[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR1.24]



[Page 9-13]

 

                        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.  1.24  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, 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



[[Page 10]]



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.

    (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 at 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at NARA, call 202-741-6030, or go 

to: http://www.archives.gov/federal--register/code--of--federal--

regulations/ibr--locations.html.

    (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 at 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at NARA, call 202-741-6030, or go 

to: http://www.archives.gov/federal--register/code--of--federal--

regulations/ibr--locations.html.

    (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.,



[[Page 11]]



College Park, MD 20740, or at the National Archives and Records 

Administration (NARA). For information on the availability of this 

material at NARA, call 202-741-6030, or go to: http://www.archives.gov/

federal--register/code--of--federal--regulations/ibr--locations.html.

    (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 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 Sec. Sec.  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



[[Page 12]]



wrapping is exempt from the requirements of Sec. Sec.  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 

Sec. Sec.  137.211, 137.215, and Sec. Sec.  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 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



[[Page 13]]



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]