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  1. Health Fraud Scams

Fraudulent Coronavirus Disease 2019 (COVID-19) Products

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.

Report a website that you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics.

Warning Letters

Additional COVID-19 related warning letters can be found on the Agency's Warning Letters webpage.
 
Date Issued Firm Name Product Name and Image1 Corrective Status
03/06/2020 Xephyr LLC dba N-ergetics Colloidal silver products, including Colloidal Silver 1100 PPM  
03/06/2020 GuruNanda, LLC Essential oil products *
03/06/2020 Quinessence Aromatherapy Ltd Essential oil products *
03/06/2020 Vivify Holistic Clinic Formula #1, Formula #2, Formula #3, and Eupatorium perfoliatum (Boneset) *
03/06/2020 Colloidal Vitality LLC Products labeled to contain silver *
03/06/2020 The Jim Bakker Show Silver Sol Liquid and products labeled to contain silver *
03/06/2020 Herbal Amy Inc. Coronavirus Protocol (Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core tincture, Coronavirus Immune System, and Elderberry Tincture) *
03/26/2020 Corona-cure.com Corona-Cure Coronavirus Infection Prevention Nasal Spray *
03/26/2020 Carahealth Herbal products, including "Carahealth Immune" also referred to as "Immune Tonic"  
03/30/2020 Halosense Inc. Salt therapy products *
03/30/2020 JRB Enterprise Group Inc. DBA Anti Aging Bed Colloidal silver products *
03/30/2020 Bioactive C60/FullerLifeC60 LLC "FullerLifeC60" *
03/31/2020 Neuro XPF Cannabidiol (CBD) products *
04/01/2020 Homeomart Indibuy Homeopathic drugs *
04/01/2020 Gaia's Whole Healing Essentials, LLC Colloidal silver products *
04/01/2020 Health Mastery Systems DBA Pure Plant Essentials Essential oil products *
04/06/2020 Ananda, LLC DBA Ananda Apothecary Essential oil products *
04/06/2020 Alternative Health Experts LLC DBA Immunization Alternatives Homeopathic drugs and dietary supplement products  
04/06/2020 Cathay Natural, LLC Herbal products including "CoronaDefender Herbal Sachet-S" *
04/06/2020 Native Roots Hemp Cannabidiol (CBD) products *
04/06/2020 Indigo Naturals Cannabidiol (CBD) products *
04/07/2020 CBD Online Store Cannabidiol (CBD) products *
04/07/2020 Savvy 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” *
04/08/2020 Genesis 2 Church Miracle Mineral Solution (MMS) (chlorine dioxide)  
04/08/2020 NRP Organics Ltd "Fortify Humic Beverage Concentrate” and “Electrify Fulvic Beverage Concentrate” *
04/09/2020 Free Speech Systems LLC d.b.a. Infowars.com “Superblue Silver Immune Gargle,” “SuperSilver Whitening Toothpaste,” “SuperSilver Wound Dressing Gel” and “Superblue Fluoride Free Toothpaste” *
04/09/2020 Earthley Wellness dba Modern Alternative Mama LLC Herbal tinctures and herbal remedy products *
04/10/2020 Herbs of Kedem Herbal products *
04/13/2020 Gaia Arise Farms Apothecary “True Viral Defense,” also referred to as “Viral Defense Tincture” *
04/13/2020 The GBS dba Alpha Arogya India Pvt Ltd Ayurvedic products (“Alpha 11” and “Alpha 21”)  
04/14/2020 Earth Angel Oils Essential oil products *
04/15/2020 The Art Of Cure Homeopathic drug products *
04/16/2020 Nova Botanix LTD DBA CanaBD CBD products *
04/21/2020 Copper Touch, LLC "Sani-Bar GK95” and “Sani-Disc GK95D” *
