FDA Guidance for Industry Related to Enforcement Priorities of Indicated Tobacco Products

CSMS #41905518 - FDA Guidance for Industry Related to Enforcement Priorities of Indicated Tobacco Products U.S. Customs and Border Protection sent this bulletin at 03/05/2020 08:42 AM EST   Cargo Systems Messaging Service CSMS #41905518 - FDA Guidance for Industry Related to Enforcement Priorities of Indicated Tobacco Products On January 7 th , 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 24 th , 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. 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. 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).   FINAL Enforcement Priorities For ENDS Guidance_508 Compliant.pdf Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page . You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com . This service is provided to you at no charge by U.S. Customs and Border Protection . Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes. Powered by Privacy Policy | Cookie Statement | Help