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United States • Title 21 CFR • Part 1105

Part 1105 — PART 1105—GENERAL

This section outlines the grounds on which the FDA will refuse to accept a premarket submission for a tobacco product. Reasons include submissions not pertaining to tobacco products, not being in English, being in an unreadable electronic format, lacking contact information or a U.S. agent for foreign applicants, missing required FDA forms, incomplete product identification, unspecified submission type, missing responsible official signature, or lacking an environmental assessment/categorical exclusion claim for specific application types.

What this part covers

FDA will refuse submissions that do not concern tobacco products as defined by law.
Submissions must be in English or include complete English translations.
Electronic submissions must be in a format that FDA can process, read, review, and archive.
Complete contact information, including name and address, is required.
Foreign applicants must designate an authorized U.S. agent.
Required FDA forms must be included.
Essential product identification details (manufacturer, name, category, package type/quantity, flavor) are mandatory.
The type of submission must be clearly specified.
A signature from a responsible official residing or having a place of business in the U.S. is necessary.
Premarket tobacco applications, modified risk applications, and substantial equivalence applications require a valid claim of categorical exclusion or an environmental assessment.

Sections in Part 1105

§ 1105.10

Refusal to accept a premarket submission.

(a) FDA will refuse to accept for review, as soon as practicable, a premarket tobacco product application, modified risk tobacco product application, substantial equivalence application, or exemption request or subsequent abbreviated report for the following reasons, if applicable: (1) The submission does not pertain to a tobacco product as defined in 21 U.S.C. 321(rr). (2) The submission is not in English or does not contain complete English translations of any information submitted within. (3) If submitted in an electronic format, the submission is in a format that FDA cannot process, read, review, and archive. (4) The submission does not contain contact information, including the applicant's name and address. (5) The submission is from a foreign applicant and does not identify an authorized U.S. agent, including the agent's name and address, for the submission. (6) The submission does not contain a required FDA form(s). (7) The submission does not contain the following product-identifying information: The manufacturer of the tobacco product; the product name, including the brand and subbrand; the product category and subcategory; package type and package quantity; and…

Regulatory Context

This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.

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