04/21/2020 DrJockers.com, LLC Super C, Vitamin D/K2, Zinc Charge, and ImmunoStrong Berry Liquid  
04/23/2020 Prefense LLC Prefense Hand Sanitizers *
04/27/2020 Santiste Labs LLC “DefendTM Patch” *
04/27/2020 Hopewell Essential Oils Essential oils and herbal products *
05/04/2020 Honey Colony LLC "Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver, including “Silver Excelsior Serum” *
05/04/2020 Dr. Dhole's Sushanti Homeopathy Clinic “Homeopathic Genus Epidemicus” *
05/06/2020 GlutaGenic Viral Protection Kits  
05/06/2020 Alive By Nature, Inc. “NAD+” and “NMN” sublingual gel products *
05/07/2020 Sanit Technologies LLC dba Durisan Non-alcohol based hand sanitizer products *
05/07/2020 AgroTerra, Ltd. dba Patriot Hemp Company CBD products, silver, iodine, medicinal mushroom, vitamin C, selenium, zinc, vitamin D3, astragalus, and elderberry *
05/07/2020 WashingtonsLastFrontier.Com Essential oils and dietary supplements *
05/07/2020 Chronic Lyme Treatments Herbal products, including "COVID-19 Core Formula," "Immunity Blend," and "Protection Blend" *
05/08/2020 Seanjari Preeti Womb Healing, L.L.C. Honey product, "COVID-19 COUGH Syrup" *
05/08/2020 Plum Dragon Herbs, Inc. Traditional Chinese medicine (TCM) products *
05/11/2020 Fusion Health and Vitality LLC "CORE” and “IMMUNE SHOT”  
05/11/2020 Center for New Medicine/Perfectly Healthy by Connealy MD Camu Camu’s Vitamin C, Vitality C, Immunity Kit, Vitamin D3-K2, Liquid Silver, and Power Immune *
05/14/2020 White Eagle Native Herbs Herbal products *
05/14/2020 benjaminmcevoy.com Dietary supplements *
05/15/2020 Noetic Nutraceuticals CBD products *
05/15/2020 The Golden Road Kratom Kratom products *
05/15/2020 Natural Solutions Foundation "Dr. Rima RecommendsTM Nano Silver 10 PPM” products  
05/19/2020 SpiceTac Vitamin C product *
05/20/2020 Life Unlearned, LLC Vitamin D products *
05/21/2020 Apollo Holding LLC “NoronaPak” products, including cannabidiol (CBD) and other supplement products *
05/21/2020 North Coast Biologics “nCoV19 spike protein vaccine”  
05/26/2020 Careful Cents, LLC Essential oil products *
05/26/2020 Musthavemom.com Colloidal silver, vitamins, minerals, herb oils and a homeopathic drug product *
05/26/2020 Alternavita Grapefruit seed extract, colostrum, and cod liver oil products *
05/26/2020 CBD Gaze CBD products including Restorative Botanicals Ultra High Strength Hemp Oil Supplement and Serenity Hemp Liquid Dietary Supplement *
05/28/2020 Quadrant Sales & Marketing, Inc. Non-alcohol based hand sanitizer product *
05/28/2020 StayWell Copper Products “Germ Stopper” products *
06/01/2020 Dr. Sherrill Sellman HealthMax Nano-Silver Liquid, Silver Biotics Silver Lozenges with Vitamin C, and Silver Biotics Silver Gel Ultimate Skin & Body Care (collectively, “your silver products”)  
06/04/2020 EUCYT Laboratories LLC Products derived from human umbilical cord blood and umbilical cord, VidaCord™, VidaGel™ and VidaStem™; an exosome product, XOsomes™; and an amniotic fluid derived product, VidaFlo™  
06/08/2020 organic-beauty-recipes.com Essential oil products *
06/10/2020 www.outoftheboxremedies.com Iodine products *
06/10/2020 Medakit Ltd "COVID-19 Rapid Test Kit” (aka “COVID-19 IgM/IgG Rapid Test” and “Covid-19 Fast Test Kit”) *
