FDA: Raps loom vs Vicki Belo firm
The Food and Drug Administration (FDA) has warned that the Belo Medical Group (BMG) owned by beauty expert and dermatologist to the stars Dr. Vicki Belo may face administrative and criminal charges for selling unregistered cosmetic products.
In a statement, Food and Drug Administration (FDA) Director General Nela Charade Puno said some BMG employees had refused to allow the agency’s representatives to inspect the firm’s clinic and pharmacy.
“The Belo Medical Group’s pharmacy is under FDA’s jurisdiction and we have legal authority to enter and inspect it, [during] reasonable hours and [in a reasonable] manner… They can be cited for contempt or obstruction of justice for their refusal,” Puno added.
Based on surveillance and test-buy operations conducted by FDA agents at the firm’s clinic in Alabang, Muntinlupa City, on Friday last week, 11 of the skin care products being sold by BMG were not registered with the government agency.
Allen Bantolo, FDA Regulatory Enforcement Unit chief, identified these products as ZO Medical by Zein Obagi MD Glycogent Exfoliation Accelerator 10% concentration; ZO Medical by Zein Obagi Foamacleanse Gentle Foaming Cleanser for all types; ZO Medical by Zein Obagi Oclipse Sunscreen/Primer SPF 30 Protection; Belo Illuminating Cream Alpha Arbutin+Liquorice; Belo Prescriptives Keralyt 2 Cream; ZO Medical by Zein Obagi MD Melamix Skin Lightener & Blending Creme Hydroquinone USP 4%; ZO Medical by Zein Obagi MD Melanin Skin Bleaching & Correcting Creme Hydroquinone USP 4%; Belo Prescriptives Acne Astringent; Belo Prescriptives Belo White; Belo Prescriptives DLC Peeling Creme; and ZO Medical by Zein Obagi MD Cebatrol.
“The Belo Medical Group, or any drug or cosmetic company for that matter, may claim that their products are safe and their efficacy are proven. But they cannot sell them to the public unless they have undergone product evaluation and certification from the FDA, a measure that the government undertakes to ensure their safety and efficacy,” Bantolo said.
Puno stressed that the FDA stamp of approval was meant to ensure that all food, drugs and cosmetic products sold in the market had been certified as safe for public use.
In a statement on Wednesday, BMG said it was cooperating with the FDA and shared its objective “of safeguarding our consumers from harmful products.”
The company pointed out, however, that the surveillance operation was not prompted by any complaint of harm or injury from the use of any BMG product but by “registration issues.”
“We also want to emphasize that the ZO products in question are approved by the US FDA. They have been long available in the US market and have been carefully studied and have been proven to be safe and effective,” it said.
BMG added that the locally sold ZO products had previously been registered and their applications of renewal were still pending with the FDA.
“Should there be a need, we will pull out the products with pending registration renewal applications while we sort out all documentary requirements with the FDA,” it said.
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