FDA authorizes 20 ZYN nicotine pouches to be marketed with modified risk claim
The orders let Swedish Match say ZYN may pose lower risks than cigarettes after the FDA reviewed consumer understanding, youth risk and population impact.
- On Tuesday, the Food and Drug Administration issued modified risk granted orders to Swedish Match USA, Inc. for 20 ZYN nicotine pouch products following scientific review.
- Bret Koplow, acting director of the FDA's Center for Tobacco Products, noted the review ensures users have "science-based information about the relative harms" of tobacco products.
- A 2023 randomized, controlled study found that switching from cigarettes to nicotine pouches reduced exposure to harmful chemicals by approximately 42 percent to 96 percent within one week.
- These orders expire in five years, during which Swedish Match must conduct postmarket surveillance to assess user behaviors and understanding of risk-related information on ZYN packaging.
- With more than 24 million American adults still smoking, Raymond Niaura, a psychologist at New York University, said the decision "recognizes evidence supporting the claim that using Zyn is safer than smoking cigarettes.
25 Articles
25 Articles
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