WARNING LETTER
Strategia Project Management, Inc.
MARCS-CMS 615307 —
September 28, 2021
Product:
Drugs
Recipient:
Recipient Name
Chris Mashburn
Recipient Title
Chief Operating Officer
Strategia Project Management, Inc.
1000 Jorie Blvd. Suite 370
Oak Brook
,
IL
60523
United States
info@microsure.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date: September 28, 2021
RE: Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet addresses https://www.microsure.com and https://www.microsure.com/shop on September 28, 2021. We also reviewed your social media websites at Internet addresses, https://twitter.com/microsure_?lang=en and https://www.facebook.com/microSURE.HandSanitizer, where you direct consumers to your website, https://www.microsure.com, to purchase your products.
The FDA has observed that your website offers a non-alcohol-based topical antiseptic product
1
for sale in the United States and that the product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
2
and other serious infections in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, this product is a misbranded drug under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee). The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and 301(d) of the FD&C Act, 21 U.S.C. 331(a) and (d). These violations are described in more detail below.
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, there was a Presidential declaration of a national emergency in response to COVID-19 that has been extended.
4
Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 or other conditions.
Some examples of the claims on your websites that establish the intended use (as defined in 21 CFR 201.128) of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 and other serious infections include, but may not be limited to, the following:
“Has the microSURE technology been tested against Coronavirus?
5
...
Yes. Strategia has conducted direct testing on SARS-CoV-2 (the virus responsible for causing COVID-19) and has also tested against murine coronavirus as well. It is important to understand that ‘coronavirus’ is a general term that refers to a family of viruses within a particular subset. Coronavirus is a positive sense single stranded linear RNA enveloped virus with a helical capsid symmetry. This family of viruses includes Middle East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS), amongst other viruses as well.” [from your website https://www.microsure.com/faq]
“Does microSURE™ technology kill mold and mildew?...Yes. In addition to being bactericidal (meaning it kills bacteria), our solution has been proven to also destroy viruses and eliminate fungus, mold and algae” [from your website https://www.microsure.com/faq]
“microSURE™ is a Strategia Company that was developed by Dr. Erwin Lo, Neurosurgeon and founder. Dr. Lo collaborated over 15 years ago with a group of experts as it relates to material science and biotechnology, to develop a very unique soluble antimicrobial solution to protect multiple diverse surfaces including the human skin. The antimicrobial affect occurs when the solution dries and mechanically attaches, leaving behind a microscopic silica dioxide crystalline-like layer, which eradicates many bacteria and viruses.” [from your website https://www.microsure.com/about-us]
Based on the above claims and statements, your microSURE Hand Sanitizer product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, microSURE Hand Sanitizer is intended for use as a consumer topical antiseptic.
This consumer topical antiseptic product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or under other exceptions not applicable here. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your microSURE Hand Sanitizer drug product is GRASE for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
We note that over-the-counter (OTC) topical antiseptic products had been the subject of rulemaking under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by the “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016) (Consumer Antiseptic Rubs Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub.
Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they meet the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.
However, your consumer topical antiseptic product does not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
According to the product’s website, https://www.microsure.com, microSURE Hand Sanitizer contains the active ingredient benzalkonium chloride. However, the product’s website, https://www.microsure.com makes claims that include, but are not limited to, the claim that the product’s “…antimicrobial affect occurs when the solution dries and mechanically attaches, leaving behind a microscopic silica dioxide crystalline-like layer, which eradicates many bacteria and viruses.” According to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. The website claim described above for silica dioxide demonstrate that it is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because the ingredient is intended to furnish pharmacological activity. “Silica dioxide” is not a permitted active ingredient, either as a sole ingredient or in combination with other ingredients like benzalkonium chloride for use in consumer antiseptic hand rub drug products under the 1994 TFM. Products with these active ingredients do not conform to the TFM.
6
In addition, your labeling suggesting that your consumer topical antiseptic product is effective in preventing infection or disease from SARS-CoV-2, the novel coronavirus that causes COVID-19, is effective against murine coronavirus, Middle East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS), mold, mildew, and algae, and that it is fungicidal and virucidal in general, go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule.
7
We are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that your antiseptic products are GRASE for the above-described intended uses. Accordingly, your antiseptic product is a new drug under section 201(p) of the FD&C Act. In addition, there are no FDA-approved applications in effect for your antiseptic product and, accordingly, it is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d). We note that your antiseptic products also do not conform to any temporary policy FDA has implemented during the public health emergency.
8
This antiseptic product is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and it is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA.
Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov
describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that 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 http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, 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. We note however, removal from the published list should not be interpreted to mean that you have properly addressed all other violations for your products and that you are free to proceed with their continued marketing.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C 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 misbranded or unapproved new drugs 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 referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_________________________________
1
Your antiseptic drug product is microSURE Hand Sanitizer.
2
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
3
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists. (originally issued on Jan. 31, 2020., and subsequently renewed) available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx).
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (originally issued Mar. 13, 2020, and subsequently renewed), available at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/notice-on-the-continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic/).
5
According to your website, “microSURE technology . . . formed the basis for all of the microSURE products that we have developed,” which include “skin sanitizers.” [https://www.microsure.com/post/design-a-stunning-blog]
6
The use of more than one active ingredient for such products is not consistent with the 1994 TFM. Therefore, microSURE Hand Sanitizer goes beyond the conditions outlined in its applicable TFM and as such it is not eligible for marketing without an approved application.
7
The 1994 TFM covers health care antiseptics that are indicated for use to help reduce bacteria that potentially can cause disease and health care and consumer antiseptics that are indicated for use to decrease bacteria on the skin. 59 FR at 31443.
8
Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry:
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms for violations of section 505 of the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. Because microSURE Hand Sanitizer is not consistent with the formulations described in these guidances, it does not fall within any temporary Agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act.
Content current as of:
09/30/2021
Regulated Product(s)
Drugs