FDA Provides Compliance Policy
FDA published the revised guidance, "Listing of Ingredients in Tobacco Products."
This guidance is intended to assist manufacturers and importers of tobacco products.
FDA published the revised guidance, “Listing of Ingredients in Tobacco Products.” This guidance is intended to assist manufacturers and importers making tobacco product ingredient submissions to FDA, as required by the Tobacco Control Act.
The guidance announces 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. For example, ingredients of cigarette paper should be submitted to FDA as it is burned during the use of a cigarette and produces constituents that are inhaled by the smoker. Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement includes, but is not limited to, coils, wicks and mouthpieces. For additional examples of what components and parts require an ingredient listing submission, please read the guidance.
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 submits ingredient information, what information is included in the submissions, how and when to submit the information, FDA’s compliance policies, and definitions.
FDA would like to remind manufacturers and importers of deemed tobacco products that were on the market as of Aug. 8, 2016, that the deadline to submit ingredient listings is May 8, 2018. For small-scale manufacturers, the deadline is Nov. 8, 2018.
FDA has developed new resources to assist those preparing ingredient listing submissions, such as product-specific step-by-step instructions and alternative format spreadsheets. For more information on how to submit ingredient listings by mail or online through the CTP Portal, please visit our new Submit Ingredient Listing for Tobacco Products webpage.
For entities that need help with technical assistance in order to comply with the deadline, please contact FDA at 1.877.CTP.1373 (1.877.287.1373) Monday-Friday, 9 a.m. – 4 p.m. EDT. Users should select Option 1 for general ingredient listing questions or Option 2 for technical questions related to the eSubmitter and CTP Portal.