General Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act
This electronic document was downloaded from the GPO web site, September 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the
GPO web site or from the current printed version.[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.1]
[Page 5]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart A--General Provisions
Sec. 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 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 Sec. 1.20 and of principal display
panel in Secs. 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter;
and the requirements pertaining to uniform location, lack of
qualification, and separation of the net quantity declaration in
Secs. 101.105(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this
chapter to type size requirements for net quantity declaration in
Secs. 101.105(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this
chapter, to initial statement of ounces in the dual declaration of net
quantity in Secs. 101.105(j) and (m), 201.62(i) and (k), 501.105(j) and
(m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial
statement of inches in declaration of net quantity in Secs. 201.62(m),
701.13(o) and 801.62(m) of this chapter, to initial statement of square
inches in declaration of net quantity in Secs. 201.62(n), 701.13(p) and
801.62(n) of this chapter, to prohibition of certain supplemental net
quantity statements in Secs. 101.105(o), 201.62(o), 501.105(o),
701.13(q) and 801.62(o) of this chapter, and to servings representations
in Sec. 501.8 of this chapter 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.
[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.3]
[Page 5]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart A--General Provisions
Sec. 1.3 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.
[[Page 6]]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.4]
[Page 6]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart A--General Provisions
Sec. 1.4 Authority citations.
(a) For each part of its regulations, the Food and Drug
Administration includes a centralized citation of all of the statutory
provisions that provide authority for any regulation that is included in
that part.
(b) The agency may rely on any one or more of the authorities that
are listed for a particular part in implementing or enforcing any
section in that part.
(c) All citations of authority in this chapter will list the
applicable sections in the organic statute if the statute is the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair
Packaging and Labeling Act. References to an act or a section thereof
include references to amendments to that act or section. These citations
will also list the corresponding United States Code (U.S.C.) sections.
For example, a citation to section 701 of the Federal Food, Drug, and
Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371).
(d) If the organic statute is one other than those specified in
paragraph (c) of this section, the citations of authority in this
chapter generally will list only the applicable U.S.C. sections. For
example, a citation to section 552 of the Administrative Procedure Act
would be listed: 5 U.S.C. 552. The agency may, where it determines that
such measures are in the interest of clarity and public understanding,
list the applicable sections in the organic statute and the
corresponding U.S.C. section in the same manner set out in paragraph (c)
of this section. References to an act or a section thereof include
references to amendments to that act or section.
(e) Where there is no U.S.C. provision, the agency will include a
citation to the U.S. Statutes at Large. Citations to the U.S. Statutes
at Large will refer to volume and page.
(f) The authority citations will include a citation to executive
delegations (i.e., Executive Orders), if any, necessary to link the
statutory authority to the agency.
[54 FR 39630, Sept. 27, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.20]
[Page 6-7]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart B--General Labeling Requirements
Sec. 1.20 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. 231-233), 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. 635, as amended; 15 U.S.C. 257-257i).
(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
[[Page 7]]
Sec. 101.105(f) applicable to such unit containers is waived if the
units are in compliance with all the other requirements of this part.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.21]
[Page 7]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart B--General Labeling Requirements
Sec. 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, or cosmetic shall be deemed to
be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by
statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use
of the article under: (i) The conditions prescribed in such labeling or
(ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph
(a) of this section may be required, among other appropriate regulatory
procedures, by
(1) Regulations in this chapter promulgated pursuant to section
701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling for food, drugs, devices, or cosmetics under the act.
