Inspections, Compliance, Enforcement, and Criminal Investigations
Andes Natural 9/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
SEP 21 2012
VIA CERTIFIED MAIL
Julio Bernabe, Managing Member
Andes Natural Skin Care LLC
1802 North Carson Street
Carson City, NV 89701
Dear Mr. Bernabe:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your web sites at the Internet addresses http://www.andes-natural.com, ttp://www.bioskincare.com, http:/ /bioacnecare.com, http:/ /bioskinforte.com, http:/ /www.bioskinrepair.com, and http://bioskinexfol.com in August 2012. Based on this review, your products BioSkinCare, Bio Skin Rejuvenation, BioSkinclear, Bio Acne Care, BioSkinforte, BioSkinexfol, and BioSkinrepair appear to be promoted for uses 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 are 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:
BioSkinCare (at www.andes-natural.com)
• "[T]riggers your body's own skin regeneration activators"
• "[R]epairs sun damaged tissues at the cellular level"
• "[T]akes away acne, rosacea, scars, skin blemishes and deep under skin lesions accumulated by excess UV exposure ... "
• "[T]akes away all imperfections and blemishes: acne, scars, keratosis bumps, razor nicks and burns, actinic keratosis lesions, ... ezcema [sic], dermatitis, the effects on the skin of radiotherapy for cancer, blisters, scrapes, cuts ... "
• "[A]ctivates the fibroblast stem cells which favor the proliferation of new healthy connective tissues and all the structural elements of healthy skin, smoothing facial crater-like skin texture."
• "Inhibits microbiological activity of dangerous, pathogenic skin bacteria, including acne."
• "Regulates dermal fibroblast proliferation and excess collagen, and thus prevents and reduces abnormal scars such as keloid and hyperthropic scarring and slowly but consistently gets rid of ice-pick scars or pitted acne scars."
• "[Y]our skin will react to the biological enzymes by activating its own biological response modifiers thereby interacting with your body's immune system and repair mechanisms to treat skin injuries (cuts, bruises, abrasions, acne lesions, scarring), dysfunctional tissues (keratosis, keloid and hypertrophic scars ... ) and prevent immune-mediated inflammatory skin disorders (inflammatory acne, rosacea, eczema and most dermatitis reactions)."
• "Topical application of the cream on skin wounds and scars regulates or decreases dermal fibroblast proliferation and excess collagen production, and thus prevents and reduces keloid and hyperthropic scarring."
• "[E]nhances the skin's natural regenerative responses by stimulating new capillary formation (angiogenesis), and the orchestrated biosynthesis of collagen, elastin and the water-holding proteoglycans and glycosaminoglycans."
Your web site also contains disease claims in the form of personal testimonials about your BioSkinCare product, including:
• "The scars in my upper arms ... are getting lighter."
• "I started to get severe acne on my face and neck ... I feel like I have found a miracle cure."
• "I have gotten not only my mother using it for her stretch marks ... but now my close friend for ... acne ... and ... it worked ... "
• "I ... have had cystic acne for 10 years ... I can't say that it completely prevents the cysts from appearing but they ... are much less frequent and much less severe."
• "I have ... used your product for an open wound (size of a pencil eraser) on a black mole removed by my doctor .... This product healed my wound faster than it would with an OTC prescription."
• "[T]he inflammation on my face has considerably reduced .... Also it has cleared up my psoriasis!"
Bio Skin Rejuvenation (at www.bioskinrejuvenation.com)
• "[R]educes melanin hyperpigmentation and a biomimetic peptide that inhibits the accumulation of melanin pigments."
• "[L]imiting both melanin production (tan) and skin reddening (erythema)."
• "Promotes cell proliferation and new synthesis of collagen and elastin .... "
• "Protects from UV A radiation"
• "Acts as an anti-inflammatory as it metabolizes or breaks down the denatured proteins into amino-acid components, which otherwise cause inflaming, and releases them for
rebuilding of the skin structures"
• "Blocks melanin synthesis and reduces the formation of unwanted pigmentation, allowing control over skin tone and brown spots."
• "[T]he secretion has been used on patients that have been diagnosed with malignant tumors and need radio-therapy. The results have been highly satisfactory in radiodermatitis of neck and breasts."
• "The secretion also shows a UV A cytoprotective activity. It protects cells from noxious stimuli from Ultra Violet radiation which justifies the claim that applying it on skin protects the skin from UVA radiation."
• "[I]nhibiting the production of the enzyme tyrosinase, leading to clearer complexion and a reduction in skin pigmentation."
• "(R]egulates pigmentation tone for the total skin surface, lightening the complexion."
• "[E]liminating the INFLAMMATORY effect of a 'foreign body' induced by otherwise remaining denatured collagen"
• "[T]riggers the repair of cells damages by UV radiation .... "
• "[R]egulation of epidermal pigmentation tone."
BioSkinclear (at www.andes-natural.com/acne)
• "Gel for Acne & Rosacea Inflammation"
• "[E]liminates redness and post inflammatory hyperpigmentation."
