Inspections, Compliance, Enforcement, and Criminal Investigations
Holistic Healing Devices
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
JAN 11 2010
VIA FEDERAL EXPRESS
Holistic Healing Devices
5592 Municipal Square
Greendale, Wisconsin 53129
RE: Devices listed on www.holistichealingdevices.com
Refer to CTS #GEN0900848 when replying to this letter
Dear Mr. Kreil
The Food and Drug Administration (FDA) has learned that your firm is marketing the Body/Molecular Enhancer, the Thermo Therapy Unit for prostate and vaginal use, and the Breast Health Beauty Spa Equipment in the United State (U.S.) without marketing clearance or approval, in violation of the Federal food Drug and Cosmetic Act (the Act).
The Office of Compliance in the Center for Devices and Radiological Health (CDRH) reviewed the promotional materials available on your website, www.holistichealingdevices.com, for medical devices, including the Body/Molecular Enhancer, the Thermo Therapy Unit for prostate and vaginal use and the Breast Health Beauty Spa Equipment on January 7 2010. The products are device within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(b) because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation treatment or prevention of disease or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review four records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale which is a violation of the law. These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B) because you do 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 (IDE) under section 520(g) of the Act 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by sections 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 devices are 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 products may be legally marketed.
Specifically, your website makes a variety of medical claims for the Body/Molecular Enhancer, the Thermo Therapy Unit for prostate and vaginal use, and the Breast Health Beauty Spa Equipment. For example, your website states:
Body/Molecular Enhancer - "People have reported relief with Fibromyalgia, Lupus, paralysis, gangrene, edema, heart conditions, arthritis, severe back pain, swelling, Increased energy, increased mental clarity, better sleep, help with abnormal cells and soooooo much more like the big C and Diabetes;" "lmproves nutrient absorption and assimilation because the cells become more permeable (opens up);" "Improves digestive because the blood flow gets to the stomach to aid in digestion and stimulates metabolism becuase [sic] it improves the liver/pancreas function;" "'Speeds recovery after surgery and injuries because the circulation is improved;" and "Releases toxins and heavy metals, moves the lymphatic system."
Thermo Therapy Unit for prostate and vaginal use - "Thermo Therapy Units are for vaginal conditions, the healing of hemorrhoids and correction of various prostate conditions using hyperthermia;" and '''The unit can also be used on lowered and weakened immune systems to promote the production of leukocytes (white blood cells) by making the body believe it is fighting a non-existent fever."
Breast Health Beauty Spa Equipment - "[E]liminate cellular tissue;" "Remove measles;" and "Lymphs [sic] toxin removal."
The Office of Compliance requests that Holistic Healing Devices immediately cease the dissemination of promotional materials for medical devices including, but not limited to, the Body/Molecular Enhancer, the Thermo Therapy Unit for prostate and vaginal use, and the Breast Health Beauty Spa Equipment, the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for your medical devices including, but not limited to, the Body/Molecular Enhancer, the Thermo Therapy Unit for prostate and vaginal use, and the Breast Health Beauty Spa Equipment the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Amy Skrzypchak at the Food and Drug Administration, 10903 New Hampshire Avenue, WO66-3621, Silver Spring, Maryland 20903. facsimile at (301) 847-8138. We remind you that only written communications are consider 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 your medical devices including, but not limited to the Body/Molecular Enhancer, the Thermo Therapy Unit for prostate and vaginal use, and the Breast Health Beauty Spa Equipment comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and