WARNING LETTER

BMHshop MARCS-CMS 612991 — April 26, 2021

Product:: Medical Devices

Recipient:: BMHshop; United States; vipcustomer@baimaclub.com

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER

DATE: April 26, 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 www.bmhshop.comon March 29, 2021. 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/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).

FDA’s review of your website revealed the following statements that establish that the KN95 Dust Mask, Medical Grade/Surgical Mask, and Disease Prevention Mask for Child are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:

Representing the KN95 Dust Mask as “Anti-COVID-19”, “PROTECTIVE MASK TAKE CARE OF YOU AND YOUR FAMILY…COVID-19…”, “…Quarantine Antivirus”, and “Full Face Mask Protection Filtration >95%” [https://www.bmhshop.com/products-detail.php?ProId=436]
Representing the Medical Grade/Surgical Mask as “Effective prevention of COVID- 19” and “Multiple protection Against virus infection” [https://www.bmhshop.com/products.php?CateId=17; https://www.bmhshop.com/products-detail.php?ProId=170]
Representing the Disease Prevention Mask for Child as “…Children Prevent Disease Mask”, “ANTI-VIRUS”, “Anti-COVID-19”, and “BEST FACE MASKS FOR BACTERIA AND VIRUSES” [https://www.bmhshop.com/productsdetail.php?ProId=424]

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/Surgical Mask, (which your website represents is manufactured by Shenzhen Keyu Electronic Material Trading Co., Ltd), and the Disease Prevention Mask for Child (which, although the text is blurry, your website appears to represent 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. 21 CFR 807.39.

Your website contains a number of false or misleading representations, including but not limited to:

Displaying a “Certification of Registration” issued by “HealReg Service Inc.” (HealReg Service Certificate) alongside KN95 Dust Mask product information. The HealReg Service Certificate “certifies that Zhongshan Dongfeng HuangShang Electronic Factory…has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The HealReg Service Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo² and an illustration of an eagle and a U.S. flag (or a similar flag).
Displaying a “Certification of Registration” issued by “Shenzhen SHT Testing Technology Co. Ltd.” (Shenzhen Certificate) alongside Medical Grade/Surgical Mask product information. The Shenzhen Certificate “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…” The Shenzhen Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo2 and an illustration of an eagle and a U.S. flag (or a similar flag).
Displaying a “Certification of Registration” alongside Disease Prevention Mask for Child product information wherein the text, although blurry, appears to represent and certify that “Huizhou Shuangzuan Protection Technology Co., Ltd” (Huizhou Certificate) “has completed the FDA Establishment Registration and Listing with the US Food & Drug…” Although some of the text is illegible, the Huizhou Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo² and an illustration of an eagle and a U.S. flag (or a similar flag).

Taken together, the HealReg Service Certificate, bearing the FDA logo, positioned near images of and information about the KN95 Dust Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Zhongshan Dongfeng HuangShang Electronic Factory is or was registered with FDA and that the firm is or was in possession of a registration number. In addition, display of the Shenzhen Certificate, bearing the FDA logo, near images of and information about the Medical Grade/Surgical Mask is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Shenzhen Keyu Electronic Material Trading Co., Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Further, display of the Huizhou Certificate, bearing the FDA logo, near images of and information about the Disease Prevention Mask for Child is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Huizhou Shuangzuan Protection Technology Co., Ltd is or was registered with FDA and the firm is or was in possession of a registration number. Although the HealReg Service Certificate and Shenzhen Certificate 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. 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 have 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 health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.³ In addition, on March 13, 2020, the President declared 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 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 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 products 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# 612991 or CTS Number CPT2001079when 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.

Sincerely,
/S/

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

Cc:
Jasmine Qiu
Zhongshan Dongfeng HuangShang Electronic Factory
2/F, No.172, South of Dongfeng Avenue, Anle village,
Dongfeng Town, Zhongshan City Guangdong, CN 528425

US Agent:
Yueting Zhu
South Bay Innovation, LLC
2525 Vista Industria
Compton, CA 90221
Ctb-lab@outlook.com

Simon Lee
HealReg Service Inc.
13 Barksdale Professional Center, Newark DE 19711
Ctb-lab@outlook.com

Huanqing Chen
Shenzhen Keyu Electronic Material Trading Co., Ltd.
D25, Floor 3, Building 23, Dayun Software Town, 8288 Longgang Avenue,
Yuanshan street, Longgang District, Shenzhen Guangdong, CN 518000

US Agent:
Wilson Cheung
704 Bergen St 1fl
Harrison, NJ US 07029
Email: Wilson.Cheung.FDA@gmail.com

Shenzhen SHT Technology Co. Ltd.
Room 613, Bozhi Centre, Chentian Industrial Area,
Xixiang Street, Baoan District, Shenzhen, China
Email: 348547703@qq.com

Mr. Lian
Huizhou Shuangzuan Protection Technology Co., Ltd
Plant No. 108, Tangquan Section, Huizhou Avenue
Huicheng District, Huizhou City, China
E-mail: admin@beist88.com

US Agent: Angla Li
4402 Gertrude Dr
Fremont, CA US 94536
Email: xv393fbhh@sina.cn

_________________________

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 Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration has been renewed for an additional 90 days three times. The most recent renewal went into effect on October 23, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. October 2, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx).

4 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential-actions/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).