Sec.

1.102c Prescription and insulin-containing drugs in package form; labeling re declaration of net quantity of contents.

1.102d Over-the-counter drugs and devices in package form; labeling re declaration of net quantity of contents. 1.103 Drugs and devices; forms of making required statements.

1.104 Drugs; statement of ingredients. 1.105 Prescription-drug advertisements. Drugs and devices; directions for use. Drugs and devices; exemptions. Drugs and devices; statement of policy re Spanish-language versions of required labeling statements.

1.106 1.107 1.108

1.115 Definition of term "insulin."

COSMETICS

1.8b

1.315

1.80

1.317 Payment for samples.

1.9

1.10

Food; labeling; designation of ingredients.

1.320

Granting of authorization.

1.11

Special dietary uses.

1.322

Costs chargeable in connection with relabeling and reconditioning inad. missible imports.

ADMINISTRATIVE

(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 §§ 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 (i) 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 F.R. 10730, July 21, 1967, as amended at 33 F.R. 9482, June 28, 1968]

§ 1.1a

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) cf 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) (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 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) (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 1⁄2 pint and 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