Manufacturers, traders, and distributors of household/urban hazardous substances (HUHS) should take note that the Food and Drug Administration (FDA) has extended the validity of their license to operate (LTO), with the extension to stay until further notice, according to the Bureau of Customs (BOC).
The BOC in Customs Memorandum Circular (CMC) No. 95-2025 seeks to inform the HUHS industry stakeholders of the automatic extension of the validity of the FDA’s LTO as the customs agency orders port officials and personnel to accept these LTOs as long as certain documentary requirements are met.
Signed by Customs Commissioner Bienvenido Rubio last May 8, CMC 95-2025 was issued to accommodate a request from the FDA’s Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) to the BOC to disseminate the information that the validity of the LTOs issued to HUHS establishments has been extended.
The Center explained that “due to unforeseen circumstances, there has been a delay in the implementation of the online application platform” for the renewal of the LTOs.
“As such, the interim guidelines outlined in FDA Advisory No. 2024-1660 will remain in effect until further notice,” the CCHUHSRR continued in its written request dated April 2, 2025.
To recall, through FDA Advisory 2024-1660 issued in December 2024, the FDA had said it expected to onboard the FDA eServices Portal System for the licensing of HUHS establishments and make it accessible to stakeholders within the first quarter of 2025. Once the system was available, all applications pertaining to the issuance of the LTO of HUHS establishments were supposed to be lodged through the portal.
The Center now asks the BOC to extend “further regulatory flexibilities” to the HUHS industry players “through the automatic extension of the validity of their LTOs” to ensure that the delay in implementing the online application platform “does not hamper business operations including… the release of imported shipments of HUHS products from the BOC.”
To be permitted to use its expired LTO, the HUHS company needs to submit to the FDA, through its Food and Drug Action Center, a letter of request and a declaration statement following the guidelines of FDA Advisory No. 2024-0543.
Released in March last year, FDA Advisory 2024-0543 provides the procedural guidelines for the onboarding of the licensing procedures for HUHS establishments on the FDA eServices Portal System.
Moreover, the CCHUHSRR said that in lieu of a valid LTO, the HUHS distributor-importer must submit the following documents to the BOC to facilitate the release of their imported HUHS products:
• A copy of the expired LTO as HUHS distributor-importer
• Acknowledgement receipt from the FDA of the submitted letter of request and declaration statement
Any concerns about the LTO extension may be sent to the FDA’s HUHS Licensing Section at cchuhsrr.lrd.huhs@fda.gov.ph.
