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2020 Warning Letters - Health Fraud

Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. For all FDA Warning Letters, click here.


Letter Issue Date Company Name Issuing Office Subject
12/28/2020 Smarter Nutrition, Inc. Division of Human and Animal Food Operations West V New Drug/Misbranded
12/22/2020 Speedwinds Nutrition, Inc. Division of Human and Animal Food Operations West VI New Drug/Misbranded
12/22/2020 New Leaf Pharmaceuticals, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
12/22/2020 NextL3vel Services Group, LLC dba This Stuff Is Good For You Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
12/22/2020 Wellness BioSciences Rx Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
12/22/2020 G & L Wellness, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
12/22/2020 Bee Delightful Division of Human and Animal Food Operations West III Unapproved New Drugs/Misbranded
12/21/2020 Riverstone LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/21/2020 Sparrow Health & Performance LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/18/2020 Reddy Naturals Division of Human and Animal Food Operations East III New Drug/Misbranded
12/18/2020 Rowpar Pharmeceuticals Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/15/2020 Phoenix Biotechnology, Inc. CDER Office of Compliance Finished Pharmaceuticals/Unapproved new drug
12/10/2020 Prairie Dawn Herbs Division of Human and Animal Food Operations West IV New Drug/Misbranded
12/10/2020 iThrive.health Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/10/2020 Indigenous Products Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/09/2020 Bodyhealth.com, LLC Division of Human and Animal Food Operations East IV New Drug/Misbranded
12/07/2020 Paradigm RE LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/04/2020 Desert Alchemist LLC Division of Human and Animal Food Operations West IV New Drug/Misbranded
12/02/2020 Smoky Mountain Naturals, LLC Division of Human and Animal Food Operations East V New Drug/Misbranded
12/02/2020 Heavenly Natural Products Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/02/2020 Health & Wellness Center International One, L.L.C. dba Hotze Vitamins Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/02/2020 Rat's Army Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
12/01/2020 Mushroom Revival, Inc. Division of Human and Animal Food Operations East I New Drug/Misbranded
11/30/2020 Avazo-Healthcare, LLC Center for Devices and Radiological Health Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/30/2020 Valentus, Inc. Division of Human and Animal Food Operations West I New Drug/Misbranded
11/23/2020 Industry Lab Diagnostic Partners Center for Devices and Radiological Health Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/20/2020 Natures Boost LLC Division of Human and Animal Food Operations West VI New Drug/Misbranded
11/18/2020 Pro Breath MD, LLC dba Dentist Select and OraCare Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/18/2020 Vibrant Health Care, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/18/2020 Red Moon Herbs Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/17/2020 Bonagens Division of Human and Animal Food Operations East III New Drug/Misbranded
11/17/2020 Innovative Medicine LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/17/2020 ChromaDex Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/10/2020 Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/02/2020 NovaBay Pharmaceuticals, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/30/2020 Spartan Enterprises Inc. dba Watershed Wellness Center Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/29/2020 JC Ayur Life LLC Division of Human and Animal Food Operations West V Dietary Supplement/New Drug/Misbranded
10/29/2020 Natural Sprout Co. LLC Division of Human and Animal Food Operations West II New Drug/Misbranded
10/29/2020 Trask and Roth Inc. dba Trask & Roth Research and Manufacturing Center for Devices and Radiological Health Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/28/2020 Eagles Song Health and Wellness LLC Division of Human and Animal Food Operations West VI New Drug/Misbranded
10/27/2020 World Nutrition, Inc. Division of Human and Animal Food Operations West IV New Drug/Misbranded
10/23/2020 Beepothecary LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/23/2020 Peterson Research Laboratories LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/23/2020 Predator Nutrition Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/20/2020 ForYou, Inc. Division of Human and Animal Food Operations East III CGMP/Dietary Supplement/Adulterated/Misbranded
10/16/2020 Immusist, LLC Division of Human and Animal Food Operations West VI New Drug/Misbranded
10/16/2020 For Our Vets LLC dba Patriot Supreme Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/15/2020 LVWellness & Aesthetics Center for Devices and Radiological Health Unapproved, Adulterated, and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
10/09/2020 Before Brands Inc Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
10/09/2020 Prollergy Corporation/Ready Set Food Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded
10/06/2020 Haloderm, Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
10/06/2020 Oneness Labs Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
10/05/2020 Physician 360, Inc. Center for Devices and Radiological Health Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
09/29/2020 Tonic Therapeutic Herb Shop & Elixir Bar Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
09/11/2020 KetoKerri LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
09/09/2020 Pharmacy Plus, Inc. dba Vital Care Compounder Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19
09/01/2020 1 Party At A Time Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/28/2020 Dr. Sam Robbins, Inc. dba HFL Solutions, LLC Division of Human and Animal Food Operations West V New Drug/Misbranded
08/27/2020 Lattice Biologics, Ltd. Center for Biologics Evaluation and Research Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
08/26/2020 Hampshire Labs, Inc. Division of Human and Animal Food Operations West I New Drug/Misbranded
08/25/2020 Renewal Supplements LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
08/25/2020 Nutritional Supplements Corporation Inc Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Misbranded
08/25/2020 Savvy Holistic Health dba Holistic Healthy Pet Center for Veterinary Medicine Unapproved New Animal Drug Products
08/19/2020 Living Senior, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/19/2020 Durazo Medical Biomagnetism Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019
