherwise disqualified from such

consideration, is two, two members

shall constitute a quorum for purposes

of such matter.

§ 200.42 [Amended]

4. In newly redesignated § 200.42, in

paragraph (a) the reference to ‘‘§ 200.42’’

is revised to read ‘‘§ 200.43’’ and in

paragraph (b) the reference to

‘‘§ 200.41(a)’’ is revised to read

‘‘§ 200.42(a)’’.

§ 200.43 [Amended]

5. In newly redesignated

§ 200.43(c)(1), the reference to

‘‘§ 200.42(a)’’ is revised to read

‘‘§ 200.43(a)’’ and the reference to

‘‘§ 200.41’’ is revised to read ‘‘§ 200.42’’.

§ 200.401 [Amended]

6. In § 200.401(a), the reference to

‘‘§ 200.41 or § 200.42’’ is revised to read

‘‘§ 200.42 or § 200.43’’.

Dated: March 30, 1995.

By the Commission.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 95–8259 Filed 4–4–95; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 93N–0283]

RIN 0905–AD89

Food Labeling; Placement of the

Nutrition Label on Food Packages

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

food labeling regulations to provide

increased flexibility in the placement of

the nutrition label on packaged foods. In

situations in which the principal

display and information panels cannot

accommodate all the required labeling

information, and the package has a total

surface area available to bear labeling of

greater than 40 square inches (sq in), the

amendment allows the nutrition label to

be placed on any panel that can be

readily seen by the consumer. This

action is being taken in response to

comments received on the final rule of

January 6, 1993, entitled ‘‘Food Labeling

Regulations Implementing the Nutrition

Labeling and Education Act of 1990;

Opportunity for Comments,’’

(hereinafter ‘‘the implementation final

rule’’), and on the proposed rule of

August 18, 1993, entitled ‘‘Food

Labeling; Placement of the Nutrition

Label on Food Packages.’’

EFFECTIVE DATE: May 5, 1995.

FOR FURTHER INFORMATION CONTACT:

Arletta M. Beloian, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5430.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Principal Display Panel and

Information Panel

Under FDA’s regulations (§ 101.1 (21

CFR 101.1)), the part of a label that is

most likely to be displayed, presented,

shown, or examined by a consumer

under customary conditions of display

for retail sale is called ‘‘the principal

display panel.’’ This panel must include

the statement of identity for the product

and its net weight. In addition, to

provide consistency and uniformity in

the presentation of label information to

consumers, FDA has provided for a

second display panel for information

that must be included on the label but

that is not required to appear on the

principal display panel. This alternate

panel is called ‘‘the information panel’’

(§ 101.2 (21 CFR 101.2)).

The information panel is defined in

§ 101.2(a) as that part of the label that

is immediately contiguous and to the

right of the principal display panel.

Section 101.2(a)(1) specifies that if the

first panel to the right of the principal

display panel is too small to

accommodate the necessary

information, or is otherwise unusable

label space, the panel immediately

contiguous and to the right of that part

of the label may be used as the

information panel. Accordingly, FDA’s

regulations direct manufacturers to

move the information required to appear

on the information panel as a unit when

the first available information panel will

not accommodate all the required

information. Pursuant to § 101.2(e), all

information appearing on the

information panel must be presented in

one place without other intervening

material.

Section 101.2(b) states that the

ingredient listing; name and place of

business of the manufacturer, packer, or

distributor; and nutrition information

must appear either on the principal

display panel or on the information

panel, unless otherwise specified by

regulation. Section 101.2(d)(1) requires

that all information required to appear

on the principal display panel or the

information panel appear on the same

panel unless there is insufficient space,

in which case it may be divided

between the principal display panel and

information panel in accordance with

§§ 101.1 and 101.2. In determining the

sufficiency of the available space, under

§ 101.2(d)(1), any vignettes, designs, and

other nonmandatory label information

are not to be considered.

B. Mandatory Nutrition Labeling

In the Federal Register of January 6,

1993, FDA issued a final rule entitled

‘‘Food Labeling: Mandatory Status of

Nutrition Labeling and Nutrient Content

Revision, Format for Nutrition Label’’

(58 FR 2079) (hereinafter referred to as

‘‘the mandatory nutrition labeling final

rule’’), which included provisions to

require nutrition labeling on most foods

that are regulated by FDA and to specify

a new format for declaring nutrition

labeling. FDA took this action, in part,

to implement the Nutrition Labeling and
Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations 17203

Education Act of 1990 (Pub. L. 101–

535), which amended the Federal Food,

Drug, and Cosmetic Act. Section 101.9(i)

(21 CFR 101.9(i)), which FDA added to

its regulations as part of the mandatory

nutrition labeling final rule, states that,

except as provided in § 101.9(j)(13), the

location of the nutrition label must be

in accordance with § 101.2.

