Inspections, Compliance, Enforcement, and Criminal Investigations

Sarkli Repechage Ltd 8/18/16

  

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

Public Health Service
Food and Drug Administration
 New Jersey District Office
Central Region
Waterview Corporate Center  
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331- 4900
FAX: (973) 331- 4969

 

August 18, 2016
 
 
 
WARNING LETTER
 
VIA UNITED PARCEL SERVICE
16-NWJ-14  
 
Lydia Sarfati, Owner                                                             
Sarkli/Repechage, Ltd.
300 Castle Road
Secaucus, NJ 07094-1600
 
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.repechage.com/ in June 2016 and has determined that you take orders there for the products Hydra 4 Red-Out® Calming Cleanser, Hydra 4 Red-Out® Serum, and Biolight™ Brightening Daytime Protection Cream. The claims on your website establish that the products are drugs under sections 201(g)(1)(B) and/or 201 (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Hydra 4 Red-Out® Calming Cleanser
  • “[N]ormalize skin bacteria that is responsible for red, irritated and sensitive skin conditions including rosacea…”
  • “Micro Silver…soothes chronically inflamed and irritated skin, while…anti-inflammatories such as Quercetin and Rutin help further calm skin…”
Hydra 4 Red-Out® Serum 
  • “Micro Silver with …anti-inflammatories, such as Quercetin and Rutin, to help calm…skin conditions including rosacea…”
  • “Micro Silver, an important anti-bacterial ingredient that has superior anti-microbial, anti-inflammatory…properties… 
Hydra 4 Red-Out® Serum & Hydra 4 Red-Out® Calming Cleanser
  • On website under active ingredients:
    • “Rutin-…anti-inflammatory agent…has the ability to regenerate vitamin C… maintain healthy blood circulation…”
    • “Quercetin-…anti-inflammatory properties…can increase the production of both collagen and fibronectin…”
    • Aloe Barbadensis Leaf Juice Powder (Organic)…anti-inflammatory agent…protect the skin from UV damage…”
    • “Mirabilis Jalapa Extract … is commonly used in areas of Brazil to treat inflammatory and painful diseases…”
    • Rosmarinus Officinalis (Rossemary) Leaf Extract-has antimicrobial properties…”
    • “Melissa Officinalis (Balm Mint) Leaf Extract …known for calming the skin and treating inflammation…protect [skin] against UV-radiation…” 
Biolight™ Brightening Daytime Protection Cream
  • “Laminaria Complex contains two select EcoCert Seaweeds combined with Willow Bark, Goto Kola and Licorice Extracts to …reduce inflammation…”
  • On website under active ingredients:
o   “Hexapeptide-2… decreasing melanin synthesis”
o   “Bellis Perennis (Daisy) Flower Extract…Reduces UV-stimulated induction of melanin biosynthesis. The binding affinity of melanocyte- stimulating hormone (alpha-MSH) to its receptor and tyrosinase activity is both down regulated.”
o   “Glycyrrhiza Glabra (Licorice) Root Extract-The ingredient known for skin lightening benefits of the plant is Glabridin. Glabridin inhibits pigmentation by preventing tyrosinase activity without cytotoxicity.”
o   “Gotu Kola (Centella Asiatica Extract) …increase collagen growth and synthesis and promote connective tissue vascularization. It has been found to increase tensile strength of skin and promote rapid healing of skin. Gotu Kola has been found to stimulate dermal fibroblasts (connective tissue forming cells)”
o   Rosmarinus Officinalis(Rosemary) Leaf Extract… Has natural antimicrobial properties.”
 
Your 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. 
 
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 do so 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.
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054, Attn. Stephanie Durso, Acting Director of Compliance. If you should have any questions regarding any issue in this letter, please contact Robert J. Maffei, Compliance Officer by telephone at 973-331-4906.                                                                                           
 
Sincerely yours,
/S/          
Craig W. Swanson
Acting District Director
New Jersey District Office

Page Last Updated: 09/19/2016
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