FDA issues public health warning against the Original Porcelana® Astringent Improved Formula

The Food and Drug Administration (FDA) has warned the public against the purchase and use of the Original Porcelana® Astringent Improved Formula which has been marked as a potential health hazard to consumers.

In FDA Advisory No. 2019-119, 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.

The FDA says Hydroquinone and/or Tretinoin (Retinoic Acid) shall be classified as a home remedy, over-the-counter, or prescription drug depending on the amount present as per Administrative Order No. 13 s. 1999.

Accordingly, because the Original Porcelana® Astringent Improved Formula has not complied with existing standards, the FDA says consumers who use these products are risking their health and safety. Using the product may result in adverse reactions including skin irritation, itchiness, anaphylactic shock and even, organ failure.

Along with FDA’s warning to the public not to purchase the Original Porcelana® Astringent Improved Formula comes the warning for establishments not to distribute this product until they have already been covered by the appropriate authorization (cosmetic notification). Merchants who ignore the warning shall face regulatory actions and sanctions.

The FDA also called on All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) to ensure that the Original Porcelana® Astringent Improved Formula is not sold or made available in their localities or areas of jurisdiction.

Porcelana’s headquarters is located in Apas, Cebu City. While their products are mainly sold in Cebu, they also make their way to other parts of the country through online sellers. Apart from the Original Porcelana® Astringent Improved Formula,  Porcelana also sells facial wash, day and night creams whitening body lotion, soaps, and sunblock.

To be sure that the product you apply to your skin is safe, the  FDA advises the public to always check if a cosmetic product has been notified with FDA by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

To report any suspicious and/or illegal activity involving THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail them at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.