Inspections, Compliance, Enforcement, and Criminal Investigations

Zo Skin Health Inc. 8/29/16

  

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                                                                                                   
 
WL 41 -16 
August 29, 2016                                                                                                      
 
Dr. Zein Obagi
ZO Skin Health Group, LLC
270 N. Canon Dr. Ste. 100
Beverly Hills, CA 90210
 
Re: CMS #499082
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://zoskinhealth.com/ in June 2016 and has determined that you take orders there for the products Ossential® Growth Factor Serum Plus, Ossential® Daily Power Defense, and Ossential® C-Bright Serum 10% Vitamin C. 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 articles 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. 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:
 
Ossential® Growth Factor Serum Plus  
  • “Helps stimulate cell renewal” 
Under Advanced Information: 
  • “Disodium acetyl glucosamine phosphate and fermented red ginseng extract: Stimulates cellular regeneration, collagen production and synthesis of glycosaminoglycans (GAGs)”
  • “Retinol: Stimulates …collagen production…”
  • “Hydrolyzed sericin: Enhances production of collagen and hyaluronic acid”
  • “DNA repair and protection complex: Enhances DNA repair and protects DNA from future damage”
 
Ossential® Daily Power Defense
  • Promotes healthy cell regeneration
  • Helps support skin’s natural mechanism to repair damage and protect against future skin damage 
Under Advanced Information: 
  • “Ultrasomes (UV-endonuslease) and roxisomes (glycosylase): Enzymes that initiate and speed up the repair to DNA”
  • “Retinol (vitaine): Stimulates …collagen production”
  • “Matrixyl 3000 (palmitoyl oligopeptide and palmitoyl tetrapeptide-7): Stimulates collagen production” 
Ossential® C-Bright Serum 10% Vitamin C
  • “Helps prevent new pigment from forming”
  • Powerful antioxidants help defend against environmental triggers that cause pigmentation 
Under Advanced Information: 
  • “Tetrahexyldecyl ascorbate: Proven to prevent new pigment formation by up to 80% by inhibiting new melanin formation; helps to stimulate healthy collagen production and reduce wrinkle depth” 
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.
 
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to:
 
Kelly Sheppard, Director
Compliance Branch
U.S. Food & Drug Administration
19701 Fairchild
Irvine, CA 92618
 
If you have any questions about the contents of this letter, please contact Ms. Mariza Jafary, Compliance Officer at (949) 608-2977 (phone) or (949) 608-4415 (fax).
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
SP: MMJ
 
Cc:     
David M. Mazzara, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
PO Box 997435
Sacramento, California 95899-7435
Attn: FDA Correspondence

 

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