How FDA Is Monitoring the COVID-19 Product Market

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FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working with online marketplaces, domain name registrars, payment processors, and social media websites to remove unproven claims from their platforms.

To date, FDA has issued over 65 warning letters. In certain instances, FDA has followed those warning letters by asking DOJ to initiate formal legal proceedings against a product manufacturer. For some categories of products, FDA has used press announcements to effectively provide a generalized warning to all manufacturers in the space. Below we tabulate all of the enforcement efforts that FDA has been using to try to keep fraudulent COVID‑19 products off the market.

Warning Letters

FDA and FTC sent their first round of warning letters three months ago. Now, FDA has issued at least 66 warning letters to firms selling fraudulent products with claims to prevent, diagnose, treat, mitigate, or cure COVID-19.

The products include (1) CBD products, (2) dietary supplements and vitamins, (3) essential oils, (4) herbal products, (5) homeopathic products, (6) sanitizer products, (7) products labeled to contain chlorine dioxide or colloidal silver, and (8) others. FDA has taken issue with various marketing claims—ranging from #coronavirus hashtags to statements made on pop-up windows. The below chart lists the warnings letters by product category and identifies some of the problematic statements that FDA has identified. This reference chart should be useful in helping to determine where FDA is focusing its enforcement efforts when it comes to COVID‑19 claims. Links to warning letters are also provided for each product.

