Inspections, Compliance, Enforcement, and Criminal Investigations
Toby's Nose Filters, Inc. 02-Aug-06
Department of Health and Human Services
Public Health Service
Center for Devices and Radiological Health
August 2, 2006
RETURN RECEIPT REQUESTED
Mr . Toby McCormick
Toby's Nose Filters, Inc .
3585 N Courtenay Parkway #6
Merritt Island, FL 32953
Dear Mr . McCormick :
On June 7, 2006, the Food and Drug Administration (FDA) obtained information from your Internet web site, http://www.Birdflufilter.net/, that revealed a serious regulatory problem involving Bird Flu Nose Filters and the Bird Flu Surgical Mask that are offered for sale and commercially distributed by your firm. (These nose filters are also sold through your website, http://www.NoseFilters.com.)
Your web site makes statements indicating that the masks and filters that you sell offer protection against the bird flu virus and more generally can kill microbes, including bacteria and viruses. For example, under the heading of "Concerned about the Bird Flu Virus? You should be!" the website states:
Toby's Nose Filters, Inc. with the assistance of the NASA funded SATOP program has developed a solution to your problem dealing with viruses and-bacteria. The answer is impregnated copper oxide material. This material does not just filter the virus, it kills it on contact. The impregnated copper fabric is found both in the nose filters and masks sold on this website.
Similarly, under a section entitled, "Bird Flu Protection," your website makes the statement "This NIOSH N95 mask is the only mask with built-in anti-microbial fiber protection, killing microbes on contact. Our nose filters contain exactly the same material." In addition it states, "...for the absolute maximum protection, wear a bird flu nose filter all the time. When you are exposed to crowds, or animals, especially birds, put on your Bird Flu Mask.
These and other similar statements throughout your website indicate that Bird Flu Nose Filters and the Bird Flu Surgical Mask are intended for use in the cure, mitigation, treatment, or prevention of disease and are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 321(h). The law requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products by FDA before you 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 for which approval is not required.
Our records do not show that approval or clearance has been obtained for Bird Flu Nose Filter or the Bird Flu Surgical Mask to protect one from viruses that cause bird (avian) flu.
Accordingly, these products are adulterated under section 501 (f) (1) (B) of the Act, 21 U.S.C. 351 (f) (1) (B), in that they are class III devices under section 513(f), 21 U.S.C. 360c(f), and you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a), 21 U.S.C. 360e(a), or approved applications for investigational device exemption under section 520(g), 21 U.S.C. 360j(g). These products are also misbranded under section 502(o), 21 U.S.C. 352(o), because notices or other information respecting them were 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 may also 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.
It is necessary that you take action now. Please respond in writing, within fifteen (15) working 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.