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WARNING LETTER

Varigard, LLC MARCS-CMS 616757 —

Product:
Drugs
Recipient:
Recipient Name
Mike Paolillo
Recipient Title
Chief Executive Officer
Varigard, LLC

428 E. Section Ave
Foley, AL 36535-2713
United States

info@varigard.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

Date: December 29, 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 websites at the Internet addresses, https://www.varigard.com/ and https://shop.varigard.com/ on August 11, 2021. We also reviewed your social media websites at Internet addresses, https://twitter.com/varigard and https://www.facebook.com/varigard/, where you direct consumers to your website, https://www.varigard.com/ to purchase your products.

The FDA has observed that your websites offer alcohol-based consumer topical antiseptic products1 for sale in the United States and that the products are intended to mitigate, prevent, treat, diagnose, or cure COVID-192 and other serious infections in people. Based on our review, these products are unapproved new drugs 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, these products are misbranded drugs 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 these products into interstate commerce is prohibited under sections 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 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 product labels and 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:

“LAB TESTS PROVE VARIGARD TRAPS AND KILLS COVID-19” [from the product labels for Varigard Hand Sanitizing Lotion]

“Varigard™ Formulas Provide the Longest Lasting Personal and Surface Protection Against Deadly Pathogens including COVID-19.” [from your website https://www.varigard.com/]

“Varigard…2 Hours of protection per use…Proven to kill actual COVID-19 (SARS-CoV-2)” [from your website https://www.varigard.com/]

“Instead of relying on alcohol alone, our products use patented organic polymers designed to prevent germs from spreading through contact long after application.

“We have now successfully tested against the original SARS-CoV-2 strain and also the B117 Uk Strain with incredible results. We are also the only hand sanitizer that has put our products through human trials to endure [sic] it’s the safest product on the market.”

Independent labs confirm Varigard hand sanitizer traps and kills SARS-CoV-2 (actual COVID-19), Staph, MRSA, E. coli, Pneumonia and other common, deadly viruses for two hours after each application. [from your website https://www.varigard.com/products/hand-sanitizer-gel?hsLang=en]

“So, you can imagine how happy I was to hear that Varigard has invented a hand sanitizer that not only kills and sequesters the most common hospital germs like STAPH, MRSA, ECOLI, and PNEUMONIA but now has proven at one of the top COVID-19 testing facilities in the country that Varigard hand sanitizer kills and sequesters COVID-19…Christopher Clements…Former CEO, Kindred Hospital, Hollywood, FL” [from your website https://www.varigard.com/]

Why Should I Use Varigard?...Varigard traps and kills SARS-CoV-2 (COVID-19) and a host of other dangerous pathogens for more than 2 hours after application…. [from your website https://www.varigard.com/faq?hsLang=en]

Is Varigard Hand Sanitizer flammable or explosive in high temperatures?...No. Due to the fact that Varigard contains 62% alcohol, the FDA and DOT require that our label list our hand sanitizer as flammable…Varigard’s proprietary ingredients make it flame retardant and combustion resistant even under significant temperatures. Even if you were able to ignite our Varigard hand sanitizer, it would self-extinguish within a few seconds. For the best possible outcome, please follow all instructions and heed all warnings on the product label.” [from your website https://www.varigard.com/faq?hsLang=en]

“Synergy Laboratories verified that Varigard is now effective against the B117 UK strain of SARS-CoV-2 (COVID-19) after it was identified in Mobile, Alabama. This is another major step in the world's fight against COVID-19…” [from your Facebook page, https://www.facebook.com/varigard/ posted on 5/1/2021]

Varigard Technologies Proven to Prevent the Tactile Spread of SARS-CoV-2, B.1.617.2 – DELTA Variant [from your twitter page, https://twitter.com/varigard posted on 8/5/2021]

Based on the above claims and statements, your consumer topical antiseptic 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, Varigard Hand Sanitizing Lotion 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 these products, 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 Varigard Hand Sanitizing Lotion 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 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 products’ labels, Varigard Hand Sanitizing Lotion products contain the active ingredient ethyl alcohol 62%. However, the products’ website, https://www.varigard.com/ makes claims that include, but are not limited to, the claim that your products use “patented organic polymers designed to prevent germs from spreading through contact long after application.” 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. Although you do not list “patented organic polymers” as active ingredients on your products’ labels, the website claims described above for patented organic polymers demonstrate that they are “active ingredients” as defined in 21 CFR 201.66(b)(2) because the ingredients are intended to furnish pharmacological activity. Patented organic polymers are not permitted active ingredients for use in consumer antiseptic hand rub drug products under the 1994 TFM, either by themselves or when used in combination with other ingredients like ethyl alcohol. Products with these active ingredients do not conform to the TFM.5

In addition, your labeling claims, suggesting that your alcohol-based antiseptic products are effective in preventing infection or disease from the novel coronavirus that causes COVID-19 and from other pathogens, go beyond merely describing the general intended use of an antiseptic as set forth in the 1994 TFM.6 Your labeling claims, suggesting that your alcohol-based antiseptic products provide up to 2 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19, are not permitted under the 1994 TFM, or any of the amendments to the TFMs discussed above. 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, 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 Varigard Hand Sanitizing Lotion products are GRASE for the above-described intended uses. Accordingly, your Varigard Hand Sanitizing Lotion products are new drugs under section 201(p) of the FD&C Act. In addition, there are no FDA-approved applications in effect for Varigard Hand Sanitizing Lotion products 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 Varigard Hand Sanitizing Lotion products also do not conform to any temporary policy FDA has implemented during the public health emergency.7

These consumer topical antiseptic products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading. Specifically, 21 CFR 201.66(c)(5)(ii)(C) requires a flammability warning within a product’s Drug Facts panel when its applicable OTC monograph requires it. An alcohol-based consumer topical antiseptic subject to the 1994 TFM (as further amended by the Consumer Antiseptic Rubs Proposed Rule), must include a flammability warning, (i.e., “Flammable, keep away from fire or flame”)8 in its labeling. Although Varigard Hand Sanitizing Lotion drug products include flammability warnings, their labeling also includes statements that they are flame retardant and combustion resistant even under significant temperatures. Alcohol-based consumer topical antiseptics bearing such flame retardant or combustion resistant statements are false or misleading because the products are flammable.

Varigard Hand Sanitizer Gel and Varigard Hand Sanitizer are further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on the products’ labels, above the term, “REGISTERED,” which creates the impression that the drugs are approved or legally marketable (see 21 CFR 207.77(b)). As previously noted, your Varigard Hand Sanitizing Lotion products are not the subject of an FDA-approved application. Therefore, a labeling representation suggesting that your products are FDA-approved is false or misleading.

These antiseptic products are also 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 they are 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 these products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a).

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 alcohol-based consumer antiseptic drug products are Varigard Hand Sanitizing Lotion in 2 oz, 16 oz, and 1-gallon containers (also known as Varigard Hand Sanitizer Gel) and in 1.5 ml containers, packaged in a box consisting of fifty 1.5 ml containers or 1 case with 16 boxes consisting of one-hundred and fifty 1.5 ml containers (also known as V-Card).

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 (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-nationalemergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic/).

5 The use of more than one active ingredient for such products is not consistent with the 1994 TFM. Therefore, Varigard Hand Sanitizer Gel and Varigard Hand Sanitizer go beyond the conditions outlined in their applicable TFM and as such they are not eligible for marketing without an approved application.

6 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.

7 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 Varigard Hand Sanitizing Lotion products 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.

8 59 Fed Reg at 31442

 
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