Search

CHPA presentations at Food and Drug Administration OTC Part 15 hearing - Over-the-Counter Medications: A Success Story.

FDA announced a reopening of the administrative record for the rulemaking for OTC laxative drug products. CHPA sees this as an appropriate time to get clarification on an allowable statement of identity for OTC laxative drug products that contain fiber.

Because of FDA's safety concerns regarding the control and monitoring of levomethorphan, CHPA supports the control of levomethorphan as an impurity and respectfully submits the following comments regarding the proposed updates to the DXM monograph as proposed in the IRA published in PF 40(3).

These comments are submitted on behalf of CHPA in response to the National Institutes of Health notice entitled, “Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information”.

Letter to Drs. Femia and Santos regarding multiple active ingredient product monographs.

Enclosed are comments on the recent notice from the California Office of Environmental Health Hazard Assessment regarding 22 chemicals to be discussed at a meeting of the Developmental and Reproductive Toxicant Identification Committee. These comments address manganese.

These comments address the four parabens that are on the prioritization list. As these ingredients serve an important preservative function and have been extensively reviewed and approved by expert bodies, they should be considered low priority for DARTIC review.

As FDA is recognized as an authoritative body by Proposition 65, we believe that OEHHA should await the outcome of FDA's review rather than bringing BP-3 to the DARTIC for review.