Title 21 CFR reference

(a) This part sets forth the procedures and requirements for submitting a premarket tobacco product application (PMTA), the general procedures FDA will follow when evaluating a PMTA, and postmarket reporting requirements. (b) This part does not apply to modified risk tobacco product applications, except that single applications seeking both a marketing granted order under section 910(c) of the Federal Food, Drug, and Cosmetic Act and an order under section 911(g) of the Federal Food, Drug, and Cosmetic Act must satisfy the requirements of this part in addition to the requirements of section 911 of the Federal Food, Drug, and Cosmetic Act. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (d) This part does not apply to “premium” cigars as defined in § 1114.3.

(a) An applicant may at any time make a written request using the appropriate form to withdraw a PMTA that FDA has not acted on as described in § 1114.29. The withdrawal request must state: (1) Whether the withdrawal is due to a health concern related to the tobacco product and, if so, a description of those concerns, including the extent, duration, and frequency of the health effects, and what gave rise to the concerns, such as reports of adverse experiences; (2) The application STN; and (3) The name(s) of the new tobacco product that is the subject of the application. (b) An application will be considered withdrawn when FDA issues an acknowledgement letter stating that the application has been withdrawn. (c) The application is an Agency record, even if withdrawn. FDA will retain the withdrawn application under Federal Agency records schedules. The availability of the withdrawn application will be subject to FDA's public information regulation in Part 20 of this chapter.

An applicant may transfer ownership of a PMTA. At or before the time of transfer, the new owner and the former owner must submit information to FDA using the appropriate form as follows: (a) The new and former owner must sign and submit a notice to FDA stating that all of the former applicant's rights and responsibilities relating to the PMTA have been transferred to the new owner. This notice must identify the name and address of the new owner and the PMTA transferred by tobacco product name(s) and STN. (b) The new owner must sign and submit a notice to FDA containing the following: (1) The new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application and marketing granted order, if applicable; (2) The date that the change in ownership is effective; (3) Either a statement that the new owner has a complete copy of the application, including all amendments, the marketing granted order (if applicable), and any records that are required to be kept under § 1114.45, or a request for a copy of the application, including all amendments, and the modified risk order (if applicable) from FDA's files in accordance with part 20…

Supplemental PMTA submission.(a) Applicants that have received a marketing granted order for a tobacco product may, as an alternative format of submitting an application that meets the content requirements of § 1114.7, submit a supplemental PMTA to seek marketing authorization for modifications to such product, which result in a new tobacco product under section 910(a)(1) of the Federal Food, Drug, and Cosmetic Act. Supplemental PMTAs must include new information concerning modifications that create the new tobacco product but allow the applicant to satisfy the remaining application requirements by cross-referencing applicable content from the previously submitted PMTA for the original tobacco product. Applicants may submit supplemental PMTAs only for modifications that require the submission of limited new information or where specified in a rule under section 907 of the FD&C Act. Except as permitted in a rule under section 907 of the Federal Food, Drug, and Cosmetic Act, an applicant may not submit a supplemental PMTA where: (1) Modifications to the product that result in the new tobacco product require the submission of new information or revisions to the PMTA for the original…

General.(a) An applicant may, as an alternative format of submitting an application that meets the content requirements of § 1114.7 or 1114.15 (if applicable), submit a resubmission to address deficiencies set forth in a marketing denial order. The resubmission must contain new information necessary to address application deficiencies and cross-reference applicable content from the PMTA that received the marketing denial order. An applicant may utilize the resubmission format for the same tobacco product for which FDA issued a marketing denial order or a new tobacco product that results from modifications to the product necessary to address the deficiencies described in a marketing denial order. An applicant may not submit a resubmission when: (1) It incorporates new information or revisions to the PMTA for the original product to the extent that reviewing a resubmission for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review; or (2) The marketing denial order states that the applicant may not submit a resubmission. Required format.(b) The resubmission must comply with…

During the course of reviewing an application, FDA may communicate with an applicant about relevant matters, including scientific, medical, and procedural issues that arise during the review process and inspections. These communications may take the form of telephone conversations, letters, electronic communications, or meetings, and will be documented in the administrative file in accordance with § 10.65 of this chapter.

Acceptance review.(a) (1) After an applicant submits a PMTA, FDA will perform an initial review of the PMTA to determine whether it may be accepted for further review. FDA may refuse to accept an application that: (i) Does not comply with the applicable format requirements in § 1114.7(b), § 1114.15, or § 1114.17 (as applicable); (ii) Is not administratively complete because it does not appear to contain the information required by § 1114.7 (excluding product samples), § 1114.15 or § 1114.17, as applicable; (iii) Does not pertain to a tobacco product subject to chapter IX of the Federal Food, Drug, and Cosmetic Act (as required by § 1105.10 of this chapter); or (iv) FDA can otherwise refuse to accept under § 1105.10. (2) If FDA accepts an application for further review, FDA will issue an acknowledgement letter to the applicant that specifies the PMTA STN. If FDA determines that it will require product samples as part of the PMTA, it will send instructions on how and where to submit product samples, as described in § 1114.7(e) of this chapter. (3) If FDA refuses to accept an application, FDA will issue a letter to the applicant identifying the deficiencies, where practicable,…

After receipt of an application, FDA will: (a) Refuse to accept the application as described in § 1114.27(a); (b) Issue a letter administratively closing the application; (c) Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error; (d) Refuse to file the application as described in § 1114.27(b); (e) Issue a marketing granted order as described in § 1114.31; or (f) Issue a marketing denial order as described in § 1114.33.

For purposes of this part: Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or (2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product, but: (i) Solely controls moisture and/or temperature of a stored tobacco product; or (ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product. Additive means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include…

(a) FDA will issue a marketing granted order if it finds that none of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply. A marketing granted order becomes effective on the date it is issued. (b) FDA may include, as part of the marketing granted order: (1) Restrictions on the sale and distribution of the product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, to the extent that it would be authorized to impose such restrictions under a regulation issued under section 906(d) of the Federal Food, Drug, and Cosmetic Act; (2) Any restrictions on the sales, distribution, advertising, and promotion of the new tobacco product that the applicant proposed to be included as part of a marketing granted order under section 910(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act to support a finding by FDA that permitting the product to be marketed would be appropriate for the protection of the public health; and (3) Requirements to establish and maintain records, and submit postmarket reports under section 910(f) of the Federal Food, Drug and Cosmetic Act in addition to those described…

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

Grounds for withdrawal.(a) FDA will withdraw a marketing granted order for a new tobacco product issued under this part if FDA determines that: (1) Any of the grounds for withdrawal under section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act apply; or (2) Any postmarket requirement imposed by the marketing granted order or by this part has not been met, which results in FDA finding that one or more of the grounds for withdrawal specified in section 910(d)(1) of the Federal Food, Drug and Cosmetic Act apply. Advice and other information.(b) (1) FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw a marketing granted order. (2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw a marketing granted order. Informal hearing.(c) Prior to withdrawing a marketing granted order, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter. Order issuance.(d) If the applicant does not request a hearing or, if after the part 16 hearing is held, the Agency decides to proceed with the withdrawal, FDA will…

(a) FDA will temporarily suspend a marketing granted order if FDA determines that there is a reasonable probability that the continued distribution of such tobacco product would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market. (b) Before temporarily suspending a marketing granted order of a tobacco product, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter. (c) If, after offering the holder of the marketing granted order an opportunity for a part 16 hearing, the Agency decides to proceed with the temporary suspension, FDA will issue an order temporarily suspending the marketing granted order for a tobacco product. (d) After issuing an order temporarily suspending the marketing granted order, FDA will proceed expeditiously to withdraw the marketing granted order for the tobacco product.

A marketing granted order authorizes the marketing of a new tobacco product in accordance with the terms of the order. Prior to the introduction or delivery for introduction into interstate commerce of a new tobacco product that results from modification(s) to the product, an applicant must submit a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and obtain a marketing granted order for the new tobacco product, unless the new tobacco product can be legally marketed through another premarket pathway.

Required reports.e.g.,(a) Each applicant that receives a marketing granted order must submit to FDA all information required by the terms of the marketing granted order and by this section as described below. Each postmarket report must be well-organized, legible, and written in English. Documents that have been translated from another language into English ( original study documents written in a language other than English) must be accompanied by the original language version of the document, a signed statement by an authorized representative of the manufacturer certifying that the English language translation is complete and accurate, and a brief statement of the qualifications of the person that made the translation. Periodic reports.(1) Each applicant must submit a periodic report to the Center for Tobacco Products (CTP) within 60 calendar days of the reporting dates specified in the applicant's marketing granted order for the life of the order and as may be required for the submission of a supplemental PMTA under § 1114.15. The report must include the following: (i) A cover letter that contains the PMTA STN, tobacco product name(s) (including the original name described in…

Record retention by the applicant.(a) (1) Each applicant that receives a marketing granted order must maintain all records necessary to facilitate a determination of whether there are or may be grounds to withdraw or temporarily suspend the marketing granted order, including records related to both the application and postmarket reports, and ensure that such records remain readily available to the Agency upon request (including where records are maintained by a third party on an applicant's behalf). These records include, but are not limited to: (i) All documents submitted to FDA as part of an application, periodic postmarket reports, and adverse experience reports; (ii) All documentation demonstrating whether each: (A) Nonclinical laboratory study was conducted in accordance with good laboratory practices that support the reliability of the results, such as the records described in part 58 of this chapter; and (B) Clinical investigator has any financial conflicts of interest that may be a source of bias, such as the documentation described in part 54 of this chapter; (iii) All other documents generated during the course of a study necessary to substantiate the study results,…

General.(a) FDA will determine the public availability of any part of an application and other content related to such an application, including all data and information submitted with or incorporated by reference in the application, under this section and part 20 of this chapter. Confidentiality of data and information prior to an order.(b) Prior to issuing an order under this part: (1) FDA will not publicly disclose the existence of an application unless: (i) The applicant has publicly disclosed or acknowledged (as such disclosure is defined in § 20.81 of this chapter), or has authorized FDA in writing to publicly disclose or acknowledge, that the applicant has submitted an application to FDA; or (ii) FDA refers the application to TPSAC. (2) Except as described in paragraph (b)(4) of this section, FDA will not disclose the existence or contents of an FDA communication with an applicant regarding its application except to the extent that the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular FDA communication. (3) Except as described in paragraph (b)(4) of this…

Electronic format requirement.(a) Applicants submitting any documents to the Agency under this part must provide all required information to FDA using the Agency's electronic system, except as provided in paragraph (b) of this section. The application and all supporting information must be submitted in an electronic format that FDA can process, review, and archive. Waivers from electronic format requirement.www.fda.gov/tobacco-products(b) An applicant may submit a written request, that is legible and in English, to the Center for Tobacco Products asking that FDA waive the requirement for electronic format and content. Waivers will be granted if use of electronic means is not reasonable for the applicant. To request a waiver, applicants can send the written request to the address included on our website (). The request must include the following information: (1) The name and address of the applicant, a list of individuals authorized by the applicant to serve as the contact person and contact information. If the applicant has submitted a PMTA previously, the regulatory correspondence should also include any identifying information about the previous submission. (2) A statement…

An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements to receive a marketing granted order. A new tobacco product may not be introduced or delivered for introduction into interstate commerce under this part until FDA has issued a marketing granted order for the product.

General.(a) The PMTA must contain sufficient information for FDA to determine whether any of the grounds for marketing denial order specified in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply. The application must contain the following sections: (1) General information (as described in paragraph (c) of this section); (2) Descriptive information (as described in paragraph (d) of this section); (3) Product samples (as described in paragraph (e) of this section); (4) Labeling and description of marketing plans (as described in paragraph (f) of this section); (5) Statement of compliance with 21 CFR part 25 (as described in paragraph (g) of this section); (6) Summary (as described in paragraph (h) of this section); (7) Product formulation (as described in paragraph (i) of this section); (8) Manufacturing (as described in paragraph (j) of this section); (9) Health risk investigations (as described in paragraph (k) of this section); and (10) The effect on the population as a whole (as described in paragraph (l) of this section); (11) Certification statement (as described in paragraph (m) of this section). Format.i.e.,e.g.,(b) (1) The application must be…

General.(a) FDA may request, or an applicant may submit on its own initiative, an amendment to a PMTA containing information that is necessary for FDA complete the review of a pending PMTA. An amendment must include the appropriate form and specify the STN assigned to the original submission and, if submitted other than at FDA's request, the reason for submitting the amendment. An amendment must also include the certification statement set forth in § 1114.7(m), with the appropriate information inserted, and signed by an authorized representative of the applicant. Review of an amendment.(b) Submission of an amendment may affect the timing of review of an amended submission as follows: e.g.,(1) If the amendment is a major amendment ( an amendment that contains significant new data from a previously unreported study, detailed new analyses of previously submitted data, or substantial new manufacturing information), FDA will restart the 180-day review period after receipt of the amendment. i.e.,(2) If FDA requests a minor amendment ( an amendment that is not a major amendment) and receives a written response submitting the requested amendment, FDA may pause the review period for the…