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Updated FAQ on FDA Guidance Document with Enforcement Priorities for Certain Flavored Electronic Nicotine Products

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their January 23rd online bulletin. Reposted with permission.

Earlier this month, NATO published a list of questions regarding the FDA Guidance Document titled: “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.”  Based on questions asked by attendees of the NATO webinar referenced above, the Frequently Asked Questions list has been updated below.

Question:  When does the Final Guidance Document go into effect?

Answer:  The FDA will begin enforcement of the Guidance policy on Thursday, February 6, 2020.

Question:  Which electronic nicotine delivery products cannot be sold under the Final Guidance document?

Answer:  Beginning February 6, 2020, flavored cartridge-based and pod-based electronic nicotine delivery products (other than tobacco-flavored, menthol flavored or non-flavored cartridge-based or pod-based electronic nicotine products) cannot be legally manufactured, distributed or sold unless a specific product has received a Pre-Market Tobacco Authorization (PMTA) approval order from the FDA on or before February 6, 2020.  If a manufacturer of a flavored cartridge-based or pod-based electronic nicotine delivery product (other than a tobacco-flavored, menthol flavored or non-flavored cartridge-based or pod-based electronic nicotine product) has submitted a PMTA application which is under review by the FDA, the flavored cartridge-based or pod-based electronic nicotine delivery product still cannot be legally sold on or after February 6, 2020 until the FDA reviews the PMTA application and issues a PMTA approval order.

Question:  What is a “cartridge-based” electronic nicotine delivery product?

Answer:  The FDA defines a “cartridge-based” electronic nicotine delivery product as consisting of “a cartridge or pod that holds liquid that is to be aerosolized through product use” and “a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.”  This means that a cartridge or pod is separate from the actual electronic cigarette device and must be fit into or be attached to the device.

Question:  Does a manufacturer have to file a PMTA application for each product SKU or one PMTA application for a brand family or all of its products?

Answer:  A manufacturer needs to file a PMTA application with the FDA for each product SKU.  One PMTA application cannot cover an entire brand family or all of the products made by the manufacturer.

Question:  Can a flavored cartridge-based or pod based electronic nicotine product (other than a tobacco-flavored, menthol flavored or non-flavored cartridge-based or pod-based electronic nicotine product) that is removed from the marketplace by February 6, 2020 be reintroduced into the marketplace if the FDA approves a manufacturer’s PMTA application?

Answer:  Yes, the approved product can be reintroduced to the marketplace after the FDA issues a PMTA approval order.

Question:  If a manufacturer files a PMTA application with the FDA by May 12, 2020 for a tobacco-flavored or menthol-flavored cartridge-based or pod-based electronic nicotine product, how long can the product remain on the market?  If the PMTA application is denied by the FDA, is there a sell-through period for the product?

Answer:  The FDA has a twelve-month period from the date that a PMTA application is filed to review the application and decide whether to approve or deny the application.  During this review period, the tobacco-flavored or menthol-flavored cartridge-based or pod-based electronic nicotine product that is the subject of the PMTA application can remain on the market.  If the PMTA application is denied, then the product would be considered to be illegally on the market as of the date the FDA denial order is issued and there would most likely not be a sell-through period for the product.

Question:  Can self-contained, sealed, disposable electronic cigarette products continue to be sold after February 6, 2020?

Answer:  Yes, a self-contained, sealed, disposable electronic cigarette product can continue to be sold after February 6, 2020 whether flavored or not by any kind of retailer.  However, a manufacturer will need to file a PMTA application for the disposable electronic cigarette product with the FDA on or before May 12, 2020 in order to allow the product to continue to be sold during the FDA PMTA application review period as explained above.

Question: Can flavored and non-flavored non-cartridge-based or “open system” electronic nicotine delivery products continue to be sold after February 6, 2020?

Answer:  Yes, any retailer can continue to sell any kind of non-cartridge-based or “open system” electronic nicotine delivery products after February 6, 2020 by any kind of retailer.  However, a manufacturer will need to file a PMTA application for the non-cartridge-based or “open system” electronic nicotine delivery product with the FDA on or before May 12, 2020 in order to allow the product to continue to be sold during the FDA PMTA application review period as explained above.

Question:  Can bottles of nicotine e-liquid that are used with open system electronic cigarette products continue to be sold?

Answer:  Yes, bottles of nicotine e-liquids that are intended for use in open system electronic nicotine products can continue to be sold after February 6, 2020 by any kind of retailer.  However, a manufacturer will need to file a PMTA application for the bottles of nicotine e-liquids that are intended for use in open system electronic nicotine products with the FDA on or before May 12, 2020 in order to allow the product to continue to be sold during the FDA PMTA application review period as explained above.

