WARNING LETTER
Quadrant Sales & Marketing, Inc.
MARCS-CMS 607625 —
May 28, 2020
Product:
Drugs
Recipient:
Recipient Name
Robert Cefail
Recipient Title
President
Quadrant Sales & Marketing, Inc.
1940 Rainbow Dr
Clearwater
,
FL
33765
United States
bob@intouchmarketing.us
lindabatdorf@earthlink.net
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date:               May 28, 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://cleanhandsandmore.com/ on April 30, 2020. The FDA has observed that your website offers a non-alcohol based hand sanitizer product for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[1]
in people. Based on our review, this product is an unapproved new drug 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 this product 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.
[2]
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
[3]
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 a product that is 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 product for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Some examples of the claims on your website, https://cleanhandsandmore.com
,
that establish the intended use (as defined in 21 CFR 201.128) of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include, but may not be limited to, the following:
“What does Purifi™ kill? Purifi™ protects by killing bacteria, viruses, mold, mildew, fungi, algae and yeast on contact. In addition, it destroys odor causing bacteria, both gram negative and gram positive. Although not on our label, extensive third-party testing has conclusively proven that Purifi™ destroys all three - MRSA, C. Diff. and H1N1 - as well a wide array of other viruses. Under the present regulatory environment, the product is certified against Corona Virus. As there are 1000’s of viruses, the antimicrobial industry is allowed to certify based on model organisms for the main categories of virus: enveloped, non-enveloped, RNA, DNA, various families, etc. For the family of Corona Virus, the human Influenza A or sub-set H1N1, is the model which the product on which Purifi™ Hand Sanitizer is based has been tested to destroy/ inactivate.”
“Purifi™’s fast drying lightweight foam forms a germ fighting breathable microscopic barrier that lasts for hours and persists through hand washing.”
“NEXT GENERATION HAND SANITIZER: Purifi’s patented, formulation kills VIRUSES, BACTERIA & MORE AND LASTS For HOURS . . .”
“Purifi™ gently applies a breathable soap-silicon protective barrier to your hands, continuously destroying harmful germs and disrupting germ adhesion to your skin. . . The patented antimicrobial technology safely kills microbes on contact. It is not absorbed by the skin but instead bonds to the surface for up to 24-hours. As your skin sheds daily, the Purifi™ comes off. For maximum protection, application every 6 hours is recommended.”
The above noted website claims are supplemented by a metatag used to bring consumers to your website through Internet searches. The metatag is:
”kills VIRUSES, BACTERIA &amp; MORE AND LASTS For HOURS”
Based on the above claims, your hand sanitizer product is a drug as defined by section 201(g)(1)(B) of the
FD&C Act,
21 U.S.C. § 321(g)(1)(B), because it is 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 it is intended to affect the structure or any function of the body. Specifically, your hand sanitizer is intended for use as a consumer antiseptic rub.
Your hand sanitizer product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, is in effect
for your hand sanitizer product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your hand sanitizer product is GRASE for use under the
conditions suggested, recommended, or prescribed in its labeling
. Accordingly, your hand sanitizer product is an unapproved new drug 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 product contains benzalkonium chloride as the active ingredient, it does 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 does 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, yo
ur labeling claims suggesting
that your product
is 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
.
[4]
Additionally, your labeling claims suggesting that your hand sanitizer product provides 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, this product 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 sanitizer is GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, your hand sanitizer is a new drug 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 sanitizer and, accordingly, it is an
unapproved new drug 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 sanitizer also does 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 product 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 website, product’s label, and other labeling and promotional materials to ensure that
you are not misleadingly representing your product 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 product is 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]
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
[2]
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).
[3]
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/).
[4]
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:
05/29/2020
Regulated Product(s)
Drugs