(2) Permit a statement of differences of opinion with respect to the
effectiveness of a drug unless each of the opinions expressed is
supported by substantial evidence of effectiveness as defined in
sections 505(d) and 512(d) of the act.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.23]
[Page 7]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart B--General Labeling Requirements
Sec. 1.23 Procedures 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(i) 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 a variation or exemption based upon any of the
foregoing statutory provisions, including proposed findings if section
5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts
10, 12, 13, 14, 15, 16, and 19 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.24]
[Page 7-11]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart B--General Labeling Requirements
Sec. 1.24 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 Sec. 101.105(j) of this
chapter, 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,
[[Page 8]]
and placement requirements of Sec. 101.105 of this chapter 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 paragraph (a)(2) 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 \1/2\ 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
Sec. 101.3 (a) and (d) of this chapter 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 Sec. 101.3 of this chapter 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
Sec. 101.5 of this chapter 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 Sec. 101.5 of this chapter. The
declaration required by Sec. 101.5 of this chapter 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
Sec. 101.105(f) of this chapter if the required content declaration is
blown, formed, or molded into the surface of the bottle in close
proximity to the closure.
(iv) Where a trademark on a soft drink package also serves as, or
is, a statement of identity, the use of such trademark on the package in
lines not parallel to the base on which the package rests shall be
exempted from the requirement of Sec. 101.3(d) of this chapter that the
statement be in lines parallel to the base so long as there is also at
least one statement of identity in lines generally parallel to the base.
(v) A multiunit retail package for soft drinks in cans shall be
exempt from the declaration regarding name and place of business
required by Sec. 101.5 of this chapter 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 Sec. 101.5 of this chapter. The
declaration required by Sec. 101.5 of this chapter may appear on the top
of soft drinks in cans if the statement is conspicuous and easily
legible, provided that when the declaration is embossed, it shall appear
in type size at least one-eighth inch in height, or if it is printed,
the type size shall not be less than one-sixteenth inch in height. The
declaration may follow the curvature of the lid of the can and shall not
be removed or obscured by the tab which opens the can.
[[Page 9]]
(6)(i) 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 \1/2\-
liquid pint and \1/2\-gallon measure-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirements of
Sec. 101.105(b)(2) of this chapter 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. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street NW., suite 700, Washington, DC.
(ii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in 1-liquid pint, 1-liquid quart, and \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of
National Bureau of Standards Handbook 44,'' Specifications, Tolerances,
and Other Technical Requirements for Weighing and Measuring Devices,
Sec. 4.45 ``Measure-Containers,'' which is incorporated by reference,
are exempt from the dual net-contents declaration requirement of
Sec. 101.105(j) of this chapter. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street NW., suite 700, Washington, DC.
(iii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirement of
Sec. 101.105(f) of this chapter that the declaration of net contents be
located within the bottom 30 percent of the principal display panel.
Copies are available from the Center for Food Safety and Applied
Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street NW., suite 700,
Washington, DC.
(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-and-half,
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, low-fat 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 Sec. 101.105(b)(2) of this chapter 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 paragraph (a)(7)(i) of this section,
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the
placement requirement of Sec. 101.105(f) of this chapter 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 paragraph (a)(7)(i) of this section,
when packaged
[[Page 10]]
in containers of 1-pint, 1-quart, and \1/2\-gallon capacities are exempt
from the dual net-contents declaration requirement of Sec. 101.105(j) of
this chapter.
(8) Wheat flour products, as defined by Secs. 137.105, 137.155,
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and
137.205 of this chapter, packaged:
(i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages
are exempt from the placement requirement of Sec. 101.105(f) of this
chapter 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 Sec. 101.105(j) of this chapter
provided the quantity of contents is expressed in pounds.
(9)(i) 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 Sec. 101.105(f) of this chapter 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):
(i) In 8-ounce and in 1-pound packages is exempt from the
requirements of Sec. 101.105(f) of this chapter 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
Sec. 101.105(j)(1) of this chapter 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 Secs. 101.3 and
101.105(f) of this chapter 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 Sec. 166.110 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 Sec. 101.105(f) of this
chapter 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 Sec. 101.105(j)(1) of this chapter 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
Secs. 137.211, 137.215, and Secs. 137.230 through 137.290 of this
chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags
are exempt from the placement requirement of Sec. 101.105(f) of this
chapter 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 \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and
1-gallon capacities are exempt from the placement requirement of
Sec. 101.105(f) of this chapter 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
[[Page 11]]
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 \1/2\-gallon capacities are exempt from the dual net-contents
declaration requirement of Sec. 101.105(j) of this chapter.
