Imagini ale paginilor
PDF
ePub

CHAPTER HFOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION,

AND WELFARE

(Parts 1 to 119)

SUBCHAPTER A- GENERAL

Part 1

2 3 4 5 8 9

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. 85 Seafood inspection. 86–119 Reserved]

SUBCHAPTER A GENERAL

PART 1-REGULATIONS FOR THE EN

FORCEMENT OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND THE FAIR PACKAGING AND LABELING ACT

GENERAL

Boc. 1.1 1.18

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 making

requirod statements. 1.104 Drugs; statement of ingredients. 1.105 Prescription-drug advertisementa. 1.106 Drugs and devices; directions for use. 1.107 Drugs and devices; exemptions. 1.108 Drugs and devices; statement of pol

loy re Spanish-language versions of

required labeling statements. 1.115 Definition of term "insulin."

1.1b

1.10

General
Poods, drugs, devices, and cosmetics;

labeling; procedure for requesting
variations and exemptions from re-

quired label statements. Packages; definition; presence of man

datory label information. Exemptions from required label statements.

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

formas. Presentation of views under section

806 at the actio

1.2 1.3

1.4 1.3

1.6

1.7

1.8

1.88

OOSOFTICS 1.201 Cosmetic; labeling; misbranding. 1.2018 Cosmetics in package form; principal

display panel. 1.202 Cosmetics in package form; labeling

re identity. 1.202a Cosmetics in package form; labeling

re name and place of business of manufacturer, packer, or distrib

utor. 1.202b Cosmetics in package form; labeling

re declaration of net quantity of

contents. 1.203 Cosmetic; labeling requirements, form

of stating. 1.204 Cosmetic; labeling requirements; ex

emptions.

IMPORTS AND BORIS 1.816 Definitions. 1.816 Notice of sampling. 1.817 Payment for samples. 1.318 Hearing. 1.819 Application for authorization. 1.820 Granting of authorization. 1.821 Bonds. 1.822 Costs chargeable in connection with

ralaboling and reconditioning Ipadmissible importa.

ADMINISTRATIVO 1.700 Examinations and investigations, samples.

GENERAL AUTHORITY: 88 1.1 to 1.10 issued under soos. 4, 6, 80 Stat. 1297, 1299, 1800, 8008. 403, 602, 701, 52 Stat. 1047, 1060, 1064, 1068; 18 U.S.O. 1453, 1456, 21 U.S.O. 848, 352, 862, 871.

FOOD Food in package form; principal dis

play panel. Pood in package form, labeling; iden

tity. Food labeling, name and place of busi

ness of manufacturer, packer, or distributor. Food labeling; declaration of net

quantity of contents; when exempt. Food labeling; number of servings. Food; labeling; prominence of ro

quired statomants. Food; labeling; designation af ingrodi

anata. Special dietary UBES. Food; labeling; artificial flavoring or

coloring, chomioal preservativa. Food; labeling; misbranding.

[ocr errors][merged small][merged small][merged small][merged small]

DRUGS AND DEVICES

1.100 Drugs; name. 1.101 Drugs and devices; labeling, mais

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 re

identity. 1.1028 Over-the-counter drugs and devices in

package form; labeling re identity. 1.102b Drugs and devices in package forma; labeling re name and place

of businens of manufacturer, packer, or distributor

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 causing of such act to be done.

(b) The definitions and interpreta- of reasonable variations and exemptions tions of terms contained in section 201 for small packages from the required of the Federal Food, Drug, and Cosmetic declaration of net quantity of contents. Act shall be applicable also to such terms Section 5(b) of the Fair Packaging and when used in regulations promulgated Labeling Act provides for the establishunder that act.

