Happi Staff04.30.20
The US FDA has sent Prefense LLC, Muscatine, IA, a warning letter for offering Prefense Hand Sanitizers for sale in the United States that it said were intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases in people.
The agency reviewed the company’s website (www.prefense.com) on April 6, 2020 and its social media sites (Twitter and LinkedIn) as well as links from other websites (www.safety-med.com, www.mdsassociates.com, and www.apollosafetyproducts.net).
Based on that review, FDA said the 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).
Some of the laims that were flagged by FDA included:
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).
FDA notes 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.
According to FDA, 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.
According to FDA, 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.
FDA said the products were labeled with Amosilq (benzalkonium chloride/silica complex) as the active ingredient, although 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 the products does not conform to the relevant labeling conditions in the 1994 TFM and its subsequent amendments, noted FDA.
Specfically, FDA said the company’slabeling 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, 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, said FDA. 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.
The agency reviewed the company’s website (www.prefense.com) on April 6, 2020 and its social media sites (Twitter and LinkedIn) as well as links from other websites (www.safety-med.com, www.mdsassociates.com, and www.apollosafetyproducts.net).
Based on that review, FDA said the 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).
Some of the laims that were flagged by FDA included:
- “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 . . . Prefense 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, Prefense 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/]
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).
FDA notes 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.
According to FDA, 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.
According to FDA, 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.
FDA said the products were labeled with Amosilq (benzalkonium chloride/silica complex) as the active ingredient, although 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 the products does not conform to the relevant labeling conditions in the 1994 TFM and its subsequent amendments, noted FDA.
Specfically, FDA said the company’slabeling 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, 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, said FDA. 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.
