Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29701

1The type size and location requirements apply

to all information required to appear on the label

of any package of food under certain regulations

that are referenced in § 101.2. The information must

appear either on the principal display panel or the

information panel unless otherwise specified in the

regulations. Section 101.2(a) defines the term

‘‘information panel’’ as it applies to packaged food,

and § 101.2(b) identifies referenced regulations.

Section 101.2(c) requires that information required

by the referenced regulations be in letters or

numbers of at least one-sixteenth inch in height,

unless otherwise exempted by regulation.

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 16, 1995, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ANM MT E5 Libby, MT

Libby Airport, MT

(Lat 48°17′02′′N, long. 115°29′25′′W)

That airspace extending upward from 700

feet above the surface within a 7-mile radius

of the Libby Airport and within 4 miles each

side of the 345° bearing from the Libby

Airport extending from the 7-mile radius to

10 miles northwest of the airport; that

airspace extending upward from 1,200 feet

above the surface within an area bounded by

a line beginning at lat. 48°19′00′′N, long.

115°42′00′′W; to lat. 48°19′00′′N, long

115°16′00′′W; to lat. 48°45′00′′N, long.

115°22′00′′W; to lat. 48°45′00′′N, long.

115°50′00′′W, to point of beginning.

* * * * *

Issued in Seattle, Washington, on May 28,

1996.

Richard E. Prang,

Acting Assistant Manager, Air Traffic

Division, Northwest Mountain Region.

[FR Doc. 96–14875 Filed 6–11–96; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 70, 71, 80, 101, 107, 170,

172, 173, 174, 175, 177, 178, 184, and

1250

[Docket No. 96N–0149]

Food Standards; Reinvention of

Regulations Needing Revisions;

Request for Comments on Certain

Existing Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it intends to review its human food

labeling regulations pertaining to: The

exemption for soft drinks from

requirements for the type size and

placement of certain information on the

information panel, requirements for

listing ‘‘statements of identity,’’ and

requirements for flavor labeling; its

infant formula regulations to ensure that

they fully reflect the Federal Food,

Drug, and Cosmetic Act (the act); and its

regulations pertaining to the discharge

of waste aboard casino ships, passenger

ships, and ferries. The agency is also

conducting a review of its food additive

regulations to consolidate existing

regulations. As part of this review of

agency regulations, the agency is

soliciting comments from all interested

persons on whether the above

regulations should be retained, revised,

or revoked. FDA solicits comments on

the benefits or lack of benefits of such

regulations in facilitating domestic, as

well as international, commerce and on

the value of these regulations to

consumers. The agency also solicits

comments on alternative means of

accomplishing the statutory objectives

that led to the adoption of the subject

regulations. This review is in response

to the Administration’s ‘‘Reinventing

Government’’ initiative which seeks to

ease the burden on regulated industry

and consumers.

DATES: Written comments by September

10,1996.

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:

Corinne L. Howley, Center for Food

Safety and Applied Nutrition (HFS–24),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–4272.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1995, President Clinton

announced plans for the reform of the

Federal regulatory system as part of the

Administration’s ‘‘Reinventing

Government’’ initiative. In his March 4

directive, the President ordered all

Federal agencies to conduct a page-bypage review of all of their regulations to

‘‘eliminate or revise those that are

outdated or otherwise in need of

reform.’’

In response to this directive, FDA

issued proposals to revoke a number of

regulations (60 FR 53480, October 13,

1995; 60 FR 56513 and 56541,

November 9, 1995) and an advance

notice of proposed rulemaking

(ANPRM) to review standards of

identity, quality, and fill of container

(60 FR 67492, December 29, 1995). The

agency has completed the review of its

food regulations in response to the

President’s initiative and as a result is

publishing two documents elsewhere in

this issue of the Federal Register. This

document is an ANPRM to review

regulations that the agency believes may

need to be revised. In addition to

requesting information on the following

issues, FDA requests any other

comments relevant to the regulations

discussed herein that would assist the

agency in fulfilling its mission to protect

the interest of consumers.

II. Soft Drinks

Elsewhere in this issue of the Federal

Register, FDA is proposing a number of

changes in § 101.2 (21 CFR 101.2)

pertaining to information that must

appear on the information panel of the

label. FDA explains in that document

that it considers a number of

exemptions from the type size and

placement requirements in § 101.2 to be

obsolete, and the agency is proposing to

remove them. 1 The exemptions that

FDA is proposing to remove appear in

§ 101.2(c), but that paragraph also

contains a number of exemptions that

the agency is not proposing to revoke.

Among the latter exemptions is a

provision for soft drinks in § 101.2(c)(4).

FDA is undecided about whether to

retain this provision because the agency

does not know enough about

nationwide packing practices for these

products. For example, this provision

exempts soft drink bottles that were

manufactured before October 31, 1975,

from the type size and placement

requirements. The agency does not

know, however, whether any bottles

manufactured before that date are still

in use. If not, this exemption is obsolete

and should be removed. Other soft drink

exemptions may also be obsolete, or in

need of revision, to respond more

efficiently to changes in labeling

practices that have resulted from the

Nutrition Labeling and Education Act

(the 1990 amendments). The agency

needs to know more about how firms

are presenting newly required

information to consumers on labels and

on labeling materials other than labels

(e.g., counter cards, posters), as well as

whether they are encountering any

difficulties associated with such

presentation, before it can determine

whether it should pursue further

rulemaking activities for soft drinks. For

example, where soft drink

manufacturers are using posters for

some label information, there may be

ample free space to present ingredient
29702 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

information in relatively large type size.

Would consumers be better informed by

such a presentation of this information

than they would with smaller type size

on the soft drink package itself? If FDA

were to permit alternative labeling

locations for information required to

appear on the information panel, would

the current soft drink exemptions still

be needed? FDA requests comments on

these issues from all interested parties.

III. Statements of Identity

Section 101.3(a) and (b) (21 CFR

101.3(a) and (b)) requires that the

principal display panel of the label of

food in package form bear a statement

of identity of the food product.

Specifically, § 101.3 requires that the

statement of identity be in terms of the

name of the food as required by Federal

law or regulation or, in the absence of

such, of the common or usual name for

the food. If no such common or usual

name has been established, the

statement of identity must be an

appropriately descriptive term. When

the nature of the food is obvious,

however, a fanciful name commonly

used by the public for the food may be

used.

