Inspections, Compliance, Enforcement, and Criminal Investigations
BioHarmonics Research and Consulting 14-Oct-05
Department of Health and Human Services
Public Health Service
Atlanta District Office
October 14, 2045
VIA HAND DELIVERY
Alan E. Townsend, Managing Director
BioHarmonics Research and Consulting
4215 Jimmy L. Smith Parkway
Hiram, GA 30141
Dear Mr. Townsend:
During an inspection of your establishment on June 7-9, 2005, an investigator from the Food and Drug Administration (FDA) determined that your firm is a manufacturer and own label distributor of "The Harmonizer™." This product is promoted in your BioEnergy Manual and on your internet sites [www.bioharmonics.com and www.rifebioharmonics.com] as a frequency generator with 18 preset programs, designed specifically for the BioHarmonics Program. It is described as the only frequency generator specially designed and endorsed for BioHarmonics therapy. The Harmonizer ™ is promoted as "The Preferred Frequency Therapy" and as superior to other frequency devices for therapeutic treatment of the bioenergy system.
Your manual which accompanies each Harmonizer™ shipment states that the Harmonizer™ helps the bioenergy system to tune itself and bring it back into a harmonious health state. Your BioEnergy Manual 2003 for the Harmonizer™ includes general instructions on the use of the device and an extensive listing of the conditions and ailments which it can be used for. These conditions include cancer, circulation problems, neurological disorders, respiratory ailments, urinary tract disorders, blood clots, male disorders, sinusitis, skin conditions, digestive tract disorders, female disorders, eye conditions, ear problems, colon disorders, breast problems, and many others.
Under a United States Federal law, the Federal Food, Drug, and Cosmetic Act (the Act), this product is considered to be a medical device 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. Medical devices are defined in section 201(h) of the Act [21 U.S.C. 321(h)]. The law requires that manufacturers of medical devices obtain marketing clearance for their products from FDA before they offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be either safe and effective or substantially equivalent to another device already legally marketed in this country. Our records do not show that you obtained marketing clearance before you began offering your device for sale. The kind of information you need to submit in order to obtain this clearance is described on FDA's device web site at www.fda.gov/cdrh/devadvice. The FDA will evaluate this information and decide whether your product may be legally marketed.
Because you do not have marketing clearance from the FDA, marketing your product is a violation of the law. In legal terms, the device is adulterated under section 501(t)(1)(B) [21 U.S.C. 351(f)(1)(B)] and misbranded under section 502(o) [21 U.S.C. 352(o)] of the Act. Your device is misbranded under the Act because you did not submit a premarket notification submission in accordance with section 510(k) [21 U.S.C. 360(k)] of the Act. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that your device is substantially equivalent to other legally marketed devices, your device is also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a device requiring pramarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency [Title 21, Code of Federal Regulations (21 CFR) 847.81(b)].
Your device is also misbranded under section 502(o) in that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered with FDA. You have failed to register with FDA as a manufacturer of medical devices.
You should know that this serious violation of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. 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.
It is necessary for you to take action on this matter immediately. Please let this office know in writing within fifteen (15) working days from the date you receive this letter what steps you are taking to correct the problem. We also ask that you explain how you plan to prevent these violations from happening again. If you need more time, let us know why and when you expect to complete your corrections. Please direct your response to Philip S. Campbell, Compliance Officer, at the letterhead address.
Finally, 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 for your Harmonizer™ device and does not necessarily address other obligations you have under the law. You should also immediately review the other products you currently distribute to determine if they also comply with applicable FDA regulations. If you have. more specific questions about how FDA marketing requirements affect your device(s), or about the content of this letter, please feel free to contact Mr. Campbell at (404) 253-1280.
Mary H. Woleske, Director