Submit Ingredient Listing for Tobacco Products

In response to feedback from industry, FDA's Center for Tobacco Products (CTP) has provided manufacturers with additional information and updated forms to assist with electronic submission of ingredient listings for tobacco products, focusing on deemed tobacco products.

Note: FDA recommends electronic submissions of all ingredient listing information. In order to submit online, you will need to request an Industry Account Manager (IAM) account for CTP Portal.

How to submit:

Submit Online:

FDA recommends electronic submissions of all ingredient listing information.

Request an Industry Account Manager (IAM) account for CTP Portal, if your company does not already have an IAM.
Prepare your submission electronically using the FDA's eSubmitter software.
Download step-by-step instructions for preparing an electronic submission of any tobacco product ingredient listing.

Watch FDA’s new webinar: Examples of Ingredient Listing Spreadsheets by Product Category for more information.
FDA-Provided Spreadsheets for ingredient listing submissions
Note: FDA's eSubmitter software includes an option (c) to attach product, component, and ingredient information using a single FDA-provided spreadsheet, which is available for:

E-liquids:

Alternative format spreadsheet for e-liquids (also available in eSubmitter)

Step-by-step instructions for using the e-liquids spreadsheet

Leaf-wrapped cigars

Alternative format spreadsheet for leaf-wrapped cigars (also available in eSubmitter)

Step-by-step instructions for using the leaf-wrapped cigars spreadsheet

Any tobacco product

Alternative format spreadsheet for any tobacco product (also available in eSubmitter)

Step-by-step instructions for using the any tobacco product spreadsheet
Submit online via the CTP Portal.

Submit by Mail:

If you are unable to submit online, mail submissions to CTP's Document Control Center, using FDA Form 3742 (PDF).

Example Completed Ingredient Listing Paper Forms

Guidance

FDA issued a revised guidance, Listing of Ingredients in Tobacco Products, to assist manufacturers and importers submitting ingredient listings, and to clarify the process.
Sections for reporting components and parts both in eSubmitter and in the current paper form FDA 3742 still include fields for information related to components and parts for which FDA does not intend to enforce the ingredient listing submission requirements. See the guidance for more information.

Components or Parts

FDA intends to enforce the ingredient listing submission requirement of section 904(a)(1) only with respect to those components or parts:

made or derived from tobacco, or
containing ingredients that are burned, aerosolized or ingested during tobacco product use.

This includes:

Cigar binder
Cigar filler
Cigar wrapper
Cigarette paper
Cigarette tobacco
E-liquids

Pipe tobacco
Roll-your-own (RYO) tobacco
RYO rolling paper
RYO tube
Smokeless tobacco
Waterpipe tobacco

At this time, FDA does not intend to enforce the ingredient listing submission requirements for the following, including but not limited to:

Bowls
Cartomizers
Charcoal
Coils
Connection adapters
Digital display, lights, and buttons to adjust settings
Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors

Hoses
Mouthpieces
Pipes
System software
Tanks
Waterpipes
Wicks

Ingredient Listing for Multiple Products

FDA believes that manufacturers/importers can satisfy the ingredient listing requirement by providing one ingredient listing that corresponds with multiple products, under the following conditions:

Any tobacco product:

Identical per weight composition of ingredients for tobacco products sold under multiple brands/subbrands
Identical per weight composition of ingredients for tobacco products sold in multiple product sizes (volume or quantity, NOT packaging size)

E-liquids (in addition to above):

Identical in chemical composition to one another or
Identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ. (Per weight composition of ingredients other than PG/VG/nicotine cannot differ)

See the revised guidance for more information and specific examples.

Note: Manufacturers/importers must also identify all brands/subbrands and product sizes for the associated tobacco products in the submission.

When to Comply

Cigarettes, smokeless tobacco, or roll-your-own tobacco
- 90 days before the product is delivered for introduction into interstate commerce
Finished tobacco products regulated by the final deeming rule, such as cigars, dissolvables, hookah tobacco, nicotine gels, pipe tobacco, and electronic nicotine delivery systems (including e-liquids), entering the market as of August 8, 2016:
- November 8, 2018 for "small scale tobacco product manufacturers" (All other ingredient listing submissions for "finished tobacco products" regulated by the final deeming rule had a compliance date of May 8, 2018.)
- Note: For deemed finished tobacco products entering the market after August 8, 2016, you must submit ingredient listing 90 days before the product is delivered for introduction into interstate commerce.