FLER at APE

The U.S. Food and Drug Administration issued guidance on May 8, 2026, titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” The document describes FDA enforcement policies for certain electronic nicotine delivery system products and nicotine pouch products marketed without premarket authorization.

2Firsts supports new tobacco and nicotine companies entering the U.S. market with full-chain PMTA compliance services.

among both youth and adults. However, industry groups and regulators warn that the illicit vape market remains a growing concern.

According to Reuters, Australia’s state of Victoria introduced legislation to give police and the state tobacco licensing regulator stronger powers to shut businesses selling illegal tobacco, with non-compliant operators facing fines of more than A$2.4 million and up to 20 years in prison.

The Australian Bureau of Statistics (ABS) has released its first estimate of the illicit nicotine market, finding that about 80% of cigarettes, vapes and other nicotine products consumed in 2025 came from illegal sources, reigniting debate over tobacco taxation and enforcement policies.

The U.S. Food and Drug Administration (FDA) said its youth e-cigarette prevention campaign, “The Real Cost,” prevented about 444,000 U.S. youth from starting e-cigarette use between 2023 and 2024 and blocked more than $42 million in unauthorized e-cigarette sales that would have been used by youth.