On 31 March 2022, through 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Hazardous Substances Regulation and Research’ dated 09 February 2021”, the Food and Drug Administration (FDA) repealed FC No. 2021-004, effectively returning the jurisdiction over rubbing alcohol products with concentrations of 70% and beyond to the Center for Drug Regulation and Research (CDRR). The same issuance provided for the transitory period within which affected stakeholders may comply with the applicable guidelines for securing the appropriate authorizations.
Further, on 24 May 2022, through FDA Advisory (FA) No. 2022-1090, the FDA addressed frequently-asked questions (FAQs) on FC No. 2022-001 for issues and concerns received from the cosmetics industry and other concerned stakeholders in order to assist industry compliance to FC No. 2022-001.
In view of the foregoing, and to aid in the regulatory compliance of all affected stakeholders, the FDA hereby reiterates the following provisions of FC No. 2022-001 and FA No. 2022-1090:
- Issued provisional authorizations, such as LTO, CPN and previously-granted additional product lines for rubbing alcohol products with concentrations of 70% and beyond will be recognized as valid only until its validity date but not exceeding 31 December 2022.
- Beyond 31 December 2022, affected products are expected to be removed at the retailer level, and the necessary inventory and recall of these products shall be performed.
- Affected establishments are expected to secure the appropriate authorizations from the CDRR to continue producing and marketing rubbing alcohol products with concentrations of 70% and beyond. Any unauthorized products that are found in the market beyond 31 December 2022 will be subject to penalties and sanctions, following due process.
To guide the public in checking the status of a cosmetic product, a footnote will be placed in the Cosmetic Product Notification section of the FDA Verification Portal to reflect the following statement, for ease of reference:
“Note: Certificates of Product Notification (CPNs) issued under FDA Circular No. 2021-004 for rubbing alcohol products with concentrations of 70% and beyond will automatically be considered invalid beyond 31 December 2022. All concerned are hereby directed to access the Frequently-Asked-Questions (FAQs) through the following link: https://tinyurl.com/FAQsFC2022-001”
The FDA Verification Portal may be accessed at https://verification.fda.gov.ph. For reports, complaints and/or adverse events on the use of the cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or please call the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.