This regulation also requires, among

other things, that where the food is

marketed in optional forms (whole,

slices, diced), the particular form be

considered a necessary part of the name

(§ 101.3(c)). This provision does not

affect the required declarations of

identity under definitions and standards

of identity for foods that specify other

ways of declaring the optional forms of

the food.

Section 101.3(d) requires that the

statement of identity be presented in

bold type on the principal display panel

of the label, be in a type size that is

reasonably related to the most

prominent printed matter on such

panel, and be in lines generally parallel

to the base on which the package rests

as it is designed to be displayed. These

provisions were established to meet the

prominence and conspicuousness

requirements of section 403(f) of the act

(21 U.S.C. 343(f)).

The requirement that the type size in

which the statement of identity appears

be reasonably related to the largest type

size used on the principal display panel

has been informally interpreted by FDA

to mean that the statement of identity

must appear in type not less than onehalf the size of the largest printed matter

on the principal display panel.

However, the agency has observed that

brand name identifications and flavor

declarations often appear many times

larger than the statement of identity on

the food label. The agency requests

comments on whether the statements of

identity are sufficiently conspicuous in

light of other representations on the

principal display panel. If they are not,

how should the regulation be changed

to ensure that the type size used for the

statement of identity will be adequate?

For example, should FDA’s informal

guidance be established as a

requirement in a regulation? Should a

different criterion be established,

perhaps related to the area of the

principal display panel, similar to the

requirement for net contents

declaration?

FDA is also aware that some identity

statements are not placed parallel to the

base on which the container rests. Does

this create problems for consumers in

reading labels? Are there specific needs

for variations from this requirement that

should be provided for by special

exemptions? For example, do

advancements in packaging foods and in

displaying them justify exemptions for

certain types of packaging?

Section 101.3(e) defines the term

‘‘imitation’’ and how it is to be used in

the labeling of foods. This provision

states that a food shall be deemed to be

an imitation, and thus subject to the

requirements of section 403(c) of the act,

if it is a substitute for and resembles

another food but is nutritionally inferior

to that food. If the food is an imitation,

as so defined, then the label of the food

must bear in type of uniform size and

prominence, the word ‘‘imitation’’ and,

immediately thereafter, the name of the

food imitated.

When section 403(c) of the act was

adopted in 1938, Congress was seeking

to protect the consumer from the

uninformed purchase of an inferior

substitute product that could be

mistaken for a traditional food product

(38 FR 2138, January 19, 1973). In 1973,

in proposed regulations pertaining to

imitation foods, the agency noted that

vast strides in food technology had

taken place since section 403(c) of the

act was enacted, and that since 1938

many new wholesome and nutritious

food products had entered the

marketplace, some of which resembled

and substituted for traditional foods (38

FR 2138). The agency stated that it was

no longer the case that such products

were necessarily substandard compared

to the traditional foods for which they

substituted. However, FDA still believed

that the consumer must be protected

from the unwitting purchase of a

product that is different from what he or

she may reasonably expect (38 FR 2138).

FDA proposed that the term ‘‘imitation’’

only be applied to substitute foods that

are nutritionally inferior to the foods for

which they substitute (38 FR 2143 at

2148). In its final regulation (38 FR

20703, August 2, 1973), FDA confirmed

this view and defined nutritional

inferiority as any reduction in the

content of an essential nutrient that is

present in a measurable amount.

Over the years, FDA has received

questions as to when a food is

considered to resemble and substitute

for a traditional food, so that it is subject

to the provisions of this regulation. The

agency has advised that where there is

no standard of identity for the food in

parts 130 through 169 (21 CFR parts 130

through 169), no common or usual name

regulation in part 102 (21 CFR part 102),

or no provision for the food in the

nutritional quality guideline that

appears in part 104 (21 CFR part 104),

the product must be evaluated in terms

of whether it resembles or purports to be

(has similar functional, physical, and

organoleptic properties), and whether it

substitutes for, a food product that has

a commonly understood identity or

common or usual name. For example,

there are products on the market that are

textured, colored, flavored, and shaped

to resemble crabmeat. These products

resemble and substitute for crabmeat,

and when they are nutritionally inferior

to crabmeat, they must be labeled

‘‘imitation crabmeat.’’

In addition, manufacturers have often

sought advice on how a food should be

labeled when it resembles and

substitutes for a traditional food but is

not nutritionally inferior to the

traditional food. In some cases, the

agency has recommended the use of the

term ‘‘substitute’’ as part of the name of

such a food. For example, the agency

has advised that a beverage made by

replacing the milkfat in milk with

vegetable oil, and which is not

nutritionally inferior to milk, could be

labeled as a ‘‘milk substitute.’’ The

agency stated that the name would be

followed by a descriptive phrase, such

as ‘‘made with skim milk and vegetable

oil’’ or ‘‘contains 3 percent soybean oil

to replace the milkfat,’’ to inform the

consumer as to the difference between

the milk substitute and milk.

In view of these questions, the agency

is seeking comment on whether it

should develop more in-depth guidance

to assist manufacturers in naming new

food products. If so, how should this be

accomplished: through revision of the

regulations in §§ 101.3 or 102.5

(common or usual

name), a Compliance Policy Guide, or

other less formal guidance, such as an

addendum to FDA’s Food Labeling

Guide? In developing comments on this

issue, interested parties should keep in

mind that FDA has published an

ANPRM seeking comment on whether
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29703

and how standards of identity and

common or usual name regulations

should be revised (60 FR 67492). Many,

though not all, of the foods subject to

§ 101.3(e) resemble and substitute for

foods subject to those regulations. FDA

will evaluate any proposed changes in

its policy on labeling of imitation foods

in light of any changes it ultimately

decides to make in its approach to

standards of identity and common or

usual name regulations.