Products	Marketing Statements
CBD Products
CBD products	“Find the best CBD Oil to help fight Coronavirus.” “Let the power of CBD help you combat your illness, covid-19, coronavirus . . . .”
CBD products	“CBD, Coronavirus and the Immune System” [from website and a March 4 post on social media website] “CBD & the Coronavirus . . . Read studies at NNLifestyle.com . . . #cbd #coronavirus #cbdcoronavirus #cbdoil #immunesystem #health #virus #cbdtincture #recovery #nan ocbd #cbdlife #hemp #naturalcures #nnlifestyles #noeticnutraceuticals” [from a March 11 post on social media website]
CBD products	“5 ways CBD can Boost Your Immune System during the virus” [from website] “Especially those of us with autoimmune disease, taking CBD (in various forms) can be especially good during this time.” [from website]
CBD products	On the webpage entitled, “Can CBD Help With The Corona Virus?” in addition to the above claims, you display images of several CBD products and provide links to purchase them [from website] “Can CBD help with Corona Virus? Possibly! But one thing is for sure, it will help you relax when everyone else is panicking.” [from a March 9 post on social media]
CBD products	“Don’t Fear the #CoronaVirus FIGHT it with us! Soap, immune boosting oils & more!” [from a March 12 post on social media website] “IMPORTANT CORONA VIRUS UPDATE (COVID 19)”
CBD products	“Updated information on CBD (ACD2 receptors) and anti-viral effects in age of coronavirus: . . . Is CBD an Anti-Viral Agent for Coronavirus, Influenza, MERS, and Sars [sic] Plus Key Antiviral Supplements?” and the image of viruses with the words “CBD Anti VIRAL?” [from a February 26 post on social media website] “There’s so much worry and panic today about COVID19/Coronavirus. We should not panic but take some extra care of ourselves to boost our immune systems. Here’s what we’re doing to help boost our immune systems! . . . Read our new blog post about how CBD and natural supplements can boost our immune system.” [from a March 4 post on social media website]
CBD products	“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 stop 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.” [from website] “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: [website] [from March 19 posts on social media websites]
Dietary Supplements and Vitamins
Vitamin C product	“I take Vitamin C daily and just reordered some to be sure I don’t run out before Coronavirus season does! Consider it cheap insurance . . .” [from website] “New SpiceTac blog post. Why you should think about Vitamin C! . . . Your Coronavirus Secret Weapon – Vitamin C” [from a March 14 post on social media website]
Vitamin D products	“For most people, COVID-19 is not serious, while for others it can be fatal. The data from this study along with decades of research on the immune-supportive effect of healthy vitamin D levels should be enough to convince everyone to make this a priority.” “The bottom line? In order to give yourself the best defense against the coronavirus, begin with optimizing your vitamin D status to at least 30 ng/ml starting today.”
Super C, Vitamin D/K2, Zinc Charge, and Immuno-Strong Berry Liquid	“Take Vitamin C for Coronavirus . . . I also recommend taking a vitamin C supplement, such as Super C. Take 500 mg, 2 times daily for prevention and do 3-5 grams, 2-4 times daily if you are feeling symptomatic.” [from website] “I recommend that you take a daily Vitamin D/K2 supplement for both prevention and treatment.” [from website]
“NoronaPak” products, including supplement products	“Naturally derived supplements to Fortify your Immune system and battle symptoms of the flu! . . . FORTIFY YOUR BODIES [sic] DEFENSE AGAINST #covid19” [from an April 14 post on social media] “Naturally derived supplements to Fortify your Immune system and battle symptoms of the flu! . . . FORTIFY YOUR BODIES [sic] DEFENSE AGAINST #covid 19 . . . #cbd #cbdmovement #cbdhealth #zinc #selenium #nacetylcysteine #vitamind #vitaminc . . . [graphic with the following text ‘NORONAPAK IS DESIGNED TO PROVIDE YOU WITH A NATURALLY-SOURCED, PHARMACIST CURATED REGIMEN TO READY YOUR BODY AND BATTLE YOUR FLU-LIKE SYMPTOMS.’” [from an April 14 post on social media]
Dietary supplements	“Top 7 Supplements for Boosting your Immune System . . . With global panic around coronavirus at an all time high, now is the time to improve your health. You can do that by . . . adding in smart supplementation . . . . These are supplements I have taken and benefited from for years. They have been studied endlessly, and could be promising additions to your supplement stack if you’re worried about coronavirus” “NAC (N-acetylcysteine) [website] . . . It’s early days still in regards to NAC and coronavirus, but seeing as the supplement has a wide range of immune-boosting properties, this makes it a sensible investment and my top recommendation. You can learn more and buy NAC here [website].”
Grapefruit seed extract, colostrum, and cod liver oil products	On a webpage titled “4 Proven Ways To Protect Yourself Against Coronavirus,” you represent that “Everyone is concerned about Coronavirus and looking for ways to protect themselves” “Clearance of cellular debris is also important after any viral infection, cod liver oil. Anti oxidants also help in this regard . . . Cod Liver Oil [website].”
Essential Oils
Essential oils and dietary supplements	“Licorice Root For Coronavirus? . . . ‘Licorice root as a potential treatment for Coronavirus (COVID-19).’” [from website] The statements “In one study, glycyrrhizin – a compound found in licorice root – was found to be the most active in inhibiting replication of the SARS virus (which is a coronavirus). ‘One of the significant antiviral candidates under study during the period immediately after SARS was the Licorice Root . . . ’” [from website]
Essential oil products	“Can you use essential oils to boost your immune system and fight coronavirus? Yes! Essential oils are one of the best tools to strengthen your immune system naturally& . . . .” “Eucalyptus [website] essential oil . . . has antiseptic agents that help fight . . . viruses.”
