Inspections, Compliance, Enforcement, and Criminal Investigations

Aegeia Skin Care, LLC 2/17/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204  

 

February 17, 2017
 
2017-DAL-WL-12
 
WARNING LETTER
 
UPS Overnight
 
Rebecca Sue Wachsler, Founder
Aegeia Skin Care, LLC
3128 NASA Road 1
Seabrook, Texas 77586
 
Ms. Wachsler:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.aegeiaskincare.com/ in December 2016 and has determined that you take orders there for the products Purifying Facial Cleanser, Refining Facial Toner, Nourishing Clay Mask, and Silken Body Butter.  The claims on your website establish that the products are 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/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any 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:
 
Purifying Facial Cleanser 
  • “[S]timulating circulation.”
  • “Green Tea…promote cellular generation…”
  • “Essential Oils help to combat acne, rosacea, eczema…”
  • Oatmeal [an ingredient in the product]: “[U]sed in baths to treat insomnia and anxiety as well as a variety of skin conditions, including burns and eczema.”
  • Lavender [an ingredient in the product]: “[T]his herb has also been used as a remedy for a range of ailments from insomnia and anxiety to depression and fatigue…Lavender has many other health benefits: antibacterial, antidepressant, anti-inflammatory, antispasmodic, anti-toxic, antiviral. Studies have shown that lavender…reduces irritability, apprehension, stress, nervous tension, insomnia, nightmares…”
  • Vanilla Essential Oil [an ingredient in the product]: “Vanilla Essential Oil…protect the body from…infections and even some forms of cancer, such as those of prostrate, colon etc. It also helps assist the body in repairing the damages already done. It lowers blood pressure…” 
Refining Facial Toner 
  • “Antibacterial & antimicrobial properties…”
  • “Tea Tree Essential Oil for antiseptic properties…”
  • Witch Hazel Hydrosol [an ingredient in the product]: “North American Indians used witch hazel to treat bruises, sprains, skin problems and internal injuries or bleeding. Today, witch hazel is used for its healing…properties for a speedier recovery from burns, skin abrasions, dermatitis, and inflammation… The key ingredient in witch hazel is a tannin acid derivative called catechol tannin. When applied to wounds, cuts and abrasions, tannins constrict the tiny capillaries below the skin surface...It is antiseptic and possesses strong anti-inflammatory and anti-oxidant properties; it can be useful in healing varicose veins, hemorrhoids, cracked or blistered skin and to sooth eczema and psoriasis. It is effective in soothing sunburn, stings and bug bites.” 
Nourishing Clay Mask 
  • “Dead Sea Clay…stimulating vital facial circulation.”
  • “Kaolin Clay…stimulating circulation.”
  • “Green Tea…promote cellular generation…”
  • “Essential Oils help to combat acne, rosacea, eczema…”
  • Dead Sea Mud [an ingredient in the product]: 

o  “Soothes and heals psoriasis, eczema, and dermatitis”

o   “Reduces the occurrence of acne…”

o   “Reduces skin allergies and reactions…”

o   “Improves blood circulation and natural skin regeneration”

  • Coconut Oil [an ingredient in the product]: “Coconut oil also has natural antibacterial, anti-fungal and antimicrobial properties which provide a protective layer on your skin and can help facilitate healing of skin conditions such as rashes, acne and other infections.  Coconut oil contains medium-chain triglycerides which are broken down by the good bacteria on the skin into free fatty acids which contribute to the acidic environment on the skin to repel disease-causing germs.”
  • Chamomile flowers [an ingredient in the product]: “Chamomile flower essential oil has anti-inflammatory properties and is used to encourage digestion and boost the immune system. Antibiotic and anti-inflammatory activity is exhibited when used topically… Other benefits associated with chamomile include: 
o   Relaxing sleep aid
o   Anti-inflammatory
o   Boosts the immune system
o   Relieves muscle spasms
o   Lessens menstrual cramps in women
o   Relaxes the nerves
o   Reduces inflammation
o   Improves liver function”
 
Silken Body Butter
  • “Kokum Seed Butter helps reduce degeneration of skin cells, soften skin, heal ulcerations & fissures…”
  • “Shea Butter from Northern Africa promotes fast healing of small wounds, cuts, scrapes, & burns, in addition to performing as an anti-inflammatory agent. It also provides natural UV protection.”
  • “Essential oils…repair damaged cells & act as an antibacterial shield.”
  • Aloe Vera [an ingredient in the product]: “The many benefits of aloe vera include:
o   Soothing skin injured by burns, irritations, cuts and insect bites.
o   Speeding the healing of skin wounds, burns, and other injuries.
o   Relieving itching and swelling of irritated skin.
o   Killing fungus and bacteria.” 
  • Kokum Seed Butter [an ingredient in the product]: “Kokum Seed Butter has a remarkable ability to…heal ulcerations and fissures of lips, hands and soles of feet. It helps reduce degeneration of the skin cells…” 
  • Vitamin E [an ingredient in the product]: “Vitamin E oil is used to treat sunburns. It…soothes the minor damages attained caused by ultraviolet radiations…Vitamin E oil is useful for fading scars on the skin. When it is regularly applied on acne scars or scars caused due to some bruises, it first softens the area and then lightens the mark within a few weeks. The scars will disappear within a few months. It is equally effective in reducing stretch marks.”
  • Jojoba Oil [an ingredient in the product]: “This natural oil is a well-known medicinal oil used for treating eye and throat infections and skin disorders…Benefits of Jojoba Oil include…Helping lighten and heal scars…”
  • Shea Butter [an ingredient in the product]: “It can be effective at treating the following conditions: fading scars, eczema, burns, rashes…and in lessening the irritation of psoriasis… Other benefits of Shea Butter include: Promotes quicker healing of small wounds, burns, cuts and scrapes…” 
  • Hemp Seed [an ingredient in the product]: “Other notable benefits:
o   Helps heal skin lesions…
o   Reduces inflammation of skin and joints
o   Contains pain-killing and anti-nausea properties”
 
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 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 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.  You may respond in writing to 4040 North Central Expressway, Suite 300, Attn: Jamie M. Bumpas, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact Jamie M. Bumpas at 214-253-5336, or at the letterhead address.
 
 
Sincerely,
/S/ 
Gerald D. Bromley
Acting Dallas District Director
  
 
Cc:      
Mr. Greg Wilburn
Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756

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