FDA files criminal charges against Belo Medical Group over sales of unregistered cosmetic products

FDA files criminal charges against Belo Medical Group over sales of unregistered cosmetic products

The Food & Drug Administration has filed administrative and criminal charges against the Belo Medical Group regarding the alleged sale of unregistered cosmetic products.

The FDA has insisted the company stop selling 11 products, which are said to be unregistered. These include: 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% and Belo Prescriptives Acne Astringent.

Regulatory Enforcement Unit chief Allen Bantolo said, “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.”

The Belo Medical Group is said to be blocking any inspection of the product with some staff refusing the FDA access to its clinic or pharmacy – a move that the FDA says could see some staff face contempt or obstruction of justice charges.

FDA Director General Nela Charade Puno said, “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.”

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