FDA Extends Deadline to File Ingredients

Some welcome news out of Washington. Today, FDA extended the deadline to file ingredients from 2/8/16 to 8/8/17. The Guidance, https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM527044.pdf, states in relevant part:

The preamble to the deeming rule (81 FR 28974) stated that FDA does not intend to enforce the requirement to submit ingredient listing for manufacturers and importers of newly deemed tobacco products that were introduced into interstate commerce on or before August 8, 2016 provided submissions are received by February 8, 2017, or August 8, 2017 for small-scale manufacturers. However, FDA recognizes that some manufacturers of newly deemed products are not familiar with the forms for listing ingredients and, therefore, may need additional time to complete them accurately. In addition, we are aware that some manufacturers may need to prepare and submit multiple lists. Therefore, at this time, for manufacturers and importers of newly deemed tobacco products (21 CFR part 1100) that were introduced into interstate commerce on or before August 8, 2016, FDA does not intend to enforce the requirement to submit ingredient information according to section 904(a)(1) until August 8, 2017. For small scale manufacturers of newly deemed tobacco products (21 CFR part 1100) that were introduced into interstate commerce on or before August 8, 2016, FDA does not intend to enforce the requirement to submit ingredient information according to section 904(a)(1) until February 8, 2018. FDA believes that this additional time will allow manufacturers to prepare higher quality submissions. However, because we may receive a large number of submissions from certain firms, we encourage manufacturers to begin the process as early as possible.

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