THE Food and Drug Administration (FDA) on Wednesday filed administrative and criminal charges against a popular beauty clinic for refusing to be inspected and for allegedly selling unregistered cosmetic products.
The FDA last week ordered the Belo Medical Group (BMG) to stop its sale of 11 unregistered cosmetic products after its operatives conducted surveillance and test-buy operations in one of its branches in Alabang, Muntinlupa City.
FDA Director General Nela Charade Puno said some of the skin-care firm’s employees would be facing contempt or obstruction of justice charges for refusing to allow FDA agents to inspect their clinic and pharmacy.
“The Belo Medical Group’s pharmacy is under FDA’s jurisdiction and we have legal authority to enter and inspect it, in reasonable hours and manner, by our inspectors. They can be cited for contempt or obstruction of justice for their refusal,” she said.
According to Article 2, Section 2 (t) of the FDA’s general powers, functions and duties, FDA agents may “enter at reasonable hours, any factory, warehouse, or establishment in which health products are manufactured, processed, packed, or held, for introduction into domestic commerce, or are held after such introduction, or to enter any vehicle used to transport or hold such health products in domestic commerce; and to inspect, in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished or unfinished materials, containers, and labeling therein;”
Regulatory Enforcement Unit chief Allen Bantolo identified the cosmetic and drug products which the FDA prohibited the BMG from selling 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; and Belo Prescriptives Keralyt 2 Cream;
ZO Medical by Zein ObagiMD 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 FDA said these products did not pass through its registration and certification processes, which means the company was not allowed to sell them to the public without FDA approval.
“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.
Director General Puno said the FDA approval was to ensure that all food, drugs and cosmetic products being sold in the market were safe for public use or consumption.
She also advised the public to purchase only FDA-registered food, health and beauty products.
“The consumers can look for the FDA registration number on the products’ label. If they can’t find those markings, we urge the public to report to us the sale and distribution of those products,” she said. KENNETH HERNANDEZ