NIOSH Conformity Assessment Letter

to Manufacturers

NIOSH CA 2022-1041

February 2022

 

Subject: Effective Immediately – NIOSH fraud and fraudulent statements 

policy and new information about using NIOSH marks 

This notice and NIOSH CA 2022-1040 supersede NIOSH CA 2021-1032
Document Number

NIOSH CA 2022-1041

Page 2 of 3

This NIOSH Fraud and Fraudulent Statements Policy was first included in the February 2021 Conformity 

Assessment Letter to Manufacturers (NIOSH CA 2021-1032). That notice also offered prioritization 

guidance and is now superseded by this notice NIOSH CA 2022-1041 (fraud and fraudulent statements) 

and NIOSH CA 2022-1040 (February 2022 prioritization guidance).

The fraud and fraudulent statements information has been updated to include information for NIOSH 

approval holders that the marks N95, N99, N100, P95, P100, the NIOSH logo, and the term “NIOSHapproved” have been recorded as certification marks.

NIOSH RESPIRATOR APPROVAL PROGRAM CERTIFICATION MARKS

The marks N95, N99, N100, P95, P100, the NIOSH logo, and the term “NIOSH-approved” have been 

recorded with the U.S. Patent and Trademark Office (USPTO) as certification marks. NIOSH, as the 

certifying federal entity for the Respirator Approval Program, owns the certification marks meaning 

that NIOSH controls who can use the marks. Accordingly, NIOSH allows approval holders to use these 

certification marks only if their respirators meet NIOSH’s regulatory standards set forth in Title 42, Part 

84, of the Code of Federal Regulations (42 C.F.R. Part 84).

While these marks have historically been protected under common law (as opposed to a trademark 

registration), these marks are now registered with the USPTO, as federal registrations, as well as in 

various foreign countries and are subject to additional protections under the Lanham Act, 15 U.S.C. §§ 

1051 et seq. and foreign trademark laws. Thus, any misuse of the aforementioned marks, on products 

released to the market, including respirators that have failed to satisfy NIOSH’s regulatory 

requirements or have not received NIOSH approval, is a direct violation of applicable trademark law and 

NIOSH may pursue action as necessary. 

Subject: Effective Immediately – NIOSH fraud and fraudulent statements policy and 

new information about using NIOSH marks

This notice and NIOSH CA 2022-1040 supersede NIOSH CA 2021-1032
Document Number

NIOSH CA 2022-1041

Page 3 of 3

FRAUD AND FRAUDULENT STATEMENTS

If the NIOSH Respirator Approval Program determines, at any time, that an applicant1 or a third party 

acting on behalf of the applicant has engaged in any of the following:

• making any materially false, fictitious, or fraudulent statement or representation, including any 

omission or concealment of substantive fact in any application or application-related material 

or communication; or

• misrepresenting or misusing the NIOSH manufacturers’ code, respirator approval number, or 

NIOSH title or logo; or

• misrepresenting or misusing certification marks including the term “NIOSH-approved” and the 

NIOSH particulate protections N95, N99, N100, P95, and P100,

the NIOSH Respirator Approval Program will discontinue the processing of any current application for 

a certificate of approval from the applicant for the duration of the HHS COVID-19 public health 

emergency declaration first issued on January 31, 20202 and will not process any new application for a 

certificate of approval from the applicant for that same time period.

Information concerning suspected fraud related to the NIOSH Respirator Approval Program will be 

reported to the Department of Health and Human Services’ Office of Inspector General (OIG). Any 

person who knowingly and willfully makes any false statement, misrepresentation, concealment of 

fact, or any other act of fraud to obtain any benefit from the NIOSH Respirator Approval Program is 

subject to civil and/or administrative remedies as well as felony criminal prosecution and may, under 

appropriate criminal provisions, be punished by a fine or imprisonment or both pursuant to 18 U.S.C. § 

1001.

Additionally, due to ongoing, heightened concerns over fraud and misrepresentation, NIOSH will not 

respond to emails that lack recognizable company domains. Examples include emails that look like 

3894876@hotnet.net, cv2009@vip.126.com, or 3273865@qq.com. NIOSH will only respond to 

inquiries concerning an approval application or request from an email address recognizably associated 

with a legitimate business or stakeholder.

1 “Applicant” means an individual, partnership, company, corporation, association, or other organization that designs, 

manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such 

respirator. See 42 C.F.R. § 84.2. 2 See https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx for the most current Renewal of the 

Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of 

Coronavirus Disease 2019 (COVID-19) Pandemic.