OTC Medicines

CHPA appreciates that FDA has taken the time to review the data associated with certain isolated or synthetic carbohydrates not listed as a dietary fiber and looks forward to engaging with FDA in efforts to clarify and improve the regulation of all dietary supplements.

Herein CHPA provides comments on Citizen Petition #FDA-2016-P-43881, which requests an amendment of the marketing status for loperamide (Imodium) from nonprescription to prescription.

CHPA comments on what should be included in a sectoral annex on pharmaceuticals in the TBT chapter of NAFTA.

Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.

Herein, CHPA provides comments on Citizen Petition FDA-2017-P-27331 which requests the addition of a warning to labeling for all OTC drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach noting that these products do not eliminate the risk of esophageal cancer.