Submissions

CHPA looks forward to working closely with FDA and other key stakeholders throughout the OMUFA reauthorization process as we work together to ensure the continued success of FDA’s OTC monograph program.

Pursuant to 16 C.F.R. § 1.31, through this petition, Petitioners respectfully request that FTC withdraw the notice of penalty offenses that were sent to nearly 700 companies.

CHPA strongly urges the Food and Drug Administration to deny the petition to repeal 21 CFR 73.575, which permits the use of TiO2 in food and dietary supplements. Based on extensive scientific research and regulatory evaluations, TiO2 is deemed safe for use as a food additive when consumed within established regulatory limits.

Industry appreciates this guidance to enable the assembly of suitable and successful OMORs. FDA must adopt standards and expectations consistent with the intent of OMUFA, rather than the NDA paradigm, with which it is very familiar.

CHPA appreciates this opportunity to comment on the Synthetic Dye Petition submitted to the California Department of Public Health requesting that a warning be placed on food and dietary supplement products related to adverse neurobehavioral effects purportedly associated with ingestion of synthetic food dyes.

CHPA tracks FDA progress vs. OMUFA goals and activities referenced in legislation. These goals were negotiated between the Agency and Industry prior to the legislation and cover the 5-year period for OMUFA I (October 1, 2020 – September 30, 2025).

CHPA strongly encourages FDA to provide further clarity regarding the appropriate human factors information in premarket submissions that involve a change from prescription use to over-the-counter use and associated changes from a predicate device as compared to modifications to a sponsor’s own device.