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

Recent Natural Disasters

For entities who need additional time to comply with the Nov. 8, 2018, deadline because they were directly impacted by recent natural disasters, please send an email to FDA at ASKCTP@fda.hhs.gov . The Agency will assess each situation on a case-by-case basis.

How to submit:

Submit Online:

FDA recommends submitting ingredient listings online.

Watch FDA’s new webinar: Using FDA Tools to Submit Ingredient Listings Electronically for more information.

  1. Request, in writing, an Industry Account Manager (IAM) account for CTP Portal, if your company does not already have an IAM.
  2. 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. (PDF)

    Watch FDA’s new webinar: Examples of Ingredient Listing Spreadsheets by Product Category for more information
     

  3. 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).


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. 

Video Guides for Ingredient Listing Submissions


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.gov

 

Page Last Updated: 10/19/2018
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