Essential oil products	“The immune-building, antiviral essential oil blends in this category are beneficial for prevention and treatment of Wuhan Corona Virus, and also help to protect against flu, respiratory and other antibiotic-resistant viruses . . . . All antiviral blends in this category are featured at 60% Off to allow wide distribution during flu season and also for protection against the rapidly expanding Corona Virus epidemic SARS-CoV-2.” “[O]n the Corona virus epidemic, the key concept is prevention. Rub on top of the feet, wrists, and chest; spritz & diffuse. – Wuhan Coronavirus Update, 03/20)” [On product page for “Antiviral Respiratory;” internal quotation marks omitted]
Essential oil products	“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?” “Historically, aromatic herbs and spices have proven useful in times of airborne illness precisely because of their . . . anti-viral properties.”
Essential oil products	“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 . . . .” [from website] “#coronavirus #covid #prevention #preventativehealth #symptoms #essentialoil #aromatherapy . . . PUREPLANETESSENTIALS.COM . . . Corona Virus COVID-19 Safety Tips +Plus Hand Sanitizer EO Recipe [from a March post on social media website]
Essential oil products	“Municipalities of Wuhan have declared that people should use Pure essential oils as a preventative therapy . . . #coronavirus #essentialoils” [from a February 5 post on social media website] “Essential oils have great potential in the field of biomedicine as they effectively destroy several bacterial, fungal, and viral pathogens . . . the essential oils are effective against a diverse range of pathogens.” [from website]
Essential oil products	“Eucalyptus radiate . . . has a powerful antibacterial, antifungal and anti-infectious action, which makes it extremely useful for all types of infection.” [from website] “In my opinion, Eucalyptus radiata is better suited than globulus for chronic respiratory conditions and viral or bacterial infections, especially with young children.” [from website]
Essential oils and herbal products	“Hopewell Essential Oils is dedicated to using pure plant extracts. . . tested for their . . . therapeutic quality . . . View our more recent newsletter on the Coronavirus - What We Currently Know and How We Plan to be Prepared [hyperlink[4]]” [from website] “Coronavirus . . . The new Coronavirus strain (COVID-19) is a respiratory virus with typical respiratory symptoms such as fever, shortness of breath and difficulty breathing . . . If we become ill [sic], we follow these tips: . . . Fresh ginger is less drying than dried ginger, and if available, can be used interchangeably with cardamom . . . .” [from website]
Herbal Products
Herbal products	“YAHWEH (All plagues, viruses, fungus, Corona Virus [sic] . . . An all natural herbal formula thats [sic] immediate action within minutes distroys [sic] all plagues, viruses . . . Starts to work within minutes against all respiratory diseases such as Corona Virus [sic], SARS.” [from website] “KOLON KLEEN, Works Against Corona Virus [sic] . . . . Recomended [sic] for the Corona Virus [sic] and any other respiratory viruses or flu.” [from website]
Herbal products	“Stephen Buhner COVID Herbal Blends . . . Core Formula . . . Immunity Blend . . . Protection Blend . . . .” “Andrographis . . . Shown to have anti-inflammatory, antiviral, and antioxidant benefits. One capsule twice a day is the recommended dose of the herbal supplement if you exhibit symptoms of the virus.”
Herbal products	“Corona Virus Prevention . . . Kalita – Throat Inflammations spray . . . Also effective for thorough treatment of internal inflammations such as lungs . . . for strong throat inflammation: 3-5 sprays in the throat each time” [from website] “Corona Virus Prevention . . . Tahar – Natural Disinfectant Spray . . . suitable for spraying disinfections: disinfecting hands.” [from website]
Herbal tinctures and herbal remedy products	“Worried about your fam [sic] coming down with colds, flu, or even worse – the coronavirus? Luckily, natural remedies can help! We’ve put together a Respiratory Aid Kit to help get through the respiratory illnesses more quickly and more easily. Click below to shop.” Below this claim is a graphic displaying your “Breathe Well” product. [from a March 18 posting on social media website] “Don’t panic and assume the worst when it comes to the coronavirus -yet! . . . if you are worried, here are some coronavirus prevention tips . . . Take key supplements to boost your immune system naturally- our Immune Support Collection is a MUST-HAVE for every family” [from a March 13 post on social media website]
Herbal products including “CoronaDefender Herbal Sachet-S”	“Chinese Medicine treatments for Coronavirus Disease . . . How can we prepare for Coronavirus Disease 2019 (COVID-19)?” [from website] “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 website]
Herbal products, including “Carahealth Immune”	“Coronavirus (COVID-19, SARS-CoV-2) pandemic has no medical treatment. Natural antiviral herbs boost immunity & decrease virus virulence to achieve herd immunity.” [from website] “Natural medicine to prepare for a global pandemic . . . Covid-19 is a corona virus like Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) and . . . Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV). Haemagglutinin exists in the structure of the coronavirus and is a target for herbal treatment. Neuraminidase inhibitors are the cornerstones of the management of patients hospitalised for suspected MERS-CoV infection and SARS corona virus hence neuraminidase is also a target for herbal treatment” [from website]
Coronavirus Protocol (Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core tincture, Coronavirus Immune System, and Elderberry Tincture)	“Corona virus treatment. Stephen Buhner has analyzed how corona viruses infect tissues, what tissues they infect, and the herbs that are useful to interrupt that process, as well as the herbs useful to shut down the cytokine cascade they create. Here is his protocol . . . . [T]his is a rather extensive protocol because the particular corona virus that is now spreading world wide is exceptionally potent in its impacts. All the herbs are specific in one way or another for this virus. A number of the herbs are strongly antiviral for corona viruses . . . . The formulations are preventative as well as specific for acute infections . . . .” [from website] “Stephen Buhner has used this with other corona virus infections, including SARS, it works well.” [from website]