06/15/2020 antibodiescheck.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” *
06/15/2020 Sonrisa Family Dental dba www.mycovidtest19.com “Cellex Test Kit” and “Leccurate Test Kit” *
06/15/2020 Sovereign Laboratories, LLC “PRO Vital C-LD®,” “PRO Colostrum-LD®,” “Vital C-LDTM,” and “Colostrum-LD®”   
06/15/2020 FRS International, LLC Quercetin-containing soft chew and liquid concentrate products  
06/17/2020 KBMO Diagnostics, LLC “COVID-19 Fingerstick Test Kit” *
06/17/2020 Modern Allergy Management LLC dba Direct Med Solutions LLC "COVID-19 Fingerstick Test Kit" *
06/18/2020 Project 1600 Inc. Cannabidiol (CBD) products *
06/19/2020 North Isle Wellness Center Methylene Blue products, including Blu Block *
06/25/2020 Curativa Bay Corporation Advanced Hypochlorous Skin Spray *
06/26/2020 Nuance Health, LLC “Swype Shield” *
06/26/2020 SuperHealthGuard and Loyal Great International Ltd. Lianhua Qingwen Capsule *
06/29/2020 Epro E-Commerce Limited dba DealExtreme and DX.com “Wondfo Novel Coronavirus (2019-nCoV) Antibody Detection Kit” *
06/30/2020 Center for Wellness and Integrative Medicine "COVID Supplement Protection Pack” (also referred to as the “COVID Household Value Pack”), Thymosin-Alpha, and Methylene Blue Capsules *
07/06/2020 Shen Clinic, LLC Traditional Chinese Medicine (TCM) products, including "SHUANG HUANG LIAN" and "Gan Mao Ling" *
07/06/2020 Lianhuaqingwencaps.com Traditional Chinese medicine (TCM) product, “Lianhua Qingwen” *
07/06/2020 Lotus Herbal Supplements Traditional Chinese medicine (TCM) product, “Lianhua Qingwen Capsules” *
07/06/2020 Butterfly Expressions LLC Blessed waters, essential oils, hand sanitizers, homeopathic products, and tinctures *
07/06/2020 SinoTradition.com Traditional Chinese medicine (TCM) products, including "Lianhua Qingwen Capsules" and "Qing Fei Pai Du Tang" *
07/07/2020 Ionogen, LLC “Ionopure Skin & Hands” *
07/10/2020 Health Beauty Love Tincture, “E-Munity" *
07/13/2020 Kegan Wellness “She Vitamin C Tablets,” “She+ Tablets,” and “Giloe+ Tablets” *
07/21/2020 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics2 Umbilical 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” *
07/23/2020 AkivaMed Inc. “COVID-19 Antibody Rapid Test Kit” *
07/23/2020 Holistic Health International, LLC At-home stool sample collection kit, “SARS-COV-2 STOOL TEST (SCV)”  *
07/24/2020 CoreMedica Laboratories, Inc. At-home sample collection kit, “COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit” *
07/24/2020 Fair Price Labs, Inc. At-home sample collection kit *
07/30/2020 Vapore LLC dba Mypurmist Mypurmist  *
08/03/2020 MMSTabs.com MMS Products *
08/06/2020 Canadian Chaga "Chaga products" including "124 Chaga Capsules,” “Chaga Tea,” and “Canadian Chaga Tincture” *
08/07/2020 H-Lab Life “Multi-Use Spray” products *
08/10/2020 Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health Group Basic Immune Support Kit, Enhanced Immune Support Kit, and Ultra Immune Support Kit  
08/11/2020 Oxford Medical Instruments USA, Inc. Salt inhaler products, including "OMI Salt Therapy Pipes" *
08/14/2020 SilveryGuy Colloidal Silver  *
08/17/2020 Predictive Biotech CoreCyteTM  
08/17/2020 PA Green Wellness LLC dba A Predictive Biotech Certified Facility CoreCyte™ *
08/18/2020 Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals “COVID-19 test package” *
08/19/2020 Durazo Medical Biomagnetism  “Biomagnetism Magnetic Therapy DIY Kits”  
08/19/2020 Living Senior, LLC CBD products *
08/27/2020 Lattice Biologics, Ltd. Amniotic fluid product (sometimes referred to as AmnioBoost)  
09/01/2020 1 Party At A Time BetterFly, a niacin containing product *
09/09/2020 Pharmacy Plus, Inc. dba Vital Care Compounder “COVID PACK” and “COVID ‘POSITIVE’ PACK”  *
09/11/2020 KetoKerri 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”  *
09/22/2020 Nephron Pharmaceuticals Corporation ANDA 78202 Budesonide Inhalation Suspension, for inhalation suspension  
09/29/2020 Tonic Therapeutic Herb Shop & Elixir Bar Herbal products *
10/05/2020 Physician 360, Inc. Physician 360 COVID-19 Rapid Test  
10/07/2020 Prairie Dawn Herbs Herbal products *
10/07/2020 Griffo Botanicals Herbal tincture products *
10/15/2020 LVWellness & Aesthetics “COVID-19 ANTIBODY TEST KIT," ViraFend Multi-Virus Defense product *
10/16/2020 For Our Vets LLC dba Patriot Supreme CBD products *
10/23/2020 Beepothecary LLC Bee products, including “Elderberry, Honey & Propolis Syrup,” “BEEbread,” and “BEEHive Delight,”  
10/23/2020 Peterson Research Laboratories LLC "Simple Silver”   
10/23/2020 Predator Nutrition Elixir (labeled to contain oxymatrine, berberine, and ecklonia cava), Salidroside, Unbreakable (labeled to contain BPC-157), Vitamin C + Bioflavonoids & Rosehip, Vitamin D3, and Ashwagandha *
10/29/2020 Trask and Roth Inc. dba Trask & Roth Research and Manufacturing “Lateral Flow Testing Device” *
10/30/2020 Spartan Enterprises Inc. dba Watershed Wellness Center “Dissolve BioActive Silicate,” and products labeled to contain silver *
11/02/2020 NovaBay Pharmaceuticals, Inc.  ANTIMICROBIAL LID & LASH SOLUTION, PURE HYPOCHLOROUS ACID, 0.01%, 20 m   *
11/10/2020 Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary X-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  
11/17/2020 Innovative Medicine LLC “Nadovim”  
11/17/2020 ChromaDex “Tru Niagen products”  
11/18/2020 Pro Breath MD, LLC dba Dentist Select and OraCare “OraCare Health Rinse” and “OraCare Operatory Pre-Rinsing Set” *
11/18/2020 Vibrant Health Care, Inc.  Umbilical cord derived cellular product  *
11/18/2020 Red Moon Herbs American 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 *
11/23/2020 Industry Lab Diagnostic Partners “COVID-19 Testing Kit” *
11/30/2020 Avazo-Healthcare, LLC COVID-19 test kit products and CBD products  
12/02/2020 Rat's Army “VIRUS BIOSHIELD" *
12/02/2020 Health & Wellness Center International One, L.L.C. dba Hotze Vitamins “Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics," “Dr. Hotze’s Kids Immune Pak,” and “Dr. Hotze’s Teen Immune Pak”  
12/02/2020 Heavenly Natural Products C60 (Carbon 60) and colloidal silver products, including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION” *
12/07/2020 Paradigm RE LLC "Thymosin Alpha 1” *
12/10/2020 iThrive.health Vitamins, quercetin, zinc and omega-3 products *
12/10/2020 Indigenous Products Mineral products *
12/18/2020 Rowpar Pharmeceuticals CloSYS Oral Spray, CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths, and CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths products *
