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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.

Previous Years: 2019 2018 | 2017 | 2016 | 2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007


Letter Issue Date Company Name Issuing Office Subject
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 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 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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