Formula #1, Formula #2, Formula #3, and Eupatorium perfoliatum (Boneset)	“With active infection: very strong boneset tea, to 6x day. I have used this with other corona virus infections, including SARS, it works well.” [from a January 27 post on social media website] “As the deadly cornavirus [sic] rapidly spreads across the globe with no antidote available . . . Stephen Harrod Buhner has created an updated coronavirus protocol specifically for the Wuhan outbreak.” [from website]
Homeopathic Products
“Homeopathic Genus Epidemicus”	“Homeopathy Treatments Available For: . . . Coronavirus (2019-nCov) Prevention” [from website] “[W]hile talking about his experience and views on necessity of preventive Homeopathy Genus Epidemicus in current #COVID19 pandemic, makes a passionate argument in favour of #Homeopathy. #HomeopathyForCOVID19” [from a March 28 post on social media website]
Homeopathic drugs and dietary supplement products	You provide a “Recommendation Using Homeopathy to Prevent Coronavirus,” including numerous different products and links to purchase such products [from website] You provide “Top Homeopathic Remedies For Treatment Of Coronavirus Diagnosis or Symptoms,” including numerous different products and links to purchase such products [from website]
Homeopathic drug products	“NEW CORONAVIRUS: ALL EYES ON INDIA . . . what does India know about the new coronavirus and COVID-19 disease . . . India reports that it has 23,531 people under observation, with no current infections or deaths . . . How is this possible . . . Could India’s dependence on homeopathy be one reason for the difference . . . [from website] “CORONA-KIT & CONSULTATION . . . THIS IS OUR CORONA-KIT . . . THIS KIT CONTAINS GENUS EPIDEMICUS REMEDIES FOR COVID19” [from website]
Homeopathic drugs	“Best Homeopathy Preventive Medicine for Corona Virus Infection . . . . Arsenicum album 30 could be taken as prophylactic medicine against Corona virus infections . . . . It has recommended one doze of Arsenicum album 30, daily in empty stomach for three days. The dose should be repeated after one month by following the same schedule in case Corona virus infections prevail in the community. . . Dr. Pranjali [Video] Tips for Corona Virus Infection . . . . Homeomart associate recommends the following preventive medicines for Corona Virus infection . . . coronavirus homeopathy . . . Preventive Medicine . . Influenzinum 200 . . . Curative medicine . . . Arsenic 30.” [from website] “Clinical Indications: Arsenic Album . . . This medicine is highly recommended to treat respiratory complaints (in conditions like common cold, pneumonia, and severe acute respiratory syndrome (SARS). As per group of experts on the scientific advisory board of CCRH, it acts as a prophylactic (preventive) medicine in Corona virus infection.” [from website]
Sanitizer/Antimicrobial Products
Non-alcohol based hand sanitizer product	“Purifi™’s fast drying lightweight foam forms a germ fighting breathable microscopic barrier that lasts for hours and persists through hand washing.” “NEXT GENERATION HAND SANITIZER: Purifi’s patented, formulation kills VIRUSES, BACTERIA & MORE AND LASTS For HOURS . . . .”
Non-alcohol based sanitizer products	“The following steps can help protect you and your loved ones from coronavirus . . . If soap and water are not readily available, use Durisan hand sanitizer . . . .” [from website] “Durisan® . . . Our hand sanitizers . . . attack and destroy the germs that can lead to coronavirus or even flu and the common cold. Durisan products pierce the cell wall to destroy germ and viruses, meaning they cannot survive—or mutate into cleaner and drug-resistant super bugs.” [from website]
Prefense Hand Sanitizers	“We hate to say it, but coronavirus is in the U.S. and close to home in Chicago. Nasty stuff but that’s why the best defense is Prefense!” [from a January 24 post on social media website] “Coronavirus now a global emergency . . . ! Be safe out there – the best defense is Prefense hand sanitizer – up to 24 hour protection from one application – it works when it dries!” [from a January 30 post on social media website]
“Germ Stopper” products	“Copper Destroys Viruses and Bacteria. It could destroy norovirus, MRSA, virulent strains of E. Coli, and coronaviruses – including the novel strain currently causing the #COVID19 pandemic.” [from a March 18 post on social media website] “We all know that viruses spread through touch, saliva, intimate contact, contaminated food and water and insects, so getting an extra layer of protection on you via StayWell Copper means you’ve got natural antimicrobial copper killing germs and viruses like Coronavirus for you 24/7.” [from a January 24 post on social media website]
“Sani-Bar GK95” and Sani-Disc GK95D”	“Examples of Microbes Killed by our CopperTouch Products Include . . . Coronaviruses” “Is copper effective against coronaviruses? . . . . In a recent study by US health organizations, copper was shown to be more effective than any other surface tested at deactivating (killing) the HCoV-19 coronavirus.”
Products labeled to contain Silver
Colloidal silver products	“Coronavirus~Using Colloidal Silver to . . . Boost Your Immune system . . . Colloidal silver is the key to protecting yourself from the corona virus. It is recommended to take colloidal silver at least 3 times a day to keep your immune system functioning to its highest capacity. Also, if you begin to show symptoms of the virus, up your doses to 5 times a day. In a medical system that is failing, which is being witnesses in Chine[sic] right now, there is no other solution to protecting yourself from the corona virus . . . . To purchase our Colloidal Silver, visit our website. Please email and contact us with any questions at services@gaiaswholehealingessentials.org” [from website] “Gaia’s Colloidal Silver . . . Remedies & Health Benefits of Colloidal Silver: Colloidal silver it’s an effective treatment for All types of infections and diseases . . . . It possesses . . . antiviral . . . properties. Colloidal silver is used to treat infections due to . . . viruses . . . Colloidal silver is also used for lung conditions . . . .” [from website]
