Description
The draft guidance provides details for those who seek to market a tobacco product as modified or lower risk including how to organize and submit an MRTP application, what scientific studies and analyses should be submitted, and what information should be collected through postmarket surveillance and studies.
Scope & Applicability
Product Classes
4Relating to the withdrawal of an order for introduction into interstate commerce
Comparison product for health risk assessment
Tobacco product not commercially marketed as of February 15, 2007
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
8Entity responsible for submitting NDINs
Body overseeing clinical study ethics
TPSAC reviews MRTPAs and reports recommendations
Governs top dose in clinical studies
Individuals who do not currently use tobacco, including youth and former users
Entity submitting development data and knowledge; Entity performing the work process for change
Includes any person who manufactures, fabricates, assembles, processes, or labels a tobacco product.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
8Biological property that may be altered by manufacturing changes
Confidential information handled under 21 CFR Part 20.
Standard for determining protocol adequacy
Evidence that product characteristics remain consistent across batches.
How consumers understand labeling and marketing
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Product characteristic that may be reduced in MRTPs
Standard for issuing orders taking into account users and non-users
Identified Hazards
Hazards
3Substances in tobacco products that users are exposed to
Known health risks of tobacco products evaluated in nonclinical studies.
Likelihood of developing physical or psychological dependence
Related CFR Sections (1)
- 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 →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)
- Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) (Status: Draft)