Inspections, Compliance, Enforcement, and Criminal Investigations

Ageless Aesthetics 7/18/16

  

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

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

 

July 18, 2016
 
VIA UPS Overnight
 
WARNING LETTER
 
John Robert Insinger, Founder
Ageless Aesthetics, Inc.
3250 Quentin St.
Unit 132
Aurora, CO 80011
DEN-16-11-WL
Dear Mr. Isinger:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://medik8.us/ in June 2016 and has determined that you take orders there for the products White Balance ClickTM Intense Brightening Serum, White BalanceTM Click Oxy-R Ultra Brightening Serum, and Growth FactorTM. 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:
 
White Balance ClickTM Intense Brightening Serum 
  • “Proven significant whitening activity of 97.3%*”
  • “Targets all types of pigmentation concerns: dark spots, age spots, melisma, freckles, and blotchiness and helps to prevent future appearance of pigmentation”
  • “Linoleic Acid…improving melanin dispersion”
  • “L-Leucine – inhibits the transport of L-Tyrosine and L-phenylalanine into melanocytes, therefore nurturing it with inhibitive precursor for melanin formation”
  • “N-Acetyl Glucosamine – skin whitening agent” 
White BalanceTM Click Oxy-R Ultra Brightening Serum  
  • “The patent-pending stabilisation technology addresses and helps to inhibit the appearance of melanin-based pigmentation (caused by sun damage).”
  • “Oxyresveratrol (Oxy-R) – Oxy-r is a skin lightening ingredient with patent-pending stablisation technology.”
  • “Gluconolactone – A poly-lactic acid (PHA) that … break down stubborn melanin deposits. Helps provide protection from UV damage.” 
Growth FactorTM
  • “Stimulates production of collagen and elastin (fibroblasts)”
  • “sh-Oligopeptide-1 (EGF): obtained by biotechnology, triple-filtered and liposome stabilized. Activates the skin receptors stimulating…skin regeneration” 
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 U.S. Food & Drug Administration, Denver Federal Center, Building 20, 6th Avenue & Kipling Street, PO Box 25087, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions about the contents of this letter, please contact Ms. Della Fave at 303.236.3006 or via email at sarah.dellafave@fda.hhs.gov.
 
Sincerely,
/S/  
LaTonya M. Mitchell
District Director

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