Hand Sanitizer Firm Flagged by FDA
By Happi Staff | 05.11.20
Sarasota, FL-based Durisan cited by agency for non-alcohol-based product.
The US Food and Drug Administration (FDA), following a reviewed the company’s website and social media pages, has issued a warinng letter to Sanit Technologies LLC dba Durisan, Sarasota FL, for selling non-alcohol based hand sanitizer products in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 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).
Some examples of the claims 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:
The hand sanitizer 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). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, are in effect for your hand sanitizer 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 products are GRASE for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, your hand sanitizer 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).
FDA said that it noted that 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) added section 505G to the FD&C Act. Under 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety and effectiveness in a TFM that is the most recently applicable proposal or determination issued under 21 CFR Part 330 -- and that were not classified in such a TFM 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 labeling conditions, and comply with all other applicable requirements for nonprescription drugs.
Although the hand sanitizer products contain benzalkonium chloride as the active ingredient, they 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. Specifically, your labeling claims suggesting that your products are effective in preventing infection or disease from specific pathogens including 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. Additionally, FDA said, that the company’s labeling claims suggesting that its hand sanitizer 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.
FDA said it was are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that Durisna’s 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, as described in newly-added subsection 505G(a)(6). 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.
Some examples of the claims 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:
- “Durisan @DurisanProducts . . . We are water-based and alcohol free . . . We kill 99% of Human Coronavirus, Influenza A (H1N1 & H7N9), Rotavirus, SARS Associated Coronavirus, Respiratory Syncytial Virus (RSV), among others . . . #2019nCoV #coronavirus #killscoronavirus #viruskiller…” [from a January 31, 2020 post on your Facebook webpage at https://www.facebook.com/DurisanProducts/]
- “The following steps can help protect you and your loved ones from coronavirus . . . If soap and water are not readily available, use Durisan hand sanitizer . . .” [from your website https://durisan.com]
- “Durisan® . . . Our hand sanitizers...attack and destroy the germs that can lead to coronavirus or even flu and the common cold. Durisan products pierce the cell wall to destroy germ and viruses, meaning they cannot survive—or mutate into cleaner and drug-resistant super bugs.” [from your website https://durisan.com]
- “The Durisan difference is that our water-based hand sanitizer doesn’t evaporate and maintains effectiveness for up to 24 hours and eight hand washes.” [from your website https://durisan.com]
- “Durisan® . . . 100% ALCOHOL FREE Our alcohol-free hand sanitizer . . .moisturize and condition the skin while killing 99.9% of illness causing germs for up to 24 hours.” [from your website https://durisan.com]
- “Durisan @DurisanProducts . . . CORONAVIRUS PREVENTION . . . WASH HANDS WITH WATER AND SOAP/SANITIZER . . .” [from a April 2, 2020 at 8:55am post on your Facebook webpage at https://www.facebook.com/DurisanProducts/]
- “Durisan @DurisanProducts . . . Washing your hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after blowing your nose, coughing, or sneezing, can assist in the prevention of the coronavirus disease 2019 (COVID-19). For those who want an extra layer of protection and live in the Sarasota area, Durisan products are available direct to consumers at our factory.” [from a March 5, 2020 post on your Facebook webpage at https://www.facebook.com/DurisanProducts/]
The hand sanitizer 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). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, are in effect for your hand sanitizer 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 products are GRASE for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, your hand sanitizer 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).
FDA said that it noted that 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) added section 505G to the FD&C Act. Under 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety and effectiveness in a TFM that is the most recently applicable proposal or determination issued under 21 CFR Part 330 -- and that were not classified in such a TFM 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 labeling conditions, and comply with all other applicable requirements for nonprescription drugs.
Although the hand sanitizer products contain benzalkonium chloride as the active ingredient, they 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. Specifically, your labeling claims suggesting that your products are effective in preventing infection or disease from specific pathogens including 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. Additionally, FDA said, that the company’s labeling claims suggesting that its hand sanitizer 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.
FDA said it was are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that Durisna’s 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, as described in newly-added subsection 505G(a)(6). 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.
