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.
CHPA and members of our Dietary Supplements Committee appreciate the opportunity to comment on the recently released Draft Guidance outlining FDA’s approach to food allergen labeling.
In general, members are very satisfied with the existing regulations for content on the PDP, and recommend that no additional guidance on this topic is needed.
