Issuance of a marketing denial order.
21 C.F.R. § 1114.33
in effectEffective: 2024-07-01(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026