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The U.S.Food and Drug Administration (FDA) has authorized 20 ZYN nicotine pouch products to carry a 'modified risk' claim, stating that switching from cigarettes to these pouches reduces risks of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.However, the FDA explicitly warns that nicotine pouches are not safe or approved as smoking cessation tools.
The decision allows Swedish Match, the manufacturer of ZYN, to market specific products as a less harmful option for adults who fully transition away from cigarettes.This ruling comes amid rapid global growth of nicotine pouches, with 23.4 billion units sold in 2024, a 50% increase from the previous year.
The World Health Organization (WHO) cautions that nicotine pouches are gaining popularity among adolescents and young adults due to their 'strong youth appeal and high addiction potential,' raising concerns about attracting new users.
While the FDA's modified risk tobacco product (MRTP) order applies only to 20 specific ZYN products and requires full cessation of cigarette use, the agency emphasizes that quitting all tobacco and nicotine products remains the healthiest option.
The ruling reflects regulators catching up to a cultural shift in nicotine consumption, as alternatives like vapes, heated tobacco devices, and nicotine patches compete in a fragmented market.Critics argue the decision may inadvertently normalize nicotine use among younger demographics, despite the FDA's cautionary stance.