Consumer Law

FDA issued warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19

The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19). We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.

NOTE: An asterisk (*) under the table column “Corrective Status” indicates the firm’s listed product(s) are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19). This status only concerns sale of the listed product(s) for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19) and in no way indicates whether the listed products otherwise comply with the laws and regulations enforced by FDA. FDA will monitor all listed firms for recurrence of the conduct cited in the warning letters.

SOURCE: FDA

 

 

Date IssuedFirm NameProduct Name and ImageCorrective Status
01/12/2021AusarHerbs“Corona Destroyer Tea” 
01/12/2021Allimax UsAllicin capsules, creams, gels, sprays, and liquid products 
01/04/2021Coco’s Holistic Specialties & Apothecary4-Thieves Florida Tea ConcentrateExternal Link Disclaimer and 4-Thieves Florida Tea Powder 
12/21/2020Riverstone LLC“Flu Immune Drops,” “L-Lysine,” “Lysine Extra,” and “Monolaurin” 
12/21/2020Sparrow Health & Performance LLCOrganic Liposomal Vitamin C, Nanoemulsified D3K2, and Immune Support Package (which includes Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on) 
12/18/2020Rowpar PharmeceuticalsCloSYS Oral Spray, CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths, and CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths products 
12/10/2020iThrive.healthVitamins, quercetin, zinc and omega-3 products*
12/10/2020Indigenous ProductsMineral products*
12/07/2020Paradigm RE LLC“Thymosin Alpha 1”*
12/02/2020Rat’s Army“VIRUS BIOSHIELD”*
12/02/2020Health & Wellness Center International One, L.L.C. dba Hotze Vitamins“Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and ProbioticsExternal Link Disclaimer,” “Dr. Hotze’s Kids Immune Pak,” and “Dr. Hotze’s Teen Immune Pak” 
12/02/2020Heavenly Natural ProductsC60 (Carbon 60) and colloidal silver products, including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTIONExternal Link Disclaimer” 
11/30/2020Avazo-Healthcare, LLCCOVID-19 test kit products and CBD products 
11/23/2020Industry Lab Diagnostic Partners“COVID-19 Testing Kit” 
11/18/2020Pro Breath MD, LLC dba Dentist Select and OraCare“OraCare Health Rinse” and “OraCare Operatory Pre-Rinsing Set”*
11/18/2020Vibrant Health Care, Inc. Umbilical cord derived cellular product 
11/18/2020Red Moon HerbsAmerican Ginseng Elixir, Ashwagandha, Astragalus, Breathe Clear, Chickweed, Dandelion, Echinacea, Elderberry, Elderberry Elixir, Elecampane, Garlic Elixir, Ginkgo, Hyssop, Kudzu, Lobelia, Lung Support, Mushroom Elixir, Turmeric, Usnea, Violet, Viral Spiral, Wild Cherry Bark Syrup, and Yarrow 
11/17/2020Innovative Medicine LLC“Nadovim” 
11/17/2020ChromaDex“Tru Niagen products” 
11/10/2020Sage Woman Herbs, Ltd. dba Sage Consulting & ApothecaryX-tra Strength CV Bundle, Golden Mushroom Blend, Golden Mushroom Blend Tincture, Moducare Chewables, Vitamin C with Bioflavonoids,  Protocol for Life Balance K2 MK-7 & D3, Sovereign Silver Bio-Active Silver Hydrosol, Super Elderberry Syrup, Respiratory Tonic, Cistus Incanus Tea, Manuka Honey, Respiratory/Head Lungs, Shuang Huang Lian, Winter Rescue, and Winter Rescue Tincture 
11/02/2020NovaBay Pharmaceuticals, Inc. ANTIMICROBIAL LID & LASH SOLUTION, PURE HYPOCHLOROUS ACID, 0.01%, 20 m*
10/30/2020Spartan Enterprises Inc. dba Watershed Wellness Center“Dissolve BioActive Silicate,” and products labeled to contain silver*
10/23/2020Beepothecary LLCBee products, including “Elderberry, Honey & Propolis Syrup,” “BEEbread,” and “BEEHive Delight,” 
10/23/2020Peterson Research Laboratories LLC“Simple Silver” 
10/23/2020Predator NutritionElixir (labeled to contain oxymatrine, berberine, and ecklonia cava), Salidroside, Unbreakable (labeled to contain BPC-157), Vitamin C + Bioflavonoids & Rosehip, Vitamin D3, and Ashwagandha 
