FDA warns against sale and use of original Porcelana astringent

The Food and Drug Administration (FDA), has directed drug stores, department stores, supermarkets and other establishments in Cebu, Davao and CDO to stop selling the Original Porcelana ® Astringent Improved Formula–or face regulatory actions and sanctions.

In the latest FDA Advisory No. 2020-061, Original Porcelana ® Astringent Improved Formula has been classified as an adulterated cosmetics product as it has been found to be positive for the presence of Hydroquinone and Tretinoin, ingredients that are NOT allowed to be part of a cosmetic. As per Administrative Order No. 13 s. 1999, the FDA says Hydroquinone and/or Tretinoin (Retinoic Acid) shall only be classified as home remedy, over-the-counter, or prescription drug depending on the amount present.

Accordingly, because it failed to comply with these standards, the FDA says Original Porcelana ® Astringent Improved Formula poses potential hazards to the consuming public.  Using the product may result in adverse reactions including skin irritation, itchiness, anaphylactic shock and even, organ failure.     

This is the second time in less than a year that Original Porcelana ® Astringent Improved Formula failed to comply with the regulations of the FDA.                                                  

To report any sale or distribution of Original Porcelana ® Astringent Improved Formula, the online reporting facility eReport can be accessed at www.fda.gov.ph/ereport.