Skin Biology, Inc. 10/11/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
October 11, 2012
In reply refer to Warning Letter SEA 13-01
Charlene Pickart, President/Co-Owner
Skin Biology, Inc.
4122 Factoria Boulevard SE, Suite 200
Bellevue, Washington 98006-5259
Dear Ms. Pickart:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.reverseskinaging.com in October, 2012. Based on this review, your “Copper Sun Tanning & Firming Body Lotion,” “CP Serum,” “BioHeal Cream,” “LacSal Serum,” “Exol Serum,” “Folligen Spray,” “TriReduction Cream,” “Emu Oil S for Skin,” “Protect & Restore Cream,” and “Squalane” products appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(B) and/or section 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 website indicate that these products 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, 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 website include:
In the “Benefits & Testimonals” tab on the purchase page for BioHeal and under the Testimonials tab on the main page of your website, your website contains claims in the form of the following personal testimonials:
- "I had two cysts on my face that would not heal . . .. I finally ordered BioHeal and applied it. . . . The wounds turned darker and started to close up. Within a week, they were healed even though a crater type scar remained. . . . [M]y grandmother had a horrible case of shingles. Nothing the doctor gave her worked even after months of treatment. I brought down some BioHeal for her to use and 7 to 10 days later it was completely healed."
- “I had been burned by very hot coolant from my cars radiator after I opened the radiator cap. The physicians at the hospital thought I would need skin transplants but I started using BioHeal four days after the burn and had complete healing.”
CP Serum and Emu Oil S for Skin
Under the “Eczema, Sjogrens” section in the “Skin Condition” category, in the “RESULTS” tab, your website contains the following claim:
- “ ‘It Worked for Me’ . . . Problem: Eczema (a painful skin inflammation) on her index fingers and thumbs. What she did: tried a Copper-Peptide lotion (CP Serum) meant to be a skin care product, after reading a newspaper story about non-surgical ways to reduce wrinkles. . . . How she did it: Dawson’s hands were so affected that ‘there would be cracks and splits, and they’d be bleeding.’ The story about Copper-Peptide creams mentioned that the creams were originally developed for burn victims and diabetics whose wounds wouldn't heal. . . . Small studies had shown that skin treated with Copper-Peptides had less pigmentation, reduced wrinkling . . ..”
In the “Benefits & Testimonials” tab on the purchase page for Emu Oil S for Skin, your website contains claims in the form of the following personal testimonials:
- “[H]ad a patch of psoriasis on the side of one eye for years. Dermatologists gave me medicines for years without success. Four nights of the Emu Oil for Skin cleared the psoriasis.”
In the “Benefits & Testimonials” tab on the purchase page for Folligen Spray, your website contains claims in the form of the following personal testimonials:
- “[A]fter just 3 applications of the Folligen Spray and Shampoo and Conditioner, I am thrilled to see my hair growing thicker and longer. The biggest bonus though is truly amazing - My hair is now returning to its original youthful brunette color . . ..”
- “My 89 year old mother's hair was shedding and she had developed a bald spot. After she used Folligen Spray, the shedding stopped.”
Under the Testimonials tab on the main page of your website, your website contains a claim in the form of the following personal testimonial:
- “The TriReduction has done wonders . . . in reducing some flat warts elsewhere on my body . . ..”
Copper Sun Tanning & Firming Body Lotion
In the “Benefits & Testimonials” tab on the purchase page for Copper Sun Tanning & Firming Body Lotion, your website contains a claim in the form of the following personal testimonial:
- “I live in Florida and have been using your copper peptides [an ingredient in this product] for three years. When I started my face had extensive sun damage. Recently, my face was examined with sun damage detection system (ultraviolet photography) and found to be free of sun damage except for a small area around my lips where I do not use the copper peptide creams.”
Protect & Restore Cream
Under the Testimonials tab on the main page of your website, your website contains claims in the form of the following personal testimonials:
- “P&R cleared up the eczema on my hands in three days.”
- “I have been trying your products with amazing results. I developed severe cystic acne once reaching the age of 35. I am having wonderful results with P & R #3. I would like to add, I have been to numerous dermatologists for years! There has never been one treatment that can compare to your product.”
LacSal Serum and Exfol Serum
Under the “Acne” section in the “Skin Condition” category, in the “ABOUT THE CONDITION” tab, your website contains the following claim:
- “The key for reducing the appearance of pitted acne seems to be gently massaging LacSal Serum or Exfol Serum into the pitted scar on a daily basis to help slowly dissolve and remove scar tissue. . .. As scar tissue is replaced with healthy skin, the skin’s surface seems to pull itself flat like a balloon.”
In the “Usage & How It’s Different” tab on the purchase page for Squalane, your website contains the following claim:
- “Squalane/Squalane . . . compounds have some anti-cancer properties (Lee and Langer 1983) . . .. In animal studies, mice were protected against the toxicity and injury of radiation when fed a diet supplemented with 2% Squalane (Storm et al, 1993). The compounds also have some anti-fungal properties and enhances the effects of Amphotericin B (Fungizone) against a variety of candida species Masuda et al, 1982).”
Under the Testimonials tab on the main page of your website, in the “Sensitive Skin Concerns Testimonials” section, your website contains the following claim:
- “I was amazed to see enough improvement on the first squalane application to apply makeup relatively smoothly, and within three days, I saw a 97% improvement in my dermatitis . . .. I highly recommend replacing at least one of the daily corticosteroid applications with squalane. It’s more effective and carries none of the insidious medical risks of steroids.”
Male Hair Loss
In the “ABOUT THE CONDITION” tab, you claim:
- “Many of our customers have reported that the combination of Folligen and emu oil often help revitalize hair. Recently, Dr. Michael Holick (Boston University Medical Center) reported a clinical study that found emu oil accelerated skin regeneration and also stimulated hair growth. He wrote - ‘The hair follicles were more robust, the skin thickness was remarkably increased... Also, we discovered in the same test that over 80 percent of hair follicles that had been 'asleep' were awakened, and began growing hair.’ ”
Your products are not generally recognized as safe and effective for the above referenced uses; therefore, the products are “new drugs” as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505 of the Act [21 U.S.C. § 355], new drugs may not be legally marketed in the United States without 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.
Furthermore, your products “BioHeal Cream,” “CP Serum,” “Emu Oil S for Skin,” and “Squalane” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
This letter is not an all-inclusive list 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 all of 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 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, 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].
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. Include any documentation necessary to show that correction has been achieved. 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 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.
Your written response should be sent to Lisa M. Althar, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Bothell, Suite 210, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Lisa Althar at 425-302-0427.
Charles M. Breen
cc: Loren Pickart, Vice-President/Co-Owner
Skin Biology, Inc.
4122 Factoria Boulevard SE, Suite 200
Bellevue, Washington 98006-5259