- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
DATE: April 13, 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 websites at the Internet addresses, https://manhattanstitching.com/shop and https://www.promoplace.com/manhattanstitchingon February 11, 2021, where you offer the “KN95 Face Mask”, “3-ply Face Mask”, and “3-Ply Disposable Youth Face Mask” for sale in the United States. We also reviewed your social media pages at https:// facebook.com/ManhattanStitchingCo/, and https://www.instagram.com/manhattanstitching/, where you direct consumers to your website, https://manhattanstitching.com/shop, to purchase your products. 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 websites revealed the following statements that establish that the KN95 Face Mask, 3-ply Face Mask, and 3-Ply Disposable Youth Face Mask are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:
• “Suitable for respiratory protection, filtering dust, haze, bacteria, droplets and other harmful particles in the air…The US Centers for Disease Control (CDC) now recommends that all Americans wear a fabric face mask outside their homes. We are not taking returns due to the Covid-19.”[https://manhattanstitching.com/shop/ols/products/cloth-face-mask-team-pack-of-50]
• “Disposable Filter Mask 3 Ply Earloop Medical Dental Surgical Hypoallergenic Breathability Comfort Breathable Beauty Medical Dust Mask…The US Centers for Disease Control (CDC) now recommends that all Americans wear a fabric face mask outside their homes. We are not taking returns due to the Covid-19.” [https://manhattanstitching.com/shop/ols/products/kn95-face-mask-pack-of-50]
• “COVID-19, Health, Hospital…Medical”[https://promo.manhattanstitching.com/p/AIMVK-OCGUG/3-ply-face-masks---standard-breathable-melt-blown-filter-disposable-face-masks---astm-level-3]
Based on our review, your websites are offering for sale in the United States, the KN95 Face Mask (which your website indicates is manufactured by JinJiang Rongxin Maternal and Child Supplies Co., Ltd.), 3-ply Face Mask, and 3-ply Disposable Youth Face Mask without marketing approval, clearance, or authorization from 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 misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its 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. See 21 CFR 807.39.
Your website contains a false or misleading representation, including but not limited to:
• Displaying a “Certificate of Registration” (Certification) issued by “Shenzhen Huawin Testing Certification Co., Ltd.” alongside KN95 Face Mask product information. The Certification states that “JinJiang Rongxin Maternal and Child Supplies Co., [Ltd.]…Has Completed With The U.S. Food and Drug Administration…Establishment Registration and Device Listing.” and incorporates unauthorized use of the FDA logo and an illustration of an eagle and a U.S. flag (or a similar flag).
The display of the Certification bearing the FDA logo positioned near images of and information about the KN95 Face Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the KN95 Face Mask and/or establishment based on the represented existence of JinJiang Rongxin Maternal and Child Supplies Co., Ltd.’s registration and possession of a registration number. Although the Certification contains language that appears to be intended to function as a disclaimer, including a statement that the Certification does not denote FDA endorsement or approval and a statement that FDA does not issue or recognize certificates of registration, the small font size and overall placement of the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certification. This representation is 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 product has been reviewed and approved by FDA.
We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue any type of 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 does not denote anything other than 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 health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.2 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.3 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 are 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# 611719 or CTS Number CPT2001786when 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
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
JinJiang Rongxin Maternal and Child Supplies Co., Ltd
No. 3 Xinya Road, Wuli Industrial Park, Jinjiang
Quanzhou, Fujian, China 362200
117 Essex Circle apt D, Guilderland
Guilderland, NY US 12084
Shenzhen Huawin Testing Certification Co., Ltd
7F U Center No. 743 Zhoushi Road
Bao’an Shenzhen, China
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/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.