NCHR Written Comment to FDA on Modified Risk Tobacco Product (MRTP) Applications for ZYN Nicotine Pouch Products

January 21, 2026 NCHR Written Comment to FDA: ZYN says it is good for public health because it is less harmful than smoking. We disagree. It has never been tested in long-term studies to determine its impact on cancer, heart disease, and other serious diseases. It is very harmful because it is marketed to children and teen non-smokers, creating an epidemic of nicotine addiction similar to the vaping epidemic among children a few years ago.

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NCHR Comment on the Reauthorization of MDUFA

September 4, 2025: NCHR’s written public comment to FDA on MDUFA says user fees should support improvements in safety and effectiveness by paying for salaries for staff to improve premarket review, post-market surveillance and other activities, and inspections of manufacturing facilities. Industry has benefitted from MDUFA’s speedier reviews and more meetings with FDA staff, but what patients and consumers need most is safer and more effective medical devices. We deserve clear information about risks and benefits, and we can’t get that when 96+% of devices are not studied in clinical trials before being sold.

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NCHR Public Comment on the Continued Implementation of the National Youth Tobacco Survey

In our public comment to the CDC, we strongly supported the continued operation of the National Youth Tobacco Survey (NYTS) for the 2026-2028 cycle. NYTS is the cornerstone of public health surveillance in this field and we reminded CDC and FDA that evaluating the youth use of tobacco products is an essential tool of U.S. public health strategies to reduce cancer, heart disease, and chronic diseases that are key to the MAHA movement.

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NCHR Written Comments on the Reauthorization of PDUFA

August 14, 2025: National Center for Health Research written comment urges FDA to use PDUFA user fees to improve drug safety and effectiveness, not just faster approvals. All programs included in Commitment Letter should emphasize the scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.

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