08/18/2020 Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/17/2020 Predictive Biotech Center for Biologics Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/17/2020 PA Green Wellness LLC dba A Predictive Biotech Certified Facility Center for Biologics Evaluation and Research Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/14/2020 SilveryGuy Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/11/2020 Oxford Medical Instruments USA, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/10/2020 Greater Peoria Physical Medicine & Rehabilitation, S.C. d.b.a. Joseph Health Group Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/07/2020 H-Lab Life Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/06/2020 Canadian Chaga Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
08/04/2020 Soluciones Cosmeticas, SA de CV Center for Drug Evaluation and Research | CDER CGMP/Adulterated/Unapproved/Misbranded
08/03/2020 MMSTabs.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/30/2020 Vapore LLC dba Mypurmist Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/24/2020 Fair Price Labs, Inc. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/24/2020 CoreMedica Laboratories, Inc. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/23/2020 AkivaMed Inc. Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/23/2020 Holistic Health International, LLC Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/23/2020 Mind, Body & Coal LLC Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 Purple Biosciences, LLC Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 LES Labs Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 Ebnsol, Inc Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 Happy Hour Vitamins Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 Vita Heaven, LLC dba Hangover Heaven Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 Double Wood LLC Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
07/23/2020 Eskbiochem SA de CV Center for Drug Evaluation and Research | CDER CGMP/Adulterated/Unapproved/Misbranded
07/21/2020 New Life International Center for Veterinary Medicine Unapproved Chloroquine Phosphate Product
07/21/2020 Fishman Chemical of North Carolina, LLC Center for Veterinary Medicine Unapproved New Animal Drug Products
07/21/2020 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics Center for Biologics Evaluation and Research (CBER) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/13/2020 Kegan Wellness Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/10/2020 Health Beauty Love Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/07/2020 Ionogen, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/06/2020 Shen Clinic, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/06/2020 Lianhuaqingwencaps.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/06/2020 Lotus Herbal Supplements Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/06/2020 Butterfly Expressions LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/06/2020 SinoTradition.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/30/2020 Center for Wellness and Integrative Medicine Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/29/2020 Epro E-Commerce Limited dba DealExtreme and DX.com Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/26/2020 SuperHealthGuard and Loyal Great International Ltd. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/26/2020 Nuance Health, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/25/2020 Curativa Bay Corporation Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/19/2020 North Isle Wellness Center Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/18/2020 Only Natural, Inc. dba Bio Nutrition, Inc. Division of Human and Animal Food Operations East I Unapproved New Drugs/Misbranded
06/18/2020 Project 1600 Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/17/2020 Modern Allergy Management LLC dba Direct Med Solutions LLC Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019
06/17/2020 KBMO Diagnostics, LLC Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019
06/11/2020 Hevert Pharmaceuticals LLC USA Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
06/15/2020 Sovereign Laboratories, LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/15/2020 FRS International, LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/15/2020 antibodiescheck.com Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/15/2020 Sonrisa Family Dental dba www.mycovidtest19.com Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/11/2020 World Health Advanced Technologies Ltd Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
06/11/2020 Medinatura Inc Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
06/11/2020 8046255 Canada Inc. DBA Viatrexx Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugs
06/10/2020 ww.outoftheboxremedies.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/10/2020 Medakit Ltd Center for Devices and Radiological Health Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/08/2020 organic-beauty-recipes.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/04/2020 EUCYT Laboratories LLC Office of Biological Products Operations - Division II Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/01/2020 Dr. Sherrill Sellman Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
06/01/2020 Morningstar Minerals LLC Division of Human and Animal Food Operations West IV Unapproved New Drugs/Misbranded
05/28/2020 StayWell Copper Products Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/28/2020 Quadrant Sales & Marketing, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/26/2020 CBD Gaze Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/26/2020 Alternavita Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/26/2020 Musthavemom.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/26/2020 Careful Cents, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/21/2020 NutraCap Labs LLC Division of Human and Animal Food Operations East III CGMP/Dietary Supplement/Adulterated
05/21/2020 North Coast Biologics Center for Biologics Evaluation and Research (CBER) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/21/2020 Apollo Holding LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/19/2020 Life Unlearned, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/19/2020 SpiceTac Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/15/2020 Natural Solutions Foundation Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/15/2020 LifeHealth Science Division of Human and Animal Food Operations East V Unapproved New Drugs/Misbranded
05/15/2020 The Golden Road Kratom Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/15/2020 Noetic Nutraceuticals Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/14/2020 benjaminmcevoy.com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/14/2020 White Eagle Native Herbs Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/11/2020 Center for New Medicine/Perfectly Healthy by Connealy MD Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/11/2020 Fusion Health and Vitality LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/08/2020 Seanjari Preeti Womb Healing, L.L.C. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/08/2020 Plum Dragon Herbs, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/07/2020 New Spirit Naturals Inc. Division of Human and Animal Food Operations West V New Drug/Misbranded
