Code of Federal Regulations

  Title 21, Volume 1, Parts 1 to 99

  Revised as of April 1, 1996

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

  CITE: 21CFR1

 

  Page 5-16

 

         TITLE 21--FOOD AND DRUGS

 

 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

 PART 1--GENERAL ENFORCEMENT REGULATIONS

 

       Subpart A--General Provisions

 

 Sec.

 1.1  General.

 1.3  Definitions.

 1.4  Authority citations.

 

 Subpart B--General Labeling Requirements

 

 1.20  Presence of mandatory label information.

 1.21  Failure to reveal material facts.

 1.23  Procedures for requesting variations and exemptions from required

           label statements.

 1.24  Exemptions from required label statements.

 1.31  Package size savings.

 1.35  ``Cents-off,'' or other savings representations.

 

         Subparts C--D  Reserved

 

      Subpart E--Imports and Exports

 

 1.83  Definitions.

 1.90  Notice of sampling.

 1.91  Payment for samples.

 1.94  Hearing on refusal of admission.

 1.95  Application for authorization to relabel and recondition.

 1.96  Granting of authorization to relabel and recondition.

 1.97  Bonds.

 1.99  Costs chargeable in connection with relabeling and reconditioning

           inadmissible imports.

 

     Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act (15

 U.S.C. 1453, 1454, 1455); secs. 201, 403, 502, 505, 512, 602, 701 of the

 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 352, 355,

 360b, 362, 371); sec. 215 of the Public Health Service Act (42 U.S.C.

 216).

 

     Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

 

       Subpart A--General Provisions

 

 Sec. 1.1   General.

 

     (a) The provisions of regulations promulgated under the Federal

 Food, Drug, and Cosmetic Act with respect to the doing of any act shall

 be applicable also to the causing of such act to be done.

     (b) The definitions and interpretations of terms contained in

 section 201 of the Federal Food, Drug, and Cosmetic Act shall be

 applicable also to such terms when used in regulations promulgated under

 that act.

     (c) The definition of package in Sec. 1.20 and of principal display

 panel in Secs. 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter;

 and the requirements pertaining to uniform location, lack of

 qualification, and separation of the net quantity declaration in

 Secs. 101.105(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this

 chapter to type size requirements for net quantity declaration in

 Secs. 101.105(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this

 chapter, to initial statement of ounces in the dual declaration of net

 quantity in Secs. 101.105(j) and (m), 201.62(i) and (k), 501.105(j) and

 (m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial

 statement of inches in declaration of net quantity in Secs. 201.62(m),

 701.13(o) and 801.62(m) of this chapter, to initial statement of square

 inches in declaration of net quantity in Secs. 201.62(n), 701.13(p) and

 801.62(n) of this chapter, to prohibition of certain supplemental net

 quantity statements in Secs. 101.105(o), 201.62(o), 501.105(o),

 701.13(q) and 801.62(o) of this chapter, and to servings representations

 in Sec. 501.8 of this chapter are provided for solely by the Fair

 Packaging and Labeling Act. The other requirements of this part are

 issued under both the Fair Packaging and Labeling Act and the Federal

 Food, Drug, and Cosmetic Act, or by the latter act solely, and are not

 limited in their application by section 10 of the Fair Packaging and

 Labeling Act.

 

  42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993

 

 Sec. 1.3   Definitions.

 

     (a) Labeling includes all written, printed, or graphic matter

 accompanying an article at any time while such article is in interstate

 commerce or held for sale after shipment or delivery in interstate

 commerce.

     (b) Label means any display of written, printed, or graphic matter

 on the

 

   Page 6

 

 immediate container of any article, or any such matter affixed to any

 consumer commodity or affixed to or appearing upon a package containing

 any consumer commodity.

 

 Sec. 1.4  Authority citations.

 

     (a) For each part of its regulations, the Food and Drug

 Administration includes a centralized citation of all of the statutory

 provisions that provide authority for any regulation that is included in

 that part.

      (b) The agency may rely on any one or more of the authorities that

 are listed for a particular part in implementing or enforcing any

 section in that part.

     (c) All citations of authority in this chapter will list the

 applicable sections in the organic statute if the statute is the Federal

 Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair

 Packaging and Labeling Act. References to an act or a section thereof

 include references to amendments to that act or section. These citations

 will also list the corresponding United States Code (U.S.C.) sections.

