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WARNING LETTER

Halosense Inc. MARCS-CMS 606153 —

Product:
Drugs
Recipient:
Recipient Name
Livia Tiba
Recipient Title
Director/CEO
Halosense Inc.

48 Knights Bridge Road
London ON N6K 3R4
Canada

halosense@salinetherapy.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

Date:                March 30, 2020

 

RE:                   Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

 

This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address www.salinetherapy.com on March 20, 2020 and March 26, 2020, respectively. We also reviewed your social media websites at Internet addresses https://twitter.com/HomeSaltTherapy and https://www.linkedin.com/today/author/liviatiba, where you direct consumers to your website, www.salinetherapy.com, to purchase your products. The FDA has determined that your website offers salt therapy products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people. FDA has determined that 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 of the FD&C Act, 21 U.S.C. § 352. 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).

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 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 on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:

  • “Becoming Familiar with Coronavirus and Preventing Transmission . . . Coronavirus Prevention . . . Currently, there’s no vaccine to prevent you from getting the Coronavirus infection. . . . A very underestimated treatment that can help protect yourself is salt therapy. Salt therapy is a treatment solely salt based. . . . All you’re doing is breathing in miniscule salt particles. The particles clear your lungs of anything that shouldn’t be there. . . . Notice how older people diagnosed with Coronavirus have more severe symptoms. They can’t fight back, therefore making the virus easy to take their lives. . . . The salt aerosol fights infections, being anti bacterial [sic], anti viral [sic] and anti fungal [sic]. It will do this inside your respiratory system and in the air you breathe. . . . To conclude, reading about Coronavirus has made individuals be on high alert and stressed out. . . . With the right preventative measures, there’s a very slim chance you will catch this disease. . . . Try salt therapy today, your future self will thank you.” [from a February 17, 2020 post on your website www.salinetherapy.com/blog/ and from a February 27, 2020 post on your social media website https://www.linkedin.com/today/author/liviatiba]

 

  • “*Saline therapy also helps the lungs fight against the novel Coronavirus*” . . . #CoronaVirus #CoronaOutBreaks . . . Saline therapy strengthens the lungs to fight against the novel Coronavirus” [from a March 18, 2020 post on your social media website https://twitter.com/HomeSaltTherapy]

You should take immediate action to correct the violations cited in this letter. The violations cited in this letter are 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 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.

If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of 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 product(s) 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.     

In addition, it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.  For COVID-19, no such study is currently known to exist for the product identified above.  Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.  You must immediately cease making all such claims for such product you advertise, market, sell, or otherwise promote or make available in the United States.  Violations of the FTC Act may result in legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov describing the specific actions you have taken to address the FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.

 

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

Sincerely,
/S/
Richard A. Quaresima  
Acting Associate Director
Division of Advertising Practices 
Federal Trade Commission

 

[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, Determination that a Public Health Emergency Exists.  Jan. 31, 2020.  (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.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/).

 
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