10/16/2020For Our Vets LLC dba Patriot SupremeCBD products*
10/15/2020LVWellness & Aesthetics“COVID-19 ANTIBODY TEST KIT,” ViraFend Multi-Virus Defense product 
10/07/2020Prairie Dawn HerbsHerbal products*
10/07/2020Griffo BotanicalsHerbal tincture products*
10/05/2020Physician 360, Inc.Physician 360 COVID-19 Rapid Test 
10/05/2020Trask and Roth Inc. dba Trask & Roth Research and Manufacturing“Lateral Flow Testing Device” 
09/29/2020Tonic Therapeutic Herb Shop & Elixir BarHerbal products*
09/22/2020Nephron Pharmaceuticals CorporationANDA 78202 Budesonide Inhalation Suspension, for inhalation suspension 
09/11/2020KetoKerri LLC“KK Black Seed Oil,” “KK Breakthrough Vitamin D with Chondroitin & Oleic,” “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid Zeolite,” and “DR. FITT FIRE FIGHTERS”*
09/09/2020Pharmacy Plus, Inc. dba Vital Care Compounder“COVID PACK” and “COVID ‘POSITIVE’ PACK”*
09/01/20201 Party At A TimeBetterFly, a niacin containing product*
08/27/2020Lattice Biologics, Ltd.Amniotic fluid product (sometimes referred to as AmnioBoost) 
08/19/2020Durazo Medical Biomagnetism “Biomagnetism Magnetic Therapy DIY Kits”External Link Disclaimer 
08/19/2020Living Senior, LLCCBD products*
08/18/2020Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals“COVID-19 test package”*
08/17/2020Predictive BiotechCoreCyteTM 
08/17/2020PA Green Wellness LLC dba A Predictive Biotech Certified FacilityCoreCyte™ 
08/14/2020SilveryGuyColloidal Silver*
08/11/2020Oxford Medical Instruments USA, Inc.Salt inhaler products, including “OMI Salt Therapy PipesExternal Link Disclaimer”*
08/10/2020Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health GroupBasic Immune Support Kit, Enhanced Immune Support Kit, and Ultra Immune Support KitExternal Link Disclaimer 
08/07/2020H-Lab Life“Multi-Use Spray” products*
08/06/2020Canadian Chaga“Chaga products” including “124 Chaga Capsules,” “Chaga Tea,” and “Canadian Chaga Tincture”*
08/03/2020MMSTabs.comMMS Products*
07/30/2020Vapore LLC dba MypurmistMypurmist*
07/24/2020CoreMedica Laboratories, Inc.At-home sample collection kit, “COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit”*
07/24/2020Fair Price Labs, Inc.At-home sample collection kit*
07/23/2020AkivaMed Inc.“COVID-19 Antibody Rapid Test Kit”*
07/23/2020Holistic Health International, LLCAt-home stool sample collection kit, “SARS-COV-2 STOOL TEST (SCV)”*
07/21/202021st Century LaserMed Pain Institute d/b/a Create Wellness ClinicsUmbilical cord derived stem cell product, Exosome product, Deluxe Immune Support Bundle” (Immune Support Bundle), “Dr. Phillip Yoo D.C.’s Signature – Emergency II COR-1:9 CV-19 Deluxe Immune Boost Protection Kit,” and “Create Wellness Clinics COVID-19 Coronavirus SARS-CoV-2 Antibody At Home Rapid Telemedicine10 Minute Telemedicine Test Kit With Virtual Consultation” 
07/13/2020Kegan Wellness“She Vitamin C Tablets,” “She+ Tablets,” and “Giloe+ Tablets”*
07/10/2020Health Beauty LoveTincture, “E-Munity”*
07/07/2020Ionogen, LLC“Ionopure Skin & Hands”*
07/06/2020Shen Clinic, LLCTraditional Chinese Medicine (TCM) products, including “SHUANG HUANG LIAN” and “Gan Mao LingExternal Link Disclaimer”*
07/06/2020Lianhuaqingwencaps.comTraditional Chinese medicine (TCM) product, “Lianhua Qingwen”*
07/06/2020Lotus Herbal SupplementsTraditional Chinese medicine (TCM) product, “Lianhua Qingwen Capsules”*
07/06/2020Butterfly Expressions LLCBlessed waters, essential oils, hand sanitizers, homeopathic products, and tinctures*
07/06/2020SinoTradition.comTraditional Chinese medicine (TCM) products, including “Lianhua Qingwen Capsules” and “Qing Fei Pai Du Tang”*
06/30/2020Center for Wellness and Integrative Medicine“COVID Supplement Protection Pack” (also referred to as the “COVID Household Value Pack”), Thymosin-Alpha, and Methylene Blue Capsules*
06/29/2020Epro E-Commerce Limited dba DealExtreme and DX.com“Wondfo Novel Coronavirus (2019-nCoV) Antibody Detection Kit”*