Question:  Should flavored cartridge-based electronic nicotine products (other than tobacco-flavored, menthol flavored or non-flavored products) be removed from store premises or wholesale warehouses by February 6, 2020?

Answer:  The FDA has informed the industry that retailers and wholesalers need to determine their own best practices for complying with the Final Guidance because flavored cartridge-based and pod-based electronic nicotine products (except tobacco-flavored and menthol-flavored products) are considered adulterated and illegal to market and sell as of February 6, 2020.  At the same time, the agency understands that retailers and wholesalers may need to store flavored cartridge-based and pod-based electronic nicotine products (except tobacco-flavored and menthol-flavored products) on and after February 6, 2020 until the products can be returned to a distributor or a manufacturer.

This means that these products should be stored in a manner to prevent customers from thinking that the products are still available for purchase and in a place within a store or a warehouse that is not accessible to the public.  NATO would recommend that retailers consider packing the flavored cartridge-based and pod-based electronic nicotine products that are to be returned in boxes and be sealed as a further precaution to prevent the products from being sold on and after February 6, 2020.

Question:  Under what circumstances would the FDA plan to take enforcement action beginning on February 6, 2020 against tobacco-flavored, menthol-flavored, or non-flavored cartridge-based or pod-based electronic nicotine products and any non-cartridge “open system” flavored electronic nicotine products?

Answer:  Beginning February 6, 2020, the FDA also intends to prioritize enforcement against those cartridge-based or pod-based tobacco-flavored, menthol-flavored, or non-flavored electronic nicotine products if the manufacturer has not taken or is not taking adequate measures to prevent minors’ access to these products, without regard to whether or not, or when, a PMTA application for such product has been submitted.  Also, the FDA will not at this time take enforcement action against “open system” electronic nicotine products nor small manufacturers such as vape shops that mix e-liquids on-site and primarily sell non-cartridge-based open system electronic nicotine products, unless: (1) they market to youth, (2) fail to take adequate measures to prevent youth access, or (3) do not file a PMTA application with the FDA by May 12, 2020.

Question:  What specific kind of actions could the FDA take to enforce the Final Guidance Document?

Answer:  FDA enforcement actions can include issuing a warning letter, issuing an import alert to refuse admission of tobacco products imported or offered for import into the United States, initiating seizure actions, taking civil court actions, and pursuing criminal prosecutions.

Question:  What can the FDA do as of May 12, 2020 regarding cartridge-based or pod-based tobacco-flavored, menthol-flavored, or non-flavored electronic nicotine products and any non-cartridge open system flavored electronic nicotine products?

Answer:  The FDA intends to prioritize enforcement against any cartridge-based, pod-based or non-cartridge based tobacco-flavored, menthol-flavored and unflavored electronic nicotine products and any non-cartridge open system flavored electronic nicotine products that are offered for sale after May 12, 2020 and for which the manufacturer has not submitted a PMTA application to the FDA by May 12, 2020 or after a PMTA application denial order is issued by the FDA in response to a timely submitted PMTA application.

Question:  How do retailers and distributors find out which manufacturers submit pre-market tobacco applications to the FDA by May 12, 2020 and/or which applications are approved or denied by the agency?  

Answer:  NATO has previously asked the FDA to issue a list of manufacturers that file pre-market tobacco applications and the FDA has declined to do so.  Retailers and distributors will need to plan to request confirmation directly from manufacturers that they have filed a PMTA application for each specific product SKU.  The FDA requires that an individual PMTA application needs to be submitted per SKU, not per brand family.  The FDA publishes a list of approved PTMA applications on the agency’s website.  The link to the FDA’s webpage for approved PMTA applications is below:

Link:https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-orders

Question:  Are retailers that mix their own e-liquids required to file PMTA applications with the FDA?

Answer:  Yes.  A retailer that mixes e-liquids is considered a manufacturer by the FDA and will need to submit a PMTA application for each kind of mixed e-liquid they make or each SKU.  If PMTA applications are not submitted by May 12, 2020, then the retailer is subject to enforcement action by the FDA and the products would be considered misbranded by the FDA and on the market illegally.

Question:  Are grandfathered products required to have a PMTA application filed with the FDA?

Answer:  No, a grandfathered tobacco product is a tobacco product commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007. Grandfathered tobacco products are regulated by the FDA and do not require a PMTA application to be legally marketed.  The FDA maintains a webpage which lists grandfathered tobacco products that the FDA has approved as grandfathered products (see link below).  Please note that this FDA list of grandfathered products is not exhaustive as it only includes those products for which manufacturers have voluntarily submitted an application to the FDA to certify that a product is a grandfathered tobacco product and that the FDA has actually determined are grandfathered tobacco products.

Link: https://www.accessdata.fda.gov/scripts/ctpGnd/