
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1]

[Page 6-11]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
Subpart B--General Labeling Requirements

Sec. 1.20  Presence of mandatory label information.

    The term package means any container or wrapping in which any food, 
drug, device, or cosmetic is enclosed for use in the delivery or display 
of such commodities to retail purchasers, but does not include:
    (a) Shipping containers or wrappings used solely for the 
transportation of any such commodity in bulk or in quantity to 
manufacturers, packers, processors, or wholesale or retail distributors;
    (b) Shipping containers or outer wrappings used by retailers to ship 
or deliver any such commodity to retail customers if such containers and 
wrappings bear no printed matter pertaining to any particular commodity; 
or
    (c) Containers subject to the provisions of the Act of August 3, 
1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4, 
1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August 
31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of 
May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i).
    (d) Containers used for tray pack displays in retail establishments.
    (e) Transparent wrappers or containers which do not bear written, 
printed, or graphic matter obscuring the label information required by 
this part.


A requirement contained in this part that any word, statement, or other 
information appear on the label shall not be considered to be complied 
with unless such word, statement, or information also appears on the 
outer container or wrapper of the retail package of the article, or, as 
stated in paragraph (e) of this section, such information is easily 
legible by virtue of the transparency of the outer wrapper or container. 
Where a consumer commodity is marketed in a multiunit retail package 
bearing the mandatory label information as required by this part and the 
unit containers are not intended to be sold separately, the net weight 
placement requirement of

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Sec. 101.105(f) applicable to such unit containers is waived if the 
units are in compliance with all the other requirements of this part.

Sec. 1.21  Failure to reveal material facts.

    (a) Labeling of a food, drug, device, or cosmetic shall be deemed to 
be misleading if it fails to reveal facts that are:
    (1) Material in light of other representations made or suggested by 
statement, word, design, device or any combination thereof; or
    (2) Material with respect to consequences which may result from use 
of the article under: (i) The conditions prescribed in such labeling or 
(ii) such conditions of use as are customary or usual.
    (b) Affirmative disclosure of material facts pursuant to paragraph 
(a) of this section may be required, among other appropriate regulatory 
procedures, by
    (1) Regulations in this chapter promulgated pursuant to section 
701(a) of the act; or
    (2) Direct court enforcement action.
    (c) Paragraph (a) of this section does not:
    (1) Permit a statement of differences of opinion with respect to 
warnings (including contraindications, precautions, adverse reactions, 
and other information relating to possible product hazards) required in 
labeling for food, drugs, devices, or cosmetics under the act.
    (2) Permit a statement of differences of opinion with respect to the 
effectiveness of a drug unless each of the opinions expressed is 
supported by substantial evidence of effectiveness as defined in 
sections 505(d) and 512(d) of the act.

Sec. 1.23  Procedures for requesting variations and exemptions from 
          required label statements.

    Section 403(e) of the act (in this part 1, the term act means the 
Federal Food, Drug, and Cosmetic Act) provides for the establishment by 
regulation of reasonable variations and exemptions for small packages 
from the required declaration of net quantity of contents. Section 
403(i) of the act provides for the establishment by regulation of 
exemptions from the required declaration of ingredients where such 
declaration is impracticable, or results in deception or unfair 
competition. Section 502(b) of the act provides for the establishment by 
regulation of reasonable variations and exemptions for small packages 
from the required declaration of net quantity of contents. Section 
602(b) of the act provides for the establishment by regulation of 
reasonable variations and exemptions for small packages from the 
required declaration of net quantity of contents. Section 5(b) of the 
Fair Packaging and Labeling Act provides for the establishment by 
regulation of exemptions from certain required declarations of net 
quantity of contents, identity of commodity, identity and location of 
manufacturer, packer, or distributor, and from declaration of net 
quantity of servings represented, based on a finding that full 
compliance with such required declarations is impracticable or not 
necessary for the adequate protection of consumers, and a further 
finding that the nature, form, or quantity of the packaged consumer 
commodity or other good and sufficient reasons justify such exemptions. 
The Commissioner, on his own initiative or on petition of an interested 
person, may propose a variation or exemption based upon any of the 
foregoing statutory provisions, including proposed findings if section 
5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts 
10, 12, 13, 14, 15, 16, and 19 of this chapter.

Sec. 1.24  Exemptions from required label statements.