06/26/2020Nuance Health, LLC“Swype ShieldExternal Link Disclaimer”*
06/26/2020SuperHealthGuard and Loyal Great International Ltd.Lianhua Qingwen Capsule*
06/25/2020Curativa Bay CorporationAdvanced Hypochlorous Skin SprayExternal Link Disclaimer*
06/19/2020North Isle Wellness CenterMethylene Blue products, including Blu BlockExternal Link Disclaimer*
06/18/2020Project 1600 Inc.Cannabidiol (CBD) products*
06/17/2020KBMO Diagnostics, LLC“COVID-19 Fingerstick Test KitExternal Link Disclaimer”*
06/17/2020Modern Allergy Management LLC dba Direct Med Solutions LLC“COVID-19 Fingerstick Test Kit”*
06/15/2020antibodiescheck.com“Antibodies Test Kit for Covid19” (aka “Corona Check Kit,” “Antibodies Check Kit,” “Covid-19 IgG/IgM Rapid Test Cassette (WB/S/P),” and “Corona Antibodies Test”*
06/15/2020Sonrisa Family Dental dba http://www.mycovidtest19.com“Cellex Test Kit” and “Leccurate Test Kit”*
06/15/2020Sovereign Laboratories, LLC“PRO Vital C-LD®,” “PRO Colostrum-LD®,” “Vital C-LDTM,” and “Colostrum-LD®” 
06/15/2020FRS International, LLCQuercetin-containing soft chew and liquid concentrate products 
06/10/2020http://www.outoftheboxremedies.comIodine products*
06/10/2020Medakit Ltd“COVID-19 Rapid Test Kit” (aka “COVID-19 IgM/IgG Rapid Test” and “Covid-19 Fast Test Kit”)*
06/08/2020organic-beauty-recipes.comEssential oil products*
06/04/2020EUCYT Laboratories LLCProducts derived from human umbilical cord blood and umbilical cord, VidaCord™, VidaGel™ and VidaStem™; an exosome product, XOsomes™; and an amniotic fluid derived product, VidaFlo™ 
06/01/2020Dr. Sherrill SellmanHealthMax Nano-Silver LiquidExternal Link Disclaimer, Silver Biotics Silver Lozenges with Vitamin C, and Silver Biotics Silver Gel Ultimate Skin & Body Care (collectively, “your silver products”) 
05/28/2020Quadrant Sales & Marketing, Inc.Non-alcohol based hand sanitizer product*
05/28/2020StayWell Copper Products“Germ Stopper” productsExternal Link Disclaimer*
05/26/2020Careful Cents, LLCEssential oil products*
05/26/2020Musthavemom.comColloidal silver, vitamins, minerals, herb oils and a homeopathic drug product*
05/26/2020AlternavitaGrapefruit seed extract, colostrum, and cod liver oil products*
05/26/2020CBD GazeCBD products including Restorative Botanicals Ultra High Strength Hemp Oil Supplement and Serenity Hemp Liquid Dietary Supplement*
05/21/2020Apollo Holding LLC“NoronaPak” products, including cannabidiol (CBD) and other supplement products*
05/21/2020North Coast Biologics“nCoV19 spike protein vaccine” 
05/20/2020Life Unlearned, LLCVitamin D products*
05/19/2020SpiceTacVitamin C product*
05/15/2020Noetic NutraceuticalsCBD products*
05/15/2020The Golden Road KratomKratom products*
05/15/2020Natural Solutions Foundation“Dr. Rima RecommendsTM Nano Silver 10 PPM” productsExternal Link Disclaimer 
05/14/2020White Eagle Native HerbsHerbal products*
05/14/2020benjaminmcevoy.comDietary supplements*
05/11/2020Fusion Health and Vitality LLC“CORE” and “IMMUNE SHOTExternal Link Disclaimer” 
05/11/2020Center for New Medicine/Perfectly Healthy by Connealy MDCamu Camu’s Vitamin CExternal Link Disclaimer, Vitality C, Immunity Kit, Vitamin D3-K2, Liquid Silver, and Power ImmuneExternal Link Disclaimer*
05/08/2020Seanjari Preeti Womb Healing, L.L.C.Honey product, “COVID-19 COUGH SyrupExternal Link Disclaimer”*
05/08/2020Plum Dragon Herbs, Inc.Traditional Chinese medicine (TCM) products*
05/07/2020Sanit Technologies LLC dba DurisanNon-alcohol based hand sanitizer products*
05/07/2020AgroTerra, Ltd. dba Patriot Hemp CompanyCBD productsExternal Link Disclaimer, silver, iodine, medicinal mushroom, vitamin C, selenium, zinc, vitamin D3, astragalus, and elderberry*
05/07/2020WashingtonsLastFrontier.ComEssential oils and dietary supplements*
05/07/2020Chronic Lyme TreatmentsHerbal products, including “COVID-19 Core FormulaExternal Link Disclaimer,” “Immunity BlendExternal Link Disclaimer,” and “Protection BlendExternal Link Disclaimer”*
