WARNING LETTER
Oxford Medical Instruments USA, Inc.
MARCS-CMS 609104 —
August 11, 2020
Product:
Drugs
Recipient:
Recipient Name
Istvan Magyar
Recipient Title
CEO
Oxford Medical Instruments USA, Inc.
2173 Salk Avenue, Suite 250
Carlsbad
,
CA
92008
United States
contact@oxfordmedicals.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Federal Trade Commission
WARNING LETTER
Date:               August 11, 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 reviewed your website at the Internet address https://www.oxfordmedicals.com on August 4, 2020 and August 10, 2020, respectively. The FDA has observed that your website offers salt inhaler 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. 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 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 website that establish the intended use of your salt inhaler products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:
“BREATHING SALT THERAPY AND THE CORONAVIRUS . . . As the world continues the
search for its vaccine and possible cure, here are some of the top preventive habits resulting from breathing salt therapy that will ensure your respiratory tract is in the best condition to effectively fight the coronavirus pandemic and keep you healthy from other respiratory complications like pneumonia. . . . It is proven that the use of breathing salt therapy helps to reduce any symptoms of many respiratory conditions or complications. The therapy involves the process of breathing salty air through high-quality salt pipes that aids someone to reduce respiratory disorders especially during this era of coronavirus. . . . Ease any symptoms that point to respiratory conditions and avoid infections that would leave you extremely ill in case you get exposed to the coronavirus with breathing salt therapy! . . . In a nutshell, powerful breathing salt therapy is important in treating both lower and upper respiratory illnesses . . . using anti-inflammatory and anti-bacterial properties by cleansing airways, improve sleep and strengthening the immune system. . . . BOOST THE IMMUNITY OF YOUR LUNGS AND RESPIRATORY TRACTS WITH BREATHING SALT THERAPY” accompanied by images of viruses and your salt inhaler products. [from a March 31, 2020 blog posting on your website https://www.oxfordmedicals.com.]
“WHEN IT COMES TO CORONAVIRUS (COVID-19), TAKE OUR ADVICE, DON’T GET IT . . . If you have underlying healthy [
sic
] conditions such as respiratory illness, you will be at higher risk of being infected by the virus. So the best thing you can do is empower your body so that it can effectively fight off the corona virus. If you are looking for proven tactics to empower your immune system and prevent your body from being affected by viruses, we recommend the following triple protection plan. 1. BREATHING SALT THERAPY . . . The breathing salt therapy is a natural alternative treatment that capitalizes on micro salt particles absorbed by inhaled air to boost the natural self-cleansing mechanism of the respiratory system. . . . To learn more about the OMI Salt Therapy Pipes, please visit our website below” accompanied by an image of your salt inhaler product. [from a May 28, 2020 blog posting on your website https://www.oxfordmedicals.com.]
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 website, 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 product 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 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
.
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 products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.  You must immediately cease making all such claims. 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/
Serena Viswanathan
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 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 has been renewed for an additional 90 days twice. The most recent renewal went into effect on July 25, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. July 23, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.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/).
Content current as of:
08/12/2020
Regulated Product(s)
Drugs