We are encouraged that the agency is seeking to provide guidance on how to utilize the TEA process and that the agency has acted on TEAs and has published notices of eligibility for ingredients and conditions based on TEA submissions.
These comments are in response to the "interpretive rule" DEA published to provide a "Clarification of the Exemption of Sales by Retail Distributors of Pseudoephedrine and Phenylpropanolamine Products."
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.
CHPA wishes to draw attention to the restrictive environment on where nonprescription medicines can be sold in Japan as a barrier to market entry for such products.
The following comments are submitted by the Joint Oral Care Task Group of CHPA and the Cosmetic, Toiletry, and Fragrance Association with respect to the establishment of a Monograph for OTC Antigingivitis/Antiplaque Drug Products.
The CHPA External Analgesics Task Group submits these comments in response to FDA's reopening of the administrative record for the OTC external analgesics rulemaking and the agency's proposal to amend the tentative final monograph for external analgesics.
CHPA welcomes the underlying rationale for the proposed rule, including the move by the FDA towards global harmonization of safety reporting requirements in alignment with the EU and Japan.
This Citizen Petition requests the Commissioner of Food and Drugs to take the following action with respect to the Final Monograph for OTC Sunscreen Drug Products.