05/06/2020GlutaGenicViral Protection KitsExternal Link Disclaimer 
05/06/2020Alive By Nature, Inc.“NAD+External Link Disclaimer” and “NMNExternal Link Disclaimer” sublingual gel products*
05/04/2020Honey Colony LLC“Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver, including “Silver Excelsior Serum”*
05/04/2020Dr. Dhole’s Sushanti Homeopathy Clinic“Homeopathic Genus Epidemicus”*
04/27/2020Santiste Labs LLC“DefendTM Patch”*
04/27/2020Hopewell Essential OilsEssential oils and herbal products*
04/23/2020Prefense LLCPrefense Hand Sanitizers*
04/21/2020Copper Touch, LLC“Sani-Bar GK95External Link Disclaimer” and “Sani-Disc GK95DExternal Link Disclaimer”*
04/21/2020DrJockers.com, LLCSuper CExternal Link Disclaimer, Vitamin D/K2, Zinc ChargeExternal Link Disclaimer, and ImmunoStrong Berry Liquid 
04/16/2020Nova Botanix LTD DBA CanaBDCBD products*
04/15/2020The Art Of CureHomeopathic drug products*
04/14/2020Earth Angel OilsEssential oil productsExternal Link Disclaimer*
04/13/2020Gaia Arise Farms Apothecary“True Viral Defense,” also referred to as “Viral Defense Tincture”*
04/13/2020The GBS dba Alpha Arogya India Pvt LtdAyurvedic products (“Alpha 11” and “Alpha 21”) 
04/10/2020Herbs of KedemHerbal products*
04/09/2020Free Speech Systems LLC d.b.a. Infowars.com“Superblue Silver Immune GargleExternal Link Disclaimer,” “SuperSilver Whitening ToothpasteExternal Link Disclaimer,” “SuperSilver Wound Dressing Gel” and “Superblue Fluoride Free ToothpasteExternal Link Disclaimer”*
04/09/2020Earthley Wellness dba Modern Alternative Mama LLCHerbal tinctures and herbal remedy products*
04/08/2020Genesis 2 ChurchMiracle Mineral Solution (MMS) (chlorine dioxide)External Link Disclaimer 
04/08/2020NRP Organics Ltd“Fortify Humic Beverage ConcentrateExternal Link Disclaimer” and “Electrify Fulvic Beverage ConcentrateExternal Link Disclaimer”*
04/07/2020CBD Online StoreCannabidiol (CBD) products*
04/07/2020Savvy Holistic Health dba Holistic Healthy Pet“China Oral Nosode,” also called “China Corona Nosode,” and the “CV Respiratory Kit,” under the description “AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES”*
04/06/2020Ananda, LLC DBA Ananda ApothecaryEssential oil products*
04/06/2020Alternative Health Experts LLC DBA Immunization AlternativesHomeopathic drugs and dietary supplement products 
04/06/2020Cathay Natural, LLCHerbal products including “CoronaDefender Herbal Sachet-S”*
04/06/2020Native Roots HempCannabidiol (CBD) products*
04/06/2020Indigo NaturalsCannabidiol (CBD) products*
04/01/2020Homeomart IndibuyHomeopathic drugs*
04/01/2020Gaia’s Whole Healing Essentials, LLCColloidal silver products*
04/01/2020Health Mastery Systems DBA Pure Plant EssentialsEssential oil products*
03/31/2020Neuro XPFCannabidiol (CBD) products*
03/30/2020Halosense Inc.Salt therapy products*
03/30/2020JRB Enterprise Group Inc. DBA Anti Aging BedColloidal silver products*
03/30/2020Bioactive C60/FullerLifeC60 LLC“FullerLifeC60External Link Disclaimer”*
03/26/2020Corona-cure.comCorona-Cure Coronavirus Infection Prevention Nasal Spray*
03/26/2020CarahealthHerbal products, including “Carahealth Immune” also referred to as “Immune Tonic” 
03/06/2020Xephyr LLC dba N-ergeticsColloidal silver products, including Colloidal Silver 1100 PPMExternal Link Disclaimer 
03/06/2020GuruNanda, LLCEssential oil products*
03/06/2020Quinessence Aromatherapy LtdEssential oil products*
03/06/2020Vivify Holistic ClinicFormula #1External Link Disclaimer, Formula #2External Link Disclaimer, Formula #3External Link Disclaimer, and Eupatorium perfoliatum (Boneset)External Link Disclaimer*
03/06/2020Colloidal Vitality LLCProducts labeled to contain silver*
03/06/2020The Jim Bakker ShowSilver Sol LiquidExternal Link Disclaimer and products labeled to contain silver*
03/06/2020Herbal Amy Inc.Coronavirus ProtocolExternal Link Disclaimer (Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core tincture, Coronavirus Immune System, and Elderberry Tincture)*

