February 27, 2026: In response to a request for written comments, NCHR told the FDA why we oppose exemptions from 510(k) premarket review for computer-aided radiology devices. NCHR warns that these tools can influence diagnosis and triage decisions and should undergo rigorous evaluation to ensure safety, effectiveness, and equitable performance in real-world clinical settings.
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Testimony of Dr. Akashleena Mallick at the FDA TPSAC Meeting on ZYN Nicotine Pouch Products Submitted by Swedish Match U.S.A, Inc.
January 22, 2026 NCHR Comment to FDA: Dr. Akashleena Mallek told FDA we disagree that ZYN nicotine pouches are less dangerous than smoking. ZYN has never been tested in long-term studies to determine its impact on cancer, heart disease, and other serious diseases. It is especially 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.
Read More »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.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Advisory Committee Meeting on Risks of 3 Heat Sticks And Other IQOS Tobacco Products
Diana Zuckerman spoke on behalf of NCHR and CPTF at Oct 2025 FDA Tobacco Advisory Committee TPSAC meeting on whether Phillip Morris heat sticks and other IQOS products should continue to be marketed as low risk. We pointed out that these products have evidence of substantial risks in the short-term and long-term risks are likely to be greater.
Read More »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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