Colloidal silver products	“Colloidal Silver CoronaVirus Convenience Package . . . PLUS the A2B reusable nebulizer to get the powerful anti viral solution into the lungs, throat, and sinuses!” [from website] “Utilize colloidal silver with a nebulizer to get the silver solution into your lungs, throat and sinus immediately during the times of Coronavirus outbreak!” [from website]
Colloidal silver products	“Preventing The Contraction Of The Novel Coronavirus is Elementary . . . . Even though there are no vaccines available to combat these coronaviruses, there is a home remedy of Colloidal Silver 100 ppm that has worked effectively on coronaviruses successfully for the last 123 years . . . . In the mean time [sic] there are some tips to prevent contracting the coronavirus: . . . Use Home remedy, Colloidal silver 1100 PPM, to support immune system” “What is Coronavirus Treatment and Prevention? . . . Colloidal silver 1100 PPM, Home remedy for 123 years! (testing showed every known coronavirus killed in 4 min. in vitro) . . . . Although there are 650,000 deaths a year from enfluenza, [sic] the regular flu and infects over 2,000,000 deaths from pneumonia a year, these two viruses pale in comparison to the potential danger to the coronavirus flu. It is very contagious and quick to kill. Colloidal Silver kills all viruses.”
Products labeled to contain silver	“Wellness!! Vital Silver!!! Simple!!! Go on the offense this year against viruses including the Coronavirus – it’s simple!” [from a February 6 post on social media website] “Structured Silver allows a silver particle-cluster of silver to kill multiple bacteria, viruses, and yeast/candida pathogens throughout the body until it is safely excreted.” [from website]
Silver Sol Liquid and products labeled to contain silver	“Silver Solution has been proven . . . to kill every pathogen it has ever been tested on . . . and it can kill any of these known viruses . . . .” “So the virus, like the coronavirus that we’re talking about … affects the lung tissue so what you can do . . . put it straight . . . in a nebulizer which then creates a steam and you breathe it in and it will go directly into your lungs where that virus is and any other infection.”
“Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver	“There may be natural ways to take control and prevent viral infections from taking hold, coronavirus included . . . .” “We may not know the full story about how the coronavirus came to be, but we are not helpless.” [from March 13 article on website titled, “The Best Coronavirus Treatment is Prevention”]
“Superblue Silver Immune Gargle,” “SuperSilver Whitening Toothpaste,” “SuperSilver Wound Dressing Gel” and “Superblue Fluoride Free Toothpaste”	A video posted on 3/10/2020, titled “Experts Say Trump Must Seal The Border Like Israel & Italy Or Face Massive Coronavirus Surge.” At minute 31:08, you state “I’m not going to belabor this, I’m just gonna tell ya, that for just your daily life, and your gums and your teeth and for regular viruses and bacteria, the patented Nano Silver we have, the Pentagon has come out and documented, and homeland security have said this stuff kills the whole SARS corona family, at point blank range. Well of course it does, it kills every virus. But they found that, this is 13 years ago, and the Pentagon uses the product we have. And the product we have in private label is about to be in Walmart . . . the Nano Silver toothpaste in the Superblue with the tea tree and the iodine, that’s the Superblue’s amazing, and we have the whitening toothpaste that has the Nano Silver and a lot more as well . . . they are at infowarsstore.com” [from website] A video embedded on your website that was posted on 2/9/2020, titled “Coronavirus – Is This The Virus that DIDN’T Cry Wolf?” At minute 2:30, “we’re independently sponsored by InfoWars,” and at minute 3:50, “If you are concerned about the Coronavirus or the Flu or the common cold, then I recommend you to go to the Infowars store, pick up a little bit of silver that really acts its way to boost your immune system and fight off infection . . . .” At minute 3:58, the video shows your Superblue Silver Immune Gargle product. [from website]
HealthMax Nano-Silver Liquid, Silver Biotics Silver Lozenges with Vitamin C, and Silver Biotics Silver Gel Ultimate Skin & Body Care (collectively, “your silver products”)	“In light of all the 24/7 news stories about the COVID19 situation, I wanted to share the most effective strategies that I personally recommend and use to support and enhance my immune system . . . . I recommend that you incorporate this protocol into your personal program . . . . Patented Nano- Silver SilverSol Technology®.” [from website] “I’m talking about the patented SilverSol Nano-Silver-Technology® range of products as a liquid, gel or lozenges . . . ! It has also been tested on various kinds of viruses including SARS with great success in de-activating all forms safely. [from website]
Colloidal silver, vitamins, minerals, herb oils, and a homeopathic drug product	“Coronavirus \| Prevention, Treatment, Plan . . . The coronavirus, aka COVID-19, has caused quite a scare here in the US . . . Here’s what you need to know about Coronavirus, how to prevent Coronavirus, natural remedies to treat Coronavirus and how to have a plan so you don’t have to live in fear.” [from website] “CORONAVIRUS TREATMENT . . . There are no approved treatments and very few effective antiviral medications to treat it. All the more reason to arm yourself with knowledge on who to treat Coronavirus naturally . . Luckily, natural remedies don’t come with side effects and toxic ingredients like pharmaceuticals and vaccines do so it is also my preferred way to treat any virus.” [from website]
