- Medical Devices
- Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com
- Mr. Edward Mauro
107 Pinckney St
Oldsmar, FL 34677
- Issuing Office:
- Center for Devices and Radiological Health
DATE: May 28, 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://buymedicalmasksnow.com/ on April 22, 2021. The FDA has observed that your website offers the “KN95 Mask FFP Level 2” and “3-ply Certified Masks FFP Level 2” 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 FFP Level 2 and 3-ply Certified Masks FFP Level 2 are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:
• Representing the KN95 Mask FFP Level 2, with the device name “KN95 BFE>95% Protective Mask” as “Medical Masks” that offer a “FILTRATION RATE GREATER THAN 95%” for the “medical professional or facility” to “Prevent the Spread of Coronavirus”
• Representing the 3-ply Certified Masks FFP Level 2 as “Medical Masks” for the “medical professional or facility” to “Prevent the Spread of Coronavirus”, “Effectively block visible objects such as droplets”, and “Filter non-oily particulate matter from the air”
Based on our review, your website is offering for sale in the United States the KN95 Mask FFP Level 2 and 3-ply Certified Masks FFP Level 2 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 the labeling is false or misleading. The devices are not FDA “Certified,” and so express statements to the contrary are false...
Your website contains a number of false and/or misleading representations, including but not limited to:
• Stating that the KN95 Mask FFP Level 2 and 3-ply Certified Masks are “FDA Certified” in the products’ descriptions
• Unauthorized use of the FDA logo2 displayed alongside images of and information about the KN95 Mask FFP Level 2 and 3-ply Certified Masks FFP Level 2
• Displaying the FDA logo on the N95 Mask FFP Level 2 packaging
To date, FDA has not cleared, approved, authorized or “Certified” the KN95 Mask FFP Level 2 and 3-ply Certified Masks FFP Level 2 offered for sale by your firm. In addition, display of the FDA logo on and near your firm’s devices is misleading because it creates the impression of official FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the devices and/or your establishment. 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 product has 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, 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 product(s) 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 product(s) 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 613952 or CTS Number CPT 2000797 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
Source Direct Products, Inc.
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/