WARNING LETTER
Vapore LLC dba Mypurmist
MARCS-CMS 608953 —
July 30, 2020
Product:
Drugs
Recipient:
Vapore LLC dba Mypurmist
1130 Burnett Avenue, Suite P
Concord
,
CA
94520
United States
care@mypurmist.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Federal Trade Commission
WARNING LETTER
Date:               July 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 https://www.mypurmist.com/
on June 25, 2020 and July 28, 2020,
respectively
.  The FDA has observed that your website offers Mypurmist 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 a combination product that includes an unapproved new drug (sterile water for the purposes described below) 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, the drug is misbranded under section 502 of the FD&C Act, 21 U.S.C. § 352.  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).
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 at https://www.mypurmist.com/pages/homepage-v-2 that establish the intended use of your product and misleadingly represents it as safe and/or effective for the treatment or prevention of COVID-19 include:
“Novel Coronavirus / Covid-19: What to know about steam inhalation . . . [o]n this page we will provide you with guidance about steam inhalation and how to manage the symptoms of Novel Coronavirus.”
“Mypurmist help [
sic
] alleviate the symptoms of an upper respiratory infection such as the Novel Coronavirus (cough, runny nose, fever and breathing). The US Dept. of Homeland Security has shown that Novel Coronavirus is inactivated at a combination of 95°F temperature and >40% humidity . . . Mypurmist safely provides a temperature of 115°F and a humidity of 100%, thereby maximizing these two factors in a combination well beyond the study parameters.”
“Does Mypurmist help or treat pneumonia caused by Novel Coronavirus? . . . Mypurmist has not asked the FDA to be allowed to promote the use of Mypurmist for pneumonia and it has not specifically been tested for this use. However, doctors and leading healthcare institutions frequently recommend the use of warm humified air for patients with pneumonia as palliative treatment to relieve symptoms, and improve your quality of life.”
“What temperature of steam does Mypurmist put out? How effective is it to help kill Novel Coronavirus in sinus? The highest temperature of Mypurmist is calibrated at 115º . . . There are no studies that measure at which temperature Novel Coronavirus specifically inactivate or stop replicating . . . But several studies have indicated that viruses inactivate/stop replicating at around 108º.”
“Does using Mypurmist steam inhalation disable the virus? It is well established that Coronavirus quickly loses its ability to replicate at a combination of high temperature (above 80 F) and high humidity (above 95% Rh). Mypurmist provides 100% Rh humidity and a temperature of up to 115F, thereby maximizing these two factors in combination.”
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 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://
HYPERLINK "http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products"
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 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 product identified above.  Thus, any coronavirus-related prevention or treatment claims regarding such product is 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 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/).
Content current as of:
07/31/2020
Regulated Product(s)
Drugs