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                Manufacturing

Manufacturing

                        Electronic Submissions for Tobacco Products
          Submit Tobacco Product Applications for Deemed Tobacco Products
          Tobacco User Fees
          Submit Documents via the CTP Portal
          Submit Ingredient Listing for Tobacco Products
          Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions Home
          Tobacco Products
          Compliance, Enforcement & Training
          Manufacturing
          Submit Ingredient Listing for Tobacco ProductsManufacturing Submit Ingredient Listing for Tobacco Products
  
  	
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    PrintIn 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.

On this page:

How to submit
	Guidance
	Components or Parts
	Ingredient Listing for Multiple Products
	When to Comply
	Video Guides for Ingredient Listing SubmissionsHow to submit:

**Submit Online:**

FDA recommendselectronic submissionsof 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

Cigarettes: Example Listing of Ingredients Form
	E-Cigarettes: Example Listing of Ingredients FormGuidance

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 revisedguidance 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.Video Guides for Ingredient Listing Submissions

Using FDA Tools to Submit Ingredient Listings Electronically
Examples of Ingredient Listing Spreadsheets by Product Category (33:23)

Using a TPMF for Ingredient Listing Submissions
Using a TPMF for Ingredient Listing Submissions (12:01)

Using FDA Tools to Submit Ingredient Listings Electronically
Using FDA Tools to Submit Ingredient Listings Electronically (9:05)

For assistance, please contact CTP:

**General ingredient listing questions:**

Call 1.877.CTP.1373 (1.877.287.1373) Monday - Friday, 9 a.m. - 4 p.m. EDT.
	Select option 1
	Email AskCTP@fda.hhs.gov**Technical questions related to eSubmitter and CTP Portal:**

Call 1.877.CTP.1373 (1.877.287.1373) Monday-Friday, 9 a.m. – 4 p.m. EDT.
	Select option 2
	Email CTPeSub@fda.hhs.govAdditional Resources

Guidance: Listing of Ingredients in Tobacco Products
	Using eSubmitter to Prepare Tobacco Product Submissions
	Submit and Reference Tobacco Product Master Files

                                                                                  Content current as of:
      06/17/2020
              
              
Regulated Product(s)
		 TobaccoManufacturing

          
                        Electronic Submissions for Tobacco Products
          Submit Tobacco Product Applications for Deemed Tobacco Products
          Tobacco User Fees
          Submit Documents via the CTP Portal
          Submit Ingredient Listing for Tobacco Products
          Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions
 
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