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  5. Covalon Technologies Inc. - 614350 - 05/06/2021
  1. Warning Letters

WARNING LETTER

Covalon Technologies Inc. MARCS-CMS 614350 —

Product:
Drugs
Recipient:
Recipient Name
Brian Pedlar
Recipient Title
CEO
Covalon Technologies Inc.

1660 Tech Avenue, Unit 5
Mississauga ON L4W 5S7
Canada

bpedlar@covalon.com
cfredric@covalon.com
Issuing Office:
Center for Drug Evaluation and Research

United States

WARNING LETTER

Date:               May 6, 2021

TO:                 Christopher Fredric, Senior Director, Regulatory Affairs

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 address https://www.covaguard.com/ on March 24, 2021. We also reviewed your social media websites at https://www.instagram.com/covaguard/ and https://www.facebook.com/covaguard/, where you direct consumers to your website, https://www.covaguard.com/, to purchase your products. The FDA has observed that your website offers non-alcohol based hand sanitizer products[1] for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[2] and other conditions in people. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products 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.[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 and other conditions 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 and other conditions.

Some examples of the claims on your websites that establish the intended use (as defined in 21 CFR 201.128) of your products and misleadingly represent them 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:

  • “Does the CovaGuard™ formula kill the COVID-19 virus (SARS-CoV2)? Preliminary testing indicates that the CovaGuard formula kills 99.9% or greater of SARS-CoV2 virus (COVID-19) within 60 seconds of contact…” [from your website https://www.covaguard.com/pages/faqs]
  • “BAC [(benzalkonium chloride)] is highly effective at deactivating and killing a wide variety of pathogens, including coronaviruses…” [from your website https://www.covaguard.com/pages/how-it-works]
  • “The BYU scientists who conducted the study. . . treated samples of the novel coronavirus with benzalkonium chloride, which is commonly used in alcohol-free hand sanitizers, and several other quaternary ammonium compounds regularly found in disinfectants. In most of the test cases, the compounds wiped out at least 99.9% of the virus within 15 seconds.” [from a December 1, 2020 news release titled, “Alcohol-free hand sanitizer just as effective against COVID as alcohol-based versions“ directly linked from your website https://www.covaguard.com/pages/how-it-works via a hyperlink titled, “Check it out for yourself!”]
  • “‘Our results indicate that alcohol-free hand sanitizer works just as well, so we could, maybe even should, be using it to control COVID,’ said lead study author Benjamin Ogilvie.” [from a December 1, 2020 news release titled, “Alcohol-free hand sanitizer just as effective against COVID as alcohol-based versions“ directly linked from your website https://www.covaguard.com/pages/how-it-works via a hyperlink titled, “Check it out for yourself!”]
  • “24hr Protection” [from your products’ labels on your website https://www.covaguard.com/collections/all]
  • “All day protection from bacteria and germs. One spray protects for 24 hours. Yup, 24 hours.” [from your website https://www.covaguard.com/]
  • “One spray. Protects all day.™” [from your website https://www.covaguard.com/]
  • “Our technology not only kills germs on contact, but unlike traditional sanitizers, continues to kill bacteria and pathogens for up to 24 hours.” [from your website https://www.covaguard.com/pages/how-it-works]
  • “. . .With CovaGuard, you can rest easy knowing that your hands are protected for 24 hours. One spray protects all day!” [from a January 28, 2021 post on your Facebook webpage at https://www.facebook.com/covaguard/]
  • “24-hr protection against germs” [from your Instagram webpage at https://www.instagram.com/covaguard/]

Based on the above claims, your hand sanitizer products are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as consumer topical antiseptics.

These consumer topical antiseptic products are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are 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, are in effect for these drug products, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your hand sanitizer drug products are GRASE for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, these drug products are unapproved new drugs 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 “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 are in conformity with 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 products do 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.  

Specifically, your labeling claims suggesting that your topical antiseptic products are effective in preventing infection or disease from the novel coronavirus that causes COVID-19 go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM. In addition, your labeling claims, suggesting that your consumer antiseptic  products provide up to 24 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19, do not conform to the 1994 TFM or any of the amendments to the TFM discussed above. Time-specific extended efficacy claims, especially when related to serious-disease related pathogens, endanger the public health by creating a false sense of security for the general public that may result in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms. As a result, these products may give users the false impression that they need not rigorously adhere to interventions such as social distancing and exercising good hygienic practices that have been demonstrated to curb the spread of COVID-19. Users who do not follow these interventions are at increased risk for contracting COVID-19 and for spreading disease if they have been exposed to the virus, thereby prolonging the pandemic and increasing its associated morbidity and mortality.

We are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that your hand sanitizers are GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, your hand sanitizers are new drugs under section 201(p) of the FD&C Act. In addition, there are no FDA-approved applications in effect for your hand sanitizers and, accordingly, they are unapproved new drugs 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 hand sanitizers also do not conform to any temporary policy FDA has implemented for alcohol-based hand sanitizer products during the public health emergency.[5]

In addition, these consumer topical antiseptic products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are 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 address 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 and that you do not make claims that misbrand the products in violation of the FD&C Act. 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 adequately correct any violations 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 actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.

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 hand sanitizer drug products include “COVAGUARD ANTIMICROBIAL HAND SANITIZER SPRAY 8oz,”  “COVAGUARD ANTIMICROBIAL HAND SANITIZER SPRAY 3.38oz,” “COVAGUARD ANTIMICROBIAL HAND SANITIZER SPRAY 2.02oz,”  “COVAGUARD MASK ANTIMICROBIAL HAND SANITIZER SPRAY 8oz,” “COVAGUARD MASK ANTIMICROBIAL HAND SANITIZER SPRAY 3.38oz,” and “COVAGUARD ANTIMICROBIAL HAND SANITIZER FOAM 3.38oz.”   

[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/2019-nCoV.aspx).

[4] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).

[5] See, e.g., Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).  Because your hand sanitizers are not consistent with the formulations described in these guidances, they do 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.

 
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