FDA establishes enforcement priorities policy for unauthorized ENDS and nicotine pouch products

Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), manufacturers must obtain FDA premarket authorization for “new tobacco products,” including ENDS, before marketing them in the United States. The standard for a premarket tobacco product application (PMTA) requires manufacturers to submit scientific data demonstrating that the product is “appropriate for the protection of the public health.”

Despite this statutory requirement, a substantial number of ENDS products are commercially available without having completed the Section 910 review process due to a variety of reasons, including a backlog of FDA review that has resulted in many products remaining in limbo pending agency action. FDA issued guidance in April 2020 stating that it will prioritize flavored, cartridge-based ENDS, among others, for enforcement. The new guidance withdraws the April 2020 guidance and is informed by updated youth-use data and a revised framework for allocating agency resources. Further, as a practical matter for manufacturers, the new guidance defines the conditions under which FDA will deprioritize enforcement of certain ENDS and oral nicotine pouch products.  

Scope of the guidance

The guidance applies to two product categories subject to Section 910:

• ENDS, such as e-cigarettes, vapes, vape pens, e-hookahs, e-cigars, e-pipes, cigalikes, and personal vaporizers that contain nicotine from any source; and
• Oral nicotine pouch products, such as tobacco products placed between the gum and lip that contain nicotine extracted from tobacco leaf or synthetically derived, and that do not contain cut, ground, powdered, or leaf tobacco.

Products that FDA will deprioritize

For ENDS and oral nicotine pouch products marketed without FDA authorization, FDA “generally does not intend to prioritize enforcement of the premarket authorization requirement” where two conditions are satisfied:

• Condition 1: Accepted and filed PMTA or qualifying sPMTA, meaning the product is subject to a pending PMTA that FDA has accepted for review and filing, as set forth in the guidance, or is subject to a supplemental PMTA (sPMTA) that FDA has accepted and that has been pending for more than 180 days. Applications that FDA has refused to accept or refused to file do not qualify.
• Condition 2: Additional data requirement for non-tobacco-flavored ENDS, meaning, for non-tobacco-flavored ENDS only, FDA must additionally have determined that the pending application includes data sufficient to evaluate whether the product is appropriate for the protection of the public health (APPH).

In addition, to promote transparency, FDA will create and maintain a public-facing webpage listing manufacturers and products that fall within the policy. Manufacturers whose applications are in scientific review should contact their FDA regulatory health project manager (RHPM) or the Center for Tobacco Products’ enforcement priorities email address to request inclusion on the list, and may cross-reference relevant sections of their pending PMTA rather than resubmitting information. The guidance clarifies that inclusion on the list does not ensure that FDA will not pursue case-by-case enforcement and has no bearing on whether a product will ultimately receive premarket authorization. This public identification process follows a similar effort executed in 2021 where FDA published a list of tobacco products that were the subject of timely applications and would thus not be subject to enforcement per the April 2020 guidance.

Products that FDA will still prioritize regardless

Even for products that satisfy the conditions above, FDA will still prioritize enforcement of those that have the following characteristics:

• Presumptively underage-appealing elements, such as depiction of a cartoon-like fictional character, disguising the product’s nature as a vaping product, or resemblance to a children’s toy, phone, or gaming platform; or
• Significant public health or safety concerns, such as high nicotine content; serious adverse experiences, or a greater number of unexpected adverse experiences than authorized comparable products; absence of child-resistant packaging; or potential fire hazard.

FDA underscored its enforcement posture towards products in the exceptions category on the heels of the new guidance, issuing warning letters to eight retailers for selling unauthorized nicotine pouches and dissolvable tobacco products designed to resemble candy, breath strips, and cough drops—“a blatant ploy,” said Center for Tobacco Products Acting Director Bret Koplow, “to target children and mask the true nature of these products.”

Assessing your position under the policy

The new guidance provides additional compliance considerations for manufacturers currently marketing or seeking to market ENDS or oral nicotine pouch products in the U.S. without premarket authorization, including a substantial number based in China and other non-U.S. jurisdictions that may face particular challenges in assessing PMTA status, addressing application deficiencies, and navigating U.S. packaging and marketing requirements and youth-access considerations.

Key considerations include:

• Eligibility assessment. Manufacturers should evaluate whether their products and pending applications satisfy the policy’s conditions, including verifying accepted-and-filed status and the adequacy of APPH data in the pending application.
• Application gap analysis. Manufacturers with applications that have not successfully completed acceptance and filing review should assess whether their submissions address the common deficiencies that FDA identifies in the guidance and take corrective action where possible.
• Youth-appeal and packaging compliance. Manufacturers should audit product design, packaging, labeling, and marketing materials for features that could trigger the youth-appeal or public health or safety exceptions, including child-resistant packaging compliance.
• RHPM engagement. Manufacturers whose applications are in scientific review should consider contacting their FDA RHPM or the Center for Tobacco Products to seek inclusion on the public-facing webpage.
• Ongoing monitoring. Because the new guidance is nonbinding, manufacturers should maintain active compliance programs and monitor regulatory developments.

In addition to the federal framework, some U.S. states also have additional restrictions on the marketing of ENDS and oral nicotine pouch products that manufacturers must consider.

For assistance navigating FDA’s enforcement priorities policy, including assessing eligibility, addressing application deficiencies, or managing related compliance risks, please contact the authors of this alert or your usual Hogan Lovells attorney.

Authored by Xin Tao, Heidi Gertner, Eva Marie Schifini, and Stephanie Agu.