Liquid Silver, Camu Camu’s Vitamin C, Vitaly C, Immunity Kit, Vitamin D3-K2, and Power Immune	“What am I taking to build my Immune System? Camu Camu’s Vitamin C. High dose Vitamin C is an antidote to viruses. It has been used for many years . . . . #covid2019” [from a March 9 post on social media website] “The #Coronavirus is on everyone’s mind right now. The key to not catching the virus is to keep your immune system as strong as possible. Perfectly Healthy’s Immunity Kit created by Leigh Erin Connealy MD is a potent combination of Vitamin C, Echinacea, Agaricus, and Berberine.” [from a March 11 post on social media website]
Silver, CBD products, iodine, medicinal mushroom, selenium, zinc, vitamin C, vitamin D3, astragalus, and elderberry	“Colloidal silver is a potent antiviral . . . Take this as a preventative, and as a treatment for Coronavirus. Double your dose if you start to feel seek [sic] . . . Links to our trusted source of Colloidal Silver for Coronavirus: [website]” “Iodine . . . a potent antiviral . . . Links to our trusted source of Nascent Iodine for Coronavirus: [website]”
Other Products
Miracle Mineral Solution (MMS) (chlorine dioxide)	“14 people who were confirmed cases of COVID-19 (in Europe), took MMS and have recovered their health. All of these tested positive and when re-tested after taking MMS, they came out negative for COVID-19.” “If you have COVID-19: --Take Protocol 6 and 6 to start. This is one 6-drop dose of MMS, then one hour later take another 6-drop dose of MMS. --After two 6-drop doses of MMS, go on hourly doses of 3 activated drops in 4 ounces of water hourly . . . . --For children, follow the same instructions as above and cut the amounts in half.”
“Fortify Humic Beverage Concentrate” and “Electrify Fulvic Beverage Concentrate”	“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 website] A social media 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 post on social media website]
Honey product, “COVID-19 COUGH Syrup”	“COVID-19 COUGH Syrup . . . THIS IS VERY STRONG MOLASSES . . . [add] tablespoon to a cup of hot water. Drink this honey daily. Will cause frequent urination. Stay hydrated. Drink only water while detoxing with this honey . . . designed to remove waste from internal and external cells. [from website] “COVIDXIX SYRUP this is over 175 ingredients t [sic] requires three days of preparation . . . . We added over 175 herbs to syrup . . . . This is very strong . . . . Can pour directly into hot water and drink. May also add this syrup to Hot Apple Cider for Children. Safe for Elderly Men and Women.” [from website]
Salt therapy products	“Becoming Familiar with Coronavirus and Preventing Transmission . . . Coronavirus Prevention . . . Currently, there’s no vaccine to prevent you from getting the Coronavirus infection . . . . A very underestimated treatment that can help protect yourself is salt therapy. Salt therapy is a treatment solely salt based . . . . All you’re doing is breathing in miniscule salt particles. The particles clear your lungs of anything that shouldn’t be there . . . . Notice how older people diagnosed with Coronavirus have more severe symptoms. They can’t fight back, therefore making the virus easy to take their lives . . . . The salt aerosol fights infections, being anti bacterial [sic], anti viral [sic] and anti fungal [sic]. It will do this inside your respiratory system and in the air you breathe . . . . To conclude, reading about Coronavirus has made individuals be on high alert and stressed out . . . . With the right preventative measures, there’s a very slim chance you will catch this disease . . . . Try salt therapy today, your future self will thank you.” [from a February 17 and February 27 post on social media website] “Saline therapy also helps the lungs fight against the novel Coronavirus” . . . #CoronaVirus #CoronaOutBreaks . . . Saline therapy strengthens the lungs to fight against the novel Coronavirus” [from a March 18 post on social media website]
“FullerLifeC60”	“Will you get Coronavirus? . . . 6 steps for protection from the Coronavirus . . . up your immunity with foods rich in antioxidants and bioactive protection such as Carbon 60 (C60)” “[B]oth the flu and Coronavirus illness thrive on individuals with weakened immune systems . . . Coronavirus is scary, but the flu is deadlier and more widespread. Those who get very ill or die have weakened immune systems. Have the highest probability of staying healthy by making your immune system the strongest possible. FullerLifeC60 does this for just a dollar a day (plus shipping) . . . The stronger your immune system is the less likely you are to get sick. C60 improves the efficiency of mitochondria inside your cell and thereby enhances your immune system to better defend against infection.”
“Viral Defense Tincture”	On your product webpage for “True Viral Defense,” below the title “Cases of coronavirus outside China,” you display a color-coded world map with a key indicating the number of coronavirus cases and in the adjacent product description state “True Viral Defense . . . mount a strong defense against whatever Virus you encounter. Its [sic] the BEST DEFENSE you will ever find.” [from website] Your product name, “True Viral Defense,” when displayed adjacent to maps of coronavirus cases.
Traditional Chinese medicine products	On a page titled, “CHINESE HERBS TO HELP MAINTAIN IMMUNE SYSTEM HEALTH DURING CORONA VIRUS, COVID-19 AND CYTOKINE STORM” “If you are concerned about protecting your health and the health of those you love as the world is facing the continued spread of COVID-19, Chinese medicine may have much to offer that could be life-saving.”
“China Oral Nosode,” described as “AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES”	The product description “AN330 –CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES. Holistic Animal Remedies . . . For all Species” “China Oral Nosode is the homeopathic nosode called a homeoprophylasix [sic] of Corona Virus to Assist Immunity.”
