Inspections, Compliance, Enforcement, and Criminal Investigations

Hollywood Skincare International Inc. 4/14/16

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone:   407-475-4700
FAX: 407-475-4770

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-16-13
April 14, 2016
 

 


Nick Manas, President
Hollywood Skincare International, Inc.
215 South 21st Avenue
Hollywood, FL, 33020
 
Dear Mr. Manas:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.dermasetskin.com/ in February 2016, and has determined that you take orders there for your “DermaSet Stem Cell 3D Renewal Treatment” product. The claims on your website establish that the product is a drug under section 201(g)(1)(B)/(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)/(C)]because it is intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals. As explained further below, introducing or delivering this product 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 product is intended for use as a drug include:
 
Unapproved New Drugs
 
Product Website Claims
  • “Removes Wrinkles Instantly”
Product Ingredient Claims
 
Sea Fennel Stem Cell
  • “The Sea Fennel stem cell has the effect of lightening the skin…”
  • “Tests using a 0.5% concentration of the culture have shown a clear reduction of uneven pigmentation and obvious lightening if the skin.”
  • “This marine ingredient …offering protection against UVB induced free radicals.”
Apple Stem Cell
  • “It provides amazing benefits to our skin by … stimulating regeneration of cell tissues…” 
Dimethylmethoxy chromanyl palmitate (DHP) [chromabright™]
  • “DHP is a new synthetic peptide that has revolutionized the process of skin lightening.”
  • [E]liminating the harsh effects that were once associated with previous lightening procedures. DHP…reverses the signs of aging caused by UV rays.” 
Palmitoyl oligopeptide & palmitoyl tetrapeptide 7 (POPT7) [matrixyl®]
  • “POPT7 … increases cell communication and gene activation for the skin healing, thus it plays a fundamental role in the reconstruction of the skin tissue.”
Acetyl hexapeptide 8 (AH8) [Argireline extract]
  • “Acetyl Hexapeptide8… works in a similar way to Botox treatments.”
  • “AH8 blocks the message that commands the face to tense up, thus interfering with the message being sent the brain. In doing so, the facial muscles remain relaxed, and wrinkles are kept at bay.” 
Tetrahexyldecyl ascorbate [bv-osc™]
  • “A super anti-oxidant …eliminates age spots, contains protection from ultraviolet A and B and boosts collagen synthesis.” 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 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 Randall L. Morris, Compliance Officer. If you have any questions regarding this letter, you may contact Randall L. Morris via email at Randall.Morris@fda.hhs.gov or by telephone 407-475-4741.
  
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District

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