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🇩🇿 Algeria /Health & Science

FDA grants modified-risk authorizations to 20 ZYN nicotine pouch products

From Algérie360 · () French

Translated from French and summarized by DistantNews. Read the original for the full story.

At a glance

Press release Official statement New plan
  • The US Food and Drug Administration granted modified-risk tobacco product authorizations for 20 ZYN nicotine pouch products, the first such authorizations issued for nicotine pouches.
  • The authorization allows Philip Morris International to communicate that using ZYN instead of cigarettes reduces the risk of several smoking-related diseases, including lung cancer and cardiovascular disease, under FDA-approved terms.
  • PMI said the decision expands its modified-risk authorizations across ZYN, some IQOS products and eight General snus products.

ZYN has become the first nicotine pouch to receive modified-risk tobacco product authorizations from the US Food and Drug Administration. The FDA issued the authorizations for 20 ZYN products, allowing Philip Morris International’s US business to communicate a specific reduced-risk message under the terms of the decision.

Using ZYN instead of cigarettes reduces the risk of oral cancer, cardiovascular disease, lung cancer, stroke, emphysema and chronic bronchitis.

· US Food and Drug Administration authorization messageThe statement that PMI US may communicate for the authorized ZYN products under the terms of the FDA decision.

The authorized message says that using ZYN instead of cigarettes reduces the risk of oral cancer, cardiovascular disease, lung cancer, stroke, emphysema and chronic bronchitis. PMI US chief executive Stacey Kennedy called the decision an important step for adult nicotine consumers in the United States.

Kennedy said the authorization gives adults access to information supported by FDA-validated data. She said those data indicate that switching from cigarettes to ZYN reduces the risk of some smoking-related diseases, including cardiovascular disease and lung cancer. She also described the decision as confirmation of the agency’s approach of evaluating products according to their risk profiles and communicating its conclusions transparently.

The FDA’s decision represents an important step for more than 45 million adult nicotine consumers in the United States.

· Stacey KennedyPMI US chief executive Stacey Kennedy’s reaction to the FDA authorizations.

ZYN became the first nicotine pouch authorized for sale in the United States after a scientific review in January 2025. With the latest decision, PMI now holds modified-risk authorizations for ZYN, certain IQOS devices and consumables, and eight General snus products.

This decision ensures that the adults concerned have access to accurate, science-based information, including FDA-validated data showing that switching from cigarettes to ZYN reduces the risk of certain smoking-related diseases such as cardiovascular disease and lung cancer.

· Stacey KennedyKennedy explained how PMI views the authorization and its information for adult consumers.

Nicotine pouches deliver nicotine through absorption in the mouth and do not require tobacco combustion or smoke inhalation. PMI says this can reduce exposure to some harmful and potentially harmful substances compared with combustible tobacco products such as cigarettes. The company presents the products as part of its broader effort to build a smoke-free future and expand beyond tobacco and nicotine over time.

More broadly, it confirms the agency’s scientific approach of evaluating products according to their risk profile and communicating its findings transparently.

· Stacey KennedyKennedy’s description of what the FDA decision demonstrates about the agency’s regulatory approach.
About this summary

Originally published by Algérie360 in French. Translated, summarized, and contextualized automatically by DistantNews, with a note on how the source frames the story. Not individually reviewed before publishing. How this works.

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