Submissions

CHPA and members of our Dietary Supplements Committee appreciate the opportunity to comment on the recently released Draft Guidance outlining FDA’s approach to food allergen labeling.

CHPA appreciates the opportunity to provide input for Agency consideration as it works to finalize the regulations for ACNU.

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.

This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

CHPA appreciates the opportunity to provide comments on NIH ODS strategic plan 2022-2026.

Comments regarding Citizen Petition from Greenberg Traurig requesting that FDA issue the administrative order for OTC external analgesics, and that FDA confirm and clarify for which specific indications OTC external analgesic drug products in patch/plaster/poultice dosage forms are generally recognized as safe and effective.

CHPA believes that FDA’s issuance of the 2022 Draft Guidance is premature. Instead, FDA’s priority should be on finalizing the 2016 Draft NDI Guidance and clarifying unanswered questions about the scope and applicability of the NDI notification requirement.

CHPA appreciates the opportunity to provide feedback on the notice requesting comments on the Inactive Ingredient Database (IID). Responses to each of the questions listed by FDA in the March 22, 2022 notice are provided.