Inspections, Compliance, Enforcement, and Criminal Investigations

Episciences Inc 12/2/15

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22215 261 Avenue SE, Suite 210
Bothell, WA 98021
Telephone: 425-302-0340
FAX: 425-302-0402

 

December 2, 2015
 
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 16-04
 
Carl R. Thornfeldt, M.D.
Chief Executive Officer
Episciences, Inc.
10211 West Emerald Street
Boise, Idaho 83704
 
WARNING LETTER
 
Dear Dr. Thornfeldt:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.epionce.com in December 2015 and has determined that you take orders there for your products “Lytic Gel Cleanser,” “Milky Lotion Cleanser,” “Lite Lytic TX,” “Lytic Plus Tx,” “Lytic Sport Tx,” “Lytic Tx,”“Extreme Barrier Cream,” and “Medical Barrier Cream. ”  The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles (other than food) intended to affect the structure or any function of the human body, rendering them 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 21 U.S.C. § 321(g)(1)(C)]. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include:
 
Your web page titled “How Epionce Helps” (http:www/epionce.com/the-epionce-system/how-epionce-helps/) contains a list of links for skin diseases or other conditions, such as acne, dermatitis/eczema, diabetes related conditions, hyperpigmentation, keratosis pilaris, psoriasis, radiation dermatitis, rosacea, and skin aging. These links connect to other web pages where you recommend your Epionce products be used as part of a “regimen” for a particular skin disease or other condition. These recommendations are accompanied by links to the recommended Epionce products. For example:
 
·       On your web page for the “Regimen for Patients with Diabetes” you recommend using an “Epionce cleaner for skin type,” “Lytic Gel Cleanser,” a “Lytic product suitable for skin type and/or condition,” and an “Extreme Barrier Cream or Medical Barrier Cream.”
 
o   On this page you also state:
 
• “Epionce is the perfect solution to help improve the visible skin conditions associated with diabetes.”
 “Regular use of a topical anti-inflammatory… like Epionce strengthens the skin’s natural ability to repair and protect itself. A healthy skin barrier will help reduce the severity of skin conditions that are common with diabetes….”
 
·       On your web page for the “Regimen for Improving Eczema Symptoms” you recommend using a “Milky Lotion Cleanser” or “Lytic Gel Cleanser for very scaly and/or infected skin,” a “Lytic product suitable for skin type and/or condition,” and a “Medical Barrier Cream” or “Extreme Barrier Cream once in remission.”
 
o   On this page you also state:
 
 “Epionce is the perfect solution to quickly hydrate and restore skin barrier function while reducing inflammatory factors that worsen the symptoms of eczema. Regular use helps reduce the severity of dryness, scaling and itching.”
 “Using a topical anti-inflammatory and barrier repair system like Epionce can help improve barrier function by restoring the correct ratio of key fatty acids found in healthy skin.”
 
·       On your web page for the “Regimen for Improving Psoriasis Symptoms” you recommend using a “Lytic Gel Cleanser,” a "Lytic Plus Tx,” and an “Extreme Barrier Cream…for hydration, barrier repair and anti-inflammatory properties.”
 
o   On this page you also state:
 
 “Epionce is the perfect solution to help relieve the symptoms of psoriasis....”
 “Epionce helps relieve itching and tenderness….”
 
·       On your web page for the “Regimen for Improving Rosacea Symptoms” you recommend using a “Milky Lotion Cleanser” or a “Lytic Gel Cleanser for oily/acne prone skin,” a “Lite Lytic Tx,” and a “Renewal Facial Product.”
 
o   On this page you also state:
 
 “Epionce is the perfect solution to help manage the symptoms by improving barrier function and reducing inflammatory factors that can make rosacea worse.”
 “[Epionce] effectively improves the skin by reducing redness/flushing, irritation and bumps.”
 “Daily use of a barrier repair and anti-inflammatory system like Epionce…may be beneficial to improve your condition.”
 
·       On your web page for the “Regimen to Improve Radiation Dermatitis” you recommend using a “Milky Lotion Cleanser,” a “Lytic product,” and a “Medical Barrier Cream.”  
 
o   On this page you also state:
 
 “Epionce is the perfect solution to help prepare and improve skin function before, during, and after cancer therapy. It can help relieve the redness, swelling and blistering during treatment while reducing pigment changes, dryness and itching post-treatment.”
 