    The following exemptions are granted from label statements required 
by this part:
    (a) Foods. (1) While held for sale, a food shall be exempt from the 
required declaration of net quantity of contents specified in this part 
if said food is received in bulk containers at a retail establishment 
and is accurately weighed, measured, or counted either within the view 
of the purchaser or in compliance with the purchaser's order.
    (2) Random food packages, as defined in Sec. 101.105(j) of this 
chapter, bearing labels declaring net weight, price per pound or per 
specified number of pounds, and total price shall be exempt from the 
type size, dual declaration,

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and placement requirements of Sec. 101.105 of this chapter if the 
accurate statement of net weight is presented conspicuously on the 
principal display panel of the package. In the case of food packed in 
random packages at one place for subsequent shipment and sale at 
another, the price sections of the label may be left blank provided they 
are filled in by the seller prior to retail sale. This exemption shall 
also apply to uniform weight packages of cheese and cheese products 
labeled in the same manner and by the same type of equipment as random 
food packages exempted by this paragraph (a)(2) except that the labels 
shall bear a declaration of price per pound and not price per specified 
number of pounds.
    (3) Individual serving-size packages of foods containing less than 
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants, 
institutions, and passenger carriers, and not intended for sale at 
retail, shall be exempt from the required declaration of net quantity of 
contents specified in this part.
    (4) Individually wrapped pieces of penny candy and other 
confectionery of less than one-half ounce net weight per individual 
piece shall be exempt from the labeling requirements of this part when 
the container in which such confectionery is shipped is in conformance 
with the labeling requirements of this part. Similarly, when such 
confectionery items are sold in bags or boxes, such items shall be 
exempt from the labeling requirements of this part, including the 
required declaration of net quantity of contents specified in this part 
when the declaration on the bag or box meets the requirements of this 
part.
    (5)(i) Soft drinks packaged in bottles shall be exempt from the 
placement requirements for the statement of identity prescribed by 
Sec. 101.3 (a) and (d) of this chapter if such statement appears 
conspicuously on the bottle closure. When such soft drinks are marketed 
in a multiunit retail package, the multiunit retail package shall be 
exempt from the statement of identity declaration requirements 
prescribed by Sec. 101.3 of this chapter if the statement of identity on 
the unit container is not obscured by the multiunit retail package.
    (ii) A multiunit retail package for soft drinks shall be exempt from 
the declaration regarding name and place of business required by 
Sec. 101.5 of this chapter if the package does not obscure the 
declaration on unit containers or if it bears a statement that the 
declaration can be found on the unit containers and the declaration on 
the unit containers complies with Sec. 101.5 of this chapter. The 
declaration required by Sec. 101.5 of this chapter may appear on the top 
or side of the closure of bottled soft drinks if the statement is 
conspicuous and easily legible.
    (iii) Soft drinks packaged in bottles which display other required 
label information only on the closure shall be exempt from the placement 
requirements for the declaration of contents prescribed by 
Sec. 101.105(f) of this chapter if the required content declaration is 
blown, formed, or molded into the surface of the bottle in close 
proximity to the closure.
    (iv) Where a trademark on a soft drink package also serves as, or 
is, a statement of identity, the use of such trademark on the package in 
lines not parallel to the base on which the package rests shall be 
exempted from the requirement of Sec. 101.3(d) of this chapter that the 
statement be in lines parallel to the base so long as there is also at 
least one statement of identity in lines generally parallel to the base.
    (v) A multiunit retail package for soft drinks in cans shall be 
exempt from the declaration regarding name and place of business 
required by Sec. 101.5 of this chapter if the package does not obscure 
the declaration on unit containers or if it bears a statement that the 
declaration can be found on the unit containers and the declaration on 
the unit containers complies with Sec. 101.5 of this chapter. The 
declaration required by Sec. 101.5 of this chapter may appear on the top 
of soft drinks in cans if the statement is conspicuous and easily 
legible, provided that when the declaration is embossed, it shall appear 
in type size at least one-eighth inch in height, or if it is printed, 
the type size shall not be less than one-sixteenth inch in height. The 
declaration may follow the curvature of the lid of the can and shall not 
be removed or obscured by the tab which opens the can.

