FDA issues ingredients reminder

FDA issues ingredients reminder

October 22, 2018

The US Food and Drug Administration has issued a reminder that the ingredient-listing compliance deadline for small-scale manufacturers of ‘deemed’ products on the market as of August 8, 2016, is November 8, 2018.

And it is informing those that need additional time to comply with the November 8 deadline because they were directly impacted by recent natural disasters to contact it by email at CTPRegistrationandListing@fda.hhs.gov. The Agency said it would ‘assess each situation on a case-by-case basis’.

‘Deemed tobacco products entering the market after August 8, 2016, must submit the ingredient information at least 90 days before the product is introduced to interstate commerce,’ the FDA said in a note issued yesterday through its Center for Tobacco Products. ‘FDA encourages manufacturers to start the process as early as possible.

‘In April 2018, FDA published a revised Listing of Ingredients in Tobacco Products guidance to assist manufacturers and importers preparing tobacco product ingredient submissions. The guidance announced that FDA currently intends to enforce the ingredient listing submission requirements of section 904(a)(1) only with respect to finished tobacco products and their components or parts that are made or derived from tobacco, or containing ingredients that are burned, aerosolized or ingested during tobacco product use.

‘The guidance also streamlines requirements for manufacturers by clarifying ways in which tobacco product manufacturers or importers can satisfy the ingredient listing requirements by providing one listing that corresponds to multiple products. It explains the statutory requirement to submit a list of all ingredients in tobacco products; who is required to submit ingredient information; what information must be included in the submissions; how and when to submit the information; FDA’s compliance policies; and definitions.

‘In response to industry feedback, FDA has developed three webinars to assist manufacturers with the submission of tobacco product ingredient listings:

  • Using FDA Tools to Submit Ingredient Listings Electronically;
  • Using a Tobacco Product Master File (TPMF) for Ingredient Listing Submissions;
  • Examples of Ingredient Listing Spreadsheets by Product Category.’

More information is available at the FDA’s Submit Ingredient Listing for Tobacco Products page.

Category: Breaking News

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