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WARNING LETTER

NRP Organics Ltd MARCS-CMS 606066 —

Product:
Drugs

Recipient:
Recipient Name
James Rutherford
NRP Organics Ltd

(b)(6)
Canada

info@nrporganics.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

Date:               April 8, 2020

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) reviewed your websites at the Internet addresses at www.nrporganics.com and www.coronaviruscures.com on March 25, 2020. On the same date, we also reviewed your social media websites at www.facebook.com/nrporganics and www.instagram.com/nrporganics, where you directed consumers to your website, www.nrporganics.com, to purchase your products. The FDA observed that your websites offered “Fortify Humic Beverage Concentrate” and “Electrify Fulvic Beverage Concentrate” products for sale in the United States, and these products were intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people. Based on our review, these products were 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 were 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 violated 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 sold products that were intended to mitigate, prevent, treat, diagnose or cure COVID-19 in people.   

Some examples of the claims on your websites that established the intended use of your products and misleadingly represented them as safe and/or effective for the treatment or prevention of COVID-19 include:

  • “HUMIC SUBSTANCES ARE A CLINICALLY PROVEN ANTI-VIRAL THAT COULD HELP FIGHT COVID-19.” [from your website www.nrporganics.com]
  • “YES, research shows Fulvic and Humic substances are extremely effective as anti-viral, anti-oxidant, anti-microbial, and anti-inflammatories. The benefits of adding this into your daily regimen are far more than immune support, but for now, we are going to talk about what makes them anti-viral and how that may help you reduce the severity of a virus-like COVID-19.” [from your website www.nrporganics.com]   
  • “As we age, gut microbia actually reduces and that could be the reason why older people are more at risk for severity of illnesses like Covid-19 and yearly influenza . . . WE CAN CONCLUDE FROM THIS RESEARCH THAT HUMIC SUBSTANCES HAVE A POSITIVE INFLUENCE ON GUT BACTERIA AND RESPIRATORY INFECTIONS, AND ARE PROMISING FOR THE PREVENTION OF MANY VIRAL DISEASES.” [from your website www.nrporganics.com]     
  • “CORONAVIRUS CURES . . . PROTECT YOU, AND THE ONES YOU LOVE WITH HUMIC AND FULVIC ANTIVIRUS! . . . With most viruses, the inhibitory effect of (Humic Acid) is directed specifically against an early stage of virus replication namely virus attachment to cells” [from your website www.coronaviruscures.com]     
  • “Humic acid is very helpful for latent infections because once the virus reactivates it prevents the newly created viruses from entering your cells and reproducing, reducing your viral load over time.” [from your website www.coronaviruscures.com]     
  • A Facebook post describing how a virus attacks cells, with an image of viruses, and the hashtags “#fulvicacid #fulvic #humicacid #electrify #fortify #virus #coronavirusoutbreak #wuhan #sars #chinavirus #worldhealthorganization #coronavirus #plagueinc #epidemia #coronavirus” [from a February 3, 2020 post on your Facebook website at www.facebook.com/nrporganics]
  • An Instagram post describing different viruses and the hashtags “#fulvicacid #fulvic #humicacid #humic #electrify #fortify #virus #coronavirusoutbreak #wuhan #sars #chinavirus #worldhealthorganization #coronovirus #plagueinc #epidemia #coronavírus” [from a February 1, 2020 post on your Instagram webpage at www.instagram.com/nrporganics]   

We note that, as of the date of this letter, the websites described above appear to be down. Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that these violations do not recur.

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 representing your products 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 prevent the recurrence of future violations.

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, with a notation that, as of the date of this letter, your firm’s listed products are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of COVID-19. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products.  

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 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-CDER@fda.hhs.gov.   

Sincerely,

/S/

Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
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).

[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/).