FDA orders retailers and sellers to stop sale of astringent brand

BUSINESS
February 14, 2020

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THE Food and Drug Administration (FDA), has directed drug stores, department stores, supermarkets and other establishments to stop the sale of an astringent 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 said brand 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.

The products in question that are contained in the advisory constitute Lot/Batch No. AOH01 with a manufacturing date of August 2019 and expiry date of August 2021; and Lot/Batch No. 1041905 with a manufacturing date of April 2019 and expiry date of April 2021. In the label, the products were alleged to be manufactured in Apas, Cebu City.

 

Accordingly, because it failed to comply with these standards, the FDA says they are classifying the said brand 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.    

For more information, please click on the following FDA advisory: https://ww2.fda.gov.ph/attachments/article/647685/FDA%20Advisory%20No.%202020-061.pdf

 

This is the second time in less than a year that this particular brand  failed to comply with the regulations of the FDA. Last year, the FDA also issued an advisory against the use and sale of this particular 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 said brand, the online reporting facility eReport can be accessed at www.fda.gov.ph/ereport.


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