Department of Health and Human Services
Public Health Service
PO Box 3012
October 23, 1998
VIA FEDERAL EXPRESS
Craig Story, President
Pure Health Solutions, Inc.
105 N 1st Ave #285
Sandpoint, ID 83864
Ref. No. SEA 99-2Mr Story:
On August 27, 1998, Engineer Neil F. Sheller cdected information that revealed a serious regulatory problem involving the product known as the Health Energizer™.
The Federal Food, Drug, and Cosmetic Act (Act), United States Federal law, considers this to be a medical device because it is used to diagnose or treatamedical condition or to affect the structure or function of the body. The law requires manufacturers of medical devices to obtain marketing clearance for their products from the Food and Drug Administration (FDA) before they may 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 other devices already legally marketed in this country.
Our records do not show that you obtained marketing clearance before you began offering your product for sale. The kind of information you need to submit in order to obtain this clearance is described in the enclosed materials. The FDA will evaluate this information and decide whether your product may be legally marketed.
Marketing your product is a violation of the law until you have marketing clearance from FDA. The product is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Your product is adulterated under the Act because you did not obtain premarket approval based on information developed by you that shows your device is safe and effective. Your product is misbranded under the Act because you did not submit information that shows your device is substantially equivalent to other devices that are legally marketed.
This is a serious violation of the law and 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. Other 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 let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problem. We also ask that you explain how you plan to prevent this fi-om happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response to Thomas S. Piekarski, Compliance Officer, at the above mailing address.
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 device and does not necessarily address other obligations you have under the law. You may obtain generaI itiormation about all of FDA's requirements for manufacturers of medical devices by contacting our Division of Small Manufacturers Assistance at 800-638-2041 or through the Internet at www.fda.gov.
Roger L. Lowell
This page was posted on August 20, 2006.