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.

Reporting Unlawful Sales of Medical Products on the Internet

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

Spotlight

• Thai National Charged with Fraudulently Selling Unapproved Chloroquine Phosphate as A Treatment for Covid-19
• Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
• FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
• CDC - Counterfeit Respirators/Misrepresentation of NIOSH-Approval
• CDC - Buyer Beware: How to Avoid Scams, Fraud, & Rumor During an Emergency
• Flickr Album: Fraudulent Coronavirus Disease 2019 (COVID-19) Products

News and Updates

• FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
• Improper Use of Thermal Imaging Devices: FDA Safety Communication
• Health Fraud & COVID-19: What You Need to Know (Podcast)
• FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
• Semana Nacional de Protección al Consumidor: La FDA se mantiene alerta para proteger a los consumidores de las estafas relacionadas con las vacunas contra el COVID-19
• Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
• 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams
• Purported Biotech Executive Charged with Introducing Misbranded Drug into Interstate Commerce for Distribution of "COVID-19 Vaccine"
• Maryland U.S. Attorney’s Office Seizes Two Domain Names Purporting to be Websites of Biotechnology Companies Developing Treatments for Covid-19
• FDA Protects Patients and Consumers from Fraud During COVID-19
• Utah Man Posing as Medical Doctor to Sell Baseless Coronavirus Cure Indicted on Fraud Charges
• Tulare County Man Indicted for Falsely Marketing Herbal Mixtures as FDA-Approved Treatment for COVID-19
• FDA Updates on Hand Sanitizers with Methanol
• FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
• Chinese Manufacturer Charged with Exporting Misbranded and Defective Masks Falsely Purporting to be N95 Respirators
• Federal Court Issues Temporary Restraining Order against Fort Davis Businessman Offering Fraudulent Coronavirus Cures/Treatments
• Federal judge enters temporary injunction against Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal Silver Products for COVID-19
• FDA Continues to Combat Fraudulent COVID-19 Medical Products
• Former Naturopath Charged Criminally for Trafficking in Misbranded Drugs Claiming They Could Prevent COVID-19
• Court Orders Halt to Sale of Silver Product Fraudulently Touted as COVID-19 Cure
• Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment
• Federal judge enters emergency injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
• Carmel Valley Physician Charged with Fraud for Selling Purported COVID-19 “Miracle Cure”
• FDA Warns Company Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19 
• U.K. National Charged with Shipping Mislabeled and Unapproved ‘Treatments’ for Patients Suffering from COVID-19
• Consumer Update: Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
• FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
• FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

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.