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Frequently Asked Questions on FDA Guidance Document with Enforcement Priorities for Certain Flavored E-Cigarettes

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their January 7th online bulletin. Reposted with permission.

Today, the FDA Final Guidance Document titled “Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” was officially published in the Federal Register.  Click the link below for the published version of the Final Guidance Document.

(https://www.federalregister.gov/documents/2020/01/07/2019-28539/enforcement-priorities-for-electronic-nicotine-delivery-systems-and-other-deemed-products-on-the).

In response to the NATO News Bulletin issued on January 2, 2020 regarding this Final Guidance Document, members have asked questions about the Guidance Document.  Those questions and NATO’s answers are below.

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

Answer:  In the Final Guidance document, the FDA states that the agency will prioritize enforcement targeting certain electronic nicotine delivery products thirty days after publication in the Federal Register.  With the Final Guidance published in the Federal Register today, this means that the FDA will begin enforcement 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 electronic nicotine delivery products other than tobacco-flavored, menthol flavored or non-flavored products cannot be manufactured, distributed or sold unless a specific product has received a Pre-Market Tobacco Application approval order from the FDA.

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 attached to the device.

Question:  Can self-contained, sealed, disposable electronic cigarettes continue to be sold?

Answer:  Yes, a self-contained, sealed, disposable electronic cigarette product can continue to be sold whether flavored or not by any kind of retailer.

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 cigarette products can continue to be sold whether flavored or not by any kind of retailer.

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 Final Guidance does not permit the manufacture, distribution or sale of flavored cartridge-based electronic nicotine products, other than tobacco-flavored, menthol flavored or non-flavored products, as of February 6, 2020.  While the Final Guidance does not state that these products should be removed from stores or warehouses, there is the possibility that if a FDA inspector conducts a store or warehouse inspection and flavored cartridge-based electronic nicotine products (other than tobacco-flavored, menthol flavored or non-flavored products) are present in the store or warehouse, then the inspector may cite the retailer with a violation of federal tobacco regulations.  In fact, the Final Guidance does state that the FDA enforcement priority will include focusing on retail stores.  If possible, the best practice may be to plan to have flavored cartridge-based electronic nicotine products (other than tobacco-flavored, menthol flavored or non-flavored products), removed from the store or warehouse premises by February 6, 2020 to avoid the risk of a FDA violation.

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

Answer:  Yes, any retailer can continue to sell any kind of non-cartridge-based or “open system” electronic nicotine delivery products.

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

Answer:  The FDA intends to prioritize enforcement against those cartridge-based tobacco-flavored, menthol-flavored, or non-flavored electronic nicotine products and any non-cartridge flavored electronic nicotine products if: (1) they lack a premarket authorization order from the FDA, and (2) 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 premarket 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 premarket authorization by May 12, 2020.

Question:  What 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 and refusing admission of tobacco products imported or offered for import into the United States, initiating seizure or injunction court actions, and criminally prosecuting persons engaging in illicit trade in tobacco products.

Question:  When will the FDA take enforcement action against cartridge-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 or non-cartridge based product, flavored or unflavored, that is offered for sale after May 12, 2020 and for which the manufacturer has not submitted a premarket authorization application to the FDA by Mary 12, 2020 or after a negative order is issued by FDA in response to a timely submitted 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.  While NATO intends to ask the FDA again to issue a list of pre-market application filings, retailers and distributors will need to otherwise plan to request confirmation directly from manufacturers that they have filed a pre-market tobacco authorization for each specific product SKU.  An individual pre-market tobacco application needs to be submitted per SKU, not per brand family.  The FDA publishes on its website the final approval or denial decision on pre-market tobacco applications.

Question:  Are retailers that mix their own e-liquids required to file pre-market tobacco 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 pre-market tobacco application for each kind of mixed e-liquid they make or each SKU.  If pre-market tobacco 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.