Belo Medical Group to face sanctions for refusing inspection, sale of unregistered products

The Food and Drug Administration (FDA) on Wednesday released an advisory announcing that the Belo Medical Group (BMG) and its employees are facing administrative and criminal charges, after the FDA conducted surveillance and test-buy operations in its Alabang clinic in Muntinlupa City on February 9 and ordered BMG to stop selling 11 of its unregistered skin care products. 

BMG employees who were present at the time allegedly refused to allow FDA agents to inspect the clinic and its 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,” FDA Director General Nela Charade G. Puno was quoted as saying.

She cited Article 2, Section 2 (t) of the FDA’s general powers, functions and duties which permits FDA agents to enter the premises of establishments at reasonable hours, any factory, warehouse, or establishment where health products are manufactured or held to conduct inspections in a reasonable manner.

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% 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 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
• ZO Medical by Zein Obagi MD Cebatrol

Bantolo said that these products did not pass through the FDA registration and certification process.

“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,” Bantolo explained.

Puno added, "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."

Puno urged the public to be discerning and only purchase products that have the FDA's stamp of approval, marking it safe for public use and consumption.

In a statement released to GMA News Online, BMG clarified that FDA's surveillance of its Alabang clinic did not come from a complaint or any harm or injury from the use of any of its product. "The issues raised by the FDA...pertained to registration issues of some of our products," it further read.

According to the statement, the BMG employees present during Friday's operation were confused and scared by the manner the surveillance was conducted.

"The FDA personnel were accompanied by policemen and some refused to show their valid IDs upon request," read the BMG statement, adding its lawyer made attempts to speak with the head of operations of the surveillance team but he refused.

In its statement, BMG clarified that (1) the products in question have been approved by the US FDA, (2) the products in question have been previously registered by the FDA and (3) the  application for their renewal of registration has been filed and is already pending with the FDA.

"We recognize and share the objective of the FDA to safeguard our consumers from harmful products. Thus we are cooperating with them and are finalizing our answer to the order served on our Alabang clinic," the statement added. — LA, GMA News