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Title 21 — Food and Drugs

Chapter 9 — Federal Food, Drug, and Cosmetic Act

§ 345. Regulations making exemptions

Statutory text

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 sections 343(q) and 343(r) of this title.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

  1. Pub. L. 75–675 § 405 · 52 Stat. 1040

    Enacted · 21 U.S.C. § 345

    June 25, 1938, ch. 675, § 405, 52 Stat. 1049

    Source evidence

    Code source credit
    June 25, 1938, ch. 675, § 405, 52 Stat. 1049

    Enacted provision · exact public law section
    Sec. 405. regulations making exemptions The Secretary shall promulgate regulations exempting Regulations making exemptions. from any labeling requirement of this Act (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 Act upon removal from such processing, labeling, or repacking establishment.

  2. Nutrition Labeling and Education Act of 1990

    Pub. L. 101–535 § 5(a) · 104 Stat. 2353

    Inserted · 21 U.S.C. § 345

    Pub. L. 101–535 inserted at end “This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.”

    Source evidence

    Code amendment note
    Pub. L. 101–535 inserted at end “This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.”

    Enacted provision · exact public law section
    (a) Section 405.— Section 405 (21 U.S.C. 345) is amended by adding at the end the following: “This section does not apply to the labeling requirements of sections 403(q) and 403(r).”.

    Effective date note
    Amendment 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.

2 of 2 references resolved to an enrolled provision

Editorial Notes

Amendments

1990—Pub. L. 101–535 inserted at end “This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.”

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment 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 (), 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.

Credits

1938–1990 · 2 acts
  1. 1938June 25, 1938, ch. 675, § 405, 52 Stat. 1049
  2. 1990Pub. L. 101–535, § 5(a), , 104 Stat. 2362.
Show as published

(June 25, 1938, ch. 675, § 405, 52 Stat. 1049; Pub. L. 101–535, § 5(a), , 104 Stat. 2362.)

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USLM identifier /us/usc/t21/s345