In § 101.3(e)(4), FDA has defined

nutritional inferiority to include any

reduction in the content of an essential

nutrient that is present in a measurable

amount. A measurable amount of an

essential nutrient under this regulation

is 2 percent or more of the Daily

Reference Value of protein listed under

§ 101.9(c)(7)(iii) (21 CFR 101.9(c)(7)(iii))

and of potassium listed under

§ 101.9(c)(9) and of the Reference Daily

Intake (RDI) of any vitamin or mineral

listed under § 101.9(c)(8)(iv). In the

Federal Register of December 28, 1995

(60 FR 67164), FDA established RDI’s

for several nutrients and revised the

definition of nutritional inferiority to

accommodate those new RDI’s where

practicable. The agency stated that as

substitute products proliferate, it is

important to ensure that these products

contain essential nutrients in amounts

consistent with the reference food, so

that consumers can continue to have

confidence that a varied diet will supply

adequate nutrition (60 FR 67164 at

67169).

The agency is requesting comment on

the appropriateness of the current

definition of nutritional inferiority for

the purpose of determining whether a

food is an imitation. Fat and calories are

currently excluded from the nutrients to

be considered when determining

nutritional inferiority. The agency did

not reevaluate this provision when it

revised the definition of nutritional

inferiority in the December 28, 1995,

final rule. Nonetheless, it now seeks

comment on whether that definition

should be further revised. Should the

definition be changed to take into

account current dietary guidelines? For

example, should sodium, saturated fat,

and cholesterol be excluded from the

nutrients to be considered? On the other

hand, if a substitute food is modified to

achieve a nutrition goal, such as a

reduction in the sodium content of the

diet, and as a consequence the fat or

calorie content of the food is increased

to achieve a more palatable product,

should such a product be considered to

be nutritionally inferior? Is there some

other way of highlighting such a change

on the label?

FDA notes that the concept of

nutritional inferiority is widely used in

the agency’s regulations and

interpretations. For example, FDA relies

on this concept in the definition of the

term ‘‘substitute’’ food in § 101.13

Nutrient content claims—general

principles. Section 101.13(d) states that

a ‘‘substitute’’ food is one that may be

used interchangeably with another food

that it resembles, i.e., to which it is

organoleptically, physically, and

functionally (including shelf life)

similar, and to which it is not

nutritionally inferior, unless it is labeled

as an ‘‘imitation.’’ In addition, the

general standard of identity, § 130.10

Requirements for foods named by use of

a nutrient content claim and a

standardized term (21 CFR 130.10),

explains how to derive statements of

identity for foods that substitute for and

resemble traditional standardized foods.

This regulation specifically references

§ 101.3(e) and provides for the addition

of nutrients to the new food so that it

will not be nutritionally inferior to the

traditional standardized food that is

named in the statement of identity.

Thus, comments that suggest changes in

the definition of nutritional inferiority

in § 101.3(e) should also consider the

effect of such changes on the labeling of

foods covered by other regulations such

as those mentioned here.

IV. Flavors

FDA’s flavor labeling regulation,

§ 101.22 (21 CFR 101.22), has generated

many questions over the years. Some

representatives of the food industry

have complained that this regulation is

so complex that it is subject to a

multitude of differing interpretations. In

light of such complaints, FDA believes

that it should attempt to revise this

regulation to make it more user friendly

and, at the same time, to make flavor

designations on food labels more

meaningful to consumers. Comments on

the existing regulation will help the

agency to achieve this goal.

Section 101.22 lists a variety of

characteristics that would make the

flavoring used in a food either

‘‘artificial’’ or ‘‘natural.’’ The regulation

does not, however, contain an adequate

definition for either term. Before a firm

can decide how to describe the flavoring

used in its product, it may have to

engage in a rather arduous analysis. For

example:

In § 101.22(a), FDA defines an

‘‘artificial flavor’’ or ‘‘artificial

flavoring’’ as any substance, the

function of which is to impart flavor,

which is not derived from a spice, fruit

or fruit juice, vegetable or vegetable

juice, edible yeast, herb, bark, bud, root,

leaf, or similar plant material, meat,

fish, poultry, eggs, dairy products, or

fermentation products thereof. The

term ‘‘artificial flavor’’ also includes

those synthetic flavoring substances and

adjuvants listed in §§ 172.515(b) and

182.60 (21 CFR 172.515(b) and 182.60)

except where the flavors are derived

from natural sources.

This definition would be simpler if

FDA could state that the term ‘‘artificial

flavor’’ generally connotes a synthetic

source. However, the agency has

traditionally viewed this term as having

wider application than simply to

synthetic substances. For example, FDA

has advised that when a flavor from a

natural source is used in a food product

to simulate a flavor of a food other than

the one from which the flavor is

derived, the food to which the flavor is

added must be labeled as ‘‘artificially

flavored’’ (38 FR 20718, August 2,

1973). Thus, a ‘‘lemon’’ type pie, made

with natural flavor derived

predominantly from citrus products,

could not be identified simply as

‘‘lemon pie’’ without misleading the

consumer. It must be labeled as ‘‘citrus

pie’’ or ‘‘artificially flavored lemon pie.’’

This position has led to considerable

confusion because often manufacturers

do not consider the end use of the

flavoring, in addition to its source, in

determining whether the food should be

labeled as being ‘‘artificially flavored.’’

Further, the exception in the

definition of ‘‘artificial flavor’’ that

permits substances that are listed as

synthetic flavoring substances and

adjuvants in §§ 172.515(b) and 182.60 to

be designated as ‘‘natural’’ when they

are derived from ‘‘natural sources’’ has

resulted in a very broad category of

substances labeled as ‘‘natural flavor.’’

There is confusion regarding the

interpretation of ‘‘natural source’’ in this

context. Should this provision be

retained? If so, how should it be phrased

so that it can be interpreted

consistently?

The agency’s definition for ‘‘natural

flavor’’ is also very complex. In

§ 101.22(a)(3), FDA defines ‘‘natural

flavor’’ or ‘‘natural flavoring’’ as the

essential oil, oleoresin, essence or

extractive, protein hydrolysate,

distillate, or any product of roasting,

heating or enzymolysis, that contains

the flavoring constituents derived from

a spice, fruit or fruit juice, vegetable or

vegetable juice, edible yeast, herb, bark,

bud, root, leaf, or similar plant material,

meat, seafood, poultry, eggs, dairy

products, or fermentation products

thereof, whose significant function in

food is flavoring rather than nutritional.

