WARNING LETTER
CofixRx, LLC
MARCS-CMS 626860 —
April 05, 2022
Product:
Drugs
Recipient:
Recipient Name
Dennis Kaiser
Recipient Title
Founder & CEO
CofixRx, LLC
40900 Woodward Avenue, Suite 111
Bloomfield Hills
,
MI
48304
United States
dennis@cofixrx.com
customerservice@cofixrx.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date: April 05, 2022
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://cofixrx.com on January 4, 2022. The FDA also reviewed the labeling on your product packaging for your drug product, CofixRX Nasal Spray.
The FDA has observed that your website offers your non-alcohol-based antiseptic product, CofixRX Nasal Spray, for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
1
and other conditions 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). Furthermore, this product is a misbranded drug under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee). The introduction or delivery for introduction of this product 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.
2
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.
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 and other conditions 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 product label and website that provide evidence of the intended uses (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 and other conditions include, but may not be limited to, the following:
“DESTROYS SARS CoV-2 and other COLD & FLU viruses in 15 seconds” [from your CofixRX Nasal Spray product label]
“CofixRX™ is an antiviral nasal spray that offers up to 8 hours of protection from many cold and flu viruses.” [from your CofixRx Nasal Spray product label]
“Lasts for up to 8 hours per application.” [from your website https://cofixrx.com]
“CofixRX utilizes patent-pending technology that is effective 45 seconds after application and lasts up to 8 hours, reducing the need for constant re-applications.” [from your website https://cofixrx.com]
Based on the above claims and statements, your CofixRX Nasal Spray 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 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 it is intended to affect the structure or any function of the body. Specifically, CofixRX Nasal Spray is intended for use as both a consumer and health care topical antiseptic.
This consumer and health care topical antiseptic 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. A new drug 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 it is lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or under other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your CofixRX Nasal Spray drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this drug 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 had been the subject of a rulemaking under the Agency’s OTC Drug Review. In particular, consumer topical antiseptics 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 including patient antiseptic skin preparations.
Section 505G of the FD&C Act governs 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, including the active ingredient, and comply with all other applicable requirements.
However, your CofixRX Nasal Spray product does not conform to the 1994 TFM, nor any other TFM, proposed rule, or final rule and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
4
Specifically, your labeling claims, suggesting that CofixRX Nasal Spray is effective in preventing infection or disease from the novel coronavirus that causes COVID-19 and other viruses, go beyond merely describing the general intended use of an antiseptic as set forth in the 1994 TFM.
5
In addition, your labeling claims, suggesting that CofixRX Nasal Spray provides up to 8 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19, are not permitted under the 1994 TFM or any of the amendments to the TFMs discussed above. 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 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, CofixRX Nasal Spray 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.
In addition, according to the product labeling, CofixRX Nasal Spray is intended to be applied inside the nostrils. Consumer and health care antiseptic products intended for administration inside the nostrils are not permitted under the 1994 TFM, as further amended by the Consumer Antiseptic Rubs Proposed Rule and the Health Care Antiseptics Proposed Rule.
6
CofixRX Nasal Spray is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is misleading. Specifically, your product website contains the following language: “Is CofixRx approved by FDA? The active ingredient in CofixRX, Povidone-iodine, is FDA approved to be used in over-the-counter products…” This language misleadingly suggests that your product is FDA approved, when in fact, there is no FDA approved application in effect for this drug product.
In addition, CofixRX Nasal Spray is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is 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 product as safe and effective for a COVID-19-related use for which it has 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 address 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 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 corrective 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 appropriate corrective 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 Becker, Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Cc:
Adam Fovenesi
Executive Vice President
LRX Biotceh, LLC.
4255 N. Atlantic Blvd.
Auburn Hills, MI 48326
tonyo@lrxbiotech.com
_______________________
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, 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
).
3
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
).
4
We note that CofixRX Nasal Spray also does 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). Because your non-alcohol-based topical antiseptic product is not consistent with the formulations described in these guidances, it does not fall within any temporary Agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act. Additionally, 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.
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 at 31443.
6
The 2016 Consumer Antiseptic Rubs Proposed Rule covered consumer antiseptic products intended for use without water. Under the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, only consumer topical antiseptic products intended for use on the hands without water are permitted. Products intended for other areas of the body such as the nose are not permitted. The 2015 Health Care Antiseptics Proposed Rule covered health care antiseptic products intended for use without water. Under the 1994 TFM, as amended by the 2015 Health Care Antiseptics Proposed Rule and 2017 Health Care Antiseptics Final Rule, certain health care topical antiseptic products intended for use without water, including patient antiseptic skin preparations, are permitted. Health care antiseptic products intended for use inside the nose are not permitted because the inside of the nose is a mucous membrane.
Content current as of:
04/08/2022
Regulated Product(s)
Drugs