Are Nicotine Pouches FDA Approved?

Since being authorised to do so in 2022, the U.S. Food and Drug Administration (FDA) has made significant strides in regulating non-tobacco nicotine products, including nicotine pouches. Through this authorisation, many nicotine pouches have been FDA-approved, marking a crucial step in providing smokers with less harmful alternatives.

The nicotine pouch, a harm-reduced alternative with proven effectiveness, is a porous product ‘placed in the mouth between the gum and cheek, where it releases nicotine.’ Removing the need for combustion, nicotine pouches offer a safer experience for smokers.

The FDA’s monitoring and controlled approval of alternative products such as nicotine pouches is part of a broader strategy to reduce the harms associated with traditional tobacco products by encouraging smokers to switch to potentially less harmful alternatives. The rigorous process that non-tobacco nicotine products, such as nicotine pouches, have to go through to get approval ensures that approved products meet high-quality standards. It is only these approved products that can then make it onto the US market. 

Given this, it is important to know that nicotine pouches that meet the required standards are FDA-approved. If you are a smoker in the US and want to switch to nicotine pouches, you can find more information on the FDA website here.

Read more about the science of harm reduction.