Natural flavors include natural essence

or extractives obtained from plants
29704 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

listed in 21 CFR 182.10, 182.20, 182.40,

and 182.50 and part 184 (21 CFR part

184) and such substances listed in 21

CFR 172.510.

Recognizing that, with advances being

made in the technology of flavor

development, the distinctions

established in its regulations and policy

statements may need to be modified,

FDA requests comments on whether

and, if so, how the definitions of natural

and artificial flavor should be revised.

For example, if a substance from a

natural source is used to produce an

intermediate product that is further

reacted with another substance from a

natural source, e.g., hydrolyzed by use

of enzymes or other substances, should

the resultant flavor, which obviously

differs from its original natural source,

be permitted to be labeled as ‘‘natural,’’

or should the new flavoring compound

be considered to be ‘‘an artificial flavor’’

because the new flavor is not native to

the natural sources? Should

hydrolysates and their reaction products

continue to be considered as natural

flavors? What about flavors produced by

the Maillard reaction? Would it be better

to define ‘‘natural flavor’’ and simply

provide that ‘‘artificial flavor’’

constitutes all flavor that does not fall

within that definition, or vice versa?

Does it make sense to simply abandon

the distinction between ‘‘artificial’’ and

‘‘natural’’ flavoring as no longer being

relevant to the interests and

understanding of consumers and to

simply provide for the use of the term

‘‘flavor added’’ on the principal display

panel and as part of the ingredient list?

In addition, FDA would like to focus

attention on the designation of

characterizing flavors on food labels in

accordance with § 101.22(i). This matter

has provided another source of

confusion. Section 101.22(i) provides

that if the label or labeling or

advertising makes any direct or indirect

representations with respect to the

primary recognizable flavors of a food,

by word, vignette (e.g., by depiction of

a fruit) or other means, or if for any

reason the manufacturer or distributor

of the food wishes to designate the type

of flavor in the food other than through

the statement of ingredients, such flavor

shall be considered to be the

characterizing flavor and shall be

designated in the following way:

1. If the food contains no artificial

flavor that simulates, resembles, or

reinforces the characterizing flavor, the

name of the food on the principal

display panel or panels of the label shall

be accompanied by the common or

usual name of the characterizing flavor,

e.g., ‘‘vanilla,’’ in letters not less than

one-half the height of the letters used in

the name of the food.

2. If the food is one that is commonly

expected to contain a characterizing

food ingredient, e.g., strawberries in

‘‘strawberry shortcake,’’ and the food

contains natural flavor derived from

such ingredient, but the amount of the

characterizing ingredient is insufficient

to independently characterize the food,

or the food contains no such ingredient,

the name of the characterizing flavor

may be immediately preceded by the

word ‘‘natural’’ and shall be

immediately followed by the word

‘‘flavored’’ in letters not less than onehalf the height of the letters in the name

of the characterizing flavor, e.g.,

‘‘natural strawberry flavored shortcake’’

or ‘‘strawberry flavored shortcake.’’

3. If none of the natural flavor used

in the food is derived from the product

whose flavor is simulated, the food in

which the flavor is used shall be labeled

either with the flavor of the product

from which the flavor is derived or as

‘‘artificially flavored.’’

4. If the food contains both a

characterizing flavor from the product

whose flavor is simulated and other

natural flavor that simulates, resembles,

or reinforces the characterizing flavor,

the name of the food shall be

immediately followed by the words

‘‘with other natural flavor’’ in letters not

less than one-half the height of the

letters used in the name of the

characterizing flavor.

5. If the food contains any artificial

flavor that simulates, resembles, or

reinforces the characterizing flavor, the

name of the food on the principal

display panel or panels of the label shall

be accompanied by the common or

usual name of the characterizing flavor,

in letters not less than one-half the

height of the letters used in the name of

the food, and the name of the

characterizing flavor shall be

accompanied by the words ‘‘artificial’’

or ‘‘artificially flavored,’’ in letters not

less than one-half the height of the

letters in the name of the characterizing

flavor, e.g., ‘‘artificial vanilla,’’

‘‘artificially flavored strawberry,’’ or

‘‘grape artificially flavored.’’

6. Wherever the name of the

characterizing flavor appears on the

label (other than in the statement of

ingredients) so conspicuously as to be

easily seen under customary conditions

of purchase, the words prescribed by

§ 101.22(i) shall immediately and

conspicuously precede or follow such

name, without any intervening written,

printed, or graphic matter, with certain

exceptions.

These provisions are so complex that

it is not surprising that they have

frequently been the cause of confusion

and varying interpretations by both

manufacturers and regulators. The

regulation needs to be clarified. In

addition, developments in food

processing since the regulation was

adopted have resulted in the

manufacture of more diverse products

using natural and artificial flavors.

The agency requests comment on how

the use of flavors should be declared on

the food label. Some manufacturers

have contended that declaration of

natural and artificial flavors in the

ingredient list is sufficient to inform

consumers of their role in the food.

FDA’s position has been that consumers

can be misled unless the characterizing

flavor of the food is described as

‘‘flavored’’ when flavoring substances

are needed to characterize the food. The

agency’s position has been that the term

‘‘artificial’’ should be used to describe

the flavor unless it is a natural flavor

and is from the same source as the

flavor of the food.

What is the best way to inform the

consumer of the use and the role of a

flavoring substance in a food? How

should a combination of natural and

artificial flavors be declared? The

agency requests suggestions for

revisions of § 101.22(i) and

substantiating information regarding

why the suggested revisions are

appropriate, and how they would affect

marketing practices.

Further, § 101.22(i) requires that the

flavor supplier certify, in writing, that

any flavor it supplies that is designated

as containing no artificial flavor does

not, to the best of the supplier’s

knowledge and belief, contain any

artificial flavor, and that the supplier

has not added any artificial flavor to it.

Although the agency is not aware of any

concerns about labeling of flavors

supplied to manufacturers, it requests

comments on the suitability of these

requirements.

