- Medical Devices
16777 SW 36th Street
Miramar, FL 33027
- Issuing Office:
- Center for Devices and Radiological Health
DATE: September 3, 2021
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at https://www.databazaar.com/collections/kn95-respirator-masks on August 17, 2021. The FDA has observed that your website offers the “KN95 Mask” for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
FDA’s review of your website revealed the following statements that establish that the KN95 Mask is intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:
- Representing that the KN95 Mask is a “Non-NIOSH Approved Respirator” that provides "> 95% Filtration” and is “used … by healthcare professionals against… infectious agents, and viruses”, “for protection against the coronavirus” and to “…prevent the spread of germs and protect yourself from airborne particles, pollen, and other allergens”. [https://www.databazaar.com/collections/kn95-respirator-masks].
Based on our review, your website is offering for sale in the United States the KN95 Mask (which your website represents is manufactured by Dongguan Sengtor Plastics Products CO., LTD.) without marketing approval, clearance, or authorization from the FDA. Accordingly, these products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
In addition, the KN95 Face Mask is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. Specifically, your website contains false or misleading representations, including but not limited to:
- Stating that the KN95 Masks are “CDC Approved & FDA Certified KN95 Mask…”, “FDA Approved & CDC Registered”, “FDA CE Certified”, “Appendix A: Authorized Imported, Non-NIOSH Approved Respirators” alongside images of and information about the KN95 Mask [https://www.databazaar.com/collections/kn95-respirator-masks]
- Unauthorized use of the FDA logo displayed alongside images of and information about the KN95 Mask [https://www.databazaar.com/collections/kn95-respirator-masks]
FDA has not approved the KN95 Masks, so statements to the contrary are false. Further, display of the FDA logo on and/or near images of and information about the respective products, combined with statements about having active status with the FDA, is misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS2. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-193. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described above, you sell products that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of any adulterated and misbranded products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. This letter is not meant to be an all-inclusive list of violations that exist in connection with the product or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations.
This letter is not meant to be an all-inclusive list of violations that exist in connection with the product or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing the products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, authorized by FDA and that you do not make representations that misbrand the product(s) in violation of the Act.
This letter notifies you of our concerns and provides you with an opportunity to address them. Please notify this office in writing within fifteen 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. Your firm’s response should be comprehensive and address all violations included in this letter. If you believe that the product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the Document number CMS Case Number 617199 or CTS Number CPT2001486 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Assistant Director, Paola Barnett at 301-796-5462 or Paola.Barnett@fda.hhs.gov.
Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Dongguan Sengtor Plastics Products CO.,
No.16 Puxin Commercial Street, Shipai Town
Dongguan, Guangdong CN 523338
Email: email@example.com or firstname.lastname@example.org
UGK-LVM UNITED INC.
6547 N Academy Blvd
Berkeley Lake, GA 80918
1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
3 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.