Standard: HHS - 21 CFR PART 1107

ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS

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Scope:

General requirements. Under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e(j)(3)), FDA may exempt from the requirements relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j), tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if FDA determines that:

(1) Such modification would be a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act (a legally marketed tobacco product);

(2) A report under section 905(j)(1) intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and

(3) An exemption is otherwise appropriate.

 

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 1107
Publish Date: 2016-04-01
Page Count: 2
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 1107 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV
21 CFR PART 1107 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV

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