ONPs and FDA Regulations

The Federal Drug Administration (FDA) does regulate oral nicotine pouches, under the Tobacco Control Act. Any product that contains nicotine, including synthetic nicotine must follow laws and regulations under the ACT, regardless of if they are advertised as “tobacco-free”. The Tobacco Control Act governs sale restrictions to youth, requires product warning labels, lists potential risks linked to usage backed by scientific-based evidence, ensures all product ingredients are clearly disclosed and grants the state, local and tribal delegated authority with rules and regulations for the sale of oral nicotine pouches.¹⁰

The FDA implemented a program in 2020 to help authorities prevent the misuse of tobacco products by youth and young adults. With the rise of enticing, flavored products, these new guidelines required all flavored tobacco products to be subjected to a detailed, science- based review to meet statutory FDA standards of protocol.¹¹ Currently the FDA has not granted approval of any kind of nicotine pouch to assist as a smoking cessation method due to limited research.¹²