[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: 21CFR1.23]



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                        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



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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.