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    (6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water 
ices, quiescently frozen confections (with or without dairy 
ingredients), special dietary frozen desserts, and products made in 
semblance of the foregoing, when measured by and packaged in \1/2\-
liquid pint and \1/2\-gallon measure-containers, as defined in the 
``Measure Container Code of National Bureau of Standards Handbook 44,'' 
Specifications, Tolerances, and Other Technical Requirements for 
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which 
is incorporated by reference, are exempt from the requirements of 
Sec. 101.105(b)(2) of this chapter to the extent that net contents of 8-
fluid ounces and 64-fluid ounces (or 2 quarts) may be expressed as \1/2\ 
pint and \1/2\ gallon, respectively. Copies are available from the 
Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street NW., suite 700, Washington, DC.
    (ii) The foods named in paragraph (a)(6)(i) of this section, when 
measured by and packaged in 1-liquid pint, 1-liquid quart, and \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of 
National Bureau of Standards Handbook 44,'' Specifications, Tolerances, 
and Other Technical Requirements for Weighing and Measuring Devices, 
Sec. 4.45 ``Measure-Containers,'' which is incorporated by reference, 
are exempt from the dual net-contents declaration requirement of 
Sec. 101.105(j) of this chapter. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-150), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street NW., suite 700, Washington, DC.
    (iii) The foods named in paragraph (a)(6)(i) of this section, when 
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid 
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the 
``Measure Container Code of National Bureau of Standards Handbook 44,'' 
Specifications, Tolerances, and Other Technical Requirements for 
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which 
is incorporated by reference, are exempt from the requirement of 
Sec. 101.105(f) of this chapter that the declaration of net contents be 
located within the bottom 30 percent of the principal display panel. 
Copies are available from the Center for Food Safety and Applied 
Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street NW., suite 700, 
Washington, DC.
    (7)(i) Milk, cream, light cream, coffee or table cream, whipping 
cream, light whipping cream, heavy or heavy whipping cream, sour or 
cultured sour cream, half-and-half, sour or cultured half-and-half, 
reconstituted or recombined milk and milk products, concentrated milk 
and milk products, skim or skimmed milk, vitamin D milk and milk 
products, fortified milk and milk products, homogenized milk, flavored 
milk and milk products, buttermilk, cultured buttermilk, cultured milk 
or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent 
butterfat), and acidified milk and milk products, when packaged in 
containers of 8- and 64-fluid-ounce capacity, are exempt from the 
requirements of Sec. 101.105(b)(2) of this chapter to the extent that 
net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be 
expressed as \1/2\ pint and \1/2\ gallon, respectively.
    (ii) The products listed in paragraph (a)(7)(i) of this section, 
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the 
placement requirement of Sec. 101.105(f) of this chapter that the 
declaration of net contents be located within the bottom 30 percent of 
the principal display panel, provided that other required label 
information is conspicuously displayed on the cap or outside closure and 
the required net quantity of contents declaration is conspicuously 
blown, formed, or molded into or permanently applied to that part of the 
glass or plastic container that is at or above the shoulder of the 
container.
    (iii) The products listed in paragraph (a)(7)(i) of this section, 
when packaged

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in containers of 1-pint, 1-quart, and \1/2\-gallon capacities are exempt 
from the dual net-contents declaration requirement of Sec. 101.105(j) of 
this chapter.
    (8) Wheat flour products, as defined by Secs. 137.105, 137.155, 
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and 
137.205 of this chapter, packaged:
    (i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages 
are exempt from the placement requirement of Sec. 101.105(f) of this 
chapter that the declaration of net contents be located within the 
bottom 30 percent of the area of the principal display panel of the 
label; and
    (ii) In conventional 2-pound packages are exempt from the dual net-
contents declaration requirement of Sec. 101.105(j) of this chapter 
provided the quantity of contents is expressed in pounds.
    (9)(i) Twelve shell eggs packaged in a carton designed to hold 1 
dozen eggs and designed to permit the division of such carton by the 
retail customer at the place of purchase into two portions of one-half 
dozen eggs each are exempt from the labeling requirements of this part 
with respect to each portion of such divided carton if the carton, when 
undivided, is in conformance with the labeling requirements of this 
part.
    (ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen 
eggs are exempt from the placement requirements for the declaration of 
contents prescribed by Sec. 101.105(f) of this chapter if the required 
content declaration is otherwise placed on the principal display panel 
of such carton and if, in the case of such cartons designed to permit 
division by retail customers into two portions of one-half dozen eggs 
each, the required content declaration is placed on the principal 
display panel in such a manner that the context of the content 
declaration is destroyed upon division of the carton.
    (10) Butter as defined in 42 Stat. 1500 (excluding whipped butter):
    (i) In 8-ounce and in 1-pound packages is exempt from the 
requirements of Sec. 101.105(f) of this chapter that the net contents 
declaration be placed within the bottom 30 percent of the area of the 
principal display panel;
    (ii) In 1-pound packages is exempt from the requirements of 
Sec. 101.105(j)(1) of this chapter that such declaration be in terms of 
ounces and pounds, to permit declaration of ``1-pound'' or ``one 
pound''; and
    (iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous 
label copy wrapping is exempt from the requirements of Secs. 101.3 and 
101.105(f) of this chapter that the statement of identity and net 
contents declaration appear in lines generally parallel to the base on 
which the package rests as it is designed to be displayed, provided that 
such statement and declaration are not so positioned on the label as to 
be misleading or difficult to read as the package is customarily 
displayed at retail.
    (11) Margarine as defined in Sec. 166.110 of this chapter and 
imitations thereof in 1-pound rectangular packages, except for packages 
containing whipped or soft margarine or packages that contain more than 
four sticks, are exempt from the requirement of Sec. 101.105(f) of this 
chapter that the declaration of the net quantity of contents appear 
within the bottom 30 percent of the principal display panel and from the 
requirement of Sec. 101.105(j)(1) of this chapter that such declaration 
be expressed both in ounces and in pounds to permit declaration of ``1-
pound'' or ``one pound,'' provided an accurate statement of net weight 
appears conspicuously on the principal display panel of the package.
    (12) Corn flour and related products, as they are defined by 
Secs. 137.211, 137.215, and Secs. 137.230 through 137.290 of this 
chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags 
are exempt from the placement requirement of Sec. 101.105(f) of this 
chapter that the declaration of net contents be located within the 
bottom 30 percent of the area of the principal display panel of the 
label.
    (13)(i) Single strength and less than single strength fruit juice 
beverages, imitations thereof, and drinking water when packaged in glass 
or plastic containers of \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and 
1-gallon capacities are exempt from the placement requirement of 
Sec. 101.105(f) of this chapter that the declaration of net contents be 
located within the bottom 30 percent of the principal display panel: 
Provided, That other required label information is conspicuously 
displayed on the cap or