V. Infant Formula

Part 107 (21 CFR part 107) provides

for labeling of infant formulas, for terms

and conditions that a manufacturer

must meet with respect to exempt infant

formulas, for required levels of nutrients

in infant formulas as prescribed by

statute, and for recalls of infant formulas

in appropriate circumstances. Congress

passed the Infant Formula Act of 1980

(the 1980 act) (Pub. L. 96–359), which

amended the act to add section 412 (21

U.S.C. 350a). In 1985, FDA partially

implemented the 1980 act by

establishing subparts B, C, and D in part

107 regarding the labeling of infant

formula, exempt infant formulas, and

nutrient requirements for infant
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29705

formula, respectively (50 FR 1833,

January 14, 1985; 50 FR 48183,

November 22, 1985; and 50 FR 45106,

October 30, 1985). In 1986, Congress, as

part of the Drug Enforcement,

Education, and Control Act of 1986 (the

1986 amendments) (Pub. L. 99–570),

completely revamped section 412 of the

act to address concerns that had been

expressed by Congress and consumers

about the 1980 act and FDA’s

implementation of those provisions.

In 1990, Congress passed the 1990

amendments which amended the act to

add paragraphs (q) and (r) to section

403. While the 1990 amendments

exempt infant formulas subject to

section 412 of the act from the nutrition

labeling provisions of section 403(q) of

the act, only infant formulas subject to

section 412(h) of the act (exempt infant

formulas) are exempt from the nutrient

content and health claims provisions of

section 403(r).

The agency is considering what

changes need to be made to part 107 in

light of the 1986 and 1990 amendments

to the act. Subpart D of part 107—

Nutrient Requirements was not affected

by either the 1986 or 1990 amendments

and is not being reconsidered under this

review. In 1989, the agency responded

to the provisions of the 1986

amendments on recalls by establishing

subpart E in part 107—Infant Formula

Recalls (54 FR 4006, January 27, 1989).

To assist in the update of subparts B

(Labeling) and C (Exempt Infant

Formulas) of part 107, the agency

requests comments on what matters

need to be addressed.

Section 412(h)(1) of the act states that

‘‘any infant formula which is

represented and labeled for use by an

infant—(A) who has an inborn error of

metabolism or a low birth weight, or (B)

who otherwise has an unusual medical

or dietary problem, is exempt from the

requirements of * * *’’ section 412(a)

(adulteration provisions of the act for

failure to meet the nutrient

requirements of the act, failure to meet

the quality factor requirements, and

failure to process the infant formula in

compliance with the good

manufacturing practices and quality

control procedures), (b) (quality factors

and good manufacturing requirements

including quality control procedures),

and (c) (registration, submission, and

notification requirements). Section

412(h)(2) of the act provides that the

Secretary of Health and Human Services

(and by delegation FDA) may by

regulation establish terms and

conditions for the exemption of an

infant formula from the requirements of

section 412(a), (b), and (c).

In 1980, the House Committee on

Interstate and Foreign Commerce stated:

The Committee recognizes the need to

make special formulas available without the

imposition of cumbersome regulations which

may discourage formula manufacturers from

committing resources into this vital public

service. Conditions on exemptions

promulgated under this authority should not

make access to special formulas difficult.

Instead, they should insure that such

formulas are manufactured to the same high

standards of quality required of formulas for

normal infants. The Committee recognizes

the importance of these products and the

continued need to make them and new

products like them, readily available to the

public.

(H. Rept. 96–936, 96th Cong., 2d sess.,

1980, p.10.)

The agency is soliciting comment on

what terms and conditions should be set

for the exemption of an infant formula

from the requirements of section 412(a),

(b), and (c) of the act.

In the past, FDA and infant formula

manufacturers have disagreed on how to

interpret section 412(h) of the act in

light of the current regulations on

exempt infant formula in § 107.50. One

manufacturer stated that the statute and

regulations do not envision a premarket

designation or clearance for exempt

formulas. Another manufacturer

asserted that section 412(h)(1) of the act

exempts these formulas from section

412(c) (registration and submissions),

and that § 107.50(b)(4) only requires

notification to FDA of any change in

ingredients or processes that may result

in an adverse impact on the levels of

nutrients or on the availability of

nutrients before the first processing of

the infant formula. This manufacturer

argued that, consequently, there is no

requirement to give notice to the agency

90 days before marketing any exempt

infant formula that has been changed in

formulation or processing.

The agency has deep reservations

about both of these industry assertions.

The first would mean that infants who

need an exempt formula, and who are

by definition among the most

vulnerable, would receive the least

protection from the law. The second

would raise significant questions about

the agency’s ability to carry out its

mandate to ‘‘insure that such formulas

are manufactured to the same high

standards of quality required of

formulas for normal infants.’’ The

agency would be unable to do so unless

it receives notification of ‘‘major

changes’’ in exempt infant formula at

least 90 days before the marketing of the

changed formula. The agency requests

comment on what terms and conditions

should be set for the exemption of an

infant formula from the requirements of

section 412(c) of the act (registration

and submissions).

Problems also have occurred in the

regulation of infant formulas that meet

the statutory definition of an exempt

infant formula, i.e., formulas that are

intended for infants who have an inborn

error of metabolism or a low birth

weight, or who otherwise have an

unusual medical or dietary problem, but

that do not need an exemption from any

of the nutrient, quality factor, or good

manufacturing requirements (including

quality control procedures) of the act. In

1980, the House Committee on Interstate

and Foreign Commerce stated that it

recognized that infants suffering from

special medical disorders, such as

phenylketonuria, or severe kidney

diseases, require formulas tailored

specifically to their medical needs. The

Committee recognized also the need to

exempt these formulas from the

nutritional standards applicable to

formulas intended for normal, fullterm

infants. (Id.)

However, infant formulas are now being

developed that meet the nutritional

standards applicable to formulas for

normal, fullterm infants, i.e, the nutrient

requirements of § 107.100, but that are

for infants with low birth weight or with

unusual medical or dietary problems.

Thus, these formulas apparently are

exempt infant formulas under section

412(h) of the act. The agency requests

comment on what terms and conditions

should be set for the exemption of an

infant formula from the requirements of

section 412(a) of the act. Should infant

formulas that are intended for special

populations of infants but that meet the

nutrient requirements of the act be

exempted from being deemed to be

adulterated if they do not meet the same

quality factor requirements or good

manufacturing practices and quality

control procedures that are required of

infant formulas for normal, fullterm

infants? Should infant formulas that

meet the definition in the act for an

‘‘exempt infant formula’’ be exempted

from meeting the quality factor and

good manufacturing practice

requirements when they are fully

capable of meeting these requirements?

