Sanit Technologies LLC dba Durisan

WARNING LETTER Sanit Technologies LLC dba Durisan MARCS-CMS 606050 — May 07, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Mr. Troy M. Daland Recipient Title CEO Sanit Technologies LLC dba Durisan 7810 25th Court East Unit 106 Sarasota , FL 34243-2841 United States rhoffman@durisan.com info@durisan.com Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER Date:                May 7, 2020 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 website at the Internet address https://durisan.com on April 15, 2020. We also reviewed your social media websites at https://www.facebook.com/DurisanProducts/ and https://twitter.com/Durisan1, where you direct consumers to your website, https://durisan.com, to purchase your products. The FDA has observed that your website offers 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] 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 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. 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/ ] Based on the above claims, your hand sanitizer 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 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, your hand sanitizers are intended for use as consumer antiseptic rubs. Your 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). 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), 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 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 your 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 . [5] Additionally, your labeling claims suggesting that your 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. Time-specific extended efficacy claims, especially when related to serious-disease related pathogens, endanger the public health by creating 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 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 applica tions in effect for your hand sanitizers and, accordingly, t hey 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 . 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 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] Your hand sanitizer drug products include “Durisan Hand Sanitizer 550mL,” “Durisan 1000mL Antimicrobial Hand Sanitizer Kidney Refill,” and “Durisan 18mL Hand Sanitizer Credit Card Spray Mister.” [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 ). The declaration was renewed for another 90 days on April 21, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. April 21, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.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). Content current as of: 05/08/2020 Regulated Product(s) Drugs