Inspections, Compliance, Enforcement, and Criminal Investigations
Toby's Nose Filters, Inc. 5/25/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Windertey Pl., Ste. 200
Maitland, FL 32751
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 25, 2010
Mr. Lester E. McCormick
Vice President of Operations
Toby's Nose Filters, Inc.
3585 N. Courtenay Parkway, Suite 6
Merritt Island, Florida 32953
Dear Mr. McCormick:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Nasal Dilator Kit, consisting of the Breath-Mate mouth piece and the Max Air nasal dilators, and Toby's Nose Filters in the United States (US.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Heath (CDRH) reviewed your website at the Internet addresses http://www.nosefilters.com; http://nosefilters.com; and http://tobysnosefilters.net for the Nasal Dilator Kit, consisting of the Breath-Mate mouth piece and the Max Air nasal dilators, and the Toby's Nose Filters. The products are devices within the meaning of section 201(h) of the Act 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 are intended to affect the structure or function of the body.
A review of our records revealed that the Nasal Dilator Kit, consisting of the Breath-Mate mouth piece and the Max Air nasal dilators, and the Toby's Nose Filters 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) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is 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.
Additionally, a review of our records revealed that your establishment registration for Toby's Nose Filters, Inc. is not current and there is no device listing for the Nasal Dilator Kit, consisting of the Breath-Mate mouth piece and the Max Air nasal dilators, and the Toby's Nose Filters. Consequently, these devices are also misbranded under section 502(0) of the Act, 21 U.S.C. 352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. 36O(j).
You should take prompt action to correct the violations addressed in this letter. 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. Also, federal agencies are advised of the issuance of an Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action· you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Food and Drug Administration, Salvatore N. Randazzo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. We remind you that only written communications are considered official. If you have any questions about the content of this letter, please contact Mr. Randazzo at (407) 475-4712.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Emma R. Singleton
Director, Florida District