In recognizing the demands for label

space made by nutrition labeling, the

agency included a provision in the

mandatory nutrition labeling final rule

that allows nutrition information to be

presented on any label panel on

packages that have a total surface area

available to bear labeling of 40 sq in or

less (see § 101.9(j)(13)(ii)(D)). The

flexibility provided by this provision

reflects the agency’s recognition that it

is more important that the nutrition

information be presented on the

immediate package than that it be

presented in any particular place (58 FR

2079 at 2156). FDA stated that given the

consistent appearance of the nutrition

information that will be produced by

the format elements that it adopted, and

the educational efforts of government,

industry, and consumer organizations,

consumers will know to look for, and be

able to recognize, nutrition information,

even if it is not presented to the right

of the principal display panel. Section

101.9(j)(13)(ii)(D) does not provide an

exception, however, for the placement

of nutrition information on packages of

more than 40 sq in when the principal

display and information panels of those

packages cannot accommodate all of the

required information.

On January 6, 1993, the agency

published, along with the mandatory

nutrition labeling final rule and various

other final rules, the implementation

final rule (58 FR 2066). This document

gave interested persons 30 days to

comment on any technical issues that

had not been raised in earlier

comments. In response to this

document, FDA received a number of

comments that requested greater

flexibility in the placement of the

nutrition label because of the increased

amount of space needed to meet the

type size and spacing requirements of

the new nutrition label. These

comments included product labels that

illustrated the difficulties presented in

trying to place the required label

information on the information panel.

In the Federal Register of August 18,

1993 (58 FR 44091), FDA published a

proposed rule, entitled ‘‘Food Labeling;

Placement of the Nutrition Label on

Food Packages,’’ to amend its

regulations on the placement of

nutrition information on packages

having a total surface area for labeling

of greater than 40 sq in. For such

situations, the agency proposed to add

§ 101.9(j)(17). Under this provision,

when the package cannot accommodate

all information required by regulation

on its principal display panel and

information panel, the nutrition label

may be moved to any alternate panel

that can be readily seen by the

consumer. Furthermore, under proposed

§ 101.9(j)(17), the space needed for

vignettes, designs, and other

nonmandatory label information may be

considered when determining the

sufficiency of available space on the

principal display panel. FDA also

proposed to revise: (1) § 101.9(i) to make

reference to the exemption from § 101.2

for products covered by proposed

§ 101.9(j)(17), and (2) § 101.2(d)(1) to

exclude from its coverage products that

are exempt under § 101.9(j)(17). FDA

also proposed to make a number of

ancillary modifications to all of the

regulations that pertain to relative

nutrient content claims, specifically to

those sections that require that the

statement that compares the amount of

the subject nutrient in the product per

labeled serving with that in the

reference food appear either adjacent to

the most prominent claim or on the

information panel. Under the proposed

modification, the comparative

quantitative information may be placed

either adjacent to the most prominent

claim or to the nutrition label, without

regard to the panel on which the

nutrition label appears. The agency

proposed to make this modification to

each regulation in part 101 (21 CFR part

101) that pertains to relative nutrient

content claims (e.g., ‘‘more,’’ ‘‘light’’).

In addition, in response to other

comments that FDA received on the

implementation final rule, the agency

proposed to amend § 101.61(c)(2)(iii) to

require that the statement ‘‘not a sodium

free food’’ on foods that are not sodium

free and yet whose label bears a claim

of ‘‘unsalted’’ be placed adjacent to the

nutrition label rather than on the

information panel.

Interested persons were given until

October 18, 1993, to comment on the

proposal.

II. Comments and the Agency’s

Response

FDA received 19 letters, each

containing 1 or more comments, in

response to the proposal from trade

associations, food manufacturers, a state

government, and a foreign government.

The comments unanimously supported

the proposal. However, a few comments

contained suggestions for clarifying the

regulations and for modifying additional

related sections that were not covered in

the proposal. FDA is responding to

these comments in this document. In

addition, the agency received a few

comments that addressed issues such as

type size and leading (i.e., format)

requirements and specific problems

pertaining to the placement of the

ingredient list on multi-packs of readyto-eat cereals. These issues are outside

the scope of the proposal, and therefore

FDA will not address them in this

document.

