Inspections, Compliance, Enforcement, and Criminal Investigations

Crescent Health Center, Inc 4/20/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:     949-608-2900
FAX:    949-608-4415

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
April 20, 2016                                                                                                            WL # 28-16
 
Dr. Farid A. Mostamand, CEO
Crescent Health Center, Inc.
15635 Alton Parkway, Ste. 410
Irvine, CA 92618
 
 
Dear Dr. Mostamand:
 
From November 18 to December 2, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 15635 Alton Parkway, Ste. 410, Irvine, CA. In addition, FDA reviewed your websites at the Internet addresses www.skinbeautymall.com, www.agelessderma.com, and www.drskinspa.com in February 2016, and has determined that you take orders there for your products “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and “Ageless Derma Anti-Aging Intensive Skin Brightener Cream”. 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. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
 
Unapproved New Drugs
 
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.  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
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 your website, 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. 
 
Misbranded Cosmetics 
 
Even if your “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.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility and in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You are required to comply with the Act and all applicable federal regulations.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to Food and Drug Administration, CAPT Daniel Cline, Acting Director, Compliance Branch, Attention: Dr. Raymond W. Brullo, Compliance Officer, FDA/Los Angeles District, 19701 Fairchild, Irvine, CA 92612
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
cc:
 
David M. Mazzera, Ph.D., Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435

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