FDA WARNING_LETTER - Natures Pillows, Inc. and Top Dog Direct, LLC - August 28, 2024

The FDA issued a Warning Letter to William McAlister regarding the Clean Zone CPAP Sanitizer, offered for sale in the U.S. without marketing clearance or approval. The product is deemed a device under section 201(h) of the Act.

The Clean Zone CPAP Sanitizer is adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. It is also misbranded under section 502(o) for being introduced into interstate commerce without a premarket notification (510(k)) as required by 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(1).

The device's website, http://www.cleanzonenow.com, describes it as using activated oxygen to disinfect CPAP therapy devices and accessories. A previous FDA letter on May 26, 2021, informed NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC that the product appeared to be a device and not a Class I exempt medical device. The firm's response, asserting exemption as a Class I general purpose disinfectant (21 CFR 880.6890) for noncritical devices, was deemed inadequate.

The FDA clarified that CPAP therapy