A. Flexibility in Placement

1. All the relevant comments

supported FDA’s proposal in

§ 101.9(j)(17) to allow consideration of

the space needed for vignettes, designs,

and other nonmandatory label

information on the principal display

panel in deciding whether the space on

that panel and the information panel is

adequate for presentation of the

nutrition label. One comment, however,

objected to the agency’s failure to

provide for consideration of

nonmandatory information on the

information panel as part of the

determination as to whether there is

sufficient space available for the

nutrition label. The comment stated that

the agency’s position that the nutrition

facts box will be so recognizable that

consumers will not have difficulty

locating it regardless of where it appears

on the label seems to support giving

consideration to space needs for

vignettes, designs, and other

nonmandatory information on the

information panel as well as on the

principal display panel. The comment

asked that the agency clarify its intent

and permit nonmandatory label

information on the information panel to

be taken into account when deciding

whether there is sufficient space on that

panel for the nutrition facts box.

The agency’s intent in this rulemaking

was not to remove all constraints on the

placement of the nutrition label but

rather to provide added flexibility when

needed by industry to facilitate placing

the new nutrition label on food

packages. In attempting to accomplish

this purpose, the proposal did not

address the issue of nonmandatory

information on the information panel.

The agency did not see a need to alter

the current requirement in § 101.2(d)(1)

that all required information (including

the nutrition label; the ingredient list;

the name and place of business of the

manufacturer, packer, or distributor;

and the percent juice declaration) be

placed on the information panel, if not

on the principal display panel, when

there is sufficient space to do so.

In support of the proposal, FDA noted

that the appearance of many packages
17204 Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations

could be significantly affected if

regulations did not allow vignettes,

designs, and other nonmandatory

information on the principal display

panel to be considered in calculating the

amount of available label space. The

agency also noted that current industry

practice almost never places the

nutrition label on the principal display

panel unless there is no alternative

panel on the package. These two factors,

which were the impetus for the subject

proposal, do not apply to vignettes,

designs, and other nonmandatory

information on the information panel.

Thus, the interests of consumers will be

served best by continuing to have this

information appear together wherever

possible. Moreover, having the nutrition

label, the ingredient list, and the name

and place of business of the

manufacturer, packer, or distributor

appear on the same panel simplifies the

consumers’ search for this information.

The comment did not advance any

arguments that suggested a

countervailing benefit to the public from

allowing nonmandatory label

information to replace nutrition labeling

on the information panel. Accordingly,

the agency is not making the requested

change.

2. One comment stated that the

second sentence of proposed

§ 101.9(j)(17) needed to be clarified

because there was confusion in trade

publications about the significance of

nonmandatory information on the

information panel.

FDA agrees that it is necessary to

clarify the differences in the agency’s

treatment of nonmandatory information

on the principal display panel as

opposed to on the information panel.

Accordingly, the agency is revising

§ 101.9(j)(17) to add a sentence at the

end of the subparagraph that reads:

‘‘Nonmandatory label information on

the information panel shall not be

considered in determining the

sufficiency of available space for the

placement of the nutrition label.’’

B. Statements of Ingredients, and Name

and Place of Business

FDA did not propose to modify the

requirement that manufacturers list

ingredient information and the name

and place of business of the

manufacturer, packer, or distributor on

the principal display panel or the

information panel. Under § 101.9(j)(13)

and proposed § 101.9(j)(17), only the

nutrition label could be placed on

another panel.

3. Three comments urged that the

agency allow the ingredient statement

(§ 101.4) and the name and place of

business of the manufacturer, packer, or

distributor (§ 101.5) to be presented

adjacent to the nutrition label on any

other label panel that can be readily

seen by consumers when the

information panel is too small to

accommodate all the required

information. They argued that, although

consumers may now look for the

ingredient list and the name and place

of business statement on the principal

display panel or information panel, it

was likely that these statements would

be seen if listed on the same panel as

the nutrition information, which must

be readily observable. Furthermore, the

comments argued, consumers are

accustomed to seeing all of this

information on one panel, and

manufacturers often incorporate the

ingredient list, the name and place of

business statement, and the nutrition

label into one design.

Among these comments, one

recommended revised wording in

§ 101.4(a)(1) to implement the change,

i.e., to state that ingredients are to be

listed on either the principal display

panel, the information panel, or the

label panel on which the mandatory

nutrition information appears. The

comment stated that because § 101.5(a)

requires that the label of a food in

package form specify conspicuously the

name and address of the manufacturer,

packer, or distributor, that regulation

need not be amended because it allows

manufacturers the option of placing

such information in a place where the

consumer will see it.

