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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Greek Island Labs 9/7/12

  

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

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

 

WARNING LETTER
SEP 7 2012 
 
VIA CERTIFIED MAIL
 
Radcliff Consultants, LLC
Agent for
Greek Island Labs
25 S. Arizona Place, Suite 520
Chandler, AZ 85225
 
Re: 262454
 
To Whom It May Concern:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your web sites at the Internet addresses http://www.athenaskincare.com, http://adoniaorganics.com, http://www.greekislandlabs.com, http://www.lashalive.com, http://www.complexioncontrol.com, http://stemulift.com, http://www.7minutelift.com, and http://www.adonialegtone.com in July 2012. Based on this review, your products Adonia LashAlive and BrowRevive Serum, Complexion Control Serum, Adonia StemuLift Serum, Athena 7 Minute Lift, Adonia LegTone Serum, and Athena Nightly Renewal Cream appear to be promoted for conditions that cause these products to be 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 § 321(g)(1)(C)]. The claims on your web sites indicate that these products 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, rendering them drugs under the Act. The marketing of these products with claims evidencing these intended uses violates the Act.
 
Examples of some of the claims observed on your web sites include:
 
Adonia LashAlive and BrowRevive Serum           
  • Organic Cedarwood … helps to strengthen hair growth … and combat … hair loss.”
  • “Eucalyptus also offers antibacterial, anti-inflammatory benefits and can help to stimulate blood circulation on the scalp, encouraging hair growth…”
  • Organic Lavender … Human clinical studies have reported that lavender essential oil may be beneficial in … alopecia (hair loss) and as an antibacterial agent.” 
 
Complexion Control Serum
  • “Blemish Free Skin in Just 3 Days!”
  • “Clinically proven to reduce breakouts and blemishes by 84%”
  • “Reduces white heads and black heads by 92%”
  • “Organic Lime…has bactericidal…anti-inflammatory…properties.”
  • “[L]avender can…protect the skin while helping to prevent blemishes.”
  • “Palmarosa…helps in treating a range of skin infections…”
  • “Organic Patchouli …It also works aggressively to help prevent scarring.”
  • “Organic Petigraine…antiseptic properties help to clear…blemishes…”
  • “Organic Thyme[,] a potent antimicrobial, antibacterial, and antifungal…recommended for many types of skin disorders.”
 
Adonia StemuLift Serum
  • Organic Geranium … effective cell regenerator …”
  • Organic Lavender … antiseptic … properties …”
  • Organic Rosewood … cell stimulant and tissue regeneration properties …”
  • Organic Palmarosa … anti-infectious botanical, as well as an antifungal … also helps in treating a range of skin infections while offering antiseptic … benefits …”
  • Organic Rosemary Verbenone … Accelerates the cell’s natural regenerative powers.”
  • Organic Everlasting … Cell-regenerative for skin, healing for scars (increases production of new cells).”
  • Organic Thyme Linalool … Accelerates the cell’s natural regenerative powers.”
  • Organic Neroli … prevent[s] scarring and stretch marks.”
  • Organic Patchouli … known as … [an] antimicrobial ingredient …”
  • Organic Plant Stem Cells … reactivate your body’s own dormant and weak skin stem cells, pushing them to regenerate.”
  • Organic Lemon Verbena … Acts as a[n] … antiseptic and bactericide … It also improves circulation and removes toxins, ensuring optimum circulation.”
  • Organic Cedarwood … used … to ward off infections …”
 
Athena 7 Minute Lift
  • “[A] safe and effective alternative to Botox®.”
  • “[J]asmine oil is known for its anti-inflammatory properties”
  • “Chamomile…celebrated for its…anti-inflammatory properties…”
  • “[S]kin treatment with avocado oil significantly increases water soluble collagen.”
 
Adonia LegTone Serum
  • Organic Neroli Oil ... used … against plague and fevers.”
  • “Zingibain is an enzyme in ginger that has anti-inflammatory properties.”
 
Athena Nightly Renewal Cream
  • “Helps promote the development of collagen.”
  • Organic Chamomile …anti-inflammatory properties …”
 
Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act (21 U.S.C. § 355(a)) a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA). A description of the new drug approval process can be found on FDA's internet website at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped
andApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm.  Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
 
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 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
Please direct your written reply to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), Division of Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
 
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition