Title 21 CFR reference

General requirements.(a) 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. Request for an exemption under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act.(b) A request for an exemption from the requirement of demonstrating substantial equivalence may be made only by the manufacturer of a legally marketed…

(a) Subparts B through E of this part apply to a substantial equivalence report (or an SE Report) for a new tobacco product, other than “premium” cigars as defined in § 1107.12, that has: (1) Characteristics different from a predicate tobacco product and for which information is submitted to demonstrate it is not appropriate to regulate the product under section 910(b) and (c) of the Federal Food, Drug, and Cosmetic Act because the new tobacco product does not raise different questions of public health or (2) The same characteristics as a predicate tobacco product. (b) These subparts set forth procedures and requirements for the submission to FDA of an SE Report under sections 905 and 910 of the Federal, Food, Drug, and Cosmetic Act; the basic criteria for establishing substantial equivalence; and the general procedures FDA will follow when evaluating submissions.

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 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 the term does not include tobacco or…

An applicant may submit an SE Report intended to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product. The applicant must submit the SE Report at least 90 calendar days prior to the date the applicant intends to introduce or deliver for introduction a new tobacco product into interstate commerce for commercial distribution. The applicant cannot begin commercial distribution of the new tobacco product until FDA has provided the applicant an order stating that the Agency has determined that the new tobacco product is substantially equivalent to a predicate tobacco product, unless the new tobacco product has received authorization to be marketed through another premarket pathway.

Overview.(a) The SE Report must provide information uniquely identifying the new tobacco product and the predicate tobacco product, and compare the new tobacco product to either a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or a tobacco product that FDA previously found to be substantially equivalent. The SE Report must provide sufficient information as described in this section to enable FDA to determine whether the new tobacco product is substantially equivalent to a tobacco product that was commercially marketed (other than for test marketing) in the United States as of February 15, 2007. If FDA cites deficiencies and requests information to support a statement in the SE Report, the applicant must provide that information for review to continue, or FDA may issue an order under § 1107.48. FDA generally intends to refuse to accept an SE Report for review if it does not comply with § 1105.10 and this section. The SE Report must contain the following information: (1) General information (as described in paragraph (c) of this section); (2) Summary (as described in paragraph (d) of this section); (3) New…

The SE Report must include a comparison of the characteristics of the new tobacco product to the predicate tobacco product. Where test data is submitted, the testing information must include the test protocols, quantitative acceptance criteria, and test results (including means and variances, data sets, and a summary of the results). Comparison testing must be conducted on a sufficient sample size and on test samples that reflect the finished tobacco product composition and design. The SE report must state whether the same test methods were used for the new tobacco product and the predicate product, and if the methods differed, an explanation as to how the results of the different test methods can be compared. The SE report must identify national and international standards used to test the new and predicate tobacco products and explain any deviations from the standard, or state that no standards were used for the testing. The SE report must include the following: Comparison of product design.i.e.,(a) The SE Report must include a description of the product designs of the new and predicate tobacco products and an identification of any differences. The SE Report must include, in a…

(a) Except as provided in paragraphs (b) and (c) of this section, the applicant may submit an amendment to an SE Report in accordance with subpart C of this part. If an applicant chose to submit a health information summary with its SE Report under § 1107.18(j)(1), the applicant must submit with the amendment a redacted copy of the amendment that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ 20.61 and 20.63 of this chapter. (b) An applicant may not amend an SE Report to change the predicate tobacco product. (c) An applicant may not amend an SE Report after FDA has closed the SE Report under § 1107.44 or it has been withdrawn under § 1107.22. (d) In general, amendments will be reviewed in the next review cycle as described in § 1107.42.

(a) An applicant may at any time make a written request to withdraw an SE Report for which FDA has not issued an order. The withdrawal request must state: (1) Whether the withdrawal is due to a health or safety concern related to the tobacco product; (2) The submission tracking number; and (3) The name of the new tobacco product that is the subject of the SE Report. (b) An SE Report will be considered withdrawn when FDA issues a notice stating the SE Report has been withdrawn. (c) The SE Report is an Agency record, even if withdrawn. FDA will retain the withdrawn SE Report under Federal Agency records schedules. The availability of the withdrawn SE Report will be subject to FDA's public information regulations in part 20 of this chapter.

An applicant may transfer ownership of its SE Report. On or before the time of transfer, the new and former applicants are required to submit information to FDA as follows: (a) The former applicant must sign and submit a notice to FDA that states that all of the former applicant's rights and responsibilities relating to the SE Report have been transferred to the new applicant. This notice must identify the name and address of the new applicant and the SE Report transferred. (b) The new applicant must sign and submit a notice to FDA containing the following: (1) The new applicant's commitment to agreements, promises, and conditions made by the former applicant and contained in the SE Report; (2) The date that the change in ownership is effective; (3) Either a statement that the new applicant has a complete copy of the SE Report and order (if applicable), including amendments and records that are required to be kept under § 1107.58, or a request for a copy of the SE Report from FDA's files by submitting a request in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the SE Report to the new applicant under the…

Definition.(a) The term “Pre-Existing Tobacco Product” means a tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007. A Pre-Existing Tobacco Product is not subject to the premarket requirements of section 910 of the Federal Food, Drug, and Cosmetic Act. Record maintenance.(b) (1) Each applicant who submits an abbreviated report under section 905(j)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act and receives a letter acknowledging the receipt of an abbreviated report from FDA must maintain all records (including those created by third parties on the applicant's behalf) that support the submission. Such records may include, but are not limited to: (i) A copy of the abbreviated report and, if applicable, the exemption request and all amendments thereto. (ii) A copy of the acknowledgement letter issued in response to an abbreviated report and, if applicable, the exemption order issued by FDA. (iii) Documents related to formulation of product, design specifications, packaging, and related items. (iv) Documents showing design specifications are consistently met. (v) Documents related to product…

