NCHR Written Comment to FDA on Testosterone Replacement Therapy for Men

February 9, 2026 NCHR Written Comment to FDA: Testosterone hormone therapy (TRT) for men is widely promoted to men as a treatment for fatigue, weight gain, mood changes, and declining vitality. However, evidence from well-designed clinical trials shows limited benefits and raises important safety concerns. Testosterone is not a proven treatment for normal aging, and long-term risks remain insufficiently studied. Larger, long-term research is needed before FDA makes decisions about changing indication, labeling and warnings, because rigorous scientific evidence is more important than marketing claims or anecdotal experience. This is also true regarding testosterone for women.

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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.

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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.

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