 For example, a citation to section 701 of the Federal Food, Drug, and

 Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and

 Cosmetic Act (21 U.S.C. 371).

     (d) If the organic statute is one other than those specified in

 paragraph (c) of this section, the citations of authority in this

 chapter generally will list only the applicable U.S.C. sections. For

 example, a citation to section 552 of the Administrative Procedure Act

 would be listed: 5 U.S.C. 552. The agency may, where it determines that

 such measures are in the interest of clarity and public understanding,

 list the applicable sections in the organic statute and the

 corresponding U.S.C. section in the same manner set out in paragraph (c)

 of this section. References to an act or a section thereof include

 references to amendments to that act or section.

     (e) Where there is no U.S.C. provision, the agency will include a

 citation to the U.S. Statutes at Large. Citations to the U.S. Statutes

 at Large will refer to volume and page.

     (f) The authority citations will include a citation to executive

 delegations (i.e., Executive Orders), if any, necessary to link the

 statutory authority to the agency.

 

  54 FR 39630, Sept. 27, 1989

 

 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

 

   Page 7

 

 and the unit containers are not intended to be sold separately, the net

 weight placement requirement of 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

 

   Page 8

 

 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 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

 

   Page 9

 

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

 Washington, DC 20204, 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.

 

   Page 10

 

     (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 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

 

   Page 11

 

 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 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

 

 Sec. 1.31   Package size savings.

 

     Any food, drug, cosmetic, or device that bears on the label or

 labeling a representation that the consumer commodity is being offered

 at a lower price per unit of weight, measure, or count because of

 economy resulting from the size of the container or quantity of its

 contents is subject to the following conditions:

     (a) The container may bear a representation of economy by virtue of

 its size (for example, ``economy size,'' ``economy pack,'' ``big

 value,'' ``thrifty pack,'' ``bargain size,'' ``budget pack,'' etc.) only

 if:

     (1) The sponsor of the economy size promotion at the same time

 offers the same brand of that commodity in at least one other packaged

 size or labeled form.

 

   Page 12

 

     (2) Only one packaged or labeled form of that brand of commodity is

 labeled with an ``economy size'' representation.

     (3) The sponsor of the economy size promotion and all subsequent

 levels of commerce sell the commodity labeled with an ``economy size''

 representation at a price per unit of weight, volume, measure, or count

 which is substantially reduced (i.e., at least 5 percent) from the

 actual price of all other packaged or labeled units of the same brand of

 that commodity offered simultaneously.

     (b) The sponsor of the economy size promotion and all subsequent

 levels of commerce such as wholesalers and jobbers shall maintain for at

 least 1 year invoices or other records showing that the wholesale price

 per unit of weight, measure, or count in the economy size package is

 such that the retailers can sell the economy size container at a

 significantly lower price per unit.

 

 Sec. 1.35   ``Cents-off,'' or other savings representations.

 

     Any food, drug, cosmetic, or device that bears on the label or

 labeling a representation that the consumer commodity is being offered

 for retail at a reduction in retail price is subject to the following

 conditions: Provided, however, That such conditions do not apply to any

 such savings representations initiated by persons who do not

 manufacture, package, or import such commodities and who do not

 prescribe or specify by any means the manner in which such commodities

 are packaged or labeled by a manufacturer, packager, or importer:

     (a) A ``cents-off,'' or other savings representation that states or

 implies a reduction in the ordinary and customary retail price may be

 used by a manufacturer, packer, distributor, or retailer, hereinafter

 known as the sponsor, initiating such promotion only if:

     (1) An ordinary and customary selling price of such consumer

 commodity has been established at the retail level,

     (2) The sponsor's selling price and the selling price at all

 subsequent levels of commerce such as wholesalers and jobbers has been

 reduced by at least the savings differential represented on the package

 or labeling, and

     (3) The sponsor and all subsequent levels of commerce keep and

 maintain invoices or other records for each promotion and for all

 successive promotions which occur within a 12-month period for at least

 1 year subsequent to the end of the year (calendar, fiscal, or market)

 in which the promotion occurs in order to show that the invoice cost to

 the retailer has been reduced in an amount sufficient to enable the

 retailer to pass the savings on to the purchaser.