Kratom products	“Dr. Usman makes it clear that kratom (mitragyna Speciosa) contains a good amount of compounds that can strengthen the immune system and keep the coronavirus at bay.” “#Covid_19 . . . #coronavirus . . . #CoronavirusOutbreak . . . #kratom . . . #kratomsaves”
Ayurvedic products	A pop-up window on the homepage states “Reduce your risk of Coronavirus Infection” with images of the products “Alpha-11” and “Alpha-21” below it. A box on the bottom states “To order contact at +91 9300002759 or visit [website].” “Prevention and Treatment – Coronavirus / Alpha Arogya . . . According to WHO or World Health Organization, the Coronavirus strain that is currently causing havoc on the health of humans is ‘Novel Coronavirus’ (nCoV), which could become deadly for humans if not treated . . . Coronavirus Cure or treatment . . . Alpha Arogya has been instrumental in creating specialized Ayurvedic treatment to cure Coronavirus with its very effective Ayurveda cure products – Alpha 21 . . . and Alpha 11 . . . .” [from a January 28 post]
“nCoV19 spike protein vaccine”	“Should I pop up and get your vaccine started????? . . . I can test you Farhad – if you’re able to get one of those sterile lances, I just need a few drops of blood. Don’t worry – I’m immune – I have boosted myself five times with my vaccine and I have a screaming antibody titer to the spike protein and the spike protein receptor binding domain . . . and I’m not mass producing it – I can’t produce enough for the masses, but in 18 months, when the virus is long gone, everyone will have access to the vaccine that I have now since everyone (70 players) are at the door steps of the FDA to get their product mass produced and injected into ‘you’ well after the threat . . . I’m VACCINATING people with the nCov19 spike protein – it’s a recombinantly expressed protein and it goes subQ by a tiny needle and the recipient begins making antibodies to the spike protein which is also saying that they will be protected from infection. It’s like any other recombinant protein vaccine. Not rocket science . . . I can test him for antibodies too, but my thinking is (if he hasn’t already been exposed/infected) just take the vaccine because it’s a lot quicker than bleeding someone and doing the antibody test.” [from a comment on an April 17 post]
“CORE” and “IMMUNE SHOT”	“[H]e laid out a full clinical trial with a possible way to prevent and even treat coronavirus and COVID-19 . . . providing a product that every single American needs during this time as we’re all waiting for a possible vaccine, or a way to fight this terrible, terrible virus. If you’re older, the stakes are even higher. So obviously the risks of coronavirus and COVID-19 go up with age . . . . I think you’re gonna find that there’s no way that you wanna go . . . another day without this level of protection that Immune Shot can . . . we’ve been able to . . . help thousands and thousands of people already feel more confident in their fight against coronavirus” [from April 1 video] “Based on the current health crisis, we are allowing you and your family to order our immunity booster named Core, at no charge . . . . This is a powerful way for you and your family to bring the fight to COVID 19.” [from April 8 commercial email message]
“Defend Patch”	“Santiste Labs, the science driven leader in transdermal delivery has just announced the release of the DEFEND Patch in response to the global pandemic and acute health crisis of COVID-19. The company . . . created a transdermal patch that can boost your immune system and provide antiviral support all day, using all-natural ingredients. Their patent-pending composition of botanical oils uses TD-CUBED technology to provide precise, sustained release through the skin over 3 days.” [from website] “DEFEND PATCH . . . DEFEND IN THE NEWS . . . Scientists are looking into many approaches to combating a corona virus epidemic. One of the products that offers possible resistance to the novel corona virus is a transdermal patch developed by Santiste Labs LLC . . . The patches are designed to deliver CBD, or other natural substances known to have antiviral properties . . . The novel corona virus (COVID-19), first noted in December in China, is moving close to home.” [from website]
“NAD+” and “NMN” sublingual gel products	“Research shows NAD+ treatment may help prevent death from bacterial infection . . . COVID-19 parallel . . . COVID-19 also provokes a ‘cytokine storm’ from the immune system that increases inflammation and drains the body of NAD+ in response. The authors or [sic] this review believe NAD+ supplementation may prove beneficial in fighting COVID-19 for the same reason NAD+ injections prevented death in E.coli infections. NAD+ supplementation provides the body with the NAD+ needed to fight inflammation while continuing to carry out all necessary cellular functions.” [from website] “New study ties low NAD+ levels to high morbidity rates in COVID-19 . . . Low NAD+ Levels Could Be Tied to Higher Severity and Morbidity Rates in COVID-19 Pandemic . . . NAD+ is essential for our resistance to viral infections . . . NAD+ supplementation may help our immune system fight COVID-19 . . . . The added immunity protection provided by our NAD+ boosters is a good precautionary step in the fight to protect yourself from COVID-19. Discover supplements to boost your NAD+ levels and fortify your immune system here.” [from website]
Corona-Cure Coronavirus Infection Prevention Nasal Spray	“Corona-Cure Antiseptic Nasal Defense kills viruses of the Coronaviridae family including the 2019 Novel Coronavirus and SARS at their point of entry into your body.” “Our instant protection nasal spray is designed to protect your vulnerable nasal passages from infection by the 2019 Novel Coronavirus specifically and other viruses in general.”
Viral Protection Kits	“Glutagenic™’s Viral Protection Kit is being introduced due to the recent Cornona [sic] Virus outbreak . . . a great prevention strategy to utilize” [from website] “Glutathione is one of the best antioxidants for viral immunity and should be considered in both preventions as well as treatment.” [from websites]

