On 31 March 2022, the Food and Drug Administration (FDA) issued FDA Circular (FC) No. 2022-001 “Repealing FDA Circular No. 2021-004 “Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research” dated 09 February 2021” which repealed the interim guidelines provided under FC No. 2021-004, returned the jurisdiction over rubbing alcohol products with concentrations of 70% and beyond to the Center for Drug Regulation and Research (CDRR) in light of the stability in supply of these products, and provided for the transitory period within which affected stakeholders may comply with the applicable guidelines for securing the appropriate authorizations.
Following the publication of FC No. 2022-001 in The Manila Times on 21 April 2022, the FDA hereby informs all cosmetic manufacturers, traders, distributors and other concerned stakeholders, of its effectivity date on 06 May 2022.
Thus, in order to facilitate compliance to FC No. 2022-001 and to provide clarity on specific provisions of the Circular, the FDA has developed a collection of commonly-asked questions, general issues and concerns received from the cosmetics industry and other concerned stakeholders hereby annexed. The same can be found on the FDA website at https://www.fda.gov.ph/faqs/.
Dissemination of this advisory to all concerned is hereby requested.