Current § 107.50(b)(3) requires the

submission of the label and other

labeling in the notification required to

retain the exempt status of an infant

formula. Current § 107.50(b)(3) further

states that FDA will review the

submitted information under

§ 107.50(d), and current § 107.50(d)(4)

lists the criteria that FDA will use to

determine whether a deviation from the

requirements of subpart C of part 107

(Exempt Infant Formulas) is necessary

and will adequately protect the public
29706 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

health. One such criterion is whether a

deviation from the labeling

requirements of subpart B of part 107 is

necessary because, without an

exemption, the label information,

including pictograms and symbols,

could lead to inappropriate use of the

infant formula (§ 107.50(d)(4)(iii)).

FDA has held that, for an exempt

infant formula to be eligible to make

label claims that deviate in any way

from the requirements of subpart B of

part 107, a firm must show that the

labeling claims are necessary to ensure

appropriate use of the product

(§ 107.50(d)(4)(iii)), and that the public

health will be adequately protected if

these claims are made (§ 107.50(d)(4)).

This showing must be made based on a

persuasive medical, nutritional,

scientific, or technological rationale

(including any appropriate animal or

human clinical studies) (§ 107.50(b)(5)).

The agency has held that failure to

submit information that supports that an

exemption is necessary to ensure the

proper use of a formula, and failure to

show that the public health will be

adequately protected if such an

exemption is continued, provide

grounds for revoking the exempt status

of a formula. Revoking the exempt

status of a formula would mean that its

label could not deviate in any way from

the labeling requirements of subpart B

of part 107, and thus it would not be

able to bear the claims in question. The

agency solicits comments on any

changes that need to be made to

§ 107.50 (exempt infant formulas) to

ensure that the labeling of these

products will be consistent with the

public health and will not lead to the

inappropriate use of the product.

The agency also solicits comments on

any changes to subpart B of part 107

(Labeling) that may be necessary to

ensure that exempt infant formulas are

labeled appropriately. Further, the

agency solicits comments on any

changes that it needs to make in the

regulations governing the labeling of

exempt infant formulas to ensure that

the representations made for these

products are truthful and not

misleading. The 1990 amendments

exclude exempt infant formulas from

the requirements on nutrition labeling,

nutrient content claims, and health

claims (section 403(q)(5)(A)(iii) and

(r)(5)(A) of the act). The regulations

issued in response to the 1990

amendments reflect this fact

(§ 101.9(j)(7) (nutrition labeling),

§ 101.13(q)(4) (nutrient content claims),

and (§ 101.14(f)(1) (health claims)). The

agency solicits comments on any

changes that should be made to subpart

B of part 107 (Labeling) to ensure that

exempt infant formulas are labeled in a

manner that will adequately protect the

public health and that will ensure

appropriate use of the product.

VI. Food Additive Regulations

The agency has identified the

following candidates for changes to

make the regulations on food

ingredients easier to understand and to

consolidate certain existing regulations

under a single listing to minimize

redundancy.

A. Carrageenan, Carrageenan With

Polysorbate 80, Salts of Carrageenan,

Furcelleran, and Salts of Furcelleran

In the Federal Register of October 6,

1961 (26 FR 9411 and 9412), FDA

published final rules permitting the use

of the food additives carrageenan, salts

of carrageenan, furcelleran, and salts of

furcelleran in food. The agency later

published an additional final rule

permitting the use of carrageenan

processed with polysorbate 80 in food.

The original food additive petitions

requesting the use of carrageenan and

furcelleran in food were submitted to

FDA by competing producers of these

two additives. Thus, the agency issued

separate regulations for these additives

even though there are similarities in the

structure and functionality of

carrageenan and furcelleran. It may now

be appropriate to combine the

regulations on carrageenan, salts of

carrageenan, furcelleran, salts of

furcelleran, and carrageenan with

polysorbate 80 into a single regulation.

Carrageenan and furcelleran are

refined hydrocolloids that are produced

by extraction of certain species of red

seaweed in aqueous alkali, and they are

regulated for use as emulsifiers,

thickeners, and stabilizers in food under

§§ 172.620 and 172.660 (21 CFR 172.620

and 172.660). The functional properties

of carrageenan derive from the sulfated

polysaccharide that is the major

component of the additive. This

polysaccharide is composed of galactose

and anhydrogalactose hexose units.

The primary difference between

carrageenan as regulated under

§ 172.620 and furcelleran as regulated

under § 172.660 is the degree of

sulfation of the hexose units composing

the polysaccharide. Furcelleran has a

sulfate range of 8 to 19 percent on a dry

weight basis, while carrageenan may

have a sulfate content of between 20 and

40 weight percent. The degree of

sulfation of the additive is believed to

be the determining factor regarding the

additive’s ability to bind to proteins and

thus determines the additive’s

functionality in certain food

applications, including dairy

applications. In addition, the

functionality of the carrageenan

complying with § 172.620 is known to

vary with the seaweed species used to

produce the additive and with the

dominant cation in aqueous solutions of

the additive. This variation reflects the

level of three principal polysaccharide

types in commercial carrageenan. These

are known as kappa, iota, and lambda

carrageenan and differ in the number

and location of the sulfate groups on the

hexose units.

In commerce, carrageenan may

consist of a relatively pure form of one

of the three polysaccharides or a

mixture of kappa, lambda, and iota

polysaccharides along with cellulosic

material, protein, and inorganic salts.

The relative amounts of polysaccharides

can vary naturally based on their

content in the native seaweed, or

carrageenan can be formulated from

relatively pure kappa, lambda, and iota

carrageenan either by processing or by

seaweed choice. The ability to produce

carrageenan consisting of relatively pure

forms of one or the other of the

polysaccharides facilitates the

production of carrageenans with a wide

variation in properties. Thus, the

industry is able to develop carrageenans

with specific properties for specific

applications in food.

