| Public Health Service Food and Drug Administration |
5100 Paint Branch Parkway |
Department of Health and Human ServicesWARNING LETTER
MAR 1 2011
VIA OVERNIGHT DELIVERY
Joe Adams
JabaLabs, LLC
14080 Nacogdoches Road
#64
San Antonio, TX 78247
Re: 154172
Dear Mr. Adams:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web sites at the Internet addresses http://www.stemcellfacecream.com and http://www.synovialabs.com in February 2011. Based on this review, FDA has determined that your products StemCellin Intensive Emulsion, StemCellin Deep Wrinkle Serum, and Faitoz-25 are promoted for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. The claims on your web sites establish that these products are drugs because they are intended to affect the structure or function of the human body. The marketing of these products with these claims violates the Act. You may find the Act and FDA regulations through links at FDA's home page at www.fda.gov.
Examples of some of the claims found on your web site www.synovialabs.com include:
Claims for Faitoz-25 and its ingredients:
• “Lose your wrinkles! without painful injections”
• “The proven benefits of Faitoz-25
o Accelerates collagen and elastin production
o Restores firmness, [and] elasticity…
o Lose deep wrinkles in 30 days”
• “Reduce[s] expression lines & deep furrows”
• “The Argireline, Matrixyl 3000 and Snap-8 Peptides in Faitoz-25 wrinkle cream have [been] clinically shown to:
o Matrixyl 3000 decreases wrinkle volume
o Matrixyl 3000 decreases wrinkle density …
o Argireline increases skin firmness
o Argireline increases skin thickness
o Argireline increases collagen production”
• “Hyaluronic acid [an ingredient of Faitoz-25] helps reduce spider veins….”
• “Argireline mimics the actions of Botulinum by … relaxing muscle contractions....”
• “Clinical trials have shown that Matrixyl 3000 is capable of reducing … wrinkles that add years to your appearance. It was designed to promote collagen production while strengthening the essential structure of skin tissue.”
• “Snap-8 [an ingredient of Faitoz-25] is known to … reduce the depth of wrinkles … in the forehead and around the eyes.”
• “Vitamin C and E [ingredients of Faitoz-25] help … protect skin cells from free radical damage.”
• “Argireline locally disrupts nerve signals sent to muscles, relaxing the muscles ....”
• “SNAP-8 is a safer, cheaper, and milder alternative to Botulinum Toxin, topically targeting the same wrinkle-formation mechanism in the very same way.”
• “Our greaseless Faitoz-25 serum formula … improve[s] the elasticity of the skin, regenerate[s] skin stem cells, and effectively combat[s] wrinkles … inflammation, and other symptoms of prematurely aging skin.”
Your www.synovialabs.com web site also contains claims in the form of personal testimonials, including:
• “I have been using your wrinkle cream [Faitoz-25] for six weeks now. The skin around my eyes … [has] less wrinkles.”
• “Faitoz-25 wrinkle cream with 25% Argireline and Matrixyl 3000 does work in reducing my wrinkles.… I am always looking for products that make me look younger but until now I had not found any that work permanently.”
• “Ever since I started using Faitoz-25 with 25% Argireline and Matrixyl 3000 three weeks ago, I have noticed that the wrinkles on my forehead were less deep .…”
Examples of the claims found on your web site www.stemcellfacecream.com include:
Claims for StemCellin Intensive Emulsion and Deep Wrinkle Serum, and their ingredients:
• “StemCellin® with 5% PhytoCellTec™:
o Delays deterioration of essential skin cells
o Activates your own skin stem cells …
o Reverses chronological aging”
• “This incredible PhytoCellTec apple stem cell cream emulsion is the first product to harness the regenerative potential of your own facial stem cells to renew skin …. It will actually ‘rejuvenate’ your skin by ‘awakening’ your body’s own reservoir of undifferentiated stem-cells.”
• “Our greaseless StemCellin PhytoCellTec stem cell cream formulas … improve the elasticity of the skin, regenerate skin stem cells, and effectively combat wrinkles … inflammation, and other symptoms of prematurely aging skin.”
• “PhytoCellTec™ Malus Domestica is the first active [ingredient] based on plant stem cells to protect and repair skin stem cells.… The application of plant stem cell cultures to maintain and repair the function of skin stem cells is a breakthrough in anti-aging.”
• “Rosehip seed oil [an ingredient of StemCellin] contains Vitamin A, which helps to delay the effects of skin aging … and promotes collagen and elastin levels to increase. This results in firmer … skin with greater elasticity.”
• “Vitamin C [an ingredient of StemCellin] is a … natural anti-inflammatory that helps in reversing some of the effects of sun damage.”
• “Vitamin E [an ingredient of StemCellin] … protect[s] skin cells from UV-induced damage …. It reduces inflammation … by strengthening the skin's repair mechanisms.”
• “PhytoCellTec™ Malus Domestica, the cosmetic ingredient in StemCellin stem cell cream, is based on an encapsulated extract of cultured apple stem cells that was tested in a clinical trial over 4 weeks with 20 subjects. This new stem cell cream ingredient was found to significantly reduce wrinkles in the crow’s feet area.”
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)]. A new drug may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Please respond to this letter within fifteen working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Rob Genzel Jr., Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740.
Sincerely,
/s/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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