(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 § 1.1b and of "principal display panel" in 88 1.7, 1.101a, and 1.201a; and the requirements pertaining to uniform location, lack of qualification, and separation of the net quantity declaration in §§ 1.8 b(f), 1.102d(e), and 1.202b (f) to type size requirements for net quantity declaration in §§ 1.8b(i), 1.102(h), and 1.202b (i), to initial statement of ounces in the dual declaration of net quantity in §§ 1.8b (j) and (m), 1.102d (d) and (k), and 1.202b (j) and (m), to initial statement of inches in declaration of net quantity in §§ 1.102d(m) and 1.202b (o), to initial statement of square inches in declaration of net quantity in §§ 1.102d (n) and 1.202b(p) to prohibition of certain supplemental net quantity statements in §§ 1.8b (o), 1.102d(o), and 1.202b (q), and to servings representations in § 1.8c 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.

[32 FR. 10780, July 21, 1967, as amended at 88 F.R. 9482, June 28, 1968]

§ 1.la Foods, drugs, devices, and cos metics; labeling; procedure 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 (1) 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 such findings and an exemption. The procedure followed and the criteria used in acting upon exemption requests of interested persons are as follows:

(a) If the petitioner shows that he is an interested person and furnishes reasonable grounds for his proposal, the Commissioner shall publish the proposal in the FEDERAL REGISTER and afford opportunity for interested persons to comment on it. After a study of all the facts available and of the comments received, the Commissioner will act upon the proposal and publish an order, pursuant to section 701(e) of the act, to which objection may be taken by persons who would be adversely affected.

(b) Practical administration of the law requires that there be a substantial showing of merit before any proposal is published. In evaluating proposals submitted by petitioners for initiating actions, it will be the policy of the Food and Drug Administration to consider that reasonable grounds have been furnished when:

(1) The proposal includes or is accompanied by a statement of the facts that the petitioner asserts he can substantiate by evidence in the event the proceedings lead to a public hearing.

(2) The declared facts furnish substantial support of the proposal and warrant a conclusion that the proposal is reasonable.

(3) The proposal if adopted would not unduly impinge upon the consumer's right to information essential to efficient marketing and to the making of value comparisons and would not otherwise

promote deception or unfair competition. (4) Full compliance with the declarations required by law would be impracticable, deceptive, or otherwise unnecessary.

(c) Opportunity will be given to amend petitions regarded as inadequate.

(d) At any time prior to the issuance of an order acting on his proposal under section 701 (e) (1) of the act, the petitioner may withdraw his petition without prejudice to a future filing. Notice of withdrawal of the petition and termination of the rulemaking proceeding will be published in the FEDERAL REGISTER.

(e) Established exemptions are set forth in § 1.1c.

[32 F.R. 10730, July 21, 1967]

§ 1.1b Packages; definition; 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. 231233), 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. 685, as amended; 15 U.S.C. 257-2571).

(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 § 1.8b (f) applicable to such unit containers is waived if the units are in compliance with all the other requirements of this part.

[32 F.R. 10730, July 21, 1967, as amended at 32 F.R. 13277, Sept. 20, 1967]

§ 1.1c 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 § 1.8b(j), 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 § 1.8b 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 subparagraph 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 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) (1) Soft drinks packaged in bottles shall be exempt from the placement requirements for the statement of identity prescribed by § 1.8 (a) and (d) 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 § 1.8 if the statement of identity on the unit container is not obscured by the multiunit retail package.

(1) A multiunit retail package for soft drinks shall be exempt from the declaration regarding name and place of business required by § 1.8a 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 § 1.8a. The declaration required by § 1.8a 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 § 1.8b (f) if the required content declaration is blown, formed, or molded into the surface of the bottle in close proximity to the closure.

(6) (1) 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 2-liquid pint and 2-gallon measure-containers, as defined in the "Measure Container Code of

National Bureau of Standards Handbook 44," are exempt from the requirements of § 1.8b (b) (2) to the extent that net contents of 8-fluid ounces and 64-fluid ounces (or 2 quarts) may be expressed as 2 pint and 1⁄2 gallon, respectively.

