The Food and Drug Administration (FDA) filed administrative and criminal charges against The Belo Medical Group (BMG) for selling unregistered cosmetic products.
Last week, the FDA ordered BMG to halt the sale of 11 cosmetic products.
FDA Director General Nela Charade Puno said some of the company’s employees face contempt or obstruction of justice charges because of their refusal 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. They can be cited for contempt or obstruction of justice for their refusal,” she said.
Regulatory Enforcement Unit chief Allen Bantolo identified the cosmetic and drug products that the FDA stopped BMG from selling as 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; ZO Medical by Zein ObagiMD Melamix Skin Lightener & Blending Creme Hydroquinone USP 4 percent; ZO Medical by Zein Obagi MD Melanin Skin Bleaching & Correcting Creme Hydroquinone USP 4 percent; Belo Prescriptives Acne Astringent; Belo Prescriptives Belo White; Belo Prescriptives DLC Peeling Creme; and ZO Medical by Zein Obagi MD Cebatrol.
These products did not pass through the FDA registration and certification processes.
“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.