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    articulo

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    articulo

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    3 views3 pages

    12

    Uploaded by

    VGal Vilvet
    articulo

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    Home ‘Compliance Actions and Activities Warning Leters 2012 Inspections, Compliance, Enforcement, and Criminal Investigations ‘Sot-N-Me-Free Aloe Vera Co, 6/12/12 Public Health Service Deparment of Hash and Human Savcne Foad and Drug Administration Seattle District Pactic Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX! "825-483-4996 dune 12, 2012 (CERTIFIED MAIL RETURN RECEIPT REQUESTED In reply refer to Warning Latter SEA 12-24 Janet G, Heinrich, Owner and Managing Director Set-n-tie-Free Aloe Vera Co 19220 SE Stark street Portland, Oregon 97233-5751 WARNING LETTER Dear Ms, Heinrich: ‘The Food and Drug Administration (FDA) reviewed your websites at the Internet addresses wnw.sel-n-me-free.com and wnwasetamefree,net in May 2012. Based on our review, we have determined that the products "Aloe Milk Moisturizing", "Aloe Moisture Cream", “Day-Night Emllients”, Moisturizing Aloe Lotion, “Aloe Comfrey Gel”, "Aloe Facial Cleanser”, “Aloe Stic”, " 99.594 Natural Aloe Liquid", "Lavender Spa aath”, "Aloe Heat Creme", "Aloe Body Wash" and "Set-N-Me-Free body wrap systems” are promoted for conditions that cause the products to be crugs Under section 201(G)(1)(B) anc/or 201(6)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC §8 321(9)(4)(B) and 323(0)(3)(C)}. ‘The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human dody. The marketing ofthese products with these claims violates the Act, You may find the Act and the FOA's regulations through links on FDA's home page at www.fda.gov', Examples of some of the product-specific clalms observed on your website wnw.setnmefrae.net include Aloe Milk Moisturizing with Apricot / Aloe Milk Moisturizing : ‘Apricot Kernel Ot [an ingredient in your product} supplies ... 2 natural source of cancer fighting leetryl lipids.” + "Borage OM equals the GLA content found only in mother’s mile, These unsaturated fats ere incorporated Into cell membranes to help with electron movement and insulate the body against heat loss. They prevent drying and flaking of skin; the precursors of hormone-Ike Substances that supply collagen and elastin for better skin tone. ‘Aloe Moisture Cream : Natural B vitamins inthe soy and safflower oils help in cell formation and build skin immune Functions : “Soy protein [an ingredient in your product] is often documented as @ cancer preventative agent.” Day-Night Emollients + “Apricot kernel oil (an ingreétent in the product] is high in gamma-tinlenic acd that prevents the breakdown of elastic fibers and collagen that restores firmness to the tissues. These essantal elements... are a natural source of cancer fighting laetry pds. + "Natural B-vitarins inthe safflowar and avocado ols [ingredients In this preduct] help incall formation and build skin-Immune functions. ‘Thess alls renew skin flexibility by permeating natural vitamins A and E into skin calle, making regeneration of these celle occut faster. Moisturizing Alve Lotion + "Natural 8 vitamins in the soy and safflower oils [ingredients in this product] help in cell formation and build skin immune functions. These oils renew skin flexibility by permeating vitamins A and E into skin calls, making regeneration of these calls occur Taster. For these reasons 50y oll Is often suggested as'a cancer preventative." Aloe Comfrey Get . “First Aid in 2 Bottle” : “[sltops acne eruptions and irritations . . : “tAlntiseptc for aftercare, helps with Ingrown halr, acne eruptions.” : “[Moreatment for psoriasis and eczema.” : “[Alids wounds end areas of infection.” : “[Helo to prevent injures to the skin tissues and increase the healing rate when these tissues are damaged. + “Aloe vera (an ingredient in your product} is an antiseptic, fungicide and a bactericide, This natural wound serum speeds reliet for burns, ‘cus, abrasions, and stops iten caused By tissue restoration or bug bites, . [Use Aloe Comfrey Gel generously... to heal the affected skin tissue area.” Aloe Facial Cleanser + “The high B vitamin content ofthe soy oll [an ingredient in the product) restores the estrogen levels to the skin cells that help in blood cell formation and proper immune system functions for te skin. For these reasons, soy oll fe often suggested as 8 cancer preventative.” top agora 7h 3 + “Chamomile [an ingredient in the product] |s an antiinflammatory and anti-microbial herd. This, slong withthe aloe, soothes irritation and reduces swelling or puffiness, This product is excellent for use on skin coneitions such as eczema and psoriasis. = Aloe Stic : “Aloe Stic contains 11% ofthis (tea tree oll] ant-inflammatory, anti-bacterial substance.” + "The lipophilic nature of tea tree oll enables it to chemically combine with fats and other lips, The strong solvency of this oll assists in ‘leaning out and dissolving pustules and cysts. This obviously makes a great acne treatment.” + “Use this Aloe Stic to ease the dry, flaking and cracking skin on psoriasis areas, Comfort comes immediately to dry cracked feet by

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