PCB Tutorial

Lesson 8 — Coding Tobacco Products

Tobacco Products — Industry Codes 98

Glossary

The following terms are used when coding products under Industry Codes 98:

Tobacco product: the term “Tobacco Product” means any product made or derived from tobacco 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); and The term “Tobacco Product” does not mean an article that is a drug under section 201(g)(1) of the FD&C Act, a device under section 201(h) of the FD&C Act, or a combination product described in section 503(g) of the FD&C Act. 21 USC § 321(rr). See Drug and Device definitions below.

Drug: The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement. 21 USC § 321(g)(1).

Device: The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. 21 USC § 321(h).

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. 21 CFR § 1100.3.

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. 21 CFR § 1100.3.

E-liquid: For product coding purposes E-liquid is defined as liquid nicotine and nicotine-containing liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other ingredients) made or derived from tobacco. Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities

The following terms describe the FDA tobacco product code:

FDA Product Code: FDA product codes are seven digit alphanumeric codes that help FDA classify FDA regulated products. The FDA product code contains five sub elements: the industry code, the class code, the subclass code, the process indicator code, and the product code.

Industry Code: The first two characters of the FDA Product Code represent the various industries regulated by the FDA. The industry code is always numeric. The industry code for tobacco products is 98.

Class Code: The third character of the FDA Product Code, this is always a letter. For tobacco products it represents the general type of product, such as smokeless tobacco or cigarettes.

Subclass Code: The fourth character of the FDA product code, this is always a letter. For tobacco products the subclass code is used to reflect the flavor of the product.

Process Indicator Code: The fifth character of the FDA product code. For tobacco products the PIC code represents the intended use of the product.

Product Code: The final two characters of the FDA Product Code. For tobacco products the Product Code helps further identify the specific product.

Product Code Builder: The product code builder is an online tool/application created to help industry select the proper FDA product code for their product.

The Tobacco Products Classes

Industry Code 98 — 
CLASS NAME PRODUCT EXAMPLES
A Cigarette Tobacco Cigarette tobacco means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter also apply to cigarette tobacco. 21 USC § 387(4).
B Cigarettes Cigarette (1) means a product that: (i) is a tobacco product and (ii) meets the definition of the term "cigarette" in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and (2) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco. 21 USC § 387(3).
C Smokeless Tobacco Smokeless tobacco means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity. 21 USC § 387(18).
D Roll your own tobacco Roll-your-own tobacco means any tobacco product that, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. 21 USC § 387(15).
E Cigarette Component, Part or Accessory Cigarette component, part, or accessory means any component, part, or accessory of a product that falls within class A or class B.
F Roll-Your-Own Component, Part or Accessory Roll-your-own component, part, or accessory means any component, part, or accessory of a product that falls within class D.
G Cigar Cigar means a tobacco product that: (1) is not a cigarette and (2) is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco. 21 CFR § 1143.1.
H Cigar Component or Part Cigar component or part means any component or part of a product that falls within class G.
I Pipe Tobacco Pipe Tobacco means any smoking tobacco product intended to be smoked in a pipe.
J Waterpipe Tobacco Waterpipe tobacco means any smoking tobacco product intended to be smoked using a waterpipe.
K Waterpipe Tobacco Component or Part Waterpipe tobacco component or part means any component or part of a product that falls within class J.
L Electronic Nicotine Delivery System Electronic Nicotine Delivery System means any electronic device that delivers e-liquid in aerosol form into the mouth and lungs when inhaled or any packaged product containing an electronic device that delivers e-liquid in aerosol form in the mouth and lungs when inhaled.
M Electronic Nicotine Delivery System Component/ Part Electronic nicotine delivery system component or part means any component or part of a product that falls within class L. All E-liquids should be included under this class.
N Nicotine Delivery Product Nicotine delivery product includes any tobacco product that is a drink, gel, gum, inhaler, lozenge, dissolvable, nasal spray, oral spray, oral tablet, powder, or transdermal patch. Additionally, any other tobacco product that does not fall into any other class should be listed under this class. Please note that products which are regulated by the FDA as drugs, devices, or combination products should not be included here as they are not a tobacco product.
O Pipe, Pipe Component or Part Pipe, Pipe Component or part means any component or part of a product that falls within class I.

The Tobacco Products Subclasses

See the table below for Subclass information. For tobacco products the subclass describes the flavor of the tobacco product. All tobacco product codes including items that are not traditionally associated with flavoring (such as glass vials, waterpipe hoses, or ENDS batteries) should contain a subclass element. For such items, the appropriate subclass is A – Unflavored.

Industry Code 98  — Tobacco Products (Applies to All Classes)
SUBCLASS NAME
A Unflavored
B Flavored (Menthol)
C Flavored (Other)
D Flavored (Tobacco)

The Tobacco Products Process Indicator Codes (PIC)

Similar to the Subclass codes, the PICs vary depending on the intended use.

Industry Code 98  — 
PROCESS INDICATOR CODE NAME
A For Consumer Use
B For Further Manufacturing
C For Investigational Use

Check Your Knowledge

1. You are coding glass bottles for vaping e-cigarette liquid, which of the following Process Indicator Codes (PIC) should you choose?
2. A shipment of grape cigars is ready to be coded. Which one of the following Subclasses would you select for this product?
3. The product you are coding is a shipment of dissolvable tobacco tablets, which of the following tobacco product class codes would you select?

Code the Products

Now you will have a chance to practice coding some Tobacco Products. Below you will find six product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the Product Code Builder application.

Have notepaper and a pen or pencil handy. As you code each product, jot down the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application, it will take you to the beginning of the Tutorial.

FRUITY PEBBLES E-LIQUID FOR CONSUMER USE

Tobacco Products

Electronic Nicotine Delivery System Component/Part

Flavored (Other)

For Consumer Use

Fruit Pebbles
E-Liquid

ENDS SOFTWARE FOR INVESTIGATIONAL USE

Tobacco Products

Electronic Nicotine Delivery System Component/Part

Unflavored

For Investigational Use

Ends Software

EMPTY GLASS ELIQUID BOTTLES FOR FURTHER MANUFACTURING

Tobacco Products

Electronic Nicotine Delivery System Component/Part

Unflavored

For Further Manufacturing Use

Empty Glass
E-Liquid Bottles

CHERRY E-HOOKAH KIT FOR CONSUMER USE
(several ingredients)

Tobacco Products

Electronic Nicotine Delivery System

Flavored (Other)

For Consumer Use

E-Hookah kit

GRAPE CIGARS FOR CONSUMER USE

Tobacco Products

Cigar

Flavored (Other)

For Consumer Use

Grape cigars

Check your answers — Click on reveal code for each product description to reveal the correct product code. Compare it with the one you got. Did you get the correct code? If not, determine which element was incorrect. You can go back to the Product Code Builder application and try again.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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