WARNING LETTER

Recipient:
Mr. Puneet Nanda
GuruNanda LLC
6645 Caballero Blvd.
Buena Park, CA 90620
United States

contact@gurunanda.com

Issuing Office:
Center for Drug Evaluation and Research | CDER
United States

Date March 6, 2020

TO: contact@gurunanda.com – Mr. Puneet Nanda, GuruNanda, LLC
6645 Caballero Blvd.
Buena Park, CA 9062

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 reviewed your website at the Internet address [www.gurunanda.com] in February 2020. We have also reviewed your social media sites at [www.twitter.com/GuruNandaEO] and [www.facebook.com/gurunandaEO], where you direct consumers to your website [www.gurunda.com] to purchase your essential oil products. The FDA has determined that your website offers essential oil products for sale in the United States and that these products are intended to mitigate, prevent, treat, cure or diagnose COVID-191 in people. FDA has determined that these products are 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 are 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 is prohibited under section 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide as a result of confirmed cases of COVID-19. 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 such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

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

• “Modern drug therapy targets individual genes, with epidemics similar to CoronaVirus that are highly mutated and drug resistant; we need to use therapeutic benefits of essential oils to target the virus itself not just the specific gene type – GuruNanda #coronavirus” from a February 5, 2020 post on your Twitter website [www.twitter.com/GuruNandaEO]

• You link to the webpage “MY PERSONAL ANALYSIS OF ESSENTIAL OILS AGAINST PATHOGENS” on http://www.gurunanda.com with the hashtags “#essentialoils . . . #china #coronavirus . . . #prevention” from a February 5, 2020 post on your Facebook website [www.facebook.com/gurunandaEO]

• “Municipalities of Wuhan have declared that people should use Pure essential oils as a preventative therapy . . . #coronavirus #essentialoils” from a February 5, 2020 post on your Facebook website [www.facebook.com/gurunandaEO]

• “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 your website [www.gurunanda.com]

• “Against Virus Essential oils might interfere with virion envelopment, designed for entry into host cells. Possible mechanisms of actions include the inhibition of virus replication by hindering cellular DNA polymerase and alteration in phenylpropanoid pathways.” from your website [www.gurunanda.com]

• Since the flu is spreading so quickly, we want to give 50% off for the essential oils . . . Simply type “Corona” in the code box to save immediately.” from your website [www.gurunanda.com]

• “Just what is this new Coronavirus, and how can you prevent and/or treat it? After reading this article, you’ll be well equipped and informed to decrease your chances of becoming infected.” from your [website http://www.gurunanda.com]

You should take immediate action to correct the violations cited in this letter. The violations cited in this letter are not meant to be an all-inclusive list. 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 correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter 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 corrective actions 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 complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. 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 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) listed 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.

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. To make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act.

There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19). Thus, the claims cited above are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims. In addition, you are advised to review all claims for your products and immediately cease making claims that are not supported by competent and reliable scientific evidence. 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/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

Sincerely,
/S/
Richard A. Quaresima
Acting Associate Director Division of Advertising Practices
Federal Trade Commission


1 COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified in Wuhan, China.