WARNING LETTER
Holistic Health International, LLC
MARCS-CMS 607885 —
July 23, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Dr. Amy Yasko and Edward Yasko
Holistic Health International, LLC
279 Walkers Mills Road
Bethel
,
ME
04217
United States
info@holistichealth.com
cs@diagnosticsolutionslab.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date: July 23, 2020
CC: Diagnostic Solutions Laboratory, LLC
31 Lupi Court
Suite 250
Palm Coast, FL 32137
5895 Shiloh Road
Suite 101
Alpharetta, GA 30005
CC: regulatory-inquiries@amazon.com
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites on May 13, 2020 at the Internet addresses www.holisticheal.com and https://www.ch3nutrigenomics.com/, where you host a “Discussion Group” called “Dr. Amy’s Forum: Where Science & Caring Meet” that directs consumers to your website, www.holisticheal.com. Additionally, FDA has observed your products offered for sale at https://www.amazon.com. Your website and the webpage, https://www.amazon.com/CoV-2-Stool-COVID-19-RT-PCR-Technology/dp/B087V5J7TX/ offered for sale an at-home stool sample collection kit that instructed customers to send the sample to Diagnostic Solutions Laboratory, LLC for COVID-19
1
PCR testing, specifically, the “SARS-COV-2 STOOL TEST (SCV),” also referred to as “SARS COV-2 Stool Test (COVID-19 Test Using RT-PCR Technology).” Based on our review, the SARS-COV-2 STOOL TEST is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people, and thus, is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
The SARS-COV-2 STOOL TEST, which the product’s package indicates is manufactured by Diagnostic Solutions Laboratory, was offered for sale and distributed in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from FDA. Accordingly, the 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 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). The 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.
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 sold a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. We request that you take immediate corrective action to prevent the sale of such unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
We remind you that, to date, FDA has not approved, cleared, or authorized any at-home stool sample collection kit for COVID-19 testing. Different and potentially serious public health risks are presented with sample collection in the home versus a healthcare setting. Such risks may include, but are not limited to, whether a lay user can safely and properly collect the specimen; whether the components of the specimen transport media are safe for use in the home environment; adequate stability of the specimen given the time lapse between collection and testing; proper shipment; and the potential impact of shipping conditions on the sample. Your website and product listing on Amazon.com included statements that indicated that the SARS-COV-2 STOOL TEST was intended to be used for at-home stool sample collection for COVID-19 PCR testing. Such statements included the following:
• “Now offering an AT HOME non-invasive stool test (PCR Technology Test) for individuals concerned about the current COVID-19 Virus.” [www.holisticheal.com/sars-cov-2-stool-test.html]
• “AT HOME non-invasive stool test (PCR Technology Test)” [https://www.amazon.com/CoV-2-Stool-COVID-19-RT-PCRTechnology/dp/B087V5J7TX/]
• A post on Dr. Amy’s Forum dated April 3, 2020 and titled, “Stool Test Available for COVID-19” states: “I would like to announce that we finally have access to a coronavirus stool test (the lab has labeled this stool test as: SARS-CoV-2). This is an at home stool test.” The post directs consumers to your website, www.holisticheal.com, to order and is signed “Dr. Amy.” [https://www.ch3nutrigenomics.com/phpBB3/viewtopic.php?f=147&t=39781&p=245859&hilit=covid#p245859]
For more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-pandemic. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”
4
provides information about FDA’s policies intended to help expand testing capacity by facilitating the development and use of COVID-19 tests during the public health emergency.
You should take immediate action to prevent future violations. This letter is not meant to be an all-inclusive list of violations that exist in connection with the product(s) or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its 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 the product(s) as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, authorized by FDA and that you do not make claims that adulterate or misbrand the product(s) in violation of the Act.
Within 48 hours, please send an email to
COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to prevent future violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to prevent future 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 are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis or cure 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 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 prevent the sale of unapproved, uncleared, and unauthorized product(s) 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 the product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDRH@fda.hhs.gov.
Sincerely,
/S/
Timothy Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Office of Product Evaluation and Quality
Center for Devices and Radiological Health
___________________________
1
As explained below, 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/
)
.
4
Accessible at https://www.fda.gov/media/135659/download.
Content current as of:
08/12/2020
Regulated Product(s)
Medical Devices