FDA WARNING_LETTER - Toby's Nose Filters, Inc.

On May 25, 2010, the FDA issued a Warning Letter to Toby's Nose Filters, Inc. for marketing the Nasal Dilator Kit (Breath-Mate mouthpiece and Max Air nasal dilators) and Toby's Nose Filters without marketing clearance or approval. The FDA's Office of Compliance reviewed the firm's websites (nosefilters.com, tobysnosefilters.net) and determined these products are "devices" under the Federal Food, Drug, and Cosmetic Act.

The devices are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to submit a 510(k) premarket notification.

Furthermore, Toby's Nose Filters, Inc.'s establishment registration is not current, and the devices are not listed, rendering them misbranded under section 502(o) for being manufactured in an unregistered establishment and not included in a required device list.

The FDA requires prompt corrective action within fifteen working days, including a written explanation of steps taken, documentation, and a timetable for future corrections. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and denial of Certificates to Foreign Governments. This letter is not an exhaustive list of violations, and the