(ii) The foods named in subdivision (i) of this subparagraph, when measured by and packaged in 1-liquid pint, 1-liquid quart, and 1⁄2-gallon measurecontainers, as defined in the "Measure Container Code of National Bureau of Standards Handbook 44," are exempt from the dual net-contents declaration requirement of § 1.8b(j).

as

(iii) The foods named in subdivision (i) of this subparagraph, when measured by and packaged in 2-liquid pint, 1-liquid pint, 1-liquid quart, 1⁄2-gallon, and 1-gallon measure-containers, defined in the "Measure Container Code of National Bureau of Standards Handbook 44," are exempt from the requirement of § 1.8b (f) that the declaration of net contents be located within the bottom 30 percent of the principal display panel.

(7) (1) 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-andhalf, 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, lowfat 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 § 1.8b(b)(2) 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 subdivision (1) of this subparagraph, when packaged in glass or plastic containers of 2-pint, 1-pint, 1-quart, 1⁄2-gallon, and 1-gallon capacities are exempt from the placement requirement of § 1.8b (f) 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 subdivision (i) of this subparagraph, when packaged in containers of 1-pint, 1-quart, and 1⁄2gallon capacities are exempt from the dual net-contents declaration requirement of § 1.8b(j).

(8) Wheat flour products, as defined by §§ 15.1, 15.10, 15.20, 15.30, 15.50, 15.60, 15.70, 15.75, 15.80, and 15.90 of this chapter, packaged:

(1) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages are exempt from the placement requirement of § 1.8b (f) 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 § 1.8b(j) provided the quantity of contents is expressed in pounds.

(9) (1) 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 § 1.8b (f) 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):

(1) In 8-ounce and in 1-pound packages is exempt from the requirements of § 1.8b (f) that the net contents declaration be placed within the bottom 30 percent of the area of the principal display panel;

(11) In 1-pound packages is exempt

from the requirements of § 1.8b (j) (1) 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 §§ 1.8(d) and 1.8b (f) 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 § 45.1 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 § 1.8b (f) 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 § 1.8b(j) (1) 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 §§ 15.500 through 15.514 of this chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags are exempt from the placement requirement of § 1.8b (f) 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 2-pint, 1-pint, 1-quart, 1⁄2gallon, and 1-gallon capacities are exempt from the placement requirement of § 1.8b (f) 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 2-gallon capacities are exempt from the dual net-contents declaration requirement of § 1.8b(j).

(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-fluidounce capacity, are exempt from the requirements of § 1.8b(b) (2) 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 2 gallon (or half gallon), respectively. (b) Drugs. (1) 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 § 1.102d(b), (i), and (j), and from the dual declaration requirements of § 1.102d (1), 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° F. (20° C.).

[82 F.R. 10781, July 21, 1967, as amended at 33 F.R. 6861, May 7, 1968; 33 F.R. 9482, June 28, 1968; 83 F.R. 10141, July 16, 1968; 33 FR. 10206, July 17, 1968; 33 FR. 10391, July 20, 1968; 33 F.R. 11902, Aug. 22, 1968; 33 F.R. 12039, Aug. 24, 1968; 33 FR. 19007, Dec. 20, 1968; 34 F.R. 931, Jan 22, 1969; 34 F.R. 11541, July 12, 1969; 34 F.R. 15354, Oct. 2, 1969; 34 F.R. 15840, Oct. 15, 1969]

DEFINITIONS

AUTHORITY: §§ 1.2 and 1.3 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted.

§ 1.2 Labeling; label; 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 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.

(Secs. 4, 6, 80 Stat. 1297, 1299, 1800, secs. 403,

602, 52 Stat. 1047, 1050, 1054; 15 U.S.C. 1453, 1455, 21 U.S.C. 843, 352, 862) [82 F.R. 10781, July 21, 1967]

8 1.3 Difference of opinion among experts.

The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation.

(Sec. 201, 52 Stat. 1041, as amended; 21 U.S.C. 821) [20 F.R. 9526, Dec. 20, 1955]

PROHIBITED ACTS AND PENALTIES AUTHORITY: 1.4 to 1.6 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted.

§ 1.4 Guaranty.

In case of the giving of a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. (Sec. 301, 52 Stat. 1042, as amended; 21 U.S.C. 381) [20 FR. 9526, Dec. 20, 1955] § 1.5 Guaranty; definition, and suggested forms.

(a) A guaranty or undertaking referred to in section 303 (c) (2) of the act may be:

(1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or

(2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking.

(b) The following are suggested forms of guaranty or undertaking under section 303 (c) (2) of the act:

(1) Limited form for use on invoice or bill of sale.

(Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty or undertaking) (2) General and continuing form,