12/21/2020 Riverstone LLC “Flu Immune Drops,” “L-Lysine,” “Lysine Extra,” and “Monolaurin” *
12/21/2020 Sparrow Health & Performance LLC Organic 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)  *
01/04/2021 Coco's Holistic Specialties & Apothecary 4-Thieves Florida Tea Concentrate and 4-Thieves Florida Tea Powder *
01/12/2021 AusarHerbs “Corona Destroyer Tea” *
01/12/2021 Allimax Us Allicin capsules, creams, gels, sprays, and liquid products *
01/25/2021 EnMed MicroAnalytics, Inc. “COVID-19 BLOOD SPOT COLLECTION PACKET” and the “SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET” *
01/25/2021 PYRLess Group, LLC dba Dr. Fitt Buffered C Powder, Get Well 2 Day Vit A, Get Well 2 Day Vit D3, Robynzyme, and OMG Cell Protek  
02/16/2021 Dr. Paul's Lab “COVID-Aid Tincture” *
02/18/2021 SafaLab, Inc. The Prevention 12 Pak (also referred to as the Coronavirus Prevention 12 Pak), consists of the products SOUL, CORE, Cellular Detox, Turb-O2, Vitamin C (Anti-Oxidant Assist), Vitamin D3 (Light Assist), Glutathione, Selenium, Zinc, Vitamin A, Melatonin, and Iod Assist (Iodine) *
02/18/2021 B4B Corp. Earth Tea Extra Strength *
02/18/2021 Mercola.com, LLC “Liposomal Vitamin C,” “Liposomal Vitamin D3,” and “Quercetin and Pterostilbene Advanced”  
02/26/2021 Orvic dba Webstore-USA “COVID-19 BLOOD SPOT COLLECTION PACKET” and the “SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET” *
03/01/2021 Ageless Global, LLC “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray”  
03/04/2021 Opgal Optronic Industries Ltd. “Therm-App MD” and “Therm-App MD Pro”  
03/04/2021 Thermavis “Multi-Person Thermal Screening Camera”  
03/04/2021 Thermoteknix System Limited “FevIR Scan 2”  
03/04/2021 Westminster International Ltd “WG 520” and “WG 620”  
03/04/2021 Workswell Group s.r.o. “MEDICAS”  
03/04/2021 CreativeStar Solutions “Artemis TI-CS-T11 Thermal Scanner” and “Artemis Gateway”   
03/04/2021 Omega Engineering Inc. “TI-120GTS”  
03/04/2021 Dubak Electrical Group “DuThermX”  
03/04/2021 Shenzhen Sunell Technology Corporation Bi-Spectrum Fever Screening Network Camera (SN-T5P-F), Temperature Screening Thermographic Network Bullet Camera (SN-F22-B), AI Fever Screening Network Camera With Integrated Blackbody (SN-T5H-P-F), and Fever Screening Body Temperature Measurement Network Camera Accurate ±0.3℃ (SN-T5/F)  
03/04/2021 Omnisense Systems Pte Ltd Sentry MK4  
03/05/2021 CAMA Wellness Center/IodoRios Company, LLC Hand wipe product *
03/12/2021 Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials “AIR PURIFY AROMAMIST,” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST,” and “ROSE FREQUENCY TONGUE TINCTURE” *
03/18/2021 Block Scientific “QUIKPACII COVID-19 ANTIBODY TEST KIT” and the “Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)”  
03/24/2021 Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs “COVID-19 IgM/IgG Rapid Test”  
03/25/2021 Ikcon Investments, Inc dba Ikcon Medical “Akcutest COVID-19 Antibody Test” and the “Lumigenik COVID-19 Antigen Rapid Test”   
04/01/2021 Natural Adventure, LLC Purity Sanitizer with 70% Alcohol and Purity Essential Oil Blend products *
04/06/2021 Sethi Laboratories “Rapid COVID-19 Antibody Self Test Kit” and a “Rapid COVID-19 Antigen Self Test Kit” *
