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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Body, Mind & Soul, Inc. 3/13/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

 

March 13, 2013
WARNING LETTER
 
Colette Haddad
Owner
Body, Mind & Soul, Inc.
415 Jarvis Street, Suite 335
Toronto, Ontario M4Y 3C1
Canada
 
RE: Celluderm  
Refer to CMS # 392869 when replying to this letter.
 
Dear Ms. Haddad:
 
The Food and Drug Administration (FDA) has learned that your firm is marketing the Celluderm in the United States . This product is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. As explained below, this device is being marketed without required clearance or approval in violation of the Act.  
 
During an inspection of your contract manufacturer, Innovative Med Inc., FDA learned that your firm is marketing and distributing the Celluderm as a therapeutic massager. 
 
The Office of Compliance in the Center for Devices and Radiological Health reviewed your website, www.bmsoul.com/celluderm.html and your Operator’s Manual and Technology Manual for the Celluderm.  The Celluderm appears to be a therapeutic massager. A therapeutic massager is identified by 21 CFR 890.5660 as an electrically powered device. Generic devices of this type are intended for medical purposes, such as to relieve minor muscle aches and pains. However, you are marketing the Celluderm for other intended uses.  For example, Page 3 of the Celluderm Operating Manual states:
 
  • “Celluderm System on its own is a highly effective method of stimulating the lymphatic system and reducing congestion…drains the fat that has been released into the blood and lymphatic system and attacks the top layer of the fat, breaking up the congestion that contributes to sluggish lymphatic flow”.
  • " ...break up fat congestion pulling the breakdown of fats through the softened cell membrane and into the interstitial fluid"
  • “Celluderm treatment progressively wears down congestion by manipulating body tissue using a vacuum suction massage.”
     
Additionally, Page 1 of the Technology Manual states:
 
“Benefits of Celluderm Treatments
 
  • Immune System Booster
  • Reduces Water Retention and Edema
  • Fibromyalgia Relief
  • Restless Legs Relief
  • Relieves Headaches
  • Breast Cyst Reduction”
 
Because the Celluderm is distributed with new intended uses, it exceeds the limitations of exemption described in 21 CFR 890.9 and is not exempt from premarket notification.
 
Therefore, the Celluderm is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The Celluderm is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency.  21 CFR 807.81(b).  The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
The Office of Compliance requests that Body, Mind & Soul immediately cease the dissemination of promotional materials for Celluderm the same as or similar to those described above. You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. 
 
Additionally, under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2013.
 
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
 
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for Celluderm the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.  Please direct your response to LaShanda Longat the Food and Drug Administration, 10903 New Hampshire Ave. WO66-3520, Silver Spring, MD 20993, facsimile at (301) 847 - 8137.  We remind you that only written communications are considered official.
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Celluderm comply with each applicable requirement of the Act and FDA implementing regulations. 
 
Sincerely yours,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
    Radiological Health