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    Online Exclusives

    FDA Warning Letters Address Coronavirus Claims

    Agency’s latest round cites essential oil and CBD companies.

    FDA Warning Letters Address Coronavirus Claims
    Christine Esposito, Managing Editor04.09.20
    The US Food & Drug Administration has ramped up its efforts to tamp down sketchy claims and false promises related to treating and preventing coronavirus. The latest warning letters sent by the agency have hit companies selling products such as essential oils, sachets and CBD.

    Citing the Jan. 31, 2020 Department of Health and Human Services (HHS) declaration of a public health emergency and the March 13, 2020 Presidential declaration of a national emergency in response to COVID-19, the FDA said it 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.”  

    Here is a rundown of some letters related to companies that operate in and around the personal care sphere.

    Health Mastery Systems, DBA Pure Plant Essentials, Ashland, OR, was sent a warning letter for claims made on its website www.pureplantessentials.com, related to essential oils.  They included “Research Essential Oils Respiratory Infections – Soothing For Corona Virus Symptoms — Respiratory Formula. . . Essential oils, because of their volatility, can easily pass through the respiratory system and reach both the upper and lower parts of the respiratory tract via inhalation . . . You can use steam to effectively soothe cold or flu symptoms, like sore throats, nasal congestion, or other respiratory symptoms. Corona virus symptoms of cough, fever and breathing issues may benefit from a respiratory steam and provide comfort and support during the illness. A respiratory steam works by trapping the essential oil vapors in hot water and delivering them to provide soothing support to the respiratory system. . . . Tags: essential oil corona virus symptoms essential oil to use for corona virus symtoms[sic] essential oils corona virus . . .”

    Additionally, the company also made the following claims: “Corona Virus Covid-19 Safety Tips +Plus Sanitizer EO Recipe . . . A 2014 study showed the antiviral efficacy and mechanisms of action of oregano oil . . . Tags: Corona virus essential oil hand sanitizer recipe . . . essential oils to prevent infections COVID-19 essential oils to use for Corona virus . . . best anti virus essential oils . . .” as well as “#coronavirus #covid #prevention #preventativehealth #symptoms #essentialoil #aromatherapy . . . … . Corona Virus COVID-19 Safety Tips +Plus Hand Sanitizer EO Recipe,” which was made on www.facebook.com/kgstileshealthmastery.

    Further, Health Mastery Systems/Pure Plant Essentials also stated on its Facebook page (www.facebook.com/kgstileshealthmastery) “Essential Oil Respiratory Formula – Soothing Support for Symptoms like Corona Virus . . . #respiratory #infection #essentialoils #disease #prevention #natural healing . .. …. . Research Essential Oils Respiratory Infections – Soothing Support for Corona Virus Symptoms – Respiratory Formula.” 

    Boulder, CO-based Ananda, LLC, DBA Ananda Apothecary, was also cited for claims on its website related to essential oils. Those claims included: “Build and Manage Your Immunity: A Coronavirus Antidote? What if you had a magic key to help keep your immune system strong and less likely to succumb to illness?” and “Essential oils are unique allies in times of airborne illness because of their volatile natures and their inherent . . . anti-viral qualities. . . . This quality makes them extremely effective for respiratory conditions by way of inhalation. It is this inherent, diffusive quality that allows essential oils to be used to strengthen the immune system.”  It also made the follow statements: “Six ways to Use the Benefits of Anti-viral essential oils . . . Steam Inhalation;” “Build and Manage Your Immunity: A Coronavirus Antidote? What if you had a magic key to help keep your immune system strong and less likely to succumb to illness?;” and “Essential oils are unique allies in times of airborne illness because of their volatile natures and their inherent . . . anti-viral qualities. . . . This quality makes them extremely effective for respiratory conditions by way of inhalation. It is this inherent, diffusive quality that allows essential oils to be used to strengthen the immune system.” 

