Preparing for the FDA’s Tobacco Ingredient Listing Compliance Deadline

FDA Updates Guidance for Tobacco Product Ingredient Listing Requirements

An important compliance deadline is looming for manufacturers and importers of deemed tobacco products. If your tobacco product was on the market as of Aug. 8, 2018, you are expected to submit your ingredient listings to to the U.S. Food and Drug Administration (FDA) by May 8, 2018. Small-scale manufacturers have a bit longer to submit their list as the deadline for them is Nov. 8, 2018.

There has been some confusion around what the FDA plans to enforce and what it will be looking for in the submitted ingredients list. The FDA will be enforcing ingredient listing submission for components or parts of products that are made or derived from tobacco or those that contain 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

The FDA will not enforce the ingredient listing for:

  • 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

Manufacturers and importers of tobacco products can satisfy the ingredient listing requirement by providing the FDA with one listing that relates to multiple products if the tobacco products are identical per weight composition of ingredients for tobacco products sold under multiple brands/sub-brands or if it is identical per weight composition of ingredients for tobacco products sold in multiple product sizes (volume or quantity, NOT packaging size). Manufacturers and importers are required to identify all brands and sub-brands and product sizes for the associated tobacco products in the submission.

For manufacturers of e-liquids, one listing can be submitted if the tobacco products are identical in chemical composition to one another or if they are identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ.

Ingredient lists can be submitted in several different ways:

  • Entered into the eSubmitter (as instructed in the software)
  • Submitted manually via the CTP-provided spreadsheets (good for manufacturers with only a few products or those who don’t have complex ingredients)
  • Entered and submitted through one of the FDA’s alternative product-specific spreadsheets and in the eSubmitter
  • Submitted through your own spreadsheet that lists all product, ingredient, and component information.
  • Submitted via snail mail to the CTP’s Document Control Center

For additional resources and tools to help understand the requirements of the ingredient listing for tobacco products, click here. To review the recently revised “Guidance for Industry: Listing of Ingredients in Tobacco Products” document from the FDA, click here.