On January 7th, 2020 the U.S. Food and Drug Administration published a Guidance for Industry (GFI) titled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization”. This guidance does not in any way alter the fact that it is illegal to market any new tobacco product without premarket authorization. The enforcement prioritization against the indicated ENDS products began on February 24th, 2020.
Per the GFI, FDA intends to prioritize enforcement against any flavored, cartridge-based, ENDS products (other than tobacco or menthol flavors) that are offered for sale in the United States without having premarket authorization. For the purposes of defining the ENDS products being prioritized under this GFI, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS, where the cartridge or pod is disposed of after use. For more information please reference the GFI.
As part of the admissibility process, imported tobacco products, specifically ENDS covered under the GFI, may be subject to additional FDA review and examination to determine compliance with the premarket requirements.
When transmitting the FDA message set information as part of an electronic entry of tobacco products via ACE, all tobacco products that contain a flavor other than tobacco or menthol are expected to be transmitted under subclass C, “Flavored (Other)”. Please send any questions or concerns to the email address for the Product Code Builder Feedback PCBFeedback@fda.hhs.gov.
Please make this information available to importers of record, consignees, manufacturers, shippers and other stakeholders that may be affected by the Agency’s import program.
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Operational questions related to the importation of tobacco products may be sent to FDAImportsInquiry@fda.hhs.gov.
- Comments or questions regarding the aforementioned GFI should be directed to FDA’s Center for Tobacco Products at (877) 287-1373.
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Technical questions about tobacco data requirements and/or the supplemental guide may be sent to FDA’s ACE Support Center at ACE_Support@fda.hhs.gov or (877) 345-1101 (domestic toll-free)/(571) 620-7320 (local/international).
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