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CHAPTER FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION,

AND WELFARE

(Parts 1 to 119)

SUBCHAPTER A-GENERAL

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Regulations for the enforcement of the Federal Food, Drug, and Cosmetic

Act and the Fair Packaging and Labeling Act.
Administrative functions, practices, and procedures.
Statements of general policy or interpretation.
Official records and information.
Food; exemptions from labeling requirements.
Color additives.
Color certification.

SUBCHAPTER B-FOOD AND FOOD PRODUCTS

10 Definitions and standards for food. 14 Cacao products. 15 Cereal flours and related products. 16 Macaroni and noodle products. 17 Bakery products. 18 Milk and cream. 19 Cheeses, processed cheeses, cheese foods, cheese spreads, and related foods. 20 Frozen desserts. 22 Food flavorings. 25 Dressings for food. 27 Canned fruits and fruit juices. 29 Fruit butters, fruit jellies, fruit preserves, and related products. 31 Nonalcoholic beverages. 36 Shellfish. 37 Fish. 42 Eggs and egg products. 45 Oleomargarine, margarine. 46 Nut products. 51 Canned vegetables. 53 Tomato products.

Seafood inspection. 86–119 [Reserved]

85

SUBCHAPTER A GENERAL

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Soc. 1.1020 Prescription and insulin-containing

drugs in package form; labeling re declaration of net quantity of con

tents. 1.102d Over-the-counter drugs and devices in

package form; labeling re declara

tion of net quantity of contents. 1.108 Drugs and devices; forms of malding

requirod statemento. 1.104 Drugs; statement of ingredients. 1.106 Prescription-drug advertisementa. 1.106 Drugs and devices; directions for wo. 1.107 Drugs and dovices; exemptions. 1.108 Drugs and devices; statement of pol

toy re Spanish-language versions of

required labeling statements. 1.116 Definition of term "insulin."

1.1b

1.10

General
Poods, drugs, devices, and cosmetics;

labeling; procedure for requesting
variations and exemptions from ro-

quired label statements. Packages; definition; presence of man

datory label information. Exemptions from required label statemente.

DEFINITIONS Labeling; label; definitions. Difference of opinion among experts. PROEIBITED ACTS AND PENALTIES Guaranty. Guaranty: definition, and suggested

forms. Presentation of views under section

808 at the actor

1.2 1.8

1.4 15

1.6

OOSTATICS 1.201 Cosmetic; labeling; misbranding. 1.201a Cosmetics in package form; principal

display panel. 1.202 Cosmetics in package form; labeling

re identity. 1.202a Cosmetics in package form; labeling

to name and place of business of manufacturer, packer, or distri).

utor. 1.202b. Cosmetics in package form; labeling

re declaration of net quantity of

contents. 1.209 Cosmetic; labeling requirements, form

of stating. 1.204 Cosmetic; labeling requirements; ex

emptions.

IMPORTS AND BOORT3

Foop 1.7

Food in package form; principal dis

play panal. 1.8

Pood in package form, labeling; iden

tity. 1.88 Pood labeling, name and place of busi

ness of manufacturer, packer, or dis

tributor. 139 Pood labeling; doclaration of net

quantity of contents; when exempt. 1.80 Food labeling; number of servings. 1.9 Food; labeling; prominence of re

quired statomants. 1.10 Food; labeling; dostgration of ingredi

anta. 1.11 Special dietary uses. 1.12 Pood; labeling; artifdal flavoring or

coloring, ahamical preservativa. 1.16 Pood; labeling; misbranding.

DruaS AND DEVICES 1.100 Drugs; name. 1.101 Drugs and devices; labeling, mate

branding. 1.1018 Over-the-counter drugs and devices in

package form; principal display

panel. 1.102 Prescription and insulin-containing

drugs in package form; labeling te

Identity. 1.1024 Over-the-counter drugs and devices in

package form; labeling re identity. 1.1026 Drugs and devices in package form;

labeling re name and place of busineds of manufacturer, packer, or distributor.

1.816 Definitions. 1.816 Notice of sampling. 1.817 Payment for samples. 1.818 Hearing. 1.819 Application for authorization. 1.820 Granting of authorization. 1.821 Bonds. 1.822 Oosts chargeable in connection with

rolaboling and reconditioning Ipadmissible importa.

ADMINISTRATIVE 1.700 Examinations and investigations, samples.