    Cathay Natural, LLC, a company based in Kansas City, MO, was also flagged for COVID-19 prevention claims made online related to Traditional Chinese Medicine. Some examples include the following: “Surprisingly, several hospitals designated for mild-moderate COVID-19 patients that are dominated by and fully implemented with Traditional Chinese Medicine (TCM) treatments reported zero medical worker infection and very low or zero conversion rate to severe cases. This was in vast contrast with significant medical worker infections and about 15-20% conversion to sever [sic] cases in certain hospitals that do not use the TCM treatments. Such a big contrast let [sic] many frontline doctors to call for mandatory implementation of Chinese herbal medicine treatments, which eventually become part of the CDC official guide for diagnosis and treatment of COVID-19 in China.” Other examples are: “[S]ome senior chief physicians in charge of many frontline doctors in multiple hospitals simultaneously . . . were surprised to see the great outcome with TCM. . . . [T]hose senior physicians . . . eventually became the ones who strongly called for implementation of TCM in the prevention and treatment of COVID-19 in China. This was how it became CDC’s treatment option in China." and “Chinese Herbal Solutions for Coronavirus Disease 2019 . . . See below for a selection of the Chinese herbal products that were reported with success in China for the prevention and treatment of the COVID-19:” [from your website http://cathayherbs.com/coronavirus-disease]

    In addition to pills and herbal teas, the company promoted “CoronaDefender Herbal Sachet-S" that was reportedly “Formulated for modifying your body surface so that the Novel Coronavirus stands less chance to survive on your body.” 

    CBD brands making claims related to coronavirus were also listed in this latest round of FDA Warning Letters. 

    NeuroXPF, Las Vegas, NV, was flagged by the FDA for claims such as “Crush Corona . . . While  scientists around the world are working 24/7 to develop a COVID-19 vaccine, it will take many more months of testing before it’s approved and available. However, there’s something you can do right now to strengthen your immune system. Take CBD . . . CBD can help keep your immune system at the top of its game. . . . We want everyone to take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection. So, we’re making all of our products more affordable.”  According to FDA the company also stated, “Crush Corona! Your best defense against the COVID-19 blitz starts with a strong immune system. It’s what protects your body from the everyday attacks of bacteria, viruses, parasites and a host of other nasties. Learn more here: https://neuroxpf.com/crush-corona/."

    Native Roots Hemp, too, linked cannabis and Coronavirus. Examples flagged by FDA include: “Cannabis Indica speeds up Recovery from Coronavirus . . . Severe acute respiratory syndrome (SARS) is a viral respiratory disease caused by the SARS coronavirus (SARS-CoV). . . . Curing coronavirus infection prevents clinical SARS. Cannabis indica speeds up recovery. . . . Two plants Cannabis sativa and Cannabis indica Their [sic] resins contain hundreds of cannabinoids. I recommend only cannabis indica extracts which are not psychoactive . . . ‘Cannabis indica resin is antiviral and inhibits cell proliferation.'"

    Further, Native Roots stated “Don’t Fear the #CoronaVirus FIGHT it with us! Soap, immune boosting oils & more!” in a March 12 post on its Facebook page, and “Please be advised that our team at Native Roots Hemp takes the virus seriously. . . . We have offered FREE full-spectrum hemp oil to all team members to assist with keeping their Endocannabinoid System healthy, which manages our body’s immune system.”

    Also, a company called Indigo Naturals also made some CBD-COVID-19-related claims on its website and in blog posts that the agency found concerning. These included: “Is CBD An Anti-Viral Agent For Coronavirus, Influenza, MERS, and SARS . . . CBD Anti Viral? . . . The headlines are frightening from Wuhan, China when we first wrote this. . . .What about CBD? We’ve seen reports of CBD having both antibacterial and antiviral effects. . . . Can CBD Help with Viruses Like Coronavirus And Influenza . . . CBD’s real benefit may be on the high-end immune response as we saw with MS: Moreover, CBD administration at the time of viral infection exerts long-lasting effects, ameliorating motor deficits in the chronic phase of the disease in conjunction with reduced microglial activation and pro-inflammatory cytokine production. . . .CBD will boost two of the T-cells powerful weapons (interferon and IL2) WHEN T cell function is LACKING. When T cell activity is too strong, it will actually suppress that activity . . . Levels of T cells in the lungs are important for the new coronaviruses.” 

    And CBD Online Store, Laguna Hills, CA, (www.facebook.com/CBDOnlineStore  linked to https://cbd-online-store.com) also made claims that concerned FDA such as “Can CBD Help With The Corona Virus? . . . Corona Virus / Covid-19 . . . Unless you are living in a cave, you know what Corona Virus is . . . Some medical researchers are finding the disease (sic) effects the lungs . . . Inflammation is the problem here . . . We have been saying on our blog since the beginning about the powerful anti-inflammatory effects of CBD . . . CBD has been found to decrease inflammations naturally, and through communicating with your endocannabinoid system.” 

    CBD Online Store was also cited for a Facebook post on March 9, which is might be one of our favorites, especially in these heavy times: “Can CBD help with Corona Virus?  Possibly!  But one thing is for sure, it will help you relax when everyone else is panicking.” 
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