Inspections, Compliance, Enforcement, and Criminal Investigations

Golden Caviar Skin Care 7/13/15

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

July 13, 2015

WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
 
Pooneh Manshadi
Golden Caviar Skin Care
18732 Via Verona
Irvine, CA 92603-3441 US
 
Re: CMS #454039
 
Dear Ms. Manshadi:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://goldencaviarskincare.com/ in April 2015, and has determined that you take orders there for your products  which you market as dietary supplements, “Blood Pressure Support Formula,” “COQ-10 30MG,” “Joint Support 4700 MG,” and “Mood Boost Mood Formula,” and for your topical products,  “Alpha Arbutin Cream (Whitening Cream),” “Bio Whitening,” “Caviar Lifting & Firming Serum with Zinc,” “Heal & Conceal,” “Redness Calming Serum.” As described below, your website promotes these products for conditions that cause the products to be drugs under the Federal Food, Drug, and Cosmetic Act (the Act). In addition, as described below, these products are misbranded under the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.  You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
The following products, which you market as dietary supplements, are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Blood Pressure Support Formula
 
  • “[R]educe hypertension…”
  • “[H]as been shown to lower blood pressure levels.”
  • “[H]ave been proven to have antihypertensive effects.”
 
 
COQ-10 30MG
 
  • “Evidence suggests people who take statin drugs to treat high cholesterol levels may be simultaneously depleting their CoQ10 levels. Many cardiologists are now recommending CoQ10 to patients as an adjunct to traditional medical treatments.”
 
Joint Support 4700 MG
 
  • “Our joint Support is the answer for relief of Arthritis pain…”
  • “[G]reat for preventing Osteoporosis.”
 
Mood Boost Mood Formula
 
  • “Anti-Depressant capsules…”
  • “[H]elp with, relief of…anti-depressant, Insomnia…Obsessive Compulsive…”
 
The following topical 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 201(g)(1)(C)]. The claims on your website indicate that these products 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, rendering them drugs under the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Alpha Arbutin Cream (Whitening Cream)
 
  • “[H]elp get rid of dead skin…”
  • “Reduces and prevents hyper-pigmentation…”
  • “GREAT for reducing acne and acne scars!”
 
Bio Whitening
 
  • “[H]elps to stop the formation of melanin pigment…”
  • “[H]elp to exfoliate dark surface cells…”
  • “Lightens skin Blocks and inhibits tyrosinase activity Limits melanin production Reduces redness (erythema).”
 
Caviar Lifting & Firming Serum with Zinc
 
  • “It helps repair damaged tissues and heal wounds. Great for anyone wanting to do away with old acne scars or suffering from Rosacea.....We have found the solution.”
 
On the FAQ Page:
 
  • “The most effective products for skin elasticity and wrinkles are found in our Caviar Lifting Serum. “Mini Botox in a Bottle”
 
Heal & Conceal
 
  • “[A] natural antiseptic and antibacterial…”
  • “[E]nhance the healing process by reducing inflammation…”
 
Redness Calming Serum
 
  •  “[A]nti-inflammatory properties”
  • “[G]reat for those with psoriasis.”
Your “Blood Pressure Support Formula,” “COQ-10 30MG,” “Joint Support 4700 MG,” and “Mood Boost Mood Formula,” “Alpha Arbutin Cream (Whitening Cream),” “Bio Whitening,” “Caviar Lifting & Firming Serum with Zinc,” “Heal & Conceal,” and “Redness Calming Serum,” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Furthermore, your “Caviar Lifting & Firming Serum with Zinc,” “Redness Calming Serum,” “Blood Pressure Support Formula,” “Joint Support 4700 MG,” and “Mood Boost Mood Formula” products are offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
In addition, your “Golden Caviar” products are misbranded within the meaning of section 502(a) of the Act [21 U.S.C. § 352(a)] in that the labeling is false and misleading in any particular. Specifically, on your FAQ page you state “All of our products are FDA approved in FDA approved laboratories;” however, FDA has not approved these products and FDA does not approve laboratories. In addition, FDA does not approve cosmetics or dietary supplements.
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to promptly correct these violations may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. 
 
You should direct your written reply to Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions regarding this letter, you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.
                                                                                               
Sincerely,
/S/                                                                                               
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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