FDA Guidance Document
The FDA’s 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 in early January.
The guidance describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS (electronic nicotine delivery systems) products that do not have premarket authorization – vital information for every facet of the industry.
The National Association of Tobacco Outlets (NATO) took the opportunity to answer many of the questions about the Guidance Document that its members have been asking, which it shared with the press:
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… 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 on 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 an 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: 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. Stay tuned.