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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Set-N-Me-Free Aloe Vera Co. 6/12/12


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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA  98021-4421
Telephone:   425-486-8788
FAX:   425-483-4996


June 12, 2012
In reply refer to Warning Letter SEA 12-24
Janet G. Heinrich, Owner and Managing Director
Set-N-Me-Free Aloe Vera Co.
19220 SE Stark Street
Portland, Oregon 97233-5751
Dear Ms. Heinrich:
The Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.set-n-me-free.com and www.setnmefree.net in May 2012. Based on our review, we have determined that the products “Aloe Milk Moisturizing”, “Aloe Moisture Cream”, “Day-Night Emollients”, “Moisturizing Aloe Lotion”, “Aloe Comfrey Gel”, “Aloe Facial Cleanser”, “Aloe Stic”, “ 99.5% Natural Aloe Liquid”, “Lavender Spa Bath”, “Aloe Heat Creme”, “Aloe Body Wash” and “Set-N-Me-Free body wrap systems” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC §§ 321(g)(1)(B) and 321(g)(1)(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 body. The marketing of these products with these claims violates the Act.  You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the product-specific claims observed on your website www.setnmefree.net include:
Aloe Milk Moisturizing with Apricot / Aloe Milk Moisturizing
  • “Apricot Kernel Oil [an ingredient in your product] supplies . . . a natural source of cancer fighting laetryl lipids.”
  • “Borage Oil equals the GLA content found only in mother’s milk. These unsaturated fats are 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-like substances that supply collagen and elastin for better skin tone.

Aloe Moisture Cream

  • “Natural B vitamins in the soy and safflower oils help in cell formation and build skin immune functions.”
  • “Soy protein [an ingredient in your product] is often documented as a cancer preventative agent.”

Day-Night Emollients

  • “Apricot kernel oil [an ingredient in the product] is high in gamma-linolenic acid that prevents the breakdown of elastic fibers and collagen that restores firmness to the tissues. These essential elements . . . are a natural source of cancer fighting laetryl lipids.”
  • “Natural B-vitamins in the safflower and avocado oils [ingredients in this product] help in cell formation and build skin-immune functions. These oils renew skin flexibility by permeating natural vitamins A and E into skin cells, making regeneration of these cells occur faster.”

Moisturizing Aloe Lotion

  • “Natural B 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 cells, making regeneration of these cells occur faster. For these reasons soy oil is often suggested as a cancer preventative.”

Aloe Comfrey Gel

  • “First Aid in a Bottle”
  • “[S]tops acne eruptions and irritations . . . .”
  • “[A]ntiseptic for aftercare, helps with ingrown hair, acne eruptions.”
  • “[T]reatment for psoriasis and eczema.”
  • “[A]ids wounds and areas of infection.”
  • “[H]elp to prevent injuries 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 relief for burns, cuts, abrasions, and stops itch caused by tissue restoration or bug bites.”
  • “[U]se Aloe Comfrey Gel generously . . . to heal the affected skin tissue area.”

Aloe Facial Cleanser

  • “The high B vitamin content of the soy oil [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 the skin. For these reasons, soy oil is often suggested as a cancer preventative.”
  • “Chamomile [an ingredient in the product] is an anti-inflammatory and anti-microbial herb. This, along with the aloe, soothes irritation and reduces swelling or puffiness. This product is excellent for use on skin conditions such as eczema and psoriasis . . . .”

Aloe Stic

  • “Aloe Stic contains 11% of this [tea tree oil] anti-inflammatory, anti-bacterial substance.”
  • “The lipophilic nature of tea tree oil enables it to chemically combine with fats and other lipids. The strong solvency of this oil assists in cleaning 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 eliminating the inflammation of corns, calluses and bunions. Itching from insect bites, poison oak or rashes is stopped for hours after applying Aloe Stic.”
  • “[S]lows recurring cold sores.”

Natural Aloe Vera Liquid / 99.5% Natural Aloe Liquid

  • “Spray or splash on rashes, sunburn, excema [sic], psoriasis patches for temporary itch and irritation relief.”
  • “Soak the feet in a pan of aloe liquid. The enzymes will soften calluses. Aloe’s ‘wound aiding’ hormones will stop itching caused by athlete’s foot fungus . . . .”

Aloe Lavender Spa Bath / Lavender Spa Bath

  • “Lavender Spa Bath shows excellent results on psoriasis or eczema type skin problems.”

Aloe Heat Creme

  • “Use . . . as an arthritis relief.”
  • “[C]an easily become an arthritis treatment!”
  • “Heat Creme works well with sprains, strains, torn ligaments, etc. It also relieves the discomfort of menstrual pain and headaches.”

Aloe Body Wash

  • “Aloe Body Wash shows excellent results on psoriasis or eczema type skin problems.”
  • “Set-N-Me-Free has documented that when obese people begin to use Aloe Body Wash daily, their body weight can drop several pounds during the first month.”

Body Wrap Solution Gel

  • “Aloe [an ingredient in the product] penetrates toxin-cleansing herbs through the protein wall of the fat cell. The herbs move stored toxins into the body’s lymphatic system creating size loss.”
  • “Thus the herbs can move toxins from fat cells through intercellular osmosis, to the inner lymph system, creating a size loss.”
In addition, your website www.set-n-me-free.com includes multiple claims about aloe vera gel generally that establish that these products, which contain aloe vera gel, are intended for use as drugs. For example:
Under the heading “Info” and under the subheading “Articles,” on the page titled “PHARMACOLOGICAL ACTIVITIES OF ALOE VERA GEL”:
  • “It anesthetizes the tissue in the area to which it is applied relieving pain deep beneath the surface including pain associated with joints and sore muscles.”
  • “It is bactericidal when it is maintained in high concentration for several hours in direct contact with infectious bacteria.”
  • “It is virucidal when in direct contact with high concentration for long periods of time.”
  • “It is fungicidal under the same conditions.”
  • “It is antipyretic-reduces the fever or heat of sores.”
  • “It is anti-inflammatory. Its action is similar to that of a steroid.”
  • “It is antipruritic-stops itching. (see Aloe Comfrey Gel)”
  • “It breaks down and digests dead tissue including pus through action of proteolytic enzymes hastening the regenerative phase of healing.”
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 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.
Furthermore, because these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, these products are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these products fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not an all-inclusive list of violations in your products and their labeling.  It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
We request that you notify this office in writing, within fifteen working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Cynthia White, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Cynthia White at (425) 302-0322.
Charles M. Breen
District Director