(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.

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 tobacco, or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.

Adverse experience means any unfavorable physical or psychological effect in a person that is temporally associated with the use of or exposure to a tobacco product, whether or not the person uses the tobacco product, and whether or not the effect is considered to be related to the use of or exposure to the tobacco product.

Applicant means any person that submits a premarket tobacco product application to receive a marketing granted order for a new tobacco product.

Brand means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name(s), identifiable pattern of colors, or any combination of such attributes.

Characteristics means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.

Commercially marketed means selling or offering for sale a tobacco product in the United States to consumers or to any person for the eventual purchase by consumers in the United States.

Component or part means any software or assembly of materials intended or reasonably expected:

(1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or

(2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.

Composition means the materials in a tobacco product, including ingredients, additives, and biological organisms. The term includes the manner in which the materials, for example, ingredients, additives, and biological organisms, are arranged and integrated to produce a tobacco product.

Constituent means any chemical or chemical compound in a tobacco product that is or potentially is inhaled, ingested, or absorbed into the body, any chemical or chemical compound in an emission (e.g., smoke, aerosol, droplets) from a tobacco product, that either transfers from any component or part of the tobacco product to the emission or that is formed by the product, including through combustion or heating of tobacco, additives, or other components of the tobacco product.

Container closure system means any packaging materials that are a component or part of a tobacco product.

Design means the form and structure concerning, and the manner in which components or parts, ingredients, software, and materials are integrated to produce a tobacco product.

Finished tobacco product means a tobacco product, including all components and parts, sealed in final packaging (e.g., filters or filter tubes sold to consumers separately or as part of kits, or e-liquids sealed in final packaging sold to consumers either separately or as part of kits) or in the final form in which it is intended to be sold to consumers.

Harmful or potentially harmful constituent or HPHC means any chemical or chemical compound in a tobacco product or tobacco smoke or emission that:

(1) Is or potentially is inhaled, ingested, or absorbed into the body, including as an aerosol or any other emission; and

(2) Causes or has the potential to cause direct or indirect harm to users or nonusers of tobacco products.

Heating source means the source of energy used to burn or heat the tobacco product.

Ingredient means tobacco, substances, compounds, or additives contained within or added to the tobacco, paper, filter, or any other component or part of a tobacco product, including substances and compounds reasonably expected to be formed through a chemical reaction during tobacco product manufacturing.

Label means a display of written, printed, or graphic matter upon the immediate container of any article.

Labeling means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.

Line data means an analyzable dataset of observations for each individual study participant, laboratory animal, or test replicate.

Marketing denial order means the order described in section 910(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act stating that the product may not be introduced or delivered for introduction into interstate commerce.

Marketing granted order means the order described in section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act stating that the new tobacco product may be introduced or delivered for introduction into interstate commerce.

Material means an assembly of ingredients. Materials are assembled to form a tobacco product or components or parts of a tobacco product.

New tobacco product means:

(1) Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

(2) Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

Other features means any distinguishing qualities of a tobacco product similar to those specifically enumerated in section 910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other features include harmful and potentially harmful constituents and any other product characteristics that relate to the chemical, biological, and physical properties of the tobacco product.

Package or packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.

Premarket tobacco product application or PMTA means the application described in section 910(b) of the Federal Food, Drug, and Cosmetic Act. This term includes the initial premarket tobacco product application and all subsequent amendments.

“Premium” cigar means a type of cigar that:

(1) Is wrapped in whole tobacco leaf;

(2) Contains a 100 percent leaf tobacco binder;

(3) Contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);

(4) Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);

(5) Has no filter, nontobacco tip, or nontobacco mouthpiece;

(6) Does not have a characterizing flavor other than tobacco;

(7) Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and

(8) Weighs more than 6 pounds per 1,000 units.

Serious adverse experience means an adverse experience that results in any of the following outcomes:

(1) Death;

(2) A life-threatening condition or illness;

(3) Inpatient hospitalization or prolongation of existing hospitalization;

(4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;

(5) A congenital anomaly/birth defect; or

(6) Any other adverse experience that, based upon appropriate medical judgment, may jeopardize the health of a person and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Submission tracking number or STN means the number that FDA assigns to submissions that are received from an applicant, such as a PMTA and a supplemental PMTA.

Tobacco product means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term “tobacco product” does not mean an article that under the Federal Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device (section 201(h)); a combination product (section 503(g)); or a food (section 201(f)) if such article contains no nicotine or no more than trace amounts of naturally occurring nicotine.

Tobacco product manufacturer means any person, including a repacker or relabeler, who:

(1) Manufactures, fabricates, assembles, processes, or labels a tobacco product, or

(2) Imports a finished tobacco product for sale or distribution in the United States.

Unexpected adverse experience means an adverse experience occurring in one or more persons in which the nature, severity, or frequency of the experience is not consistent with:

(1) The known or foreseeable risks of adverse experiences associated with the use or exposure to the tobacco product as described in the PMTA and other relevant sources of information, such as the product labeling and postmarket reports;

(2) The expected natural progression of any underlying disease, disorder, or condition of the persons(s) experiencing the adverse experience and the person's predisposing risk factor profile for the adverse experience; or

(3) The results of nonclinical investigations.

Vulnerable populations means groups that are susceptible to tobacco product risk and harm due to disproportionate rates of tobacco product initiation, use, burden of tobacco-related diseases, or decreased cessation. Vulnerable populations can include, but are not limited to, youth and young adults, those with lower socioeconomic status, certain races or ethnicities, sexual or gender minorities, underserved rural populations, those pregnant or trying to become pregnant, those in the military or veterans, and those with mental health conditions or substance use disorders.