On Medical Treatments & Products Archives

NCHR Testimony at the Meeting of the Nonprescription Drugs Advisory Committee Concerning Oral Phenylephrine (PE) as a Nasal Decongestant

September 11, 2023: Orally administered phenylephrine (or PE) as a nasal decongestant should not be on the market because it has not been shown to work. Millions of dollars have been wasted by consumers on a product that has been shown in research to act similar to a placebo.

NCHR Comments on Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development

September 11, 2023, NCHR supports the FDA’s draft guidance with key recommendations. NCHR urges the FDA to add standardized protocols for instances of participant non-adherence, disease flair up, and acute illness. NCHR also recommends including specific guidance for crossover clinical trial design and more objective measures for dietary compliance rather than food diaries to strengthen the quality of the clinical trials performed among the IEM patient population, reduce confounding, and improve data interpretability.

NCHR Comments on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination FDA Draft Guidance

September 11, 2023: Tattoos are common in the U.S. and almost half tattoo inks are contaminated. NCHR supports FDA’s draft guidance to improve the safety of tattoo ink and recommends that labels describing the links be available to consumers and sterile dilution techniques should be required and explained. NCHR urges FDA to develop an information toolkit to increase
consumer awareness about reporting any adverse reactions to tattoos.

Dr. Diana Zuckerman’s Testimony at the FDA Advisory Committee Meeting on Microbiology Devices on HBV Assays

September 7, 2023: We testified that FDA’s plan to reclassify hepatitis B (HBV) assays from high risk (Class III) to moderate risk (Class II) would mean lack of evidence of accuracy. Why do that when there are already accurate assays available? Lowering the standards would harm patients by resulting in inappropriate treatments.

NCHR Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products

September 7, 2023: NCHR provided comments on the FDA guidance regarding the registration and listing of cosmetic product facilities and products required in the Modernization of Cosmetics Regulation Act of 2022. We support these requirements and provide recommendations to improve the guidance.