07.01.16
The US FDA has sent a warning letter to Crescent Health Center, Inc. following an inspection of its manufacturing facility in Irvine, CA in late 2015 and a review of its three websites (skinbeautymall.com, agelessderma.com and drskinspa.com) in early 2016 where it sells Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream and Ageless Derma Anti-Aging Intensive Skin Brightener Cream products.
In a letter to Dr. Farid A. Mostamand, CEO of Crescent Health Center Inc. FDA maintained that product labels and labeling establish that Crescent’s “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and “Ageless Derma Anti-Aging Intensive Skin Brightener Cream” products are promoted for uses that cause the products to be drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(B) and/or 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body.
According to FDA, even if the company’s Ageless Derma Face Brightening Cream and Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream products did not make therapeutic claims, which make them unapproved new drugs, “they are misbranded within the meaning of section 602(b) of the Act [21 U.S.C. §362(b)] in that the label does not include: your firm’s current address, and, if the distributor is not the manufacturer, a statement on the label with the qualifying phrase ‘manufactured for...’ or ‘distributed by…’, as required by 21 CFR 701.12.”
In a letter to Dr. Farid A. Mostamand, CEO of Crescent Health Center Inc. FDA maintained that product labels and labeling establish that Crescent’s “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and “Ageless Derma Anti-Aging Intensive Skin Brightener Cream” products are promoted for uses that cause the products to be drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(B) and/or 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body.
According to FDA, even if the company’s Ageless Derma Face Brightening Cream and Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream products did not make therapeutic claims, which make them unapproved new drugs, “they are misbranded within the meaning of section 602(b) of the Act [21 U.S.C. §362(b)] in that the label does not include: your firm’s current address, and, if the distributor is not the manufacturer, a statement on the label with the qualifying phrase ‘manufactured for...’ or ‘distributed by…’, as required by 21 CFR 701.12.”