Despite the existence of an accelerated approval channel, the U.S. Food and Drug Administration (FDA) has decided to delay processing the market applications for nicotine pouch products such as Zyn and Velo.

According to informed sources, regulators are primarily concerned that these products may pose health risks to non-smokers and minors. These tobacco alternatives absorb nicotine directly through the oral mucosa and have rapidly expanded in the US market in recent years. Industry giants British American Tobacco’s Velo and Altria Group-backed Zyn brand originally aimed to accelerate their market launch via the FDA’s “modified risk tobacco product” certification pathway. This mechanism allows companies to gain a marketing advantage by scientifically proving their products are less harmful than traditional cigarettes.However, the FDA review found that nicotine pouches may attract groups who have never used tobacco, especially teenagers. Internal reports indicate that fruity flavors and discreet usage methods can easily lead to misuse by minors. Meanwhile, although tobacco companies like Philip Morris have not directly entered this field, their regulatory experiences with heated tobacco products are now being referenced by peers.Industry insiders analyzed that delays in approval may impact the strategic planning of companies specializing in nicotine pouches, such as Turning Point Brands. While companies emphasize that their products aim to help adult smokers reduce harm, regulators continue to require additional evaluations on secondhand exposure risk and child ingestion prevention. This tug-of-war reflects the difficult balance between public health concerns and business interests for new types of nicotine products.