The agency has considered these

comments and is not making the

requested change because a change of

the magnitude of that suggested was not

foreshadowed by the proposal. The

ingredient statement and the name and

place of business statements have

appeared on either the principal display

or the information panels for nearly 20

years. Allowing the ingredient list and

the name and place of business of the

manufacturer, packer, or distributor to

move off the information panel

whenever there is insufficient space for

them to appear with the nutrition label

would represent a significant

redefinition of what constitutes the

information panel. While the portion of

the food supply that would be affected

is unknown, it could be substantial.

Companies interested in pursuing this

suggestion should submit a citizen

petition under § 10.30 (21 CFR 10.30)

that would address the possible

ramifications of such a change on food

packages and on consumers’ use of the

required label information.

It should be noted, however, that

under § 101.2(a)(1), when there is

insufficient space on the panel

immediately contiguous and to the right

of the principal display panel for all

required components, the ingredient

list; the name and place of business of

the manufacturer, packer, or distributor;

and the nutrition label may be moved as

a unit to the next panel immediately

contiguous and to the right of that

panel.

C. Clarification

4. One comment requested that FDA

allow for the placement of nutrition

information on either side of a centerseamed back panel, such as on flexible

film bags used for snack foods that do

not have information printed on the

sides, top, or bottom of the package. The

comment argued that the bag is easily

rotated from front to back, and that the

full center-seamed back panel is in plain

view.

Section 101.2(a) states that the

‘‘information panel’’ is that part of the

label immediately contiguous and to the

right of the principal display panel

when observed facing the principal

display panel. If the part of the label

immediately contiguous and to the right

of the principal display panel is too

small to accommodate the necessary

information, the next panel immediately

contiguous and to the right of the fold

may be used (see § 101.2(a)(1)). In the

case of flexible film bags of snack foods

with folded or pleated side panels that

do not provide any additional usable

label space, the back panel of the bag is

the information panel. FDA interprets

the back panel to be the full back panel

of the flexible bag, regardless of the

presence or absence of a seam.

Therefore, the nutrition label may be

located on any part of the back panel.

Wherever it is placed, however,

§ 101.2(e) requires that there be no

intervening material between it and the

other pieces of required information.

III. Other Provisions

5. All comments addressing the aspect

of the proposal on relative nutrient

content claims supported the proposed

requirement that the comparative

quantitative information be positioned

adjacent to the most prominent claim or

to the nutrition label. However, in light

of § 101.2(e), which states that all

required information on the information

panel appear in one place without other

intervening material, the agency is

concerned that the proposed codified

language pertaining to relative claims in

§§ 101.54, 101.56, 101.60, 101.61, and

101.62 that would require quantitative

information to be ‘‘declared adjacent to

the most prominent claim or to the

nutrition label * * *’’ might be

interpreted to mean that when the
Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations 17205

nutrition label remains on the

information panel, the quantitative

information has to be immediately

adjacent to the nutrition label rather

than being allowed to be placed

elsewhere on the information panel in

proximity with other required

information, as is in fact the case. Such

a literal interpretation of the words

‘‘adjacent to the nutrition label’’ could

have the unintended effect of requiring

current labels containing relative claims

to be redesigned for the sole purpose of

relocating the quantitative information.

The same concern exists for

§ 101.61(c)(2)(iii), which addresses the

placement of the statement ‘‘not a

sodium free food’’ on foods that are not

sodium free and yet whose label bears

a claim of ‘‘unsalted.’’

To prevent such a misunderstanding,

FDA is modifying the codified language

pertaining to relative claims (i.e.,

‘‘more’’ claims: § 101.54(e)(1)(iii)(B) and

(e)(2)(iii)(B); ‘‘light’’ claims:

§ 101.56(b)(3)(ii), (c)(1)(ii)(B),

(c)(2)(ii)(B), and (g); calorie claims:

§ 101.60(b)(5)(ii)(B), (b)(6)(ii)(B),

(c)(4)(ii)(B), and (c)(5)(ii)(B); sodium

claims: § 101.61(b)(6)(ii)(B) and

(b)(7)(ii)(B); and fat, fatty acid, and

cholesterol claims: § 101.62(b)(4)(ii)(B),

(b)(5)(ii)(B), (c)(4)(ii)(B), (c)(5)(ii)(B),

(d)(1)(ii)(F)(2), (d)(2)(iii)(E)(2),

(d)(2)(iv)(E)(2), (d)(4)(i)(C)(2),

(d)(4)(ii)(D)(2), (d)(5)(i)(C)(2), and

(d)(5)(ii)(D)(2)) and the general

principles governing nutrient content

claims in § 101.13(j)(2)(iv)(B) (21 CFR

101.13(j)(2)(iv)(B)) to state that the

quantitative information ‘‘shall appear

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.’’ (For

clarity, FDA is making a small change

in the placement of the illustrative

example in these regulations and, for

consistency, is adding an example to

§ 101.62(d)(4)(i)(C)(2).) Likewise, the

agency is modifying § 101.61(c)(2)(iii),

which pertains to the placement of the

statement ‘‘not a low sodium food,’’ to

state that the statement shall appear

‘‘adjacent to the nutrition label of the

food bearing the claim, or, if the

nutrition label is on the information

panel, it may appear elsewhere on the

information panel in accordance with

§ 101.2 of this chapter.’’

IV. Environmental Impact

The agency previously considered the

environmental effects of this rule as

announced in the proposed rule of

August 18, 1993 (58 FR 44091). No new

information or comments have been

received that would affect the agency’s

previous determination that there is no

significant impact on the human

environment and that an environmental

impact statement is not required.

V. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this final rule will

allow for increased flexibility in

complying with labeling rules, and

therefore results in positive net benefits,

the agency certifies that the final rule

will not have a significant economic

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, 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

amended as follows:

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 (5 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 101.2 is amended by

revising paragraph (d)(1) to read as

follows:

§ 101.2 Information panel of package form

food.

* * * * *

(d)(1) Except as provided by

§ 101.9(j)(13) and (j)(17), all information

required to appear on the principal

display panel or on the information

panel pursuant to this section shall

appear on the same panel unless there

is insufficient space. In determining the

sufficiency of the available space,

except as provided by § 101.9(j)(17), any

vignettes, designs, and other

nonmandatory label information shall

not be considered. If there is insufficient

space for all of this information to

appear on a single panel, it may be

divided between these two panels

except that the information required

pursuant to any given section or part

shall all appear on the same panel. A

food whose label is required to bear the

ingredient statement on the principal

display panel may bear all other

information specified in paragraph (b) of

this section on the information panel.

* * * * *

3. Section 101.9 is amended by

revising paragraph (i) and by adding

new paragraph (j)(17) to read as follows:

§ 101.9 Nutrition labeling of food.

* * * * *

(i) Except as provided in paragraphs

(j)(13) and (j)(17) of this section, the

location of nutrition information on a

label shall be in compliance with

§ 101.2.

(j) * * *

(17) Foods in packages that have a

total surface area available to bear

labeling greater than 40 square inches

but whose principal display panel and

information panel do not provide

sufficient space to accommodate all

required information may use any

alternate panel that can be readily seen

by consumers for the nutrition label.

The space needed for vignettes, designs,

and other nonmandatory label

information on the principal display

panel may be considered in determining

the sufficiency of available space on the

principal display panel for the nutrition

label. Nonmandatory label information

on the information panel shall not be

considered in determining the

sufficiency of available space for the

nutrition label.

* * * * *

4. Section 101.13 is amended by

revising paragraph (j)(2)(iv)(B) to read as

follows:

§ 101.13 Nutrient content claims—general

principles.

* * * * *

(j) * * *

(2) * * *

(iv) * * *

(B) This statement shall appear

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information
17206 Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

* * * * *

5. Section 101.54 is amended by

revising paragraphs (e)(1)(iii)(B) and

(e)(2)(iii)(B) to read as follows:

§ 101.54 Nutrient content claims for ‘‘good

source,’’ ‘‘high,’’ and ‘‘more.’’

* * * * *

(e) * * *

(1) * * *

(iii) * * *

(B) Quantitative information

comparing the level of the nutrient in

the product per labeled serving with

that of the reference food that it replaces

(e.g., ‘‘Fiber content of white bread is 1

gram (g) per serving; (this product) 3.5

g per serving’’) is declared adjacent to

the most prominent claim or to the

nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

(2) * * *

(iii) * * *

(B) Quantitative information

comparing the level of the nutrient in

the product per specified weight with

that of the reference food that it replaces

(e.g., ‘‘The fiber content of ‘X brand of

product’ is 2 g per 3 oz. This product

contains 4.5 g per 3 oz.’’) is declared

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

6. Section 101.56 is amended by

revising paragraphs (b)(3)(ii),

(c)(1)(ii)(B), (c)(2)(ii)(B), and (g) to read

as follows:

§ 101.56 Nutrient content claims for ‘‘light’’

or ‘‘lite.’’

