Baltimore District Office
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
August 10, 2017
Ms. Kathi Kirschner, Owner
Skin 2 Spirit, LLC
865 Dolington Acres Rd.
Newtown, PA 18940-2717
Dear Ms. Kathi Kirschner:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.skin2spirit.com/ in April 2017 and has determined that you take orders there for the products Shea Body Butter Creme, Magnesium Oil, Organic Caffeine Eye Whip, Advanced Hyaluronic Acid Antiaging Serum, Organic Bioclear Pink Grapefruit Acne Face Wash, Organic Bioclear Pink Grapefruit Face Toner, and Organic Coconut Rose Face Whip. The claims on your website establish that the products are drugs under section 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 321 (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or 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:
• "Magnesium Chloride has been known to have many therapeutic benefits and may help:
o Restore magnesium at the cellular level
o Reduce muscle aches, pains, cramps & spasms
o Improve sleep quality
o Improve mood
o Relieve stress and anxiety
o Reduce leg cramps
o Restless Leg Syndrome
o Relieve migraines
o Reduce PMS symptoms
o Increase energy levels
o Faster muscle repair after workouts"
Organic Caffeine Eye Whip
• "Caffeine Extract, known for increasing circulation ... "
• "ROSE HIP SEED OIL [(an ingredient in your product)]: Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."
• "CUCUMBER PEEL EXTRACT [(an ingredient in your product)]: ... has antiinflammatory ... properties."
Advanced Hyaluronic Acid Antiaging Serum
• "Hyaluronic Acid has recently been used to create Hylaform Gel, an FDA Approved injectable material that aestheticians and plastic surgeons predict will replace collagen injections because the risk of reaction is lower (most collagen being of bovine origin) and Hylaform Gel is more effective, and the results last longer than those of collagen injections."
Organic Bioclear Pink Grapefruit Acne Face Wash
• "Addition of CLOVE [(an ingredient in your product)], an antiseptic, and CAYENNE [(an ingredient in your product)], an anti-inflammatory ingredient that helps soothe redness, fade dark spots and promotes healing of Acne scars."
• "Also includes WILLOW BARK [(an ingredient in your product)], a 100% pure and natural way to help stop Acne in its tracks! Willow Bark, or Salicin, is a derivative of Salicylic Acid, the key additive in many skin-care products for the treatment of acne."
• "WILLOW BARK [(an ingredient in your product)] ... reduce inflammation, soothes pain."
• "PINK GRAPEFRUIT ESSENTIAL OILS [(an ingredient in your product)] ... reduce oil production."
• "CLOVE [(an ingredient in your product)] ... Has antibacterial properties, and some of its primary components are known to be toxic to Propionibacterium Acnes bacteria."
• "CAYENNE [(an ingredient in your product)] ... anti-inflammatory."
• "WITCH HAZEL [(an ingredient in your product)] ... reduces oil production."
Organic Bioclear Pink Grapefruit Face Toner
• "ORGANIC ROSE HYDROSOL [(an ingredient in your product)] ... helps to regulate sebum, and its antibacterial properties can be helpful in the prevention of acne."
• "ORGANIC ALOE [(an ingredient in your product)] ... reduce inflammation and swelling. Aloe vera also reduces redness."
• "LAVENDER ESSENTIAL OIL [(an ingredient in your product)] ... Balances oil production ... "
• "TEA TREE OIL [(an ingredient in your product)] ... Destroys bacteria that cause Acne flare-ups."
Organic Coconut Rose Face Whip
• "LICORICE ROOT [(an ingredient in your product)], which has excellent antiinflammatory properties ... "
• "ROSE HIP SEED OIL [(an ingredient in your product)] ... Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."
• "VITAMIN C [(an ingredient in your product)] ... skin whitening agent ... "
• "Licorice extract [(an ingredient in your product)] can inhibit the melanogenesis and is thus used also as skin whitening agent."
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 marketed 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.
You should 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 (15) 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. Your written response should be sent to Robin M. Rivers, Compliance Officer, Food and Drug Administration, U.S. Customhouse, Room 900, 2nd & Chestnut Streets, Philadelphia, PA 19106. If you have any questions about the contents of this letter, please contact Ms. Rivers at (215)717-3076 (telephone), (215)597-8212 (facsimile) or robin.rivers@FDA.HHS.GOV (e-mail).
Baltimore District Director
Program Division Director
Human and Animal Foods, Division II Eas
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director
This page was posted on April 30, 2019.