The only distinguishing

characteristics that FDA incorporated

into the regulations for furcelleran and

carrageenan were a limitation on the

degree of sulfation for the

polysaccharide that is the functional

component of each additive and a

listing of the different seaweed sources

of the additives. The differing

specifications (sulfate content and

seaweed source) incorporated into the

regulations for carrageenan and

furcelleran were included solely to

differentiate between these two similar

additives. There is no safety concern

regarding the sulfate content of the

respective additives. Given this fact,

there is no reason to distinguish

between the additives on the basis of

sulfate content, and no reason why the

sulfate specifications for the two

additives could not be combined in one

regulation.

The first detailed specifications that

FDA adopted for furcelleran and

carrageenan were the specifications

included in the first edition of the Food

Chemicals Codex (FCC). The

specifications for furcelleran in the first

edition of the FCC were identical to

those for carrageenan except for the

percent sulfate content of the additive

and the listed seaweed sources.

Subsequent editions of the FCC did not

include a separate specification for
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29707

furcelleran, in part because the additive

was so similar to carrageenan that it was

generally considered as a form of

carrageenan, and in part because the

total use level of furcelleran was only a

fraction of the use level of carrageenan.

Indeed, the current specification for

carrageenan adopted by the Food and

Agriculture Organization/World Health

Organization Joint Expert Committee on

Food Additives (JECFA) includes the

additive regulated in the United States

as furcelleran. Therefore, inclusion of

furcelleran under the U.S. regulation for

carrageenan would be a step toward

harmonizing U.S. regulations with the

JECFA specification recognized

internationally.

When FDA issued separate

regulations for salts of carrageenan and

salts of furcelleran, the agency was

primarily concerned about the

possibility of economic deception

resulting from an artificial increase of

one or more of the inorganic salts that

are typically components of these

additives. In addition, the agency’s

concern in issuing a separate regulation

for carrageenan with polysorbate 80 was

to ensure that carrageenan processed

with polysorbate 80 would be properly

labeled. At the time the regulations for

carrageenan, furcelleran, salts of

carrageenan, salts of furcelleran, and

carrageenan with polysorbate 80 were

issued, the chemistry of carrageenan

and of furcelleran was well known. At

that time, it was known that the

addition of salts containing one or

another cation would alter significantly

the gelation properties of given forms of

the additive.

The level of sophistication with

which carrageenan and carrageenan-like

substances such as furcelleran are

developed, marketed, and used reflects

a high degree of understanding in the

industry regarding the identity and

functionality when used in food.

Therefore, it may well be advantageous

to simplify the regulation of salts of

carrageenan, furcelleran, salts of

furcelleran, and carrageenan with

polysorbate 80 by eliminating the

separate regulations for these substances

and by providing for all of them to be

marketed as carrageenan. The agency is

specifically soliciting comments

regarding whether such a change should

be made, and, if so, what changes to

existing specifications, and what

additional specifications, may be

required in a regulation to permit the

combining of referenced regulations.

B. Use of Metals in Contact With Food

FDA is considering publishing a

proposal to list, in 21 CFR part 182,

certain metals as generally recognized as

safe (GRAS) for use in contact with

food. In addition, FDA is considering

ways to make publicly available those

uses of metals that have been the subject

of a favorable opinion letter issued by

agency employees because of the

insignificant potential for the metals to

migrate into food.

Historically, the use of metals as

components of food-contact articles has

generally resulted in low dietary

exposure. The chemical inertness and

hardness of many metals is such that

there is little or no likelihood that the

metal will migrate to food in other than

insignificant amounts. In addition,

because metals are typically used in the

manufacture of repeat-use articles, the

concentration of any migrant would be

extremely low because of the large

volume of food processed.

While FDA employees have issued

opinion letters over the past three

decades on the agency’s lack of safety

concern about the low exposure from

such uses of metals, this information

has not been made publicly available in

any sort of systematic and widespread

way. As a result, the agency continues

to receive inquiries on the same metals

that have been previously found to be

acceptable for use in contact with food,

either because their use is GRAS, or

because the potential for them to

migrate to food is insignificant.

To help alleviate this situation, the

agency is considering whether to list in

part 182 those metals that FDA has

stated in opinion letters are GRAS for

use as indirect food additives. FDA has

reviewed its files and is aware of

opinion letters stating that the following

metals are GRAS for use in contact with

food: Aluminum and aluminum foil;

stainless steel (grades 302, 303, 304,

304F, 316, 321); 416 and 440C stainless

steel for use as a ring on filter bags; tin

plate; and iron for food contact use in

breweries.

The agency is interested in

information on whether other metals are

GRAS when used in contact with food

and the basis for such a finding.

In addition to the metals listed above,

the agency is aware of opinion letters

that have been written by agency

employees on various metals agreeing

that their use as a component of foodcontact articles would not require a food

additive petition or regulation because

of an insignificant potential for

migration to food. FDA has considered

that, in some cases, the composition of

some of the metal alloys that have been

the subject of such letters may be

confidential information. The agency is

interested in comments on what

procedures for making such letters

publicly available would be most

effective as well as in information that

would help it to determine whether data

in such letters, such as the composition

of alloys, are confidential, and thus not

releasable, or are common information

that can be made public.

FDA invites public comment on all of

these matters.

VII. Interstate Conveyance Sanitation

(21 CFR Part 1250)

FDA regulates the construction and

operation of conveyances (trains,

planes, buses, and vessels) in interstate

traffic under parts 1240 and 1250 (21

CFR parts 1240 and 1250) of its

regulations. These regulations cover

environmental health and food safety

requirements for the conveyances

themselves, including their water and

waste systems. They also cover the

conveyance servicing areas and vehicles

used for boarding drinking water and

food and for offloading wastes.

In § 1250.93, FDA focuses on vessels

operating in fresh water lakes and rivers

and specifically prohibits the discharge

of sewage and ballast or bilge water

within areas adjacent to domestic water

intakes.

C. Concerns

1. FDA regulates vessels in interstate

traffic that operate in both fresh and salt

waters.

2. These vessels generate several

waste streams involving both liquid and

solid wastes. Improper disposal of some

of these wastes have important public

health implications beyond the possible

contamination of public drinking water

supplies addressed by the existing

regulation. One example is the possible

contamination of molluscan shellfish

growing and harvesting areas, which is

of concern because shellfish are often

consumed raw.

