Tobacco Products

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 ingredient listings be submitted online. In order to use the CTP Portal to submit online, you will need to request, in writing, an Industry Account Manager (IAM) account.


Guidance updates

Updated April 2018:

  • 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 updated guidance for more information.

Ingredient listing requirements for 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:

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

This includes:

  • Cigar filler
  • Cigar binder
  • Cigar wrapper
  • Pipe tobacco
  • Waterpipe tobacco
  • E-liquids
  • Cigarette tobacco
  • Cigarette paper
  • Smokeless tobacco
  • Roll-your-own (RYO) tobacco
  • RYO rolling paper
  • RYO tube

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

  • Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors
  • System software
  • Digital display, lights, and buttons to adjust settings
  • Connection adapters
  • Cartomizers
  • Coils
  • Wicks
  • Tanks
  • Mouthpieces
  • Pipes
  • Waterpipes
  • Hoses
  • Bowls
  • Charcoal

When to provide one ingredient listing submission that corresponds to multiple products

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

Any tobacco product with:

  • 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)

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

Manufacturers/importers of e-liquids can satisfy ingredient listing requirements by providing one listing for multiple brand/subbrands and product size if all tobacco products covered by that listing are:

  1. Identical in chemical composition to one another or
  2. Identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ. (Note: Per weight composition of ingredients other than PG/VG/nicotine cannot differ among the products covered by that listing)

See the revised guidance for more information and specific examples.


Submission spreadsheet options for electronic submissions

FDA provides several options to assist industry with ingredient listing electronic submissions. We encourage industry to use an FDA-provided spreadsheet, downloaded directly from this site or eSubmitter to ensure use of the most updated spreadsheet. Options include:

  1. Enter product, component, and ingredient information manually into eSubmitter, as instructed in the software.
  2. Enter product and ingredient information using separate FDA-provided spreadsheets, and enter component information manually. This may be a good option for manufacturers who only have a few products, or whose products do not have a lot of complex ingredients.
  3. Attach product, component, and ingredient information using a single FDA-provided spreadsheet available on this webpage and in eSubmitter.
  4. Attach your own spreadsheet to list all product, ingredient, and component information. Spreadsheet must include all the information required by the FDA.

Read more about submitting to FDA here: Submit Documents via the CTP Portal.


Product-specific tools

E-liquids

If you are a manufacturer of e-liquids, with a large number of products that require ingredient listing submissions, consider using:

Leaf-wrapped cigars

If you are a manufacturer of leaf-wrapped cigars with a large number of products that require ingredient listing submissions, consider using:

This spreadsheet is intended to only report leaf tobacco and complex ingredients not made to your specifications. For leaf-wrapped cigars containing complex ingredients made to your specifications (e.g., custom prepared for you) or single chemical substances, consider using the Any Tobacco Product alternative format spreadsheet.

Any tobacco product

If you are a manufacturer of any tobacco product and are preparing to submit ingredient listings for your products, consider using:


Compliance deadlines


How to submit:

Submit Online:
Prepare your submissions electronically using the FDA’s eSubmitter software and tools for tobacco products and submit online via the CTP Portal.

In order to use the CTP Portal, you will need to request, in writing, an Industry Account Manager (IAM) account.

Download step-by-step instructions for electronic submission of any tobacco product ingredient listing. (PDF)

Submit by Mail:
If you are unable to submit online, mail submissions to CTP’s Document Control Center, using FDA Form 3742 (PDF).

Sample Completed Ingredient Listing Paper Forms


For additional technical assistance, please contact FDA at 1.877.CTP.1373 (1.877.287.1373) Monday-Friday, 9 a.m. – 4 p.m. EDT. Users should select Option 1 for general ingredient listing questions or Option 2 for technical questions related to the eSubmitter and CTP Portal. Technical assistance is also available through email. Contact AskCTP@fda.hhs.gov for general ingredient listing questions or CTPeSub@fda.hhs.gov for technical questions related to the eSubmitter and CTP Portal.

Page Last Updated: 06/05/2018
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