ment by regulation of exemptions from (c) The definition of “package" in certain required declarations of net $ 1.1b and of "principal display panel” in quantity of contents, identity of com$$ 1.7, 1.101a, and 1.2018; and the re- modity, identity and location of manuquirements pertaining to uniform loca- facturer, packer, or distributor, and from tion, lack of qualification, and separation declaration of net quantity of servings of the net quantity declaration in $$ 1.8 represented, based on a finding that full b(f), 1.102d(e), and 1.202b(f) to type compliance with such required declarasize requirements for net quantity decla- tions is impracticable or not necessary ration in $$ 1.8b(i), 1.102(h), and 1.202b for the adequate protection of consumers, (i), to initial statement of ounces in the and a further finding that the nature, dual declaration of net quantity in form, or quantity of the packaged con$$ 1.8b (j) and (m), 1.102d (d) and (k), sumer commodity or other good and sufand 1.202b (1) and (m), to initial state- ficient reasons Justify such exemptions. ment of inches in declaration of net The Commissioner, on his own initiative quantity in $$ 1.102d(m) and 1.202b(o), or on petition of an interested person, to initial statement of square inches in may propose such findings and an exdeclaration of net quantity in 8$ 1.102d emption. The procedure followed and the (n) and 1.202b(p) to prohibition of cer- criteria used in acting upon exemption tain supplemental net quantity state- requests of interested persons are as ments in 8$ 1.8b(o), 1.102d(0), and 1.202b follows: (g), and to servings representations in (a) I the petitioner shows that he is § 1.8C are provided for solely by the Fair an interested person and furnishes resPackaging and Labeling Act. The other sonable grounds for his proposal, the requirements of this part are issued un- Commissioner shall publish the proposal der both the Fair Packaging and Labeling in the FEDERAL REGISTER and afford opAct and the Federal Food, Drug, and portunity for interested persons to comCosmetic Act, or by the latter act solely, ment on it. After a study of all the facts and are not limited in their application available and of the comments received, by section 10 of the Fair Packaging and the Commissioner will act upon the proLabeling Act.

posal and publish an order, pursuant to [82 F.R. 10780, July 21, 1967, as amended at section 701 (e) of the act, to which ob33 FR. 9482, June 28, 1968]

jection may be taken by persons who $ 1.la Foods, drugs, devices, and cos

would be adversely affected.

(b) Practical administration of the metics; labeling; procedure for requesting variations and exemptions

law requires that there be a substantial from required label statements.

showing of merit before any proposal

is published. In evaluating proposals Section 403(e) of the act (in this part

submitted by petitioners for initiating 1, the term "act" means the Federal actions, it will be the policy of the Food Food, Drug, and Cosmetic Act) provides and Drug Administration to consider for the establishment by regulation of that reasonable grounds have been furreasonable variations and exemptions nished when: for small packages from the required (1) The proposal includes or is accomdeclaration of net quantity of contents. panied by a statement of the facts that Section 403(1) of the act provides for the the petitioner asserts he can substantiate establishment by regulation of exemp- by evidence in the event the proceedings tions from the required declaration of lead to a public hearing. ingredients where such declaration is (2) The declared facts furnish subimpracticable, or results in deception or stantial support of the proposal and unfair competition. Section 502(b) of warrant a conclusion that the proposal the act provides for the establishment by is reasonable. regulation of reasonable variations and (3) The proposal if adopted would not exemptions for small packages from the unduly impinge upon the consumer's required declaration of net quantity of right to information essential to efficient contents. Section 602(b) of the act pro- marketing and to the making of value vides for the establishment by regulation 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 a (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 (1) 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

8 1.lc Exemptions from required label forth in 8 1.10.

statements. [82 F.R. 10730, July 21, 1967)

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

part: The term “package” means any con- (a) Foods. (1) While held for sale, a 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 retail 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 s 1.8b(j), bearing labels declaring net (b) Shipping containers 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 g 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; 15 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 retail establishments.

