Does the agency correspondence identify the exact addressee entitled to rely on it?

Does the agency correspondence identify the exact addressee entitled to rely on it?

The company's position rests on written documents that name their own audience, and on no correspondence at all.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. The company classifies the NanoFlashing™ Air Filter as a device under section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act and the definition at 40 C.F.R. § 152.500(a). Under 40 C.F.R. § 152.500(b), a device is not required to be registered under FIFRA section 3, and the requirements listed there apply instead. The company publishes no agency decision about the article and claims none. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. The same rule holds for the European Commission's answer that the company's Statement of Regulatory Status quotes. On 16 December 2025 the European Commission answered a written question in the European Parliament about filtration technologies. The answer did not name the company or the product.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 3.6; 40 C.F.R. § 152.500, as published on eCFR.

Reviewed on 21 September 2026.