Temporary Restraining Orders

FDA’s warning letters have escalated into legal action in at least two instances. As we previously reported, FDA warned a seller of chlorine dioxide products to remove its products from the market within 48 hours. After the seller “made clear that they had no intention of taking corrective action,” DOJ obtained a temporary restraining order against it.

Likewise, DOJ obtained a temporary restraining order against a seller of colloidal silver products who, despite “remov[ing] their COVID-19-related webpages for a time, . . . resumed marketing their colloidal silver products as a treatment for COVID-19 in violation of law.”

In both cases, FDA indicated there was a lack of adequate data to establish the safety and effectiveness of the products for “any use,” let alone for the novel coronavirus. The agency expressed concern that such claims could cause consumers to delay or stop appropriate medical treatment. Although it gave the product manufacturers an opportunity to take corrective action, it ultimately followed through on the threat of legal action.

Press Announcements

FDA has also used daily press announcements to communicate with COVID-19 product manufacturers, most notably at-home test and serology test manufacturers.

In one such announcement, FDA warned that it had not authorized any test for self-collection—despite a wave of tests that were preparing to hit the market. It has recently signaled more openness to the concept, though. As we previously reported, it has granted emergency use authorizations (EUA) to an at-home collection kit, saliva-based at-home collection kit, and standalone at-home collection kit. It has even started providing a Home Specimen Collection Molecular Diagnostic EUA Template to further support the development of tests for self‑collection at home.

Similarly, FDA has published several press announcements like this one explaining its stance on serology tests. The agency previously maintained a fairly relaxed policy for serology tests, since mid-March, permitting commercial antibody tests to be marketed and used without FDA EUA review if they followed certain criteria. But FDA updated this policy last month, shortly after a congressional subcommittee criticized the agency for “fail[ing] to police” the coronavirus serological antibody test market. We discussed the policy change here.

Follow Morrison & Foerster’s Products Liability and Life Sciences blogs to stay informed as we continue to report on FDA’s evolving role in the medical product industry. Our COVID-19 Resource Center also provides multidisciplinary guidance to help you face these developing issues.

Erin M. Bosman
Partner
Julie Y. Park
Partner

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