* * * * *

(b) * * *

(3) * * *

(ii) Quantitative information

comparing the level of calories and fat

content in the product per labeled

serving size with that of the reference

food that it replaces (e.g., ‘‘lite

cheesecake—200 calories, 4 grams (g) fat

per serving; regular cheesecake—300

calories, 8 g fat per serving’’) is declared

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2; and

* * * * *

(c) * * *

(1) * * *

(ii) * * *

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference food that it replaces (e.g., ‘‘lite

soy sauce 500 milligrams (mg) sodium

per serving; regular soy sauce 1,000 mg

per serving’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

(2) * * *

(ii) * * *

(B) Quantitative information

comparing the level of sodium per

labeled serving size with that of the

reference food that it replaces (e.g., ‘‘lite

canned peas, 175 mg sodium per

serving; regular canned peas 350 mg per

serving’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

* * * * *

(g) The term ‘‘lightly salted’’ may be

used on a product to which has been

added 50 percent less sodium than is

normally added to the reference food as

described in § 101.13(j)(1)(i)(B) and

(j)(1)(ii)(B), provided that if the product

is not ‘‘low in sodium’’ as defined in

§ 101.61(b)(4), the statement ‘‘not a low

sodium food,’’ shall appear adjacent to

the nutrition label of the food bearing

the claim, or, if the nutrition label is on

the information panel, it may appear

elsewhere on the information panel in

accordance with § 101.2 and the

information required to accompany a

relative claim shall appear on the label

or labeling as specified in § 101.13(j)(2).

7. Section 101.60 is amended by

revising paragraphs (b)(4)(ii)(B),

(b)(5)(ii)(B), (c)(4)(ii)(B), and (c)(5)(ii)(B)

to read as follows:

§ 101.60 Nutrient content claims for the

calorie content of foods.

* * * * *

(b) * * *

(4) * * *

(ii) * * *

(B) Quantitative information

comparing the level of the nutrient per

labeled serving size with that of the

reference food that it replaces (e.g.,

‘‘Calorie content has been reduced from

150 to 100 calories per serving.’’) is

declared adjacent to the most prominent

claim or to the nutrition label, except

that if the nutrition label is on the

information panel, the quantitative

information may be located elsewhere

on the information panel in accordance

with § 101.2.

* * * * *

(5) * * *

(ii) * * *

(B) Quantitative information

comparing the level of the nutrient in

the product per specified weight with

that of the reference food that it replaces

(e.g., ‘‘Calorie content has been reduced

from 108 calories per 3 oz to 83 calories

per 3 oz.’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

* * * * *

(c) * * *

(4) * * *

(ii) * * *

(B) Quantitative information

comparing the level of the sugar in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘Sugar content has been lowered from

8 g to 6 g per serving.’’) is declared

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

(5) * * *

(ii) * * *

(B) Quantitative information

comparing the level of the nutrient in

the product per specified weight with

that of the reference food that it replaces

(e.g., ‘‘Sugar content has been reduced

from 17 g per 3 oz to 13 g per 3 oz.’’)

is declared adjacent to the most

prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

8. Section 101.61 is amended by

revising paragraphs (b)(6)(ii)(B),

(b)(7)(ii)(B), and (c)(2)(iii) to read as

follows:

§ 101.61 Nutrient content claims for the

sodium content of foods.

* * * * *

(b) * * *

(6) * * *

(ii) * * *

(B) Quantitative information

comparing the level of the sodium in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘Sodium content has been lowered from

300 to 150 mg per serving.’’) is declared

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information
Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations 17207

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

* * * * *

(7) * * *

(ii) * * *

(B) Quantitative information

comparing the level of sodium in the

product per specified weight with that

of the reference food that it replaces

(e.g., ‘‘Sodium content has been reduced

from 217 mg per 3 oz to 150 mg per 3

oz.’’) is declared adjacent to the most

prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

* * * * *

(c) * * *

(2) * * *

(iii) If the food is not sodium free, the

statement, ‘‘not a sodium free food’’ or

‘‘not for control of sodium in the diet’’

appears adjacent to the nutrition label of

the food bearing the claim, or, if the

nutrition label is on the information

panel, it may appear elsewhere on the

information panel in accordance with

§ 101.2.

* * * * *

9. Section 101.62 is amended by

revising paragraphs (b)(4)(ii)(B),

(b)(5)(ii)(B), (c)(4)(ii)(B), (c)(5)(ii)(B),

(d)(1)(ii)(F)(2), (d)(2)(iii)(E)(2),

(d)(2)(iv)(E)(2), (d)(4)(i)(C)(2),

(d)(4)(ii)(D)(2), (d)(5)(i)(C)(2), and

(d)(5)(ii)(D)(2) to read as follows:

§ 101.62 Nutrient content claims for fat,

fatty acid, and cholesterol content of foods.

