FDA’s Latest Warning Letter

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 (www.skinbeautymall.com, www.agelessderma.com and www.drskinspa.com) In February 2016 where it sells Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream and Ageless Derma Anti-Aging Intensive Skin Brightener Cream products.
 
“Based on our inspection and review of your product labels and labeling, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations,” the agency penned in a letter to Dr. Farid A. Mostamand, CEO of Crescent Health Center Inc.
 
The claims on your product labels and labeling establish that your “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.  
 
Examples of some of the product label and labeling claims that provide evidence that your products are intended for use as drugs include, but are not limited to, the following:
 
Product Labels:
•    “Ageless Derma Anti-Aging Intensive Skin Brightener”: “[C]linically proven to reduce all types of hyperpigmentation…to lighten the skin…”
•    “Ageless Derma brand Stem Cell and Peptide Anti-Wrinkle”: “[I]mproves the firmness and elasticity of skin, removes crow’s feet…”
 
From www.skinbeautymall.com:
 
On the “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” page:
•        “Argireline reduces the depth of wrinkles…by attenuating muscle contraction…”
•        “Coenzyme 10…prevents damage to collagen and elastin production…reduction in fine wrinkles…application before sun exposure protects against sun damage…”
•        “Matrixyl 3000…significant decrease in wrinkle density, depth, volume roughness…”
•        “PhytoCellTec Malus Domestica…decrease in wrinkle depth…”
•        “Syn®-Coll is an effective and needle-free alternative to collagen injections…increased collagen sysnthesis (sic)…”
•        “Vialox Powder significantly reduces muscle contraction as an injection-free alternative to Botox…”
•        “Ageless Derma Peptide and Stem Cell Anti-Wrinkle Cream…eradicate your lines and wrinkles…”
 
On the “Ageless Derma Anti-Aging Intensive Skin Brightener Cream” page:
•        “[C]linically proven to reduce all types of hyperpigmentation…It can even remove scars that may have been plaguing you for years”
•        “This intensive skin brightener contains NET-DG-Licorice Root, a natural anti-inflammatory agent…”
•        “BV-OCS…a powerful whitener…and collagen protector… increases the synthesis of collagen…”
•        “Biowhite…inhibits tyrosinase activity…”
•        “Belides…is a skin-whitening agent…is an inhibitor of tyrosinase…”
•        “[A]lpha Arbutin…tyrosinase inhibitor…even excess tanning accidents can be reduces(sic) and lightened and thus minimize the dangerous effects of excess UV exposure…”
 
On the “Dynamic Ingredients Make Anti-Wrinkle Cream and Amazing Find” page which promotes the “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and provides links to information about the ingredients of the product:
•        “Argireline…reduction of the depth of wrinkles…” and on the linked ingredient information page: “[L]ikened to being a brief version of Botox…”
•        “Coenzyme Q10…enhance the production of elastin and collagen in the skin…”
•        “Syn-Coll…[W]ill increase synthesis of collagen…”
•        “Vialox Powder…reduction in depth of wrinkles…” and on the linked ingredient information page: “[W]idely known to be similar to Botox…can exhibit a Botox-like reduction in wrinkles…”
•        “PhytoCellTec Malus Domestica…will repair the DNA of the skin…and protect it from the sun’s harmful rays…visible reduction in wrinkles and fine lines…”
•        “Matrixyl 3000…reduction of wrinkles…”
 
From your website, www.agelessderma.com:
 
On the “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” page:
•        “[R]evitalize your body’s natural abilities to heal itself…proven in laboratory studies to stimulate growth in cultures of aged human epidermal stem cells…demonstrated measurably reduced wrinkle depth…”
•        “Argireline reduces the depth of wrinkles…by attenuating muscle contraction…”
•        “Vialox Powder significantly reduces muscle contraction as an injection-free alternative to Botox…”
 
On the “Ageless Derma Anti-Aging Intensive Skin Brightener Cream” page:
•        “[F]reckless, age spots, brown spots, liver spot or changes in skin pigmentation …Ageless Derma Anti-Aging Intensive Skin Brightener….”
•        “This intensive skin brightener contains NET-DG-Licorice Root, a natural anti-inflammatory agent…”
•        “BV-OCS…a powerful whitener…and collagen protector… …”
•        “Biowhite…inhibits tyrosinase activity…”
•        “Belides…is a skin-whitening agent…is an inhibitor of tyrosinase…”
•        “[A]lpha Arbutin…tyrosinase inhibitor…even excess tanning accidents can be reduced and lightened and thus minimize the dangerous effects of excess UV exposure…”
 
On the “face-whitening-cream-brown-spots” page which promotes the “Ageless Derma Anti-Aging Intensive Skin Brightener Cream” and provides links to information about the ingredients of the product:
•        [W]ill lighten and even out your skin tone within weeks…”
 
•        “Niacinamide is an anti-inflammatory ingredient…proven to improve acne and act as a lightener on the skin…helps to protect the skin against damage from UV rays…”
 
From your website, www.drskinspa.com:
 
On the “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” page:
•        “[W]ill diminish fine lines and wrinkles, eradicate crow’s feet…abolishing wrinkles has never been so easy…”
 
On the “Ageless Derma Anti-Aging Intensive Skin Brightener Cream” page:
•        “[C]linically proven to reduce all types of hyperpigmentation…”
 
Your “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and “Ageless Derma Face Brightening Cream” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
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.”