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WARNING LETTER

Prefense LLC MARCS-CMS 605488 —

Product:
Drugs

Recipient:
Recipient Name
Mr. Michael Reiber
Prefense LLC

2509 Pettibone Avenue
Muscatine, IA 52761
United States

Mike.reiber@prefense.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

 

Date                April 23, 2020

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

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.prefense.com on April 6, 2020.  We have also reviewed your social media sites at www.twitter.com/prefense and https://www.linkedin.com/company/prefense-llc/ where you direct consumers to your website www.prefense.com to purchase your products. The FDA has observed that your website www.prefense.com directly links and directs consumers to the websites www.safety-med.comwww.mdsassociates.com, and www.apollosafetyproducts.net, where your products can be purchased.  The FDA has further observed that these aforementioned websites offer Prefense Hand Sanitizers[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 diseases 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). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d). 

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, the President declared 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 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.

Some examples of the claims that establish the intended use (as defined in 21 CFR 201.128) of Prefense Hand Sanitizers and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include, but may not be limited to, the following:

  • “We hate to say it, but coronavirus is in the U.S. and close to home in Chicago. Nasty stuff but that’s why the best defense is Prefense!” [from a January 24, 2020 post on your Twitter webpage at https://twitter.com/prefense]
  • “Coronavirus now a global emergency! . . . Be safe out there – the best defense is Prefense hand sanitizer – up to 24 hour protection from one application – it works when it dries!” [from a January 30, 2020 post on your Twitter webpage at https://twitter.com/prefense]
  • “One Dose of Patented Prefense™ Hypoallergenic Foam Hand Sanitizer Lasts up to 24 Hours and is Safe for Children! Stop worrying about germ transfers and enhance your Infection Control protocol. Prefense™ is a revolutionary, non-toxic, high-level hospital-grade foam hand sanitizer that continually protects against bacteria, fungi and viruses including all strains of staph, strep, E.coli, drug resistant MRSA, Wuhan COVID-19 Coronavirus and more with just one application daily...and is safe for children!” [from a page on the website www.apollosafetyproducts.net which you directly link to from your website www.prefense.com]
  • “4/5/2020 WORLD PANDEMIC  COVID-19 Coronavirus update: 1,273,709 confirmed cases / 69,546 reported deaths / 45,4592 [sic] in critical condition . . . PrefenseTM is a revolutionary non-toxic, non-flammable hand sanitizing foam that protects you from germs with just one application per day!  It’s like wearing an invisible glove.  Perfect for health care providers and young school children . . . Prefense™ is a revolutionary, non-toxic high-level hospital-grade foam hand sanitizer that protects against pathogens, bacteria, fungi and viruses such as staph, strep, E.coli, MRSA, Wuhan Coronavirus COVID-19 and influenza strains with just one application daily. . . . Traditional alcohol-based products only kill germs that are actively on your skin, but don’t protect you after the product is dry.  While other formulas lost their effectiveness in seconds, PrefenseTM gets stronger with each dose. The active ingredients in Prefense ™ safely bond with your skin, and protect you from pathogens up to 24 hours or for 10 hand washes. More and more hospitals are switching to Prefense!” [from a page on the website www.mdsassociates.com which you directly link to from your website www.prefense.com]       
  • Sanitize your hands with Prefense® nonalcoholic Hand & Skin sanitizer that can protect you for extended periods of time. Our unique product has the active ingredient suspended and stabilized in a silica matrix solution that bonds with your skin. It contains no alcohol and lasts for up to 24 hours or through 10 hand washing [sic]. 1 dose lasts for up to 24 hours and comes in an easy to use foam that provides easy coverage to your entire hand . . . When applied to the hands, quaternary ammonium organosilane bind to the skin via covalent, electrostatic, or hydrogen bonds, forming an antimicrobial layer to inactivate existing skin pathogens as well as pathogens that contaminate the skin long after application of the sanitizer.” [from your website www.prefense.com]
  • “Prefense Alcohol-Free Hand Sanitizer is the first and only product on the market today that kills germs on contact and offers continuous protection for up to 24 hours or 10 hand washings with only one application . . . Prefense kills MRSA, staph, strep, E coli and many other germs on contact.” [from a page on the website http://safety-med.com which you directly link to from your website www.prefense.com]
  • “Prefense Hand and Skin Sanitizer offers an alternative to Alcohol based Gels. Prefense has a unique formulation that bonds to you [sic] skin forming a physical barrier between your skin and pathogens found in everyday life. These bonds last up to 24 hours or through 10 hand washing cycles. One application lasts all day.” [from your Linkedin webpage at https://www.linkedin.com/company/prefense-llc/]

Based on the above claims, Prefense Hand Sanitizers 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 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.  Further, your Prefense Hand Sanitizers are intended for use as both consumer and health care personnel antiseptic rubs.

Prefense Hand Sanitizers 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 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).  No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, are in effect for your Prefense Hand Sanitizers, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that Prefense Hand Sanitizers are generally recognized as safe and effective (GRASE) for use under the conditions suggested, recommended, or prescribed in their labeling.  Accordingly, Prefense Hand Sanitizers 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 have been the subject of ongoing 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) and “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015).  Over the course of this rulemaking, benzalkonium chloride, ethyl alcohol, and isopropyl alcohol were classified as Category III, 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 or health care personnel antiseptic rub.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), recently enacted on March 27, 2020, added section 505G to the FD&C Act.  Under 505G(a)(3) of the FD&C Act, drugs that were classified as Category III in a TFM 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 labeling conditions, and comply with all other applicable requirements for nonprescription drugs.

Your Prefense Hand Sanitizers do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rub proposed rule and the 2015 Health Care Antiseptic proposed rule, nor any other TFM or final rule, and do not meet the conditions under section 505G(a)(3) of the FD&C Act, as added by the CARES Act, for marketing without an approved application under section 505.  First, we note that your products are labeled with Amosilq (benzalkonium chloride/silica complex) as the active ingredient. Amosilq was not a proposed active ingredient in the rulemaking for topical antiseptic drug products.  Second, even if benzalkonium chloride were considered the active ingredient in Prefense Hand Sanitizers, the labeling for your products does not conform to the relevant labeling conditions in the 1994 TFM and its subsequent amendments.[5]

Specifically, your labeling claims suggesting that Prefense Hand Sanitizers are effective in preventing infection or disease from specific pathogens such as “staph, strep, E.coli, drug resistant MRSA, Wuhan COVID-19 Coronavirus and more go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM. Additionally, your labeling claims suggesting that Prefense Hand Sanitizers 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, may lead to a false sense of security for the general public and 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 such, 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 Prefense Hand Sanitizers are GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, Prefense Hand Sanitizers 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 they also do not conform to any temporary policy FDA has implemented for alcohol-based hand sanitizer products during the public health emergency

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 or other disease 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 correct 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.

If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. 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.

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] The Prefense Hand Sanitizer product line includes the over-the-counter (OTC) drug products, “Prefense Foam Hand Sanitizer, Scented,” “Prefense Foam Hand Sanitizer, Unscented,” “Prefense Hand Sanitizer, Scented,” and “Prefense Hand Sanitizer, Unscented.” These products  are sold in a variety of sizes and package configurations (i.e., 1.5oz bottles; 8oz bottles; 33.8oz refills; 64oz refills; and 8oz starter kits).

[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 Alex M. Azar II, Determination that a Public Health Emergency Exists.  Jan. 31, 2020.  (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).

[4] President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19).  Mar. 13, 2020.  (Accessible 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 31402 at 31443).