The Belo Medical Group and some of its employees are facing administrative and criminal charges for their alleged refusal to have their pharmacy inspected and for selling 11 cosmetic and drug products not registered with the Food and Drug Administration.
FDA Director General Nela Charade G. Puno said some of the skin-care firm’s employees face contempt or obstruction of justice charges for their refusal to allow FDA agents to inspect their clinic and pharmacy.
“The Belo Medical Group’s pharmacy is under DFA’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.
The FDA earlier ordered the BMG to stop selling 11 of its unregistered skin care products after FDA operatives conducted surveillance and test-buy operations in its clinic in Alabang in Muntinlupa City last Friday.
Puno cited Article 2, Section 2 (t) of the FDA’s general powers, functions and duties which states that FDA agents can “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.”
Retired Police Gen. Allen Bantolo, chief of the DFA’s Regulatory Enforcement Unit, identified the cosmetic and drug products which the DFA prohibited the BMG from selling as follows: ZO Medical by Zein Obagi; MD Glycogent Exfoliation Accelerator 10 percent 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.
The other unregistered BMG products were: 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.
Bantolo said the 11 skin care products did not pass through the FDA registration and certification processes, and this meant the company is not allowed to sell them to the public without the state regulator’s approval.
“The Belo Medical Group, or any drug or cosmetic company for that matter, may claim that 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,” he explained.
For her part, Puno said the FDA’s stamp of approval was meant to ensure that all food, drugs and cosmetic products that are being sold in the market have government stamp of approval as safe for public use or consumption.
“The manufacture, importation, selling or offering for sale of cosmetics products without FDA approval or found to contain harmful or toxic substances is in direct violation of Republic Act No. 9711, otherwise known as the FDA Act of 2009, and Republic Act No. 7394, otherwise known as the Consumer Act of the Philippines,” she added.
Puno also advised the public to purchase only DFA-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.