Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa R. Burchi and Barbara A. Christianson

On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19).  The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus.

The agencies sent the letters to the following companies:

  1. Vital Silver;
  2. Quinessence Aromatherapy Ltd.;
  3. N-ergetics;
  4. GuruNanda, LLC;
  5. Vivify Holistic Clinic;
  6. Herbal Amy LLC; and
  7. The Jim Bakker Show.

Each of the seven companies have advertised products as able to treat or prevent COVID-19/coronavirus.  The unapproved products include teas, essential oils, and colloidal silver.

According to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent the virus.  FDA Commissioner Stephen M. Hahn, M.D. stated: “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health.  We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one.  The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses.”

The letters state that one or more of the efficacy claims made by the marketers are unsubstantiated and therefore may violate the FTC Act.  The letters advise the recipients to cease immediately making all claims that their products can treat or cure coronavirus. 

FTC Chair Joe Simons stated: “There already is a high level of anxiety over the potential spread of coronavirus.  What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims.  These warning letters are just the first step.  We’re prepared to take enforcement actions against companies that continue to market this type of scam.”

Commentary

FTC and FDA have pledged to continue to monitor social media, online marketplaces, and incoming complaints to ensure these products do not continue to make such claims.  The letters sent emphasize that, if the false claims do not cease, FTC may seek a federal court injunction and an order requiring money to be refunded to consumers and instructing the recipients to notify the FTC within 48 hours of the specific actions they have taken to address FTC’s concerns.

In addition, the FTC recently issued a new consumer blog post with information about how to identify and avoid coronavirus-related scams.  Coronavirus: Scammers follow the headlines notes that scammers are creating websites to sell bogus products, and using fake emails, texts, and social media posts as a ruse to take consumers’ money and obtain personal information.  It then warns consumers of the “red flags” to monitor when shopping for products related to the virus.

EPA also has been active in this area, announcing the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19 and also announcing its process for expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants. 


 

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that due to the outbreak of SARS-CoV-2, the coronavirus that causes COVID-19, it is expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.

EPA states that only claims that do not require review of new efficacy data are being expedited at this time.  Companies can submit these claims as non-Pesticide Registration Improvement Extension Act (PRIA 4) fast-track amendments.  Registrants are asked not to include other label changes typically covered under amendments and notifications as part of the submission to add Emerging Viral Pathogen claims.

EPA requests that registrants include the following information in a letter to ensure the efficient processing of submissions:

  • A subject line that clearly indicates “Emerging Viral Pathogen Claim for SARS-CoV-2”;
  • A request to make emerging viral pathogen claims;
  • A description of how the product meets the eligibility criteria for use against one or more categories of viral pathogens consistent with the guidance;
  • The identification of the virus(es) from the product label that the registrant is using to support the emerging viral pathogen claims and the study ID number (MRID) that supports the claim;
    • Note: EPA recommends using the minimum number of supporting viruses needed for the emerging pathogen claim in order to expedite EPA’s review
  • An up-to-date matrix (Form 8570-35); and
  • A request to add the Terms of Registration outlined in Attachment I of the Emerging Viral Pathogens Guidance.

Registrants should also submit a revised master label with a separate section for emerging viral pathogen claims that includes the generic claim statements identified in Attachment I of the Emerging Viral Pathogens guidance document.

EPA requests that applications are submitted through EPA’s CDX portal and email .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX_2020_XXXXXXX) once an application was submitted to expedite the application.

If approved, the product will be added to List N: Disinfectants for Use Against SARS-CoV-2, during the next update to the list, which is scheduled to be updated in the next two weeks.

Additional information is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.


 

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19.  Products on EPA’s “List N: Disinfectants for Use Against SARS-CoV-2” are registered disinfectants qualified for use against SARS-CoV-2 approved through EPA’s Emerging Viral Pathogen Program (Program).  Currently there are 85 products listed that are qualified for use against SARS-CoV-2.  Of note, EPA states that if the directions for use for viruses/virucidal activity of the listed products provide different contact times or dilutions, the longest contact time or most concentrated solution should be used.

EPA issued guidance for the Program in 2016; the guidance was intended to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens.  In the event of an outbreak, companies with pre-approved products can make off-label claims (e.g., technical literature distributed exclusively to healthcare facilities, physicians, nurses, and public health officials; 1-800 consumer information services; company websites (non-label related); social media) for use against the outbreak virus.  These emerging pathogen statements will not appear on marketed (final print) product labels.  Additional information on EPA’s activation of its Emerging Viral Pathogen Program is available on our blog.

Companies with EPA-registered disinfectants that wish to add their products to List N, should provide the information as outlined below to .(JavaScript must be enabled to view this email address).

  1. Ensure that the product has a previously approved emerging viral pathogen claim.
  2. Provide the product name and EPA Registration number.

It is important to note that in releasing today’s list of products, EPA states in red bold font: “Note: There may be additional disinfectants that meet the criteria for use against SARS-CoV-2.  EPA will update this list with additional products as needed.” 

In addition, EPA has updated other lists of antimicrobial products registered with EPA for claims against common pathogens:

  • List B: EPA Registered Tuberculocide Products Effective Against Mycobacterium tuberculosis;
  • List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 Virus;
  • List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus;
  • List E: EPA’s Registered Antimicrobial Products Effective Against Mycobacterium tuberculosis Human HIV-1 and Hepatitis B Virus;
  • List F: EPA’s Registered Antimicrobial Products Effective Against Hepatitis C Virus;
  • List G: EPA’s Registered Antimicrobial Products Effective Against Norovirus;
  • List H: EPA’s Registered Antimicrobial Products Effective Against Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococcus faecalis or faecium (VRE);
  • List K: EPA’s Registered Antimicrobial Products Effective Against Clostridium Difficile Spores; and
  • List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants.

Additional information on EPA’s List of Antimicrobial Products Registered with EPA for Claims Against Common Pathogens is available here.


 

By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On January 29, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has activated its Emerging Viral Pathogen Guidance for Antimicrobial Pesticides (Guidance) in response to the discovery of the novel coronavirus (2019-nCoV).  According to the World Health Organization (WHO), coronaviruses cause numerous illnesses, from the common cold to Severe Acute Respiratory Syndrome (SARS).  First identified in Wuhan, China, the 2019-nCoV coronavirus is a new strain that had not been previously seen in humans.

EPA developed its Guidance in 2016 to address emerging pathogens.  Under this Guidance, EPA provides pesticide registrants with a voluntary “two-stage process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label.”  These pathogens may not be identified on a label because the occurrence of emerging viral pathogens is less common and predictable than established pathogens and because the pathogens are often unavailable commercially and standard methods for laboratory testing may not exist.  EPA’s intent is for the Guidance to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens associated with certain human or animal disease outbreaks.  Registrants with a pre-qualified emerging viral pathogen designation can include an efficacy statement in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites.  Additional information on the Guidance is available here and here.

EPA will likely work closely with registrants as they take steps to use these procedures to make claims related to coronavirus.  EPA notes that coronaviruses are enveloped viruses, meaning they are one of the easiest to kill with the appropriate disinfectant product, and thus using such products could help to limit the spread of these viruses.  Registrants that do not meet the criteria set forth in this Guidance yet make claims related to the coronavirus could face enforcement action for selling or distributing misbranded pesticides.  EPA states that it is working closely with the Centers for Disease Control and Prevention (CDC) to identify and address 2019-nCoV in a timely manner and will continue to monitor developments closely.

Information on the coronavirus is available on CDC’s website.


 
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