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outside closure and the required net quantity of contents declaration is 
conspicuously blown, formed, or molded into or permanently applied to 
that part of the glass or plastic container that is at or above the 
shoulder of the container.
    (ii) Single strength and less than single strength fruit juice 
beverages, imitations thereof, and drinking water when packaged in 
glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-
quart, and \1/2\-gallon capacities are exempt from the dual net-contents 
declaration requirement of Sec. 101.105(j) of this chapter.
    (iii) Single strength and less than single strength fruit juice 
beverages, imitations thereof, and drinking water when packaged in 
glass, plastic, or paper (fluid milk type) containers of 8- and 64-
fluid-ounce capacity, are exempt from the requirements of 
Sec. 101.105(b)(2) of this chapter to the extent that net contents of 8 
fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2\ 
pint (or half pint) and \1/2\ gallon (or half gallon), respectively.
    (14) The unit containers in a multiunit or multicomponent retail 
food package shall be exempt from regulations of section 403 (e)(1), 
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements 
for label declaration of the name and place of business of the 
manufacturer, packer, or distributor; label declaration of ingredients; 
and nutrition information when:
    (i) The multiunit or multicomponent retail food package labeling 
meets all the requirements of this part;
    (ii) The unit containers are securely enclosed within and not 
intended to be separated from the retail package under conditions of 
retail sale; and
    (iii) Each unit container is labeled with the statement ``This Unit 
Not Labeled For Retail Sale'' in type size not less than one-sixteenth 
of an inch in height. The word ``Individual'' may be used in lieu of or 
immediately preceding the word ``Retail'' in the statement.
    (b) Drugs. Liquid over-the-counter veterinary preparations intended 
for injection shall be exempt from the declaration of net quantity of 
contents in terms of the U.S. gallon of 231 cubic inches and quart, 
pint, and fluid-ounce subdivisions thereof as required by Sec. 201.62 
(b), (i), and (j) of this chapter, and from the dual declaration 
requirements of Sec. 201.62(i) of this chapter, if such declaration of 
net quantity of contents is expressed in terms of the liter and 
milliliter, or cubic centimeter, with the volume expressed at 68 [deg]F 
(20 [deg]C).
    (c) Cosmetics. Cosmetics in packages containing less than one-fourth 
ounce avoirdupois or one-eighth fluid ounce shall be exempt from 
compliance with the requirements of section 602(b)(2) of the Federal 
Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging 
and Labeling Act:
    (1) When such cosmetics are affixed to a display card labeled in 
conformance with all labeling requirements of this part; or
    (2) When such cosmetics are sold at retail as part of a cosmetic 
package consisting of an inner and outer container and the inner 
container is not for separate retail sale and the outer container is 
labeled in conformance with all labeling requirements of this part.

[42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47 
FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3, 
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, 
Nov. 6, 2001]

Subparts C-D [Reserved]