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

exempted by this subparagraph except

that the labels shall bear a declaration ers which do not bear written, printed, or 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 12 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.

or

(4) Individually wrapped pieces of National Bureau of Standards Handbook penny candy" and other confectionery 44,” are exempt from the requirements of of less than one-half ounce net weight $ 1.8b(b) (2) to the extent that net conper individual piece shall be exempt tents of 8-fluid Ounces and 64-fluid from the labeling requirements of this ounces (or 2 quarts) may be expressed as part when the container in which such 12 pint and 1/2 gallon, respectively. confectionery is shipped is in conform- (ii) The foods named in subdivision ance with the labeling requirements (i) of this subparagraph, when measof this part. Similarly, when such con- ured by and packaged in 1-liquid pint, fectionery items are sold in bags or boxes, 1-liquid quart, and 12-gallon measuresuch items shall be exempt from the containers, as defined in the "Measure labeling requirements of this part, in- Container Code of National Bureau of cluding the required declaration of net Standards Handbook 44,” are exempt quantity of contents specified in this part from the dual net-contents declaration when the declaration on the bag or box

requirement of g 1.8b(j). meets the requirements of this part.

(iii) The foods named in subdivision (5) (1) Soft drinks packaged in bottles

(i) of this subparagraph, when measured shall be exempt from the placement re- by and packaged in 12-liquid pint, quirements for the statement of identity 1-liquid pint, 1-liquid quart, 12-gallon, prescribed by $ 1.8 (a) and (d) if such

and 1-gallon measure-containers, as statement appears conspicuously on the defined in the "Measure Container Code bottle closure. When such soft drinks are

of National Bureau of Standards Handmarketed in a multiunit retail package, book 44,” are exempt from the requirethe multiunit retail package shall be ment of $ 1.8b(f) that the declaration of exempt from the statement of identity net contents be located within the botdeclaration requirements prescribed by tom 30 percent of the principal display $ 1.8 if the statement of identity on the panel. unit container is not obscured by the (7) (1) Milk, cream, light cream, coffee multiunit retail package.

or table cream, whipping cream, light (i) A multiunit retail package for whipping cream, heavy or heavy whipsoft drinks shall be exempt from the ping cream, sour or cultured sour cream, declaration regarding name and place half-and-half, sour or cultured half-andof business required by $ 1.8a if the half, reconstituted or recombined milk package does not obscure the declara- and milk products, concentrated milk tion on unit containers or if it bears a and milk products, skim or skimmed milk, statement that the declaration can be vitamin D milk and milk products, fortifound on the unit containers and the fied milk and milk products, homogenized declaration on the unit containers com- milk, flavored milk and milk products, plies with $ 1.8a. The declaration re- buttermilk, cultured buttermilk, cultured quired by $ 1.8a may appear on the top milk or cultured whole buttermilk, lowor side of the closure of bottled soft fat milk (0.5 to 2.0 percent butterfat), drinks if the statement is conspicuous and acidified milk and milk products, and easily legible.

when packaged in containers of 8- and (ii) Soft drinks packaged in bottles 64-fluid-ounce capacity, are exempt from which display other required label in- the requirements of $ 1.8b(b) (2) to the formation only on the closure shall be extent that net contents of 8 fluid ounces exempt from the placement requirements and 64 fluid ounces (or 2 quarts) may be for the declaration of contents prescribed expressed as 12 pint and 42 gallon, by 8 1.8b (f) if the required content dec- respectively. laration is blown, formed, or molded into (1) The products listed in subdivision the surface of the bottle in close proxim- (1) of this subparagraph, when packaged ity to the closure.

in glass or plastic containers of 12-pint, (6) (1) Ice cream, french ice cream, 1-pint, 1-quart, 12-gallon, and 1-gallon ice milk, fruit sherbets, water ices, quies- capacities are exempt from the placecently frozen confections (with or with- menü requirement of $ 1.8b (f) that the out dairy ingredients), special dietary declaration of net contents be located frozen desserts, and products made in within the bottom 30 percent of the semblance of the foregoing, when meas- principal display panel, provided that ured by and packaged in 12-liquid pint other required label information is conand 42-gallon measure-containers, as de- spicuously displayed on the cap or outfined in the "Measure Container Code of side closure and the required net quantity

« ÎnapoiContinuați »