The Food and Drug Administration (FDA) has issued an FDA Memorandum Circular No. 2020-001 “Interim Guidelines for the Issuance of Provisional License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers of Rubbing Alcohol Products Under the Center for Cosmetics Regulation and Research” on 19 March 2020 and its amendments in response to the declaration of the community quarantine due to the COVID-19 pandemic.
As part of postmarketing surveillance, the FDA received reports that several rubbing alcohol products and alcohol-based sanitizers are being packaged in containers similar with the ones used for bottled drinking water, drinks/beverages and liquor bottles which are intended for ingestion. This current practice confuses the consuming public and may put consumers at risk of serious injury or death, if these products are accidentally ingested.
Pursuant to Sec. 24 of Republic Act 3720 as amended, A Cosmetic shall be deemed to be misbranded:
(d) If its container is so made, formed, or filled as to be misleading.
All concerned cosmetic manufacturers, traders and distributors are sternly warned and hereby directed to recall these misbranded products. The FDA encourages retailers to remove these non-compliant cosmetic products from store shelves and online platforms. Execution of appropriate regulatory sanctions shall be implemented upon issuance of this Advisory.
To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic product, the online reporting facility, eReport can be accessed at [email protected], or call us at 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.