NIOSH Conformity Assessment Letter

to Manufacturers

NIOSH CA 2023-1056

April 2023

 

Subject: NIOSH fraud and fraudulent statements policy and information 

about the NIOSH Respirator Approval Program certification marks

This notice supersedes NIOSH CA 2022-1041-R1.
Document Number: NIOSH CA 2023-1056 Page 2 of 3

The NIOSH Fraud and Fraudulent Statements Policy, published as a letter to manufacturers in July 2022

(NIOSH CA 2022-1041-R1), has been updated because the HHS COVID-19 public health emergency is no 

longer being renewed effective May 11, 2023. This notice provides updated information for NIOSH 

approval holders, applicants, and other interested parties about several NIOSH Respirator Approval 

Program certification marks that have been registered with the U.S. Patent and Trademark Office 

(USPTO). 

NIOSH RESPIRATOR APPROVAL PROGRAM CERTIFICATION MARKS

NIOSH, on behalf of the Department of Health and Human Services (HHS), registered several

certification marks with the USPTO that are specific to NIOSH Approved® respirators to help combat 

the sale of respirators that are counterfeit or are misrepresented as being approved by NIOSH. These

registered certification marks currently include the NIOSH stylized logos with and without full text, 

NIOSH Approved®, and certification marks, such as N95® and P100®, that correspond to the approved 

respiratory protection levels for powered and non-powered air-purifying respirators (APRs). The

registered certification marks can be found on the NIOSH Post-market Evaluations Conducted by 

NIOSH webpage under the section Protecting End Users from Wearing Respirators Being 

Misrepresented as NIOSH Approved® Respirators.

HHS is the owner of these certification marks and NIOSH, as the certifying federal entity for the 

Respirator Approval Program, is the custodian of these marks. This means that NIOSH administers and 

controls who can use these marks. Accordingly, the certification marks may only be used by approval 

holders in reference to respirators that NIOSH has approved under 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, they are now registered with 

the USPTO and are therefore subject to additional protections under the Lanham Act, 15 U.S.C. §§ 

1051 et seq. In addition to being registered in the United States, N95 and NIOSH Approved are 

registered in several international jurisdictions. Any misuse of the aforementioned marks on products 

released to the market or associated with their packaging or marketing description, including (1) 

respirators that have failed to satisfy NIOSH’s regulatory requirements or have not received NIOSH 

approval, and (2) any other type of face-worn products falsely claiming to be approved by NIOSH, is a 

direct violation of applicable trademark law and may be subject to enforcement action.

Subject: NIOSH fraud and fraudulent statements policy and information about the 

NIOSH Respirator Approval Program certification marks
Document Number: NIOSH CA 2023-1056 Page 3 of 3

FRAUD AND FRAUDULENT STATEMENTS

If the NIOSH Respirator Approval Program determines, at any time, that an approval holder, applicant,

1

a third party acting on behalf of the applicant, or any other entity 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 manufacturer code, respirator approval number, or 

NIOSH title or logo; or

• Misrepresenting or misusing any NIOSH or Respirator Approval Program-associated certification 

marks,

this information may be reported to the HHS Office of the General Counsel (OGC) and the 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 may be 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 concerns over fraud and misrepresentation, NIOSH will not respond to emails that 

lack recognizable company domains. Examples include emails such as 3894876@hotnet.net, 

cv2009@vip.126.com, or 3273865@qq.com. NIOSH will only respond to inquiries about an approval 

application or request from an email address recognizably associated with a legitimate business or 

organization.

P100 is a certification mark of the U.S. Department of Health and Human Services (HHS) registered in the United States.

N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United 

States and several international jurisdictions.

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.