WARNING LETTER
Everything Health LLC
MARCS-CMS 613718 —
May 24, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Tamika Moseley
Everything Health LLC
1445 293rd Ave NE
Carnation
,
WA
98014
United States
info@ssnaturalhealing.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Federal Trade Commission
WARNING LETTER
Date: May 24, 2021
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://ssnaturalhealing.com on February 23, 2021 and May 11, 2021, respectively. We also reviewed your social media websites at https://www.facebook.com/ssdallastx/, https://www.instagram.com/tamikamoseley/, and https://twitter.com/sicklesolution, where you direct consumers to your website https://ssnaturalhealing.com to purchase your products. The FDA has observed that your website offers the product CoronaBox 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 an unapproved new drug 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, this product is a misbranded drug 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, there was a Presidential declaration of 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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
According to your website, your CoronaBox product consists of the products Cordyceps, Vitamin D3/K2 Magnesium, Ginger Root, Probiotics, and Sea Moss Gel. Your websites also refer to the CoronaBox product as the “corona basket,” “Corona box,” “coronavirus boxes,” “(orona box,” and “the regimen.” Some examples of the claims on your websites that establish the intended use of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include:
• “Coronavirus disease 2019 (COVID-19) is a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Let’s take a look at natural alternatives we can apply to our daily lives to protect the body and prevent against this virus. The main areas we want to focus on are: gut, immune, and respiratory health . . .
Cordyceps . . . It has been used for centuries in Asia as a tonic to soothe the lung for the treatment of respiratory disease.” [from your webpage https://www.ssnaturalhealing.com/coronavirusprevention-tips]
• “The Corona box is all you need to kick that nasty virus! . . . If you have questions while taking the regimen, please do not hesitate to email me: info@ssnaturalhealing.com.” [from your CoronaBox product webpage, https://www.ssnaturalhealing.com/product-page/coronabox]
• “The corona baskets are $99.00 with FREE shipping and will come with a step by step regimen for getting over corona and also a maintenance regimen to follow AFTER corona to PREVENT BEING A COVID LONG HAULER!!!! . . . The corona basket will contain (probiotic,D3/k2/mag, ginger, cordyceps, and sea moss gel) www.ssnaturalhealing.com” [from a December 31, 2020 post on your social media webpage https://facebook.com/ssdallastx/]
• “I want to let the world know! I have coronavirus boxes that I ship out daily!!!! I am reversing corona by using GODS [SIC] MEDICINE CABINET. . .” [from a February 2, 2021 post on your social media webpage https://facebook.com/ssdallastx/]
• “Anyone can order a (corona [sic] box by sending 99.00 to my PayPal . . . We simply do not have to suffer from this virus! Once we boost the immune system, boost the gut and alkaline the body – the virus will die! No sickness can survive in an alkaline environment! [from a January 9, 2021 post on your social media webpage https://instagram.com/tamikamoseley/]
• “I was exposed to the coronavirus at work . . . After two days of being tested, I received my results, and I was positive for the coronavirus. My son and my mom had to get tested as well. They were exposed from being around me everyday. Both of them were positive as well. I reached out to Tamika and did a consultation with her. My mom, my son and I did the regimen that was given by Tamika. After a few days of doing her regimen, we ended up with negative results. If we didn’t do the regimen from Tamika, I would not have known how we would have survived it.” [from a December 5, 2020 post on your social media webpage https://twitter.com/sicklesolution, in which you posted a testimonial by “Anonymous”]
• “As long as the people will take what they need to take to prevent corona, and we talked about this, probiotics, natural antibiotics, D3 K2 Magnesium, vitamin C, sea moss, all these things, all reverse corona on a daily basis.” [from 0:39-0:56 of a February 1, 2021 YouTube video that “Everything Health with Tamika” posted on the webpage https://youtube.com/watch?v=nCQItNnhCdE. During this statement, the screen shows the following: “THE TRUTH ABOUT COVID”]
You should take immediate action to address 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-CFSAN@fda.hhs.gov
describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations 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 actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
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 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-CFSAN@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. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction. In addition, pursuant to the COVID-19 Consumer Protection Act, Section 1401, Division FF, of the Consolidated Appropriations Act, 2021, P.L. 116-260, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of COVID-19 are subject to a civil penalty of up to $43,792 per violation and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b). 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/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
Sincerely,
/S/
Serena Viswanathan
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, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
3
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
Content current as of:
06/08/2021
Regulated Product(s)
Food & Beverages