WARNING LETTER
Invisi Smart Technologies UK LTD
MARCS-CMS 614512 —
August 24, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Saba Yussouf
Recipient Title
CEO
Invisi Smart Technologies UK LTD
112 Cumberland House
80 Scrubs Lane
London
NW10 6RF
United Kingdom
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
August 24, 2021
Re: Invisi Smart Mask
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019
Dear Ms. Saba Yussouf:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at https://www.invisismart.com/, https://shop.invisismart.com/, and https://twitter.com/InvisiSmart on, June 21, 2021. The FDA has observed that your websites offer the ISM5 Invisi Smart Mask, ISM5 Invisi Smart Mask (Black Edition) and the ISM30 Invisi Smart Mask 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-19
1
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 masks are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:
“
ISM30 Invisi Smart Mask
, Invisi Smart technology has been tested against the SARSCoV-2 virus’s spike protein by the University of Cambridge.”
“Invisi Smart Mask™ has been tested against human coronavirus and not a weaker strain from the feline coronavirus subfamily.”
“Invisi Smart Mask™ kills viruses and bacteria as they come into contact with the mask allowing you to wear your mask with confidence all day… and for the next 30 days!”
“Our self–disinfecting technology allows you to safely wear the Invisi Smart Mask™ without the need to wash it.”
“Our main ingredient, titanium dioxide, … is generally recognized as safe (GRAS) by the FDA, with up to 1% allowance in food products without having to add it to the ingredients label.”
Based on our review, your websites are offering for sale in the United States the above mentioned mask models without marketing approval, clearance, or authorization from the FDA. Accordingly, your devices 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 your intent to introduce them into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
FDA contacted your firm on October 8, 2020, and informed you that you must submit a premarket notification submission before marketing these devices in the U.S. On October 14, 2020, FDA contacted your firm again and discussed certain claims that remained on your website. FDA further reiterated that you must submit a premarket notification submission prior to distributing devices of this type in the U.S. FDA asked your firm to provide your plan regarding these masks to FDA by October 19, 2020. FDA had another teleconference meeting with your chief scientific officer per your request to discuss FDA regulations on October 15, 2020. On October 22, 2020, FDA sent an email in response to your written feedback request regarding FDA regulations and again asked your firm to provide a plan for premarket notification submission. FDA did not receive a response from you to this email.
A review of your websites on June 21, 2021, shows that your products are still being marketed without FDA approval, clearance, or authorization. To date, FDA has not cleared, approved, or authorized the three mask models cited above.
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, the President declared 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 herein, 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 such unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
If you believe that your devices meet the requirements for Emergency Use Authorization (EUA) under section 564 of the FD&C Act for claims associated with use of your devices for COVID-19, please submit an email to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov. Guidance regarding the applicable criteria and the information to include in an EUA submission is available at https://www.fda.gov/media/97321/download.
Our office requests that your firm immediately cease activities that result in the misbranding or adulteration of these devices, such as the commercial distribution of the devices for the uses discussed above.
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.
FDA is advising consumers not to purchase or use certain products that are not in compliance with FDA requirements and are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken corrective actions and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you are not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of 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 product(s) listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
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 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, Rm 3657
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS #614512 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: Cynthia J. Chang, Ph.D. at 301-796-6891.
Sincerely yours,
/S/
Binita S. Ashar, MD, MBA, FACS
Director
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
______________________
1
COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified in Wuhan, China.
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-emergencyconcerning-novel-coronavirus-disease-covid-19-outbreak/
Content current as of:
08/26/2021
Regulated Product(s)
Medical Devices