* * * * *

(b) * * *

(4) * * *

(ii) * * *

(B) Quantitative information

comparing the level of fat in the product

per labeled serving with that of the

reference food that it replaces (e.g., ‘‘Fat

content has been reduced from 8 g to 4

g per serving.’’) is declared adjacent to

the most prominent claim or to the

nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

* * * * *

(5) * * *

(ii) * * *

(B) Quantitative information

comparing the level of fat in the product

per specified weight with that of the

reference food that it replaces (e.g., ‘‘Fat

content has been reduced from 7.5 g per

3 oz to 5 g per 3 oz.’’) is declared

adjacent to the most prominent claim, to

the nutrition label, or, if the nutrition

label is located on the information

panel, it may appear elsewhere on the

information panel in accordance with

§ 101.2.

* * * * *

(c) * * *

(4) * * *

(ii) * * *

(B) Quantitative information

comparing the level of saturated fat in

the product per labeled serving with

that of the reference food that it replaces

(e.g., ‘‘Saturated fat reduced from 3 g to

1.5 g per serving’’) is declared adjacent

to the most prominent claim or to the

nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

* * * * *

(5) * * *

(ii) * * *

(B) Quantitative information

comparing the level of saturated fat in

the product per specified weight with

that of the reference food that it replaces

(e.g., ‘‘Saturated fat content has been

reduced from 2.5 g per 3 oz to 1.7 g per

3 oz.’’) is declared adjacent to the most

prominent claim or to the nutrition

label, except that if the nutrition label

in on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

* * * * *

(d) * * *

(1) * * *

(ii) * * *

(F) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘Contains no cholesterol compared with

30 mg cholesterol in one serving of

butter. Contains 13 g of fat per serving.’’)

is declared adjacent to the most

prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

(2) * * *

(iii) * * *

(E) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘Cholesterol lowered from 30 mg to 5

mg per serving; contains 13 g of fat per

serving.’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

(iv) * * *

(E) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘Cholesterol lowered from 30 mg to 5

mg per serving; contains 13 g of fat per

serving.’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

* * * * *

(4) * * *

(i) * * *

(C) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘[labeled product] 50 mg cholesterol per

serving; [reference product] 30 mg

cholesterol per serving’’) is declared

adjacent to the most prominent claim or

to the nutrition label, except that if the

nutrition label is on the information

panel, the quantitative information may

be located elsewhere on the information

panel in accordance with § 101.2.

(ii) * * *

(D) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per labeled serving with that of

the reference food that it replaces (e.g.,

‘‘Cholesterol lowered from 55 mg to 30

mg per serving. Contains 13 g of fat per

serving.’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.

* * * * *

(5) * * *

(i) * * *

(C) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per specified weight with that

of the reference food that it replaces

(e.g., ‘‘Cholesterol content has been

reduced from 35 mg per 3 oz to 25 mg

per 3 oz.’’) is declared adjacent to the

most prominent claim or to the nutrition

label, except that if the nutrition label

is on the information panel, the

quantitative information may be located

elsewhere on the information panel in

accordance with § 101.2.
17208 Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Rules and Regulations

(ii) * * *

(D) * * *

(2) Quantitative information

comparing the level of cholesterol in the

product per specified weight with that

of the reference food that it replaces

(e.g., ‘‘Cholesterol lowered from 30 mg

to 22 mg per 3 oz of product.’’) is

declared adjacent to the most prominent

claim or to the nutrition label, except

that if the nutrition label is on the

information panel, the quantitative

information may be located elsewhere

on the information panel in accordance

with § 101.2.

* * * * *

Dated: March 24, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–8067 Filed 3–31–95; 4:32 pm]

BILLING CODE 4160–01–P

21 CFR Part 876

[Docket No. 92N–0382]

Gastroenterology-Urology Devices;

Effective Date of Requirement for

Premarket Approval of Testicular

Prosthesis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to require the filing of a premarket

approval application (PMA) or a notice

of completion of a product development

protocol (PDP) for the testicular

prosthesis, a generic type of a surgically

implanted medical device intended to

simulate the presence of a testicle

within the male scrotum. Commercial

distribution of this device must cease,

unless a manufacturer or importer has

filed with FDA a PMA or a notice of

completion of a PDP for its version of

the testicular prosthesis within 90 days

of the effective date of this regulation.

