Recipient:

Recipient Name

Jesse Pelletier, MD

Recipient Title

President

Halodine, LLC

111 NE 1st St, Suite 806
Miami, FL 33132-2506
United States

[email protected]
Issuing Office: Center for Drug Evaluation and Research

United States


WARNING LETTER

Date: July 7, 2021

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 websites at the Internet addresses https://halodine.com/ and https://shop.halodine.com on June 23, 2021. The FDA also reviewed your social media websites at Internet addresses, https://twitter.com/TheHalodine and https://facebook.com/halodine, where you direct consumers to your website, www.halodine.com, or https://shop.halodine.com, to purchase your products. In addition, the FDA has reviewed the labeling on your product packaging for the Halodine nasal and oral “sanitizer” product lines that include the over-the-counter (OTC) drug products, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse.

The FDA has observed that your websites offer non-alcohol-based antiseptic products1 for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-192 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 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 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-19.4 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 or other conditions.

Some examples of the claims on your websites 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:

“Halodine Fights the Spread of COVID-19” [from a brochure on your website https://halodine.com/]5

“HALODINE NASAL ANTISEPTIC SWABSTICK is a nasal sanitizer that kills SARS-CoV-2 (the virus that causes COVID-19) in less than 15 seconds.” [from a brochure on your website https://halodine.com/]5

“In vitro efficacy of a povidone-iodine nasal antiseptic for rapid inactivation of SARS-CoV-2.” [from the CDC Library website6 which is directly linked from your website https://halodine.com/ via a hyperlink titled, “As featured on the CDC website”]

“Povidone-iodine nasal antiseptic (PVP-I) inactivated SARS-CoV-2 within 15 seconds in vitro…” [from the CDC Library website6 which is directly linked from your website https://halodine.com/ via a prominent hyperlink titled, “As featured on the CDC website”]

“Nasal decontaminants have been advocated as a way to sterilize the nasal cavity in persons with SARS-CoV-2 infection, as well as for prophylaxis in exposed persons to reduce transmission and to diminish the severity of disease. These early results demonstrate effectiveness of PVP-I against SARS-CoV-2 in vitro. More comprehensive studies should be undertaken to examine the safety and potential in vivo effectiveness of PVP-I as a possible measure to mitigate viral transmission.” [from the CDC Library website6 which is directly linked from your website https://halodine.com/ via a prominent hyperlink titled, “As featured on the CDC website”]

“Prophylactic and therapeutic topical povidone-iodine in coronavirus disease 2019 (COVID-19): What is the evidence?” [from your website https://halodine.com/science/]. .”

“PVP-I has demonstrated wide viricidal activity against both enveloped and non-enveloped viruses,…and specifically against other pathogenic coronaviruses (Middle East Respiratory Syndrome-coronavirus [MERS-Cov], severe acute respiratory syndrome-coronavirus [SARS-CoV].” [from Wiley Online Library website7 which is directly linked from your website https://halodine.com/ via a link next to the title, “Prophylactic and therapeutic topical povidone-iodine in coronavirus disease 2019 (COVID-19): What is the evidence?”]

“…A peer reviewed study added to the CDC library said the spray can kill up to 99 percent of the COVID-19 virus in the nose in15 seconds.” [from the CBS17.com website8 which is directly linked from your website https://halodine.com/news/ via a link next to the title, “Could nasal sprays be tool in COVID-19 infection protection?”]

“Dr. Samuel Barone, president, and chief medical officer for Halodine, said its nasal swabs and liquids and mouth rinse and spray provide another layer of protection from the coronavirus for those using masks and gloves.” [from the Miami Laker website9 which is directly linked from your website https://halodine.com/news/ via a link next to the title, “Halodine and Free COVID-19 clinical trials in Miami Lakes through March 5”]

“Halodine is a non-toxic proprietary antiseptic developed for repeated nasal and oral administration proven effective against SARS-CoV-2 and other infections.” [from your website https://twitter.com/TheHalodine posted at the top of the webpage]

“Can Nasal Sprays Combat COVID-19? @omnia_health looks at fighting viral spread with #Halodine.” [from your website https://twitter.com/TheHalodine posted on 3/22/2021]

“If you’re concerned that masks aren’t enough, try @TheHalodine. It’s like hand sanitizer for the nose and mouth, the sources of spreading viruses. Very cool how it keeps you and others safe by reducing the risk of spreading COVID.” [from your website https://twitter.com/TheHalodine retweeted from @drdrew on 2/20/2021]

“Halodine helps reduce the spread of viral transmission in both the nose and mouth. If exposed, research shows it can lower the viral load of covid ( and other viruses) in the body and can shorten the duration of infection. My husband tested positive and immediately used the mouth and nose rinse daily. His symptoms stayed extremely mild and he tested negative within 7 days.” [https://facebook.com/halodine posted on 4/20/2021]

“Use of Halodine, in addition to other important measures such as wearing a mask, washing hands and social distancing, can help reduce virus transmission for up to 4 hours per application.” [from your website https://halodine.com/faqs/]

“…Masks provide a first layer of personal protection, but Halodine provides an additional layer of tested protection for up to 4 hours, helping keep you and others safe.” [from your website https://shop.halodine.com]10

Based on the above claims and statements, your topical antiseptic11 and oral antiseptic12 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, Halodine Nasal Antiseptic Swabstick and Halodine Nasal Antiseptic are intended for use as both consumer and health care topical antiseptics. Halodine Oral Antiseptic Spray and Halodine Oral Rinse are intended for use as oral antiseptics.

