Description
Section 910(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 16 387j(g)) gives FDA the authority to issue regulations to exempt tobacco products intended for investigational use from the requirements of chapter IX of the FD&C Act, including premarket submission requirements. To date, FDA has not issued such regulations; consequently, investigational tobacco products are not exempt from FD&C Act requirements, including premarket submission requirements. This draft guidance supersedes the draft guidance of the same title dated September 2015 and, when final, will describe FDA’s current thinking regarding the definition of investigational tobacco product and discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective or FDA provides written notice of its intent to change its enforcement policy.
Scope & Applicability
Product Classes
4Tobacco products intended for investigational use; A tobacco product intended for investigational use that is a new tobacco product or does not conform to standards; The primary product category governed by this guidance; Tobacco products intended for study or research use.
Deemed tobacco products subject to premarket authorization; ENDS products are subject to enforcement priorities regarding premarket authorization.; ENDS products on the market without premarket authorization; Referred to as ENDS throughout the guidance regarding enforcement priorities.
Tobacco product not commercially marketed as of February 15, 2007
Relating to the withdrawal of an order for introduction into interstate commerce
Stakeholders
5Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting NDINs
Entity responsible for submitting applications under section 524B
Entity to which obligations may be transferred
Regulatory Context
Attributes
2Required for tobacco products to be legally marketed
A functional role of sodium in food
Identified Hazards
Hazards
1HPHCs in tobacco products and smoke/emissions.
Related CFR Sections (2)
- 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 →
- 21CFR1100.3§ 1100.3 Definitions.
For the purposes of this part:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
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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
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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
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Louisiana State University Health Science Center IRB
- 2024-09-11
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Mid-Link Testing Company, Ltd
See Also (8)
- Bioresearch Monitoring Technical Conformance Guide (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)
- Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors (Status: Final)
- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry (Status: Final)
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)