The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is circulating the draft on the proposed FDA Circular, provisionally entitled “Further Regulatory Flexibilities for the Implementation of FDA Circular No. 2020-025 ‘Implementing Guidelines for DOH Administrative Order No. 2019-0019’” for comments.
The proposed issuance aims to:
1. Provide the guidelines for the grant of regulatory flexibilities for HUHS establishments in light of the transition of the licensing process to the FDA eServices Portal System;
2. Establish a one (1)-year transitory period extension for HUHS product registration and labeling requirements; and,
3. Provide the interim guidelines for the implementation of FDA Circular No. 2020-025.
In view of the foregoing, all concerned stakeholders, including HUHS Manufacturers, Distributors, Traders and other related establishments are requested to submit any comments on the proposed issuance.
All comments are requested to be submitted in MSWord Format via email to [email protected] on or before 20 December 2023 using the attached “Template for Comments”.
Thank you very much.