Title 21 — Food and DrugsRelease 119-73
§345 Regulations making exemptions
Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER IV— - FOOD › § 345
Summary
The Secretary must make rules that exempt small open containers of fresh fruits and vegetables and food that, by trade practice, will be sent to other places to be processed, labeled, or repacked in large amounts, only if not contaminated or incorrectly labeled when removed. Excludes sections 343(q) and 343(r).
Full Legal Text
Title 21, §345
Food and Drugs — Source: USLM XML via OLRC
The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of section 343(q) and 343(r) of this title.
Legislative History
Notes & Related Subsidiaries
Editorial Notes
Amendments
1990—Pub. L. 101–535 inserted at end “This section does not apply to the labeling requirements of section 343(q) and 343(r) of this title.”
Statutory Notes and Related Subsidiaries
Effective Date
of 1990 AmendmentAmendment by Pub. L. 101–535 effective six months after the date of the promulgation of final
Regulations
to implement section 343(r) of this title, or if such
Regulations
are not promulgated, the date proposed
Regulations
are to be considered as such final
Regulations
(Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title.
Construction
of
Amendments
by Pub. L. 101–535
Amendments
by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
Executive Documents
Transfer of Functions
For
Transfer of Functions
of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
Reference
Citations & Metadata
Citation
21 U.S.C. § 345
Title 21 — Food and Drugs
Last Updated
Apr 6, 2026
Release point: 119-73