Your web page www.epionce.com/resources/ contains links to PDF files summarizing clinical trials that you claim demonstrate the effectiveness of your Epionce treatment regimen. For example, in the summary titled “Lytic Products Visibly Reduce Actinic Keratoses” you explain that “[a]ccording to an independent, 16 week double-blind, controlled clinical study, visible facial non-hypertrophic actinic keratoses, not involving the nose, were reduced in severity by 75.5% while 61.9% completely resolved after daily use of Epionce® Lite Lytic Tx and Lytic Tx.” In other summaries you describe clinical trials which favorably compare your Epionce treatment regimen to prescription drug products. For example, in the summary titled Melano Corrective System vs Obagi Nu Derm System for Hyperpigmentation,” and “Comparing Epionce and Prevage® MD,” you state that  the Epionce Melano Corrective System is shown to have “comparable efficacy” to the Obagi Nu Derm system, “the prescription gold standard for treating visible signs of hyperpigmentation.” These summaries demonstrate that your Epionce products are intended for use in the cure, mitigation, treatment or prevention of disease and/or affect the structure or any function of the human body and as such are drugs.
 
In addition, an electronic copy of your product catalog can be accessed from your www.epionce.com/resources/ web page and includes claims such as, but not limited to:
 
      “helps reduce irritation and inflammatory factors associated with acne, rosacea, dermatitis and psoriasis.” 
 
This catalog also includes a table denoting which of your firm’s products are appropriate for treating various conditions, such as “Dark Spots/Pigment,” “Acne,” “Rosacea,” “Psoriasis,” and “Eczema.”
Your Facebook page, https://www.facebook.com/Epionce/photos, which has a link to your website at https://www.epionce.com/, where products can be purchased directly, provide further evidence that your products are intended for use as drugs. A few examples found in the “Photos” section of your Facebook page are as follows:
 
•     “Add [Epionce] Intensive Nourishing Cream with Anti-Inflammatory, Keratolytic & Barrier Repair technology to your regimen.” 
•     “Essential Recovery Kit … for faster healing…”
•     “Thanks to [Epionce] Nourishing Cream [my skin is] . . . much less prone to rosacea breakouts…”
     “Spray [Epionce] Purifying Toner on back, arms & legs followed by [(Epionce)] Renewal Body Lotion to reduce body acne…”
•     “Suffering from #eczema? #Epionce Milky Lotion Cleanser & lots of Medical Barrier Cream can help”
•     “You can wash hair & head with [Epionce] Lytic Gel Cleanser to reduce flaking & itch caused by dandruff…”
 
The evidence  summarized above establishes that your Epionce products are intended for use in the cure, mitigation, treatment or prevention of disease and/or to affect the structure or function of the human body, and therefore are “drugs” as defined by section 201(g) of the Act [21 U.S.C. § 321(g)]. Furthermore, each of these products is a “new drug,” as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because its composition is such that it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. 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). The introduction of an unapproved new drug into interstate commerce violates section 301(d) of the Act [21 U.S.C. § 331(d)].  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.
 
 
The Act’s premarket approval requirement for new drugs helps ensure, among other things, that the public is not misled by unsubstantiated claims of safety and effectiveness. The Act’s premarket approval requirement for new drugs also leads to approved product labeling that conveys important information related to the safe and effective use of the product for its intended use, such as indications, dosage, precautions, warnings, and contraindications, as well as information regarding the level of efficacy for each approved intended use. Drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] when the labeling fails to bear adequate directions for use. Adequate directions for use are “directions under which the layman can use a drug safely and for the purposes for which it is intended” (21 C.F.R.§ 201.5).   Your products “Milky Lotion Cleanser,” “Lytic Gel Cleanser,” “Lytic Tx,” “Lytic Plus Tx,” “Lite Lytic Tx,” “Extreme Barrier Cream,” and “Medical Barrier Cream”are offered for the conditions psoriasis, rosacea, and radiation dermatitis 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 and 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 do so may result in enforcement 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. § 334 and 332].
 
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 that 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.
 
Your reply should be sent to Maria P. Kelly-Doggett, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427. 
 
Sincerely,
/s/ 
Miriam R. Burbach
District Director
 
cc: Idaho Department of Health and Welfare  
      450 West State Street, 4th Floor
      Boise, Idaho 83720-0036

 

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