WARNING LETTER
Kleenhanz, LLC
MARCS-CMS 605499 —
April 19, 2022
Product:
Drugs
Recipient:
Recipient Name
Mr. Lance FitzSimon
Kleenhanz, LLC
1102 E Sonterra Blvd Ste 100
San Antonio
,
TX
78258-4063
United States
lance@kleenhanz.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date: April 19, 2022
RE: Unapproved 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 www.kleenhanz.com in April 2022, where you direct consumers to retailers including Amazon.com to purchase your products. We also reviewed your social media website at Internet address https://twitter.com/kleenhanz, where you direct consumers to the page on your website, www.kleenhanz.com, with links to retailers where your products can be purchased.
The FDA has observed that your website offers Kleenhanz® Towelettes topical antiseptic products
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 conditions 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 section 502(ee) of the FD&C Act, 21 U.S.C. § 352(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 subsequently 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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 or other conditions.
Some examples of the claims observed on your websites that provide evidence of the intended uses (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 conditions include, but may not be limited to, the following:
• “Coronavirus is very real and not going away anytime soon! Get #Kleenhanz now on Amazon to protect your family!!” [from a post on your Twitter webpage at https://twitter.com/kleenhanz]
• “Protect yourself against Coronavirus: Think of your hands as your number one problem. Get Kleenhanz for you and your family!” [from a post on your Twitter webpage at https://twitter.com/kleenhanz]
• “In the Classroom . . . Kleenhanz® has been proven to reduce absenteeism in schools . . . In Medical Offices… More and more doctors are discovering the effectiveness and convenience of Kleenhanz® as a superior germ killer that is easier to use between patient exam rooms and so much easier on their hands than constant washing or alcohol based hand sanitizers. Kleenhanz® was not intended to replace surgical sanitizers, but for most other sanitary functions, Kleenhanz® is highly effective. If you visit a clinic or hospital you know there are elevated levels of germs, bacteria and virus inside. Use Kleenhanz® to reduce your exposure. Remember, Kleenhanz® kills MRSA!” [from your website www.kleenhanz.com]
• “Kleenhanz vs. Viruses . . . Since 2002, Kleenhanz scientists have been working to develop a superior alternative to harsh alcohol based hand sanitizers. Our goal was to develop a germ, bacteria and virus killing hand sanitizing wipe . . . The result is Kleenhanz . . . Is Kleenhanz® effective against viruses? Yes, Kleenhanz® is effective against many viruses, like H1N1, Hepatitis, Herpes, HIV, Chlamydia and dangerous bacteria like MRSA.” [from your website www.kleenhanz.com]
• “kleenhanz…Handwashing On-the-Go…Kleenhanz® has been proven effective against the following microorganisms:*
. . .Candida albicans . . . E Coli MG1655 type . . . Pseudomonas aeruginosa” [from your website www.kleenhanz.com]
• “kleenhanz…Handwashing On-the-Go…The active ingredients in Kleenhanz® have been proven effective against many microorganisms including the following:** . . . Chlamydia trachomatis . . . Enterococcus VRE . . . Enterovirus . . . Haemophilus influenza . . . Hepatitis type B & C . . . Herpes simplex type 1 & 2 . . . Human immunodeficiency virus (HIV) type 1 . . . Influenza A2 . . . Influenza A (H1N1) . . . Mycobacterium . . . Neisseria gonorroheae [sic]. . . Norwalk . . . Rotavirus . . . Staphylococcus aureus MRSA . . . Treponema pallidum . . . Vibrio vulnificus” [from your website www.kleenhanz.com]
Based on the above claims, your Kleenhanz® Towelettes 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 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, your Kleenhanz® Towelettes are intended for use as both a consumer and health care topical antiseptic.
These consumer and health care 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 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 Kleenhanz® Towelettes are GRASE for use under the conditions suggested, recommended, or prescribed in its 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).
5
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, consumer topical antiseptic 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 “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.
Health care topical antiseptics were addressed in the 1994 TFM, as further amended by “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) (Health Care Antiseptics Proposed Rule), and “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Final Rule, 82 FR 60474 (December 20, 2017)(Health Care Antiseptics Final Rule). Over the course of these rulemakings, six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine) were classified as Category III for use in health care antiseptic 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 health care antiseptics.
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 and comply with all other applicable requirements.
However, your Kleenhanz® Towelettes products do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule and the 2015 Healthcare Antiseptics Proposed Rule, nor any other TFM, proposed rule, or final rule and do 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 product label, benzalkonium chloride is identified as the active ingredient for Kleenhanz® Towelettes products. However, your website, www.kleenhanz.com, describes your Kleenhanz® Towelettes products as containing two active ingredients, benzalkonium chloride and benzethonium chloride. For example, the website describes the products as “…a germ, bacteria and virus killing hand sanitizing wipe using newer science methods and two active quaternary ammonium compounds (QACs), benzalkonium chloride and benzethonium chloride. The result is Kleenhanz®, an alcohol free, superior germ and bacteria killing hand cleaning and sanitizing wipe that leaves your hands feeling soft while providing persistent germ killing protection.” According to 21 CFR 201.66(b)(2), an “active ingredient” is 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 benzethonium chloride does not appear to be included on some of the product labels of the Kleenhanz® Towelettes products, your website claims described above demonstrate that benzethonium chloride is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because the ingredient is intended to furnish pharmacological activity. Benzethonium chloride is not a permitted active ingredient, either as a sole ingredient or in combination with other ingredients like benzalkonium chloride, for use in consumer antiseptic hand rub drug products under the 1994 TFM. Consumer antiseptic rub drug products with this active ingredient do not conform to the TFM. In addition, the use of more than one active ingredient is not consistent with the 1994 TFM for either consumer antiseptic rub drug products or healthcare topical antiseptic drug products.
In addition, your labeling includes claims that your Kleenhanz® Towelettes products are effective in preventing infection or disease from the coronavirus that causes COVID-19. Your website located at www.kleenhanz.com also contains claims that your Kleenhanz® Towelettes products are effective in preventing disease or infection from other pathogens, including but not limited to, “...Human immunodeficiency virus (HIV) type 1… Hepatitis type B & C…Herpes simplex type 1 & 2…Influenza A (H1N1) …MRSA… Staphylococcus aureus…Enterococcus VRE… Neisseria gonorroheae [sic]…Influenza A2… Norwalk… Rotavirus…Candida albicans… E Coli MG1655 type…Chlamydia trachomatis…” Such indications go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings.
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Your Kleenhanz® Towelettes 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.
You should take immediate action to address 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 and that you do not make claims that misbrand the products in violation of the FD&C Act.
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 any violations, as well as copies of related documentation. Failure to adequately correct any violations 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 actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such actions. 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/
Carolyn E. Becker, J.D.
Director, Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
________________________________
1
These products are marketed in different sizes and package configurations.
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/default.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-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic/
).
5
We note that Kleenhanz® Towelettes also do not conform to any temporary policy FDA has implemented during the public health emergency. In March 2020, the Agency published three guidance documents to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). On December 31, 2021, these guidances were withdrawn, and firms were required to cease distribution, by March 31, 2022, of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. See, 86 FR 56960, October 13, 2021.
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.
Content current as of:
04/21/2022
Regulated Product(s)
Drugs