FDA Orders Retailers and Sellers to Stop the Sale of Porcelana Astringent Due to Health Risks
The Food and Drug Administration (FDA), has directed drug stores, department stores, supermarkets, and other establishments to stop the sale of THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA which continues to be sold commercially in Davao, CDO, Cebu and other parts of the country. The FDA says merchants who ignore the warning and continue to sell the product shall face regulatory actions and sanctions.
In the latest FDA Advisory No. 2020-061, THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA 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 be classified as a home remedy, over-the-counter, or prescription drugs depending on the amount present.
Accordingly, because it failed to comply with these standards, the FDA says they are classifying THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA as an adulterated cosmetics product which 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 THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA failed to comply with the regulations of the FDA.
Last year, the FDA also issued an advisory against the use and sale of the THE ORIGINAL PORCELANA® ASTRINGENT after it was found that they were using Hydroquinone and Tretinoin beyond the levels allowed for a cosmetic product.
To report any sale or distribution of THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA, the online reporting facility eReport can be accessed at www.fda.gov.ph/ereport.