(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-
fluid-ounce capacity, are exempt from the requirements of
Sec. 101.105(b)(2) of this chapter 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 \1/2\ gallon (or half gallon), respectively.
(14) The unit containers in a multiunit or multicomponent retail
food package shall be exempt from regulations of section 403 (e)(1),
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements
for label declaration of the name and place of business of the
manufacturer, packer, or distributor; label declaration of ingredients;
and nutrition information when:
(i) The multiunit or multicomponent retail food package labeling
meets all the requirements of this part;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than one-sixteenth
of an inch in height. The word ``Individual'' may be used in lieu of or
immediately preceding the word ``Retail'' in the statement.
(b) Drugs. 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 Sec. 201.62
(b), (i), and (j) of this chapter, and from the dual declaration
requirements of Sec. 201.62(i) of this chapter, 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 [deg]F
(20 [deg]C).
(c) Cosmetics. Cosmetics in packages containing less than one-fourth
ounce avoirdupois or one-eighth fluid ounce shall be exempt from
compliance with the requirements of section 602(b)(2) of the Federal
Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging
and Labeling Act:
(1) When such cosmetics are affixed to a display card labeled in
conformance with all labeling requirements of this part; or
(2) When such cosmetics are sold at retail as part of a cosmetic
package consisting of an inner and outer container and the inner
container is not for separate retail sale and the outer container is
labeled in conformance with all labeling requirements of this part.
[42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47
FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3,
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035,
Nov. 6, 2001]
Subparts C-D [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.83]
[Page 11-12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.83 Definitions.
For the purposes of regulations prescribed under section 801(a),
(b), and (c) of the Federal Food, Drug, and Cosmetic Act:
(a) The term owner or consignee means the person who has the rights
of a consignee under the provisions of sections 483, 484, and 485 of the
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
(b) The term district director means the director of the district of
the Food and Drug Administration having jurisdiction over the port of
entry through which an article is imported or offered for import, or
such officer of the district as he may designate to act in his behalf in
administering and enforcing
[[Page 12]]
the provisions of section 801 (a), (b), and (c).
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.90]
[Page 12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.90 Notice of sampling.
When a sample of an article offered for import has been requested by
the district director, the collector of customs having jurisdiction over
the article shall give to the owner or consignee prompt notice of
delivery of, or intention to deliver, such sample. Upon receipt of the
notice, the owner or consignee shall hold such article and not
distribute it until further notice from the district director or the
collector of customs of the results of examination of the sample.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.91]
[Page 12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.91 Payment for samples.
The Food and Drug Administration will pay for all import samples
which are found to be in compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act. Billing for reimbursement should be made
by the owner or consignee to the Food and Drug Administration district
headquarters in whose territory the shipment was offered for import.
Payment for samples will not be made if the article is found to be in
violation of the act, even though subsequently brought into compliance
under the terms of an authorization to bring the article into compliance
or rendered not a food, drug, device, or cosmetic as set forth in
Sec. 1.95.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.94]
[Page 12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.94 Hearing on refusal of admission.
(a) If it appears that the article may be subject to refusal of
admission, the district director shall give the owner or consignee a
written notice to that effect, stating the reasons therefor. The notice
shall specify a place and a period of time during which the owner or
consignee shall have an opportunity to introduce testimony. Upon timely
request giving reasonable grounds therefor, such time and place may be
changed. Such testimony shall be confined to matters relevant to the
admissibility of the article, and may be introduced orally or in
writing.
(b) If such owner or consignee submits or indicates his intention to
submit an application for authorization to relabel or perform other
action to bring the article into compliance with the act or to render it
other than a food, drug, device, or cosmetic, such testimony shall
include evidence in support of such application. If such application is
not submitted at or prior to the hearing, the district director shall
specify a time limit, reasonable in the light of the circumstances, for
filing such application.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.95]
[Page 12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to
bring the article into compliance with the act or to render it other
than a food, drug, device or cosmetic may be filed only by the owner or
consignee, and shall:
(a) Contain detailed proposals for bringing the article into
compliance with the act or rendering it other than a food, drug, device,
or cosmetic.
