FDA Approves 11 Philip Morris Zyn Ultra Pouches

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The Food and Drug Administration authorized the marketing of 11 of Philip Morris International's Zyn Ultra nicotine pouches, while others remain under review.

The FDA approved 10 products with 9-milligram nicotine concentrations and one with an 11-milligram concentration. Other 11-milligram items are under review.

In June, the FDA granted modified risk orders for 20 Zyn pouches, allowing the product to carry language that "Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."

To date, the FDA has authorized 43 nicotine pouches, including 23 under a pilot program intended to streamline the review process, the agency said Friday.

 
 

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