LAKEVILLE, Minn. — The FDA will begin enforcement of its guidance document “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” on Feb. 6. Retailers need to know how that guidance will affect their business practices.
Beginning that day, flavored cartridge- and pod-based ENDS products (other than tobacco-flavored and menthol-flavored cartridge or pod-based ENDS products) may be manufactured, distributed or sold only if the FDA has issued a premarket tobacco authorization (PMTA) approval order for the specific product. A cartridge or pod is separate from the electronic cigarette device and must be fit into or be attached to the device, in contrast to self-contained, sealed, disposable electronic cigarette products, non-cartridge-based or “open system” ENDS products and bottles of nicotine e-liquids used in open-system ENDS products.
The FDA requires a PMTA application for each specific product SKU; applications do not cover entire brand families or all products from a manufacturer, so retailers must determine whether a particular flavored cartridge- or pod-based ENDS SKU has FDA approval. If an application has been filed but the FDA’s decision is pending, it has not been approved and must be removed from the market as of Feb. 6 until the FDA approves the PMTA application.
Flavored ENDS products that can continue to be sold by any retailer up until May 12, 2020, are disposable, sealed electronic cigarettes; open-system ENDS products; and bottles of nicotine e-liquids intended for use in open-system ENDS products, whether flavored or not. Manufacturers need to file a PMTA for each ENDS product with the FDA by May 12, 2020, to keep their products on the market after May 12 and while the FDA is reviewing PMTA applications.
The FDA advises retailers and wholesalers to adopt practices to ensure compliance with the prohibition on marketing or selling flavored ENDS products. The agency understands retailers and wholesalers may need to store products unsold by Feb. 6 until they can be returned to a distributor or manufacturer. Retailers should consider storing these products in an area not accessible to the public, preferably packed and sealed to prevent customers from thinking they are available for purchase.
Beginning Feb. 6, the FDA also intends to prioritize enforcement against cartridge- or pod-based tobacco-flavored, menthol-flavored or nonflavored electronic nicotine products if the manufacturer has not taken or is not taking adequate measures to prevent underage access to these products. The FDA will also take enforcement action against open-system electronic nicotine products or small manufacturers such as vape shops that mix e-liquids on-site and primarily sell non-cartridge-based open-system electronic nicotine products, if they market to youth or do not take adequate measures to prevent youth access.
FDA enforcement actions can include warning letters, import alerts to refuse admission of specific tobacco products into the United States, seizure actions, civil court actions and criminal prosecutions.
For a list of the FDA’s approved PMTA applications, click here. A list of pending PMTA applications will not be available from the FDA. Retailers will need to obtain information about pending applications from distributors and manufacturers so they can satisfy themselves that an application was filed on time and has not been denied.
The FDA’s final guidance is both comprehensive and complex, so the above information highlights only the most important features from a retailer’s perspective. Each retailer should become familiar with the details of the guidance and how it affects the retailer's particular business practices and procedures. To view the full FDA guidance document, click here.
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