WARNING LETTER
www.outoftheboxremedies.com
MARCS-CMS 608263 —
June 10, 2020
Product:
Drugs
Recipient:
Recipient Name
John Burket
www.outoftheboxremedies.com
66/3 Emek Hahula
Modiin
71703
Israel
yburket@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Federal Trade Commission
WARNING LETTER
Date:               June 10, 2020
RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to ad
vise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your websites at the Internet addresses www.outoftheboxremedies.com, www.outsidetheboxremedies.yolasite.com
,
and www.outoftheboxremedies.net
,
on June 1, 2020 and June 8, 2020, respectively. We also reviewed your social media website at www.facebook.com/outoftheboxremedies, where you direct consumers to your website, www.outoftheboxremedies.com
,
to purchase your products. The FDA has observed that your website offers iodine 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 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:
“Coronavirus Terminator . . . ‘I have suggested that people put iodine into a nebulizer for aerosol treatment for transdermal effect into the lung tissues in the case of lung cancer, emphysema, asthma, and tuberculosis. . .  So effective is iodine that aerosols can be effective in sterilizing a room at levels not even detectable by humans.’ . . .  To which I would add viruses of any type, including mutated viruses and corona COVID-19. Adding Lugol's iodine to ‘Ciggy Juice’ ramps up the application of antiviral iodine to sensitive lung tissue. . . . More information on this wonderful product can be found on my blog at www.outoftheboxremedies.net
”
[from your websites https://www.outoftheboxremedies.com/#!/Coronavirus-Terminator-vaping-pen-100-ml-iodine-solution/p/180279268/category=0 and
https://outsidetheboxremedies.yolasite.com/]
“Coronavirus Terminator Refill (100 ml, 3.4 oz) . . . The Coronavirus Terminator Refill contains Lugol's iodine, a known antiviral. This antiviral, antibacterial medicine is ideal for killing any alien microbes in the lungs.” [from your websites
https://www.outoftheboxremedies.com/#!/Coronavirus-Terminator-Refill-100-ml-3-4-oz/p/183746255/category=0 and https://outsidetheboxremedies.yolasite.com/]
“Iodine Kills ALL Viruses . . . ‘I have suggested that people put iodine into a nebulizer for aerosol treatment for transdermal effect into the lung tissues in the case of lung cancer, emphysema, asthma, and tuberculosis.’ To which I would add viruses of any type, including mutated viruses and corona COVID-19. Ways to Apply Iodine to Kill Coronavirus (COVID19) or Any Other Virus . . . The highly contagious Coronavirus can enter the body through the nose, mouth, eyes, and ears. Yes, even the ears can receive viruses. Taking iodine in the form of Lugol’s iodine internally is a good first step, but one must start with a small dosage and work up to larger doses over a period of weeks to avoid severe itching, especially in people over 50. . . . Be sure to visit Out of the Box Remedies to order anti-COVID19 iodine products.” [from a March 10, 2020 blog posting on your website
https://outoftheboxremedies.net/
and a March 10, 2020 posting by John Burket on your Facebook social media website www.facebook.com/OutOfTheBoxRemedies/]
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://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 are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims for products that 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 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.
[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:
06/11/2020
Regulated Product(s)
Drugs