CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR1114.33]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER K - TOBACCO PRODUCTS

PART 1114 -- PREMARKET TOBACCO PRODUCT APPLICATIONS

Subpart C - FDA Review

Sec. 1114.33 Issuance of a marketing denial order.

(a) Issuance. FDA will issue a marketing denial order if:

(1) Upon the basis of the information submitted as part of the application and any other information before FDA with respect to the new tobacco product, FDA finds that any of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply;

(2) The applicant does not permit an authorized FDA employee, at a reasonable time and in a reasonable manner, an opportunity to:

(i) Inspect the facilities and controls described in the application; or

(ii) Have access to, copy, and verify all records pertinent to the application, which results in FDA finding that one or more of the grounds for denial specified in section 910(c)(2) of the Federal Food, Drug and Cosmetic Act apply.

(b) Description of deficiencies. The marketing denial order will, where practicable, identify measures to remove the application from deniable form.