Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
Center for Devices and Radiological Health
August 2, 2006
RETURN RECEIPT REQUESTED
5537 Balboa Ct .
Pinson, AL 35126
Dear Mr . Etheredge:
On March 3, 2006, the Food and Drug Administration (FDA) obtained information from your Internet web site, http://www.paradevices.com/, that revealed you are promoting the ParaZapper™ without premarket clearance or approval from FDA.
The law requires that manufactures 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 newly introduced devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
According to your web site, "[t]he Parasite Zapper originally introduced by Dr. Hulda Clark can provide relief from many illnesses caused by parasites such as giardia, cryptosporidium, flukes, other colon parasites and intestinal parasites in humans." You further claim, for example, that:
ParaZapper is a "safe, simple, easy way to eliminate parasites" that cause colds and flu;
ParaZapper "can be an effective arthritis pain remedy";
ParaZapper can reduce "food allergies, allergy, low resistance to illnesses such as colds and flu, asthma, diarrhea, ibs ( irritable bowel syndrome ), colitis, chronic fatigue syndrome, and malaise";
ParaZapper is "safe and effective" for treating "persistant or recurring athletes foot, foot fungus, toenail fungus, ringworm, and other fungus symptoms."
Your product is therefore a device as that term is defined in section 201(h) of the Federal Food, Drug and Cosmetic Act ("the Act") because it is intended for use in the cure, mitigation, treatment, or prevention of disease.Our records do not show that you have received clearance or approval from FDA to market the ParaZapper™. Indeed, as your web site acknowledges, "FDA approval has not been applied for" for the ParaZapper™.
Accordingly, this product is adulterated under section 501 (f) (1) (B) of the Act, 21 U.S.C. 351 (f) (1) (B) , in that it is a class III device under section 513(f), 21 U.S.C. 360c(f), and you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a), 21 U.S.C. 360e(a), or an approved application for investigational device exemption under section 520(g), 21 U.S.C. 360j(g). The product is also misbranded under section 502(o), 21 U.S.C. 352(o), because a notice or other information respecting it was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k). For a product requiring premarket approval, the notification required by section 510(k) is deemed to be satisfied when a PMA is pending before the agency, 21 CFR 807.81(b).
This serious violation of the law may result in the FDA taking regulatory action without further notice to you. Such action can include, but is not limited to, seizing your product inventory, obtaining a court injunction against further marketing your products, or seeking civil money penalties. Individuals and businesses that violate the Act also may be subject to criminal prosecution. Also, Federal agencies are informed about the warning letters we issue, such as this one, so that they may consider this information when awarding government contracts.
Please respond in writing, within 15 days of receiving this letter, by explaining the specific steps you have taken to correct this violation and to assure that similar violations will not occur. If you need additional time, please explain the reason for the delay and advise us when you expect to respond. Please address your response to Carolyn Niebauer, Chief, General Hospital Devices Branch, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road (HFZ-320), Rockville, Maryland 20850. If you have any questions concerning the contents of this letter, you may contact Ms. Niebauer by telephone at (240) 276-0115 or by facsimile at (240) 276-0114.
You should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket clearance or approval for your devices and does not necessarily address other obligations you have under the Act. You may obtain general information about FDA requirements for medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or through the Internet at http://www.fda.gov.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health