[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR1.20]



[Page 7-8]

 

                        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



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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 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.