What retailers need to know about the FDA’s new tobacco enforcement guidance

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In May, the FDA released a new guidance document titled, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” Since its release, many retailers have been asking what this means for stores that sell vapor products and nicotine pouches.

For starters, this guidance replaces previous FDA enforcement discretion policies for these product categories and provides greater clarity about which products the agency is less likely to prioritize for enforcement.

Under the new policy, the FDA generally does not intend to prioritize enforcement against unauthorized vapor and nicotine pouch products if the manufacturer has a pending premarket tobacco product application (PMTA) that has been both accepted and filed for scientific review by the FDA. The policy also applies to supplemental applications (sPMTAs) for modifications to already FDA-authorized products that have been accepted by the FDA and have been pending for more than 180 days.

For nontobacco-flavored vapor products, the FDA also expects the application to include the scientific data needed to determine whether the product is appropriate for the protection of public health (e.g., switching data showing added benefit to adult smokers).

One significant aspect of the guidance is that it applies regardless of when the application was submitted. There are, however, exceptions to this policy. The FDA has stated that it may still prioritize enforcement against products that appear to appeal to underage users. Examples include products that feature cartoon-style characters, disguise the fact that they are vaping products, or resemble children’s toys, phones or gaming devices.

The FDA also may prioritize enforcement against products that present a “significant public health or safety concern that is greater than generally presented by ENDS or nicotine pouch products or other tobacco products.” As examples, the FDA listed products with high nicotine levels, products associated with serious adverse events or a larger number of unexpected adverse experiences compared with authorized products, products without child-resistant packaging or products that may pose a fire risk.

It is important for retailers to understand that products covered by the FDA’s “non-prioritized” enforcement policy are not the same as FDA-authorized products. Only 26 nicotine pouch products and 45 vapor products have received marketing authorization through the PMTA process. Products that fall within the FDA’s new enforcement priorities policy remain unauthorized products.

FDA's plans for an upcoming public list

The FDA has indicated that it plans to create a public-facing list of manufacturers and products that generally fall within this enforcement policy. NATO has long advocated for greater transparency from the FDA so retailers can better understand which products the agency does not currently intend to prioritize for enforcement.

According to the FDA, manufacturers that believe their products qualify for inclusion on the list and wish to participate can work with their FDA regulatory health project manager to have their information included. The agency plans to update the list on an ongoing basis as manufacturers and products become eligible or lose eligibility under the policy.

While the FDA has not announced a launch date for the webpage, it is expected to be available in the near future.

For retailers, this guidance provides welcome clarity. While it does not make unauthorized products legal, it gives businesses greater insight into the FDA’s enforcement priorities and should help retailers make more informed decisions about the products they choose to stock and sell.

The full guidance is available through the FDA Center for Tobacco Products Newsroom.

David Spross is the executive director of the National Association of Tobacco Outlets in Washington, D.C. 

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