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  5. AusarHerbs - 610976 - 01/12/2021
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WARNING LETTER

AusarHerbs MARCS-CMS 610976 —

Product:
Drugs
Food & Beverages
Recipient:
AusarHerbs

201 S. D Street
Madera, CA 93639
United States

Support@ausarherbs.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

WARNING LETTER

Date:   January 12, 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://ausarherbs.com/ on December 17, 2020 and December 21, 2020, respectively. The FDA has observed that your website offers “Corona Destroyer Tea” for sale in the United States in two options, “Prevention” and “Reversal,” 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, 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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Some examples of the claims on your website and product label 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:

  • The name of the product, “Corona Destroyer Tea,”[4] and the two formula options “Prevention” and “Reversal.”
  • “Based upon the notes and files left behind by Dr. Sebi his fellow colleagues and trusted family members have recommended this formula to prevent and destroy what is being called Corona virus/ Covid 19. … This formula will reversed [sic] Covid 19 in 7 days, every time. Symptoms gone in 3 days.” [from your website https://ausarherbs.com/product/corona-destroyer-tea/].
  • “Based upon the notes and files left behind by Dr. Sebi his fellow colleagues and trusted family members have recommended this formula to prevent and destroy what is being called Corona virus.” [from the product label image on your website at https://ausarherbs.com/product/corona-destroyer-tea/].

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 immediately address this matter 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 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 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 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 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/
William A. Correll
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 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 three times.  The most recent renewal went into effect on October 23, 2020.  Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. October 2, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.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]  Although your website refers to this product as “Coronavirus Destroyer Tea,” the image of the product label shown on your website bears the name “Coronavirus Destroyer.”  Either name is a claim indicating that the product is intended to cure, treat, mitigate, and/or prevent COVID-19. 

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