Inspections, Compliance, Enforcement, and Criminal Investigations

Pharmagel International 5/22/15

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

MAY 22, 2015

WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
Sheri Schauwecker
Pharmagel International
21530 Gledhill Street
Chatsworth, CA 91311
 
 
Re: CMS #454039
 
Dear Ms. Schauwecker:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.pharmagel.net/ in March 2015. Based on this review, you take orders there for your products “Beta-C®,” “Bio-A® Concentrate,” “Eye Firmé®,” “Pharma Clear® Medicated Moisturizer,” and “Slender Shaper®,” which appear to be promoted for uses that cause the products to be drugs under section 201(g)(1)(B) and (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and (g)(1)(C)]. The claims on your website indicate that the 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 the Act. 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 on the website http://www.pharmagel.net/ that provide evidence that your products are intended for use as drugs include:
 
Beta-C®
  • “[H]elps erase and repair the ravages of sun damage”
  •  “[S]timulates collagen production”
  • “BHA penetrates skin to… neutraliz[e] bacteria.”
  • “[A]ge-repairing antioxidant that encourages . . . collagen production”
  •  “[A]n age-repairing antioxidant that promotes the regeneration of damaged . . . skin”
  • “[A]nti-inflammatory”
 
Bio-A® Concentrate
  • “The anti-aging formula speeds healing and increases surface circulation…”
  • “[B]IO-A CONCENTRATE helps control acne by reducing inflammation and bacteria production.”
  • “Retinol reduces that red inflamed appearance associated with Rosacea and acne.”
 
Eye Firmé®
  •  “[S]timulates collagen formation”
  •  “[P]rimary anti-inflammatory”
  •  “[E]chinacea – anti-inflammatory”
  • “Vitamin C supports … production of collagen.”
  • “[P]romotes the regeneration of damaged skin… helps heal wounds …stimulates white blood cells…enhances the immune and lymphatic system”
 
Pharma Clear® Medicated Moisturizer
  • “[C]alms inflammation and redness”
  •  “[P]roven to stimulate collagen and elastin production, assists natural skin repair that helps heal scar tissue”
  • “[H]elps correct the appearance of Rosacea”
  • “[H]eals and prevents acne production … allowing foom [sic] for new cell growth.”
  • “[M]ildly antibiotic …”
  • “Tea Tree - Anitseptic, antifungal and antibacterial”
  • “Tocopherol (Vitamin E) is an age-repairing antioxidant that promotes the regeneration of damaged …skin.”
  • “Copper Peptide is a…powerful skin regeneration agent that effectively treats acne…while calming irritated and inflamed skin. Copper also stimulates collagen and elastin formation.”
 
Slender Shaper®
  • “[I]ncreases fat metabolism”
  • “[W]ake up circulation to help move fat-trapping fluids.”
  • “Fatty areas of the body, neck and chin melt away as fat and water are excreted from skin cells. Cellulite starts to disappear…”
  • “[A] reduction in cellulite in just two weeks”
  • “[E]nhances skin cell’s ability to use oxygen”
  • “[A]ssist with fat metabolism”
  • “[A]nti-inflammatory and decongestant”
  • “[A]ssists with cell absorption”
Your “Beta-C®,” “Bio-A® Concentrate,” “Eye Firmé®,” “Pharma Clear® Medicated Moisturizer,” and “Slender Shaper®” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in 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 in the form of an approved New Drug Application (NDA), as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also 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.
 
A drug is misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)]), can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your “Bio-A® Concentrate” and “Pharma Clear® Medicated Moisturizer” products are intended for prevention or treatment of one or more diseases that are is not amenable to self-diagnosis or treatment. Accordingly, “Bio-A® Concentrate” and “Pharma Clear® Medicated Moisturizer” fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
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 working days, state the reason for the delay and the time frame within which the corrections will be implemented. 
 
You should direct your written reply to Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions regarding this letter, you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.                                                                                               
                                                                                   
Sincerely,
/S/                                                                                               
William A. Correll
Director
Office of Compliance
Center for Food Safety
       and Applied Nutrition

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