04/07/2021 Allure Imports Silver Soul Immune Support, Silver Soul Body Spray and Vitality C60 *
04/07/2021 About Mineral Puriton topical skin products *
04/13/2021 Trinity Natural Health & Pain Management, Inc. “COVID-19 Formula” *
04/13/2021 Anytime COVID Test LLC “Covid-19 Test Kit”   
04/13/2021 Manhattan Stitching Company, Inc. “KN95 Face Mask”, “3-ply Face Mask”, and “3-Ply Disposable Youth Face Mask”  
05/04/2021 Baltimore Beauty Security Square Mall GenBody COVID-19 Ag test and the GenBody COVID-19 IgM/IgG test *
05/06/2021 Disinfect & Shield DISINFECT™ & SHIELD HAND SANITIZER  
05/06/2021 Covalon Technologies Inc. non-alcohol based hand sanitizer products *
05/19/2021 BGP, LLC “BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug”  
05/24/2021 Beauty & Spa Concepts, DBA Beenefits Brazilian Propolis Extract  
05/24/2021 Everything Health LLC CoronaBox  
05/27/2021 OCLO LLC/OCLO Nanotechnology Science Various chlorine dioxide products, including "OCLO 3000" *
06/07/2021 Amplicon Land, LLC “QuikPacII COVID-19 IgG/IgM Test”  *
06/10/2021 Innova Medical Group, Inc. SARS-CoV-2 Antigen Rapid Qualitative Test  
06/22/2021 Pacific Center of Health/Pacific Center of Health & Acupuncture Immune Builder, High Risk Environment Pack- NO SYMPTOMS, Anti-Viral Herbal Formula, Anti-Viral Herbal Pack – ACUTE ILLINESS, Kitchen Sink, Lung Formula Dry Cough, Lung Formula Wet Cough, Colloidal Silver and Post COVID-19 Recovery products *
07/07/2021 Halodine, LLC Halodine nasal and oral “sanitizer” product lines that include the over-the-counter (OTC) drug products, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse  
07/09/2021 USH Diagnostics, Inc./covidinstanttest.net “Rapid Dual Antibody Test,” “Rapid 10 Minute Antigen Test” and a “Saliva Test Kit” *
07/09/2021 Biopolygen Corp. “COVIGEN AG-1 Covid-19 Self Detection Kit,” the “COVIDEX AB-1 Covid-19 Self Detection Kit,” and the “COVID-19 Antigen and Antibody Combo Set” *
07/20/2021 Jordan’s Crossing Herbal Connections “Germaphobe’s Delight Spray”  
07/26/2021 Vivera Pharmaceuticals, Inc. “COVxRDA Saliva Antigen Test” and a “COVx-RDA Nasal Antigen Test”  
07/26/2021 Vivera Pharmaceuticals, Inc. VIVERA + OMECARE Home Specimen Collection Kit  
07/28/2021 Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. Nitric Oxide Support and Melatonin products *
07/29/2021 Lepu Medical Technology -Beijing- Co., Ltd. Neutralization Antibody Test kit (Colloidal Gold, Fluorescent, Elisa), a SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), and a Saliva Antigen Rapid Test   
08/03/2021 Blue Willow Biologics A non-alcohol-based consumer antiseptic nasal product  
08/10/2021 Secret of the Islands Salt scrub products *
08/19/2021 Mahita, LLC dba PushMyCart “Patanjali Coronil Kit,” “Dr. Reckeweg Arsenic Album Dilution 30 CH,” “SBL Arsenicum Album Dilution 30 CH,” “Kerala Ayurveda Balarishtam,” and “Kottakkal Balarishtam" *
08/24/2021 Invisi Smart Technologies UK LTD "ISM5 Invisi Smart Mask," "ISM5 Invisi Smart Mask (Black Edition)" and "ISM30 Invisi Smart Mask"  
09/03/2021 Databazaar.com “KN95 Mask” *
09/28/2021 Strategia Project Management, Inc. Non-alcohol-based topical antiseptic product, microSURE™   