(b) Specify the time and place where such operations will be carried
out and the approximate time for their completion.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.96]
[Page 12-13]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.96 Granting of authorization to relabel and recondition.
(a) When authorization contemplated by Sec. 1.95 is granted, the
district director shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision
of an officer of the Food and Drug Administration or the U.S. Customs
Service, as the case may be;
(4) A time limit, reasonable in the light of the circumstances, for
completion of the operations; and
(5) Such other conditions as are necessary to maintain adequate
supervision and control over the article.
(b) Upon receipt of a written request for extension of time to
complete such operations, containing reasonable grounds therefor, the
district director may grant such additional time as he deems necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the district director.
[[Page 13]]
(d) If ownership of an article covered by an authorization changes
before the operations specified in the authorization have been
completed, the original owner will be held responsible, unless the new
owner has executed a bond and obtained a new authorization. Any
authorization granted under this section shall supersede and nullify any
previously granted authorization with respect to the article.
[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.97]
[Page 13]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.97 Bonds.
(a) The bonds required under section 801(b) of the act may be
executed by the owner or consignee on the appropriate form of a customs
single-entry or term bond, containing a condition for the redelivery of
the merchandise or any part thereof upon demand of the collector of
customs and containing a provision for the performance of conditions as
may legally be imposed for the relabeling or other action necessary to
bring the article into compliance with the act or rendering it other
than a food, drug, device, or cosmetic, in such manner as is prescribed
for such bond in the customs regulations in force on the date of request
for authorization. The bond shall be filed with the collector of
customs.
(b) The collector of customs may cancel the liability for liquidated
damages incurred under the above-mentioned provisions of such a bond, if
he receives an application for relief therefrom, upon the payment of a
lesser amount or upon such other terms and conditions as shall be deemed
appropriate under the law and in view of the circumstances, but the
collector shall not act under this regulation in any case unless the
district director is in full agreement with the action.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.99]
[Page 13-14]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart E--Imports and Exports
Sec. 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
The cost of supervising the relabeling or other action in connection
with an import of food, drugs, devices, or cosmetics which fails to
comply with the Federal Food, Drug, and Cosmetic Act shall be paid by
the owner or consignee who files an application requesting such action
and executes a bond, pursuant to section 801(b) of the act, as amended.
The cost of such supervision shall include, but not be restricted to,
the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station, as provided by law.
(c) The charge for the services of the supervising officer, which
shall include administrative support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-11/4 employee, except that such services performed by a customs
officer and subject to the provisions of the act of February 13, 1911,
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 266 percent of the
equivalent hourly rate of regular pay of the supervising officer (GS-11/
4) and the analyst (GS-12/4) is computed as follows:
Hours
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
9 legal public holidays--New Years Day, Washington's 72
Birthday, Memorial Day, Independence Day, Labor Day,
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
Day.........................................................
Annual leave--26 d........................................... 208
Sick leave--13 d............................................. 104
--------
Total.................................................... 384
Net number of working hours.............................. 1,696
Gross number of working hours in 52 40-hr weeks................ 2,080
Working hour equivalent of Government contributions for 176
employee retirement, life insurance, and health benefits
computed at 8\1/2\ pct. of annual rate of pay of employee.....
--------
Equivalent annual working hours.......................... 2,256
--------
Support required to equal to 1 man-year........................ 2,256
Equivalent gross annual working hours charged to Food and 4,512
Drug appropriation......................................
Note: Ratio of equivalent gross annual number of working hours
charged to Food and Drug appropriation to net number of annual working
hours 4,512/1,696=266 pct.
(e) The minimum charge for services of supervising officers and of
analysts shall be not less than the charge for 1
[[Page 14]]
hour, and time after the first hour shall be computed in multiples of 1
hour, disregarding fractional parts less than \1/2\ hour.