General principles.(a) During the course of reviewing an SE Report, FDA may communicate with applicants about relevant matters, including scientific, medical, and procedural issues that arise during the review process. These communications may take the form of telephone conversations, letters, or emails, and will be documented in the SE Report in accordance with § 10.65 of this chapter. Meeting.(b) Meetings between FDA and applicants may be held to discuss scientific and other issues. Requests for meetings will be directed to the Office of Science, Center for Tobacco Products, and FDA will make every attempt to grant requests for meetings that involve important issues. Acceptance of an SE Report for review.(c) After receiving an SE Report under § 1107.18, FDA will either refuse to accept the SE Report for review or issue an acceptance for review letter. Notification of deficiencies in an SE Report submitted under § 1107.18.(d) FDA will make reasonable efforts to communicate to applicants the procedural, administrative, or scientific deficiencies found in an SE Report and any additional information and data needed for the Agency's review. The applicant must also provide…

Initial review cycle.(a) FDA intends to review the SE Report and either communicate with the applicant as described in § 1107.40 or take an action under § 1107.44 within 90 calendar days of FDA's receipt of the SE Report, or within 90 calendar days of determining that the predicate was found to be commercially marketed (other than for test marketing) in the United States as of February 15, 2007 (if applicable), whichever is later. This 90-day period is called the “initial review cycle.” Additional review cycles.(b) If FDA issues a deficiency notification under § 1107.40(d) during the initial review cycle, FDA will stop reviewing the SE Report until it receives a response from the applicant or the timeframe specified in the notification of deficiencies for response has elapsed. If the applicant fails to respond within the time period provided in the notification of deficiency, FDA will issue an order denying marketing authorization under the criteria set forth in § 1107.48. If the applicant's response to the notification of deficiencies provides the information FDA requested, but FDA identifies additional deficiencies, FDA may issue an additional deficiency notification. Each…

After receipt of an SE Report, FDA will: (a) Refuse to accept the SE Report for review if it does not comply with § 1107.18 and § 1105.10 of this chapter; (b) Request additional information as provided in § 1107.40(d); (c) Issue a letter administratively closing the SE Report if it is not possible to make a determination on an SE Report; (d) Issue a letter canceling the SE Report if FDA finds the SE Report was created in error; (e) Issue an order as described in § 1107.46 finding the new tobacco product to be substantially equivalent and in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act; or (f) Issue an order as described in § 1107.48 denying marketing authorization because the new tobacco product is: (1) Not substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States on February 15, 2007, or (2) Not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act.

If FDA finds that the information submitted in the SE Report establishes that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007, and finds that the new tobacco product is in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, FDA will send the applicant an order authorizing marketing of the new tobacco product. A marketing authorization order becomes effective on the date the order is issued.

General.(a) FDA will issue an order that the new tobacco product cannot be marketed if FDA finds that: (1) The information submitted in the SE Report does not establish that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007; or (2) The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act. Basis for order.(b) The order will describe the basis for denying marketing authorization.

Grounds for rescinding a substantially equivalent order.(a) FDA may rescind a substantially equivalent order allowing a new tobacco product to be marketed if FDA determines that: (1) The tobacco product for which the order has been issued: (i) Does not have the same characteristics as the predicate tobacco product; or (ii) Has different characteristics and there is insufficient information demonstrating that it is not appropriate to require a premarket tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act because the product does not raise different questions of public health; or (2) The SE Report (including any submitted amendments) contains an untrue statement of material fact; or (3) Concerning an SE Report that compared the new tobacco product to a tobacco product that FDA previously found substantially equivalent, (i) The predicate tobacco product relied on in the SE Report has been found ineligible because its SE Report (including any amendments) contains an untrue statement of material fact; or (ii) A predicate tobacco product on which any of the previous substantial equivalence determinations was based, going back to the…

Each applicant that receives an order under § 1107.46 authorizing the marketing of a new tobacco product must maintain all records required by this subpart and that support the SE Report for a substantial equivalence order. These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. All records must be retained for a period of not less than 4 years from the date of the order even if such product is discontinued.

General.(a) FDA will determine the public availability of any part of an SE Report and other content related to such an SE Report 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 section: (1) FDA will not publicly disclose the existence of an SE Report unless: (i) The tobacco product has been introduced or delivered for introduction into interstate commerce for commercial distribution; or (ii) The applicant has publicly disclosed or acknowledged the existence of the SE Report (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 the SE Report to FDA. (2) FDA will not disclose the existence of or contents of an FDA communication with an applicant regarding its SE Report except to the extent that the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence of or contents of that particular FDA communication. (3) FDA will not disclose information contained in an SE Report unless the applicant has…

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 SE Report and all supporting information must be in an electronic format that FDA can process, read, review, and archive. Waivers from electronic format requirement.www.fda.gov/tobaccoproducts(b) An applicant may submit a written request that is legible and written 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 person requesting the waiver. 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, list of individuals authorized for the applicant to serve as the contact person, and contact information including an email address. If the applicant has submitted an SE Report previously, the regulatory correspondence must also include any identifying information…