(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 § 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.

(ii) 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 1⁄2 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).

(iii) The foods named in subdivision (i) of this subparagraph, when measured by and packaged in 1⁄2-liquid pint, 1-liquid pint, 1-liquid quart, 2-gallon, and 1-gallon measure-containers, as 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) (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-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 2 pint and 1⁄2 gallon, respectively.

(ii) The products listed in subdivision (i) 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 (1) 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 8 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;

(ii) 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 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 (i), 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. 10731, July 21, 1967, as amended at 33 F.R. 6861, May 7, 1968; 33 F.R. 9482, June 28, 1968; 33 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 1.8 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. 408,

602, 52 Stat. 1047, 1050, 1054; 15 U.S.C. 1453, 1455, 21 U.S.C. 843, 352, 362) [82 F.R. 10781, July 21, 1967]

§ 1.3 Difference of opinion among experts.

The existence of 8 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.321) [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. 331) [20 F.R. 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,

The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or on the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed as of the date of such shipment or delivery, to be, on such date, not adulterated or mis. branded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not 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 of undertaking)

(c) The application of a guaranty or undertaking referred to in section 303 (c) (2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes adulterated or misbranded within the meaning of the act, or becomes an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce.

(d) A guaranty or undertaking referred to in section 303 (c) (3) of the act shall state that the shipment or other delivery of the color additive covered thereby was manufactured by a signer thereof. It may be a part of or attached to the invoice or bill of sale covering such color. If such shipment or delivery is from a foreign manufacturer, such guaranty or undertaking shall be signed by such manufacturer and by an agent of such manufacturer who resides in the United States.

(e) The following are suggested forms of guaranty or undertaking under section 303 (c) (3) of the act:

(1) For domestic manufacturers:

(Name of manufacturer) hereby guarantees that all color additives listed herein were manufactured by him, and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act. (Signature and post-office address of manufacturer.)

(2) For foreign manufacturers:

(Name of manufacturer and agent) hereby severally guarantee that all color additives listed herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.

(Signature and post-office address of manufacturer.)

(Signature and post-office address of agent.)

(f) For the purpose of a guaranty or undertaking under section 303 (c) (3) of the act the manufacturer of a shipment or other delivery of a color additive is the person who packaged such color.

(g) A guaranty or undertaking, if signed by two or more persons, shall state that such persons severally guarantee the article to which it applies.

(h) No representation or suggestion that an article is guaranteed under the act shall be made in labeling. (Sec. 303, 52 Stat. 1043; 21 U.S.C. 388) F.R. 9526, Dec. 20, 1955, as amended at 28 FR. 6898, June 21, 1968]

§ 1.6

[20

Presentation of views under section 305 of the act.

(a) Presentation of views under section 305 of the act shall be private and informal. The views presented shall be confined to matters relevant to the contemplated proceeding. Such views may be presented by letter or in person by the person to whom the notice was given, or by his representative. In case such person holds a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views.

(b) Upon request, seasonably made, by the person to whom a notice appointing a time and place for the presentation of views under section 305 of the act has been given, or by his representative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall be addressed to the office of the Food and Drug Administration which issued the notice. (Sec. 305, 52 Stat. 1045, as amended; 21 U.S.C. 335) [20 F.R. 9527, Dec. 20, 1955]

FOOD

AUTHORITY: §§ 1.7 to 1.15 issued under secs. 4, 6, 80 Stat. 1297, 1299, 1800, secs. 408, 602, 701, 52 Stat. 1047, 1050, 1054, 1055 as amended; 15 U.S.O. 1453, 1455, 21 U.S.C. 348, 352, 362, 871.

§ 1.7 Food in package form; principal display panel.

The term "principal display panel” as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under

customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term “area of the principal display panel" means the area of the side or surface that bears the principal display panel, which area shall be:

(a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side;

(b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference;

(c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious "principal display panel" such as the top of a triangular or circular package of cheese, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. [32 F.R. 10731, July 21, 1967, as amended at 32 F.R. 13278, Sept. 20, 1967]

§ 1.8 Food in package form, labeling; identity.

(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.

(b) Such statement of identity shall be in terms of:

(1) The name now or hereafter specified in or required by any applicable Federal law or regulation; or, in the absence thereof,

(2) The common or usual name of the food; or, in the absence thereof,

(3) An appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food.

(c) Where a food is marketed in various optional forms (whole, slices, diced, etc.), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bearing a reasonable relation to the size of the letters forming the other components of the statement of identity; except that if the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the statement. This specification does not affect the required declarations of identity under definitions and standards for foods promulgated pursuant to section 401 of the act.

(d) This statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

[32 F.R. 10731, July 21, 1967]

§ 1.8a Food labeling; name and place of business of manufacturer, packer, or distributor.

(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as "Manufactured for tributed by

"Dis

or any other wording that expresses the facts.

(d) The statement of the place of business shall include the street address, city, State, and ZIP Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for