12/01/2021 DermaCare Biosciences, LTD. Easy Rapid Now COVID-19 Nasal Swab Antigen Test (Colloidal Gold)  
12/29/2021 Varigard, LLC Alcohol-based consumer topical antiseptic products  
01/03/2022 Amcyte Pharma, Inc. Nasitrol *
02/17/2022 Lusys Laboratories, Inc. COVID-19 IgG/IgM Antibody Test and a COVID-19 Viral Antigen Test  
02/22/2022 My Natural Treatment Thyme, black seed, eucalyptus, rosemary and peppermint oil products *
03/07/2022 Viraldine, LLC Non-alcohol-based antiseptic products *
03/10/2022 Soda Pharm “Cold/Flu/COVID Pack,” “Cold and Congestion Loose Leaf Tea,” “Goldenseal Extract,” “Cool Down Loose Leaf Tea,” “Resistance Extract,” “Ache Ease Herbal Drink Syrup,” “Pain Release Extract,” “Headache Blend Extract,” “Vapor Balm,” and the “Mustard Plaster” products  
03/15/2022 Iotech International, LLC “ioRinse” (also referred to as “ioRinse™ RTU”) and “ioCleanse Molecular iodine Hand Cleanser”  
03/24/2022 Applied Biological Laboratories Inc. “Biovanta Dual Action Throat Spray” and “Biovanta Triple Action Lozenges”  
03/25/2022 Iodine Products Inc Liquid Mask Spray Anti-Viral and The COVID-Killer *
03/28/2022 Greenway Herbal Products LLC Cannabidiol (CBD) products *
03/28/2022 UPSY LLC Cannabidiol (CBD) products *
03/28/2022 Functional Remedies, LLC D/B/A Synchronicity Hemp Oil Full-Spectrum Hemp Oil and cannabidiol (CBD) products *
03/28/2022 Nature's Highway Cannabidiol (CBD) products *
03/28/2022 Heaven’s Organic LLC Cannabidiol (CBD) products *
03/28/2022 Cureganics Cannabidiol (CBD) products  
03/28/2022 CBD Social Cannabidiol (CBD) products

 

*
04/05/2022 CofixRx, LLC CofixRX Nasal Spray  
04/06/2022 Sensory Cloud, Inc FEND product  *
04/19/2022 Kleenhanz, LLC Kleenhanz® Towelettes topical antiseptic products  
06/30/2022 W.H.P.M, Inc. First Sign SARS-CoV-2 Antigen Test Kits, First Sign COVID-19 Surveillance Test kit, First Sign SARS-CoV-2 Antigen Test Packs (bulk products), and cobranded COVISURE SARS-CoV-2 Antigen Test Kits  
08/04/2022
FluxxLab LLC
Covid-19 Immune Support Tincture and the CBDA+CBD Oil Tincture products *
09/28/2022 Bespoke Apothecary LLC COVID kit and Post Virus Recovery Herbal Tea  *
10/06/2022 Empowered Diagnostics LLC CovClear COVID-19 Rapid Antigen Tests and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests *
10/24/2022

Lakpura LLC

 Beam Suwa Dharani, Sethsuwa ‘Suwa Dharani’ Immune Enhancing Medicinal Drink, Siddhalepa Lakpeyawa, Siddhalepa Ayurveda Herbal Balm, Siddhalepa Cough Syrup, Siddhalepa Sarshapadi Oil, Siddhalepa Natural Asamodagam Spirit, Siddhalepa Kolaselesma Oil, Siddhalepa Live Long Healthy Pack, and Ceylon Teas *
11/01/2022 Alternative Health Distribution LLC d/b/a CannaAid Cannabidiol (CBD) products *
01/05/2023 PharmaCanna Cannabinoid products, including CBDefense 2000  
01/10/2023 Purecraft LLC Cannabidiol (CBD) products  
01/10/2023 Medical Mikes, Inc. Cannabidiol (CBD) products  

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.
 
1 Product name linked to Flickr image when available.
2 Although the recipient of this letter appears to have addressed the specific violations cited in the Warning Letter, the agency continues to have concerns pertaining to the firm’s marketing of regenerative medicine products.
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