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The FDA launches a pilot program to speed up nicotine pouch approvals using general studies, aiming to boost smoking cessation tools amid rising youth use concerns.
The FDA is launching a pilot program to ease research requirements for nicotine pouch manufacturers, relying on general studies instead of product-specific data to assess their potential to help smokers quit.
This shift could streamline approvals in the U.S., the world’s largest market for smoking alternatives, and may influence future reviews of other products like vapes.
While nicotine pouches are growing rapidly in popularity—with projected sales rising to nearly $50 billion by 2033—concerns persist over their appeal to children, especially due to sweet flavors and candy-like packaging.
The FDA has urged child-resistant packaging amid rising exposure cases, particularly among young children, though no age restrictions currently exist.
La FDA lanza un programa piloto para acelerar las aprobaciones de bolsas de nicotina utilizando estudios generales, con el objetivo de impulsar las herramientas para dejar de fumar en medio de las crecientes preocupaciones de los jóvenes por el uso.