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WARNING LETTER

Disinfect & Shield MARCS-CMS 613716 —

Product:
Drugs
Recipient:
Recipient Name
Despo Caldwell
Recipient Title
CEO
Disinfect & Shield

1616 Fountain View Drive
Houston, TX 77057
United States

contact@disinfectandshield.com
Issuing Office:
Center for Drug Evaluation and Research

United States

WARNING LETTER

Date:               May 6, 2021   

RE:                  Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)

Dear Ms. Caldwell,

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.disinfectandshield.com/ on May 5, 2021, where consumers can purchase your product. The FDA has observed that your website offers DISINFECT™ & SHIELD HAND SANITIZER 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, this product is an unapproved new drug 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(a) and (ee) of the FD&C Act, 21 U.S.C. § 352(a) and (ee). The introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) and (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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 or other conditions.

Some examples of the claims observed on your website that provide evidence of 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:

  • “COVID-19 99.99% KILL” [from your website https://www.disinfectandshield.com]
  • “COVID-19 Testing Hand Sanitizer Disinfect & Shield’s hand sanitizer was conducted (sic) to evaluate the virucidal properties against Coronavirus strain 229E. Under the conditions of the evaluation, the Disinfect & Shield Hand Sanitizer reduced the infectivity of Coronavirus by >3.00 log following a 30-second and a 60-second exposure.” [from your website https://www.disinfectandshield.com/pages/covid-19-testing-hand-sanitizer]
  • “Disinfect & Shield 8-Hour Shield Hand Sanitizer protects 700X longer than typical hand sanitizer products with aloe vera. . . . It has been tested against SARS-Cov-2 surrogates and remains effective against harmful bacteria and viruses for up to 24 hours! . . . Our product has been tested to be effective for more than 8 hours, however, skin cells naturally shed prior to 8 hours or by abrasion. Reapply as needed.”   [from your website https://www.disinfectandshield.com/products/2oz-8-hour-hand-sanitizer]
  • “Effectiveness . . . The 8 Hour Hand Sanitizer has been tested against major superbugs such as MRSA. Even 24 hours after application, some of the hand sanitizer remains in action, protecting you from harmful bacteria and viruses. Traditional alcohol-based sanitizers evaporate almost immediately after application, leaving your skin susceptible to harmful bacteria and viruses . . .“ [from your website https://www.disinfectandshield.com/pages/how-it-works]
  • “What’s the Proof That Is (sic) Disinfect & Shield is Effective? Several laboratories have conducted extensive testing of the Disinfect & Shield product against numerous viruses, bacteria, molds, and fungi – enveloped and non- enveloped, including strains of SARS, H1N1, and EBOLA virus. None of these organisms was able to penetrate or survive contact with the Disinfect & Shield protective coating.” [from your website https:// www.disinfectandshield.com/pages/faq]

Based on the above claims, DISINFECT™ & SHIELD HAND SANITIZER 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 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, DISINFECT™ & SHIELD HAND SANITIZER is intended for use as consumer antiseptic rub.

This 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 its 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, is in effect for this product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your DISINFECT™ & SHIELD HAND SANITIZER drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this 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 “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.

DISINFECT™ & SHIELD HAND SANITIZER 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.

The labeling of DISINFECT™ & SHIELD HAND SANITIZER suggests it is effective in preventing infection or disease against numerous viruses, bacteria, molds, and fungi including specific diseases and pathogens such as “COVID-19” and “H1N1, and EBOLA virus.” These labeled intended uses go beyond merely describing the general intended use of topical antiseptic as set forth in the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule.[5]

Additionally, your labeling claims suggesting DISINFECT™ & SHIELD HAND SANITIZER provides up to 8 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 amendment to the TFM. Time-specific extended efficacy claims, especially when related to serious-disease related pathogens, may lead to 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, DISINFECT™ & SHIELD HAND SANITIZER 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 topical antiseptic is GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, your DISINFECT™ & SHIELD HAND SANITIZER is a new drug under section 201(p) of the FD&C Act. In addition, there are no FDA-approved applications in effect for DISINFECT™ & SHIELD HAND SANITIZER and, accordingly, it is therefore 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 it also does not conform to any temporary policy FDA has implemented for alcohol-based hand sanitizer products during the public health emergency.[6]

In addition, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your firm’s website misleadingly implies that FDA has endorsed or approved your DISINFECT™ & SHIELD HAND SANITIZER products in some manner. For example, you display the phrase “FDA Listed.” In that presentation, the term “FDA” appears in a unique graphical form used as the agency’s official logo for many years. Additionally, you state your products are “FDA Registered.” To state that any drug product is “FDA Registered” is inaccurate; drugs are subject to listing with FDA, not registration. Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed. (21 CFR 207.77(a)). This language is misleading because the general public is not likely to be familiar with the details of FDA regulation. The use of “FDA Listed” with the agency’s official logo and “FDA registered” to describe your products misleadingly suggests that your products are approved or endorsed by FDA in some way when this is not true. Thus, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because its labeling is false or misleading in any particular.

Lastly, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. § 352(ee), because DISINFECT™ & SHIELD HAND SANITIZER is 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 is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. § 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).

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 or other disease-related use for which they have not been approved by FDA and that you do not make claims that misbrand your 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 any 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 corrective actions to cease 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 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) 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 DISINFECT™ & SHIELD HAND SANITIZER in  2 ounce and 1- gallon sizes.

[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] 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.

[6] See, e.g., Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).  Because DISINFECT™ & SHIELD 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.

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