05/07/2020 Chronic Lyme Treatments Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/07/2020 WashingtonsLastFrontier.Com Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/07/2020 AgroTerra, Ltd. dba Patriot Hemp Company Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/07/2020 Sanit Technologies LLC dba Durisan Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/06/2020 Alive By Nature, Inc. Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/06/2020 GlutaGenic Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/04/2020 Dr. Dhole's Sushanti Homeopathy Clinic Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
05/04/2020 Honey Colony LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/28/2020 The Dragontree Apothecary LLC Division of Human and Animal Food Operations West VI Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
04/27/2020 Hopewell Essential Oils Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/27/2020 Santiste Labs LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
04/23/2020 Prefense LLC Center for Drug Evaluation and Research | CDER Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) and Other Diseases
04/23/2020 BIOTA Biosciences LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
04/21/2020 DrJockers.com, LLC Center for Food Safety and Applied Nutrition (CFSAN) Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/21/2020 Copper Touch, LLC Center for Drug Evaluation and Research | CDER Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
04/20/2020 Humaworm Office of Human and Animal Foods Operations East 5 Unapproved New Drugs/Misbranded
04/20/2020 Homero Corp DBA Natures CBD Oil Distribution Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
04/16/2020 Nova Botanix LTD DBA CanaBD Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/16/2020 Global Vitality, Inc. dba Enzyme Process International Division of Human and Animal Food Operations West IV Unapproved New Drugs/Misbranded
04/16/2020 Lose Fat Gain Life M&B Center for Food Safety and Applied Nutrition (CFSAN) Unapproved New Drugs/Misbranded
04/15/2020 The Art Of Cure Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/14/2020 Earth Angel Oils Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/13/2020 The GBS dba Alpha Arogya India Pvt Ltd Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/13/2020 Gaia Arise Farms Apothecary Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/13/2020 JusByJulie.Com LLC Office of Human and Animal Food Operations East Division 1 New Drug/Misbranded
04/10/2020 Herbs of Kedem Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/09/2020 BIOTA Biosciences LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
04/09/2020 Earthley Wellness dba Modern Alternative Mama LLC Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/09/2020 Free Speech Systems LLC d.b.a. Infowars.com Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/08/2020 NRP Organics Ltd Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/08/2020 Genesis 2 Church Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/07/2020 Savvy Holistic Health dba Holistic Healthy Pet Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/07/2020 CBD Online Store Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/06/2020 Alternative Health Experts LLC DBA Immunization Alternatives Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/06/2020 Indigo Naturals Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/06/2020 Ananda, LLC DBA Ananda Apothecary Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/06/2020 Cathay Natural, LLC Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/06/2020 Native Roots Hemp Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/01/2020 Gaia's Whole Healing Essentials, LLC Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/01/2020 Homeomart Indibuy Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
04/01/2020 Health Mastery Systems DBA Pure Plant Essentials Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/31/2020 KetoKerri LLC Center for Food Safety and Applied Nutrition (CFSAN) New Drug/Labeling/Misbranded
03/31/2020 NeuroXPF Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/30/2020 Bioactive C60/FullerLifeC60 LLC Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/30/2020 Halosense Inc. Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/30/2020 JRB Enterprise Group Inc. DBA Anti Aging Bed Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/27/2020
Doctor's Signature Sales and Marketing International Corp. dba Life Force International
Office of Human and Animal Foods Division 5 West New Drug/Misbranded
03/26/2020 Corona-cure.com Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/26/2020 Carahealth Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/20/2020 Images Unlimited Products, d.b.a. Cellect Products & Oglethorpe, Ltd. Division of Human and Animal Food Operations East I Unapproved New Drugs/Misbranded
03/20/2020 Bulletproof 360 Inc Division of Human and Animal Food Operations West VI CGMP/Dietary Supplement/Adulterated/Misbranded
03/06/2020 Quinessence Aromatherapy LTD Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/06/2020 GuruNanda LLC Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/06/2020 Colloidal Vitality LLC/Vital Silver Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/06/2020 Xephyr, LLC dba N-Ergetics Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/06/2020 Vivify Holistic Clinic Center for Drug Evaluation and Research | CDER Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/06/2020 The Jim Bakker Show Center for Food Safety and Applied Nutrition (CFSAN) Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
03/06/2020 Herbal Amy Inc Center for Food Safety and Applied Nutrition (CFSAN) Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)
02/21/2020 Warner Herb Co. Office of Human and Animal Foods Operations-East Unapproved New Drugs/Misbranded
02/18/2020 R-Garden LLC Division of Human and Animal Food Operations West VI CGMP/Dietary Supplement/Adulterated/Misbranded
02/12/2020 Nature Essence Small Molecule Co., LTD Division of Human and Animal Food Operations East V Cosmetics/Adulterated/Misbranded
01/17/2020 GOJO Industries Inc Division of Pharmaceutical Quality Operations III Unapproved New Drugs/Misbranded
01/13/2020 Wave Miami LLC Division of Pharmaceutical Quality Operations I Unapproved New Drugs/Misbranded
*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.

 

 

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