Recent tests confirmed that the pH balance of Special RDL Babyface Astringent is only 1.89 when the safe and allowed pH balance level for astringents should not be less than 2.
Further tests showed that astringents and other skin-whitening products and peeling solutions with a pH below 2 have a high potential to cause severe skin irritation, crusting of the face or even death of living tissues on the face.
The beauty product has been in the market since last year although the Bureau of Food and Drugs (BFAD) rejected RDL Pharmaceutical Laboratory’s original application for registration citing its non-conformity to product specifications.
BFAD director William Torres said earlier that RDL Pharmaceutical Laboratory in Davao violated BFAD regulations when it marketed the said astringent without the necessary certificate of registration.
He also confirmed that BFAD seized 423 boxes or more than 60,000 bottles of the product in August the same year at the RDL Pharmaceutical Laboratory in Davao City which he allowed to be sold allegedly after the product was registered.
However, BFAD documents revealed that Torres allowed the release of the seized astringent not because it had already been registered but "for reason of financial burden," meaning he allowed the product to be sold to save the manufacturer from financial difficulties.
BFAD first found formulation problems with the RDL astringent early last year. It was still unregistered but already being sold. BFAD concluded that the product was "not only adulterated but misbranded."
"There was a wide intra-lot variability in terms of potency in the samples submitted such that the said subject product would likely reveal different percentages of potency," BFAD said.
While RDL has also been found to fall short of BFAD standards on good manufacturing practice, Torres confirmed in a recent radio interview that the company is already putting up newer facilities. — Ella Oducayen