- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
DATE: May 21, 2021
Re: “3 ply Surgical Mask,” “Disposable Protective Mask,” “Mask Disposable Protective,” and “Personal Protective Face Mask”
Dear Mr. Hakim:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://masksupply.store/ on March 12, 2021. The FDA has observed that your website offers the “3 ply Surgical Mask,” “Disposable Protective Mask,” “Mask Disposable Protective,” and “Personal Protective Face Mask” for sale in the United States. Based on our review, these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).We also note that the Personal Protective Face Mask is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people.
FDA’s review of your website revealed the following statements that establish that the products are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, including but not limited to:
- The name of the “3 ply Surgical Mask” represents that the product is a surgical mask [https://masksupply.store/]
- Display of an image of the Disposable Protective Mask, represents that the product is “Anti fungus…anti flu” and has a “>95% Pellet matters filter ratio” [https://masksupply.store/]
- Display of an image of the Mask Disposable Protective, represents that the product is “Anti-germ” [https://masksupply.store/]
- Representation that the Personal Protective Face Mask is “for COVID-19 Prevention” [https://masksupply.store/]
The 3 ply Surgical Mask, Disposable Protective Mask (which your website indicates is manufactured by “WEIDA Medical apparatus Co., Ltd”), Mask Disposable Protective, and Personal Protective Face Mask are offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the 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 products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to a firm’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. 21 CFR 807.39.
Your website contains a number of false or misleading representations, including but not limited to:
- Stating that the Personal Protective Face Mask is “FDA Approved,” incorporating unauthorized use of FDA’s logo2 [https://masksupply.store/]
- Unauthorized use of FDA’s logo2 displayed in an image of the Mask Disposable Protective’s package [https://masksupply.store/]
- Displaying a “Certificate of FDA Registration” also referred to as a “FDA Certificate 3 Ply Mask” (Certificate) issued by “UCL-Reg Service Inc” near information about the products. The Certificate may be viewed by clicking on a link to “View Our Certificates.” The Certificate “certifies that Weida Medical Equipment (Wuxi) Co. Ltd … has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” Although some of the text is illegible, the Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo and an illustration of an eagle with the U.S. flag (or a similar flag) [https://masksupply.store/images/worldofgivingcovid19-certificate.pdf]
FDA has not approved the Personal Protective Face Mask, so statements to the contrary are false. Further, the unauthorized use of the FDA logo on an image of the Mask Disposable Protective is misleading because it implies FDA approval, clearance, authorization, endorsement, or other evaluation of the device. In addition, the Certificate, displayed near images of and information about the 3 ply Surgical Mask, Disposable Protective Mask, Mask Disposable Protective, and Personal Protective Face Mask, is misleading because it implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the devices and/or establishment based on representations that Weida Medical Equipment (Wuxi) Co. Ltd is or was registered and that the firm is or was in possession of a registration number. Although blurry, the Certificate may contain language intended to function as a disclaimer. However, the small font size and overall placement of any such language could be easily overlooked and would not limit or otherwise mitigate the misleading impression created by the use of the Certificate. These 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 has been reviewed and approved by FDA.
We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue device registration certificates to medical device establishments, including to sellers and manufacturers. When an establishment registers and lists its devices, the resulting entry in FDA’s Establishment Registration & Device Listing Database merely denotes that the establishment has provided certain information to 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 b health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.4 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 a product 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. We advise you to review your website, product labels, and other labeling and promotional materials to ensure 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 address 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 any actions your firm has taken. If your firm’s planned 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 products are 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# 612585 or CTS Number CPT2000665 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.
Donna Engleman, MS. BSN.
Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Dalcom USA Ltd.
11 Middle Neck
Great Neck, NY 11021
Email Address: Fred.Hakim@masksupply.com
Weida Medical Equipment (Wuxi) Co., Ltd.
No. 155, Wuyu Road, Yuqi Street, Huishan District
Wuxi Jiangsu, CN 214000
143 Division St
New York, NY 10002
602 Rockwood Road
Wilmington, DE 19802
1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2 The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy).
3 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.
4 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/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.