US: heated tobacco, herbal heated tobacco, oral tobacco and nicotine pouch regulation

Nicotine pouches are included within the category of tobacco products at the US federal level, so federal law applies. Additionally, non-tobacco nicotine products (which include synthetic nicotine products) fall within the authority of the Food and Drug Administration (FDA) to regulate tobacco products, since the passing of federal legislation in 2022.

A premarket tobacco product application (PMTA) must be submitted to the US Food and Drug Administration (FDA) for each product looking to enter the US market.

According to the Alcohol and Tobacco Tax and Trade Bureau, a tax would generally be applied to the sticks used with heated tobacco devices, applying the federal tax on small cigarettes.

This two-report bundle offers detailed analysis of the regulatory framework currently in place for heated tobacco products, herbal heated tobacco products, oral tobacco and nicotine pouches in the US, covering all policy areas, including labelling and advertising requirements as well as barriers to market entry.