Description
The final rule “Premarket Tobacco Product Applications and Recordkeeping Requirements” (the final PMTA rule) published in theFederal Registerof October 5, 2021 (86 FR 55300), and on November 4, 2021, it became effective. The final PMTA rule sets forth content and format requirements for PMTAs and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. FDA intends to update this guidance to ensure the recommendations on preparing and submitting PMTAs for electronic nicotine delivery systems (ENDS) are consistent with the requirements of the final PMTA rule.
Scope & Applicability
Product Classes
10Subject to the deeming rule, including e-cigarettes and vape pens
A subcategory of ENDS involving multiple components packaged together.
A subcategory of ENDS that is not prefilled.
A subcategory of ENDS requiring specific identification details.
A subcategory of ENDS requiring specific identification details.
Liquid used in ENDS products often containing nicotine
A subcategory of tobacco products discussed in the guidance; Tobacco product category requiring chemical analysis; A specific category of tobacco product components requiring additional health considerations.; Components used in ENDS products; Updated definition to include nicotine from any source
A type of electronic nicotine delivery system; A hardware component of ENDS with specific design factors.
Electronic nicotine delivery systems subject to the deeming rule
Tobacco product not commercially marketed as of February 15, 2007
Stakeholders
9Entity responsible for submitting NDINs
CTP office providing support to small manufacturers
Must comply with registration if meeting facility/responsible person definitions
Body overseeing clinical study ethics
entity submitting marketing applications
Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners
Single point of contact in CTP's Office of Science
Includes any person who manufactures, fabricates, assembles, processes, or labels a tobacco product.
Independent expert committee that reviews safety and health issues.
Regulatory Context
Attributes
10Regulatory status for products similar to a predicate
Warning statements regarding the addictiveness of nicotine
Varying levels of nicotine in e-liquids (e.g., 1 mg/mL to 24 mg/mL)
E-liquid design parameter affecting performance.
E-liquid design parameter affecting performance.
Patterns of product consumption such as puff duration and intensity.
Characteristics of ingredients like particle size and deposition.
Information recommended for inclusion in the notification
A technical specification for the device component.
A quantitative property of the e-liquid.
Identified Hazards
Hazards
9Acute toxicity risk from inadvertent exposure to e-liquids
A risk of harm related to batteries in ENDS.
The addictiveness and potential for misuse of the product.
risk assessment for pharmaceuticals affecting the immune system
nonlinear dose response associated with the genotoxicity and carcinogenicity of acetaldehyde; Historical perception of aniline; Potential for a mutagenic mode of action
Risks associated with product design attributes
Safety hazard resulting from foreseeable misuse; A health risk FDA assesses in tobacco products.
Migration of constituents from packaging into the product
Safety risk associated with ENDS use.
Related CFR Sections (9)
- 21CFR25.35§ 25.35 Tobacco product applications.
The classes of actions listed in this section are categorically excluded and, therefore, normally do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR25.40§ 25.40 Environmental assessments.
(a) As defined by CEQ in 40 CFR 1508.9 , an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by secRead full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR1143.3§ 1143.3 Required warning statement regarding addictiveness of nicotine.
(a) Packages.Read full regulation →
- 21CFR1100.3§ 1100.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR1143.1§ 1143.1 Definitions.
For purposes of this part:Read full regulation →
- 21CFR1105.10§ 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:Read full regulation →
- 21CFR1107.1§ 1107.1 Exemptions.
(a) General requirements. 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, aRead full regulation →
Related Warning Letters (10)
- 2025-12-16
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Upper Limits
- 2025-12-16
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
relevantvapes.com
- 2025-12-09
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
virginiavapes.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Hellosynixvape.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
magicsmog.com
- 2025-12-03
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
naturevapeshop.com
- 2025-11-25
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
earthsbountyjuice.com
- 2025-11-18
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
lowkeydis.com
- 2025-11-18
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ecmvape.com
- 2025-11-18
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
nastyworldwide.com
See Also (8)
- Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Sponsor - Investigator - IRB Interrelationship: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Non-local IRB Review : Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Chapter 48 7348.809A Radioactive Drug Research Committee (Status: Final)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)