Oral nicotine pouch manufacturer’s reduced exposure claims require evidence and regulatory oversight

Abstract

Starting in 2020, several nicotine product manufacturers (eg, Puff Bar and Fre) exploited a loophole in the Tobacco Control Act (TCA) by claiming their products contained tobacco-free synthetic nicotine (SyN) and were not subject to the Food and Drug Administration’s (FDA) authority.1–3 In response, the US Congress passed a law in March 2022 expanding the TCA’s definition of ‘tobacco products’ to include products containing nicotine ‘from any source,’ including SyN. Non-therapeutic products containing SyN are subject to FDA regulation as tobacco products and must comply with all applicable regulations. As part of its enforcement against illegal nicotine products, FDA has issued warning letters to manufacturers (eg, Puff Bar in October 2022) and retailers of products purportedly containing SyN, and it has issued civil money penalties.4 FDA’s regulatory authority includes oversight of modified-risk tobacco products (MRTPs). An MRTP is defined, in part, as any product with labelling or advertising that ‘explicitly or implicitly’ claims to reduce risks (‘reduced harm’ claims) or exposure to specific substances (‘reduced exposure’ claims) in comparison to other tobacco products.5 Product labelling and advertising cannot include such claims unless they have been reviewed and authorized by …