     (b)(1) Each ``cents-off'' price reduction representation imprinted

 on the package or label shall be limited to a phrase which reflects that

 the price marked by the retailer represents the savings in the amount of

 the ``cents-off'' the retailer's regular price, e.g., ``Price Marked Is

 ---- Cents Off the Regular Price,'' ``Price Marked Is ---- Cents-Off the

 Regular Price of This Package'': Provided, The package or label may in

 addition bear in the usual pricing spot a form reflecting a space for

 the regular price, the represented ``cents-off,'' and a space for the

 price to be paid by the consumer. The sponsor who sells the commodity at

 retail shall display the regular price, clearly and conspicuously

 designated as ``regular price,'' on the package or label of the

 commodity or on a sign, placard, or shelf-marker placed in a position

 contiguous to the retail display of the ``cents-off'' marked commodity.

 The sponsor who does not sell at retail shall provide the retailer with

 a sign, placard, shelf-marker, or other device for the purpose of

 clearly and conspicuously displaying the retailer's regular price,

 designated as ``regular price,'' in a position contiguous to the

 ``cents-off'' marked commodity.

     (2) Other savings representations which appear on the label or

 labeling of a package, e.g., ``bonus offer,'' ``two-for-one sales,''

 ``one-cent sales,'' etc., are subject to the provisions of this section.

 Due to the infinite variety and scope of such promotions, the label

 format of such representations may differ from that set forth in

 paragraph (b)(1) of this section for ``cents-off'' promotions; however,

 such representations shall include all material facts relative

 

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 to the offer and shall in no way be misleading

     (3) For the purposes of this section, the terms ordinary and

 customary and regular when used with the term price mean the price at

 which a consumer commodity has been openly and actively sold in the most

 recent and regular course of business in a particular retail outlet or a

 trade area for a reasonably substantial period of time (at least 30

 days). For consumer commodities that fluctuate in price, the ordinary

 and customary price shall be the lowest price at which any substantial

 sales were made during said 30 days.

     (c) Shipments of consumer commodities bearing ``cents-off,'' or

 other savings representations to a given geographic trade area made by

 the sponsor initiating such promotion shall be in no greater volume than

 50 percent of the total units of that identical consumer commodity

 distributed in the same geographic trade area during any period of 12

 consecutive months comprising a calendar, fiscal, or market year.

     (d) The ``cents-off,'' or other savings promotion may not be

 employed by a sponsor on consumer commodities for distribution to a

 specific geographic trade area until after 1 month has elapsed since

 their last distribution of that identical consumer commodity bearing a

 savings representation to the same geographic trade area. The number of

 such promotions for that identical consumer commodity that may occur

 within a 12-month period comprising a calendar, fiscal, or market year

 shall not exceed a total of six with no more than three of any one type

 or kind (e.g., ``cents-off,'' ``bonus offer,'' ``two-for-one sale,''

 ``1-cent sale,'' etc.), and the total period of time for all such

 promotions shall not exceed 6 months within that 12-month period.

     (e) A newly developed consumer commodity, one which has been changed

 in a functionally significant respect, or one which is newly introduced

 into a given geographic trade area may be the subject of an

 ``introductory offer'' type promotion. Such offers are not considered

 subject to the provisions of paragraphs (a) through (d) of this section,

 provided:

     (1) Each such labeled offer is clearly and conspicuously qualified

 with the phrase ``Introductory Offer,'' and

     (2) If the introductory offer promotion is in the form of a ``cents-

 off'' representation, each such labeled offer shall include clearly and

 conspicuously in immediate conjunction therewith the phrase ``---- Cents

 Off the After-Introductory -Offer Price''; and

     (3) Labeled representations do not exceed a period of 6 months

 duration.

 

 Any subsequent price reduction promotion of the consumer commodity is

 subject to the provisions of paragraphs (a) through (d) of this section

 and shall be preceded by the 30-day period required for a determination

 of the ordinary and customary selling price in that retail

 establishment. At the time of making the introductory offer promotion,

 the sponsor must intend in good faith to offer the commodity alone,

 immediately following the introductory offer promotion, for a reasonably

 substantial period of time (at least 30 days) at the anticipated after-

 introductory-offer price. The sponsor of the introductory offer

 promotion and all subsequent levels of commerce shall sell the commodity

 at a reduction from their anticipated after-introductory-offer price

 which reduction shall be at least equal to the savings differential

 represented on the package