These consumer and health care topical antiseptics and oral 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 (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), 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, is 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 Halodine drug products are GRASE for use under the conditions suggested, recommended, or prescribed in their 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).

We note that over-the-counter (OTC) topical and oral antiseptic products had been the subject of rulemakings 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.

Oral antiseptics were addressed in a tentative final monograph (TFM) entitled “Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products”; Proposed Rule, 59 FR 6084 (February 9, 1994) (Oral Antiseptics Proposed Rule). Over the course of this rulemaking for oral antiseptics, povidone iodine at 0.5% was classified as Category I as an oral antiseptic prior to injection, dental surgery or tooth extraction for use by health care professionals (59 FR 6084 at 6122). Povidone iodine at 0.5%, when labeled for short-term use (not to exceed 7 days), was classified as Category III for use as an OTC oral antiseptic, because additional effectiveness data are needed to support a determination that a product containing this active ingredient would be GRASE for use as an OTC oral antiseptic.

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, including the active ingredient, and comply with all other applicable requirements.

However, your non-alcohol-based antiseptic products do not conform to the 1994 TFM, the Oral Antiseptics Proposed Rule, 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.

Specifically, your labeling claims, suggesting that your non-alcohol-based antiseptic products are effective in shortening the duration of infection and preventing infection or disease from the novel coronavirus that causes COVID-19, go beyond merely describing the general intended use of an antiseptic as set forth in the 1994 TFM and the Oral Antiseptics Proposed Rule.13 In addition, your labeling claims, suggesting that your non-alcohol-based antiseptic products provide up to 4 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19, are not permitted under the 1994 TFM, the Oral Antiseptics Proposed Rule, 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, 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 non-alcohol-based antiseptic products are GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, your non-alcohol-based antiseptic products are new drugs under section 201(p) of the FD&C Act. In addition, there are no FDA-approved applications in effect for your non-alcohol-based antiseptic products 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 non-alcohol-based antiseptic products also do not conform to any temporary policy FDA has implemented during the public health emergency.14

In addition, according to the product labeling, Halodine Nasal Antiseptic Swabstick and Halodine Nasal Antiseptic are 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.15

Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse are misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because their labeling is false or misleading. Specifically, labeling for these products falsely indicates that “Halodine complies with FDA OTC regulations”. However, we note that the violations described in this letter specify how these products are not legally marketed under the conditions of 505G.

In addition, these non-alcohol-based antiseptic products are 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 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 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 [email protected] 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 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. 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 [email protected]

Sincerely,
/S/

Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

________________________

1 Your non-alcohol-based antiseptic drug products include Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse.

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/2019-nCoV.aspx).

4 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).

5 (https://halodine.com/wp-content/uploads/Halodine-Nasal-Antiseptic-Swabstick-6-pack.pdf; https://halodine.com/wp-content/uploads/Halodine-Nasal-Antiseptic.pdf; https://halodine.com/wp-content/uploads/Halodine-Oral-Antiseptic-Spray.pdf; https://halodine.com/wp-content/uploads/Halodine-Oral-Rinse-10-pack.pdf)

6 (www.cdc.gov/library/covid19/092920_covidupdate.html#anchor_ClinicalTreatment)

7 (www.onlinelibrary.wiley.com/doi/full/10.1002/alr.22735?campaign=woletoc)

8 (https://www.cbs17.com/digital-stories/could-nasal-sprays-be-tool-in-covid-19-infection-protection/)

9 (https://miamilaker.com/News-Article/free-covid-19-clinical-trials-in-miami-lakes-through-march-5)

10 https://shop.halodine.com/products/halodine-nasal-antiseptic-swabstick; https://shop.halodine.com/collections/frontpage/products/halodine-nasal-antiseptic; https://shop.halodine.com/collections/frontpage/products/halodine-oral-antiseptic-spray; https://shop.halodine.com/collections/frontpage/products/halodine-oral-rinse

11 Halodine Nasal Antiseptic Swabstick and Halodine Nasal Antiseptic

12 Halodine Oral Antiseptic Spray and Halodine Oral Rinse

13 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. The Oral Antiseptics Proposed Rule covers oral antiseptics that are indicated for use in first aid to help decrease bacterial contamination in minor cuts, minor scrapes or minor oral irritation caused by dental procedures, dentures, orthodontic appliances, or accidental injury and for use by health care professionals for preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction. 59 FR at 6121-22.

14 See, e.g., Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Because your non-alcohol-based consumer antiseptic products are not consistent with the formulations described in these guidances, they do 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.

15 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.