For small-scale tobacco product manufacturers and importers in FEMA-declared areas impacted by recent natural disasters, FDA is aware that tobacco manufacturers and importers are dealing with extraordinary circumstances and may need additional time to meet the ingredient listing requirements of Section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act. As a result, FDA is extending the compliance deadline for the ingredient listing requirements to May 8, 2019, for small-scale tobacco product manufacturers and importers of deemed products on the market as of Aug. 8, 2016, in the areas affected by these recent natural disasters.

For small-scale tobacco product manufacturers and importers of deemed products on the market as of Aug. 8, 2016, not affected by recent natural disasters, the compliance date remains Nov. 8, 2018.

This extension will apply to manufacturers and importers of deemed products in the areas within each of these jurisdictions that have been designated by the Federal Emergency Management Agency (FEMA) as major disaster areas:

• Alabama Hurricane Michael (DR-4406)
• Northern Mariana Islands Super Typhoon Yutu (DR-4404)
• Kansas Severe Storms, Straight-line Winds, And Flooding (DR-4403)
• Wisconsin Severe Storms, Tornadoes, Straight-line Winds, Flooding, And Landslides (DR-4402)
• Virginia Hurricane Florence (DR-4401)
• Georgia Hurricane Michael (DR-4400)
• Florida Hurricane Michael (DR-4399)
• Guam Typhoon Mangkhut (DR-4398)
• New York Severe Storms and Flooding (DR-4397)
• Northern Mariana Islands Typhoon Mangkhut (DR-4396)
• Hawaii Hurricane Lane (DR-4395)
• South Carolina Hurricane Florence (DR-4394)
• North Carolina Hurricane Florence (DR-4393)
• Iowa Severe Storm and Tornadoes (DR-4392)
• Minnesota Severe Storms, Tornadoes, Straight-line Winds, And Flooding (DR-4390)
• Havasupai Tribe Severe Storms, Flooding, And Landslides (DR-4389)
• Nebraska Severe Storms, Tornadoes, Straight-line Winds, And Flooding (DR-4387)
• Iowa Severe Storms, Tornadoes, Straight-line Winds, And Flooding (DR-4386)
• Wisconsin Severe Storms, Straight-line Winds, And Flooding (DR-4383)
• California Wildfires and High Winds (DR-4382)
• Michigan Severe Storms, Flooding, Landslides, And Mudslides (DR-4381)
• Texas Severe Storms and Flooding (DR-4377)

For more details about ingredient listing submissions, please refer to the revised FDA Guidance for Industry Listing of Ingredients in Tobacco Products.

If you have questions about this new compliance deadline, please contact FDA at [email protected] or 1.877.287.1373.

Please note that, for the purpose of this compliance deadline, FDA considers a "small-scale tobacco product manufacturer" to be a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less.