FDA Issues New Guidance on Enforcement Priorities for Unauthorized E-Cigarettes and Nicotine Pouches

On May 8, 2026, the U.S. Food and Drug Administration (FDA) issued an important new guidance document that went into effect immediately. The guidance document explains when the agency does not intend to prioritize enforcement regarding the marketing of flavored e-cigarette products and nicotine pouch products that do not yet have premarket authorization from the FDA.

For flavored e-cigarettes and nicotine pouches, the FDA does not intend to prioritize enforcement if (1) the product has a pending Pre-Market Tobacco Application (PMTA) that has been accepted and filed and, (2) specifically for flavored e-cigarettes, if the FDA has determined that the application includes the data necessary to evaluate whether the product is appropriate for the protection of public health.

In another significant step, the FDA announced in this new guidance that the agency’s guidance issued in April of 2020 is withdrawn. The April 2020 guidance essentially prohibited the marketing of flavored cartridge-based e-cigarettes, except tobacco and menthol flavored cartridge-based e-cigarette products. This means that the agency will no longer prioritize enforcement of flavored cartridge-based e-cigarettes which have a pending PMTA.

The agency’s announcement stated that to promote transparency for consumers and retailers, FDA also will create and maintain a publicly available webpage listing those flavored e-cigarette and nicotine pouch products that the FDA does not intend to prioritize enforcement against under this new guidance policy. Read the new guidance document here.