Caroline Bradford

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.

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.

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.

5 topics to watch as MDUFA negotiations restart

MedTech Dive, Jan 13, 2025: MedTech outlines 5 key issues as MDUFA negotiations restart, including FDA staffing, device safety and effectiveness, and transparency. The article highlights growing concern from NCHR’s Diana Zuckerman and other patient and consumer groups that safety and effectiveness may receive less attention than faster device approvals.

FDA Went Against Adcomm Votes More, Held Fewer Meetings in 2025

Biospace, January 6, 2026: There were fewer FDA Advisory Committee meetings in 2025 and FDA ignored their advice much more often than usual. NCHR’s Diana Zuckerman pointed out that biased “expert panels” are used instead.