NCHR Written Comment to FDA on Modified Risk Tobacco Product (MRTP) Applications for ZYN Nicotine Pouch Products – January 21, 2026 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 espcially 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.
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 Comment to FDA: Dr. Akashleena Mallek told FDA we disagree that ZYN nicotine pouches are less likely to cause cancer 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.
We Comment on Coverage of Colorectal Cancer Non-Invasive Biomarker Screening Tests – CPTF public comment tells CMS that the ColoSense multi-target mRNA stool-based colorectal cancer screening test needs better evidence to qualify for Medicare NCD coverage. The study sample included 3x the average number of smokers in the U.S. and since smoking increases the chances of colon cancer, that may have biased the results to make the test seem more accurate than it really is. To many false positives or false negatives would make the test much less useful for patients.
NCHR Comments on Risks and Benefits of Menopause Hormone Therapy – In response to a request for public comments, NCHR tells FDA that hormones for menopause have cancer risks and benefits, depending on when women take them and what type of hormones. Menopausal Hormone Therapy (MHT) doesn’t decrease dementia or heart disease. Vaginal hormone creams have short-term benefits but any long-term risks are unknown.
CPTF Testimony at 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.
GDUFA IV Statement of Dr. Diana Zuckerman, President of NCHR – July 11, 2025: NCHR presentation at GDUFA IV July 2025 user fee meeting focuses on including patients and consumer in negotiations with FDA and industry and including metrics to show improved safety and equivalence for generic drugs.
PDUFA VIII Statement of Dr. Amanda Berhaupt, Health Policy Director of NCHR – July 14, 2025: NCHR presentation at PDUFA July 2025 user fee meeting focuses on including patients and consumers in negotiations with FDA and industry and adding metrics to ensure post-market safety and meaningful clinical outcomes for prescription drugs.
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.
Testimony of Dr. Diana Zuckerman at the FDA Plastic Surgery Advisory Panel Meeting On Dermal Fillers for the Decolletage Area – August 13, 2025: Diana Zuckerman testified at the FDA panel meeting about the risks of dermal filler for decolletage. Known risks include pain, lumps, rashes, stroke, and interference with breast cancer screening. We explained that patients and their physicians need specific information about the frequency of these risks so that they can make informed decisions about whether they want this cosmetic procedure.
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.
FDA Public Meeting on MDUFA VI: Invited Presentation of Dr. Diana Zuckerman – August 4, 2025: Diana Zuckerman presented on behalf of CPTF at FDA’s first public MDUFA VI meeting of 2025. She focused on device performance goals that enhance safety, effectiveness, and transparency prior to FDA approval or clearance, and evaluating safety, effectiveness, and information for patients post-market. A major focus was on user fees being used to improve the data needed for informed consent for patients, consumers, and providers.
NCHR Testimony FDA Advisory Committee on Oncological Drugs on Benrep for Multiple Myeloma – July 17, 2025: Dr. Diana Zuckerman testifies for NCHR about GSK study flaws of Benrep at FDA Oncology Drugs Advisory Committee. The very high risks of ocular toxicity outweighs the benefits and other better treatments are available.
GDUFA IV Statement of Dr. Diana Zuckerman, President of CPTF – July 11, 2025: Our presentation at GDUFA IV July 2025 meeting focuses on including patients and consumers in negotiations with FDA and industry and including metrics to show improved safety and equivalence for generic cancer drugs.
Public Comment Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway – March 10, 2025: We support the FDA’s decision to require that a confirmatory trial is “underway” before granting accelerated approval, but the definition of underway needs to be defined stringently and clearly. In our written public comment, we recommended setting specific benchmarks and stronger oversight to ensure timely trial completion so that patients and physicians can make informed medical decisions about products approved under the accelerated program. We also state that the closer to completion the confirmatory trial is at the time of accelerated approval, the more useful the research evidence is likely to be. We also urge that no exceptions be made to the requirement.
Statement of Dr. Diana Zuckerman At the FDA General and Plastic Surgery Devices Advisory Panel on ProSense Cryoablation System – November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.
Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting – October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.
Testimony of Laura Lytle at the FDA Patient Engagement Device Advisory Committee Meeting – October 30, 2024: NCHR’s Laura Lytle testified at the FDA Patient Engagement Device Advisory Panel meeting in support of the FDA’s proposed guidance for informed consent, but suggested 4 key areas for improvement: using a short, simple checklist to ensure that patients understand the risks; focusing on informed consent as a process not a document; simple summaries of key information; and ensuring patient privacy.
Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer – July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.
CPTF Testimony at the FDA Listening Session on Advisory Committee Meetings – June 13, 2024: NCHR testified at the FDA listening session on Advisory Committee reform. We expressed concerns about committee members with conflicts of interest and that many Consumer Representatives on advisory committees do not actually represent consumer groups or perspectives.
Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus – June 26, 2024: NCHR testified at the FDA Advisory Committee about the problems with safety data for General Snus smokeless tobacco and questioned whether safer than cigarettes.