• "Glycoconjugates also induce the proliferation on the surface of the skin of antimicrobial peptides that perform as natural antibiotics. And they signal your immune system that it is being taken care of and moderates the inflammatory response so that it does not cause acne rashes or loss of tissues: ice-pick scars."
• "[R]elieves the side effects of Accutane®."
• "Topical application ... soon after the first signs of acne pimples, prevents the cells from initiating the signaling cascade that leads to acne inflammatory reactions and healing through the scarring pathway."
• "[N]ot only relieves the effects of acne breakouts & rosacea, it can also prevent acne breakouts and rosacea when used twice a day on clean skin as a routine skin care regimen to keep skin clear of blemishes."
• "It helps as well with the repair of everyday and accumulated damage created by exposure to UV radiation .... "
• "The gel has also been effective for the treatment of rosacea symptoms, helping to halt and prevent inflammation, restore the capacity of skin to intricately orchestrate its
regeneration in an orderly way, strengthening blood vessels, cell walls and circulation; while helping to prevent further rosacea outbreaks."
• "Acne Scar Removal"
• "Heals micro-tears in the skin, softens coarse areas and opens constricting pores, plumps up ice-pick acne scars, shrinks raised or hypertrophic scars, reduces keloid scar tissues and stops their itching, and greatly diminishes post surgery scarring."
• "Protection from UV radiation .... "
Bio Acne Care (at www.bioacnecare.com)
• "Natural Solution for Zits, Pimples, Blemishes, Blackheads, Acne Breakouts."
• "[A] naturally occurring serum that supports the immune system of the skin by providing enzymes that dissolve blocked pores; skin regenerating activators that heal skin lesions; antimicrobials that keep bacteria under control ... cell communicating molecules that discern damaged cells from healthy cells and support the immune system in its fight against foreign matters and uncontrolled bacteria; and boosters of production of water holding molecules within the skin matrix that deeply moisturize the dermis & epidermis"
• "[L]icorice extract is anti-inflammatory, anti-irritant, anti-microbial ... & has a sebum regulation activity."
BioSkinforte (at www.bioskinforte.com)
• "Prevents and Clears Acne"
• "[P]owerful anti-inflammatory, antimicrobial and sebum regulation botanicals"
BioSkinexfol (at www.andes-natural.com/microdermabrasion and www.bioskinexfol.com)
• "[S]timulate collagen growth and cellular regeneration thereby improving ... sagging, reduction of imperfections and blemishes ... "
• "[R]emoval of ... abnormal scars and imperfections and the release of amino-acids that help rebuild damaged tissues quickly"
• "[D]issolve or 'digest' non functional, damaged and worn out cells deep within the skin. This explains why BIOSKINEXFOL works so well for old and rough stretch marks, for those are scar tissues deep within the skin."
• "[S]upports the protective strategies of the innate immune system of human skin ... "
• "The bioactive ingredients in BIOSKINEXFOL act as:
(1) regulators of enzyme activity;
(2) regulators of neurite outgrowth, and
(3) anti-inflammatory agents that limits oxidative damage after tissue injury;
(4) stabilizers, cofactors, and/or coreceptors for:
(4a) proteins produced by the human body that enable cells to communicate and effectively coordinate activities between one another (growth factors),
(4b) intracellular messenger molecules whose major function is to attract immune cells to sites of infection (chemokines), and
(4c) regulatory proteins released by cells of the immune system that act as intercellular mediators in the generation of an immune response (cytokines)."
• "The Glycoconjugates in the Cream help the skin to
(1) regenerate new collagen and elastin which improves skin firmness and elasticity,
(2) increase the production of water holding glycosaminoglycans which is true moisturizing,
(3) improve the skin's blood vessel microcirculation,
(4) increase the natural defense mechanism against oxidative damage, and
(5) repair damage to the protective skin barrier. As the skin is rebuilt and scars removed, the elastic properties of the skin pull it into a smooth surface. During skin remodeling, the old damaged protein is removed and replaced with new collagen and elastin fibers. This removes scar tissue, restores skin elasticity, and reduces wrinkles."
BioSkinRepair (at www.bioskinrepair.com)
• "[H]elps to prevent and reduce all types of scars, including hypertrophic and keloid scars, because it orchestrates an orderly repair of damaged skin, scarless healing &
enhanced skin regeneration"
• "[S]timulating new capillary formation (angiogenesis), and the orchestrated biosynthesis and orderly deposition of new collagen, elastin, and the water-holding proteoglycans and glycosaminoglycans in the skin matrix .... "
• "Regulates dermal fibroblast proliferation and excess collagen, and thus helps to prevent and reduce scar keloids and hyperthropic scarring."
• "Stimulates the formation of the extracellular binding between cells .... "
• "[P]otent ... anti-inflammatory and anti-itching agent."
• "Inhibits microbiological activity of dangerous, pathogenic skin bacteria, including acne."
• "Stimulates the formation of glycosaminoglycans ... helps to thicken the dermis resulting in a lessening of sagging and less fine lines and wrinkles."
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/HowDrugsareDevelopedandApproved/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 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 Quyen Tien, 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.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition