- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
DATE: March 11, 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 the Internet address https://maskshell.com/. The FDA has observed that your website offers the “KN95 Dust Masks Full Face Mask Protection Filtration >95% Safety N95 Mask” (KN95 Dust Mask), “Medical grade surgical mask”/“Disposable Anti-Dust Breathable 3-layered Masks” (Medical Grade/Surgical Mask), and “Kids Mask Disposable Protective Mask Safety Masks Children Prevent Disease Mask” (Disease Prevention Mask for Child) 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).
Based on our review, your website is offering for sale in the United States, the KN95 Dust Mask (which your website represents is manufactured by Zhongshan Dongfeng HuangShang Electronic Factory), the Medical Grade/Surgical Mask (which your website represents is manufactured by Shenzhen Keyu Electronic Material Trading Co., Ltd.), and the Disease Prevention Mask for Child (which your website represents is manufactured by Huizhou Shuangzuan Protection Technology 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, these 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. See 21 CFR 807.39.
Your website contains a number of false or misleading representations, including but not limited to:
- Unauthorized display of what appears to be FDA’s logo2 above an illustration of a mask, on the top left corner of your website.
- Displaying a “Certification of Registration” (KN95 Dust Mask Certification) issued by “HealReg Service Inc.” alongside KN95 Dust Mask product information. The Certification “certifies that Zhongshan Dongfeng HuangShang Electronic Factory…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” and incorporates unauthorized use of the FDA logo2.
- Displaying a “Certification of Registration” (Medical Grade/Surgical Mask Certification) issued by “Shenzhen SHT Testing Technology Co. Ltd.” alongside Medical Grade/Surgical Mask product information. The Certification “certifies that Shenzhen Keyu Electronic Material Trading Co., Ltd…was registered with US Food & Drug Administration…pursuit [sic] to the Code of Federal Regulations 21 CFR 807…” and incorporates unauthorized use of the FDA logo2.
- Displaying a “Certification of Registration” (Disease Prevention Mask for Child Certification) alongside the Disease Prevention Mask for Child product information. The Certification “certifies that Huizhou Shuangzuan Protection Technology Co., Ltd…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug.” Although some of the small text is blurry, the Certification incorporates unauthorized use of the FDA logo2.
Taken together, display of screenshots from FDA’s Establishment Registration & Device Listing Database and the KN95 Dust Mask Certification, bearing the FDA logo, positioned near images of and information about the product are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the KN95 Dust Mask and/or establishment based on the existence of Zhongshan Dongfeng HuangShang Electronic Factory’s registration and possession of a registration number. In addition, display of the Medical Grade/Surgical Mask and Disease Prevention Mask for Child Certifications, each bearing the FDA logo, near images of and information about the respective products is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments based on the existence of the firms’ registrations and possession of registration numbers. Although the KN95 Dust Mask and Medical Grade/Surgical Mask Certifications contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certifications do not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of such language could be easily overlooked and does not limit or otherwise mitigate the misleading impression created by the use of the Certifications. 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.
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 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 HHS3. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-194. 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 products 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.
If you are not located in the United States, please note that products that appear to be adulterated or misbranded may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
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# 611829 or CTS Number CPT2000955 & CPT2001078 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
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Zhongshan Dongfeng HuangShang Electronic Factory
2/F, No.172, south of Dongfeng Avenue, Anle village,
Dongfeng Town, Zhongshan City Guangdong, CN 528425
South Bay Innovation, LLC
1515 Maple Avenue
Torrance, CA US 90503
HealReg Service Inc.
113 Barksdale Professional Center
Newark, DE 19711
Shenzhen Keyu Electronic Material Trading Co., Ltd.
D25, Floor 3, Duilding 23, Dayun Software Town, 8288 Longgang Avenue,
Yuanshan street, Longgang District, Shenzhen Guangdong, CN 518000
704 Bergen St 1fl
Harrison, NJ 07029
Shenzhen SHT Testing Technology Co. Ltd.
Room 613, Bozhi Centre, Chentian Industrial Area,
Xixiang Street, Baoan District, Shenzhen, China email@example.com
Huizhou Shuangzuan Protection Technology Co., Ltd
NO.108 Plant Tangquan Section, Huizhou Avenue, Huicheng District
Huizhou Guangdong, CN 516023
4402 Gertrude Dr
Fremont, CA 94536
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/.