GENERAL AUTHORITY: 84 1.1 to 1.10 issued under secs. 4, 6, 80 Stat. 1297, 1299, 1800, seas. 408, 602, 701, 62 Stat. 1047, 1000, 1054, 1006; 18 U.S.O. 1458, 1455, 21 U.S.O. 848, 352, 862, 871.

8 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 causting of such act to be done.

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(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 (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 88 1.102d (n) and 1.202b(p) to prohibition of certain supplemental net quantity statements in $ $ 1.8b(0), 1.102d(0), 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. 10780, July 21, 1967, as amended at 33 F.R. 9482, June 28, 1968] 8 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. article, or, as stated in paragraph (e) of

(4) Full compliance with the declara- this section, such information is easily tions required by law would be imprac- legible by virtue of the transparency of ticable, deceptive, or otherwise unneces- the outer wrapper or container. Where & sary.

consumer commodity is marketed in & (c) Opportunity will be given to multiunit retail package bearing the amend petitions regarded as inadequate. mandatory label information as required

(d) At any time prior to the issu- by this part and the unit containers are ance of an order acting on his proposal not intended to be sold separately, the under section 701(e) (1) of the act, the net weight placement requirement of petitioner may withdraw his petition $ 1.8b (f) applicable to such unit conwithout prejudice to & future filing. tainers is waived if the units are in Notice of withdrawal of the petition and compliance with all the other requiretermination of the rulemaking pro- ments of this part. ceeding will be published in the FEDERAL (32 F.R. 10730, July 21, 1967, as amended at REGISTER.

32 F.R. 18277, Sept. 20, 1967] (e) Established exemptions are set

& l.le Exemptions from required label forth in $ 1.10.

statements. [82 F.R. 10780, July 21, 1967)

The following exemptions are granted 8 1.lb Packages; definitions presence of from label statements required by this mandatory label information.

part: The term “package” means any con

(a) Foods. (1) While keld for sale, & tainer or wrapping in which any food,

food shall be exempt from the required drug, device, or cosmetic is enclosed for declaration of net quantity of contents use in the delivery or display of such specified in this part if said food is recommodities to retall purchasers, but

ceived in bulk containers at & retail esdoes not include:

tablishment and is accurately weighed, (a) Shipping containers or wrappings measured, or counted either within the used solely for the transportation of any

view of the purchaser or in compliance such commodity in bulk or in quantity with the purchaser's order. to manufacturers, packers, processors,

(2) Random food packages, as defined or wholesale or retail distributors;

in $ 1.8b (j), bearing labels declaring net (b) Shipping containers or outer weight, price per pound or per specified wrappings used by retailers to ship or

number of pounds, and total price shall deliver any such commodity to retail be exempt from the type size, dual customers if such containers and wrap

declaration, and placement requirements pings bear no printed matter pertaining

of 8 1.8b if the accurate statement of net to any particular commodity; or

weight is presented conspicuously on the (c) Containers subject to the provi

principal display panel of the package. sions of the Act of August 3, 1912 (37

In the case of food packed in random Stat. 250, as amended; 15 U.S.C. 231

packages at one place for subsequent 233), the Act of March 4, 1915 (38 Stat.

shipment and sale at another, the price 1186, as amended; 15 U.S.C. 234–236),

sections of the label may be left blank the Act of August 31, 1916 (39 Stat. 673,

provided they are filled in by the seller as amended; 16 U.S.C. 251–256), or the

prior to retail sale. This exemption shall Act of May 21, 1928 (45 Stat. 685, as

also apply to uniform weight packages amended; 15 U.S.C. 257–2571).

of cheese and cheese products labeled in (d) Containers used for tray pack dis

the same manner and by the same type plays in retall establishments.

of equipment as random food packages (e) Transparent wrappers or contain

exempted by this subparagraph except ers which do not bear written, printed, or

that the labels shall bear a declaration graphic matter obscuring the label infor

of price per pound and not price per mation required by this part.

specified number of pounds.

(3) Individual serving-size packages A requirement contained in this part of foods containing less than 42 ounce or that any word, statement, or other less than 42 fluid ounce for use in restauinformation appear on the label shall rants, institutions, and passenger carnot be considered to be complied with riers, and not intended for sale at retail, unless such word, statement, or informa- shall be exempt from the required declation also appears on the outer container ration of net quantity of contents specor wrapper of the retail package of the ified in this part.

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