This regulation reflects FDA’s exercise

of its discretion to require a PMA or

notice of completion of a PDP for

preamendments devices.

EFFECTIVE DATE: April 5, 1995.

FOR FURTHER INFORMATION CONTACT:

Mark D. Kramer, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of January 6,

1989 (54 FR 550), the agency identified

the testicular prosthesis as one of the

high-priority devices that would be

subject to PMA or PDP requirements.

This rulemaking is consistent with

FDA’s stated priorities and Congress’

requirement that class III devices are to

be regulated by FDA’s premarket

approval review. This action is being

taken under the Medical Device

Amendments of 1976 (Pub. L. 94–295).

The preamble to this rule responds to

comments received on the proposal to

require the filing of a PMA or a notice

of completion of a PDP.

This regulation is final upon

publication and requires a PMA or a

notice of completion of a PDP for all

testicular prostheses classified under

§ 876.3750 (21 CFR 876.3750) and all

devices that are substantially equivalent

to them. A PMA or a notice of

completion of a PDP for these devices

must be filed with FDA within 90 days

of the effective date of this regulation.

(See section 501(f)(1)(A) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351(f)(1)(A)).)

In the Federal Register of November

23, 1983 (48 FR 53012 at 53024), FDA

issued a final rule classifying the

testicular prosthesis into class III

(premarket approval). Section 876.3750

of FDA’s regulations setting forth the

classification of the testicular prosthesis

intended for medical use applies to: (1)

Any testicular prosthesis that was in

commercial distribution before May 28,

1976, and (2) any device that FDA has

found to be substantially equivalent to

a testicular prosthesis in commercial

distribution before May 28, 1976.

In the Federal Register of January 13,

1993 (58 FR 4116), FDA published a

proposed rule to require the filing,

under section 515(b) of the act (21

U.S.C. 360e(b)), of a PMA or notice of

completion of a PDP for the classified

testicular prosthesis and all

substantially equivalent devices

(hereinafter referred to as the January

1993 proposed rule). In accordance with

section 515(b)(2)(A) of the act, FDA

included in the preamble to the

proposal the agency’s proposed findings

regarding: (1) The degree of risk of

illness or injury designed to be

eliminated or reduced by requiring the

device to meet the premarket approval

requirements of the act, and (2) the

benefits to the public from use of the

device (58 FR 4116 at 4118).

The preamble to the January 1993

proposed rule also provided an

opportunity for interested persons to

submit comments on the proposed rule

and the agency’s proposed findings and,

under section 515(b)(2)(B) of the act (21

U.S.C. 360e(b)(2)(B)), provided the

opportunity for interested persons to

request a change in the classification of

the device based on new information

relevant to its classification. Any

petition requesting a change in the

classification of the testicular prosthesis

was required to be submitted by January

28, 1993. The comment period initially

closed on March 15, 1993. Because of

one request, FDA extended the

comment period for 60 days to May 14,

1993, to ensure adequate time for

preparation and submission of

comments (58 FR 15119, March 19,

1993).

FDA did not receive any petitions

requesting a change in the classification

of the testicular prosthesis. The agency

did receive a total of five comments in

response to the January 1993 proposed

rule. These represent comments from

individuals, manufacturers, and

professional societies. The comments

primarily addressed issues relating to

the significant risks associated with the

use of testicular prostheses, and the

preclinical and clinical data needed to

support a future PMA application.

II. Summary and Analysis of Comments

and FDA’s Response

A. General Comments

1. One comment stated that it appears

that FDA has chosen solid silicone

elastomer testicular implants for

disparate treatment from other silicone

implants, even though the basic

chemistry, ingredients, and many

manufacturing steps are very similar to

other class II implantable silicone

products. The comment requested that

FDA describe the differences between

silicone gel-filled and solid silicone

elastomer testicular implants, and

between silicone gel-filled mammary

prostheses and solid silicone elastomer

testicular prostheses.

FDA disagrees with this comment.

The testicular prosthesis was classified

into class III in 1983 because

insufficient information existed to

determine that general controls would

provide reasonable assurance of the

safety and effectiveness of the device or

to establish a performance standard to

provide this assurance. The possible

risks identified at the time of

classification included: (1) The possible

migration of silicone gel from the

interior of the prosthesis to adjacent

tissue (with or without rupture of the

silicone elastomer shell), and (2)

possible long-term toxic effects of the

silicone polymers from which the

prosthesis is fabricated. Therefore,

requiring premarket approval for the

testicular prosthesis is consistent with

the intent to regulate this device as a

class III device even in 1983. FDA notes

that no requests for a change in