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.
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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 »NCHR Comments on The National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR)
January 14, 2026: NCHR comment to CMS explains TAVR doesn’t provide meaningful benefits to asymptomatic patients because patients in the EARLY TAVR study did not live longer or avoid disabling strokes and it did not evaluate typical Medicare patients or typical treatment or safeguards available to TAVR patients.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Circulatory System Devices Advisory Panel Meeting on V-Wave Ventura Shunt
December 3, 2025: Diana Zuckerman urges FDA Advisory Devices Panel to require more research on Ventura shunt to make sure it is more effective than sham control placebo group. She points out the well-designed study did not meet primary endpoint to improve cardiac results for patients.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Advisory Committee On Digital Health
NCHR’s Dr. Diana Zuckerman testified at the FDA Advisory Committee meeting on Digital mental health products, expressing concerns about FDA’s failure to regulate the Chatbots and other digital products being marketed as “licensed therapists” and used as psychotherapists in ways that can be extremely harmful. She urged better research but acknowledged difficulty of studying devices that are updated frequently
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