The Food and Drug Administration (FDA) in Region 11 has confirmed that the original Porcelana astringent improved formula has been banned from distribution in Davao as in other areas of the country.
However, FD-Davao supervisor Debbie Legaspi has clarified that not all Porcelana astringent products are covered by the advisory.
She said only original Porcelana not allowed for distribution or sale is the one that has chemicals that are harmful to users.
During last Wednesday’s Habi at Kape media forum at Abreeza Mall in Davao City, Legaspi told attending reporters that the original Porcelana astringent improved formula has been found positive of hydroquinone and tretinoin, which are inappropriate for cosmetic products and used only in cleaning the house not human skin. It was learned that among the side effects are skin irritation, itching, anaphylactic shock and organ failure.
She said the advisory on the product means that once found sold by outlets, it must be withdrawn from the shelves, and destroyed and never to be displayed again.
Sellers and distributors are also liable under the law.
She said that FDA agents are strictly monitoring Porcelana and other violative products sold in the Davao region market.
Legaspi also took occasion to assure reporters that the African Swine Fever which has recently been detected in some parts of Mindanao does not affect humans.
She said only pigs have receptors to the ASF virus. Humans and other animals are not.
No other animals and human beings have the receptor to the virus which has already affected the sale of hogs and other pork products, including processed foods by as much as 50 percent.
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 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 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 IMPRROVED FORMULA, the online reporting facility eReport can be accessed at www.fda.gov.ph/ereport.