3. The National Research Council’s

Marine Board and its Committee on

Shipborne Wastes, on September 6,

1995, released a new report entitled

‘‘Clean Ships, Clean Ports, Clean

Oceans: Controlling Garbage and Plastic

Wastes at Sea.’’ The report concludes

that U.S. activities to implement the

provisions of the International

Convention for the Prevention of

Pollution from Ships (1973) and its 1978

protocol are far from complete and

effective.

The report recommends interagency

cooperation among relevant Federal

agencies to promote a systems approach

to enhance total management and

control of vessel wastes in nine specific

maritime sectors. One of these sectors is

passenger day boats, casino ships, and

ferries, over which FDA has regulatory
29708 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

responsibility under the Public Health

Service Act.

Lead Federal agencies in the matter of

controlling shipborne wastes include

the U. S. Coast Guard and the

Environmental Protection Agency.

Other Federal agencies involved include

the Department of State, the National

Oceanic and Atmospheric

Administration and its National Marine

Fisheries Service, the United States

Department of Agriculture’s Animal and

Plant Health Inspection Service, and the

Maritime Administration.

D. Request for Information

FDA is considering proposing to

revise § 1250.93 of the Interstate Travel

Sanitation regulations to prohibit

discharges that would pollute salt water

and shellfish growing areas as well as

fresh water. Other agency objectives

include harmonizing FDA’s vessel waste

control requirements with those of other

Federal agencies and contributing to

meeting U. S. obligations under ratified

international agreements. FDA requests

information on what changes could be

made to § 1250.93 to assist the agency

in establishing standards for discharges

of waste from passenger boats, casino

ships, and ferries. The agency requests

information on the effects that any

suggested changes would have on the

waste discharge practices of affected

vessels.

VIII. Comments

Interested persons may, on or before

September 10, 1996, submit to the

Dockets Management Branch (address

above) written comments regarding this

ANPRM. 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.

Dated: May 31, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–14888 Filed 6–7–96; 12:17 pm]

BILLING CODE 4160–01–F

21 CFR Parts 101 and 730

[Docket No. 96N–0174]

RIN 0910–AA69

Food and Cosmetic Labeling;

Revocation of Certain Regulations;

Opportunity for Public Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revoke certain regulations that appear to

be obsolete. These regulations have been

identified for revocation as a result of a

page-by-page review of the agency’s

regulations that FDA conducted in

response to the Clinton administration’s

‘‘Reinventing Government’’ initiative,

which seeks to streamline Government

to ease the burden on regulated industry

and consumers. The agency is providing

an opportunity for comments on this

proposed rule.

DATES: Written comments by August 26,

1996. The agency is proposing that any

final rule that may issue based upon this

proposal become effective 75 days

following date of publication of the final

rule.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Corinne L. Howley, Center for Food

Safety and Applied Nutrition (HFS–24),

Food and Drug Administration, 200 C

St., SW., Washington, DC 20204, 202–

205–4272.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1995, President Clinton

announced plans for the reform of the

Federal regulatory system as part of the

administration’s ‘‘Reinventing

Government’’ initiative. In his March 4,

1995, directive, the President ordered

all Federal agencies to conduct a pageby-page review of all of their regulations

to ‘‘eliminate or revise those that are

outdated or otherwise in need of

reform.’’

In response to this directive, FDA

issued proposals to revoke a number of

regulations (see, e.g., 60 FR 53480,

October 13, 1995; 60 FR 56513 and

56541, November 9, 1995) and an

advance notice of proposed rulemaking

(ANPRM) to review standards of

identity, quality, and fill of container

(60 FR 67492, December 29, 1995). The

agency has completed its review of its

food and cosmetic regulations in

response to the President’s initiative

and as a result is publishing two

documents in this issue of the Federal

Register. This document announces

additional regulations that FDA is

proposing to eliminate or revise, and the

second document is an ANPRM that

seeks information on other food and

cosmetic regulations that appear to be in

need of revision.

II. The Proposal

A. Food Labeling Regulations

FDA has identified several food

labeling regulations in part 101 (21 CFR

part 101) as candidates for revocation or

revision and is seeking comments from

interested parties regarding its tentative

conclusions on these matters. The

following is a list of those regulations

and the agency’s tentative conclusions

concerning the needed changes:

1. Section 101.2 Information panel of

package form food

In § 101.2, paragraph (a) defines the

term ‘‘information panel’’ as it applies

to packaged food, and in paragraph (b),

the regulation provides that all

information required to appear on the

label of any package of food under

certain referenced regulations appear

either on the principal display panel or

on the information panel unless

otherwise specified in the regulations.

The referenced regulations are: § 101.4

Food; designation of ingredients, § 101.5

Food; name and place of business of

manufacturer, packer, or distributor),

§ 101.8 Labeling of food with number of

servings, § 101.9 Nutrition labeling of

food, § 101.12 Reference amounts

customarily consumed per eating

occasion, § 101.13 Nutrient content

claims general principles, § 101.17 Food

labeling warning and notice statements,

Part 101—Subpart D—Specific

requirements for nutrient content

claims, and Part 105—Foods for special

dietary use (21 CFR 105). Paragraph (c)

of § 101.2 requires that information

required by the referenced regulations

be in letters or numbers of at least onesixteenth inch in height, unless

otherwise exempted by regulation.

Paragraph (c) of § 101.2 also provides

exemptions to this type size

requirement. FDA tentatively concludes

that certain of these exemptions are

obsolete.

a. Exemptions for small packages

There are exemptions in paragraphs

(c)(1) through (c)(3) of § 101.2 for small

packages (defined according to the

surface area available to bear labeling).

These exemptions were established

before the enactment of the Nutrition

Labeling and Education Act of 1990 (the

1990 amendments) (Pub. L. 101–535).

They were designed to encourage firms

to provide nutrition information in

accordance with § 101.9, as well as a

full list of ingredients in accordance

with the regulations in § 101.4 and the

agency’s policy regarding declaration of

ingredients on standardized foods as set

out in § 101.6 (see 39 FR 15268, May 2,

1974). Before the enactment of the 1990