WARNING LETTER
LVWellness & Aesthetics
MARCS-CMS 609821 —
October 15, 2020
Product:
Drugs
Medical Devices
Recipient:
Recipient Name
Justin Hogan
LVWellness & Aesthetics
7030 FM 1488, Suite 220
Magnolia
,
TX
77354
United States
info@lvwell.com
Issuing Office:
Center for Devices and Radiological Health
United States
Center for Food Safety and Applied Nutrition
WARNING LETTER
Date:   October 15, 2020
RE:      Unapproved, Adulterated, and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.lvwell.com on various dates since August 5, 2020. We also reviewed your social media website at www.facebook.com/lvwellnessaesthetics/
,
where you direct consumers to your website, www.lvwell.com
,
to purchase your products. The FDA has observed that you offer products for sale in the United States that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[1]
in people.
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, clearance, 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, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
COVID-19 Antibody Test Kit Product
FDA observed that your website, www.lvwell.com
,
offers a serology test for at-home testing, specifically the “COVID-19 ANTIBODY TEST KIT” (referred to hereafter as “COVID-19 Test Kit”).  Based on our review, your COVID-19 Test Kit is intended for use in the mitigation, prevention, treatment, diagnosis or cure of COVID-19 in people, and thus, it is a device under section 201(h) of the FD&C Act, 21 U.S.C. § 321(h).
The COVID-19 Test Kit is offered for sale and distributed in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from FDA.
[4]
Accordingly, your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because
your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k)
. The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.
We remind you that, to date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing. Different and potentially serious public health risks are presented with testing in the home versus a healthcare setting. Such risks include, but are not limited to, whether a lay person has the ability to collect their specimen, run the test, and interpret the test result accurately. Your website, www.lvwell.com, indicates that the COVID-19 Test Kit
may be purchased directly by consumers and is intended to be used for at-home testing for COVID-19, including:
Selecting the “COVID-19” tab on your webpage provides a dropdown menu with the option of “AT-HOME TEST KITS.”  Selecting that link then lists  “COVID-19 ANTIBODY TEST KIT.”  [from your website, www.lvwell.com, and by selecting the above options directs to www.lvwell.com/covid-19-antibody-test-kit/]
From your “COVID-19 ANTIBODY TEST KITS” webpage, selecting the link “READ MORE,” directs to the webpage “IMPORTANCE OF COVID-19 ANTIBODY TESTING.”  This webpage states: “PURCHASE YOUR COVID-19 ANTIBODY TEST
$124.99 Purchase Now” [from your website, www.lvwell.com/covid-19-antibody-test-kit/, which by selecting the above options directs to www.lvwell.com/importance-of-covid-19-antibody-testing/]
Selecting the “PRODUCTS” tab on your webpage provides a dropdown menu with the option of “AT-HOME TEST KITS.”  Selecting that link then provides the option “COVID-19 ANTIBODY TEST KIT.” [from your website, www.lvwell.com, and by selecting the above options directs to www.lvwell.com/covid-19-antibody-test-kit/]
“Our COVID-19 Antibody testing is currently available for pick-up or for shipping.” [from a April 28, 2020
post on your Facebook page,
www.facebook.com/lvwellnessaesthetics/]
Please direct any inquiries to FDA regarding your COVID-19 Test Kit product to:
COVID-19-Task-Force-CDRH@fda.hhs.gov
.
ViraFend Multi-Virus Defense Product
FDA also observed that your website
www.lvwell.com
offers the ViraFend Multi-Virus Defense product for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, the ViraFend Multi-Virus Defense product is an unapproved new drug sold in violation of section 505(a) of the 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).
Some examples of the claims on your website,
www.lvwell.com
, 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:
From your webpage titled “DR. HOGAN’S TIPS DURING COVID-19” (
www.lvwell.com/dr-hogans-tips-during-covid-19/
): “WAYS TO FIGHT OFF VIRUSES: . . . The ViraFend Multi Virus Defense Formula [hyperlinks to
www.lvwell.com/virafend-multi-virus-defense-formula
]”
The “COVID-19” tab on your website provides a dropdown menu that includes the option “SUPPLEMENT SHOP,” which includes the dropdown menu option “VIRAFEND | SUPER IMMUNE BOOSTER.”  This menu option directs consumers to your webpage “VIRAFEND MULTI-VIRUS DEFENSE” (
www.lvwell.com/virafend-multi-virus-defense-formula
), which includes the following claims:
“FIGHT OFF VIRUSES”
“VIRAFEND® - MULTI-VIRUS DEFENSE  SUPPLEMENT
ViraFend is a daily dietary supplement that is a scientifically validated Virus Attachment Inhibitor and Virus Reproduction Regulator.”
“WHY DOES DR. HOGAN LOVE THIS PRODUCT?
After our extensive research on the ingredients contained within ViraFend, we feel this is an amazing adjunct therapy for our patients to help support their immune system. The goal is to support our immune system by fighting off foreign invaders — viruses are just that. Remember, viruses require a host to not only bind to, but also replicate. Research data on both Humic Acid and L-Lysine have both shown to help inhibit virus attachment and virus replication!”
“HOW DO WE KNOW VIRAFEND WORKS?
The active ingredient in ViraFend has been extensively tested by the National Institutes of Health and it was shown to be effective against every virus it was tested against.”
“WHY ARE YOU OFFERING THIS PRODUCT?
Viralogics, the creators behind ViraFend have been around for 7 years. Given the state of our country with the current pandemic, we know the good this supplement can do and we have the scientific data that has been clinically shown by the National Institute of Health that this formula has been proven effective against every virus they tested it against.”
Please direct any inquiries to FDA regarding your ViraFend
Multi-Virus Defense
product to:
COVID-19-Task-Force-CFSAN@fda.hhs.gov
.
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/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the products in violation of the Act.
Within 48 hours, please send emails to
COVID-19-Task-Force-CDRH@fda.hhs.gov
and
COVID-19-Task-Force-CFSAN@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 are not in compliance with FDA requirements and 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
https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products
. Once you have taken corrective actions to cease the sale of your unapproved, uncleared, 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.
Please direct any inquiries to FDA at the above-mentioned email addresses.
Sincerely,
/S/
Timothy Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[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/).
[4]
The “COVID-19 ANTIBODY TEST KIT” offered for sale on your website appears to be the COVID19 IgG/IgM Rapid Test manufactured by Phamatech which is currently listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2.  The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, test for which an Emergency Use Authorization (EUA) request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of tiem as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers.  Tests on the “removed” list should not be distributed in the United States unless and until an EUA is issued for the test, or the test receives marketing approval or clearance from FDA.
Content current as of:
11/03/2020
Regulated Product(s)
Drugs
Medical Devices