FDA files charges vs. Belo Medical Group for sale of unregistered skin care products

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Metro Manila (CNN Philippines, February 14) — The Food and Drug Administration (FDA) on Wednesday filed administrative and criminal charges against the Belo Medical Group (BMG) for allegedly selling unregistered skin care products.

In a statement, the FDA said it ordered the dermatology and surgical center to stop the sale of some of its unregistered products following surveillance and test-buy operations in its Alabang clinic on Friday.

Retired Police Gen. Allen Bantolo, chief of the FDA's Regulatory Enforcement Unit, identified the following cosmetic and drug products prohibited by the FDA to be sold:

  • 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

"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.

The BMG, in a statement, said the ZO products tagged as unregistered by the FDA have been long available in the United States and have been "carefully studied" and "proven safe and effective."

"The locally sold ZO products have previously been registered, with applications for renewal of the registration already filed and pending with 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 FDA," it added.

The cosmetic center also said it will cooperate with the FDA to safeguard its consumers from harmful products.

FDA Director General Nela Charade Puno, meanwhile, said the FDA's stamp of approval ensures that all food, drugs, and cosmetic products sold in the market are safe for public use or consumption.

She added the manufacture, importation, selling, or offering for sale of cosmetic products without FDA approval is a violation of the Republic Act No. 9711 or the FDA Act of 2009, and of Republic Act No. 7394, or the Consumer Act of the Philippines.

Violators may face imprisonment of up to 10 years, and a fine of up to P500,000. The FDA may also cancel any authorization it previously granted to the violator.

Puno added some of BMG's employees face contempt or obstruction of justice for refusing to allow FDA operatives to inspect the clinic and pharmacy in Alabang.

"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," Puno said.

The BMG stated the manner of the FDA surveillance "confused and scared" their personnel, as police also showed up and some refused to show their valid IDs upon request.

"Also, our lawyer attempted to speak with the leader of the policemen through the phone to clarify matters. However, the head of the policemen refused to speak with our lawyer on the phone," the statement added.